Full Federal Circuit Continues 101 Spin on Driveshaft Eligibility
| August 14, 2020
American Axle & Manufacturing v. Neapco Holdings – Part II
July 31, 2020
Opinion by: Dyke, Moore and Taranto
Dissent by: Moore
Summary:
A 6-6 split vote for en banc rehearing dooms clarification on the patent eligibility of a driveshaft manufacturing method by the full Federal Circuit. The petition for rehearing en banc for this case engendered 6 amici curiae briefs. The denial of en banc rehearing triggered 2 concurrences and 4 dissenting opinions.
Nevertheless, a new modified panel decision is issued, with different results than the first panel decision. While the first panel decision found representative claims 1 and 22 ineligible under 35 U.S.C. §101, this second panel decision still found claim 22 ineligible for essentially the same reasons as before, but remanded claim 1. Like the first panel decision, this new panel decision also includes a strong dissent by Judge Moore.
The conflicting positions of a split Federal Circuit in this case highlight the turmoil in current 101 jurisprudence.
Procedural History:
American Axle & Manufacturing, Inc. (AAM) sued Neapco Holdings, LLC (Neapco) for infringement of U.S. Patent 7,774,911 (the ‘911 patent) on a method of manufacturing driveline propeller shafts for automotive vehicles. On appeal, the Federal Circuit upheld the District Court of Delaware’s holding of invalidity under 35 U.S.C. §101 in the first panel decision issued October 3, 2019 (hereinafter, AAM I). A combined petition for panel rehearing and for en banc rehearing was filed. A modified, precedential, panel decision was issued on July 31, 2020 in response to the petition for panel rehearing (hereinafter, AAM II) – affirming the ineligibility of claim 22, its dependent claims and claim 36, but remanding claim 1 and its dependent claims to the district court. The petition for en banc rehearing was denied.
Background:
The ‘911 patent relates to a method for manufacturing driveline propeller shafts (“propshafts” that transmit power in a driveline) with liners that attenuate vibrations transmitted through a shaft assembly. During use, propshafts experience three types of vibration: bending mode vibration, torsion mode vibration, and shell mode vibration, each involving different frequencies. To attenuate the noise accompanying such vibration, various conventional methods using weights, dampers, and liners are inserted to frictionally engage the propshaft to dampen certain vibrations. However, such conventional dampening methods were designed to individually attenuate each of the three types of vibration. According to AAM, the ‘911 patent seeks to attenuate two vibration modes simultaneously, which the prior art did not do.
The CAFC focused on independent claims 1 and 22 as being “representative” claims:
| Claim 1 | Claim 22 |
| 1. A method for manufacturing a shaft assembly of a driveline system, the driveline system further including a first driveline component and a second driveline component, the shaft assembly being adapted to transmit torque between the first driveline component and the second driveline component, the method comprising: providing a hollow shaft member; tuning at least one liner to attenuate at least two types of vibration transmitted through the shaft member; and positioning the at least one liner within the shaft member such that the at least one liner is configured to damp shell mode vibrations in the shaft member by an amount that is greater than or equal to about 2%, and the at least one liner is also configured to damp bending mode vibrations in the shaft member, the at least one liner being tuned to within about ±20% of a bending mode natural frequency of the shaft assembly as installed in the driveline system. | 22. A method for manufacturing a shaft assembly of a driveline system, the driveline system further including a first driveline component and a second driveline component, the shaft assembly being adapted to transmit torque between the first driveline component and the second driveline component, the method comprising: providing a hollow shaft member; tuning a mass and a stiffness of at least one liner, and inserting the at least one liner into the shaft member; wherein the at least one liner is a tuned resistive absorber for attenuating shell mode vibrations and wherein the at least one liner is a tuned reactive absorber for attenuating bending mode vibrations. |
The district court construed claim 1’s “tuning at least one liner to attenuate at least two types of vibration transmitted through the shaft member” to mean “controlling characteristics of at least one liner to configure the liner to match a relevant frequency or frequencies to reduce at least two types of vibration transmitted through the shaft member” (emphasis in original). Claim 22’s “tuning a mass and a stiffness of at least one liner” was construed to mean “controlling the mass and stiffness of at least one liner to configure the liner to match the relevant frequency or frequencies.” Notably, the above claim interpretation for claim 1 was not mentioned in AAM I, and the district court made no distinction between claims 1 and 22 in its decision.
AAM II Panel Decision:
Claim 22
With regard to claim 22, the §101 analysis is essentially the same between AAM I and AAM II.
Under the Mayo/Alice step 1, claim 22 was deemed “directed to” Hooke’s law, mathematically relating mass and stiffness of an object to the frequency with which that object vibrates. Claim 22 merely recites “tuning a mass and a stiffness of at least one liner,” without any particular physical structures or steps for tuning. “[C]laim 22 here does not specify how target frequencies are determined or how, using that information, liners are tuned to attenuate two different vibration modes simultaneously, or how such liners are tuned to dampen bending mode vibrations.” As such, claim 22 is merely claiming a desired result (tuning a liner), without limitation to any particular structures or ways to achieve it. AAM II concludes, “[t]his holding as to step 1 of Alice extends only where, as here, a claim on its face clearly invokes a natural law, and nothing more, to achieve a claimed result.”
Notably absent from AAM II’s Alice step 1 analysis is the majority’s earlier reference in AAM I to Hooke’s law “and possibly other natural laws” in describing what natural law claim 22 is directed to.
Under the Mayo/Alice step 2, claim 22 does not recite an “inventive concept” to transform it into patent eligible subject matter. The majority summarizes AAM’s argument for an inventive concept to be merely a restatement of the desired results (tuned liners that dampen two different vibration modes simultaneously) being an advance. However, an ineligible concept cannot supply the inventive concept. And the remaining steps in claim 22 are merely conventional pre- and post-solution activity.
Claim 1
With regard to claim 1, the majority focused on three differences from claim 22.
One difference is that claim 1’s feature of “tuning at least one liner to attenuate at least two types of vibration transmitted through the shaft member” was construed by the district court to mean “controlling characteristics of at least one liner to configure the liner to match a relevant frequency or frequencies to reduce at least two types of vibration transmitted through the shaft member” (emphasis in original). Claim 22 did not require “controlling characteristics…”
Second, such “characteristics” are described in the specification to include variables other than mass and stiffness, including length and outer diameter of the liner 204, diameter and wall thickness of a structural portion 300 and the material thereof, quantity of resilient member(s) 302 and the material thereof, a helix angle 330 and pitch 332 with which resilient members 302 are fixed to the structural portion 300, the configuration of lip member(s) 322 of the resilient member 302, and the location of the liners 204 within the shaft member 200. Claim 22 did not go beyond tuning involving mass and stiffness.
Third, claim 1 requires “positioning the at least one liner.” The majority considered claim 22’s “inserting the at least one liner into the shaft member” as not being equivalent to claim 1’s “positioning” feature, without explanation. On this point, J. Moore, noted in the dissent, that this is improper sua sponte appellate claim construction which neither parties briefed nor argued. J. Moore argued claim 22’s ineligibility should not have been premised on such unsupported sua sponte claim construction.
Because of these differences, the majority held that claim 1 is not merely directed to Hooke’s law “and nothing more.” “The mere fact that any embodiment practicing claim 1 necessarily involves usage of one or more natural laws is by itself insufficient to conclude the claim is directed to such natural laws.”
But, this doesn’t mean that claim 1 is eligible. The majority notes that the district court and Neapco also raised ineligibility based on the judicial exception for an abstract idea. “But the abstract idea basis was not adequately presented and litigated in the district court.” Thus, the majority remanded the claim 1 and its dependent claims to the district court to address this abstract idea issue in the first instance.
J. Moore’s Dissent:
Like in AAM I, J. Moore’s dissent in AAM II is likewise stinging. “The majority’s decision expands §101 well beyond its statutory gate-keeping function and collapses the Alice/Mayo two-part test to a single step – claims are now ineligible if their performance would involve application of a natural law.”
- A new “Nothing More test”
J. Moore asserts that the majority created a new test, a “Nothing More test” – “when claims are directed to a natural law despite no natural law being recited in the claims.” According to the majority, claim 22’s “tuning” feature meant “controlling the mass and stiffness of at least one liner to configure the liner to match the relevant frequency or frequencies” and “[t]hus, claim 22 requires use of a natural law of relating frequency to mass and stiffness – i.e., Hooke’s law.” However, J. Moore notes that “[e]very mechanical invention requires use and application of the laws of physics. It cannot suffice to hold a claim directed to a natural law simply because compliance with a natural law is required to practice the method.”
“Section 101 is monstrous enough, it cannot be that use of an unclaimed natural law in the performance of an industrial process is sufficient to hold the claims directed to that natural law.” “All physical methods must comply with, and apply, the laws of physics and the laws of thermodynamics…[t]he fact that they do does not mean the claims are directed to all such laws.” “This case turns the gatekeeper into a barricade. Unstated natural laws lurk in the operation of every claimed invention. Given the majority’s application of its new test, most patent claims will now be open to a §101 challenge for being directed to a natural law or phenomena.”
The majority’s counterpoint: “If patentees could avoid the natural law exception by failing to recite the law itself [like here – no mention of ‘Hooke’s law’, but varying frequency attenuation (tuning) based on mass and stiffness is on its face Hooke’s law], patent eligibility would depend upon the ‘draftsman’s art,’ the very approach that Mayo rejected.”
However, avoiding the “draftsman’s art” is not the primary focus of §101. Instead, it is on preemption. That is why claims may be patent eligible under §101 if the “claimed advance” reflects an improvement in technology. As J. Moore also noted, “[t]he claims at issue contain a specific, concrete solution (inserting a liner inside a propshaft) to a problem (vibrations in propshafts).” The ‘911 claims are directed to the traditional manufacturing of a drive shaft assembly for a car, which have historically avoided any concern under §101. On this point, see also J. Stoll’s dissent on the denial of en banc rehearing below.
Another problem with the majority’s new “Nothing More test” is that it arguably requires appellate judges to “resolve questions of science de novo on appeal.” J. Moore raises a concern about appellate judges making determinations of scientific fact on appeal, in the first instance, as a matter law. Nothing in the intrinsic record (nothing in the patent and nothing in the prosecution history) mentions Hooke’s law. So, “how can we conclude, as a matter of law, the claim nonetheless clearly invokes Hooke’s law?” To J. Moore, “judges are not fact or technical experts…[t]he only appropriate fact finder is the district court and not on summary judgment.”
Indeed, during litigation both sides’ experts and the district court noted that the claims involve Hooke’s law and friction damping. Yet, the majority concludes that the natural law used is Hooke’s law “and nothing more.” The majority’s counterpoint is that even “[i]f claim 22’s language could be properly interpreted in a way such that it invokes friction damping as it does with Hooke’s law, the claims would still on its face clearly invoke natural laws, and nothing more, to achieve a claimed result.”
“A disturbing amount of confusion will surely be caused by this opinion, which stands for the proposition that claims can be ineligible as directed to a natural law even though no actual natural law is articulated in the claim or even the specification. The majority holds that claims are directed to a natural law if performance of the claimed method would use the natural law.”
- Failure to consider unconventional claim elements under Mayo/Alice step 2
Under the Mayo/Alice step 2 analysis, while the majority asserts that “[w]hat is missing is any physical structure or steps for achieving the claimed result,” J. Moore notes that AAM’s arguments identified “many” inventive concepts that should have at least precluded summary judgment. For instance, AAM argued that liners (a physical and explicitly recited claim element) were never before used to reduce bending mode vibrations. Instead of addressing all the inventive concepts laid out by AAM, “the majority creates its own strawman to knock down” (i.e., sophisticated FEA software and computer modeling that are not claimed).
- Enablement on Steroids
“[T]he majority has imbued §101 with a new superpower – enablement on steroids.” “The majority’s concern is not preemption of a natural law (which should be the focus), but rather that the claims do not teach a skilled artisan how to tune a liner without trial and error. The majority’s blended 101/112 defense is confusing, converts fact questions into legal ones and eliminates the knowledge of a skilled artisan.”
Of course, the majority clarified that there is a “how to” 1 and a “how to” 2. The “how to” 1 is a requirement under 101 that “the claim itself (whether by its own words or by statutory incorporation of specification details under section 112(f)) must go beyond stating a functional result: it must identify ‘how’ that functional result is achieved by limiting the claim scope to structures specified at some level of concreteness, in the case of a product claim, or to concrete action, in the case of a method claim.” The “how to” 2 is a different requirement that applies to the specification under §112, not to the claim. But, see, J. Stoll’s dissent below. At what level of specificity is sufficient to pass muster under the majority’s “how to” 1? How is this to be determined, absent any input by a skilled artisan? Doesn’t this “how to” inquiry involve questions of fact which should not be determined de novo as a matter of law by appellate judges?
Concurring and Dissenting Opinions on the Denial of en banc Rehearing:
J. Dyk’s concurrence argues that this modified panel decision is consistent with precedent and that there was no “new” test.
J. Chen’s concurrence also states that the panel majority’s decision is consistent with long-standing precedent, and there was no new patent-eligibility test. And, “[a]s evidenced by the majority opinion’s conclusion that claim 1 is not directed to a natural law, the narrow holding of this case should not be read to open the door to eligibility challenges based on the argument that a claim is directed to one or more unspecified natural laws.” J. Chen also disagrees about 101 being enablement on steroids, “result-oriented claim drafting raises concerns under section 101 independent from section 112.” “The lesson to patent drafters should now be clear: while not all functional claiming is the same, simply reciting a functional result at the point of novelty poses serious risks under section 101.”
J. Newman’s dissent stated “[t]he court’s new spin on Section 101 holds that when technological advance is claimed too broadly, and the claims draw on scientific principles, the subject matter is barred ‘at the threshold’ from access to patenting.” This is contrary to the warning in Alice to be careful to avoid oversimplifying the claims because ‘[a]t some level, ‘all inventions…embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.’” “The court’s notion that the presence of a scientific explanation of an invention removes novel and non-obvious technological advance from access to the patent system, has moved the system of patents from its once-reliable incentive to innovation and commerce, to a litigation gamble.”
J. Stoll’s dissent makes notable challenges to the majority’s “how to” analysis in §101’s directed to inquiry:
“Even assuming that claim 22 applies Hooke’s law (or any other unnamed law of nature), the claim seems sufficiently specific to qualify as an eligible application of that natural law. The claim identifies specific variables to tune, including ‘a mass and a stiffness of at least one liner.’ It requires that the tuned liner attenuate specific types of vibration, including ‘shell mode vibrations’ and ‘bending mode vibrations,’ and further requires that the tuned liner is inserted in a ‘hollow shaft member.’ With this level of specificity, claim 22 appears to be properly directed to ‘the application of the law of nature to a new and useful end,’ not to the law of nature itself. Yet this level of detail is insufficient in the majority’s view, and it remains unclear how much more ‘how to’ would have been sufficient to render the claim eligible under the majority’s approach.” (citations omitted).
J. Stoll also remarked, “[i]n my view, the result in this case suggests that this court has strayed too far from the preemption concerns that motivate the judicial exception to patent eligibility.”
J. O’Malley’s dissent identifies at least three problems in the majority opinion: “(1) it announces a new test for patentable subject matter at the eleventh hour and without adequate briefing; (2) rather than remand to the district court to decide the issue in the first instance, it applies the new test itself; and (3) it sua sponte construes previously undisputed terms in a goal-oriented effort to distinguish claims and render them patent ineligible, or effectively so.”
Takeaways:
- Even in traditionally eligible industrial and mechanical inventions, potential §101 issues may now be raised depending on the scope of the functional claiming being used, especially if result-oriented. J. Stoll expressed legitimate concerns about the practical effect of this modified panel decision, “[a]lthough the majority has dialed back its original decision to some degree on panel rehearing, one can still reasonably ponder whether foundational inventions like the telegraph, telephone, light bulb, and airplane – all of which employ laws of nature – would have been ineligible for patenting under the majority’s revised approach.”
- But, don’t give up. Whether defending a patent or challenging a patent on §101, the Federal Circuit is clearly split on various issues under 101. Unfortunately, §101 jurisprudence is, as J. Newman remarked, becoming a “litigation gamble.” Nevertheless, depending on who is on your panel, you may get a favorable decision. Only the Supreme Court or Congress can come to the rescue of §101.
- This case is a reminder that claim construction can change the result of the 101 determination.
- As J. Chen noted, functional, result-oriented, claiming, especially at the point of novelty, may trigger serious 101 issues, even in mechanical cases that, until now, were mostly immune to §101 attack.
- Try to include a “kitchen sink” claim. The specificity provided may help overcome such 101 issues.
- Perhaps AAM never expected such results for its independent claims. But, another lesson learned from this case is to try to preserve arguments based on the dependent claims and challenge the characterization of the “representative” claim if possible.
The CAFC’s Holding that Claims are Directed to a Natural Law of Vibration and, thus, Ineligible Highlights the Shaky Nature of 35 U.S.C. 101 Evaluations
| November 1, 2019
American Axle & Manufacturing, Inc. v. Neapco Holdings, LLC
October 9, 2019
Opinion by: Dyke, Moore and Taranto (October 3, 2019).
Dissent by: Moore.
Summary:
American Axle & Manufacturing, Inc. (AAM) sued Neapco Holdings, LLC (Neapco) for alleged infringement of U.S. Patent 7,774,911 for a method of manufacturing driveline propeller shafts for automotive vehicles. On appeal, the Federal Circuit upheld the District Court of Delaware’s holding of invalidity under 35 U.S.C. 101. The Federal Circuit explained that the claims of the patent were directed to the desired “result” to be achieved and not to the “means” for achieving the desired result, and, thus, held that the claims failed to recite a practical way of applying underlying natural law (e.g., Hooke’s law related to vibration and damping), but were instead drafted in a results-oriented manner that improperly amounted to encompassing the natural law.
Details:
- Background
The case relates to U.S. Patent 7,774,911 of American Axle & Manufacturing, Inc. (AAM) which relates to a method for manufacturing driveline propeller shafts (“propshafts”) with liners that are designed to attenuate vibrations transmitted through a shaft assembly. Propshafts are employed in automotive vehicles to transmit rotary power in a driveline. During use, propshafts are subject to excitation or vibration sources that can cause them to vibrate in three modes: bending mode, torsion mode, and shell mode.
The CAFC focused on independent claims 1 and 22 as being “representative” claims, noting that AAM “did not argue before the district court that the dependent claims change the outcome of the eligibility analysis.”
| Claim 1 | Claim 22 |
| 1. A method for manufacturing a shaft assembly of a driveline system, the driveline system further including a first driveline component and a second driveline component, the shaft assembly being adapted to transmit torque between the first driveline component and the second driveline component, the method comprising: providing a hollow shaft member; tuning at least one liner to attenuate at least two types of vibration transmitted through the shaft member; and positioning the at least one liner within the shaft member such that the at least one liner is configured to damp shell mode vibrations in the shaft member by an amount that is greater than or equal to about 2%, and the at least one liner is also configured to damp bending mode vibrations in the shaft member, the at least one liner being tuned to within about ±20% of a bending mode natural frequency of the shaft assembly as installed in the driveline system. | 22. A method for manufacturing a shaft assembly of a driveline system, the driveline system further including a first driveline component and a second driveline component, the shaft assembly being adapted to transmit torque between the first driveline component and the second driveline component, the method comprising: providing a hollow shaft member; tuning a mass and a stiffness of at least one liner, and inserting the at least one liner into the shaft member; wherein the at least one liner is a tuned resistive absorber for attenuating shell mode vibrations and wherein the at least one liner is a tuned reactive absorber for attenuating bending mode vibrations. |
As explained by the CAFC, “[i]t was known in the prior art to alter the mass and stiffness of liners to alter their frequencies to produce dampening,” and “[a]ccording to the ’911 patent’s specification, prior art liners, weights, and dampers that were designed to individually attenuate each of the three propshaft vibration modes — bending, shell, and torsion — already existed.” The court further explained that in the ‘911 patent “these prior art damping methods were assertedly not suitable for attenuating two vibration modes simultaneously,” i.e., “shell mode vibration [and] bending mode vibration,” but “[n]either the claims nor the specification [of the ‘911 patent] describes how to achieve such tuning.”
The District Court concluded that the claims were directed to laws of nature: Hooke’s law and friction damping. And, the District Court held that the claims were ineligible under 35 U.S.C. 101. AAM appealed.
- The CAFC’s Decision
Under 35 U.S.C. 101, “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof” may be eligible to obtain a patent, with the exception long recognized by the Supreme Court that “laws of nature, natural phenomena, and abstract ideas are not patentable.”
Under the Supreme Court’s Mayo and Alice test, a 101 analysis follows a two-step process. First, the court asks whether the claims are directed to a law of nature, natural phenomenon, or abstract idea. Second, if the claims are so directed, the court asks whether the claims embody some “inventive concept” – i.e., “whether the claims contain an element or combination of elements that is sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.”
At step-one, the CAFC explained that to determine what the claims are directed to, the court focuses on the “claimed advance.” In that regard, the CAFC noted that the ‘911 patent discloses a method of manufacturing a driveline propshaft containing a liner designed such that its frequencies attenuate two modes of vibration simultaneously. The CAFC also noted that AAM “agrees that the selection of frequencies for the liners to damp the vibrations of the propshaft at least in part involves an application of Hooke’s law, which is a natural law that mathematically relates mass and/or stiffness of an object to the frequency that it vibrates. However, the CAFC also noted that “[a]t the same time, the patent claims do not describe a specific method for applying Hooke’s law in this context.”
The CAFC also noted that “even the patent specification recites only a nonexclusive list of variables that can be altered to change the frequencies,” but the CAFC emphasized that “the claims do not instruct how the variables would need to be changed to produce the multiple frequencies required to achieve a dual-damping result, or to tune a liner to dampen bending mode vibrations.”
The CAFC explained that “the claims general instruction to tune a liner amounts to no more than a directive to use one’s knowledge of Hooke’s law, and possibly other natural laws, to engage in an ad hoc trial-and-error process … until a desired result is achieved.”
The CAFC explained that the “distinction between results and means is fundamental to the step 1 eligibility analysis, including law-of-nature cases.” The court emphasized that “claims failed to recite a practical way of applying an underlying idea and instead were drafted in such a results-oriented way that they amounted to encompassing the [natural law] no matter how implemented.
At step-two, the CAFC stated that “nothing in the claims qualifies as an ‘inventive concept’ to transform the claims into patent eligible matter.” The CAFC explained that “this direction to engage in a conventional, unbounded trial-and-error process does not make a patent eligible invention, even if the desired result … would be new and unconventional.” As the claims “describe a desired result but do not instruct how the liner is tuned to accomplish that result,” the CAFC affirmed that the claims are not eligible under step two.
NOTE: In response to Judge Moore’s dissent, the CAFC explained that the dissent “suggests that the failure of the claims to designate how to achieve the desired result is exclusively an issue of enablement.” However, the CAFC expressed that “section 101 serves a different function than enablement” and asserted that “to shift the patent-eligibility inquiry entirely to later statutory sections risks creating greater legal uncertainty, while assuming that those sections can do work that they are not equipped to do.”
- Judge Moore’s Dissent
Judge Moore strongly dissented against the majority’s opinion. Judge Moore argued, for example, that:
- “The majority’s decision expands § 101 well beyond its statutory gate-keeping function and the role of this appellate court well beyond its authority.”
- “The majority’s concern with the claims at issue has nothing to do with a natural law and its preemption and everything to do with concern that the claims are not enabled. Respectfully, there is a clear and explicit statutory section for enablement, § 112. We cannot convert § 101 into a panacea for every concern we have over an invention’s patentability.”
- “Section 101 is monstrous enough, it cannot be that now you need not even identify the precise natural law which the claims are purportedly directed to.” “The majority holds that they are directed to some unarticulated number of possible natural laws apparently smushed together and thus ineligible under § 101.”
- “The majority’s validity goulash is troubling and inconsistent with the patent statute and precedent. The majority worries about result-oriented claiming; I am worried about result-oriented judicial action.”
Takeaways:
- When drafting claims, be mindful to avoid drafting a “result-oriented” claim that merely recites a desired “result” of a natural law or natural phenomenon without including specific steps or details setting establishing “how” the results are achieved.
- When drafting claims, be mindful that although under 35 U.S.C. 112 supportive details satisfying enablement are only required to be within the written specification, under 35 U.S.C. 101 supportive details satisfying eligibility must be within the claims themselves.
Patent eligible Laboratory methods
| July 13, 2016
Rapid Litigation Management Ltd. v. CellzDirect, Inc.
July 5, 2016
Before Prost, Moore and Stoll. Opinion by Prost.
Summary
Patented claims at issue were directed to a method of producing a desired preparation of hepatocytes (liver cells) useful for laboratory tests such as drug safety tests. The claimed process was invented based on the discovery that liver cells are capable of surviving multiple freeze-thaw cycles, which provides desired pool samples of hepatocytes from multiple donners. The district court held that the claims were invalid under 35 U.S.C. §101. CAFC vacated the decision, holding that the claimed process is not directed to a patent-ineligible concept.
ドラッグテスト等に有用な肝細胞プールを調製する方法を記載した特許クレームが、101条の特許対象要件を満たすか否かを争われたケースである。従来は、肝細胞の冷凍保存は1回が限度であると認識されていた（一度解凍したら使い捨てとなる）。しかし、本件発明者は肝細胞を複数回冷凍保存しても使用できることを発見し、少なくとも2回の冷凍－解凍の工程を記した方法に特許を受けた。複数回の冷凍-解凍を繰り返せること利用して、異なるドナーからの肝細胞プールを無駄なく適宜に調製できるという利点がある。
近年最高裁判決の下、自然法則または自然現象を優位に超える特徴をクレームに記載しなければ特許対象にはならない。地裁は肝細胞が冷凍保存可能であることはその細胞の自然能力の発揮にすぎず、本特許の方法は自然法則の利用を優位に超える特徴を記載していないとして同特許を無効にした。高裁はその地裁判決を破棄し、従来の知見反して肝細胞の冷凍を2回以上繰り返す工程を記載した本特許の方法は従来の方法にはない利点があるから特許可能対象であると判示した。複数回の冷凍保存を行うことができるという科学的発見に基づくシンプルな発明コンセプトであるが、新規で有用な結果をもたらす方法は特許対象になりえることが示された。このケースは発見を利用する発明を新規な「方法」として記載することで特許対象になり得ることを示しているが、その肝細胞を「プロダクト」としてクレームした場合は自然物の寄せ集めであり特許対象になりえないことも示唆された（Funk Bros判決参照）。一方で、101条の特許対象要件の判断において従来技術との対比が重要な意味を持ち得ることを示した判決でもある。
Tags: laboratory technique > law of nature > method claims > patent eligibility
Fractured CAFC panel again affirms patent eligibility of isolated DNA, and applies Mayo
| August 21, 2012
Association for Molecular Pathology et al. v. U.S.P.T.O. et al.
August 16, 2012
Panel: Lourie, Bryson and Moore. Majority opinion by Lourie, concurrence by Moore, dissent by Bryson.
Less than a month after hearing oral arguments, the CAFC panel of Judges Lourie, Bryson and Moore last week issued an updated decision in the controversial AMP v. USPTO (Myriad genetics) case. The CAFC reached the same conclusion as they did last year: (1) the Plaintiffs do have standing, (2) the isolated DNA and cDNA claims are patent eligible, (3) the “analyzing” and “comparing” method claims are not patent eligible and (4) the screening method claim is patent eligible.
As with the decision last year, the panel reached a unanimous conclusion with respect to the issues of standing, subject matter eligibility of the cDNA claims, and subject matter eligibility of the method claims. However, the panel reached different conclusions with respect to the composition claims which recite isolated DNA. Since the opinions of the Court are very similar to the opinions issued in 2011, this article will focus on the Judges’ views with respect to the impact of Mayo v. Prometheus (English summary; Japanese summary) on the claims in question, and particularly with respect to the isolated DNA claims.
Tags: §101 > bilski > biotech > cDNA > DNA > law of nature > Myriad > patent eligible subject matter > Supreme Court
Summary of Oral Arguments in AMP v. USPTO remand
| July 20, 2012
July 20, 2012
In the immortal words of baseball great Yogi Berra, “It’s déjà vu all over again”. A little more than a year after they previously heard AMP v. USPTO, the CAFC panel of Judges Lourie, Bryson and Moore have once again taken up the question of whether isolated DNA and related methods are patent eligible subject matter under 35 U.S.C. §101.
Tags: §101 > bilski > biotech > diagnostics > DNA > law of nature > Mayo > Myriad > patent eligible subject matter
USPTO issues Interim Procedure for §101 examination after Prometheus v. Mayo
| July 3, 2012
Since the Supreme Court issued their decision in Mayo v. Prometheus (English discussion here; Japanese discussion here), rejections of claims based on failure to comply patent-eligible subject matter requirements of §101 seem to be on the rise. Until now, Examiners had been given only very little guidance (see here), resulting in Mayo being cited inconsistently. However, today, the USPTO has provided Examiners with additional guidance about how to handle this issue. Please click below for more information:
These guidelines should improve consistency of the manner in which Mayo and related cases are relied upon by the Examining Corps, as well as provide practitioners with a basic framework for responding to such rejections.
Keep in mind that as the CAFC (and perhaps the Supreme Court, eventually) continues to address this issue in other pending cases such as Myriad and Ultramercial, these guidelines may be revised by the USPTO.
Tags: §101 > bilski > law of nature > Mayo > Myriad > patent eligible subject matter
MAYO v. PROMETHEUS 米国最高裁判決
| March 23, 2012
No. 10–1150. Argued December 7, 2011—Decided March 20, 2012
For an English discussion of Mayo v. Prometheus, please click here.
背景
Prometheus Laboratories（以下、Prometheus）は、自己免疫疾患を治療するためのチオプリン（thiopurine）ドラッグに関する2つの特許（U.S. Patent No. 6,355,623、No.6,680,302）の独占的使用権を有する。特許クレームは、チオプリンが投与された患者の血中の代謝物量を測定し、それに合わて投与量を調整する方法に関するものである。
Tags: §101 > bilski > biotech > diagnostics > law of nature > patent eligible subject matter > Supreme Court
Supreme Court strikes down diagnostic method claims as non-patent-eligible subject matter
| March 20, 2012
Mayo Collaborative Services v. Prometheus Laboratories
March 20, 2012
Supreme Court, 9-0, opinion by Justice Breyer
Summary
Although we typically cover the CAFC in this blog, today we will be visiting the Supreme Court. The Supreme Court unanimously ruled that the diagnostic method claims in this highly-anticipated case were invalid as failing to comply with 35 U.S.C. §101. In short, the Court ruled that a claim reciting a diagnostic method (which is inherently based upon a law of nature) that applies only conventional, known steps is invalid.
Tags: §101 > bilski > biotech > diagnostics > law of nature > patent eligible subject matter > Supreme Court
