Patent Law Weblog
As part of its ongoing Supreme Court series, the American University Washington College of Law Program on Information Justice & Intellectual Property will be hosting a post-argument discussion on the Peter v. Nantkwest case beginning at 5:00 pm (Eastern) on October 7, 201 at the American University Washington College of Law in Washington, DC.
Additional information about the post-argument discussion, including registration/CLE information, can be found here. The discussion will be webcast here.
The John Marshall Law School Center for Intellectual Property, Information & Privacy Law and Intellectual Property Law Association of Chicago (IPLAC) Board of Managers will be hosting former U.S. International Trade Commission (ITC) judge Theodore R. Essex who will be presenting on "The ITC: An Insider's View" from 6:00 to 7:30 pm on October 15, 2019 at the John Marshall Law School in Chicago, IL. Mr. Essex will provide insight into one of the most consequential agencies of the U.S. Government for the enforcement of IP — the U.S. International Trade Commission (ITC), which is at the epicenter of litigation for patent disputes — not only in the U.S. but also disputes originating between companies around the globe, adjudicating cases involving billions of dollars in product value.
There is no cost to attend the lecture; however, registration is requested. Those interested in registering for the conference can do so here.
By Kevin E. Noonan —
Recently, Seth Waxman and his team filed a wonderful certiorari petition in the Athena Diagnostics v. Mayo Collaborative Serv. case, which we will discuss in a forthcoming post. Using quotations from the various combinations of Federal Circuit judges in the eight (!) opinions concurring and dissenting from refusal to grant rehearing en banc, the petition paints an accurate picture of a Court struggling to properly apply Supreme Court and its own precedent with regard to claims to reagents and methods for medical diagnostics, and failing (i.e., none of the diagnostic claims brought before the Court have passed eligibility muster).
Lest anyone think this situation exists only for medical diagnostics-related claims, consideration of today's decision in American Axle & Mfg. v. Neapco Holdings LLC will quickly dispel any such illusion. In this case, American Axle sued Neapco Holdings for infringing claims of U.S. Patent No. 7,774,911, directed to methods for manufacturing driveline propeller shafts that "attenuate[e] . . . vibrations transmitted through the shaft assembly." Claims 1 and 22 are representative according to the majority in the Federal Circuit's opinion; Judge Moore dissented, even as to this characterization:
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 granted summary judgment that these claims, and all other asserted claims, were invalid under Section 101 for being directed to a natural law (at least Hooke's law and "friction damping") and did nothing more than instruct the skilled worker to "apply" that law, in contravention of the patent eligibility requirements for satisfying Section 101 set forth in Mayo Collaborative Servs. v. Prometheus Labs., Inc. The District Court's basis for arriving at this conclusion was that the '911 specification did not provide a "particular means of how to craft the liner and propshaft in order to do so". American Axle appealed.
The Federal Circuit affirmed, in an opinion by Judge Dyk joined by Judge Taranto; Judge Moore filed what can charitably called a vociferous dissent. The majority set out its understanding of the invention and the basis for the District Court's decision to invalidate. According to the opinion, the way propshafts in automotive drivetrains are constructed can in their use cause three modes of vibration: bending, torsion, and shell modes, specifically, taken from the '911 patent specification:
Bending mode vibration is a phenomenon wherein energy is transmitted longitudinally along the shaft and causes the shaft to bend at one or more locations. Torsion mode vibration is a phenomenon wherein energy is transmitted tangentially through the shaft and causes the shaft to twist. Shell mode vibration is a phenomenon wherein a standing wave is transmitted circumferentially about the shaft and causes the cross-section of the shaft to deflect or bend along one or more axes.
Each of these vibration modes has a different frequency, according to the majority. An important component of the majority's analysis (contradicted in Judge Moore's dissent) is that the prior art addressed the vibration problem using liners, defined in the opinion as "hollow tubes made of a fibrous material (like cardboard) with outer resilient members that 'frictionally engage the inner diameter of the [propshaft].'" These liners also vibrate, so careful matching of propshaft and liner can result in damping the vibration of the propshaft, and this matching can be "tuned" by varying "certain variables" of the liner. According to the majority, "[i]t was known in the prior art to alter the mass and stiffness of liners to alter their frequencies to produce dampening. Indeed, this was sufficiently well known that prior art patents disclosed the use of particular materials to achieve dampening."
Turning to specifics, the majority identify two relevant types of attenuation of these vibrations: resistive attenuation ("a vibration attenuation means that deforms as vibration energy is transmitted through it . . . so that the vibration attenuation means absorbs . . . the vibration energy ") and reactive attenuation ("a mechanism that can oscillate in opposition to the vibration energy [of the propshaft] to thereby 'cancel out' a portion of the vibration energy"). The '911 specification (according to the majority) discloses that the prior art contained means and methods for attenuating each of the three propshaft vibration modes, but were limited insofar as they could not attenuate two vibration modes simultaneously; the specification identified a "need in the art" to dampen shell mode and bending mode vibrations simultaneously (which American Axle contended below and at the Federal Circuit comprised the "inventive concept" required by Supreme Court precedent to make their claim patent eligible). While recognizing these assertions, in the majority's view the '911 specification does not disclose how to achieve these goals (this being the basis for finding the claims were not patent eligible).
The majority set forth the now well-worn recitation of the two-step test for patent eligibility announced in Mayo and further clarified in Alice Corp. Pty. Ltd. v. CLS Bank International. First, a court asks if the claim is "direct to" a law of nature, natural phenomenon, or abstract idea. If it is, then the court must ascertain whether the claims recite an "inventive concept" that is not merely activities that are routine, conventional and well-understood and that provide "something more" than the law of nature itself and an instruction to "apply" the law. Seemingly anticipating the reaction that the opinion would engender, the majority asserts that "[t]here is no legal principle that a claim to a method of manufacturing cannot be directed to a natural law, nor are there any cases saying so." The majority believe that the '911 specification establishes that "most aspects of the '911 patent were well known in the art," meaning in context that the vibration "problem" addressed by the claimed methods, methods for attenuating resistive and reactive vibration with liners and other things, and that selection of frequencies needed for such attenuation are obtained by an application of Hooke's law (which the majority believes to have been undisputed according to select portions of testimony from both parties' witnesses).
The majority opinion gets to the analytical basis for its decision when it says that "the patent claims do not describe a specific method for applying Hooke's law in this context. They simply state that the liner should be tuned to dampen certain vibrations." This in their view "essentially amounts to the sort of directive prohibited by the Supreme Court in Mayo—i.e. 'simply stat[ing] a law of nature while adding the words ''apply it.''" The majority rejected testimony to the contrary (to the effect that axle liner tuning is not simply an application of Hooke's law) saying "[t]he problem with AAM's argument is that the solution to these desired results is not claimed in the patent. We have repeatedly held that features that are not claimed are irrelevant as to step 1 or step 2 of the Mayo/Alice analysis," citing Alice; Synopsis, Inc. v. Mentor Graphics Corp.; and Ariosa Diagnostics, Inc. v. Sequenom, Inc., in support of this legal principle. According to the majority, "the patent specification recites only a nonexclusive list of variables that can be altered to change the frequencies exhibited by a liner and a solitary example of a tuned liner (though not the process by which that liner was tuned). Most significantly, 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." And such "trial and error" methods of identifying appropriate damping frequencies were also well known in the art, according to the majority who cite the '911 specification for support. And further:
This case might well be significantly different, if, for example, specific FEA [finite element analysis] models were included in the claims. But, 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 of changing the characteristics of a liner until a desired result is achieved.
The majority then cites Supreme Court and Federal Circuit case law for the principle that ""[a] patent is not good for an effect, or the result of a certain process, as that would prohibit all other persons from making the same thing by any means whatsoever," Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174–75 (1853), and particularly Parker v. Flook (although apparently conflating or equating the rationale enunciated regarding the ineligibility of an abstract idea with their analysis of inventions based on laws of nature); the opinion then contrasted that situation with the patent-eligible invention in Diamond v. Diehr (not surprisingly, to the extent these decisions can be reconciled). The majority reiterated its basis for finding ineligibility, that there is no "physical structure or steps for achieving the claimed result of damping two different types of vibrations" and that the "focus of the claimed advance here is simply the concept of achieving that result, by whatever structures or steps happen to work." (If this language reminds anyone of the Court's reasoning in University of Rochester v. G.D. Searle, note Judge Moore's dissenting opinion that follows.) And the majority provoked Judge Moore's analytical ire in its assessment of the second step of the Alice/Mayo test to these claims, where the majority states that "it makes no difference to the section 101 analysis whether the use of liners to attenuate bending mode vibration was known in the prior art."
Judge Moore's full-throated dissent is based on her belief that "[t]he majority's decision expands § 101 well beyond its statutory gate-keeping function and the role of this appellate court well beyond its authority." She characterized the majority's analysis as merely "parrot[ing]" the Alice/Mayo test and reducing the test to the single question of whether a claim is directed to a law of nature. Judge Moore states that she is "deeply troubled by the majority's disregard for the second part of the Alice/Mayo test, its fact finding on appeal and its repeated misrepresentation of the record, in each instance to the patentee's detriment" under circumstances (appeal of summary judgment) where the proper standard is to give the non-movant (here, the patentee) the benefit of any evidentiary ambiguities. As the majority recognized, Judge Moore's primary concern is that invalidity, if it is to lie against these claims, must be based on Section 112(a) for lack of enablement, not Section 101, saying "[w]e cannot convert § 101 into a panacea for every concern we have over an invention's patentability, especially where the patent statute expressly addresses the other conditions of patentability and where the defendant has not challenged them" (an argument the majority easily rejected under Justice Breyer's similar jurisprudential disdain for any section of the Patent Statute other than Section 101 in Mayo). The Judge was equally critical of the majority's failure to identify which natural law the claims were directed to, stating that "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."
Judge Moore also believes there is sufficient disclosure of an "inventive concept" for the claims to pass Section 101 muster even if they are directed to a not completely defined (by the court) natural law. In her view there are many inventive concepts disclosed in the '911 specification, and there exists at least sufficient questions of fact regarding this aspect as to preclude summary judgment. (It should be remembered that Judge O'Malley recently called into question the propriety of another opinion by Judge Dyk, In re BRCA1– and BRCA2– Based Hereditary Cancer Test Patent Litig., where the question was whether the district court properly denied Myriad Genetics' motion for preliminary injunction and instead invalidated all claims at issue; see "Roche Molecular Systems v. Cepheid"). Here, Judge Moore enumerates a half dozen such novel uses for liners that constitute in her view an "inventive concept" (and a finding of unconventionality) sufficient to overcome Neapco Holdings' patent eligibility challenge under Section 101. When addressing the citations to the '911 specification used by the majority to support its conclusion that the claims did not satisfy the "inventive concept" (and unconventionality) prong of the Alice/Mayo test Judge Moore is blunt: "These statements are false." The Judge's reading of the very same specification identifies ample instances where the patentee distinguished the invention from what was known in the art ("More than a dozen times in the briefs and during oral argument the patentee argued that the use of liners to attenuate bending mode vibration was one of its inventive concepts."). The Judge even cites to an instance during oral argument when American Axle's counsel corrected a member of the majority when he asserted the conventionality of using liners for the claimed purpose, and that "[e]ven Neapco acknowledged that the patent states that liners had not been used to attenuate bending mode vibrations." Judge Moore characterizes these conclusions by the majority as de novo "fact-finding," including application of the disclosure of a patent (U.S. Patent No. 3,075,406) "never introduced as evidence in this case or cited by either party" to support its (erroneous, in Judge Moore's view) conclusions. "Moreover," Judge Moore states, "a disclosure in a single patent does not establish that the use of liners to attenuate bending mode vibration was "well-understood, routine, conventional activity" as required by the Supreme Court," and the majority's statement that "the inventive concept 'makes no difference to the section 101 analysis'" is "an outright rejection of the second step of the Alice/Mayo test." Judge Moore asserts that the majority's explanation that "Section 101 is concerned with whether the claims at issue recite a natural law, not whether the specification has adequately described how to make and use the concretely claimed structures and steps" is "just plain wrong" as a statement of the law.
In Judge Moore's view, "[t]he majority's true concern with these claims is not that they are directed to Hooke's Law (because this is clearly a much more complex system not limited to varying mass and stiffness), but rather the patentee has not claimed precisely how to tune a liner to dampen both bending and shell mode vibrations," and the Judge cites almost a dozen statements from the majority opinion in support of this conclusion. For Judge Moore, that deficiency is one falling properly under the scope of Section 112, not Section 101 of the statute. (Seemingly somewhat tongue in cheek, Judge Moore recites the majority's statement that if the specification had disclosed computer-based methods for determining vibration dampening frequencies it might have satisfied Section 101, and then states "[s]urely, this is the first time adding software to a claim would make it eligible.") Judge Moore further notes that:
The majority acknowledges that there is a very specific example given in the patent with precise dimensions, weights, lengths, materials, positioning, etc. Whether this disclosure combined with the knowledge of a skilled artisan would permit that skilled artisan to tune a liner to a given propshaft in order to reduce bending mode vibrations without undue experimentation is exactly and precisely the enablement test pursuant to § 112. A patentee's failure to enable his invention renders the claims invalid under § 112, it does not, however, render the claims ineligible under § 101.
and:
To be clear, according to the majority, even if these claims are enabled, they are still ineligible because the claims themselves didn't teach how. This is now the law of § 101. The hydra has grown another head.
And finally:
The majority holds that [the '911 claims] are directed to some unarticulated number of possible natural laws apparently smushed together and thus ineligible under § 101. The majority concludes that the inventive concepts "make no difference." Section 101 simply should not be this sweeping and this manipulatable. It should not be used to invalidate claims under standards identical to those clearly articulated in other statutory sections, but not argued by the parties. It should not subsume § 112. It should not convert traditional questions of fact (like undue experimentation) into legal ones. 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.
Anyone having read the Court's decision not to grant rehearing en banc in Athena Diagnostics v. Mayo Collaborative Serv. should be well aware of the fractious nature of the Section 101 inquiry among the Federal Circuit judges, and the desperate need for the Supreme Court to clarify the patent eligibility standard it recited (murkily) in its Mayo and Alice decisions. Even if in agreement with Judge Moore, it is not difficult to see how the majority arrived at its conclusions, and how easy it is to apply Section 101 in a "sweeping and manipulatable" way. When a specialized appellate court, created by Congress to harmonize and clarify U.S. patent law, can find a method of manufacturing a propshaft for an automobile to be ineligible under Section 101 as a natural law, it is clear that the Court, and as a consequence the rest of us, has clearly lost its way.
American Axle & Mfg. v. Neapco Holdings LLC (Fed. Cir. 2019)
Panel: Circuit Judges Dyk, Moore, and Taranto
Opinion by Circuit Judge Dyk; dissenting opinion by Circuit Judge Moore
By Donald Zuhn —
Today, in Honeywell Int'l v. Arkema Inc., the Federal Circuit vacated a combined Final Written Decision by the U.S. Patent and Trademark Office Patent Trial and Appeal Board in two post-grant review proceedings finding that claims 1-20 of U.S. Patent No. 9,157,017 were unpatentable. The Federal Circuit also remanded to the Board to authorize Honeywell International Inc. to file a motion seeking leave to petition the Director for a Certificate of Correction.
The '017 patent, which is owned by Honeywell and which is directed to fluoroalkene compounds used in refrigeration systems and other applications, recites a chain of priority applications dating back to 2002, all of which were incorporated by reference into the '017 patent. During prosecution of the application that issued as the '017 patent, Honeywell filed a preliminary amendment in which it cancelled all of the claims included in the original application and added new claims directed to different subject matter (i.e., automobile air conditioning systems), but failed to make corresponding amendments to the list of priority applications.
Four months after the '017 patent issued, Arkema Inc. filed two petitions for post-grant review of the '017 patent, asserting in both petitions that the priority applications listed on the face of the '017 patent did not provide written description support for the issued claims. Arkema argued that as a result, the claims of the '017 patent were only entitled to the March 26, 2014 filing date of the application from which the '017 patent issued (as opposed to a 2002 priority date), that the '017 patent was therefore eligible for PGR proceedings, and that several prior art references from 2002 to 2014 rendered the claims of the '017 patent unpatentable. The Board instituted both PGR's.
Honeywell, which asserted that it had first realized the priority chain mistake when preparing its Patent Owner Response, requested permission to file a motion for leave to request a Certificate of Correction to amend the priority claim of the '017 patent. The Board rejected Honeywell's request for authorization to file a motion for leave, indicating that Honeywell had failed to meet the requirements of 35 U.S.C. § 255, and the proceedings before the Board continued until the Board issued a combined Final Written Decision finding claims 1-20 of the '017 patent to be unpatentable. Honeywell appealed to the Federal Circuit.
On appeal, the Federal Circuit wasted little time in "conclud[ing] that the Board abused its discretion by assuming the authority that 35 U.S.C. § 255 expressly delegates to the Director: to determine when a Certificate of Correction is appropriate." The Court noted that pursuant to § 255, patentees may petition the Director to issue a Certificate of Correction to correct "a mistake of a clerical or typographical nature, or of minor character, which was not the fault of the Patent and Trademark Office," and that the patentee must show that the mistake "occurred in good faith" and that "the correction does not involve such changes in the patent as would constitute new matter or would require re-examination." The Court also noted that when a patentee seeks to correct a patent during a post-grant proceeding, the patentee must seek authorization from the Board to file a motion, and if authorization is granted, file a motion with the Board, asking the Board to cede its exclusive jurisdiction so that the patentee can seek a Certificate of Correction from the Director.
The Court, however, explained that "Section 255 does not grant the Board authority to determine whether a mistake in an issued patent is of 'minor character' or 'occurred in good faith,'" adding that this "authority is expressly granted to the Director," and "[t]he Director has not delegated its Section 255 authority to the Board, but has instead promulgated procedures by which patentees may seek the Board's leave to petition the Director for a Certificate of Correction." In the instant case, the Court noted that:
[T]he Board did not review Honeywell's motion for leave to seek a Certificate of Correction from the Director to determine if Honeywell had demonstrated a "sufficient basis" that the mistake "may" be correctable. Instead, the Board prohibited Honeywell from even filing a motion for leave. The Board refused to authorize Honeywell to file a motion for leave because "at this juncture there has been a failure to show that [the] requirements of 255 have been met."
The Court determined that by requiring Honeywell show that the requirements of § 255 had been met before authorizing Honeywell to file a motion for leave to seek a Certificate of Correction from the Director, the Board abused its discretion. The Court also pointed out that the Board lacked the information necessary to make a reasoned decision, and failed to provide an explanation or a reasoned basis for its decision, which impeded meaningful review on appeal. Moreover, the Court pointed out that it could "find nothing in the record, or in the Board's conclusory decision, that warrants denying Honeywell's request to file a motion for leave to petition the Director for a Certificate of Correction correcting the priority chain of the '017 patent."
The Court therefore concluded that the Board had erred in rejecting Honeywell's request to file a motion for leave to petition the Director for a Certificate of Correction, and vacated the Board's Final Written Decision. The Court also remanded to the Board, indicating that on remand the Board should authorize Honeywell to file a motion seeking leave to petition the Director for a Certificate of Correction, and then review Honeywell's motion for leave to evaluate whether prejudice to Arkema requires accommodation.
Honeywell Int'l v. Arkema Inc. (Fed. Cir. 2019)
Panel: Circuit Judges Newman, Reyna, and Hughes
Opinion by Circuit Judge Reyna
By Kevin E. Noonan —
In a brief Order issued September 25, 2019, the U.S. Patent and Trademark Office's Patent Trial and Appeal Board authorized the Junior Party (the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier; collectively, "CVC") in Interference No. 106,115 to file a motion opposing Senior Party's (the Broad Institute, Harvard University and MIT, collectively, "the Broad") Substantive Motion No. 1 pursuant to 37 CFR §41.104(a). As explained in an earlier post (see "Broad Institute Takes Its Turn in Interference Motion Practice"), the basis of this motion is 37 C.F.R. § 41.127(a)(1) and MPEP § 2308.03(b) (interference estoppel). If granted, the motion would resolve the interference in the Broad's favor and could possibly preclude the Junior Party from pursuing priority of invention over eukaryotic cell embodiments of CRISPR technology.
The Order sets a deadline date of October 18, 2019, for filing an opposition, and extends the page limit from 25 to 32 pages (equivalent to the extended page limit the PTAB permitted the Broad to file in its Substantive Motion No. 1. This Order is neither unexpected nor particularly informative; any decision other than outright denial of the Broad's Substantive Motion No. 1 requires granting CVC the right to have their say (and the Broad's motion is too substantive for that to occur). But these circumstances make possible a reprise of the outcome in the earlier interference between these parties (No. 106,048), wherein CVC will be prevented from having the opportunity to have the PTAB determine on the merits whether CVC's inventors (including recognized inventors of CRISPR, Jennifer Doudna and Emmanuelle Charpentier) or Feng Zhang et al. were the first to invent applications of CRISPR for use in eukaryotic cells.
For additional information regarding this and other related topics, please see:
• "Broad Institute Takes Its Turn in Interference Motion Practice," September 24, 2019
• "CRISPR Interference: Motion Practice," September 11, 2019
• "PTAB Redeclares CRISPR Interference and Grants Leave for Some (But Not All) of Parties' Proposed Motions," August 29, 2019
• "University of California/Berkeley Granted Yet Another CRISPR Patent," August 25, 2019
• "CRISPR Interference Parties Propose Motions," August 1, 2019
• "Sigma-Aldrich Wants Its Piece of CRISPR Pie," July 21, 2019
• "New CRISPR Interference: The Details," July 8, 2019
• "CRISPR Battle Joined Again," July 1, 2019
• "Another U.S. Patent Issued for CRISPR," April 28, 2019
• "CRISPR Patent Watch," March 12, 2019
• "Whither CRISPR? University of California/Berkeley Granted Another CRISPR Patent," October 30, 2018
• "Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2018)," September 10, 2018
• "The CRISPR Chronicles — Broad Institute Wins One and Loses One," January 24, 2018
• "Berkeley Files Opening Brief in CRISPR Appeal," July 31, 2017
• "University of California/Berkeley Appeals Adverse CRISPR Decision by PTAB," April 13, 2017
• "PTAB Decides CRISPR Interference in Favor of Broad Institute — Their Reasoning," February 16, 2017
• "PTAB Decides CRISPR Interference — No interference-in-fact," February 15, 2017
The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Doctrine of Equivalents: Impact of Recent Federal Circuit Decisions on Prosecution and Litigation" on October 2, 2019 from 2:00 to 3:00 pm (ET). John Livingstone of Finnegan, Sailesh Patel of Schiff Hardin, and Adam Perlman of Williams & Connoly will help practitioners understand the nuances of the Federal Circuit's recent doctrine of equivalents (DOE) jurisprudence, give practical tips both on how to build a case for infringement under the DOE and to defend against it, and offer tips for prosecution at the USPTO, particularly regarding how to narrow claims in the least damaging way.
The registration fee for the webinar is $135 (IPO member) or $150 (non-member) (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
Loeb & Loeb LLP will be offering a webinar entitled "Vive la différence — What you need to know to survive Canada's Patent Law changes" on October 2, 2019 from 12:00 to 1:00 pm (EST). H. Samuel Frostand Patricia Folkins of Bereskin & Parr LLP will discuss the 2019 revisions to the Canadian Patent Rules to comply with the Patent Law Treaty (PLT). The webinar will offer an overview of the upcoming changes in Canadian Patent Law coming into force on October 30, 2019, and specifically will answer the following questions:
• What is the PLT and why does Canada need to comply?
• What are the most significant changes to patent practice being brought in as a result of these changes?
• How will these changes impact me?
• What should I do to prepare?
While there is no cost to participate in the program, advance registration is required. Those interested in attending the webinar can register here.
Clyde & Co and McDonnell Boehnen Hulbert & Berghoff LLP will be hosting an onsite program from 5:00 pm to 6:30 pm on October 14, 2019 at The Studio at White City Place in London, England. The program will offer presentations on the following topics:
• Patenting In the USA: Is There Anything Patent Eligible? — Paul Tully and Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP
• Patent Eligibility — A UK Perspective / IP Enforcement Overview / Update on Brexit & IP — Ralph Cox
A cocktail reception will follow the program.
There is no registration fee for the program. However, those interested in attending the program must register by contacting Susan Hall at hall@mbhb.com. By registering for this event, attendees agree to Clyde & Co and MBHB processing their personal data for the purposes of facilitating the event. Additional information abouth the event can be found here.
October 2, 2019 – "Doctrine of Equivalents: Impact of Recent Federal Circuit Decisions on Prosecution and Litigation" (Intellectual Property Owners Association) – 2:00 to 3:00 pm (ET)
October 2, 2019 – "Vive la différence — What you need to know to survive Canada's Patent Law changes" (Loeb & Loeb LLP) – 12:00 to 1:00 pm (EST)
October 3-4, 2019 – Paragraph IV Disputes Master Symposium (American Conference Institute) – Chicago IL
October 14, 2019 – Intellectual Property Law Educational Program (Clyde & Co and McDonnell Boehnen Hulbert & Berghoff LLP) – London, England
By Donald Zuhn —
Last week, in Intra-Cellular Therapies, Inc. v. Iancu, the Federal Circuit affirmed a decision by the U.S. District Court for the Eastern District of Virginia affirming a determination by the U.S. Patent and Trademark Office of Patent Term Adjustment (PTA) for U.S. Patent No. 8,648,077. In affirming the District Court's grant of summary judgment in favor of the USPTO, the Federal Circuit concluded that the USPTO's determination of applicant delay was based on a permissible interpretation of statute and proper reading of the regulations.
During prosecution of the application that issued as the '077 patent, the USPTO issued a final Office action in which no claims were allowed, and the Examiner repeated the same § 103 rejections from the previous non-final Office action (and also presented new objections). Intra-Cellular responded on the three-month deadline, continuing to dispute the § 103 rejection using the same arguments that were previously found unpersuasive by the Examiner, and amending the claims to address other objections and rejections (including adding a new claim). The USPTO then issued an Advisory Action indicating that Intra-Cellular's after-final response failed to overcome the § 103 rejection for "reasons of the record" (despite overcoming certain other rejections and objections). In the Advisory Action, the Examiner also suggested amending or cancelling certain claims to overcome the outstanding § 103 and § 112 rejections and new formality objection. Twenty-one days after filing its unsuccessful first response to the final Office action, Intra-Cellular filed a second response in which it overcame all outstanding rejections and objections by adopting the Examiner's suggestions and cancelling or amending every rejected or objected to claim based on the Examiner's positions. The USPTO issued a Notice of Allowance, and the '077 patent was issued.
In calculating PTA for the '077 patent, the USPTO determined that the extra 21 days it took Intra-Cellular to file a successful response after the three-month deadline for responding to the final Office action constituted applicant delay. In particular, the USPTO determined that even though Intra-Cellular filed a response to the final Office action on the three-month deadline, that response did not constitute a proper "reply" under § 1.704(b). Intra-Cellular filed a complaint in the District Court for the Eastern District of Virginia seeking judicial review of the USPTO's PTA determination. The District Court granted summary judgment in favor of the USPTO, pointing out that "nothing in the plain language of the statute indicates that 'reasonable efforts to conclude prosecution' should be read to include an incomplete submission which fails to place the application in condition for allowance, but in some manner advances it closer to allowance." Intra-Cellular appealed the District Court's decision to the Federal Circuit.
Judge Chen, writing for the Court, begins by noting that 37 C.F.R. § 1.704(b), which provides that "an applicant shall be deemed to have failed to engage in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of three months that are taken to reply to any notice or action by the [Patent] Office making any rejection, objection, argument, or other request . . . " (emphasis in opinion), is relevant to the appeal. Thus, according to § 1.704(b), if an applicant takes longer than three months to file a "reply" to an Office action, applicant delay will accrue. Judge Chen notes, however, that § 1.704(b) does not define what constitutes a proper "reply" for cutting off applicant delay. The opinion then looks to the "backdrop of long-existing regulations governing patent prosecution practices," including 37 C.F.R. §§ 1.113(a) and (c), 1.114(b) and (c), and § 116, which establish that a "final" Office action marks the end of normal prosecution as of right, that an examiner is not obligated to engage in further examination and review of a patent application or applicant arguments after a final Office action is issued, and that an applicant has restricted options for responding to a final Office action.
With respect to the dispute before the Court, the opinion indicates that it concerns whether a particular period of 21 days, following the three-month deadline for responding to a final Office action, counts as applicant delay, and whether the District Court erred in upholding the agency's determination that Intra-Cellular's first response did not constitute a proper "reply." This determination hinged in part on the USPTO's interpretation of statutory text, and in reviewing an agency's statutory interpretation, a court does so by applying the two-step framework established in Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).
In Step 1 of its Chevron analysis, the Court asks whether a statute's plain terms directly address the precise question at issue. Here, the opinion refers to 35 U.S.C. § 154(b)(2)(C)(i) and notes that:
The precise question at issue is whether an applicant submission, filed after a final Office action, that continues to argue the merits of the examiner's rejection, without good cause, constitutes a "fail[ure] to engage in reasonable efforts to conclude prosecution" such that applicant delay would accrue under the PTA statute.
Intra-Cellular argued that because its first after-final submission addressed each outstanding objection and rejection to the claims made in the final Office action, this submission constituted a bona fide attempt to advance prosecution, thus constituting "reasonable efforts to conclude prosecution" under a plain reading of the PTA statute. However, the opinion points out that "Intra-Cellular's reading appears to be in tension with the fact that it no longer had the right to continue debating the merits of the rejection once the final Office action issued in this case." Nevertheless, the Court concluded that "[w]hen read in the context of the overall statutory scheme, . . . the language of the PTA statute does not answer the question of what type of action by an applicant constitutes 'reasonable efforts to conclude prosecution' for purposes of responding to a final Office action" (emphasis in opinion).
Moving to Step 2 of its Chevron analysis, the Court asks whether the USPTO's answer to the precise question at issue is based on a permissible construction of the statute. With respect to this question, the Court concluded that "it is permissible to interpret an after-final submission that merely continues to argue the merits of an examiner's final rejection as a 'fai[lure] to engage in reasonable efforts to conclude prosecution' such that such an applicant submission would not stop the accrual of applicant delay under the PTA statute." The opinion adds that "[w]hile § 1.704(b) does not explicitly define 'reply,' that does not mean that any type of submission by the applicant, no matter how flimsy or superficial, necessarily qualifies as a 'reply' for purposes of stopping accrual of applicant delay." Moreover, the opinion explains that:
Intra-Cellular's proposed interpretation of "reply" under § 1.704(b) as any bona fide attempt to address all rejections and objections in an Office action is impermissible because it incorrectly applies the standard for a compliant "reply" to a non-final Office action as set forth in § 1.111 to the reply to a final Office action at issue here [emphasis in opinion].
The opinion also points out that "under Intra-Cellular's interpretation, an applicant would be allowed to continue to liberally argue and make amendments without accruing applicant delay as long as it addressed all outstanding issues in the final Office action," which "would give the applicant the benefits of an RCE (which re-opens prosecution) without the concomitant PTA reduction that comes with an RCE."
The opinion concludes by rejecting Intra-Cellular's arguments against the permissibility of the Patent Office's PTA determination, including that the USPTO's PTA determination violates the Court's holdings in Gilead Scis., Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015), and Pfizer, Inc. v. Lee, 811 F.3d 466 (Fed. Cir. 2016); that the USPTO's reading of the generic recitation of "reply" in § 1.704(b) to mean a "reply in compliance with § 1.113(c)" constituted "unfair surprise"; and that the USPTO's interpretation conflicts with the USPTO's promotion of various after-final "pilot" programs that encourage applicants to engage in further prosecution after a final Office action. The Federal Circuit therefore determined that the USPTO's determination of applicant delay was supported by a permissible reading of the PTA statute, and found that the District Court did not err in granting summary judgment in favor of the USPTO.
Intra-Cellular Therapies, Inc. v. Iancu (Fed. Cir. 2019)
Panel: Circuit Judges Wallach, Chen, and Hughes
Opinion by Circuit Judge Chen
Patent Docs 