All posts by Dennis Crouch

About Dennis Crouch

Law Professor at the University of Missouri School of Law.

For Drug Treatment Patents: Prior Art Must Show Efficacy

OSI Pharma v. Apotex Inc. (Fed. Cir. 2019)

New use of a known compound: This decision focuses on OSI’s U.S. Patent 6,900,221 — a method for treating non small cell lung cancer (NSCLC) with the drug erlotinib (sold by OSI as Tarceva).  In the US dosage is about $200 per day that continues “until disease progression or unacceptable toxicity.”

44. A method for the treatment of NSCLC … comprising administering to [a] mammal a therapeutically effective amount of a pharmaceutical composition comprised of at [erlotinib] and a carrier.

Apotex petitioned the USPTO to cancel several claims, including Claim 44 so that it could begin marketing a generic version.  The PTAB agreed to hear the case and eventually cancelled the claims — finding them obvious when laid next to a prior patent (Schnur) in view either of an academic review article on anticancer drug targets (Gibbs) or OSI’s own 10-K (OSI SEC filing).

Schnur lists Erlotinib as a preferred compound for treating cancer in mammals — and note that the class of drugs (erbB) is good for treating human tumors, including “renal, liver, kidney, bladder, breast, gastric, ovarian, colorectal, prostate, pancreatic, lung, vulval, thyroid, hepatic carcinomas, sarcomas, glioblastomas, various head and
neck tumors.” (Lung emphasized in the court decision, but not in the original prior art). Schnur discloses lung cancer treatment – but does not particularly discuss “non small cell lung cancer.”

Gibbs is a review of prior publications and makes the conclusion that erlotinib (and a parallel compound) “appear to have good anti-cancer activity in preclinical models … particularly in patients with non-small cell lung cancer.”  However, when the Federal Circuit looked-into the articles cited by Gibbs — none of them provided any “data regarding the use of erlotinib to treat NSCLC.”  OSI also hired Gibbs to provide a declaration that he was “not aware of any published abstracts or articles describing the clinical or preclinical response of a NSCLC tumor to [erlotinib] that were available as of the time my article was published, and I reviewed no such abstracts or articles in drafting my article.”

The SEC Filing by the patentee is a prior printed publication from more than 1 year before OSI’s filing date. The Filing states that the company is pursuing research on Erlotinib “which targets a variety of cancers including ovarian, pancreatic, non-small cell lung and head and neck. . . . [The drug] is a potent, selective and orally active inhibitor of . . . a key oncogene in these cancers.”  The SEC Filing also indicates that Phase I safety trials had been completed and Phase II clinical trials were ongoing.  The SEC filing does not include any “DATA.”

For the Board, the combination of these references rendered the broad claim 44 obvious — the claim just requires administration of “a therapeutically effective” of the drug and a carrier.

On appeal, however, the Federal Circuit has reversed — holding that the references did not create a “reasonable expectation of success.”  As such, the Board’s factual conclusion was not supported by substantial evidence.

Over the past several years, the Federal Circuit has been rebuilding its obviousness doctrine post-KSR.  The court now asks two key questions of fact: would a person of ordinary skill in the art (1) have been motivated to combine/modify the prior art teachings in order to make the invention; and (2) have had a reasonable expectation of success in doing so.

The combination of references state rather plainly that erlotinib is believed to has anti-cancer activity against non-small cell lung cancer and that the drug is safe (enough).  On appeal, however, the Federal Circuit rejected the obviousness claim because the prior art did not provide any evidence that the drug would work in humans. “These references thus contain no data or other promising information regarding erlotinib’s efficacy in treating NSCLC.” In its explanation, the court notes that this area is “highly unpredictable” — 99.5% failure rate of NSCLC treatments entering Phase II.

The court concludes with a caveat — attempting to cabin-in this ruling:

To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring “absolute predictability of success.” We conclude only that, on these particular facts, a reasonable fact finder could not find a reasonable expectation of success. The Board’s finding is thus not supported by substantial evidence, and accordingly we reverse its obviousness determination.

The decision here has a substantial amount of merit.

What gives me a lump in my throat is that the prior art discloses almost exactly what was claimed in these broad claims — with the addition of the functional language “therapeutically effective” amount.

Hey Mechanical Engineers: Your Patents are Also Ineligible

by Dennis Crouch

American Axle & Manufacturing, Inc. v. Neapco Holdings LLC (Fed. Cir. 2019)

This case focuses on Neapco’s U.S. Patent 7,774,911 that D.Del. Judge Stark found to lack eligibility. On appeal a divided panel has affirmed — with Judges Dyk and Taranto supporting invalidity and Judge Moore writing in dissent.

The ‘911 patent covers a method of manufacturing a drive-shaft assembly with an internal-liner that is designed to reduce vibration problems. Yes –  the method of manufacture is not patent eligible because it is directed to a law of nature.

One way to see this case is as a battle between Parker v. Flook and Diamond v. Diehr.  The majority follows Flook and finds the patent is invalid.  As suggested below, the issue here also looks like Halliburton — where the patent “conveniently” uses functional language at the point of novelty.  The majority also suggests – but does not decide – that the claims lack enablement and written description.

Essentially, the claim are directed to functional improvement in drive-shaft technology — a drive shaft with an internal liner that has 2-way damping.  However, the claims do not require a particular approach to achieving the damping result. Further, according to the majority, the specification does not provide enough guidance to let readers know that something real (beyond a law of nature or abstract idea) is being claimed.

Claim 1 at issue:

A method for manufacturing a shaft assembly of a driveline system … adapted to transmit torque …, 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.

Drive shaft technology has been around for a long time and the subject of many patents.  One of the earlier U.S. patents is this 1861 Mower Machine (U.S. Patent No. 32,908).  Throughout this time, a common problem has been vibration control and various solutions have been the subject of hundreds of patents.

In this case, the core innovation disclosed in the ‘911 patent is that the shaft-liner has been attuned to dampen two types of vibration (shell mode and bending mode) and the patent provides several example shaft liner designs to accomplish this goal:

Critical Over Claiming: Rather than claiming these particular liner shapes, the patent claims a liner that is “attuned” so as to have a particular dampening profile. This is the patentee’s critical error.  In addition, the patent does not claim a particular method for attunement — just the functional result.  In considering what’s being done here, the Federal Circuit found that the claim is broadly directed to the broad physics principles associated with vibrational frequency and dampening of vibrations:

[The claims] simply state that the liner should be tuned to dampen certain vibrations. Thus, the problem is that the claims’ instruction to tune a liner 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.’” . . . [T]he mechanisms for achieving the desired result—are not actually claimed.

Since drive shafts and internal liners were already known in the art, the majority found nothing-new there — no inventive step sufficient to transform the abstract idea into a patent eligible invention.

Judge Moore’s dissent is a good read and I’ll save a post on it for this weekend.

Athena v. Mayo: Whither Diagnostic Method Patents

by Dennis Crouch

OK, here is an important case: Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, Docket No. 19-430 (Supreme Court 2019).  In its new petition, Athena asks — did the Supreme Court really intend to bar patenting new diagnostic methods absent creation of new technological equipment? [Petition for Writ of Certiorari][Appendix].

At issue are Claims 7-9 of Athena’s U.S. Patent No. 7,267,820. The district court dismissed Athena’s infringement complaint — finding the claims ineligible.  That decision was reluctantly affirmed by the Federal Circuit. The appellate court then denied en banc review — with eight separate opinions from the 12-member court.  In its Supreme Court petition, Athena now presents the question as follows:

The question presented is: Whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter, where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.

[Petition].

The invention process in this case started with the reality that the biological cause of Myasthenia gravis (MG) could be identified for only about 80% of patients.  The inventors here discovered that a substantial portion of those “unknown cause” patients generated autoantibodies to “muscle-specific tyrosine kinase” (MuSK). MuSK was previously known as a naturally occurring human protein.  Although the autoantibodies to MuSK were not previously known, but do naturally occur in individuals with the condition.  The key discovery of the inventors is the link between the autoantibodies and the particular form of MG.  Under Mayo v. Prometheus, that link is an unpatentable law of nature.

After discovering the link, the researchers designed and then patented a method of finding those MuSK antibodies to help diagnose the particular form of MG. Since the autoantibodies were not easy to directly detect, the claims requires that a lab first tag MuSK proteins with a radio-label (such as Iodine-125) and then mix the proteins with body fluid. If the autoantibody is present in the fluid then it should bind with the tagged-MuSK.  At that point, you immunoprecipitate any antibody/MuSK complex and look for the label in the precipitate.  The patent explains that these steps are well known in the art – “Iodination and immunoprecipitation are standard techniques in the art.”  However, they had never been done with MuSK and its autoantibody. At that tight level of granularity, these steps could be called “a series of specific chemical steps never previously performed” as they were in the petition.

If you think that Myriad Genetics might provide insight to this case, it will also be important to recognize that radio-labeling MuSK actually creates a new molecules — “novel man-made molecules.”

Claims 7-9 of Athena’s U.S. Patent No. 7,267,820 are at issue. These depend from a very broadly written claim 1 that Athena did not defend on appeal. Claims: 

1. A method for diagnosing neuro … disorders related to [MuSK] comprising: … detecting in a bodily fluid … autoantibodies to … MuSK.

7. A method according to claim 1, comprising

contacting [labelled] MuSK … with said bodily fluid,

immunoprecipitating any antibody/MuSK complex … from said bodily fluid and

monitoring for said label on any of said antibody/MuSK complex …,

wherein the presence of said label is indicative [of the disorder]

8. A method according to claim 7 wherein said label is a radioactive label.

9. A method according to claim 8 wherein said label is [Iodine-125].

Patent at issue.

I’ve unfortunately been reminded of Dickens multiple times this week. The Dickens link with this brief comes in the form of melodrama. The following comes from the petition introduction:

[T]he Federal Circuit issued an unprecedented cry for help from this Court to clarify the patent eligibility of medical diagnostic tests. This Court should heed that cry and provide much-needed guidance on the proper application of the judicially-created exceptions to Section 101 of the Patent Act. . . .

[Among members of the Federal Circuit] there was broad consensus that this Court’s review is desperately needed. Numerous government officials, practitioners, and scholars have echoed and amplified the message that the law of patent-eligible subject matter is in a state of turmoil and there is no more important question facing the patent system. . . .

If these claims do not even meet the threshold requirement of being the kind of subject matter eligible for patent protection, that is the end of patent eligibility for the overwhelming majority of medical diagnostic methods—leading to profound consequences for future investment in scientific research and public health.

It actually took me quite a while to write this post — I must have fainted from simply reading the introduction.

Seriously though – this is an important issue. The Federal Circuit judges agreed that this is the type of invention that SHOULD be patent eligible, but is NOT patent eligible.  The Supreme Court should also recognize that its action (or inaction) in this case will likely be followed-up by Congressional action — as such a well reasoned opinion would go far to smoothing that process.

 

 

 

Tale of a Patent: Seeking Permission to File a Motion to Petition for Correction

by Dennis Crouch

Honeywell Int’l. Inc. v. Arkema Inc. (Fed. Cir. 2019)

On Arkema’s request, the PTAB initiated a post grant review against Honeywell’s U.S.
Patent 9,157,017 (“method for producing an automobile air conditioning system for use with 2,3,3,3-tetrafluoropropene”). (Filed 4-months after patent issuance).

The patent includes a priority chain that goes back to 2002 and Honeywell thus argued that the patent was not amenable to PGR review. However, it turns out that Honeywell had a mistake in its priority chain listing — having forgotten to add one additional filing to its priority chain. Honeywell then asked the PTAB for permission to petition the PTO Director for a Certificate of Correction under Section 255.

Whenever a mistake of a clerical or typographical nature, or of minor character, which was not the fault of the [PTO], appears in a patent and a showing has been made that such mistake occurred in good faith, the Director may, upon payment of the required fee, issue a certificate of correction, if the correction does not involve such changes in the patent as would constitute new matter or would require re-examination.

35 U.S.C. § 255

Honeywell admitted that the error was not clerical or typographical and Arkena argued that it was a major change to the patent — “not proper grounds for correction.” Honeywell argued good faith — that discovered the error only after institution, and there is no suggestion that the lack of priority claim benefited the patentee in any way — just a big mistake.

To be clear about PTAB procedure — before filing a motion , you first have to get permission (leave) to file the motion. Here, Honeywell asked PTAB for permission to file a motion for leave from the PTAB to file a petition for correction. The Board did not give permission — rejecting Honeywell’s request for leave.  In the process, the Board agreed with Arkena’s “not-minor” arguments and that the correction could prejudice the petitioner.   The Board subsequently cancelled the claims – finding that without the priority chain, the late-filed claims are anticipated by intervening prior art.

A Poor Man’s Tale of a Patent

On appeal, the Federal Circuit has vacated and remanded — holding that the PTAB should allow the Certificate of Correction petition. In particular, the court found that the PTAB had “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.

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.” 35 U.S.C. § 255. That authority is expressly granted to the Director. Id. The 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. 37 C.F.R. § 1.323; MPEP § 1485.

The Federal Circuit has held that it is appropriate for the PTAB to require “sufficient basis” supporting a correction request before granting permission to petition the PTO Director.  The basic idea is that the correction process could slow-down the PTAB trial.  In this case, however, the PTAB went to far because it did not allow Honeywell to file a motion explaining its case.

By requiring that Honeywell “show that [the] requirements of 255 have 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 Board further abused its discretion by assuming the authority that § 255 delegates to the Director and deciding the merits of Honeywell’s petition for a Certificate of Correction. . . .

[B]y evaluating the merits of Honeywell’s § 255 request when Honeywell was merely requesting authorization to file a motion for leave to petition the Director, the Board “lacked the information necessary to make a reasoned decision.” [Quoting Ultratec] At that stage, the Board had not seen the language of Honeywell’s proposed correction to the priority chain language of the ’017 patent. Nor had the Board seen any evidence of whether the mistake was inadvertent and made in good faith or whether the correction prejudiced Arkema.

The Board also failed to provide an explanation or a reasoned basis for its decision. The Board provided no explanation for its conclusion that Honeywell “failed to show that the minor character prong has been met” or its conclusion that prejudice to Arkema required denial of Honeywell’s request to file a motion.

Slip opinion.  On Remand, the Federal Circuit ordered the PTAB to now allow “Honeywell to file a motion seeking leave to petition the Director for a Certificate of Correction.”

Vacated and Remanded

 

Back Out of the Deference Labyrinth—a Response to Prof. Golden

David Boundy

This is a response to Prof. Golden’s A Walk in the Deference Labyrinth: Further Comment on Facebook v. Windy City, Patently-O (Sept. 27, 2019).  In my view, Prof. Golden overlooked some things (the same things overlooked by the PTO in its brief).  When those additional factors are clearly in view, Prof. Golden’s labyrinth falls into nice straight lines of sight showing that the Chevron deference issue in Facebook v. Windy City is no labyrinth at all: the PTAB’s Proppant decision is not entitled to Chevron deference.

(more…)

USPTO Patent Open Data Conference – Oct 22

I’m looking forward to being part of the upcoming Patent Open Data Conference at USPTO-Detroit – hosted by Regional Director Damian Porcari.  Attend in person or via web. Sign-up to join the conversation:

Sign-Up: https://www.eventbrite.com/e/midwest-regional-uspto-patent-open-data-conference-tickets-74450376079

Speakers:

 

 

Patent Grants Per Year

FY2019 is over and the numbers are out.  The USPTO has issued 336,886 utility patents during the fiscal year. This is a big increase over both FY2018 (306,912) and FY2017 (315,367).

My take: The change here is substantially due to Dir. Iancu, including (but not limited to) his push on limiting the scope of examiner eligibility analysis.  The chart below superimposes images of the USPTO Director at around their start-date.  If you recall, Jon Dudas was known for limiting patent grants (“second pair of eyes review”); David Kappos opened the door with collaborative patenting (“right-sized patents”); Michelle Lee turned things back down with a focus on “patent quality”; and  finally, Andrei Iancu ‘We will not continue down the same path.’

From today’s obvious patents comes U.S. Patent 10,425,977:

1. A wi-fi connection method for a mobile terminal, comprising:

obtaining wi-fi hotspots near the mobile terminal;

obtaining a data list and location information of the wi-fi hotspots;

sending the data list and the location information to a server;

analyzing, via the server, the data list and the location information to obtain password information of an available wi-fi hotspot, and sending the password information of the available wi-fi hotspot to the mobile terminal; and

connecting, at the mobile terminal, the available wi-fi hotspot based on the password information.

USPTO removable media policy

If you are visiting the USPTO, do not bring a “personal removable media storage device.”  U.S. Gov’t computer security has been compromised on numerous occasions based via USB drive viruses. The solution is to email the file to the examiner (and yourself); bring in a “finalized CD/DVD“; or connect via a secure file sharing service (PTO suggests Kiteworks).

The prohibition is written broadly — prohibiting anyone from entering the with “devices that can operate as removable media storage devices (e.g. PDAs, digital cameras, and Apple iPods).”  Presumably, this also includes your smart phone — I have contacted the PTO for clarification.

The PTO Notice indicates that most USPTO locations will include scanning-equipment “to check removable media for policy compliance.”  However, that process will cause a delay in admittance (and invade the privacy of your device).

Supreme Court Long Conference – Patent Law

by Dennis Crouch

The Supreme Court is back in session and is holding its first conference – the Long Conference – on October 1, 2019.  The court is scheduled to consider whether to grant certiorari in a number of important patent cases:

  • Obviousness: Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., No. 18-1280 (When should the objective indicia of nonobviousness be discounted based upon alleged “blocking” by an existing prior patent).  This case is supported by five additional friend-of-the-court briefs
  • Obviousness: Senju Pharmaceutical Co., Ltd. v. Akorn, Inc., No. 18-1418 (Whether no-opinion judgments comply with 35 U.S.C. § 144; Whether objective evidence of non-obviousness must be considered before cancelling claims as obvious).
  • Prosecution Procedures: Hyatt v. Iancu, No. 18-1285 (Whether MPEP 1207.04 – allowing for reopening prosecution – violates patent applicants’ statutory right of appeal following a second rejection).
  • Eligibility: Glasswall Solutions Limited v. Clearswift Ltd., No. 18-1448 (role of factual assertions when patent eligibility is challenged in a R.12(b)(6) motion to dismiss for failure to state a claim) (Link to Berkheimer).
  • Eligibility: StrikeForce Technologies, Inc. v. SecureAuth Corporation, No. 19-103 (Facts in step two of Alice) (Link to Berkheimer).
  • Damages: Zimmer, Inc. v. Stryker Corporation, No. 18-1549 (is negligence enough for enhanced damages).
  • Litigation Procedure: Xitronix Corp. v. KLA-Tencor Corp., dba KLA-Tencor, Inc., No. 19-58; and No. 18-1170 (Does appellate jurisdiction over Walker Process claims lie in the regional circuits, or in the Federal Circuit?).
  • Litigation Procedure: Imperium IP Holdings (Cayman), Ltd. v. Samsung Electronics Co., Ltd., No. 19-101 (Overturning jury verdict and the Seventh Amendment).
  • Covered Business Method Review: IBG LLC v. Trading Technologies International, Inc., No. 19-120 (what is a “technological invention” under the CBM review program).

 

U$PTO

Likely PTO budget for FY2020 (starting Oct 1, 2019) is $3.45 Billion. 2.4% increase over FY2019. As in years past, the spending is limited by PTO collections — it cannot spend more than it collects.

Appropriations, 2019....................................  $3,370,000,000
Budget estimate, 2020...................................  $3,450,681,000

Senate Report

A Walk in the Deference Labyrinth: Further Comment on Facebook v. Windy City

by John M. Golden, Professor in Law at the University of Texas School of Law 

As noted in a Patently-O post of September 18, in Facebook, Inc. v. Windy City Innovations, LLC, Nos. 2018-1400 et al. (Fed. Cir. Aug. 12, 2019), the U.S. Court of Appeals for the Federal Circuit requested supplemental briefing on the extent to which it should give deference to the precedential interpretation of a Patent Act joinder provision that the Precedential Opinion Panel (“POP”) of the Patent Trial and Appeal Board (PTAB) adopted in Proppant Express Investments, LLC v. Oren Technologies, LLC, IPR2018-00914 (P.T.A.B. Mar. 13, 2019).  As explained in the earlier post, in Proppant, the POP interpreted the language of 35 U.S.C. § 315(c), which permits the Patent and Trademark Office (PTO) Director, in instituting an inter partes review (IPR), to “join as a party to that inter partes review any person who properly files a petition under section 311 that the Director … determines warrants the institution of an inter partes review under section 314.”  This post is not concerned with the substance of the POP’s interpretation but instead the different ways in which the Federal Circuit might resolve or avoid the deference question, which could determine more generally (i.e., in cases involving interpretation of other provisions of the Patent Act) the extent to which the Federal Circuit gives deference to statutory interpretations of the POP.  The deference question is relatively easily stated, but arguments about it can become intricate.

For starters, there are two basic forms of deference that the Federal Circuit might apply to the POP’s precedential interpretation.  First, the court may determine that the Chevron deference framework applies.  See generally Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).  Under United States v. Mead Corp., 533 U.S. 218 (2001), the Chevron deference framework applies if two threshold conditions are met: (a) Congress delegated to an agency relevant authority “to make rules carrying the force of law” in relation to a statutory scheme and (b) “the agency interpretation claiming deference was promulgated in the exercise of that authority.”  Id. at 226–27; see also Gonzales v. Oregon, 546 U.S. 243, 258–59 (2006).   If the Chevron deference framework applies, the court is to defer to the agency’s interpretation of the statute if two further conditions are met: (1) the statute is ambiguous after all the traditional tools for statutory interpretation are brought to bear and (2) the agency’s interpretation is reasonable.  See, e.g., Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016); Horvath v. United States, 896 F.3d 1317, 1321 (Fed. Cir. 2018).   The court’s assessment of whether the statute is ambiguous is often described as Chevron Step One analysis, and the court’s assessment of whether the agency’s interpretation is reasonable in light of any found ambiguity is often described as Chevron Step Two analysis.  Finally, even if the court determines that the threshold conditions for the Chevron deference framework—sometimes characterized collectively as “Chevron Step Zero,” see, e.g., Cass R. Sunstein, Chevron Step Zero, 92 Va. L. Rev. 187, 191 (2006)—are not satisfied, the court should consider giving substantial, albeit presumably less decisive, weight to the agency’s statutory interpretation in accordance with Skidmore v. Swift & Co., 323 U.S. 134 (1944); see also Mead, 533 U.S. at 234 (“Chevron did nothing to eliminate Skidmore’s holding that an agency’s interpretation may merit some deference whatever its form ….”).

In light of the Chevron and Skidmore frameworks, the Federal Circuit could resolve its deference question in any of various ways:

  • The court could duck the question of what deference framework applies by determining that its holding on statutory interpretation will be the same regardless of any potentially applicable deference or lack thereof. For example, the court could conclude that, even without giving any weight to the POP’s statutory interpretation, the Court agrees with and therefore upholds that interpretation.  Alternatively, the court could duck the deference-framework question by (a) assuming that the Chevron framework applies (i.e., that Chevron Step Zero is fully satisfied) but (b) determining that the POP’s interpretation nonetheless must be overridden because that interpretation is contrary to unambiguous statutory language (failure at Chevron Step One) or otherwise unreasonable (failure at Chevron Step Two).  Because Skidmore deference is generally understood to be weaker than Chevron deference, the court could conclude that the POP’s interpretation likewise fails any potentially applicable deference under Skidmore.  Such a decision would resolve the statutory-interpretation question at issue but would leave unanswered questions about the degree of deference, if any, that the POP’s interpretations of the Patent Act might more generally warrant.
  • The court could determine that the POP’s precedential statutory interpretation satisfies Chevron Step Zero and thus that the Chevron deference framework applies to the court’s review. The United States argues for such a ruling in its amicus curiae brief and further contends that the POP’s statutory interpretation should be upheld under Chevron because it “is not foreclosed by the text and is ‘reasonable in light of the text, nature, and purposes of the statute’ ” Brief for the United States as Amicus Curiae 11–12 [hereinafter “U.S. Brief”] (quoting Cuozzo, 136 S. Ct. at 2142).  Even after determining that the Chevron deference framework applies, however, the Federal Circuit could rule against the POP’s statutory interpretation if the court finds this interpretation to be clearly contrary to the statutory language or an unreasonable reading of ambiguous statutory language (i.e., not within a set of alternative interpretations that the ambiguous language reasonably permits).  Moreover, the Federal Circuit might limit a holding that the POP’s precedential statutory interpretations may satisfy Chevron Step Zero to apply only for interpretations resolving questions that fall within the ambit of express statutory grants of PTO rulemaking authority.  See 35 U.S.C. § 316(a)(4) (“The Director shall prescribe regulations . . . establishing and governing inter partes review. . .”); see also id. §§ 2(b)(2)(A) (“The Office … may establish regulations, not inconsistent with law, which … shall govern the conduct of proceedings in the Office”).  By disclaiming an effort to claim Chevron deference for “the POP’s interpretations of patentability provisions of the Patent Act,” U.S. Brief, supra, at 5 n.2, the Government appears to seek only such a limited holding on Chevron Step Zero.
  • The court could determine that the POP’s precedential statutory interpretation does not satisfy Chevron Step Zero. The court would then need to determine how much weight to give the POP’s interpretation in accordance with Skidmore as well as what interpretation of the statute ultimately controls.  See Mead, 533 U.S. at 234 (“Chevron did nothing to eliminate Skidmore’s holding that an agency’s interpretation may merit some deference whatever its form ….”); Merck & Co. v. Kessler, 80 F.3d 1543, 1550 (Fed. Cir. 1996).  The significance of Skidmore deference is sometimes questioned, but Yoav Dotan discusses in a forthcoming article how Skidmore deference may be viewed as a form of deference that is distinct from that of Chevron but still meaningful, Yoav Dotan, Two Concepts of Deference, 71 Admin. L. Rev. (forthcoming 2020); John M. Golden, The USPTO’s Soft Power: Who Needs Chevron Deference?, 66 SMU L. Rev. 541, 549 (2013).

The Federal Circuit’s rulings in Facebook can have significance extending substantially beyond its particular joinder question if the court goes down either routes (2) or (3)—i.e., if the court resolves the question of whether, at least under circumstances like those in Proppant, the POP’s statutory interpretation satisfies Chevron Step Zero.  Various Federal Circuit judges opined on related questions in Aqua Products, Inc. v. Matal, 872 F.3d 1290 (Fed. Cir. 2017) (en banc).  For example, Judge Moore wrote an opinion, joined by Judges Newman and O’Malley, that explicitly contended that, “where Congress has delegated authority to ‘prescribe regulations,’ ” an agency must generally engage in “regulation” in order to exercise Chevron-level interpretive authority.  Id. at 1330–31 (Moore, J.); see also id. at 1316–22 (O’Malley, J.) (indicating a similar view).  By “regulation,” Judge Moore apparently meant a rulemaking process conducted separately from adjudication, rather than the issuance of precedential holdings in adjudication.  See id. at 1331 (Moore, J.).

The United States’ brief rejects the notion that a specific statutory authorization to issue “regulations” implicitly precludes an agency from “issu[ing] binding [statutory] interpretations through other mechanisms Congress also provided”—in this case, PTAB adjudication.  U.S. Brief, supra, at 8.  In support of this position, the Government invokes a principle that agencies generally have a choice of policymaking mode—a principle with long-standing resonance in U.S. administrative law, see, e.g., Peter L. Strauss et al., Gellhorn and Byse’s Administrative Law: Cases and Comments 385 (11th ed. 2011).  U.S. Brief, supra, at 8–11 & n.4.  Alternatively, the United States’ brief might have sought to distinguish Judge Moore’s position in Aqua Products on the narrower ground that this position primarily contemplated substantive “standards,” not “rules on procedure,” which the opinion explicitly noted “are exempt from the notice-and-comment rulemaking requirements of § 553,” 872 F.3d at 1331–32 & n.4.  Perhaps the United States declined to rely on this distinction because the Government wishes to avoid having deference questions turn on sometimes tricky classifications of substance and procedure.  Joinder rules, for example, might on their face seem fundamentally procedural, cf. Luxliner P.L. Export, Co. v. RDI/Luxliner, Inc., 13 F.3d 69, 71–72 (3d Cir. 1993), but there might be an argument that the IPR joinder provision’s relationship with the statutory time bar for IPR petitions under 35 U.S.C. § 315(b) muddles its status, cf. Joseph v. Athanasopoulos, 648 F.3d 58, 65 (2d Cir. 2011) (quoting the New York Court of Appeals’ statement that “the impact of the Statute of Limitations, though often denominated as procedural, in a practical sense may also be said to be substantive,” Smith v. Russell Sage Coll., 429 N.E.2d 746, 750 (N.Y. 1981)).

In any event, given the background principle invoked by the United States, I tend to agree with Judge Hughes’ opinion in Aqua Products that Judge Moore’s opinion relied too much on the Patent Act’s specific use of the word “regulations” in expressly providing for PTO rulemaking.  See Aqua Products, 872 F.3d at 1364–67 (Hughes, J., dissenting).  The amicus curiae brief from David Boundy shows a way that Judge Moore’s position might be fortified, at least in principle, by reference to such language’s broader statutory context.  Although the Patent Act gives the Director power to act through rulemaking, the Patent Act generally assigns adjudication of proceedings such as IPRs to the PTAB.  See 35 U.S.C. § 6(b)(4); see also id. § 316(c).  Moreover, although the PTO Director can sit as a member of a multi-member PTAB panel such as the POP, the PTAB’s final decisions in such proceedings are not subject to reversal by the Director acting alone, see John M. Golden, Working Without Chevron: The PTO as Prime Mover, 65 Duke L.J. 1657, 1680 (2016), and the PTAB therefore appears to be something other than “a mere alter ego” of the Director, John M. Golden, PTO Panel Stacking: Unblessed by the Federal Circuit and Likely Unlawful, 104 Iowa L. Rev. 2447, 2454 (2019); see also id. at 2456.  Consistent with this apparent separation between the Director and the PTAB, Boundy’s brief suggests that the PTAB should be treated as an adjudicative entity that does not share in any Chevron-level interpretive authority that Congress delegated to the Director.  Brief of Amicus Curiae David E. Boundy, in Support of Neither Party 1–3 [hereinafter “Boundy Brief”]; cf. Martin v. Occupational Safety & Health Rev. Comm’n, 499 U.S. 144, 154 (1991) (stating that, with respect to “traditional agencies—that is, agencies possessing a unitary structure—the Court had “concluded that agency adjudication is a generally permissible mode of lawmaking and policymaking only because the unitary agencies in question also had been delegated the power to make law and policy through rulemaking” (emphasis in original)).

In the context of Facebook, however, there appears to be a problem for Boundy’s invocation of a lack of “consolidated rulemaking and adjudicatory authority,” Boundy Brief, supra, at 5.  Specifically, in contrast to the generality of decisions in an IPR that occur after institution, the Patent Act expressly assigns to the Director the authority to decide on IPR institution and joinder.  See 35 U.S.C.  §§ 314–15.  In combination with the Director’s express power to issue regulations, this original assignment to the Director of case-by-case determination of institution and joinder issues indicates that, from the statutory standpoint, there is “consolidated rulemaking and adjudicatory authority” over these issues.  In deciding institution and joinder issues, the PTAB’s POP apparently exercises authority delegated downward to it by the Director, rather than laterally vested in the PTAB by Congress directly.  Thus, in deciding questions of institution and joinder, the PTAB generally and the POP specifically might be viewed as acting in a manner relatively analogous to that of an adjudicatory body within a more traditionally unitary agency structure—for example, the Board of Immigration Appeals (BIA), an adjudicative body that decides matters based on authority delegated to it by the Attorney General and whose decisions, the Supreme Court has held, may merit Chevron deference.  See Golden, Working Without Chevron, supra, at 1687–89.  In short, even if the Federal Circuit is impressed by the consolidated-authority point, it might still find that the statutory interpretation in Proppant satisfies Chevron Step Zero but at the same time limit the significance of this finding by holding only that the POP’s precedential statutory interpretations are eligible for Chevron deference when those interpretations involve an issue with respect to which the Patent Act has vested both relevant rulemaking and relevant case-by-case decision-making authority in the Director—perhaps, in some circumstances, through an express grant of power to “[t]he Office,” 35 U.S.C. § 2(b)(2), whose “powers and duties” are in turn “vested in” the Director, id. § 3(a)(1).

The intricacies of the above arguments suggest that the Federal Circuit could do the patent community a substantial service by engaging with the question of what deference framework applies to a POP statutory interpretation such as that in Proppant—i.e., by pursuing path (2) or (3) in the three bullets above.  Of course, if the Federal Circuit does answer such a question of general significance, that could increase Supreme Court interest in reviewing the decision.  Several Justices have already signaled interest in reconsidering the reach and validity of the Chevron deference framework.  This past June, five Justices went out of their way to indicate a belief that the framework’s validity is an open question.  See Kisor v. Wilkie, 139 S. Ct. 2400, 2425 (2019) (Roberts, C.J., concurring in part); id. at 2446 n.114 (Gorsuch, J., concurring in the judgment); id. at 2449 (Kavanaugh, J., concurring in the judgment).  Could Facebook be yet another patent case taken up by the Supreme Court?

Design Patent Obviousness: How to Pick a Primary Reference

by Dennis Crouch

The law in this area is a total mess, and this case substantially increases the confusion. 

Campbell Soup Co. v. Gamon Plus, Inc. (Fed. Cir. 2019)

Gamon Plus’s two design patents at issue here are directed to particular aspect of a design for a gravity feed can dispenser. U.S. Design Pats. D612,646 and D621,645.  Campbell’s filed IPR challenges after Gamon sued for infringement.  After initiating the IPRs, the PTAB eventually concluded decided that the claimed design had not been proven obvious.  On appeal, the Federal Circuit has vacated and remanded — holding that the Board had improperly excluded a prior art reference (Linz) as a “primary reference” for the obviousness analysis.

OK – Look at these to “designs.”  Note here that only solid lines count for the actual patented design — the broken (ghost) lines show what the rest of the product might look like.  My replacement drawings are below – showing the design without the ghost lines.

  • D612,646 (on the left) has that curved top portion – no borders claimed so it might continue on wider or stop; two little tabs holding a can; and a portion of a cylindrical object.
  • D621,645 (on the right) is the same except the can might be longer, and the tabs are not claimed.

Design patents are governed by the same obviousness statute – Section 103 – and follow the same Graham v. John Deere inquiry. The inquiry as restated by the Federal Circuit is whether it would have been obvious to PHOSITA to have “combined teachings of the prior art to create the same overall visual appearance as the claimed design.” Apple v. Samsung (Fed. Cir. 2012).  In Apple, the court also provided a methodology of first beginning with a primary reference — a single reference whose “design characteristics … are basically the same as the claimed design” i.e., creates “basically the same visual impression.” See Durling v. Spectrum Furniture Co. (Fed. Cir. 1996); In re Rosen, 673 F.2d 388 (CCPA 1982)

The key reference in this case is Linz, but you’ll note that Linz does not disclose the tabs and neither show a can.

In its decision the PTAB found that the lack of a disclosed can was critical and that adding a “hypothetical can” would be improper. PTAB: Linz “fails to disclose a cylindrical object below the label area in a similar spatial relationship to the claimed design.”  On appeal, the Federal Circuit found that Linz was a proper primary reference since it is clear Linz “is made to hold cylindrical objects in its display area.”  Note – the Federal Circuit did an extremely poor job of explaining this key part of the holding.  The court did rule that the PTAB’s decision lacked ‘substantial evidence’ which indicates its problem is associated with improper factual conclusions rather than improper application of law. However, the court should have analyzed this case with direct reference to Durling and other design patent obviousness precedent.

In its decision, the court agreed with the PTO that the second reference – Samways – could not be a primary reference because of its “dual dispensing area” and “taller” dispensing area.  I’ll note here that this decision appears faulty since the patent itself (especially if looking at its priority documents) contemplates that the dispensers will be lined-up side-by-side — creating the same look as a double-dispenser; and, the ‘taller’ label in Samways should not be a factor since the patent as drawn does not set any limits on the height of the label portion.

On remand, the Board will need to reconsider obviousness.  In addition, the Federal Circuit ordered the Board to “also consider the non-instituted grounds for unpatentability consistent with the Supreme Court’s decision in SAS.

The opinion here was penned by Judge Moore and joined by Judge Prost.  Judge Newman wrote in dissent — arguing that a primary reference must show the can. “The cylindrical object is a major design component.”

= = = =

A third patent was invalidated by the PTAB. D595,074.  I don’t think that one was appealed. The ‘074 patent is part of the same patent family as the ones above and here you can see the way that they are designed to go side-by-side. The key prior art here was U.S. Patent No. 3,203,554, issued Aug. 31, 1965 (“Pendergrast”).

= = = = =

Another pending appeal has to do with a utility patent that is part of the same patent family. As part of the IPR, Gamon cancelled claims 1-16, and the PTAB agreed that the rest of the challenged claims were OK (not proven unpatentable).  Campbell’s appeal is pending before the Federal Circuit.

= = = = =

I pulled-up the original provisional application from this family of patents and found this interesting image (below).  Gamon (who is suing Campbell for infringement) used Cambell soup displays for the figures in its provisional patent application.

 

OpEd: “Blocking Patent” Doctrine Denies Valuable Innovation

The following OpEd comes from the CEOs of Amicus Therapeutics and Nkarta Therapeutics who argue against the Federal Circuit’s “blocking patent” decision in Acorda and in support of Acorda’s petition for writ of certiorari. – DC

= = =

“If I have seen further than others, it is by standing upon the shoulders of giants.” Sir Isaac Newton’s observation has never been more true than in the development of medicines. 

Scientific advances have brought us to the verge of a golden age of medicine. In the years ahead we have the opportunity to alleviate enormous human suffering: more and more cancers will be cured; gene therapies and precision medicines will turn fatal genetic diseases in children into diseases that kill no more; seniors and the families who care for them will no longer be afflicted by Alzheimer’s. To help ensure that we will benefit from such advances, our policies and laws must be aligned with the interests of patients. 

A patent issue pending before the United States Supreme Court, if left unaddressed, could have serious consequences for us all: slowing medical innovation by deterring researchers from improving upon existing medicines. This should alarm every patient who needs a new medicine today and every person who may need one tomorrow. 

Rarely, if ever, can scientists deliver a cure for a disease at the beginning of their research. Biology is complex and magic bullets for diseases are extraordinarily rare. In practice, scientists build new therapies brick by brick. Each incremental step can be meaningful on the way to a cure: by buying time – time with better quality of life, and time until the next advance can provide even more benefit. 

To develop these advances requires hundreds of millions – and often billions – of dollars of investment, over periods that average more than a decade. The average failure rate is about 90% for those drugs that actually make it to patient trials. Any addition to these enormous hurdles slows investment in medical innovation and deprives patients of new and more effective medicines. 

We understand this in very personal ways. One of us, John Crowley, has two children with a rare and serious neuro-muscular disorder, Pompe disease. They were not supposed to live to see kindergarten. Today those children are now in their early 20s and thriving despite their disability because of a novel medicine that has improved and significantly prolonged their lives, though it has not cured them. It has, however, given our family the chance to see birthdays and graduations that otherwise never would have been. It has also given us time to build on this progress to experiment on potentially better ways to treat our children’s devastating diseases. 

Paul Hastings was diagnosed with Crohn’s disease as an adolescent – long before any of the innovations over the last twenty years to treat this condition; as a result, he lost his colon at age 13. Had today’s medicines been developed then, he likely would not have had to. 

We have each devoted our lives and our careers to the development of innovative medical treatments. We have seen first-hand the thought, dedication and the enormous investment of human and financial capital that goes into the approval of even one new drug. We have seen that even an incremental improvement over existing treatments can result in substantial quality of life enhancements for those living with disease and disability. 

A critical case has now put the backbone of this progress – improvements to earlier innovation – under threat. In Acorda Therapeutics v. Roxane Laboratories, a lower federal court ignored 50 years of Supreme Court precedent to nullify patents that were integral to Acorda’s work in turning a failed compound into a first-of-its kind, FDA- approved medicine that improves walking in patients suffering the debilitating effects of multiple sclerosis. 

The legal issue in the case revolves around the lower court’s dramatic expansion of the so-called “blocking patent” doctrine, which weakens protections for patents for medicines, like the Acorda patents, that improve upon prior patents. 

The U.S. Supreme Court will decide next month whether to hear the case. We are deeply concerned that leaving the lower court’s ruling intact will deter investment in science and medicine needed to improve upon existing treatments. In so doing, it would deprive patients of cutting-edge medicines that can dramatically enhance the quality and length of their lives. 

The Founders authorized Congress to grant patent protections to “promote the Progress of Science.” More than two hundred years later, we are in an age of unprecedented medical innovation, but patent law is moving ominously in the other direction. Let’s not turn the clock back on the progress we all need. 

John F. Crowley is the Chairman and Chief Executive Officer of Amicus Therapeutics 

Paul Hastings is the President and CEO of Nkarta Therapeutics 

Here’s a Quarter … : Continued Tricks in Defining what as a Covered Business Method Patent

SIPCO, LLC v. Emerson Electric Co. (Fed. Cir. 2019) On appeal from CBM2016-
00095 (Covered Business Method Review).

In its final written decision, the PTAB sided with the patent challenger Emerson Electric — finding claims of SIPCO’s U.S. Patent 8,908,842 invalid as lacking eligibility and as obvious. Claims 1, 7, 9, 16, and 17.

The patent at issue requires a “low-power transceiver” connected to the internet and wirelessly connected to a remote device.  The patent included dependent claims 3 and 4 that defined the remote device as a “vending machine” and “ATM” respectively.  However, those claims were disclaimed during prosecution — and part of appeal argument is the role of disclaimed claims in construction of the remaining claims.

Note for younger attorneys, the item labeled 110 is a “pay phone.”

Covered Business Method Review (CBM) allows a third-party to challenge to certain business-method patents in an AIA-Trial.  Inter partes review (IPR) proceedings are limited to novelty and obviousness challenges and “only on the basis of prior art consisting of patents or printed publications.”  35 U.S.C. 311.  Post-grant review (PGR) proceedings have much broader scope — any condition of patentability except best-mode. 35 U.S.C. 321.  However, PGR proceedings may only be filed against post-AIA patent and must be filed within 9 months of issuance.

The third category – CBM – has the same scope of patentability challenges as PGR  (including eligibility, enablement, and indefiniteness), but can only be filed against patents that meet the definition of a “covered business method patent”

a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, except that the term does not include patents for technological inventions.

SEC. 18 of the AIA. Looking at the definition above, you’ll note that this is a narrow definition of a “business method” patent — especially the notion that it cannot cover “patents for technological inventions.” (Technological is left undefined in the statute).  Note, the CBM provisions are not codified in Title 35 because the program is not permanent — it is set to sunset 8-years after the first CBM was permitted to be filed. My calculation of that date is September 16, 2020 and no new petitions will be accepted after that date.

NonAppealable: In the appeal, SIPCO argues that its patent is a technological invention and thus should be immune from CBM challenge. And, although the PTO’s decision to initiate a CBM proceeding is “nonappealable,” the Federal Circuit has repeatedly ruled that it can review the PTO decision of whether the challenged patent satisfies the legal limits of the CBM process — i.e., whether the patent challenged in a CBM is a technological invention.

Two Step Test for Technological: The USPTO has issued regulations defining technological inventions as requiring (1) recitation of a nonobvious technological feature; and (2) solving a technical problem using a technical solution.  37 C.F.R. § 42.301(b).  Thus, claims that recite “post-solution” technology could still be deemed not technological.  A reminder here – that the judgment of whether a patent is amenable to CBM review is considered on a patent-by-patent basis — it is either all-in or all-out — and not on a claim-by-claim basis.

After reviewing “both the claims and the specification,” the Federal Circuit concluded that the invention satisfied step two of the two step test – the invention “implements a communication system that connects an unconnected, remote device with a central station . . . by taking advantage of a set of intermediate nodes … connected to the central station over an existing communication network.”  The patent discusses the problems of signal interference, contention, and hacking — and offers its solution of using a “two-step” communications and low-powered transceivers that limit transmission range.  The PTAB had not considered step 1 and so on remand the PTAB will consider whether the claims recite nonobvious technological features.  Although the court left this issue for the PTAB to decide, it noted that the nonobviousness here might be a different sort of analysis than what is used for Section 103.

Low Power = Limited Range: The Federal Circuit’s conclusion of technological solution is substantially based upon a narrow claim construction of the term “low power transceiver.”  The court found that the term should be interpreted (as properly read in light of the specification) as meaning a transceiver with a limited transmission range.  That result comes from one of the goals of the invention — avoiding conflict between transceiver communications. “It is only if the signal transmission is limited in range that the problems of unwanted circumvention, contention, and unlawful interception of the electromagnetic signals described in column six [of the patent] are alleviated.”  This construction differs from the PTAB who had found the “low power” aspect of the transceiver did not necessarily limit its range to only a few feet. This “limited range” aspect of the invention appears to be the major key to the technological result.

Writing in dissent, Judge Reyna argued that the construction of “low power” as meaning “low range” involves “improperly reading a functional limitation into the claim from a preferred embodiment.”

= = = =

Looking back to the Vending Machine and ATM limitations of cancelled Claim 3 & 4. The PTAB used those claims (and the written description) to conclude that the invention was “financial” in nature — a qualifying characterization for CBM review.  On appeal, the majority affirmed the agency’s determination.

As the Board explained, claims 3 and 4 recite the remote device being associated with an ATM or vending machine. The patent expressly contemplates that the information communicated through the claimed system is financial information that identifies the user’s bank account and the user’s identity. The Board is correct in its assessment that the concept of communicating financial information from a device associated with an ATM to a central location is “central to the operation of the claimed device” in claim 3.

Those two claims were disclaimed and SIPCO originally argued that they could not be used to show that the patent was a CBM patent.  However, at oral arguments SIPCO’s attorney conceded that it was proper for the PTO to consider those claims in its analysis.

AI at the USPTO

The USPTO has extended its public comment period on the subject of patenting artificial intelligence inventions. Due Date: October 11, 2019 now November 8, 2019.

Artificial Intelligence (AI) Patents

The PTO is also seeking a Senior Level AI Expert.

The United States Patent and Trademark Office (USPTO) is seeking a technical expert to advance the shared understanding of how to best implement the opportunities presented by Artificial Intelligence. The role will provide technical expertise in developing solutions for real-world, large-scale problems using Artificial Intelligence at the USPTO.

 Apply at USA Jobs: https://www.usajobs.gov/GetJob/ViewDetails/546501200

Supreme Court: What is the Role of Functional Claim Limitations?

by Dennis Crouch

One of the more interesting pending cases before the U.S. Supreme Court has to do with the use of functional claim language at the point of novelty. Eli Lilly and Company v. Erfindergemeinschaft UroPep GbR (Supreme Court 2019).  The Supreme Court has discussed this issue in a series of important cases — albeit most recently in 1946.

In Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946), the Supreme Court invalidated Walker’s on those grounds:

The language of the claim thus describes this most crucial element in the “new” combination in terms of what it will do rather than in terms of its own physical characteristics or its arrangement in the new combination apparatus. We have held that a claim with such a description of a product is invalid as a violation of Rev. Stat. 4888 [“he shall particularly point out and distinctly claim the part, improvement, or combination which he claims as his invention or discovery.”]

Halliburton. The Supreme Court had previously held claims invalid that use “conveniently functional language at the exact point of novelty.”  Gen. Electric Co. v. Wabash Co., 304 U.S. 364 (1938).  The question in Halliburton was whether this patenting-bar applied to claims directed to a combination of elements.  Question as presented in Halliburton:

Is the doctrine of the case of General Electric Co. v. Wabash Appliance Corp., 304 U. S. 364, condemning the use of indefinite and functional language at the exact point of novelty in a claim of a patent, applicable to a claim on a combination of elements, or should the doctrine be limited as held by the Ninth Circuit Court of Appeals, to a claim on a “single element” or “specific product”?

Halliburton Brief.  The Court answered this question affirmatively — yes the same law applies to claims in combination.

We understand that the Circuit Court of Appeals held that the same rigid standards of description required for product claims is not required for a combination patent embodying old elements only. We have a different view.

Id. Congress rejected Halliburton in the Patent Act of 1952 — allowing that “an element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof…” 35 U.S.C. 112.

The 1952 Patent Act expressly allows focused on changing the standard for combination patents, but does not seemingly apply to a claim for a single element.  One interpretation of the section 112(f) is that it reinstates the 9th Circuit holding in Halliburton distinguishing the GE case:

[Petitioner] assumes that the court … failed to consider … General Electric Co. v. Wabash Appliance Corporation, 304 U.S. 364. . . . Halliburton is mistaken. In the General Electric case the claim considered was not one for a combination of elements, but a claim for a single element.

Halliburton Oil Well Cementing Co. v. Walker, 149 F.2d 896 (9th Cir. 1945), aff’d, 326 U.S. 696 (1946), opinion set aside, 329 U.S. 1 (1946).  The invalidated claim in GE was written as follows:

25. A filament for electric incandescent lamps or other devices, composed substantially of tungsten and made up mainly of a number of comparatively large grains of such size and contour as to prevent substantial sagging and offsetting during a normal or commercially useful life for such a lamp or other device.

Patent 1,082,933 (claims 26 & 27 were also invalidated).  In invalidating the claims, the court explained that it had no need to consider whether the claim was anticipated. “The claim is invalid on its face. It fails to make a disclosure sufficiently definite.”

The claim uses indeterminate adjectives which describe the function of the grains to the exclusion of any structural definition, and thus falls within the condemnation of the doctrine that a patentee may not broaden his product claims by describing the product in terms of function. Claim 25 vividly illustrates the vice of a description in terms of function. ‘As a description of the invention, it is insufficient, and, if allowed, would extend the monopoly beyond the invention.’

The Supreme Court agreed that the claim was not “wholly functional” and doubted such a limit would be “ever true. Still, the GE court saw the problem here the inventor’s use of “conveniently functional language at the exact point of novelty.”

A limited use of terms of effect or result, which accurately define the essential qualities of a product to one skilled in the art, may in some instances be permissible and even desirable, but a characteristic essential to novelty may not be distinguished from the old art solely by its tendency to remedy the problems in the art met by the patent.

Gen. Electric Co. v. Wabash Appliance Corp., 304 U.S. 364 (1938).

= = = = =

In Lilly, the question focuses on the impact Section 112 with regards to non-combination claims.

Whether a single-step patent claim that describes its point of novelty solely in functional terms violates the rule against functional claiming set forth in Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946).

[Lilly petition]. The claim at issue is directed to a treatment for benign prostatic hyperplasia (prostate enlargement) by administering “an effective amount of an inhibitor of phosphodiesterase (PDE) V.” The claim also includes a group of compounds that might be inhibitors but that are not covered by the claim.  Lilly’s Cialis drug does serve the function of a PDE inhibitor, but Lilly argues that thousands of other drugs also fit the functional description.

The E.D. Tex. court hearing the case allowed it to go to a jury trial and confirmed the jury verdict of infringement ($20 million damages). On appeal, the Federal Circuit affirmed without opinion. (R.36 Affirmance) .

Response: Uropep has now filed its brief in opposition to certiorari. The brief primarily focuses on disputes related to the patent and procedure — arguing (1) that its claim is structural (2) the issue was not properly preserved on appeal. Uropep rewrote the question as follows:

Whether a patent claim that the district court construed as structural—a conclusion that Petitioner did not challenge in its appeal—is valid under the Patent Act.

[Opposition Brief].  Still, the brief does get into the law and particularly argues that “there is no blanket rule against functional claiming” since Congress enacted Section 112. Note that Uropep had originally waived its right to file a brief, but the Supreme Court requested briefing on the case.

One way to think about this case is to look back onto the invalidated claim 25 in GE v. Walker and ask whether that claim would be patentable now. Or, is it unpatentable because the claim sets the “size and contour” of tungsten grains according to their functional limit — “as to prevent substantial sagging and offsetting during a normal or commercially useful life for such a lamp or other device.”

= = = = =

An interesting aspect of this case is how it relates to patent eligibility.  The patentees here appear to have been the first to discover the general concept that PDE V inhibitors can serve as a treatment for benign prostatic hyperplasia. That general discovery itself is an unpatentable aspect of how the human body works — what the Supreme Court calls a Law of Nature.  As such, the patentee looked to find the broadest application of the general law — administering a PDE V inhibitor in an amount effective to treat.  In its briefing, the patentee Uropep suggests that there might have been an eligibility argument in this case, but it was waived by Lilly.

What is this Appeal About? Secrecy at the Federal Circuit

UCP International Company Ltd. v. Balsam Brands Inc., Appeal No. 18-2231 (Fed. Cir. 2019)

In a separate post, I’ll write about the underlying decision here. This post is about the opening paragraph that begins with a reference to companion case (18-1256) involving the same case:

The instant appeal is the companion to concurrently issuing Appeal No. 18-1256 (“the Merits Appeal”), where we determined that the U.S. District Court for the Northern District of California misconstrued the “pivot joint” claim term of U.S. Patent Nos. 8,062,718 (“the ’718 patent) and 8,993,077 (“the ’077 patent”) (collectively, “the Patents-inSuit”). See UCP Int’l Co. v. Balsam Brands, Inc., No. 2018-1256, slip op. at 27 (Fed. Cir. Sept. 19, 2019). We presume familiarity with our opinion in the Merits Appeal which recites the same technology and patents as the instant appeal. We, therefore, only recite the facts necessary to understand the issues on appeal here.

Unfortunately, the referenced merits decision was issued under seal and so cannot be referenced as suggested by the appellate panel.

In the lawsuit, Balsam sued Frontgate for infringing its patents covering an artificial Christmas tree. Frontgate brought-in the manufacturer UCP for indemnification. Balsam then settled with Frontgate (without notifying UCP) and in a manner that left UCP liable for infringement. The confidential information is apparently related to the settlement between Balsam and Frontgate whose contents were designated as “Highly Confidential – Outside Attorneys’ Eyes Only” in the district court litigation.  In its briefing, Balsam identified the settlement terms as “highly confidential, sensitive information.”

The Federal Circuit has asked the parties to “show cause” as to why the under seal opinion should remain under seal with briefing due by October 3. The Federal Circuit has a particular rule limiting confidential marking to 15-words.  Fed. Cir. R. 28(d)(1). “A party seeking to mark confidential more than fifteen words in any brief must file a motion with this court establishing that the additional confidentiality markings are appropriate and necessary pursuant to a statute, administrative regulation, or court rule.”  Id.

I have included the redacted sections from UCP’s brief (BELOW) and I really can’t see how it can only be 15 words that are redacted. Note that the rule does allow for “repeating the marked words” without recounting. But, there are more than 15 lines of text marked confidential with usual average of 10+ words per line.

 

. . . 

. . .