Tag Archives: Section 102

Patenting Informational Innovations: IOEngine Narrows the Printed Matter Doctrine

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by Dennis Crouch

This may be a useful case for patent prosecutors to cite to the USPTO because it creates a strong dividing line for the printed matter doctrine — applying the doctrine only to cases where the claims recite the communicative content of information. 

IOEngine, LLC v. Ingenico Inc., 2021-1227 (Fed. Cir. 2024).

In this decision, the Federal Circuit partially reversed a PTAB invalidity finding against several IOEngine patent claims. The most interesting portion of the opinion focuses on the printed matter doctrine.   Under the doctrine, certain “printed matter” is given no patentable weight because it is deemed to fall outside the scope of patentable subject matter. C R Bard Inc. v. AngioDynamics, Inc., 979 F.3d 1372 (Fed. Cir. 2020).  In this case though the Federal Circuit concluded that the Board erred in giving no weight to IOEngine’s claim limitations requiring “encrypted communications” and “program code.”

The printed matter doctrine a unique and somewhat amorphous concept in patent law that straddles the line between patent eligibility under 35 U.S.C. § 101 and the novelty and non-obviousness requirements of §§ 102 and 103. (more…)

Bringing Home the Bacon with Joint Inventorship

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Guest Post by Jordan Duenckel.  Jordan is a second-year law student at the University of Missouri, head of our IP student association, and a registered patent agent.  He has an extensive background in chemistry and food science.

HIP, Inc., v. Hormel Foods Corp., 2022-1696, — F.4th — (Fed. Cir. May 2, 2023)

Joint inventorship requires a substantial contribution to the invention. In the decision HIP, Inc. vs. Hormel, Judge Lourie writes for a unanimous panel to reverse a district court’s determination of joint inventorship involving a new process for precooking bacon. US Patent 9,980,498 has four inventors that are employees of and assigned their interest to Hormel.  HIP sued Hormel, alleging that David Howard was either the sole inventor or a joint inventor of the ’498 patent. The district court determined that Howard was a joint inventor based solely on his alleged contribution to the infrared preheating concept in independent claim 5.  

Bacon is an interesting food with unique preservation and cooking properties. Being a cured product, for food safety reasons, no additional cooking of the bacon is needed when bought off the shelf in a refrigerated section. Of course, most people are not consuming the bacon without additional cooking and some companies will precook the product for consumer convenience. When precooking, Hormel is trying to avoid the loss of salt, and therefore flavor, through condensation and prevent the creation charred off flavors (as opposed to the desirable char on a steak).  

 In the process of viability testing the new method, prior to filing the application, the inventors consulted with David Howard of Unitherm, HIP’s predecessor, to discuss methods related to Unitherm’s cooking equipment to create a two-step process of preheating then a higher temperature step. After some difficulties, Hormel leased the equipment and returned to their own R&D lab. The method created, the subject matter of the ‘498 patent, involves a first step that allows the fat of the bacon to seal the surface of the bacon and prevent condensation. The charring was remedied by adjusting the heating method of the oven in the second step of high-temperature cooking. In Hormel’s product development, Hormel tried an infrared oven and a conventional spiral oven.

HIP argued that Howard contributed to the ‘498 patent in the preheating by hot air in claim 5 and/or preheating with an infrared oven in claim 5.  Claim Five reads in the relevant part:  

  1. A method of making precooked meat pieces using a hybrid cooking system, comprising: preheating meat pieces in a first cooking compartment using a preheating method selected from the group consisting of a microwave oven, an infrared oven, and hot air to a temperature of at least 140º F. to create preheated meat pieces…

On appeal, Hormel argues that Howard’s contribution is well-known in the art and insignificant when measured against the full invention. With inventorship being a question of law, and the issuance of a patent creating a presumption of inventorship, an alleged joint inventor must provide clear and convincing evidence to substantiate their claim. In evaluating whether a significant contribution was made by Howards, the parties apply the test from Pannu v. Iolab Corp., 155 F.3d 1344, 1351 (Fed. Cir. 1998). The test requires that the alleged joint inventor: 

(1) contributed in some significant manner to the conception of the invention; (2) made a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention; and (3) did more than merely explain to the real inventors well-known concepts and/or the current state of the art. 

Analyzing the second Pannu factor, the Court found that the alleged contribution of preheating meat pieces using an infrared oven to be insignificant in quality because it was mentioned only once in the patent specification as an alternative heating method to a microwave oven and was recited only once in one Markush grouping in a single claim. In contrast, preheating with microwave ovens and microwave ovens themselves were prominently featured throughout the specification, claims, and figures. The examples and corresponding figures also employed procedures using preheating with a microwave oven, but not preheating with an infrared oven.  

Infrared heating seems to have been an afterthought in the creation of the two-step precooking method. Whatever discussions Howard might have had about the importance of the infrared, Hormel seems to have focused on microwave heating to solve the condensation problem. From one step further back, it seems absurd to permit joint ownership by a cooking equipment manufacturer when the significant discoveries and refinements of the methods were made in Hormel’s R&D facility without Howard present. The prevention of condensation and avoiding the char flavor were both made independent of Howard’s contributions. Considering the second Pannu factor, the reversal of inventorship seems appropriate.  

Overlapping Ranges in Claims and Prior Art Result in Invalidation of Patent on Transdermal Patch for Parkinson’s Disease

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By Chris Holman

UCB, Inc. v. Actavis Lab’ys UT, Inc., 2023 WL 2904757, — 4th —   (Fed. Cir. Apr. 12, 2023)

Rotigotine is a drug used to treat Parkinson’s disease. People with Parkinson’s disease experience significant gastrointestinal dysfunction, such as difficulty swallowing, which can frustrate the oral administration of drugs. However, the complications associated with oral treatment can be avoided by means of a transdermal patch that delivers the drug through the patient’s skin.  In order to cross the skin barrier, however, the drug must be in an “amorphous,” i.e., non-crystalline, form.  If the drug crystallizes in the patch, it will generally not be able to cross the skin barrier.

In 2007, UCB invented and marketed “original Neupro,” a transdermal patch for the treatment of Parkinson’s disease containing a dispersion of amorphous rotigotine and polyvinylpyrrolidone (PVP), with the PVP functioning as a stabilizer. Unfortunately, soon after original Neupro entered the market it was found that the rotigotine was crystallizing when stored at room temperature, rendering the drug ineffective.  This caused UCB to recall the product from the U.S. market in April 2008 (although it remained in limited use under a compassionate-use program). In Europe, regulators allowed original Neupro to stay on the market, under the condition that it would only be marketed under “cold-chain conditions,” i.e., it would be stored in a refrigerator.

The patent at issue in this case, U.S. Patent No. 10,130,589, is directed towards UCB’s solution to this problem, which was to essentially double the amount of PVP in the patch, from original Neupro’s weight ratio of rotigotine to PVP of 9:2 to the new, reformulated Neupro’s weight ratio of 9:4. In particular the ‘589 patent claims a method for stabilizing rotigotine by combining a non-crystalline form of rotigotine with PVP to form a solid dispersion, wherein the weight ratio of rotigotine to PVP is in a range from about 9:4 to 9:6. UCB re-entered the U. S. market with its reformulated Neupro in 2012.

In 2019, UCB sued Actavis for infringing the ‘589 patent in a Hatch-Waxman lawsuit.  The district court found the asserted claims to be invalid based on anticipation and obviousness, particularly in view of earlier-issued UCB patents, i.e., the “Muller patents,” which disclosed combinations of rotigotine and PVP present at a range of weight ratios from 9:1.5 to 9.5. Note that the Muller patents cover both original Neupro (9:2) and reformulated Neupro (9:4), while the ‘589 patent (claiming a range of 9:4 to 9:6) only covers reformulated Neupro. Significantly, UCB had successfully asserted a Muller patent in a previous ANDA suit that resulted in an injunction preventing approval of Actavis’s ANDA until the relevant Muller patent’s expiration in March 2021. The ‘589 patent would not have expired until December 2030, and thus could have delayed FDA approval of a generic version of Neupro by nine additional years.

On appeal, the Federal Circuit reversed the district court’s anticipation ruling, but affirmed on the basis of obviousness. The opinion, authored by Judge Stoll, begins by explaining that Federal Circuit precedent sets forth an established framework for analyzing whether a prior art reference anticipates a claimed range. If the prior art discloses a point within the claimed range, the prior art anticipates the claim. On the other hand, if the prior art discloses an overlapping range, the prior art anticipates the claimed range “only if it describes the claimed range with sufficient specificity such that a reasonable factfinder could conclude there is no reasonable difference in how the inventions operate over the ranges.”

In the case at hand, the prior art Muller patents disclose a range (9:1.5 to 9.5) that overlaps with the range claimed in the ‘589 patent (9:4 to 9:6). The Federal Circuit found that the district court had erred by failing to analyze this as an overlapping range case, but to instead treat this as a case in which the prior art discloses a point within the claimed range.  The Muller patents did not literally disclose any point within the range claimed in the ‘589 patent, but the district court had nonetheless concluded, based on expert testimony, that the range disclosed in the Muller patents would implicitly teach a person of skill “a few examples” of specific weight ratios, including 9:4 and 9:5 weight ratios of rotigotine to PVP. Nonetheless, the district court’s error with regard to its anticipation analysis was rendered moot when the Federal Circuit proceeded to affirm its obviousness finding.

Judge Stoll cited Federal Circuit precedent for the proposition that there is a presumption of obviousness when a claimed range overlaps with a range disclosed in the prior art. Although this presumption can be overcome if, e.g., the prior art teaches away from the claimed range, or the claimed range produces new and unexpected results, or other evidence demonstrates the nonobviousness of the claimed range, in this case the Federal Circuit agreed with the district court that UCB had failed to present evidence to rebut the presumption of obviousness.

For example, the district court had not erred in its decision to disregard the commercial success of reformulated Neupro, based on a lack of a nexus between the drug’s commercial success and the claimed invention. In particular, the Federal Circuit agreed that the existence of the Muller patents weakened UCB’s evidence of commercial success, because these patents operated as blocking patents, dissuading competitors from developing a rotigotine transdermal patch, at least until the Muller patents expired. While rejecting UCB’s suggestion that the court’s analysis had branded all co-owned patents as “blocking” patents, the court noted that in this case UCB had held exclusive worldwide rights to rotigotine for all therapeutic indications since 1998, and that until the Muller patents expired Actavis had been enjoined from marketing a generic version of reformulated Neupro.

Guest Post by Profs. Masur & Ouellette: Public Use Without the Public Using

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Guest post by Professors Jonathan S. Masur (Chicago Law) and Lisa Larrimore Ouellette (Stanford Law).

What is it that makes a use “public” for purposes of the public use bar? Does it matter whether the person doing the using is a member of the public, as opposed to the inventor? Or does it matter whether the use is itself in public, as opposed to taking place in secret behind closed doors? As it turns out, the answer to both questions is “yes,” but the questions are not as distinct from one another as that formulation might make it seem. Instead, the issue of who is doing the using turns out to affect where and how that use must occur if it is to be public use.

Begin with the question of who is doing the using. Most cases of “public use” have involved use by at least one member of the public—“a person other than the inventor who is under no limitation, restriction or obligation of secrecy to the inventor.” And when an invention is in use by a member of the public (rather than the inventor), it is blackletter law that the use can be “public use” even if it takes place entirely in secret, behind closed doors. In addition, it is also blackletter law that the use need not enable the invention to constitute prior art. No member of the public needs to see all the details of the invention or be able to reproduce it—it is enough that at least one person has come to rely on the availability of the invention free from any patent-based restriction.

But as we explain in a forthcoming article, a small line of cases suggests there is a second route to public use: even if no member of the public uses the invention, an invention can be placed in public use if it is used by the inventor, but only if it is displayed to the public in such a way that the relevant public could have understood the invention. That is, there can be public use without the public using, but only if that use is out in the open and with something like an enablement requirement. See Real-World Prior Art, 76 Stan. L. Rev. (forthcoming 2024). These cases appear to rely on an idea of constructive public knowledge: just as a conference poster can be invalidating printed publication prior art if a researcher could have learned about the invention by reading it, an inventor’s demonstration of an invention can be an invalidating public use if someone could have learned about the invention from observing the demonstration. Likewise, the Federal Circuit has held that display of an invention is not public use “if members of the public are not informed of, and cannot readily discern, the claimed features of the invention.” The only exception to these rules has come when the inventor is engaged in secret commercial use of the invention. Some courts have held that this puts the invention into public use. But more recently, the Federal Circuit has instead begun to hold that this places the invention on sale, because the whole point of the use is to exploit the invention commercially. We agree with the Federal Circuit panels that have held that the on sale bar is a better fit in these situations.

The upshot from these two lines of precedent is that the question of whether an invention is in public use depends intimately on who is doing the using. If the user is someone other than the inventor, then there is public use (a) even if the use is taking place in secret, and (b) irrespective of whether the user can figure out how the invention works (enablement). But if the inventor herself is the one doing the using, then (a) the use must be taking place in public, and (b) the use must be enabling.

As one might predict, the grouping of these two approaches under the single heading of “public use” has led to confusion among litigants and, in some cases, courts. Two new Federal Circuit decisions this month add to this “public use without the public using” line of cases and demonstrate the pitfalls of failing to keep the interlocking public use rules straight. In Minerva v. Hologic, the court held that display and demonstration of a medical device at a gynecological trade show constituted public use. The patentee, perhaps misunderstanding this line of doctrine, argued that it could not be public use because no member of the public used the invention. But the court held that “public use may also occur where, as here, the inventor used the device such that at least one member of the public without any secrecy obligations understood the invention.” Similarly, In re Wingen held that display of an inventive “Cherry Star” flowering plant at a private Home Depot event placed the plant into public use. The patentee argued that the display did not disclose the claimed genetics of the plant—which could have been a successful argument given the enablement-like inquiry imposed on other similar cases—but the court held that this argument was forfeited because it was not raised in proceedings below. It seems likely that the lawyers who argued the case before the PTAB had not thought to make this argument because they did not realize that use by the inventor requires enablement. Our article includes numerous examples of district courts that were similarly confused by the rules that vary depending on who’s doing the using.

As we explain in our article, treating enabling demonstrations by the inventor as prior art makes sense as a matter of patent policy. But lumping these cases under the “public use” umbrella has created confusion and mistakes among the lower courts. Going forward, we think the Federal Circuit should be explicit that there are two distinct routes to public use: (1) use by a member of the public—someone under no obligation of confidentiality to the inventor—which can take place in secret and need not be enabling, and (2) use by the inventor, which must take place in public and enable the invention.

Alternatively, and perhaps even better, the Federal Circuit could decide that the inventor-use category of activities instead implicates the “otherwise available to the public” prong of § 102. An enabling demonstration, where the public learns about the invention but cannot use it, could be the paradigmatic example of an activity that makes an invention available to the public without creating any other type of prior art. This is not a full solution given all the pre-AIA patents still in force, and in light of the strong policy reasons for barring pre-AIA patents that were displayed publicly we can see why courts have tried to fit these cases within the “public use” category. Regardless, for patentees and their attorneys, Minerva v. Hologic and In re Wingen serve as a reminder to avoid disclosing the details of an invention before they are ready to file a patent application—and if a disclosure does occur, they should remember to preserve the argument that it wasn’t actually enabling!

How Does One “Use” Flowers?

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by Dennis Crouch

We all love flowers, but what is their real purpose, their “use.”  That was a key question the court faced when deciding In re WinGen LLC (Fed. Cir. 2023).

The utility patent at issue covers a petunia plant.  Here, the Federal Circuit has affirmed that the claims are invalid based upon a pre-filing trade-show display of the ornamental plant — holding that the display counted as a “public use.”  “The displaying of ‘Cherry Star’ … was … undoubtedly a use for its intended purpose: ornament.”

The inventors here used conventional plant breeding to create a new form of petunia (Calibrachoa).  WinGen first obtained a plant patent (PP23,232); followed by a utility patent that was filed as a continuation-in-part (US9313959). The claims require two components (1) a particular petal phenotype and (2) a particular genotype:

Petal Phenotype: at least one inflorescence with a radially symmetric pattern along the center of the fused petal margins, wherein said pattern extends from the center of the inflorescence and does not fade during the life of the inflorescence, and

Genetic Feature: a single half-dominant gene, as found in Calibrachoa variety ‘Cherry Star,’ representative seed having been deposited under ATCC Accession No. PTA-13363.

During the reissue, the patentee disclosed the potential invalidating prior use; admitting that the claimed variety was displayed at a private Home Depot event where wholesale growers displayed their wares.  Nothing was for sale at the event, no orders were placed, and attendees were not permitted to take samples or cuttings.  However, there was also no express or implied obligation of confidentiality binding individuals who attended.

The patentee argued that the display should not be considered a public use — it was only displayed — and not used.  One case on point is Motionless Keyboard Co. v. Microsoft Corp., 486 F.3d 1376 (Fed. Cir. 2007).  In that Motionless Keyboard, the alleged prior use involved displaying the invention (a keyboard).  But there, the court found no public use because the keyboard was not hooked-up to a computer. Id.  The patentee also distinguished the old canard of Egbert v. Lippmann, 104 U.S. 333 (1881).  In Egbert, the Supreme Court premised its public use finding on the notion the inventor failed to maintain control over his invention — allowing someone to wear the corset around in public repeatedly over an extended time without any restrictions. See, Dey, L.P. v. Sunovion Pharms., Inc., 715 F.3d 1351 (Fed. Cir. 2013).  Here, however, the flower was kept in the control of the patentee despite being displayed.

In distinguishing these cases, the Federal Circuit looked to the purpose of the invention.  The oddity of this utility patent is that it claims an ornamental plant.  Although the claims were not challenged on Section 101 utility grounds, the Federal Circuit still considered the plant’s utility as it fed into the “public use” bar of Section 102.  And without fanfare, the court concluded that its purpose was ornamentation; that a display of the plant counts as ornamentation; and therefore the plant was in public use.

Although the court indicates that this situation (ornamental use of a utility patent) is a unique question of first impression, the court inexplicitly issued its decision as non-precedential. Perhaps the court simply did not want to make law based upon a logical paradox. Further, the Federal Circuit’s justification was not found in the USPTO brief in the case. Rather, the USPTO asked for a simple rule that a public use follows from display of the complete invention in a commercial setting and without any secrecy limitations.  But public display is not enough for a finding of traditional public use.

The patentee had also argued that its continued control over the plant meant that nobody at the Home Depot event could have learned of the genetic feature claim limitation.  On appeal, the Federal Circuit did not consider that argument – finding that the argument had been forfeited because it was not meaningfully presented to the lower tribunal.

The patentee told the court in briefing and at oral arguments that the claims cover an ornamental plant.  Those admissions allowed the court to rely upon that conclusion in its decision.  Here, the real utility might be found in the specification (and deposit) that provide guidance on how to grow the plant.

Note that this was a pre-AIA case.  The AIA now includes an additional catch-all “otherwise available to the public” that presumably makes it easier to show that certain public showings ‘count’ as prior art.