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Exploring the Latest in Intellectual Property Law
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No Need To Be Explicit: Implicit Finding of Expectation of Success Is Sufficient

by | Oct 5, 2023 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board unpatentability decision, finding that a combination of prior art references only requires an implicit indication of a reasonable expectation of success. Elekta Ltd. v. Zap Surgical Systems, Case No. 21-1985 (Fed. Cir. Sept. 21, 2023) (Reyna, Stoll, Stark JJ.)

Elekta owns a patent directed to a “method and apparatus for treatment by ionizing radiation.” The claimed invention uses a radiation source such as a linear accelerator (linac) mounted on concentric rings to deliver a beam of ionizing radiation to a target area on the patient. Zap challenged the patent as obvious in an inter partes review (IPR) proceeding. In its Final Written Decision, the Board agreed, concluding that a skilled artisan would have been motivated to combine the asserted prior art references. Elekta appealed.

Elekta raised three arguments on appeal:

  1. The Board’s findings on motivation to combine were not supported by substantial evidence.
  2. The Board failed to make any findings (explicit or implicit) on a reasonable expectation of success.
  3. Even if the Board made such findings, they were not supported by substantial evidence.

The Federal Circuit first considered the issue of motivation to combine the prior art references disclosing radiation imagery with references disclosing radiation therapy, noting that the obviousness determination does not always require the prior art to expressly state a motivation for every obviousness combination. Elekta had challenged the asserted combination based on a physical impracticality in combining the art due to the weight of the linac. The Board, however, disagreed largely because of the level of skill in the art in addition to its definition of the relevant field as one that “includes the engineering design of sturdy mechanical apparatuses capable of rotationally manipulating heavy devices.” The Court found that the Board’s finding of motivation to combine was supported by substantial evidence, including the prosecution history, the prior art teaching and the expert testimony of record.

The Federal Circuit next considered Elekta’s argument that the Board erred by failing to articulate findings on reasonable expectation of success. The Court explained that “an obviousness determination requires finding that a person of ordinary skill in the art would have had a reasonable expectation of success,” referring to “the likelihood of success in combining references to meet the limitations of the claimed invention.” The Court concluded, however, that unlike the motivation to combine determination, which must be an explicit analysis under KSR, a finding of reasonable expectation of success may be implicit. The Court acknowledged that this could be seen as being in tension with its review of Board determinations under the Administrative Procedure Act but concluded that “there is no such tension where the Board makes an implicit finding on reasonable expectation of success by considering and addressing other, intertwined arguments, including . . . those [regarding] a motivation to combine.”

Finally, the Federal Circuit addressed Elekta’s argument that, even if the Board made an implicit finding on reasonable expectation of [...]

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Hit Rewind: Analogous Art and Field of Endeavor

by | Sep 21, 2023 |

Addressing the Patent Trial & Appeal Board’s application of the field of endeavor and reasonably pertinent tests for determining analogous art, the US Court of Appeals for the Federal Circuit found that the Board should not have required a petitioner to precisely articulate the relevant field of endeavor for the patent and prior art using the magic words, “field of endeavor.” However, the Court agreed with the Board that the prior art was not reasonably pertinent because it concerned a different problem than the challenge addressed by the patent. Netflix, Inc. v. DivX, LLC, Case No. 22-1138 (Fed. Cir. Sept. 11, 2023) (Stoll, Hughes, and Stark, JJ.)

Netflix filed an inter partes review (IPR) challenging DivX’s patent directed toward a feature called “trick play functionality,” which refers to the ability to fast forward, rewind and skip frames in a multimedia file. The patent’s background explains that the invention generally relates to the “encoding, transmission and decoding of multimedia files.” Notably, the claimed invention implements a multimedia file based on the Audio Video Interleave (AVI) structure with an additional storage structure called an “index chunk.”

In its petition, Netflix asserted that the challenged claims were obvious over two prior art references, Zetts in view of Kaku. Kaku disclosed the use of an AVI file with an index chunk to show image data and/or play sound data in a digital camera. Kaku explained that the invention’s primary object is to reproduce a motion image in a device with minimal memory but clarified that the invention is “applicable to every electronic appliance to reproduce motion images.” Netflix asserted that Zetts disclosed a system for facilitating trick play while Kaku disclosed using an AVI file format with an index chunk to store video/audio data.

In its patent owner response, DivX argued that Kaku was non-analogous art because the challenged patent relates to facilitating trick play in streamed multimedia content, whereas Kaku utilizes M-JPEG files in limited-memory cameras. DivX similarly argued that Kaku was not reasonably pertinent to the problem of “facilitating trick play functionality in streaming services.” Netflix countered that Kaku must be considered for its AVI teachings and/or the “encoding and decoding of multimedia files,” both of which are “applicable to every electronic appliance to reproduce motion images” and render Kaku reasonably pertinent. The Board rejected Netflix’s obviousness argument, holding that it failed to identify the field of endeavor for the DivX patent or Kaku, as well as the problem to be addressed by the DivX patent. Netflix appealed.

The Federal Circuit first considered the Board’s conclusion that Netflix failed to identify an overlapping field of endeavor for Kaku and the DivX patent. The Court explained that the field of endeavor is determined by reference to explanations of the invention’s subject matter in the specification and is not limited to the specific point of novelty or the particular focus within a field. Rather, a field of endeavor may be broadly defined because it relies on the specification’s complete disclosure. Applying this principle, the [...]

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Don’t Be So Stern: Copying Carries Significant Weight in Assessing Objective Evidence

by | Aug 31, 2023 |

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board decision invalidating a patent, finding that the Board erred in assessing nexus and weight to be accorded to objective evidence of nonobviousness. Volvo Penta of the Americas, LLC v. Brunswick Corp., Case No. 22-1765 (Fed. Cir. Aug. 24, 2023) (Moore, Lourie, Cunningham, JJ.)

Volvo Penta owns a patent directed to a tractor-type stern drive for a boat. A stern drive is a type of engine that is mounted in the hull of a boat and connected to a drive unit mounted outside of the hull, typically on the stern. In the industry, this arrangement is often referred to as an inboard/outboard drive. In 2015, Volvo Penta launched its commercial embodiment of the patent called the Forward Drive and was popular particularly for wake surfing and other water sports. The Forward Drive included forward-facing propellers that increased the distance between the propeller and swimmers or surfers compared to prior pulling-type stern drive boats.

In August 2020, Brunswick launched its own drive, the Bravo Four S, which embodies Volvo Penta’s patent. On that same day, Brunswick filed a petition for inter partes review asserting that the challenged claims were anticipated or obvious based on several references, two of which were Kiekhaefer and Brandt. In response, Volvo Penta argued that a person of ordinary skill in the art would not have been motivated to combine Kiekhaefer and Brandt with a reasonable expectation of success and that the objective indicia of nonobviousness overcame any prima facie case of obviousness. In support, Volvo Penta offered evidence of copying, industry praise, commercial success, skepticism, failure of others and long-felt but unsolved need. Volvo Penta also argued that it was entitled to a presumption of nexus between the objective indicia and the claimed invention, and, even if there was no presumption, there was still nexus.

The Board found that Kiekhaefer did not anticipate the challenged claims, but it would have been obvious to redesign the stern drive of Brandt in light of Kiekhaefer’s outboard motor to arrive at the challenged claims. After finding a motivation to combine (and prima facie obviousness), the Board turned to Volvo Penta’s objective evidence of nonobviousness. The Board first determined that Volvo Penta was not entitled to a presumption of nexus because, even though the Forward Drive and Bravo Four S indisputably embody the challenged claims, Volvo Penta did not make sufficient arguments on coextensiveness. The Board also found that regardless of the presumption, Volvo Penta did not otherwise show nexus because it failed to identify the “unique characteristics” or “merits” of the claimed invention.

Despite finding no nexus, the Board still analyzed the objective evidence and concluded that Volvo Penta’s objective evidence weighed somewhat in favor of nonobviousness but that Brunswick’s strong evidence of obviousness outweighed the objective evidence. The Board therefore concluded that the challenged claims were unpatentable. Volvo Penta appealed.

Volvo Penta raised three primary arguments on appeal:

  1. The Board’s [...]

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No Two Ways About It: No Disparagement ≠ Teaching Away, Free Samples ≠ Commercial Success

by | Aug 31, 2023 |

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board invalidating two patents: one as anticipated because disclosure of a genus anticipated the claimed species, and the other as obvious because the prior art did not disparage the claimed invention and therefore was not a “teaching away.” The Court also found that free samples cannot be used to show commercial success. Incept LLC v. Palette Life Sciences, Inc., Case Nos. 21-2063; -2065 (Fed. Cir. Aug. 16, 2023) (Schall, Taranto, JJ.) (Newman, J., concurring in part, dissenting in part).

Incept owns two patents related to improved methods for treating cancer, particularly prostate cancer, using radiation. The patents describe methods of introducing a filler between a radiation-targeted tissue and other tissue to increase the distance between the two and thereby decrease the amount of radiation received by the non-targeted tissue. Palette filed inter partes review petitions against each patent, asserting that the claims of one patent were anticipated and the claims of the other were obvious. Both theories of invalidity relied on the same prior art reference, Wallace. The Board instituted review and ultimately found both patents unpatentable. Incept appealed.

As to the patent that the Board found anticipated, Incept argued that the Board erred legally by “picking and choosing” from the teachings of Wallace to piece together elements. Incept argued that Wallace teaches a genus of millions to billions of possible compositions while its patent claims a species. Thus, according to Incept, the genus had to be defined well enough that a person of ordinary skill could have envisioned each member of the genus.

The Federal Circuit found no legal error in the Board’s anticipation analysis. The Court rejected Incept’s assertion that its patent claimed a species, finding that the patent described a method to inject a composition that had the same general properties as the composition described in Wallace. The Court also found that the Board’s conclusion that Wallace taught biodegradable compositions (where Wallace stated that “a portion of the polymer may be biodegradable”) was supported by substantial evidence and noted that it was not the Court’s duty to reweigh factual determinations.

As to the Board’s obviousness finding of the other patent, Incept alleged that the Board improperly reiterated its anticipation analysis, disregarded statements in Wallace that teach away, did not separately analyze the dependent claims and disregarded evidence of commercial success. The Court was unpersuaded by any of these arguments.

First, the Federal Circuit noted that since the anticipation analysis had no error, it was not improper for the Board to rely upon that analysis for its obviousness determination. The Court noted that the Board relied on the teachings of another piece of prior art concerning the challenged patent’s displacement limitation. The Court also dismissed Incept’s allegation that the motivation to combine analysis was conclusory.

The Federal Circuit rejected Incept’s assertion that Wallace taught away from biodegradable compositions, noting that Wallace provided a preference for an alternative but did not criticize, discredit or [...]

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Petitioner Reply May Include New Evidence if Responsive to Patent Owner and Based on Original Legal Contentions

by | Aug 24, 2023 |

Addressing the issue of new invalidity theories offered during inter partes review (IPR) proceedings, the US Court of Appeals for the Federal Circuit held that a petitioner does not improperly offer new theories when it merely expands on previously raised arguments and responds to a patent owner’s assertions without advancing a “meaningfully distinct [invalidity] contention.” Rembrandt Diagnostics, LP v. Alere, Inc., Case No. 21-1796 (Fed. Cir. Aug. 11, 2023) (Moore, C.J.; Reyna, Dyk, JJ.) The Court further concluded that the patent owner waived its new theories argument by raising a general objection that did not identify which theories were allegedly new.

Alere filed an IPR petition challenging a Rembrandt patent directed to test assay devices and methods for testing biological fluids. Alere argued that the claims were obvious over two combinations of prior art references (among other grounds not at issue on appeal): MacKay in view of Charm or May, and Tydings in view of MacKay or Lee-Own. On remand from a previous appeal, the Patent Trial & Appeal Board ordered briefings on all non-instituted grounds set forth in Alere’s petition. Rembrandt filed a patent owner response without an expert declaration. Alere filed a reply attaching a declaration from its expert and responding to arguments raised by Rembrandt in its response and by the Board in its institution decision.

In a sur-reply, Rembrandt generally argued that Alere “resort[ed] to new theories in reply” but did not specifically contest the two combinations at issue while specifically objecting to other allegedly new theories. Relying on Alere’s expert testimony, the Board issued a final written decision finding the claims at issue unpatentable over the MacKay and Tydings combinations. Rembrandt unsuccessfully petitioned for Director rehearing and then appealed the decision, arguing that the Board abused its discretion by relying on Alere’s new theories and evidence and that there was a dearth of substantial evidence to support the Board’s determinations.

The Federal Circuit first considered whether Rembrandt had forfeited its new theories argument by raising a general objection without expressly objecting to the obviousness grounds at issue. Underscoring the fact that Rembrandt had specifically identified and objected to other allegedly new theories, the Court concluded that Rembrandt’s general objection was insufficient and that Rembrandt’s “objection” argument had been forfeited. The Court noted that holding otherwise would be unfair to the parties and the Board because such a general objection could not provide adequate notice.

Even though Rembrandt’s new theories argument had been waived, the Federal Circuit concluded that Alere’s reply arguments did not constitute new theories and evidence. As the Court noted, in its reply a petitioner must identify “with particularity . . . the evidence that supports the grounds for each challenge to each claim” and may “only respond to arguments raised in the corresponding opposition, . . . patent owner response, or decision on institution.” The Court further explained that a petitioner who asserts previously unidentified prior art disclosures or embodiments in its reply to make a “meaningfully distinct contention” impermissibly raises a [...]

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Hit a Nerve? Obviousness Inquiry Must Address Claims at Issue

by | Jul 20, 2023 |

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board non-obviousness decision, finding that the context of the proposed combination of prior art in the Board’s obviousness inquiry was not directed toward the context of the claim at issue. Axonics, Inc. v. Medtronic, Inc., Case No. 21-1451 (Fed Cir. July 10, 2023) (Lourie, Dyk, Taranto, JJ.)

Axonics filed petitions for inter partes review (IPR) challenging the validity of two patents owned by Medtronic as obvious. During the IPRs, the Board analyzed two prior art references, an article titled, “Electrical Stimulation of the Trigeminal Nerve Root for the Treatment of Chronic Facial Pain” by Ronald Young and a patent assigned to Gerber. The Medtronic patents described percutaneously positioning a lead to stimulate the sacral nerve. By contrast, Gerber described positioning an electrode in the sacral nerve region in a non-percutaneous way, and Young described positioning an electrode percutaneously to stimulate the trigeminal sensory root. The Board found that Medtronic’s patents were not obvious over Young in view of Gerber because of lack of motivation to combine the two prior art references. The Board also noted “that the proposed combination ‘would not be feasible in the trigeminal nerve region.’” Axonics appealed.

The Federal Circuit found that the Board erred in conducting the obviousness analysis. The Board’s proposed analysis centered on Young’s trigeminal sensory root context, not the Medtronic patents’ sacral nerve context. First, the Board questioned whether motivation to use the resulting combination of Young and Gerber existed in the trigeminal nerve context, but not in Medtronic patents’ sacral nerve context. Second, the Board found “that the relevant art [of the Medtronic patents] is medical leads specifically for sacral neuromodulation.”

Addressing the first error, the Federal Circuit explained that the prior art combination must be directed toward meeting the requirement of the claimed patent, not the requirement of the first prior art. The Court found that the Board did not conduct this analysis. Addressing the second error, the Court noted that “the relevant art” of the Medtronic patents was not “limited to medical leads for sacral-nerve stimulation.” The Court examined the specification of the patent as well as its claim and ruled that the scope of the Medtronic patents was broader than what the Board concluded.

The Court found that the Board’s errors were not harmless since the Board relied on these errors in rejecting Axonics’s obviousness arguments and provided no other reason for concluding Medtronic’s claims were not obvious. Therefore, the Court vacated the Board’s decision and remanded for further consideration.

Practice Note: In considering obviousness arguments under 35 U.S.C. § 103, keep in mind the difference between the claim at issue and the considered combination of prior art. The scope of the claim also needs to be considered based on the entirety of the patent.

Woohyeong Cho, a summer associate in the Washington, DC, office, also contributed to this case note.



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Under High Pressure: New Mechanism of Action Can’t Save Drug Administration Claims

by | Jun 22, 2023 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board ruling that method claims reciting a mechanism of action triggered by the co-administration of two known antihypertensive agents were obvious over the cited prior art. In re Couvaras, Case No. 22-1489 (Fed. Cir. June 14, 2023) (Lourie, Dyk, Stoll, JJ.)

This case arose out of applicant John Couvaras’s prosecution of patent claims reciting a method of increasing prostacyclin release in the systemic blood vessels to improve vasodilation in a human with essential hypertension by co-administering two therapeutic agents. During prosecution, Couvaras conceded that the two claimed therapeutic agents had been known as essential hypertension treatments for many decades. The examiner agreed, citing 10 references as confirmation. The examiner further found that the physiological results of co-administering the two therapeutic agents were not patentable because they naturally flowed from the claimed administration of the known antihypertensive agents.

Couvaras appealed to the Board, arguing that the increased prostacyclin release was unexpected and that objective indicia overcame any existing prima facie case of obviousness. The Board disagreed, ruling that the increased prostacyclin release was inherent in the obvious administration of the two known antihypertensive agents and that no evidence existed to support a finding of any objective indicia. Couvaras appealed.

Couvaras raised three arguments on appeal:

  1. The Board erred in affirming that a skilled artisan would have had motivation to combine the art.
  2. The claimed mechanism of action was unexpected, and the Board erred in discounting its patentable weight by deeming it inherent in the claimed method.
  3. The Board erred in weighing objective indicia of non-obviousness.

With respect to motivation to combine, the Federal Circuit agreed with the Board that the art supplied sufficient motivation to combine because the claimed therapeutic agents were known for decades to treat hypertension, finding the Board’s conclusion supported by substantial evidence. The Court found that Couvaras had forfeited a related argument for no reasonable expectation of success by failing to first raise that challenge to the Board.

The Federal Circuit also rejected Couvaras’s argument that the claimed mechanism of action was unexpected and therefore entitled to patentable weight. Couvaras argued that the Board downgraded the patentable weight of limitations drawn to the antihypertensive agents’ mechanism of action by deeming them to be merely inherent. According to Couvaras, even if the recited mechanism of action was inherent in the claimed administration of the two agents, that mechanism was unexpected because the increased prostacyclin release was unexpected and could not be dismissed as having no patentable weight due to inherency.

The Federal Circuit disagreed, explaining that Couvaras was attempting to claim a mechanism of action that naturally flows from the co-administration of two known antihypertensive agents and that “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.” The Court allowed that while mechanisms of action may not always meet the most rigid standards for inherency, “[r]eciting the mechanism for known compounds [...]

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Absent Nexus Secondary Considerations Come in Second

by and | Jun 15, 2023 |

Addressing the nexus between a secondary consideration and the claimed invention in assessing obviousness, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board finding of nonobviousness because the Board erred in its nexus analysis regarding secondary considerations. Yita LLC v. MacNeil IP LLC, Case Nos. 22-1373; -1374 (Fed. Cir. June 6, 2023) (Taranto, Chen, Stoll, JJ.)

Yita petitioned for inter partes review (IPR) of all claims of two patents. The patents share a common specification and cover vehicle floor trays that are theraformed from a polymer sheet of substantially uniform thickness. These trays (illustrated below) were designed to closely conform to the walls of the vehicle foot well so that the trays would stay in place once installed.

The Board found that the claims of one of the patents were not obvious even though an artisan would have been motivated to combine the prior art asserted (which disclosed the “close conformance” limitation) and would have had a reasonable expectation of success because the evidence of secondary considerations was overpowering and included a nexus between the evidence of success and the patented invention. The Board also found that the claims of the other patent were not obvious because the “1/8 inch limitation” regarding the thickness of the foot well was not disclosed in the prior art. The Board declined to consider Yita’s argument, which was raised for the first time in its reply brief. Yita appealed.

Yita argued that the Board committed a legal error in its analysis of the secondary consideration evidence for the first patent and abused its discretion by not considering the argument Yita raised in its reply brief regarding the other patent.

On the secondary considerations issue, the Federal Circuit explained that the Board erred in finding a nexus between the secondary consideration evidence of success and the claimed invention because the Board exclusively related to a feature that was well-known in the prior art (i.e., the close conformance between the tray and the vehicle floor). The Court explained that where the prior art teaches a well-known feature and an artisan would have been motivated to combine such prior art with an expectation of success, any secondary consideration that is exclusively related to the well-known feature will not rescue the claim from obviousness. The Court noted that while secondary considerations can be linked to an individual element of the claimed invention or to an inventive combination of elements, here the Board relied on secondary consideration evidence that was related entirely to the already well-known close conformance of the tray and vehicle floor.

The Federal Circuit next addressed Yita’s argument that the Board should have considered an argument raised in Yita’s reply brief regarding the 1/8-inch limitation. Yita failed to raise the argument that it would have been obvious to modify a prior art reference to arrive at the “1/8 inch limitation” [...]

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Obviously Prima Facie Case Overcome by Secondary Considerations

by | Jun 15, 2023 |

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board, holding that the Board did not err in finding certain challenged claims nonobvious and not unpatentable based on a showing of several objective criteria of nonobviousness and a nexus of the evidence to a commercial product embodying the claimed invention. Medtronic, Inc. v. Teleflex Innovations S.A.R.L., Case No. 21-2357 (Fed. Cir. June 05, 2023) (Moore, C.J.; Lourie, Dyk, JJ.) and Medtronic, Inc. v. Teleflex Innovations S.A.R.L., Case No. 21-2359 (Fed. Cir. June 05, 2023) (Moore, C.J.; Lourie, Dyk, JJ.)

Teleflex developed and patented a novel catheter-based stenosis intervention system that successfully mitigated long-standing risks intrinsic to existing catheter-based intervention systems, in particular damage to the coronary artery from guide catheter dislodgement or a catheter’s distal tip (i.e., the end of the catheter farthest from the insertion site). The preferred embodiments incorporated into Teleflex’s extremely successful GuideLiner products comprised a proximal substantially rigid portion (yellow), a reinforced portion (blue) and a distal flexible tip (pink), as illustrated below.

The catheters were sized so they could be inserted through standard guide catheters and thus were coined guide extension catheters. This innovative nesting feature increased guide catheter backup support while the guide extension catheter’s soft distal end was less likely to cause tissue damage once deeply inserted into patients. Teleflex’s guide extension catheters also were optimized for receiving interventional cardiological devices. This optimized function was a combination of the catheter’s coaxial lumen, that lumen’s diameter being no more than one French (i.e., 1/3 mm) less than the diameter of the guide catheter, and a proximal side opening that featured a double incline design like that illustrated above.

Teleflex’s GuideLiner was introduced in 2009 and enjoyed “undisputed commercial success and industry praise.” In 2019, Medtronic introduced its competing guide extension catheter (Telescope) and filed six inter partes review (IPR) petitions against Teleflex’s extension guide catheter family. Three of Medtronic’s petitions asserted that the challenged claims in three of Teleflex’s patents were obvious over the evacuation sheath assembly with a distal side opening used to aspirate embolic material while occluding blood flow using sealing balloons disclosed in a prior art reference (Ressemann). The other three petitions challenged claims of the other Teleflex patents as being obvious over a support catheter for delivering angioplasty balloons disclosed in a prior art reference (Kontos).

Medtronic specifically asserted that the following three elements of Teleflex’s claimed catheters were obvious:

  1. A proximal side opening. Medtronic argued that it would have been obvious to replace the proximal funnel structure of Kontos’s support catheter with the distal side opening of Ressemann’s evacuation sheath assembly.
  2. A catheter diameter that is no more than one French less than a corresponding guide catheter. Medtronic argued that in view of prior art mother-and-child dual catheter systems in which the child catheter’s diameter is no more [...]

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Analogous Art Must Be Compared to Challenged Patent

by | May 25, 2023 | ,

The US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board obviousness decision, finding that a prior art reference relating to automotive engine parts was not analogous art to the challenged patent, which related to injection devices used for drug delivery. Sanofi-Aventis Deutschland GMBH v. Mylan Pharmaceuticals Inc., Case No. 21-1981 (Fed. Cir. May 9, 2023) (Reyna, Mayer, Cunningham, JJ.)

Sanofi-Aventis owns a patent directed to a drug delivery device that can be configured to allow for the setting of different dose sizes. The main independent claim of the patent recites a spring washer element with “at least two fixing elements configured to axially and rotationally fix the spring washer relative to the housing.”

Mylan initiated an inter partes review (IPR) proceeding against the patent, arguing that the challenged claims were obvious based on a combination of three prior art references: Burren, Venezia and de Gennes. Burren described a drug injection device that used a coiled spring, while Venezia described a hypodermic syringe with a spring washer having a tongue that fit into a collar to prevent the washer from rotating relative to the collar. The third prior art reference, de Gennes, disclosed a large spring-washer-like device used in automobile engines to maintain the alignment between the engine and the transmission. Sanofi argued that de Gennes was non-analogous art because it was not in the same field of endeavor as the injection devices described in the patent and was not reasonably pertinent to a problem faced by the inventor of the challenged patent.

The Board adopted Mylan’s definition of the problem to be solved, which was “axially fixing two components relative towards each other.” Under this broad definition, the Board found that de Gennes was reasonably pertinent to the challenged patent and that claims were obvious in view of Burren in combination with Venezia and de Gennes. Sanofi appealed.

Sanofi argued that the Board erred in determining that de Gennes was analogous art. The Federal Circuit explained that in evaluating whether a reference is analogous, a patent challenger must compare the reference to the challenged patent. Applying this test, the Court found that substantial evidence did not support the conclusion that de Gennes was analogous to the challenged patent. Although Mylan had mapped de Gennes to certain elements of the challenged claims, there was no evidence that de Gennes—an automobile-related patent—was analogous to the challenged patent—a drug delivery device. The Court also found that statements that de Gennes and the challenged patent were “both interested in solving the same issue . . . [of] accommodating various cartridge lengths” were insufficient to show that de Gennes was analogous to the challenged patent.



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