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New PTO Guidance: Use KSR Flexible Approach to Obviousness

On February 27, 2024, the US Patent & Trademark Office (PTO) published updated guidance for examiners on how to make a proper determination of obviousness. The guidance expands upon and reinforces the legal framework for obviousness determinations discussed by the Supreme Court in KSR Int’l. v. Teleflex (2007) and Graham v. John Deere Co. (1966) through the lens of post-KSR precedential Federal Circuit cases. The guidance does not have the force and effect of law and is not intended by the PTO to convey any new practice or procedure.

Drawing from more than 30 Federal Circuit cases, the guidance addresses several themes. An overriding theme concerns the implementation of a flexible approach to obviousness and the need for a reasoned explanation when concluding that a claimed invention would have been obvious. In its discussion, the PTO characterizes the flexibility expressed by the KSR court and reiterated by subsequent Federal Circuit cases as mandating a proper understanding of the scope of the prior art and providing appropriate reasons to modify the prior art.

Regarding the scope and content of the prior art, the guidance draws attention to understanding the prior art and all that it may reasonably suggest to a person of ordinary skill in the art (POSITA) who would naturally apply common sense and glean suggestions from the art – even where such suggestions are not explicitly stated. Thus, the obviousness inquiry need not seek out precise teachings regarding a solution to a technological problem but can take account of the inferences, creative steps and common knowledge that a POSITA would employ. In one precedential example, the Federal Circuit held that a POSITA would have combined certain prior art elements based on common knowledge of an industry’s concern for rider stability when using water recreational devices. (Zup v. Nash Mfg. (2018).) The guidance also affirms the need for an evaluation of analogous prior art, which must be evaluated using a flexible approach when considering the “same field of endeavor” and “reasonably pertinent” tests in combination with evidence concerning the knowledge and perspective of a POSITA.

According to the guidance, a flexible approach to obviousness should provide a reasoned explanation with evidentiary support for modifying the prior art. To facilitate compact prosecution, the examiner should clearly articulate this explanation early in the prosecution. The PTO also cautions that wholesale use of “common sense” as a rationale is no substitute for reasoned analysis and evidentiary support. There should be an explanation of why common sense would have compelled a finding of obviousness, especially where limitations are not expressly disclosed in the prior art.

The guidance further emphasizes that decision-makers are not free to ignore relevant evidence before them, including Graham’s secondary considerations or other objective indicia of obviousness, to establish prima facie obviousness. At the same time, conclusory opinions by an expert in a declaration or attorney argument alone should not be accorded weight in the absence of factual support. The guidance notes that in keeping with the flexible approach to obviousness [...]

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Federal Circuit to Revisit Whether KSR Extends to Design Patents

Granting a petition for rehearing en banc, the US Court of Appeals for the Federal Circuit decided to revisit the effect of the Supreme Court’s 2007 decision in KSR International v. Teleflex on design patents. LKQ Corporation v. GM Global Technology Operations, Case No. 21-2348 (Fed. Cir. June 30, 2023) (per curiam). The Federal Circuit withdrew its earlier panel decision addressing KSR’s application to design patents.

This case arose from an inter partes review (IPR) filed by LKQ against GM alleging that GM’s design patent for a vehicle fender was obvious and/or anticipated. In its original opinion, the Federal Circuit applied its predecessor court’s design patent test for obviousness in In re Rosen (CCPA 1982), as well as its decision in Durling v. Spectrum Furniture (Fed. Cir. 1996), ultimately finding that GM’s design patent was not obvious or anticipated and affirming the Patent Trial & Appeal Board’s decision. The Federal Circuit determined that it was unclear whether the Supreme Court had overruled Durling and Rosen with KSR, so it did not apply KSR. Judge Lourie provided an additional opinion that KSR did not overrule Rosen. Judge Stark concurred in the judgment but found that LKQ had forfeited its argument that KSR overruled Rosen.

In its order for en banc review, the Federal Circuit asked the parties to address whether KSR abrogates Rosen and Durling and whether KSR applies to design patents regardless of whether it overrules or abrogates Rosen and Durling. Specifically, the Court inquired whether KSR’s “expansive and flexible approach” means that Durling’s two requirements should be modified or eliminated. Durling’s first requirement is that “[b]efore one can begin to combine prior art designs . . . one must find a single reference, ‘a something in existence, the design characteristics of which are basically the same as the claimed design.’” Its second requirement is that secondary references “may only be used to modify the primary reference if they are ‘so related to the primary reference that the appearance of certain ornamental features in one would suggest the application of those features to the other.’”

The Federal Circuit also asked the parties to address the appropriate test for evaluating the obviousness of design patents in the event the Rosen-Durling test was to be eliminated or modified.

The Federal Circuit further requested that the parties address whether eliminating the Rosen-Durling test would cause uncertainty in a settled area of law. Finally, the Court asked whether any differences between design patents and utility patents are relevant to the design patent obviousness inquiry.

The Federal Circuit indicated that the issues of anticipation and forfeiture from the initial appeal were preserved, but that additional briefing on those issues was not required. The Court invited the United States to participate as amicus curiae.

Practice Note: With the Federal Circuit granting rehearing en banc, there is a possibility that the Court may extend the obviousness analysis of KSR to design patents.




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KSR Does Not Extend to Design Patents (Yet)

Addressing the standard for obviousness of design patents, the US Court of Appeals for the Federal Circuit, in a per curiam opinion, upheld the Patent Trial & Appeal Board’s finding that a challenged design patent was not obvious over the pre-KSR design patent obviousness test or anticipated. LKQ Corporation v. GM Global Technology Operations, Case No. 21-2348 (Fed. Cir. Jan. 20, 2023) (per curiam) (Lourie, J., concurring) (Stark, J., concurring).

GM owns a design patent for the fender of a vehicle. LKQ Corp. previously held a license to the patent from GM, but negotiations to renew the license failed. Because LKQ continued to manufacture the fender after the expiration of the license, GM sent LKQ notice that it was infringing the patent. In response, LKQ petitioned for an inter partes review against GM, alleging that the patent was obvious and/or anticipated.

The Board found that LKQ had not presented enough evidence to prove that the patent was obvious or anticipated. For purposes of evaluating the obviousness of the design over prior art, the Board defined ordinary observers as “retail consumers who purchase replacement fenders and commercial replacement part buyers.” The Board concluded that, from the perspective of the ordinary observer, there were multiple differences between the patented design and the key reference, a prior art design patent. LKQ appealed.

LKQ argued that the Board erred in finding that there was no anticipation and in applying the obviousness tests of In re Rosen (C.C.P.A. 1982) and Durling v. Spectrum Furniture (Fed. Cir. 1996) because the Supreme Court of the United States overruled those tests in KSR International v. Telflex (2007).

The Federal Circuit upheld the Board’s definition of the ordinary observer. The Court found that retail purchasers of the entire vehicle would not be included in the ordinary observer group because purchasers of the product embodying the design are interested in the part itself, not the vehicle as a whole. The Court went on to uphold the Board’s application of the ordinary observer obviousness test, agreeing that the patented design created different overall impressions from the prior art for purposes of both obviousness and anticipation.

The Federal Circuit then addressed whether KSR overruled the Durling and Rosen tests for obviousness of design patents. The Court found that LKQ properly preserved the argument for appeal by asserting it in its opening brief to the Board. The Court then found that it was unclear whether the Supreme Court overruled Durling and Rosen, and therefore the Court was bound to apply the existing law. In applying the Durling and Rosen tests, the Court found that LKQ had failed to identify “the correct visual impression created by the patented design as a whole” because the prior art patent lacked certain key design features of the patented design. Thus, the Court affirmed the Board’s finding that the patent was not obvious.

Judge Lourie provided an additional opinion and addressed LKQ’s argument that KSR overruled Rosen. Lourie stated that because KSR did not involve design patents, which [...]

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It’s Highlighted and Verified: Reversal of PTAB Non-Obviousness Decision

In a relatively unusual outcome, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board (Board) decision finding non-obviousness in an inter partes review (IPR). Becton, Dickinson, and Co. v. Baxter Corp. Englewood, Case No. 20-1937 (Fed. Cir. May 28, 2021) (Dyk, J.)

Becton petitioned the Board for IPR of Baxter’s pre-America Invents Act (AIA) patent, directed to a system for preparing patient-specific doses and a method for telepharmacy. The Board decided that the patent claims were not shown to be invalid as obvious, but also found that Baxter’s secondary considerations evidence was “weak.” Becton appealed based on two contested limitations: a verification limitation and a highlighting limitation. The Federal Circuit reversed the Board, concluding that the challenged claims were obvious and explained that weak evidence of secondary considerations could not overcome the strong showing of obviousness.

First, the Federal Circuit decided that the Board erred in finding that a prior art reference that taught a remote pharmacist may verify a dose preparation did not render obvious a claimed method where a remote pharmacist must verify. The reference made clear that a non-pharmacist could not further process work without the verification step. Baxter’s own expert witness conceded that, in accordance with the teachings of the prior art, a non-pharmacist would be disciplined for continuing to process dose preparation without authorization. The Court concluded there was no significant difference between the teaching in the prior art reference and Baxter’s verification requirement.

Second, the Federal Circuit decided that the Board erred in finding that the “highlighting” limitation as it relates to a set of drug preparation steps on a computer was non-obvious. In what it characterized as a “close case,” the Board decided that a prior art reference’s teachings highlighting patient characteristics when dispensing repackaged medication did not make obvious highlighting, in a drug formulation context, prompts for additional information. Citing KSR v. Teleflex, the Court explained that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” The reference taught highlighting in terms of various inputs and information delivered. Becton’s expert testified that one of ordinary skill would understand from the reference that other information, such as prescription order information, could be displayed on the user interface. Baxter’s expert did not contradict Becton’s expert. Because “a person of ordinary skill is also a person of ordinary creativity, not an automaton,” the Board erred in using that one reference as the only source for what one of ordinary skill would consider.

Lastly, Baxter unsuccessfully argued that under pre-AIA 35 U.S.C. § 102(e)(2), one of the patent references was ineligible as prior art. Sec. 102(e)(2) provides that a prior art reference may be a “patent granted” on another’s application filed in the United States before the invention by the applicant. Baxter argued that since the claims of the reference were cancelled after a 2018 IPR, the reference no longer qualified as a “patent granted” [...]

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Doesn’t Scan: Skin Cancer Detection Device Just Combination of Familiar Elements

The US Court of Appeals for the Federal Circuit overturned a finding of non-obviousness of certain claims relating to a device for the detection of skin cancer, finding that the Patent Trial & Appeal Board erred in applying the law of obviousness. Canfield Scientific, Inc. v. Melanoscan, LLC, Case No. 19-1927 (Fed. Cir. Feb. 18, 2021) (Newman, J.)

Canfield Scientific filed a petition for inter partes review challenging the validity of claims of a Melanoscan patent as obvious in view of several prior art references. After the Board upheld the validity of the challenged claims, Canfield appealed.

The device disclosed in the patent is “an enclosure fitted with cameras and lights arranged in a manner that allows for imaging of [all or part] of non-occluded body surfaces in order to detect health and cosmetic disease.” The two challenged independent claims both required:

  • An enclosure configured to receive a person or portion thereof, wherein the enclosure defines a specified imaging position for placing the person or portion thereof within the enclosure
  • A plurality of imaging devices, wherein the plurality of imaging devices are vertically spaced relative to each other, a plurality of the imaging devices are located on opposite sides of the centerline of the specified imaging position
  • A plurality of light sources spaced relative to each other and peripheral to the plurality of imaging devices.

Canfield listed four references in support of its obviousness argument—Voigt, Hurley, Crampton and Daanen. Voigt disclosed an enclosure containing cameras and lights for analyzing and measuring images on the skin of a patient. Voigt did not disclose imaging devices (cameras) vertically and laterally spaced and on opposite sides of the center line. Instead, Voigt taught positioning the subject along the wall and positioning the cameras in a single direction.

Hurley, Crampton and Daanen each taught placement of a subject in the center of the enclosure, with cameras arranged vertically, laterally and on opposite sides of the centerline.

Canfield argued that the combined teachings of the prior art would have reasonably suggested the subject matter of the challenged claims. The Board found this argument unpersuasive, concluding that “Voigt’s rear wall would have blocked the view of the two rear-facing cameras, and Voigt’s horizontally adjustable sliders would have partially blocked the views of the remaining cameras.” Thus a person of skill in the art would not have been motivated to combine “the unmodified Voigt system with Hurley’s arrangement of imaging devices.” The Board did not discuss Crampton or Daanen.

The Federal Circuit disagreed with the Board’s conclusion and stated that the references showed the subject being imaged placed against a wall in Voigt, and centrally placed within the framework in Hurley, Crampton and Daanen. The references showed the cameras laterally and vertically spaced to each other about a center line. Citing the seminal Supreme Court KSR obviousness decision, the Federal Circuit noted that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable [...]

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