Detecting Natural Phenomena Using Conventional Techniques Found “Directed to” Natural Phenomena at Alice/Mayo Step One
Fumika Ogawa | September 16, 2022
CAREDX, INC. v. NATERA, INC.
Lourie, Bryson, and Hughes. Opinion by Lourie.
Summary
The CAFC held that genetic diagnostic method claims are ineligible for patent, finding that the claims reciting conventional laboratory techniques to perform diagnosis using a naturally occurring correlation are directed to natural phenomena under Alice/Mayo step one, and also lack additional elements to constitute enough inventive concept under Alice/Mayo step two.
Details
CareDx sued Natera and Eurofins in the U.S. District Court for the District of Delaware, asserting that their products infringed one or more patents licensed to CareDx. The district court awarded summary judgment for the defendants, holding that the patents are ineligible for patent under 35 U.S.C. §101. CareDx appealed the district court’s grant of the summary judgment motions of ineligibility.
The patents at issue, U.S. Patents 8,703,652, 9,845,497, and 10,329,607, relate to diagnosis of organ transplant status by detecting a donor’s cell-free DNA (“cfDNA”) circulating in a recipient’s body. The specification, common to all three patents, depicts prior findings that the existence of cfDNA in blood is mostly attributed to dead cells, and had been used for various diagnostic purposes, such as cancer diagnostics and prenatal testing. The specification notes that the cfDNA-based diagnostic scheme is applicable to organ transplant situations, where the recipient’s immune system kills incompatible donor’s cells which in turn release their nucleic acids into the recipient’s stream, such that an increased level of the donor-derived cfDNA may allow for detection of the transplant rejection.
Claim 1 of ‘652 patent recites:
1. A method for detecting transplant rejection, graft dysfunction, or organ failure, the method comprising:
(a) providing a sample comprising cell-free nucleic acids from a subject who has received a transplant from a donor;
(b) obtaining a genotype of donor-specific polymorphisms or a genotype of subject-specific polymorphisms, or obtaining both a genotype of donor-specific polymorphisms and subject-specific polymorphisms, to establish a polymorphism profile for detecting donor cell-free nucleic acids, wherein at least one single nucleotide polymorphism (SNP) is homozygous for the subject if the genotype comprises subject-specific polymorphisms comprising SNPs;
(c) multiplex sequencing of the cell-free nucleic acids in the sample followed by analysis of the sequencing results using the polymorphism profile to detect donor cell-free nucleic acids and subject cell-free nucleic acids; and
(d) diagnosing, predicting, or monitoring a transplant status or outcome of the subject who has received the transplant by determining a quantity of the donor cell-free nucleic acids based on the detection of the donor cell-free nucleic acids and subject cell-free nucleic acids by the multiplexed sequencing, wherein an increase in the quantity of the donor cell-free nucleic acids over time is indicative of transplant rejection, graft dysfunction or organ failure, and wherein sensitivity of the method is greater than 56% compared to sensitivity of current surveillance methods for cardiac allograft vasculopathy (CAV).
The representative claims of the three patents recite somewhat similar procedures, which may be summarized as:
- collecting a bodily sample from the recipient,
- “genotyping” or identifying genetic features that allow for distinction between the donor and recipient,
- “sequencing” or determining the makeup of cfDNA included in the sample, and
- determining, using the genetic features, the amount of cfDNA originating from the donor in the sample.
The specification depicts that the methods are performed using specific techniques that are “standard,” “well-established” and/or reported in prior patents and scientific articles, including sophisticated polymerase chain reaction (“PCR”), such as digital PCR and selective amplification, and next-generation sequencing (“NGS”), all of which are advanced, but already known, techniques in the field.
The district court held that that the asserted claims were patent ineligible as they were “directed to the detection of natural phenomena, specifically, the presence of donor cfDNA in a transplant recipient and the correlation between donor cfDNA and transplant rejection” and also, “recited only conventional techniques.”
On appeal, the CAFC performed the two-step Alice/Mayo analysis to determine patent-eligibility.
- Are the claims “directed to” laws of nature or natural phenomena? – Yes.
CareDx sought to characterize the claimed invention as directed to “improved measurement methods,” in particular, patent-eligible “use of digital PCR, NGS, and selective amplification” allowing for improved accuracy in cfDNA measurement, as opposed to “discovery of a natural correlation between organ rejection and the donor’s cfDNA levels in the recipient’s blood.” CareDx also asserted that the district court improperly considered conventionality of the claimed techniques at step one, essentially merging the two steps into a single-step analysis centered on conventionality.
The CAFC found that the claims satisfy the step one. Two contrasting precedents are notable: Illumina, Inc. v. Ariosa Diagnostics, Inc., 952 F.3d 1367, opinion modified by 967 F.3d 1319, 1327 (Fed. Cir. 2020), and Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). The CAFC noted that this case is different from Illumina, where the claimed improvement was a patent-eligible “method for preparing” a cfDNA fraction that would not occur naturally without manipulation of a starting sample; rather, the asserted claims are akin to those in Ariosa, wherein the claimed diagnostic methods, including the steps of “amplifying” (i.e., making many copies of) a cfDNA sample using PCR and “detecting” a certain type of cfDNA, so as to perform diagnosis using a natural correlation between certain conditions and the level of cfDNA, were found to be “directed to a natural phenomenon.”
The CAFC noted that the conventionally considerations are not limited to step two, and precedents have routinely performed overlapping conventionality inquiry at both stages of Alice/Mayo. The CAFC found that the use of specific laboratory techniques relied on by CareDx only amounts to “conventional use of existing techniques to detect naturally occurring cfDNA.” The CAFC added that the conventionality is supported by the specification’s numerous remarks characterizing the claimed techniques as “any suitable method known in the art” and similar boilerplate language.
- Do the claims recite additional elements, aside from the natural phenomena, which transform the nature of the claim’ into a patent-eligible application? – No.
CareDx’s main argument at step two was that the inventive concept resides in the use of the specific advanced techniques to identify and measure donor-derived cfDNA.
The CAFC disagreed, concluding that the claimed methods lack requisite inventive concept. In reaching the conclusion, the CAFC again pointed to the specification’s admissions of the conventionality of the individual techniques recited in the claims. The CAFC went on to state that “[t]he specification confirms that the claimed combination of steps … was a straightforward, logical, and conventional method for detecting cfDNA previously used in other contexts,” which adds nothing inventive to the detection of natural phenomena.
Takeaway
This case provides a reminder that conventionality of claimed elements may affect both steps of Alice/Mayo test. At step one, the effort to characterize the claim as being “directed to” a patent-eligible subject matter can be thwarted where the claimed elements are undisputedly conventional, in the absence of an unconventional element that is not a judicial exception to eligibility. And at step two, the conventionality of the individual elements and their combination prohibits finding of inventive concept.
When does the absence of evidence turn into evidence of absence? The CAFC vacate their prior decision to now hold that there must be evidence that a skilled artisan would understand silence regarding a limitation to necessarily exclude said limitation.
Adele Critchley | September 9, 2022
Novartis Pharmaceuticals v. HEC Pharms Co, Ltd, & Accord Health Care et al.
Summary:
HEC petitioned for rehearing of a CAFC prior decision in this case, (21 F 4th 1362 – Fed. Cir. 2022) in which the CAFC affirmed a final judgement of the Delaware district court determining that claims 1 to 6 of US Patent 9,187,405 are not invalid and that HEC infringes them. The CAFC Panel in the prior case was Judges, Moore (dissent) with Linn and O’Malley. Here, Chief Judge Moore with Circuit Judge Hughes (majority herein after) vacate the CAFC’s prior decision holding that the Novartis claims are invalid for inadequate written description pertaining to a negative limitation.
- Background
Novartis owns the ‘405 patents and markets a drug for treating relapsing remitting multiple sclerosis that purportedly practices the patent. HEC filed an ANDA with the FDA seeking approval to market a generic version of the drug. Novartis sued. The Delaware district count found that the claims were not invalid either as anticipated or for inadequate written description of the no-loading-dose or daily dosage limitations. HEC appeals as to the written description issue of the no-loading dose.
Claim 1 at issue recites in part “a daily dosage of 0.5 mg, absent an immediately preceding loading dose regime.” The appeal at hand being related to the underlined negative limitation. A loading dose is a higher-than-normal daily dose.
The Majority go into detail regarding what is required to satisfy the written description, stating that “[F]or negative claim limitations…. there is adequate written description when., for example, “the specification described a reason to exclude the relevant [element]… A reason to exclude an element could be found in ‘statements in the specification expressly listing the disadvantages of using’ that element and alternatives to it…. Silence is generally not disclosure.” The Majority further noted that the negative limitation may not be recited verbatim in the specification, but there “generally must be something in the specification that conveys to a skilled artisan that the inventor intended the exclusion, such as a discussion of disadvantages or alternatives.” However, the Majority further noted that while “a written descriptions silence about a negative claim limitation is a useful and important clue and may often be dispositive, it is possible that the written description requirement may be satisfied when a skilled artisan would understand the specification as inherently disclaiming the negative limitation.”
The district count had found that the negative limitation was supported because the prophetic trial described therein states “initially” giving a daily dose, thus this would inform the skilled artisan that there was no loading dose. The Majority found this interpretation erroneous arguing that because the specification says “Initially patients receive treatment for 2 to 6 months” it is clear this sentence speaks to the initial length of treatment and not the dosage. The Majority believed that one of the two Novartis experts admitted this, and that the contrary testimony by the second Novartis experts was inconsistent with the plain text of the specification and therefore carried no weight.
Next, the Majority discussed the district courts finding that the specifications disclosure of a daily dosage combined with its silence regarding a loading dose would tell a person of skill that loading doses are excluded. However, the Majority countered that a patent is not presumed complete such that things not mentioned are necessarily excluded. The Majority noted that the applicants added the limitation during prosecution to address a prior art rejection arguing that the limitation was “to specify that the [daily dosage] cannot immediately follow a loading dose regiment” and “to further distinguish their claims.” The Majority argued that if reciting “daily dosage” without mentioning a loading dose necessarily excludes said loading dose, there would have been no reason for the applicants to add the limitation.
The Majority noted that the expert testimony focused on where in the specification the patentee would have mentioned a loading dose if they intended a loading dose to be included, but that is not the issue at hand, rather the question is whether the patentee precluded the use of a loading dose. The Majority concluded that there is no evidence that a skilled artisan would understand silence regarding a loading artisan to necessarily exclude a loading dose.
Thus, the Majority vacated their prior decision and reversed the distinct courts judgement that the claims of the ‘405 patent are not invalid.
- Dissent:
Circuit Judge Linn dissented, her opinion being very reminiscent of her opinion in the prior judgment, for which she penned the Majority. CJ Linn stated that the “majority in its analysis employs the heightened standard of “necessary exclusion” against which to assess the district court’s fact findings in this case and uses that standard to conclude that the district court clearly erred.” CJ Linn argued that the central tenet of the written description jurisprudence is that the disclosure must be read from the perspective of a person of skill in the art. Here, CJ Lin argued that the district conducted an objective inquiry into the four corners of the specification and found sufficient written description, while also crediting the expert testimony. In particular, the testimony that one skilled in the art would understand the loading dose to be excluded, and that loading dose regiments have been used in the prior art for treating MS. CJ Linn concluded this is sufficient to show that claim language that precludes the administration of a loading dose is supported.
Take-away:
- When express support for a negative limitation is absent, look for evidence that a skilled artisan would understand the silence regarding the limitation to necessarily exclude said limitation.
- Be mindful of statements made during prosecution as to why an amendment is being made.
CAFC HOLDS THAT A SIMPLE ERROR IS STILL SIMPLE EVEN IF IT IS HARD TO FIND
Michael Caridi | August 23, 2022
LG Electronics Inc. v. Immervision, Inc.
NEWMAN, STOLL, and CUNNINGHAM. Opinion by Stroll. Dissent by Newman.
Summary:
CAFC affirms PTAB that LG failed to demonstrate obviousness in its IPR petitions relying on a “copy-and-paste” error which took an expert detailed analysis to locate. The Court and Board both found the error to be within the Yale standard that an obvious error of a typographical or similar nature that would be apparent to one of ordinary skill in the art who would mentally disregard the errant information as a misprint or mentally substitute it for the correct information, the errant information cannot be said to disclose subject matter.
Background:
LG Electronics Inc. appealed from the United States Patent Trial and Appeal Board’s final written decisions in a pair of inter partes review proceedings challenging claims 5 and 21 of U.S. Patent No. 6,844,990 asserted by Immervision.
The ’990 patent specification describes capturing an initial digital panoramic image using an objective lens having a non-linear image point distribution function that “expands certain zones of the image and compresses other zones of the image.” Id. at col. 3 l. 62–col. 4 l. 38. The “non-linearity of the initial image” can then be corrected to produce a final panoramic image for display. Id. at col. 4 ll. 47–53. “[T]he expanded zones of the image cover” a higher “number of pixels of the image sensor” than they would with a lens having linear image point distribution. Id. at col. 3 l. 62–col. 4 l. 10. The exemplary claim used by the Court was claim 5:
5. The method according to claim 1, wherein the objective lens compresses the center of the image and the edges of the image and expands an intermediate zone of the image located between the center and the edges of the image.
LG filed two petitions for inter partes review, each challenging a dependent claim of the ’990 patent. J.A. 322–66 (IPR2020-00179 challenging claim 5); J.A. 3338–87 (IPR2020-00195 challenging claim 21). In the petitions LG argued that U.S. Patent No. 5,861,999 (“Tada”), directed to a “Super Wide Angle Lens System Using an Aspherical Lens.”2 Tada describes four embodiments that share a general system structure and differ in aspects such as lens element thick-ness, separation distance, and lens shape. The embodiment relevant to the appeal, Embodiment 3, described by a prescription—or set of optical parameters—set forth in Table 5 of its specification.
LG argued that Tada discloses, as recited in the challenged claims, a panoramic objective lens having a non-linear image point distribution that compresses the center and edges of an image and expands an intermediate zone of the image between the center and the edges of the image. Tada, however, does not explicitly discuss the image point distribution functions of its lenses. Instead, LG relied on its expert Dr. Chipman’s declaration for the proposition that Tada’s third embodiment has a distribution function producing “a compressed center and edges of the image and an expanded intermediate zone of the image between the center and the edges of the image” as recited in challenged claims 5 and 21.
Dr. Chipman “reconstruct[ed] the lens of Figure 11 [of Tada] using the information in Table 5 of Tada” by inputting certain “information from Table 5 [as published] . . . into an optical design program.” J.A. 1486–87. LG relied exclusively on Dr. Chipman’s calculations and plots using the prescription in Table 5 to show that Tada’s third embodiment meets the compression and expansion zone limitation of the challenged claims.
In its patent owner response, ImmerVision, relied on its expert witness Mr. Aikens’ declaration, arguing that Tada’s Table 5 includes a readily apparent error that cannot form the basis of any obviousness ground. Specifically, Mr. Aikens first noticed that the physical surface of his lens model based on Tada’s Table 5 and the example lens depicted in Tada’s Figure 11 did not match. Because of this discrepancy, Mr. Aikens compared the sag table—a table of heights of a lens surface with respect to the optical axis—generated for his lens model with the sag table provided in Tada’s Table 6 corresponding to Embodiment 3. They also did not match. After Mr. Aiken’s extensive review which included comparing the ‘990 patent with its priority Japanese application, it became apparent that there was a transcription, or copy-and-paste, error in Tada. The disclosures in Tada’s Table 5, which were intended to correspond to its Embodiment 3, were actually identical to those in Table 3, which corresponded to Embodiment 2.
Based on Mr. Aiken’s Declarations, the Board found that the “disclosure of aspheric[] coefficients in Table 5 of Tada is an obvious error” that a person of ordinary skill in the art would have recognized and corrected. Further, the Board found that because the correct aspheric coefficients in Table 5 of the Japanese Priority Application do not satisfy the language of the challenged claims, LG had not met its burden to prove the challenged claims unpatentable as obvious. The Board concluded that LG did not meet its burden to prove the challenged claims would have been obvious by a preponderance of evidence.
LG appealed.
Decision:
First, the Court noted that it is undisputed that the aspheric coefficients in Tada’s Table 5 were erroneous. Therefore, their decision focused on whether substantial evidence supports the Board’s fact finding that the error would have been apparent to a person of ordinary skill in the art such that the person would have disregarded the disclosure or corrected the error.
Second, the Court set forth the legal standard for such a review, citing to In re Yale, 434 F.2d 666 (C.C.P.A. 1970), as the controlling case law. They noted that Yale held that where a prior art reference includes an obvious error of a typographical or similar nature that would be apparent to one of ordinary skill in the art who would mentally disregard the errant information as a misprint or mentally substitute it for the correct information, the errant information cannot be said to disclose subject matter. Id. at 669.
Next, the Court reviewed the Board’s fact finding. They affirmed that the Board correctly identified several aspects of the disclosure in Table 5 that would alert the ordinarily skilled artisan that the disclosure was an obvious error of a typographical or similar nature. Specifically, they noted that it was undisputed that Tada’s Tables 5 and 9 are inconsistent: the aspheric coefficients A4, A6, and A8 in Tada’s Table 5 should match the values for conditions (2)–(4) in Table 9 but do not. They contrasted this to the facts in Yale, finding precedent (describing the internal inconsistency within a reference as a signal that a person of ordinary skill “would readily recognize” as portending error). Yale, 434 F.2d at 667. Based thereon, the Court concluded that
Table 5 cannot be said to disclose a lens that compresses the center of the image and the edges of the image and expands an intermediate zone of the image located between the center and the edges of the image as required by claim 5 of the ‘990 patent.
The CAFC also reviewed LG’s arguments attempting to distinguish the current fact pattern from Yale. First, LG contended that Yale sets forth an “Immediately Disregard or Correct” standard that imposes a temporal urgency on the discovery of the error before the error can be considered “obvious” to a skilled artisan. Applying this reading of Yale, LG argued that Mr. Aikens’ “convoluted process” that took “ten to twelve hours” to complete clearly weighed against the obviousness of the error. LG asserted that because Tada remained uncorrected in the public domain for over 20 years, LG should have been able to rely on the aspheric coefficients in Tada’s Table 5 as published.
In response, the Court held that LG’s suggestion that Yale requires a person of ordinary skill in the art to immediately recognize the apparent error is incorrect. The Court affirmed the PTAB’s holding that the length of time and the “particular manner” in which the error was actually discovered “does not diminish that there is an obvious error in Tada within the meaning of Yale.”
Contrary to LG’s assertions, Yale does not impose a temporal requirement. Nor does LG cite any other authority requiring that the error be discovered within a specified amount of time. Certainly, the amount of time it takes a skilled artisan to detect an error may be relevant to whether an error is, in fact, an apparent error under Yale. But this is just one factor for the fact finder to consider as part of the overall analysis. Here, the Board considered the totality of circumstances and found that Tada’s disclosure of aspheric coefficients in Table 5 is an obvious error of a typographical or similar nature, notwithstanding the amount of time that preceded detection of the obvious error.
Second, LG argued that Yale is limited to instances in which the error is a typographical error, and therefore should be narrowly limited to errors such as spelling mistakes and similar minor, easily detectable errors. The CAFC disagreed, finding instead that while the error in Yale was typographical, the error at issue here was not so far afield as to warrant a different outcome.
The distinction between the typographical error in Yale and the copy-and-paste error here is a distinction without a difference.
Based thereon, the Court affirmed the PTAB’s ruling that LG failed to demonstrate obviousness based on the erroneous calculations set forth in the Tada reference.
Dissent
Judge Newman dissented, asserting that she could not agree that the error in the Tada Tables was typographical or similar in nature, because its existence was not discovered until an expert witness conducted a dozen hours of experimentation and calculation.
She asserted that the appearance of a few of the same numbers in two different tables in the Tada reference provides no information as to which numbers and tables are correct and which may be in error. Contrary, she considers a typographical or similar error needs to be apparent to the reader and may conveniently be ignored without impeaching the content of the information.
Judge Newman outlines the extensive history of the ‘990 patent, noting that no one detected the error until Immervision’s expert spent significant time ascertaining that an error was in fact present in the ‘990 patent. She asserts that these events that preceded the expert’s discovery of the error in the Tada reference cannot be ignored.
The specifics of what led the expert, Mr. Aikens, to discover the erroneous values in Table 5 also cast doubt on whether the error may be deemed “obvious and apparent.” Mr. Aikens testified that he had fully modeled Tada’s Embodiment 3—relying on data from Table 5—without noticing the error. … It was only after his model was completed that he noticed the lens created a distorted image, leading him to presume there was perhaps some error in Tada.
The Japanese application had the correct aspherical values in Table 5, as confirmed by a skilled expert in this technology, after many hours of corrective effort that included fully modeling three separate embodiments of the lens. In sum, the error was not of “typographical or similar nature.”
Judge Newman contrasts this to the evidence in Yale, noting that the error therein did not require calculations or experimentation, and that without the Japanese Priority Application, there is no source of the correct information in the current case.
She agreed with the panel majority that Yale establishes the correct standard to determine if an error would be obvious to a person of ordinary skill in the field, but maintains that an “obvious error” should be apparent on its face and should not require the conduct of experiments or a search for possibly conflicting information to determine whether error exists.
Take away:
Relying on an error in prior art as teaching aspects of a claim is less likely to be sufficient to establish that the subject matter was known even if the error is difficult to locate. Care needs to be taken in examining the prior art reference including contrasting to the disclosures of priority documents. The Yale standard of whether an error can be relied upon looks to the simplicity of the error not to the scrutiny necessary to locate it.
General industry skepticism may not be sufficient by itself to preclude a finding of motivation to combine
Sung-Hoon Kim | August 2, 2022
Auris Health, Inc. v. Intuitive Surgical Operations, Inc.
Decided: April 29, 2022
Prost (author), Dyke, and Reyna (dissenting)
Summary:
The Federal Circuit rejected the PTAB’s obviousness decision by holding that general industry skepticism is not relevant to the question of obviousness.
Details:
In 2018, Intuitive Surgical sued Auris Health for patent infringement of U.S. Patent No. 8,142,447 (“the ’447 patent”).
The ’447 patent
This patent is directed to robotic surgery systems.
The ’447 patent describes “an improvement over Intuitive’s earlier robotic surgery systems, which allow surgeons to remotely manipulate surgical tools using a controller.”
The ’447 patent attempts to solve problems (doctors must swap out various surgical instruments and this step could be tricky in a robotic surgical system where space is limited, different ranges of motion must be calibrated for different surgical instruments, and time is need to interchange those instruments) in the surgery via a robotic system with a servo-pulley mechanism so that doctors could swap out surgical instruments and reduce surgery time, improve safety, and increase reliability of the system.
PTAB
The PTAB determined that the prior art references asserted by Aurie – Smith and Faraz – disclosed each limitation of the claims in the ’447 patent.
The only remaining issue is whether a skilled artisan would have motivated to combine these two references.
Smith discloses “a robotic surgical system that uses an exoskeleton controller, worn by a clinician, to remotely manipulate a pair of robotic arms, each of which holds a surgical instrument.” Smith discloses that the clinician may direct an assistant to relocate the arms as necessary.
Faraz is directed an adjustable support stand that holds surgical instruments. Faraz discloses that its stand “may enable a surgeon to perform surgery with fewer assistants” because its stand “can support multiple surgical implements while [they] are being moved” and “can also provide support for a surgeon’s arms during long or complicated surgery.”
Auris argued that a skilled artisan would be motivated to combine these references to decrease the number of assistants necessary for surgery.
Intuitive argued that a skilled artisan would not be motivated to combine these references because “surgeons were skeptical about performing robotic surgery in the first place, [so] there would have been no reason to further complicate Smith’s already complex robotic surgical system with [Faraz’s] roboticized surgical stand.”
The PTAB agreed with Intuitive that there is no motivation to combine these references because there is skepticism at the time of the invention for using robotic systems during surgery in the first place.
Federal Circuit
The Federal Circuit held that general industry skepticism cannot, by itself, preclude a finding of motivation to combine.
The Federal Circuit noted that the evidence of skepticism must be specific to the invention, not generic to the field and that Intuitive provided not case law to suggest that the PTAB can rely on generic industry skepticism to find a lack of motivation of combine.
The Federal Circuit held that the PTAB was wrong to exclusively rely on Intuitive’s expert testimony that “there was great skepticism for performing telesurgery” at the time of the invention and, as a result, a skilled artisan “would not have been compelled to complicate Smith’s system further.”
Therefore, the Federal Circuit remand for further consideration of the parties’ motivation-to-combine evidence.
Dissent
Judge Reyna noted that the PTAB’s determination that Auris failed to show a motivation to combine is adequately supported by substantial evidence and was not contrary to our law on obviousness.
While Judge Reyna agreed that skilled artisans’ general skepticism toward robotic surgery, by itself, could be insufficient to negate a motivation to combine, he disagreed that it could never support a finding of no motivation to combine.
Judge Reyna believes that the majority’s inflexible and rigid rule appears to be in tension with the central thrust of KSR (rejecting the “rigid approach of the Court of Appeals” and articulating an “expansive and flexible approach” of determining obviousness).
Takeaway:
- General industry skepticism may not be sufficient by itself to preclude a finding of motivation to combine.
- Specific evidence of industry skepticism related to a specific combination of references might contribute to finding a lack of motivation to combine.
