AliveCor v. Apple: It is obvious to apply known machine-learning techniques to detect arrhythmia whether the heartbeat data originates from PPG, motion-sensor, or ECG.
The Federal Circuit affirmed PTAB findings that challenged claims were obvious where evidence supported motivation-to-combine and reasonable-understanding findings regarding machine-learning and ECG confirmation limitations.
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Holdings:
Whether prior art limited to machine learning on ECG data can support obviousness of claims broadly reciting use of machine learning to determine arrhythmia in the claimed system context: Where claims recite machine-learning functionality at a high level of generality and do not require a specific algorithm or specific data-ingestion scheme, substantial evidence may support a finding that a POSA would have found it obvious to apply known machine-learning techniques disclosed in the prior art in the claimed biomedical monitoring context, even if the reference’s exemplary implementation differs.
Scope of what a prior-art reference teaches for obviousness analysis: In evaluating motivation and what a POSA would understand, the Board may consider a reference for all that it teaches, including uses beyond the reference’s primary purpose, and may account for the inferences and creative steps a POSA would employ rather than confining the teaching to the reference’s specific exemplar.
Whether the Board conflated 'detecting' and 'confirming' arrhythmia limitations in evaluating machine-learning dependent claims.: The Board does not err where it recognizes 'detect' and 'confirm' as distinct requirements and relies on evidence that the cited machine-learning prior art teaches improving true-positive detection/arrhythmia detection (not merely confirmation), supporting obviousness under the claims’ level of generality.
Whether Shmueli teaches/ renders obvious a claim requirement to 'confirm' arrhythmia based on ECG data.: Substantial evidence can support finding a 'confirming' limitation met where the prior art discloses obtaining ECG after PPG-detected irregularity and using ECG/PPG correlation and parameter-updating feedback to validate/confirm the irregular condition, including where system operation (e.g., deciding when the irregular condition has stopped) reasonably implies ECG-based confirmation as a predicate.
Blog:
Honeywell Int'l v. 3G Licensing: Any need or problem that the patent addresses can supply a reason to make the claimed modification; the patentee's avowed purpose does not control.
The Federal Circuit reversed a Board's determination that claims directed to codeword formatting for error correction is not obvious, finding the Board improperly relied on the motivation of the patent in suit. The Board acknowledged that the only difference between claim 1 and the prior art is that the 1 and 0 in the last row of basis sequences table were switched. The court held that, contrary to KSR, the Board ignored principle that any need or problem known in the field of endeavor at the time of the invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.
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Patent in suit: 7,319,718
Claim 1 reads, in part:
[…]
encoding the information bits by combining the information bits with the basis sequences;
[…]
wherein the basis sequences Mi,n are defined as:
| I |
Mi,0 |
Mi,1 |
Mi,2 |
Mi,3 |
Mi,4 |
| 0 |
1 |
0 |
0 |
0 |
1 |
| 1 |
0 |
1 |
0 |
0 |
1 |
| [. . .] |
| 18 |
0 |
0 |
0 |
0 |
1 |
| 19 |
0 |
0 |
0 |
0 |
1 |
.
Holdings:
A motivation to modify/combine for obviousness need not be the same as the inventor’s motivation; any known need or problem in the field that the patent addresses can supply a reason to make the claimed modification, and the patentee’s avowed purpose does not control.
Obviousness does not require showing the prior art combination/modification was the best, preferred, or subject to contemporaneous consensus; it is enough that the prior art as a whole suggests the desirability of the claimed change.
In an obviousness analysis, the fact that a reference does not itself disclose the precise claimed difference (which would be required for anticipation) cannot be treated as weighing against obviousness; doing so reflects an impermissible anticipation-like requirement.
Blogs:
ImmunoGen v. Coke Morgan Stewart: Known dosing methodology to address a known problem in a predictable way is obvious to try
The Federal Circuit affirmed a bench-trial judgment that method claims were obvious where prior art disclosed similar dosing parameters and adjusted ideal body weight (AIBW) dosing was within routine optimization, including where the claimed dose is necessarily met for some patients under a prior-art TBW regimen.
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Issues/holdings:
Obviousness does not turn on the patentee’s particular motivation or the inventors’ recognized problem; any need or problem known in the field can supply a reason to combine or modify prior-art teachings, and a claimed solution to an allegedly “unknown” problem is not automatically nonobvious.
A factfinder may find motivation to try a known dosing methodology (AIBW) to address dose-related toxicities based on the general knowledge in the art and prior-art teachings—even if the methodology had not previously been used for that specific drug class—where the record supports that it was within the skilled artisan’s repertoire for dose/toxicity management.
A prior-art disclosure can render a claimed limitation obvious (or taught) where practicing the prior-art regimen would necessarily meet the claimed limitation in operation for at least some circumstances; a prior-art product/practice that sometimes embodies the claimed method teaches that aspect, and the natural result flowing from the prior-art teaching is sufficient.
Reasonable expectation of success must be tied to the scope of the claimed invention; when the claim is silent about solving a particular side effect, the expectation inquiry focuses on whether the claimed dosing would be expected to be effective for the claimed treatment, not whether it would solve an unclaimed toxicity problem.
Blogs:
Janssen Pharma. v. Teva Pharma USA: Presumption of obviousness where ranges overlap
The Federal Circuit held that, in overlapping-range cases, a challenger may establish a presumption of obviousness, i.e., a prima facie case of obviousness, by showing that the claimed values fall within or near prior-art ranges under circumstances where a skilled artisan would have been motivated to optimize and would reasonably expect similar properties. That showing shifts the burden of production, not the burden of persuasion.
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Blogs:
Shockwave Medical v. Cardiovascular Systems: Routine design choice
The Federal Circuit reversed the Board's determination of non-obviousness as to claim 5, saying “The Board [failure] to consider the combined teachings of the prior art led it to improperly discount CSI’s argument in its petition that modifying Uchiyama to place the electrodes outside the lumen would have been a routine design choice. Stated the court:
When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.”
KSR, 550 U.S. at 421. We explained in
Uber Technologies, Inc. v. X One, Inc.,
1) that when there are a limited number of well-known design choices in the prior art it would have been obvious to substitute one for the other.
On July 31, 2025, the USPTO issued a memo noting that Rule 104(b)(4) would be strictly enforced. The memo clarifies that “As a practical matter, enforcement of Rule 104(b)(4) means that applicant admitted prior art (AAPA), expert testimony, common sense, and other evidence that is not “prior art consisting of patents or printed publications” ( collectively, “general knowledge”) may not be used to supply a missing claim limitation.”
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