Obviousness

Obviousness Analysis under 35 U.S.C. § 103

A patent claim is obvious under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention. The framework for determining obviousness involves several factual inquiries, as outlined in Graham v. John Deere Co.: (A) determining the scope and content of the prior art; (B) ascertaining the differences between the claimed invention and the prior art; and (C) resolving the level of ordinary skill in the pertinent art. An explicit articulation of the reason(s) why the claimed invention would have been obvious is required.

The effective filing date of US11160455 is October 23, 2020, with a priority date of December 31, 2012.

Scope and Content of Prior Art

The following prior art documents are listed in US11160455:

• US 9,164,032 B2
• US 9,993,159 B2
• WO 2014/143276 A2
• WO 2014/105521 A1

These references are all related to optical measurement in biological tissue and remote sensing using various light sources and detection systems.

US 9,164,032 B2 (Priority claimed from 2013-12-17)

This patent pertains to non-invasive monitoring of physiological parameters. While the full text isn't provided here, the presence of US 9,164,032 B2 as a priority claim for US11160455 indicates a close relationship in subject matter, likely covering aspects of optical measurement in tissue.

US 9,993,159 B2 (Priority claimed from 2013-12-17)

Similarly, US 9,993,159 B2 is also listed as a priority claim for US11160455. This suggests it also deals with related technology in non-invasive physiological parameter measurement using optical techniques.

WO 2014/143276 A2 (Priority claimed from 2013-12-17)

This international application is also a priority document, reinforcing the idea of a family of patents related to non-invasive optical measurements.

WO 2014/105521 A1 (Priority claimed from 2013-12-17)

Another priority document, likely disclosing foundational aspects of the non-invasive optical measurement technology.

In addition to these, the detailed description of US11160455 itself discusses existing technologies and challenges that would be known to a person of ordinary skill in the art at the time of invention. For example, it mentions:

• The challenge of non-invasive glucose monitoring requiring adequate sensitivity, selectivity, and repeatability, often hampered by skin artifacts in the near-infrared.
• The use of near-infrared spectroscopy, broadband light sources (like tungsten lamps), and pattern matching (spectral fingerprinting) for identifying blood constituents.
• Various apparatuses for caries detection, including C-clamps, handheld devices, and mouth-guard type apparatuses.
• The use of fiber optics to guide light and transport signals.
• The existence of SWIR super-continuum sources for active remote sensing, spectroscopy, or hyper-spectral imaging.
• Spectroscopy using NIR or SWIR light for rapid, non-destructive, non-contact screening of pharmaceuticals, as most organic compounds have overtone or combination absorption bands in this range (e.g., 1-2.5 microns).
• Optical breast imaging, utilizing intrinsic tissue contrast (hemoglobin, water, collagen, lipid) or exogenous fluorescent probes.
• The use of optical instruments that are portable and cost-effective, especially when telecommunications and fiber optics technologies are exploited.
• The concept of increasing signal-to-noise ratio by increasing light intensity or comparing signals when sources are on versus off.
• The use of multiple optical wavelengths (e.g., three for measurement/calibration, near infrared or visible).
• Arrangements of light sources and detectors on arcs.
• The application of artificial intelligence, pattern identification, classification, and regression signal processing methodologies.
• Wearable physiological monitors using optical sensing systems to provide calibrated measurements for heart rate, blood pressure, hydration, and blood oxygenation, wearable on an appendage like the wrist or ankle.

Level of Ordinary Skill in the Art

A person having ordinary skill in the art (POSA) in this field would likely have a background in biomedical engineering, optical engineering, electrical engineering, or a related discipline, with experience in non-invasive physiological monitoring, spectroscopy, and data processing. They would be familiar with different light sources (LEDs, lasers), detectors, optical fibers, and signal processing techniques, including those involving microprocessors, wireless communication, and cloud-based systems. They would also understand the physiological challenges of non-invasive measurements and common methods to mitigate them, such as improving signal-to-noise ratio.

Obviousness Combinations and Motivations

Given the context of the prior art and the general knowledge in the field, several combinations of prior art references could render the claims of US11160455 obvious. The underlying motivation for these combinations would stem from the recognized challenges in non-invasive physiological monitoring, the desire for improved accuracy, convenience, and data processing capabilities, and the availability of known technological solutions.

Combination 1: Prior Art (US 9,164,032 B2, US 9,993,159 B2, WO 2014/143276 A2, WO 2014/105521 A1) + General Knowledge of Wireless Communication and Cloud Computing

• Claim 1 broadly describes a system comprising a wearable device, a smartphone/tablet, and a cloud. The prior art documents (US 9,164,032 B2, US 9,993,159 B2, WO 2014/143276 A2, WO 2014/105521 A1) likely disclose the core optical measurement aspects within a wearable device for physiological parameters, as they are direct priority claims.
• Motivation to Combine: By the effective filing date of October 23, 2020, the integration of wearable health devices with smartphones for data display and transmission, and with cloud-based systems for storage and further processing, was a well-established trend in the consumer electronics and healthcare industries. A POSA would be motivated to combine the optical measurement capabilities of the wearable devices described in the priority art with readily available smartphone and cloud technologies to provide enhanced user experience, remote monitoring, and advanced data analysis. The patent itself mentions "value-add services may be provided by wirelessly communicating the monitored data to a handheld device such as a smart phone, and then wirelessly communicating the processed data to the cloud for storing, processing, and transmitting to several locations." This statement in the patent acts as an explicit motivation for such a combination.

Combination 2: Prior Art (US 9,164,032 B2, US 9,993,159 B2) + Known Techniques for Signal-to-Noise Ratio Improvement

• Claim 1 (and implicitly Claims 7 and 10) details methods for increasing the signal-to-noise ratio (SNR) by increasing light intensity or comparing signals when light sources are on versus off.
• Motivation to Combine: Improving SNR is a fundamental goal in any measurement system, especially in non-invasive optical sensing where signals can be weak due to tissue scattering and absorption. The patent explicitly states that a "non-invasive system requires adequate sensitivity and selectivity, along with repeatability of the results." A POSA would be well aware of these challenges and the common techniques to address them. Increasing light intensity to improve SNR is a basic principle in optics, and comparing "light on" vs. "light off" signals (chopping or background subtraction) is a standard method to compensate for ambient light and detector dark current, thereby improving SNR. These techniques would be obvious to implement in optical measurement devices.

Combination 3: Prior Art (US 9,164,032 B2, US 9,993,159 B2) + General Knowledge of Multi-Wavelength Spectroscopy and Specific Wavelength Ranges for Blood Constituents

• Claim 1 (and implicitly Claims 7 and 10) specifies the use of a plurality of optical wavelengths, including near-infrared or visible wavelengths, and mentions that at least some light is scattered. The patent further elaborates on specific wavelengths for measuring glucose, ketones, and HbA1c (e.g., 1500-1850 nm and 2050-2500 nm in the SWIR range for glucose).
• Motivation to Combine: The use of multiple wavelengths for spectroscopy to identify and quantify different blood constituents is a well-known principle in the field, often referred to as "spectral fingerprinting." The patent states that to distinguish glucose from overlapping spectra, "it may be advantageous to have information at multiple wavelengths." A POSA would understand that different analytes have unique absorption spectra, and selecting specific wavelengths where these differences are pronounced is crucial for accurate measurement. The patent's discussion of water transmission windows, hemoglobin absorption features, and distinct peaks for glucose and ketones in the NIR/SWIR regions indicates established knowledge regarding appropriate wavelength selection for non-invasive blood measurements.

Combination 4: Prior Art (US 9,164,032 B2, US 9,993,159 B2) + General Knowledge of Wearable Device Design (e.g., Arc Arrangements, Placement on Wrist/Ear/Teeth)

• Claim 7 specifically describes LEDs and detectors arranged on one or more arcs and the device being placed on a wrist or ear. Claim 1 also mentions placement on teeth, wrist, or ear.
• Motivation to Combine: The design of wearable devices often involves conforming to body contours for comfort and effective optical coupling. Arranging light sources and detectors in an arc is a natural design choice for devices intended to be worn on curved body parts like wrists or ears to ensure consistent contact with the tissue. The selection of placement sites like the wrist, ear, or teeth is motivated by the desire to find locations with good blood perfusion and minimal interfering artifacts, as discussed in the patent (e.g., teeth having "fewer spectral artifacts than skin in the near-infrared"). A POSA would be motivated to optimize the physical arrangement of components on a wearable device for better contact and signal acquisition based on established anatomical knowledge and design principles for wearables. US20240298904A1, for instance, describes wearable physiological monitors configured for continuous measurement of physiological data, such as heart rate or blood pressure, wearable on an appendage, for example, wrist or ankle. It also mentions guiding the user to position the wearable device about a wrist of the user by presenting instructions in a user interface.

Combination 5: Prior Art (US 9,164,032 B2, US 9,993,159 B2) + General Knowledge of Artificial Intelligence and Advanced Signal Processing in Medical Devices

• Claim 10 introduces the use of artificial intelligence for decision-making and pattern identification, classification, or regression signal processing.
• Motivation to Combine: The application of AI and advanced signal processing (like pattern identification, classification, and regression) to complex datasets, such as those generated by multi-wavelength spectroscopic measurements, was a rapidly developing and widely known area of technology by 2020. Medical device development, in particular, was increasingly leveraging AI for improved diagnostic accuracy and personalized health insights. The patent itself notes that "pattern matching in spectral fingerprinting and various software techniques, the signatures from different constituents in the blood may be identified." A POSA would recognize the benefits of applying AI and sophisticated statistical methods to differentiate between spectrally similar analytes and to refine the accuracy of physiological parameter measurements, especially to overcome challenges like overlapping absorption spectra as noted in the discussion of FIG. 5.

In summary, the core inventive concept of US11160455, a multi-wavelength wearable device for non-invasive blood measurements integrated with a smartphone/cloud system, relies on combinations of known elements and techniques that a person of ordinary skill in the art would have been motivated to combine. The motivations arise from the recognized problems in the field (e.g., accuracy, convenience, data analysis), the availability of suitable technologies (e.g., smartphones, cloud computing, AI, specific optical components), and established scientific principles (e.g., spectroscopy, SNR improvement).