AI in Healthcare & Life Sciences: Mid-Year PTAB-Appeal Decisions on Enablement

Jun 27, 2024By Ronny Amirsehhi
Ronny Amirsehhi

We analyzed approximately 377 Patent Trial and Appeal Board (PTAB) appeal decisions from January 01 to June 25, 2024, specifically reviewing examiner’s rejection based on 35 U.S.C. § 112(a) enablement ground. 

Within this period, we identified one decision pertaining to a wearable device. We provide our analysis and offer recommendations to mitigate the risk of enablement rejection.

Enablement Requirement under 35 U.S.C. § 112(a)
 
In U.S. patent law, enablement is a requirement outlined in the Manual of Patent Examining Procedure (MPEP), specifically in MPEP § 2164. It means that a patent application must describe the invention clearly and in enough detail that someone skilled in the relevant field can make and use the invention without needing to do extensive extra work or guesswork, i.e., without undue experimentation.

The Wands factors, derived from the case In re Wands, 858 F.2d 731 (Fed. Cir. 1988), are used to determine whether a patent application meets the enablement requirement. These factors include:

·       The Quantity of Experimentation Needed: How much work is required to practice the invention?

·       The Amount of Direction or Guidance Provided: Does the patent give clear instructions?

·       The Presence or Absence of Working Examples: Are there practical examples demonstrating the invention?

·       The Nature of the Invention: How complex is the invention?

·       The State of the Prior Art: What is the existing knowledge in the field?

·       The Relative Skill of Those in the Art: What is the skill level of someone in the relevant field?

·       The Predictability or Unpredictability of Art: How predictable is the technology area?

·       The Breadth of the Claims: How broad are the claims in the patent?


These factors are considered together to determine if the disclosure in the patent application is sufficient for a person skilled in the art to make and use the invention without undue experimentation.


Appeal Decision
Appeal No. 2023003339: Wearable Device (March 20, 2024)
 

Background:

The case involves patent application No. 15/521,667. The patent application is related to a system designed to calculate the relative contribution of different biochemical energy systems (aerobic, alactic anaerobic, and lactic anaerobic) to an instantaneous physiological load estimate. The system consists of a wearable device that collects data from the user through motion capturing and heart rate sensors, and a server that processes this data to generate the physiological load estimate.

While the document does not explicitly mention use of artificial intelligence (AI), the underlying technology could involve AI techniques. The patent application describes the use of models and equations, which in modern contexts often involve AI for improving accuracy and handling complex data patterns. For example, the dynamic heart rate model and the system's ability to estimate physiological load, the processing of motion and heart rate signals to accurately estimate physiological load, signal processing and data analysis algorithms, real-time analysis based on the data collected by the wearable device likely involve AI, particularly machine learning models. 

The application was rejected by the Examiner under 35 U.S.C. § 112, enablement. Applicants appealed these rejections to the PTAB. The PTAB upheld the rejection of the patent application.


Representative Claim:

Claim describes a system that combines wearable technology and server-based processing to estimate the contributions of different biochemical energy systems to a user's physiological load during physical activity. Representative claim 25: 

25. A system for calculating a relative contribution of different biochemical energy systems to an instantaneous physiological load estimate, the system comprising:

(a) a wearable device for use by a user to collect data of the user, the wearable device comprising: i. a motion capturing sensor configured to generate a motion signal, wherein the motion capturing sensor comprises an accelerometer; ii. a heart rate sensor configured to generate a heart rate signal, wherein the heart rate sensor comprises an electrocardiogram (ECG) or a photoplethysmography (PPG) sensor; iii. a transmitter; and iv. a display; and

(b) a server comprising: i. a transmitter; ii. memory; and iii. a processor,

wherein the wearable device transmits the motion signal from the motion capturing sensor and the heart rate signal from the heart rate sensor to the server, wherein the processor is further configured to:

·        take a measurement of the motion signal from the motion capturing sensor and a measurement of the heart rate signal from the heart rate sensor,

·        apply a dynamic heart rate model to estimate the physiological load from the measurement of the motion signal and the heart rate signal, wherein the dynamic heart rate model is provided by the memory of the server,

·        calculate the relative contribution of each of the different biochemical energy systems to the physiological load estimate, and

·        transmit data regarding each of the relative contribution of the different biochemical energy systems to the instantaneous physiological load estimate."


Key Examiner's Arguments:

The Examiner argues that the application lacks detailed guidance on how to calculate the relative contributions of different biochemical energy systems to the physiological load estimate.

The Examiner finds that the specification uses undefined ordinary differential equations (ODEs), models, and equations. According to the examiner, the application does not provide the necessary mathematical or computational details required to implement the claimed system.

The Examiner uses the Wands factors to argue that the patent application fails to meet the enablement requirement under 35 U.S.C. § 112(a):


1.     Quantity of Experimentation Necessary:

The Examiner argues that the dynamic heart rate model and the method for calculating the relative contributions of different biochemical energy systems are not described in enough detail, requiring extensive experimentation to fill in the gaps.
 

2.     Amount of Direction or Guidance Presented:

The specification lacks clear and detailed guidance on how to apply the dynamic heart rate model and the secondary model to calculate the physiological load and its components. The Examiner highlights that the heart rate models and equations needed to calculate the physiological load are not fully defined or explained.
 

3.     Presence or Absence of Working Examples:

The Examiner notes Figures 7 and 8 of the application, which are cited by the applicant, show the outputs of the models but do not provide the detailed methodology or the models themselves. The absence of working examples increases the need for experimentation.
 

4.     Nature of the Invention:

The invention involves a complex system integrating wearable technology, data collection, and advanced modeling to estimate physiological load. The nature of the invention, which relies on sophisticated algorithms and models, inherently requires precise and detailed descriptions to be reproducible. The Examiner finds the specification lacking in this regard.
 

5.     State of the Prior Art:

The Examiner points out that the prior art does not provide sufficient methodologies for distinguishing between the three biochemical energy systems during exercise. This implies that the claimed invention goes beyond the current state of the art, requiring additional detailed guidance to be enabled. The specification fails to bridge this gap adequately.
 

6.     Relative Skill of Those in the Art:

While those skilled in the art may have a high level of expertise, the Examiner argues that the complexity and novelty of the invention mean that even skilled practitioners would require more detailed instructions to implement the system. The declaration by Mr. van Niekerk, who has a higher level of expertise than a typical skilled artisan, further underscores this point.
 

7.     Predictability or Unpredictability of the Art:

The field of physiological modeling and wearable technology is relatively unpredictable, especially when integrating multiple biochemical energy systems into a single model. This unpredictability necessitates detailed guidance to ensure that the invention can be practiced reliably and consistently. 
 

8.     Breadth of the Claims:

The breadth of Claim 25, which encompasses a comprehensive system for calculating physiological load contributions, requires a broad and detailed disclosure to be enabled. The Examiner finds that the specification does not provide enough information to support the full scope of the claim, requiring undue experimentation to achieve the claimed invention.
 

The applicant submitted a declaration from Mr. van Niekerk under 37 C.F.R. § 1.132. The declaration attempted to support the argument that the specification enables the invention by referencing seven prior art documents and deriving equations and parameters needed to determine the relative contributions of biochemical energy systems. However, the Examiner argued that the declaration introduces additional equations, parameters, and variables that are not disclosed in the specification. These include factors such as blood lactate measurements, resting metabolic rate, and other biochemical constants. The need to incorporate these additional elements indicates that the original disclosure was insufficient.


Key Appellant’s Argument:
 

The appellant argued that the specification describes the use of a dynamic heart rate model to estimate physiological load and a secondary model to segment the physiological load into contributions from different biochemical energy systems. The appellant points to specific figures (e.g., Figure 7 and Figure 8) and descriptions in the specification that they believe provide sufficient detail on the dynamic heart rate model and the secondary model. They asserted that these figures and the accompanying text outline how the models work and how they can be implemented.

The appellant further submitted a declaration from Mr. van Niekerk. The declaration explained how the models and equations described in the prior art can be combined to determine the relative contributions of different biochemical energy systems. The appellant argued that this declaration demonstrates that undue experimentation is not required, and that the invention can be practiced based on the information in the specification and common knowledge in the field.

Additionally, the appellant argued that the state of knowledge in the field should be considered. They claim that the methods for determining the contributions of different biochemical energy systems are well known to those skilled in the art. Thus, the lack of detailed equations in the specification should not be seen as a deficiency, as those skilled in the art would know how to derive and apply these equations.


PTAB Decision
 

The Board found that the specification does not adequately teach how to calculate the relative contribution of different biochemical energy systems to the instantaneous physiological load estimate. They agreed with the Examiner's conclusions on several Wand factors.

The Board also agreed with the Examiner that the figures cited by the appellant (Figures 7 and 8) do not depict the models themselves but rather the outputs. This does not provide sufficient guidance for implementing the invention.

The Board considered the declaration from Mr. van Niekerk but concurred with the Examiner that the need to reference additional documents and derive new equations indicates that the specification is not self-enabling. 

While the appellant argued that the methods for determining contributions from biochemical energy systems are known, the Board found that this does not compensate for the lack of detailed guidance in the specification. 


Conclusion:
 

The Board finds that the Examiner correctly applied the Wands factors and that the appellant's arguments and supporting declaration do not overcome the deficiencies in the specification. As a result, the rejection of the patent application under 35 U.S.C. § 112(a) is affirmed.


 Strategies to Overcome Enablement Challenges
 

To mitigate risks of enablement rejection when drafting a patent application, it is crucial to provide a detailed and comprehensive disclosure. Based on the analysis of the document provided, here are recommended strategies:

1. Detailed Description of Invention
Clearly define all models and equations used in the invention. Provide detailed mathematical formulations, including any differential equations, algorithms, and computational methods.
Describe step-by-step procedures for implementing the invention. This includes data collection methods, data processing steps, and how to apply models to derive the desired outputs.
Ensure all technical terms, variables, and parameters are well-defined. Include any necessary background information to help understand these terms.
 

2. Provide Working Examples
Include multiple working examples that demonstrate how the invention can be implemented. These should cover different scenarios and variations of the invention to show its applicability.
Provide experimental data or simulation results that illustrate the performance and accuracy of the invention. This helps validate the models and methods described.
 

3. Figures and Diagrams
Use detailed figures and diagrams to illustrate key components, processes, and results of the invention. Ensure that these figures are accompanied by thorough explanations.
Include flowcharts that outline the steps involved in the methods described, making it easier to understand the sequence of operations.
 

4. Incorporate Known Techniques
Reference and incorporate known techniques and methods from prior art where relevant. Clearly distinguish how the invention improves upon or differs from these prior methods.
Include citations to relevant scientific literature, patents, and other resources that support the methodologies used in the invention.
 

5. Address the Wands Factors
Minimize the amount of experimentation needed by providing comprehensive details and examples.
Offer clear guidance and instructions for each aspect of the invention, ensuring that a person skilled in the art can follow them without ambiguity.
Include sufficient working examples to demonstrate the practical application of the invention.
Clearly describe the invention's nature, focusing on the innovative aspects and their implementation.
Explain the state of the prior art and how the invention advances or differs from it.
Assume a reasonable level of skill in the art but avoid expecting expertise beyond that level.
Address any unpredictability in the field by providing additional details and examples.
Ensure that the breadth of the claims is supported by the detailed description and examples provided.
 

6. Use Declarations Wisely
If including expert declarations, ensure they directly address the points of enablement and provide concrete evidence that the invention can be practiced based on the specification.
Ensure that any additional information provided in declarations is consistent with and directly supported by the original specification.


These strategies will help ensure that application meets the enablement requirement and reduces the risk of rejection under 35 U.S.C. § 112(a).



 
 
 
 



Ronny Amirsehhi is a managing partner at Leo Patent Law Office. 


The opinions and recommendations expressed are those of the author and do not reflect the views of Leo Patent Law Office or its clients. This document is for general information purposes only and is not intended to be and should not be taken as legal advice.