Apple Wins Patent Suit Against Alivecor Over Portable Ecg Tech

INTRODUCTION

This suit was before Patent trial and Appeal board between the Apple Inc. (Petitioner) and the AliveCor, Inc. (Patent Owners) over the U.S. Patent No. 9,572,499 owned by AliveCor.

Apple Verses AliveCore

In this case, Petitioner has filed a Petition for an inter partes review of claims 1–20 of U.S. Patent No. 9,572,499 B2. Board after taking into account the arguments of both parties and evidence presented, Board determined that there was a reasonable likelihood that petitioner would prevail in demonstrating unpatentability of at least one challenged claim of US’499 patent and thus board instituted this inter partes review as to all challenged claims. In toto, Board has held following:

“Petitioner has demonstrated by a preponderance of evidence that claims 1-20 of US’499 are unpatentable”

ASSERTED GROUNDS OF PATENTABILITY

Petitioner asserted following grounds of unpatentability:

Ground Claims Challenged 35 U.S.C § Reference(s) / Basis
1 1-6, 10-16, 20 § 103 Shmueli (WO2012/140559, publ. Oct. 18, 2012.), Osorio (U.S. 2014/0275840, publ. Sept. 18, 2014.)
2 7-9, 17-19 § 103 Shmueli (WO2012/140559, publ. Oct. 18, 2012.), Osorio (U.S. 2014/0275840, publ. Sept. 18, 2014.), Hu 1997 (Hu et al., 44(9) “A Patient-Adaptable ECG Beat Classifier Using a Mixture of Experts Approach,” IEE Transactions on Biomed. Engineering 891–900 (1997).)

In support of Patentability challenge, Petitioner’s relies on, inter alia, the Declaration of Dr. Bernard R. Chaitman, M.D. where as Patent owner relied on declarations of Dr. Igor Efimov, Ph.D.

WHAT IS THIS PATENT ALL ABOUT?

US’499 Patent relates to medical devices, systems, and methods for detecting cardiac conditions, including cardiac arrhythmias. Parameters such as heart rate (HR), heart rate variability (R-R variability or HRV), and heart rate turbulence (HRT) may be determined. These parameters may be further analysed to detect and/or predict one or more of atrial fibrillation, tachycardia, bradycardia, bigeminy, trigeminy, or other cardiac conditions.

[Image Sources : Shutterstock]Apple verse ALiveCOre

The Specification discloses body-worn devices for detecting the occurrence of arrhythmias using a combination of ECG and PPG electrodes. PPG, or photoplethysmography, uses an optical sensor to detect the fluctuation of blood flow, and can provide a measure of heart rate. According to the Specification, fluctuations in heart rate not explained by changing activity levels may be interpreted as an advisory condition for recording an ECG, or electrocardiogram, which is a typical method for diagnosing episodes of arrhythmia.

The collected data may also be analyzed using machine learning algorithms to, for example, determine appropriate trigger thresholds, detect and predict health conditions, or provide a heart health score. “The machine learning based algorithm(s) may allow software application(s) to identify patterns and/or features of the R-R interval data and/or the raw heart rate signals or data to predict and/or detect atrial fibrillation or other arrhythmias.”

Figure 144Figure 14 reproduced aside shows one embodiment of a body-worn device which shows a smart watch 1400 which includes at least one heart rate monitor 1402 and at least one activity monitor 1404 such as an accelerometer. Analysis of signals from these monitors can be used to “determine if heart rate and activity measurements represent an advisory condition for recording an ECG,” and trigger signals for recording an ECG if an advisory condition is detected. The collected data may also be analyzed using machine learning algorithms to provide a heart health score.

Figure 10 shown below further discloses another embodiment involving a body worn device where it illustrates a method for monitoring a subject to determine when to record an electrocardiogram (ECG).

Figure 10Claims Challenged:

Petitioner challenges claims 1-20 of which Claim 1 and 11 are independent Claims. Three key prior art references were discussed in details which were:

  1. Shmueli (WO2012/140559, publ. Oct. 18, 2012.),
  2. Osorio (U.S. 2014/0275840, publ. Sept. 18, 2014.); and
  3. Hu 1997 (Hu et al., 44(9) “A Patient-Adaptable ECG Beat Classifier Using a Mixture of Experts Approach,” IEE Transactions on Biomed. Engineering 891–900 (1997).)

ANALYSIS

Board then put out the analysis of the cited references w.r.t challenged claims. Board recited the following:

Legal Position

Legal position on this matter where Board cited following:

  1. In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable [Harmonic Inc. v. Avid Technology, Inc., 815 F.3d 1356, 1363 (citing 35 U.S.C. § 312(a)(3)]
  2. Further, Board relied on KSR International Co. v. Teleflex Inc., judgement where Supreme Court summarized the four factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1 (1966) that are applied in determining whether a claim is unpatentable as obvious under 35 U.S.C 103 as follows:
    1. determining the scope and content of the prior art;
    2. ascertaining the differences between the prior art and the claims at issue;
    3. resolving the level of ordinary skill in the art; and
    4. considering objective evidence indicating obviousness or non-obviousness, if present.
  3. Board on concept of obviousness relied on Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976)) and quoted:

“[W]hen a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious”

Further, relied on Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) where Court held that “obviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success”.

Level of Ordinary Skill in Art

Board in determining the level of skill in the art relying on cases of Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983) cited following factors for consideration which were:

  1. type of problems encountered in the art,
  2. the prior art solutions to those problems,
  3. the rapidity with which innovations are made,
  4. the sophistication of the technology, and
  5. the educational level of active workers in the field.

Petitioner’s contention in regard to person skilled in Art

Petitioner asserts that a person of ordinary skill in the art would have been someone with at least a combination of Bachelor’s Degree (or a similar Master’s Degree, or higher degree) in an academic area emphasizing health science, or a related field, and two or more years of work experience with cardiac monitoring technologies (e.g., as a cardiologist). Petitioner further contends that “additional education or industry experience may compensate for a deficit in one of the other aspects of the requirements stated above.”

Patent Owner’s Contention in regard to person skilled in Art

In its Preliminary Response, Patent Owner took the position that one of ordinary skill in the art would have had “specialized engineering skills” including “a degree in biomedical or electrical engineering (or an equivalent), and/or extensive experience working with tools for detecting cardiac conditions.

Patent Owner argues that board should reject originally proposed definition in light of, for example, Petitioner’s proposed definition before the ITC, which required an engineering background and “at least two years of relevant work experience designing wearable devices and/or sensors for measuring physiological signals.

Observations of Board

Board applied modified definition, which was consistent with Petitioner’s representation before the ITC. For the purpose of this proceeding, a person of ordinary skill in the art may be a member of an interdisciplinary team including persons with backgrounds in electrical engineering, mechanical engineering, biomedical engineering, computer science, and/or cardiology, and having at least two years of relevant work experience designing, using, or analyzing data from, cardiac monitoring devices.

Board noted that Dr. Chaitman as well as Dr. Efimov neither experts possesses advanced skills in computer science, or more specifically, machine learning. Further, board observed programming skills may be relevant to the implementation of certain of the challenged claims, however, they are not prerequisites for qualifying a person of ordinary skill in art.

In light of the above, Board determined that Dr. Chaitman and Dr. Efimov are both qualified to testify as to the understanding of a person of ordinary skill in the art and experts on a particular topic of both parties would be weighed in light of the strengths and weaknesses of their respective background.

CLAIM CONSTRUCTION

Board interpreted claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b).

Under this standard, board construed the claims “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” & relied on Nidec Motor Corp. vs Zhongshan Broad Ocean Motor Co. Ltd where it was held that terms in controversy need to be construed to extent necessary to resolve the controversy.

On basis of above understanding, Board applied plain and ordinary meaning to all claim terms. Board evaluated both the assertions based on the citations found and concluded:

Ground 1: Obviousness over Shmueli and Osorio

Observations of Board: Board held that the combination of Shmueli and Osorio discloses or renders obvious the arrhythmia detection recited in the challenged claims, and that one of ordinary skill in the art would have been motivated to combine the cited references with a reasonable expectation of success of arriving at the claimed invention. Patent Owner does not specifically challenge any other element under Ground 1. Having reviewed the argument and evidence of record, Board found that Petitioner has shown by a preponderance of the evidence that claims 1–6, 10–16, and 20 are unpatentable as obvious in view of Shmueli and Osorio.

Ground 2: Obviousness over Shmueli, Osorio, and Hu 1997

Observations of Board: Board found that Hu 1997 discloses or renders obvious the “machine learning” element of claims 7–9 and 17–19. Board found that the combination of Shmueli, Osorio, and Hu 1997 discloses or renders obvious all elements of claims 7–9 and 17–19, and that one of ordinary skill in the art would have been motivated to combine the cited references with a reasonable expectation of success. Having reviewed the argument and evidence of record, Board found that Petitioner has shown by a preponderance of the evidence that claims 7–9 and 17–19 are unpatentable as obvious in view of Shmueli, Osorio, and Hu 1997.

FINAL DECISION OF PATENT TRIAL AND APPEAL BOARD

Board relying on the preponderance of evidence, that claims 1-20 are unpatentable under § 103 as obvious in view of Shmueli and Osorio, with or without Hu 1997.

Further, Board ordered that claims 1-20 of US’499 patent are held to be unpatentable.

CONCLUSION:

This case is one of the classic cases of § 103 objection i.e. obviousness. The main parties in the case were Apple Inc. and the AliveCor. AliveCor was the owner of the patent US’499 which relates to medical devices, systems and methods for detecting cardiac conditions, including cardiac arrhythmias such as a body-worn devices for detecting the occurrence of arrhythmias using a combination of ECG and PPG electrode. Apple challenged the claims of AliveCor’s patent US’499 on the grounds of unpatentability under 35 U.S.C § 103 i.e. ground of obviousness in view of 3 cited prior art references. Board highlighted the legal position on this section, level of ordinary skilled in art, comparison of claims with cited references. Observing all these factors, Board found the AliveCor’s patent claims too obvious to be patented. Thereby Apple won this battle against AliveCor over ECG device.

Author: Tushar Bawa, a legal Intern at Khurana & Khurana Advocates and IP Attorneys, in case of any queries please contact/write back to us via email to chhavi@khuranaandkhurana.com or at IIPRD.

 

 

 

 

One thought on “Apple Wins Patent Suit Against Alivecor Over Portable Ecg Tech”

Leave a Reply

Your email address will not be published.

five × four =

Archives

  • January 2023
  • December 2022
  • November 2022
  • October 2022
  • September 2022
  • August 2022
  • July 2022
  • June 2022
  • May 2022
  • April 2022
  • March 2022
  • February 2022
  • January 2022
  • December 2021
  • November 2021
  • October 2021
  • September 2021
  • August 2021
  • July 2021
  • June 2021
  • May 2021
  • April 2021
  • March 2021
  • February 2021
  • January 2021
  • December 2020
  • November 2020
  • October 2020
  • September 2020
  • August 2020
  • July 2020
  • June 2020
  • May 2020
  • April 2020
  • March 2020
  • February 2020
  • January 2020
  • December 2019
  • November 2019
  • October 2019
  • September 2019
  • August 2019
  • July 2019
  • June 2019
  • May 2019
  • April 2019
  • March 2019
  • February 2019
  • January 2019
  • December 2018
  • November 2018
  • October 2018
  • September 2018
  • August 2018
  • July 2018
  • June 2018
  • May 2018
  • April 2018
  • March 2018
  • February 2018
  • January 2018
  • December 2017
  • November 2017
  • October 2017
  • September 2017
  • August 2017
  • July 2017
  • June 2017
  • May 2017
  • April 2017
  • March 2017
  • February 2017
  • January 2017
  • December 2016
  • November 2016
  • October 2016
  • September 2016
  • August 2016
  • July 2016
  • June 2016
  • May 2016
  • April 2016
  • March 2016
  • February 2016
  • January 2016
  • December 2015
  • November 2015
  • October 2015
  • September 2015
  • August 2015
  • July 2015
  • June 2015
  • May 2015
  • April 2015
  • March 2015
  • February 2015
  • January 2015
  • December 2014
  • November 2014
  • October 2014
  • September 2014
  • August 2014
  • July 2014
  • June 2014
  • May 2014
  • April 2014
  • March 2014
  • February 2014
  • January 2014
  • December 2013
  • November 2013
  • October 2013
  • September 2013
  • August 2013
  • July 2013
  • June 2013
  • May 2013
  • April 2013
  • March 2013
  • February 2013
  • January 2013
  • December 2012
  • November 2012
  • September 2012
  • August 2012
  • July 2012
  • June 2012
  • May 2012
  • April 2012
  • March 2012
  • February 2012
  • January 2012
  • December 2011
  • November 2011
  • October 2011
  • September 2011
  • August 2011
  • July 2011
  • June 2011
  • May 2011
  • April 2011
  • March 2011
  • February 2011
  • January 2011
  • December 2010
  • September 2010
  • July 2010
  • June 2010
  • May 2010
  • April 2010