Hi, I have some doubts about conformity assessment of IIa MD. We apply Annex II with exclusion of section 4. When we launch a new MD or when we make any substantial change, we always undergo an approval process with our NB.

Recently, I have come across a manufacturer of IIa MD who claims that they launch their products without prior NB approval provided that the given MD is within the scope of the Full Quality Assurance certificate already issued, i.e., if the certificate was issued, let’s say, for catheters and they have developed a new catheter model, they can CE-mark the product and freely market it.

Most companies use the Annex II conformity assessment process to achieve CE Marking. In this process, the NB reviews your Technical File for conformity, and also reviews your quality system for conformity with regulatory requirements in the applicable directives. As part of the Annex II process, the NB will audit your design process to ensure that you have adequate design controls, and that your process for establishing and maintaining a Technical File is adequate. Once your company has adequately addressed any findings from the audit, the NB will issue your company a Full Quality Assurance (FQA) CE Certificate in accordance with Annex II.3. Once you have the certificate, your company will be able to launch new products without prior approval from the NB. The only requirement is that the new products are within the scope of the Annex II.3 certificate.

I went through the MDD several times and it seems that it depends on the interpretation of your NB. Do you agree?

Thanks in advance for the discussion.

It's seven years since the Supreme Court decided Mayo v. Prometheus, 566 U.S. 66 (2012).

My takeaway from a three year-old conversation with Gavin Bogle (below) was "diagnostic devices aren't patentable."

Of course, it's more nuanced than that, says guest contributor, medical device IP practitioner Peter Sleman.

Don't Panic.

Thank you, Joe, for the opportunity to address the Group this way.

There is a growing sense among inventors the patent system has become too complex, inconsistent, and unpredictable. A client recently shared a story of how he invented an orthopedic device, filed an application, and was granted a patent. The device was a success.

Almost a decade later, he filed suit against an infringer in a district court. Weeks before his decision, the Supreme Court decided an unrelated case known as Nautilus that “clarified” the law on indefiniteness. The District Court, taking Nautilus into consideration, deemed his claims indefinite and invalid. He lost.

It is a bitter pill to swallow. His patent claims were valid when he filed them, valid during examination, and valid when he brought suit.

But it all changed when the Supreme Court waded into patent claim construction.

Patent attorneys have become accustomed to following court decisions closely to spot trends and adjust their prosecution strategies. This is why the recent CardioNet decision in the District of Massachusetts has gotten some attention from practitioners focused on medical devices.

What happened in CardioNet?

The CardioNet suit revolved around a system and technique for monitoring cardiac activity in U.S. Patent No. 7,941,207. The patent claims relate to a heart monitor with a beat detector, a ventricular beat detector, and certain logic components that determine variabilities.

In this case, the District Court deemed the claims not patent-eligible under 35 U.S.C. § 101. This statute bars a person from attempting to patent laws of nature, natural phenomena, or abstract ideas, and over the past few years the § 101 inquiry has been informed by what is known as the Alice-test.

What exactly is Alice?

Like Nautilus, Alice was a Supreme Court decision. The Supreme Court does not look at patents often, but seismic shifts occur when it does pick up a patent case such as 2014’s Alice. To determine whether claims are patent-eligible under 35 U.S.C. § 101, the Supreme Court articulated a two-step test.

1. Ask whether the claims directed to laws of nature, natural phenomena, or abstract ideas.
2. Ask, if the claims at issue are found to be directed to laws of nature, natural phenomena, or abstract ideas, whether the elements of each claim both “individually and as an ordered combination transform the nature of the claim into a patent-eligible application.”

In CardioNet, the Court applied the Alice two-step and decided the claims to the heart monitor at issue were not patent-eligible. This is more common in software cases, but rare when the underlying technology is a medical device.

What’s next?

CardioNet decision will probably be appealed, and its reach is limited. Additionally, the specific wording in the claims of the CardioNet patent left much to be desired. Medical device innovators and manufacturers should not panic and can learn a few lessons from this case as to how to articulate a claim with enough specificity to avoid invalidation by Alice.

Will this affect me?

It depends on your field. CardioNet has almost no bearing on traditional mechanical medical devices (think orthopedics), but the same reasoning may be used to invalidate other, more complex medical devices with electronics components. As more medical devices employ sensors and processors, you can be sure that Alice will become more relevant. Look no further than the new Apple Watch heart rate monitor to see this in action.

In fact, Apple was recently granted U.S. Patent No. 1,007,6257 on a similar “seamlessly embedded heart rate monitor.” Would the claims in Apple’s patent survive Alice? That’s an interesting conversation for another time, but when you view the claims side-by-side with CardioNet claims you will see a difference in approach.

What are the implications for my business?

Patent claims are fences around your invention. It's tempting to push those boundaries and pursue a claim as broad as possible to expand your territory; yet, the broadest claims are usually the easiest to invalidate and most susceptible to an Alice challenge.

Instead, when software is involved, present claims with varying scope including general claims, intermediate claims and more narrowly-tailored claims. Presenting claims that are specific and have multiple “meaningful limitations,” will ensure that at least some of the claims will survive an Alice challenge.

Applicants can file a number of linked applications. We refer to those as “patent families.” Typically, when a patent nears allowance, the Applicant may choose to file a “continuation” application to pursue additional claims, but this must be filed before the original patent issues.

By keeping a continuation application pending, Applicants retain the opportunity to pursue adjusted claim language and scope as needed. Continuations also present a hurdle to your competitors because they may know what is protected by granted claims, but they are left with a degree of uncertainty as to what else you may be able to cover in the future.

Postscript: Alice was the progeny of Mayo and relied heavily on it to frame how one should judge whether software is patent-eligible. While Gavin's thoughts were more focused on diagnostics and attempting to claim the relationship between analyte and disease, the CardioNet decision relates to hardware/software and attempting to capture algorithms, such as those for beat detection. Alice may only be an issue for certain classes of medical devices, and steps can be taken to frame the invention as one relating to a machine, not just an algorithm or a scientific principle or relationship.

Editor's note: That was great, Peter, thank you – and I encourage other group members to contribute so meaningfully.

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A "Medically Accurate Webinar" next Wednesday

If you aid in the design, development, engineering, or manufacturing of devices for home-based patient monitoring, you'll want to attend a free session I'm co-hosting with Group member Walt Maclay.

What: "What You Need to Know Before Manufacturing a Wearable Device."

When: Live on Wednesday, January 23 at noon Eastern Standard Time and Replay on Demand shortly thereafter.

Where: Online! And it's free.

Why: Education = good. Join us! 😊

Click now to register.

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Brother, can you spare an answer?

• Gregory needs a cleanroom to pack Pasteur pipettes.
• Sean needs help quantifying the impact of fee-for-service work.
• Tsafrir needs feedback on the Spectre and Meltdown cyberattacks.
• A group member needs a contract manufacturer.
• David needs sales education audio for his long commutes.
• Joe needs more contributions like Peter Sleman's today!

Can you assist them?

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Thank you for being part of our Medical Devices Group community!

If you're looking for work, we added new jobs this week here!

Make it a great week.

Joe Hage
Founding Principal,
Medical Devices
Advisory Group

P.S. Join us for Walt's webinar next week. Click now to register.

That's a fancy health tracker on your wrist. Is it medically accurate?

Tracking devices – monitors, if you will – have been around for a long time. In the intensive care unit, the patient is monitored 24 hours.

Your fitness tracking device may not even be FDA cleared.

Medically Accurate?

You may not be terribly concerned about slight measurement errors on your fitness tracker.

Remote patient monitoring for clinical diagnoses is a completely different animal. Material health decisions rely on accuracy.

After talking with Voler Systems President Walt Maclay, I realized this is a webinar-worthy topic. Walt agreed and we'll co-host a live event will be Wednesday, January 23 at noon Eastern Daylight Time to discuss wearables and home patient monitoring.

Click here to register.

Pitfalls of Medically Accurate Measurements

Walt easily rattled off a dozen watch outs for our medical device design and development communities. We'll cover them on the 23rd but here's a taste:

• Heart rate. Heart rate is simple to implement in theory, but difficult to measure on the wrist. Measuring the electrical EKG signal requires good contact with the skin, which does not happen often. A more reliable technique is pulse plethysmography or PPG.

• Skin temperature. Skin temperature varies greatly, so it's not a good indicator of core temperature (to detect fever, for example) except at a few locations. The forehead and under-arm are the best locations, but you'd look pretty stupid wearing those. (Okay, that's not exactly what Walt said.) 😛

• Measuring EKG. Measurement points have to be rather far apart (at least 1½ inches on the chest). That's a significant issue if the device is too small. It's particularly difficult to measure EKG on the wrist.

  A device that attaches to a cell phone to measure EKG via two electrodes can do it – one thumb is placed on each electrode and held there until the measurement is captured. This works because the two thumbs are far apart on the body.

  The Apple watch uses a similar technique. You must touch the watch with the opposite hand to measure EKG.

He had much more to say. I got tired of writing. Click the register button and we'll share more on the 23rd.

Right here. That's the ticket!

Postscript

We want all that home-monitoring data so we can send patients home. In an outcome-based environment, we're getting paid the same no matter how much it costs us to treat them. They're expensive and take up available beds.

Sensor data can help manufacturers gain a competitive advantage. A wearable device can complement their main product by collecting additional data. More data, more opportunities.

Walt adds, "This isn't innovation for innovation's sake. Sensor data improves clinical outcomes, economic value, care delivery efficiencies, and patient experience. The proactive shift to value-based care strives to maintain healthy populations and prevent illness, and reduce the need for clinical visits and hospital care."

Thank you, Walt, and we invite you to join us for this free educational session.

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The Medical Devices Advisory Group

If you missed it last week, we introduced the Medical Devices Advisory Board (read about it here) and co-founding member Paula Rutledge took the lead on our first report, below. Click the image to download it.

We also added more than 30 active searches, many conducted by Paula's Legacy MedSearch group.

See the jobs here. Some need urgent filling.

Here are some new ones versus last week.

You can thank Paula in person – at the 10x Medical Device Conference. I hope the May 15-16 event is on your radar.

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New Year, New Questions!

These members have questions. Do you have the answers? Visit our community discussion board and catch up on what you missed.

• Jana in the Czech Republic has a non-EU country registration question.
• North Carolina-based Amy wants to set up an online CME course and could use your help.
• Ata in Turkey has a classification exemption question.

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Thank you for being part of our Medical Devices Group community!

If you're looking for work, check out the newly posted jobs here!

Make it a great week.

Joe Hage
Founding Principal,
Medical Devices
Advisory Group

P.S. Join us for Walt's webinar on January 23 at noon Eastern Standard Time. Click here to register.