Patenting Medical Devices


Introduction

This article is meant to be read in conjunction with my article Patentability Swamp.  In this prior article, I have discussed the newest USPTO Guidelines (October 17, 2019) pertaining to patenting matters that may incorporate patent ineligible material under 35 USC Section 101, i.e., natural law, natural products, natural phenomena or abstract ideas.  I have discussed the USPTO example attempting to explain when a medical procedure may be patentable in spite of including some aspect of natural phenomena or law of nature.

In this article, I am discussing the USPTO example of patenting a medical device that similarly includes a delivery of a natural product, i.e., an acid derived from a tree bark and useful in treating diabetes.  In this example, the hypothetical acid (named denveric acid) is obtained by processing a plant material and refining the naturally occurring acid.  Therefore the acid is a natural product.  As a side note, this naturally occurring acid is not patentable subject matter, similar to extracting the naturally occurring/existing DNA.  Reference the Supreme Court case AMP v. Myriad Genetics discussed in my article Patenting Medical Devices and Procedures.  

Discussion

The USPTO analyzes the patent eligibility of 4 hypothetical claims of a patent application wherein this naturally occurring denveric acid is utilized in treating diabetes.  The examples utilizes a sample delivery system depicted below.  The acid (or mixture) is contained in the reservoir.  The reservoir is within a housing (patch) that can be affixed to a person’s skin.  A dosage control button can be pushed, causing a needle to extend from the reservoir into the patient’s skin to deliver the treating acid.  

The example discusses 4 claim variations and evaluates whether the claims constitute patentable subject matter.  The claims are 

CLAIMS 

1. A dosage unit comprising denveric acid in a container. 

2. The dosage unit of claim 1, wherein the container is a wearable delivery device having a flexible patch-shaped housing, a needle assembly mounted on one side of the housing, a reservoir located inside the housing in which the denveric acid is stored, a dosage control button mounted on the opposite side of the housing from the needle assembly, and a delivery valve for dispensing a selected dosage of denveric acid from the reservoir to the needle assembly. 

3. The dosage unit of claim 1, wherein the denveric acid is an intermediate-acting denveric acid. 

4. The dosage unit of claim 1, further comprising protamine that is mixed with the denveric acid in the container in an amount of 0.75 mg to 1.5 mg protamine per every mg of denveric acid.

Claim Analysis

The example examines the first claim, using the methodology discussed in my prior article.  First, does the claim recite patent ineligible subject matter.  Here the claim recites denveric acid, stipulated to be a naturally occurring product.  By reciting, this includes the claim “setting forth” or “describing” an ineligible subject.  Since the claim includes ineligible subject matter, the analysis continues to an additional step, i.e., first the nature based product (denveric acid) is merely a refinement of the naturally occurring substance, it is a product of nature exception.  This was hinted above in the reference to the AMP v Myriad Genetics case.  The second prong or part of the analysis continues, i.e., whether the claim as a whole integrates the exception into a practical application.  Here the additional element is described merely as a container.  The claim does not explain how the acid is contained, what the container is, or how it is employed.  Therefore the description does not comprise a meaningful limitation but is rather akin to the court proscription of Mayo v Prometheus of “take a natural phenomena and apply it”.  Here the claim merely states “contain it”.  Therefore claim 1 in not patent eligible.

Note that this analysis does not consider other claim limitations such as lack of novelty, 35 USC Section 102, or obviousness, 35 USC Section 103.    

Continuing with the analysis of claim 2:

2. The dosage unit of claim 1, wherein the container is a wearable delivery device having a flexible patch-shaped housing, a needle assembly mounted on one side of the housing, a reservoir located inside the housing in which the denveric acid is stored, a dosage control button mounted on the opposite side of the housing from the needle assembly, and a delivery valve for dispensing a selected dosage of denveric acid from the reservoir to the needle assembly. 

Note again that the claim recites denveric acid, a natural product.  Therefore it is necessary to review the claim under the second step, i.e., whether the claim as a whole integrates the exception into a practical application.  Here the claim expands upon the description of container stated in claim 1.  The container is a wearable delivery device with a flexible patch housing, needle assembly, etc.  

Specifically, (and this is key) the second step looks to whether the claim (a) identifies additional elements beyond the judicial exception, (the exception be the denveric acid, a natural product) and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application.  

Looking at claim 2 more closely, the denveric acid is physically located in the reservoir of a wearable delivery device, a housing with a needle assembly, dosage control button and delivery valve.  The delivery device is clearly an integral part of the claim.  It is much more than the “container” stated in claim 1.  The reservoir/housing/needle assembly/dosage control/delivery valve has a practical application.  The listed assembly delivers the treatment (denveric acid) to the patient.  

Claim 2 is eligible for patent protection under 35 USC Section 101.  Again note that the above analysis does not consider whether the wearable delivery device is obvious or previously described in the prior art (Section 102 and 103 exclusions).  

Claim 3 

3. The dosage unit of claim 1, wherein the denveric acid is an intermediate-acting denveric acid. 

Analysis of this claim is interesting.  Again, think in term of the AMP v Myriad Genetics case and the isolation of naturally occurring DNA not being patent eligible but modified DNA (created in the as a subpart of the processing) may be patentable, i.e., the modified DNA is not naturally occurring.  

In the hypothetical example, the specification defines “intermediate-acting denveric acid” as acid molecules modified to retard the timing of the treatment effectiveness, i.e., the injection of the dosage provides beneficial treatment for a longer period of time post injection.  The intermediate acting denveric acid is structurally and functionally different than the naturally occurring product.  In other words, the glycemic control characteristics of the claimed denveric acid are different that naturally occurring acid.  Therefore the claim is patent eligible. 

Claim 4

4. The dosage unit of claim 1, further comprising protamine that is mixed with the denveric acid in the container in an amount of 0.75 mg to 1.5 mg protamine per every mg of denveric acid.

As in claim 3, the denveric acid has been modified and performs in a structurally and functionally different manner than the naturally occurring product.  Therefore the claim is eligible for patent protection.  

Conclusion

This summary of the USPTO furnished example hopefully points the methods to avoid the 35 USC Section 101 exceptions to patentability.  Note that the description/specification of the patent application is used in conjunction with the claim language to distinguish the elements of the claim from naturally occurring products, phenomena, natural laws or abstract ideas.  

Also the claim elements must be examined as a whole to see if the claim describes a product or method that has a limited or specific practical application and consists of more than a claim to a naturally occurring product, etc.