The Software IP Report

Computer Modeling Breast Prosthesis Survives 12(b)(6) § 101 Challenge

A court has declined, at least for the moment, to hold patent-ineligible claims directed to making a computer model of a part, in this case, a breast prosthesis.  ContourMed Inc. v. American Breast Care LP, No. 4-15-cv-02769 (TXSD March 17, 2016, Order) (Miller, J.).  Although the claims do recite use of hardware (e.g., a “scanning system”), the takeaway from this case is that courts will not uniformly hold claims invalid under 35 U.S.C. § 101 where the claims are directed primarily to gathering and processing data.

ContourMed asserted US Patent No. 7,058,439 against American Breast Care in September of 2015.  The ‘439 patent is directed to a method of forming a breast prosthesis that includes scanning the patient to generate a computer model of the prosthesis and creating a mold from the computer model. The mold is filled with a polymerizable foaming composition that cures to form the prosthesis. Here is claim 1, directed to modeling (but not actually forming) the prosthesis:

A method of forming a model of a breast prosthesis for a patient who has had one breast at least partially removed, comprising:

providing a scanning system comprising one or more imaging devices and one or more alignment markers, wherein at least one of the alignment markers comprises a tangible object, wherein the tangible object is noticeable in a scanned image and may be used to manipulate a scanned image as a reference point;

arranging at least one of the alignment markers in the middle of the body of the patient and within the field of view of at least one of the imaging devices;

determining a first set of data elements using the scanning system is based on a shape of the patient’s intact breast;

determining a first computer model of the intact breast based on the first set of data elements;

using at least one of the alignment markers in the middle of the body of the patient as a fixed reference point relative to the patient to determine alignment of the first computer model of the intact breast;

applying a reflection transformation to the first computer model of the intact breast to form a second computer model, the second computer model comprising a second set of data points that represents a mirror image of the first computer model;

determining a third set of data elements using the scanning system based on a surgical site at which the breast was at least partially removed;

determining a third computer model based on the third set of data elements; and

combining the third computer model and the second computer model to form a breast prosthesis model, wherein the second computer model defines an anterior portion of the breast prosthesis model that mirrors the intact breast and the third computer model defines a posterior portion of the breast prosthesis model that is custom fit to the surgical site.

American Breast Care filed a motion to dismiss under FRCP 12(b)(6) motion asserting that the ‘439 patent claims recite ineligible subject matter under § 101.

To resolve the 12(b)(6) motion, the District Court applied the two-part test set forth in Alice Corp. v. CLS Bank International, 134 S. Ct. 2347 (2014).

“[T]he court first asks whether the claims at issue in the ‘439 Patent are directed to an abstract idea.” Opinion, at 5.  (The second step in the analysis, which the court did not reach, is determining whether the claim elements individually and as an ordered combination transform the nature of the claim into something that is patent-eligible.)

The patent owner argued that the claims of the ’439 patent are not directed to abstract ideas because “the claimed scanning system includes an imaging device and expressly requires one or more alignment markers, adhesive tape placed on the subject prior to imaging that aids the 3D modeling process.” Opinion, at 5 (internal quotation marks and citations omitted).

Naturally, the accused infringer disagreed, arguing “that the ‘439 Patent is directed to an abstract idea because the patent claims the creation of a computer model on a generic computer using data collected conventionally using a generic scanner system.” Opinion, at 5 (internal quotation marks and citations omitted).

At this stage of the litigation (i.e., pre-claim construction), the court sided with the patent owner, holding that the ‘439 patent “falls outside of the abstract ideas in the precedent because the concept of the invention involves substantially more than mere data collection and storage and does not threaten to pre-empt the use of scanners and computer modeling in other fields.” Opinion, at 6-7.

The ‘439 patent survives, at least for now.

One interesting academic exercise is to consider whether the claims would survive a §101 challenge at the USPTO. (The ‘439 patent was filed in 2002 and issued in 2006, before §101 rejections became common at the USPTO.)

As acknowledged by the Court, “The patent claims imaging of the breast to the ultimate end of creating a breast prosthetic, using alignment markers placed on the breast and captured in the image to aid in the computer modeling.” Opinion, at 6. In my experience, this type of reasoning might convince the examiner to withdraw a §101 rejection, although some examiners might have required the applicant to add steps reciting the creation of the prosthesis from the model before withdrawing the §101 rejection.