As discussed in several previous posts (here, here), the printed matter doctrine stands for the proposition that the addition of written material to a known product does not impart patentability. This doctrine is discussed in MPEP 2112.01 (III), which states that where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.

In some situations, an applicant would like to claim instructions with a product. From a business perspective, this can be desirable because products often must have such instructions to be practical, and further it can be difficult for examiners to find prior art actually teaching instructions. The printed matter doctrine aims at preventing applicants from overreaching and obtaining patents merely because of the addition of instructions. That is why the case law (and MPEP) focus on the functional relationship requirement for the printed matter and the product - for if there is such a functional relationship, then the applicant is entitled to patent protection.

Examples where there is a functional relationship often involve some sort of positioning of certain indicia to solve a technical problem, rather than merely convening information. Consider measurement indicia on a ruler, or labeled tabs that are meant to be aligned with corresponding holes in a product that is to be assembled by a user. When dealing with instructions, it can be difficult, by themselves, to provide the necessary functional relationship.

A recent PTAB example illustrates an example of something that does not constitute a sufficient functional relationship (Appeal 2020-003579 Application 15/188,656).

1. A medical assembly, comprising: a package comprising an outer surface having a major face defining an aperture; an aperture sealing label to selectively attach to the outer surface to close the aperture and to be selectively peelable from the outer surface to expose the aperture; and five sheets arranged in a stacked configuration within the package; and printed instructions defining five steps instructing when to use each sheet disposed within the package, and when to discard the each sheet disposed within the package, to clean a Foley catheter insertion site while reducing chances for causing a catheter associated urinary tract infection.

The PTAB noted first that the instructions are not even positionally tied to any of the structural elements, and the only claimed link was that the instructions referred to the how to use the other elements in the claim.

In the present situation, there is merit for a lack of functional relationship between the printed matter and the substrate because the recited instructions may be printed on the package, on the individual sheets, upon an insert located within the package, or upon a separate instruction brochure. See e.g., Spec. ¶¶ 36–41. Regardless of how the instructions are presented, Appellant’s device would operate the same, i.e., Appellant’s sheets would still be suitable for cleaning a Foley catheter insertion site. As such, the Examiner determines that because the printed instructions limitation and the package of claim 1 do not depend on each other, they thus are not functionally related such that the printed instructions limitation would not impart patentable weight. Consequently, contrary to Appellant’s contention, the Examiner did provide a proper analysis with respect to the printed matter issue…

The PTAB also illustrates another way to analyze the issue, somewhat in reverse - take away the printed instructions limitations and look to see if that changes the claimed product’s ability to function. Stated another way, the question is: do the instructions depend in some way on the other claim elements, or do the other claim elements in some way depend upon the instructions. Here, the answer was that there was no such interrelationship:

Likewise, as we have here, removing claim 1’s printed instructions limitation does not change the ability of the recited “five sheets” within the package from being used for cleaning, e.g., a Foley catheter insertion site.

In the end, the printed instructions merely conveyed information and so did not impart patentability.

When trying to protect instructions with a product, the patent professional must look hard to discover a functional relationship and ensure that it is well-explained in the specification. Further, when the relationship is lacking, the patent professional may want to work with their client in terms of product development improvements that provide the necessary functional relationship.