Unforseen Interpretations Can Spell Trouble During Patent Prosecution

Claims are generally drafted in an open-ended format (e.g., using comprising in the preamble). That means that the applicant cannot overcome a prior art rejection by arguing that the prior art has extra features not recited in the claim. Specifications are often drafted with open ended language as well. This makes sense since, on the flip side, one does not want a cunning infringer to avoid infringement merely by adding an additional element to their product beyond what is in the claim.

Examiners can take advantage of the situation by formulating a broad interpretation of claim language in a way so as to cover the cited prior art. And unless the applicant can either convince the Office that the interpretation is unreasonable or amend the claims (with proper support) to exclude the cited art from the interpretation, the applicant can be stuck.

We see a classic example in a recent Nestle case related to baby formula compositions. The invention here relates to the recognition by the inventors that there was a statistically significant
difference in the total protein content between human milk produced for male and female infants up to 1 month postpartum. This discovery led to the development of a baby formula system with gender-specific protein content. Claim 1 on appeal is set for below:

A method of providing nutrition to infants up to 1 month of age, the method comprising:
providing a nutritional system comprising a female gender specific synthetic nutritional composition comprising a first total protein content of 0.2g to 2.0g per 100 mL, the nutritional system further comprising a male gender specific synthetic nutritional composition comprising a second total protein content of 0.7g to 2.3g per 100 mL, wherein a ratio between the first total protein content and the second total protein content is 1:3.8 to 1:1.15;
administering the female gender specific synthetic nutritional composition to a female infant up to 1 month of age; and
administering the male gender specific synthetic nutritional composition to a male infant up to 1 month of age.

The Office cited prior art that had various formulations, and which allegedly had two examples which respectfully encompassed each of the male and female formulations set forth in claim 1.

It should first be noted that Nestle cleverly drafted a claim that attempts to cover the idea that the male/female baby formulations are different, even though any given package of formula has only one of the formulations. Specifically, similar to past posts on “product line” claim formats, Nestle linked both formulations in a single claim forcing the Office to find something that had both formulations. (see an example previous post here). Whether or not this format raises other issues, such as divided infringement, etc., is left for another day.

Nestle’s claim format, however, still had the problem that if one fed the first formulation of the prior art to many babies, at least some of them would inevitably be female. Likewise, if one fed the second formulation of the prior art to many babies, at least some of them would inevitably be male. Thus, the method is allegedly disclosed by the cited art, just with extra “providing” steps. What Nestle really wanted was that the first formulation was intended to be fed to females, and the second to males. But claiming intent can be difficult.

Nestle argued against the rejection but the open-ended nature of the claim was too much. As the PTAB explains:

… the recited female/male “gender specific synthetic nutritional composition” is not compositionally limited other than the recited protein content ranges which are encompassed by the prior art ranges. As the Examiner additionally points out, claim 1 is open ended and does not prohibit administering either the male or female gender specific synthetic nutritional composition to both genders.

This conclusion was reinforced by Nestle’s alleged failure to dispute the Examiner’s position that the recited female/male gender specific composition is no more than an intended use of the synthetic composition. Whether these method claim features were properly interpreted as merely intended use is questionable, but if not challenged, is taken as admitted per the normal appellate practice rules at the PTAB.

One potential option for Nestle, if supported by the specification, could be to limit the “open-endedness” of the claims by limiting the providing of the gender-specific formulations only to the specific gender that it was designed to feed.

In any event, it can be exceedingly difficult to predict where and when an applicant may need to narrow claim scope in view of these issues. It can be prudent to include layers of support in the specification with both open and closed-ended language in some examples. In any event, Nestle may yet continue with this application and find a way forward.