I am writing a separate post on Galderma Labs., L.P. v. Amneal Pharms. LLC (Fed. Cir. March 25, 2020), but wanted to note the claim language found in Gladerma’s U.S. patent No. 8,206,740. In particular, I was first surprised to see the final element of the claim written as an “optional” limitation:
1. An oral pharmaceutical composition of doxycycline, which at a once-daily dosage will give steady state blood levels of doxycycline of a minimum of 0.1 μg/ml and a maximum of 1.0 μg/ml, the composition consisting of
(i) an immediate release (IR) portion comprising 30 mg doxycycline;
(ii) a delayed release (DR) portion comprising 10 mg doxycycline; and
optionally, (iii) one or more pharmaceutically acceptable excipients.
The MPEP offers some ambiguous thoughts on use of the term “optionally” within claim language — concluding that it may raise indefiniteness concerns where ambiguity arises from a “list of potential alternatives.” MPEP 2173.05(h) Alternative Limitations. In the usual claim situation, an “optional” limitation creates confusion because it doesn’t appear to do any actual work in the claim because a claim “comprising” a list of features may also include other features as well. In that situation, the ambiguity comes into play because we still want to assign some meaning to the claim element even though it is largely meaningless.
In the claim above, however, the “optionally” language complements a “consisting of” transition. It does substantial work because of the closed transition — without the optionally limitation a formulation having the “pharmaceutically acceptable excipients” would be found not literally infringing.
This is a trick often played by the applicant, when they argued for new and non-obvious, they inclined to include the optional feature into the claim, while doing infringement analysis they would not include.
Trick? Often, sure, but not always. Suppose the contribution to the art is some sort of tool carrier or substrate which is more adaptable to carrying a wider range of tools or other artefacts. Reciting in the claim to it, prefaced by “optionally”, one could recite something about the tools, to bring it home to the Examiner, or Judge, how much utility the claimed subject matter offers.
This is about using the word, “optionally,” in a claim, where “optionally” is followed by a genuine claim element. I use the word “optionally” for the following reason. In my opinion “optionally” is a quick, shortcut substitute for sticking in an additional dependent claim (when I do not have the time or inclination to draft a real dependent claim). Of course, the optionally element adds NO PATENTABLE WEIGHT to the claim. But during the course of eventual patent prosecution it serves as a reminder to the attorney or agent, that this claim element was proposed by the claim-drafter, to be a potential STAND ALONE DEPENDENT CLAIM. Although the above is not legal advice, please note that I have published 18 law review articles, the most ten of these being from 80 to 120 pages long. Also, please note that I have twice been characterized as an “Authority” on patent prosecution, in an Amicus Curiae and in a Writ of Certiorari, as submitted to the U.S. Supreme Court in two different cases. I have also received the annual Rossman Award (at a ceremony at the USPTO).
Ever since the EPO started to impose fees on every single claim beyond the first 15, it has been the practice of patent attorneys in Europe to hold on to as much of the value as possible of the originally US drafted and filed set of 60, 80 or 100 claims, even as they (on instructions from the instructing US law firm) crop the number down to 15 for filing at the EPO. One way to do it is, indeed, to resort to use of “optionally”, exactly as you envisage.
Thank you for your enlightening response, MaxDrei. It was certainly enlightening to me. Best regards, Tom Brody
…sounds like ‘scriviner’ tricks…
[need an icon for angry old man muttering away]
I shall be interested to read the thread of Comments. Thinking of the way alloy compositions have invariably been claimed in the UK since the 1950’s (thanks to the Mond Nickel case) I have no problem to construe this claim. It’s just like an alloy claim in Europe.
Who does have a problem? Anybody?
It appears to be an inexpensive alternative to having a dependent claim, wherein the composition further comprises item (iii).
From a scope of infringement perspective, potentially, though a dependent claim would also do work from a novelty/non-obviousness perspective, if adding the excipients distinguishes over the art.
Related question: would a dependent claim that adds an element be acceptable under Section 112? One might argue that it’s an illogical combination, e.g., that Claim 1 says “only A and B” and thus anything that says “also C” does not “further limit” Claim 1.
It narrows the claim scope. Now, all three items are required to infringe. “Further comprising” dependent claims are fairly common in the chemical arts.
One might say? Indeed. I, for one, say exactly that.
Bryan is totally correct in stating that an “optionally” clause does not further limit the claim. But as stated in my own comment, an “optionally” clause sends a message to the attorney or agent who (a year or longer after the original filing date) actually gets around to prosecuting the claims. The message that is sent to this attorney or agent (a year or more down the line), is that this “optionally” clause is the best and most valuable candidate for an additional stand-alone dependent claim (in the event that the need presents itself). When I draft a claim set, I am considerate of the person who will actually be prosecuting my claims, a year or more down the line.
Yeah, reed, that’s standard practice in Japan. But it renders the claim set unclear. When claim 1 defines 100% of what is present, there is no room for a dependent claim to add an additional ingredient.
I now believe you and Brian are exactly right. You would have a situation where the dependent claim could be infringed while the independent claim would not be. That can’t be right.
Change the hypo. What if the independent claim used “consisting essentially of” items (i) and (ii)? I think the “further comprising” language would then be allowable.
Sorry, I mean “Bryan”.
OK, reed, but for me the expression “consisting essentially of” is indefinite because it is inherently ambiguous. Why use it unless you want to argue it one way for patentability ad the other way for infringement? Maybe that’s why for the EPO it is normally not allowable in claims like these.
Not quite: An “Optionally X” claim element provides no prior art distinction – it is not an actual claim limitation, unlike a dependent claim adding that limitation.
Also, adding another element to a claimed combination does not normally avoid infringement. Does a preamble “composition consisting of” really do that?
P.S. Dennis, thank you for this flurry of blog posts to keep all of us on partial-lock-downs entertained.
Dennis, my thanks too. Paul, I agree that “optionally” does not require the presence of X, so reciting X does not help against the prior art.
See my # 2. Let’s talk about alloy claims, which in Europe (since forever) require “consisting of” for clarity but end routinely with the mantra “apart from incidental elements and impurities, if any “. You see, commercial alloys are seldom perfectly pure.
Sorry, re”adding another element to a claimed combination” what I actually meant to say was adding another material or feature to a infringing product.
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