This week Patent Baristas talked with John LeGuyader, Director of TC 1600 at the U.S. Patent and Trademark Office, about the regarding the biotech section’s take on alternate claiming strategies and restrictions:

So, first I thought it might be helpful just to go over what your role is as a Director in the USPTO and how long have you been in this position.

I oversee several areas in Technology Center 1600.  We have a new director on board as of roughly May, and previous to that I was overseeing one of our organic chemistry/pharmaceutical areas and also our immunology area, as well as what we call our Quality Shop.

We have managers that are referred to as “Quality Assurance Specialists.”  They help TC manage with quality training and also special laws cases like petitions, reissues, reexams to the extent that we still have some in the Technology Centers that are not being processed through the Central Re-Exam Unit.

I am still overseeing the immunology area, and I’m still overseeing the “Quality Shop” of the Technology Center.  And so, I’m responsible for, at a higher level, the performance of my managers.  My managers oversee art units.  They directly oversee examiners.  So, I hope to mentor and direct my managers both in the workgroup, for examination purposes, but then as part of the Quality Shop, I look at a higher level across the TC.  We look to see what our overall quality is like, where we need to do training, so forth and so on.

I have been in my current position, for about 2 ½ years now.  Before that, I was the Executive Assistant to John Doll who was and is the Commissioner of Patents. Prior to that I was a Supervisory Primary Examiner in the molecular biology area. And prior to that I was an Examiner in the molecular biology area, and I’ve been with the Office since December of 1990.

I thought I would start with what you see as the impetus or what prompted the proposed rulemaking on “Examination of Patent Applications That Include Claims Containing Alternative Language,” 72 Fed. Reg. 44992 [Docket No.: PTO-P-2006-0004].

Well, if you look historically at Markush practice, which really began back around the 1920s, it was a way for applicants to generically claim their invention when there was no true generic language to use to claim their invention, right?  For example, fruit is a generic term that covers a whole variety of individual species of fruit.  In chemistry, there is oftentimes no true generic language in which to broadly claim their invention.  And so, Markush practice came about where generic chemical formulas with variable constituents were used in order to generically claim the inventions, because there was no generic language to refer to the genre and the species of a chemical formula that would fall under a more generic chemical formula that had variable groups.

That process has been evolving ever since the ’20s where we’re really not allowed a lot of checks and balances for practitioners on the outside with regard to how broadly they can actually claim their invention via Markush practice or via alternative language.  We have some examples, and there are also practitioners on the outside that would argue similarly to what I’m arguing that sometimes these Markush claims are huge.  They can contain billions of species, and if you do the math in certain situations, they claim more molecules than there are atoms in the universe.  Now that happens to be some of the extreme examples.  I mean, not all Markush claims are outrageous.

If you go back and you look at the case law and you look at law articles throughout history until the present day, in the ’80s, there were three different court decisions: In re Harnish, In re Weber, and In re Haas (referred to as Haas II).  The Court of Customs and Patent Appeals invited the Office to deal with emerging problems in Markush practice and to do it via rule making.

At one point, in the ’70s or so, the Office was rejecting what they referred to as improper Markush grouping.  The issue percolated up to what is now the Federal Circuit and the Court told us “We’re sorry, the statute for restriction purposes [that’s 121] doesn’t permit you to reject improper Markush groups.”  Those decisions told the Office:  “Please stop doing that!”  But they explicitly said, however, that we could rule make our way out of the problem and invited the Office to rule make so that we could get a grip on the extreme Markush groupings.  And for whatever reason the Office really hasn’t seriously taken up the issue.

I think part of the reason why we’re doing it now is the extremes are beginning to become more extreme.  I think if you ask practitioners about how they feel about some of the Markush groups that are being issued, they would say that it provides a certain kind of uncertainty in the market, because the groupings can be so large, you don’t really know what the invention covers in terms of scope.  And for the outside, that can be very problematic as well.  And I can tell you I have personally attended, over the last couple of years, several meetings where practitioners themselves have gotten up and spoken about the uncertainty in the market deemed to those that have Markush claims.  Sometimes these Markush groupings are very difficult to search.

Our restriction practice allows us to limit examination in applications to an individual invention, is discretionary by the examiner, and it so happens we have no rules for limiting the examination within the Markush or within a claim of which the alternative — we don’t have the rules to allow examiners to restrict those to a single invention.  And oftentimes, I wouldn’t say how often, it does occur that Markush groupings are so large, or so broad in scope, that they can cover multiple inventions.

And so what our rule is proposing to do is in those situations where Markush groupings can be identified to embrace more than one invention, we are proposing to allow examiners to restrict within a claim, or to restrict among the alternatives, so we can limit the examination from individual invention in any situation.

As you know, there’ve been a lot of issues about how the Patent Office has problems with dealing with the patent backlog.  Are Markush claims a particular problem in the Office?  Are chemical and/or nucleic acid claims mostly at issue?

They can be.  We’ve seen more Markush groups and alternative language within claims to claim their inventions, primarily in the pharmaceutical area, within the organic chemistry area, because that is where it evolved from.  It has been generally creeping in to the biotech area, particularly as you noted for the claims with sequences.  But it is also creeping in to other technologies across the Office.

My next question is that others are saying that it doesn’t make sense to single out Markush Groups for new rules, that’s just a generic claim, whether it was a Markush or not.  Say you just claim “fruit” and leave it at that.  Then the argument is “Well, there are a lot of fruits in the world.”  How do you respond that it seems unfair to pick on Markush?

I think your original question was “arbitrary.”

Well, that’s the way it has been criticized.

My first reaction when I saw that is that the description process in and of itself would be kind of arbitrary.  I mean, we are allowing examiners — again, at their discretion — to limit examination from individual inventions via restriction process.  And so, for someone to say that:  “Well, why are you doing it on Markush or why are you per se picking on Markush or alternative-type claims?” I think they are being a big disingenuous about restriction practice in general.

Perhaps they should be criticizing restriction practice as a whole, rather than just criticizing the Office for trying to rule make and deal with the problem that the Court indicted for us to rule make on, recognizing that the Office has limited resources.  Restriction practice is one way in which we can properly limit the examination and limit it to a single invention. Really, all we’re proposing to do is to bring Markush alternative claims in line with standard restriction practice.

Now, that doesn’t mean that we are going to be able to restrict.  I mean, if these rules actually go final — and I can’t tell you whether or not that is going to occur — but if they were to go final, the practice would not abolish our standard species practice, nor would it permit examiners in every instance to restrict within the claims where Markush and alternatives are being recited.  It would only be in those instances where the Markush covers more than one invention.

I don’t’ want too far sidetracked but, in parallel with this, I don’t think it would be any surprise there’s been a lot of concern or criticism about restriction practice in and of itself has gotten out of hand, that everything is restricted and then if you try to traverse, you’ll get nowhere.  You just get a standard “We didn’t find that persuasive.”  How do you address that?

Well, I can tell you, certainly in my technology, over the last two years, that was one of the first things that I wanted to rein in and to make sure that the examiners were being consistent.  And so over the last two years, we’ve been getting a whole series of pieces of training on various parts of the restriction process, in an effort to get examiners to be consistent.

To our examiners’ credit, a really small fraction actually ends up being petitioned.  And in those instances where an examiner has done it wrong, well, we support the applicant.  We know that there are a number of  petitions I have signed in the applicant’s favor.  You know that the reverse is true too.  Sometimes what an applicant is alleging isn’t necessarily correct either.  Did we get it wrong sometimes?  Yes!  You know, but it goes both ways too.  I think sometimes the applicant is unreasonably claiming very broadly.

I’m not in a position to be able to tell applicants how they should be claiming. The things that applicants can look at, to try to see if they’re reasonably claiming their invention, and what is the predictability like in their art — and try to draft their claims accordingly or what one would recognize as being predictable in the art.  The question is, when is it and is it not reasonable?

In that regard, have there been, or will there be any, you know, guideline issues to help clarify?  Because I find that it can be somewhat subjective.

I think restriction is part logic, part procedure and part art form.  Restriction is steeped in procedure and that is part of what I think makes it difficult for both the examiners and the outside.  What we’ve tried to do in the last couple of years for our examiners is to give training and give guidelines about how to do it.

It’s a point well taken.  We have been criticized.  The Office, in general, has been criticized this year for going a bit a field in restriction process.  I think the Office recognizes that.  I think certainly 1600 does and we’re trying very hard.  Sometimes, however, it could be a judgment call.

Okay, how does the increase in technology, computer searching capabilities, and that sort of thing, counterbalance the need for restrictions or the new Markush Rules?

Yeah.  My first comment about that is that I think that with searching per se, technology has made searching very fast, but the amount of information that is now available is growing exponentially, particularly in the sequences that can be claimed.  And so while computational searching is very fast — examiners, particularly for our own counts get results back within 24-48 hours — the amount of output they actually have to look at to verify whether or not there is applicable [subject matter] is also growing exponentially.  So, it’s not so much the search itself, as it is going in and doing the analysis on the results that you get.

Have there ever been discussions of having an increased fee for Markush claims such as with multiple dependent claims?

I think that’s been kicked around quite good.  We issued a green paper a couple of years ago — I think it was in 2004 and that is available on our website — where we look at the possibility of raising fees to deal with restriction problems.  The Office determined that it wasn’t totally viable for a number of resource issues.  The other thing that you have to remember to is we don’t necessarily have direct control over our fee structure.  We have some regulatory fees, which we must cost account for and charge our applicants what it cost our business.  So that is actually a small number of fees, in comparison to all the other statutory fees that we have and those statutory fees normally set by Congress.

While you may want to lobby Congress for the ability to have fees that would parallel the kind of examination you want, I think you also have to be very careful about what you ask for.  Because, once it goes through Congress, it may not look like anything that you first envisioned.  So, we’re a bit hampered by the fact that many of our fees are statutory, and if I’m not mistaken, fees associated with restriction would also be statutory.  We would have to have Congress to change that and, like I said, you have to be careful what you ask for, because you never know ultimately what you are going to end up, once you go through that process, because there are so many interested parties. Congress wants to hear from all the interested parties and then come somewhere in the middle, right?

Okay, here’s a last one.  In a situation where the Examiner finds an elected species to be allowable but deems the claims not enabled or lacking an adequate written description over their entire scope, another provision of the proposed rule would permit the Examiner to require restriction of the claims to the elected species.  Why not allow the patentee to reduce the scope of the genus?

No, that is not exactly true.  What are currently in genus/species practice that you would use for Markush Grouping, the examiners tend to limit the initial search and examination from an individual species and they don’t have to extend examination of that claim if the broad claim is rejectable under art or under any other acceptable statutes

If the species has the same structure and function they stay together.  If the species has a different structure function, that would be a reason to split them apart and say “Okay, there’s a different invention.”  So, our proposed rule has an objective part by which you would be able to identify when you have more than one invention among a set of alternatives, or within a Markush.  That’s basically what our proposed rule says.  In no way in those situations would we restrict.  Otherwise, standard species practice as it currently exists in the USPTO is what would be applied, if the examiner wanted to restrict.  And again, remember restriction is discretionary on the part of the examiner.

The other thing that I wanted to point out , which I really didn’t get to say, is about the concern of applicants not being able to get the full scope of their invention examined.  But I would compose rules, just like in a standard restriction process, applicant could file a divisional on what would be restricted out, via our proposed rules.  So we could pursue the full scope of their invention or inventions in divisional applications.  I assure you that when you say that is potentially problematic for the applicant, because of all of the other fees associated with the additional filing.

I think people would rather have a surcharge than end up with a number of issue and maintenance fees that go on over the next 20 years.

I don’t’ disagree with you.  I think there are a number of issues.  I think practitioners on the outside are willing to pay additionally for different levels of examination.  I think you’re right.

Okay.  I’d like to know if you have any recommendations on, you know, in Markush claims.  As they currently exist, what’s your No. 1 recommendation for applicants?

If applicants come up with true generic languages, that’s the best thing they can do.  But if that’s not available, if there’s no true generic language available to claim an invention, another option is to seriously think about the breadth or scope with which they want patent protection to cover them.  And they should look to things like predictability in the arts to determine really how appropriately that breadth of scope should be claimed. Applicant should try to reasonably limit the Markush on their own.

Well, if I can ask one bonus question.

Sure, go ahead.

If you had your wish list, what would be at the top of your list for changes at the PTO?

Gosh!  I don’t have one top one.  Without giving it some careful thought, I’m going to decline to answer that at the moment. There is a whole number of things.  You know in patent practice, I can tell you that you are almost never bored because it is continually evolving.

Okay.  Well, thank you very much for your time.  I really appreciate that.

Sure.  Happy to help.

[This is part of a series of interviews where Patent Baristas gets to spend some time with thought leaders in the industry.]

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    […] website in the month of July.  The link, on Pharma Blog Review, mentioned our interview with USPTO Director John LeGuyader about alternate claiming strategies and restrictions. Chris was happy to win noting “This is very exciting, as I have never won anything like this […]