Posts Tagged ‘patent claims’

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Supplementary 112 Examination Guidelines – What’s In It For Me?

Monday, February 14th, 2011

This Post is from Mark Muller, Shareholder at Schwegman, Lundberg & Woessner, P.A.

Supplementary examination guidelines for Section 112 were recently published in the Federal Register and sent out for public comment.  While the details may not be too exciting, it’s a good opportunity to remind ourselves that when claims use functional language referencing some degree of “goodness” or fit, etc. we should always ask: Have I put something in the specification to support an absolute/relative reference for comparison, or that enables determination of that quality? 

This may seem obvious to many, but it’s surprising how often the issue arises.  The guidelines give a fairly obvious example, where a claim to a computer interface screen with an “aesthetically pleasing look and feel” (without sufficient corresponding information in the specification to define what this might mean) is noted as being insufficient to meet the requirements of Section 112.  So obvious is the problem in this case that even on its face, many would deem the claim to be lacking.  Nevertheless, examiners continue to encounter deficient claims.  As an aid to your own drafting efforts, here are some less obvious, but perhaps more common usage examples that I have made up to spur your thinking about claim elements that have the potential for exceeding the bounds of Section 112:

(more…)

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TALKING WRITTEN DESCRIPTION REQUIREMENT BLUES – ARIAD WOBBLES

Monday, October 12th, 2009

On October 5, 2009, Ariad filed a 60 page brief (not counting attached appendices) with the Federal Circuit in support of its appeal in Ariad v. Lilly. (Attached below.) As you will recall from my post of August 24th, the Fed. Cir. granted en banc rehearing of a panel decision invalidating the claims-in-suit for failure to meet the WDR. See also, my posts of April 13, 2009 and May 5, 2009, on the panel’s decision in Ariad v Lilly and Judge Linn’s concurrence, urging a return of the WDR to post-Lilly status:

“The question is, ‘Does the written description describe the invention recited in the claims – themselves part of the specification – in terms that are sufficient to enable one of skill in the art to make and use the invention and practice the best mode contemplated by the inventor?’ That is the mandate of the statute and is all our precedent required, prior to Lilly.”

The questions to be resolved en banc, however, are 1) Does s. 112(1) contain a WDR separate from the enablement requirement, and 2) If it does, what is its scope and purpose? The Ariad brief answers “no” to question 1 but seems to retract its “no” in answering question 2. As part of its short answer to question 2 on page 1 of the brief, Ariad asserts: “Properly interpreted, the statute itself requires the specification to describe (i) what the invention is, and (ii) how to make and use it.” At pages 43-46 of the Brief (the only parts you need to read if you are conversant with the debate), Ariad argues:

“[I]t necessarily follows that the statute provides no scope or purpose for a separate written description requirement. Properly interpreted, the written description requirement of s. 112(1) requires, first, that the specification describe (identify) what the invention is and second, that the specification teach how to make and use the invention…Identifying the invention is necessary for enablement, since a specification that does not teach one of ordinary skill what to make and use does not enable the skilled artisan to make and use the unidentified subject matter.”

What a minute! This seems like ascribing an “identifying function” to the WDR that is separate from the enablement requirement. A sentence later, Ariad tries to ascribe this function to the claims, stating: “However, original claims necessarily identify the subject matter that they define; since they are part of the disclosure at the time of filing and ‘constitute their own description’”.

This argument is akin to taking the position that claims that meet s. 112(2) also satisfy the “description function” of s. 112(1), but Ariad must have felt that statutory redundancy was not much of an argument, even though paragraph 2 of 112 requires “The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.”

If Judge Lourie has been the Big Bad Wolf leading the pack who supports a heightened WDR to police biotechnology, he should be licking his legal chops over arguments like this. As soon as Ariad concedes that the WDR of s. 112(1) requires the specification to describe “what the invention is,” the Pandora’s box filled with descriptors has been flung wide open; the courts are left to grapple with “How much description of the invention should the specification contain?” Well, how about “a precise definition, such as by structure, formula, chemical name, or physical properties.” Lilly, 119 F.3d at 1566. Again, it bears repeating that adequate claims do not need to contain this level of description, e.g., they can describe the invention functionally or with mixed structural/functional terminology in some cases. For example, “An antibody that binds specifically to cytokine hBAD.” Such a claim will still be weighed against the enablement requirement of s. 112(1), but a specification that adequately teaches how to “make and use” such an antibody should meet s. 112(1) without more.

As I wrote in early 2003, “the legal battle lines are sharply drawn. One camp of judges, led by Judge Rader, believes that the WDR is no more than a semantic test for the ‘right to use’ the claim language in question. If the claim language is supported by the specification, the WDR is satisfied. Enablement is a separate issue that is to be resolved by the very specific Wands factors. … The camp led by Judge Lourie expects a lot more from the WDR; along with the enablement requirement, it now imparts or denies the ‘right to claim’ the invention at issue. That is nearly as equitable a doctrine as that assigned to the doctrine of equivalents.”

At pages 46-50, the Ariad brief contains a rather confusing discussion of two cases decided in the 1850′s that is supposed to convince the Fed. Cir. that Supreme Court precedent illustrates “[t]he proper approach to the enabling-description requirement of s. 112(1)”. In my next post on Ariad, I review a hypothetical fact situation based on two biotech inventions that is a bit more modern. Eventually, we may even reach the merits of the case.
Ariad v Lilly Brief.pdf

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Hal Wegner Wakes Up ACI Biotech Patents Forum in Boston

Sunday, October 4th, 2009

On Sept. 30th, Harold C. (Hal) Wegner gave a talk on current developments that emphasized the importance of inter partes reexamination, particularly as a weapon of patent destruction. His opinion, summarized by me, is that KSR is increasingly being applied to biotech claims by Examiners. Applicants then are forced to put in declarations arguing secondary factors and to argue criticality in order to get claims allowed. Requestors are aware that, during inter partes reexamination at the PTO level, 60% of patents have all their claims cancelled and 80% have independent claims cancelled. Attacker-requestors will put in declarations to show that “everything was expected.” If the Examiner and the Board support the attacker, patentee is dead since, if the attacker put in substantial evidence, the Federal Circuit will give deference to the PTO finding. Also, if the attacker argues that a claim should be interpreted so as to read on the prior art, claim interpretation will be an open question before the Federal Circuit, who reviews claim construction de novo as a question of law.

On the other hand, Hal noted that, in the past, almost no merits appeals ever reached the Board from reexamination proceedings. This is in part because it is easy for either party to slow the proceedings nearly to a standstill by submitting boxes of prior art (I have seen a patentee in litigation do this) or by introducing hundreds of claims. Hal also noted that, as of 2002, no reexaminations had been concluded by appeal to the Federal Circuit. If Director Kappos manages to shorten the appeal process at the Board, as by moving Examiners from the corps to the Board, in the fairly near future all of these patent-killing mechanisms could rise in prominence.

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GETTING TO ALLOWANCE – SEVEN HABITS OF HIGHLY EFFECTIVE CLIENTS

Friday, May 29th, 2009

1. Tell Your Patent Attorney What You Want Your Patent To Do.

IP attorneys are continuously told that we should be business partners with our clients, not just patent scribes. But there are lots of ways to protect an invention. Be open and just tell us: Is the patent “for show or for go”? Is it perceived to be vital to the company or a “home run” for the university, or is it a safety filing to cover a limited advance to keep a productive inventor (or top boss) happy. Is it intended to be a shot in the dark, or part of a shotgun blast of applications into an important emerging technology? Don’t walk into a car lot and say “I want your best car!” unless you really mean it.

2. A Stitch (or Question) In Time Saves Nine (Hours of Work).

Deliver as much information as you can to your attorney about possible bar dates, such as publications and offers for sale, no matter how obscure. Design disclosure forms to encourage inventors to both reveal all the disclosures and art that they have generated or are aware of, and to raise and help resolve inventorship questions. Before you file is the time to discuss possibly conflicting ownership rights and license obligations.

3. Remember To Protect The Invention.

I grew up as an attorney hearing, “At least protect the invention!”. Although clients nearly always will press their IP attorneys to protect the known universe with each claim, this isn’t always the best way to begin. It is often wiser to protect the “now” first and the “future” later on. In other words, narrow claims may not cover the future, but overly broad claims may well cover the past. Recognize the advantages of deciding to file narrow claims initially, and then broadening them later. If your attorney warns about problems with the written description, utility or enablement requirements, please listen. Finally, don’t forget to help your attorney weave a good story into all those complex structures and drawings. Examiners like to hear why the invention will revolutionize medicine or telecommunications.

4. Push Back (At The Patent Office ) As Hard As You Are Pushed.

Almost all Office Actions contain rejections, so don’t be discouraged. Help your attorney meet every ground of rejection raised by the Examiner, then go the extra mile. Raise the legal ante with additional evidence of the merits of the invention, such as Rule 132 Declarations, to show unpredictability of success or unexpected results. Document that your inventor is an expert in the field, not a “garage shop wizard.” If the Examiner draws baseless conclusions, challenge him/her to put them in declaration form. Rely on authorities such as technical dictionaries and review articles. Help your attorneys argue the facts, and expect them to argue the law.

Amendments and other written responses should look like appeal briefs. They should include copies of case law and cite from it. Your attorney should keep up with changing internal Patent Office policies.

5. Let Your Attorney Talk To The Examiner.

Some rejections can be easily rebutted in writing, but most of the time it is very difficult to “write your way to success.” Traveling to the Patent Office to conduct a personal interview with the Examiner is costly, but nine times out of ten it reduces the total cost of prosecution, and results in a shorter written record. It is simply impossible to know what an Examiner is thinking from a written Office Action. Face-to-face, your attorney will quickly discover what the key issues are, and hopefully, will build personal rapport that can help in Patent Office dealings for years to come. But don’t expect to be invited along and don’t insist that your inventors or licensees attend as well. “Obvious to try” can mean many things to many people. A slip of an untrained lip can sink your patent ship.

When your attorney calls you and says that some agreement was reached, or that the Examiner is willing to compromise, please respond quickly. Better yet, run through likely scenarios ahead of time, and authorize your attorney to accept certain “deals” over the phone, or even during the interview.

6. Realize That Prosecution Does Not End With Final Rejection.

Don’t give up, or order your attorney to appeal, if you receive a final rejection. Authorize your attorney to respond quickly, and to submit further declarations, if necessary to make or re-make your key points. If the issues are few and clearly focused, ask the attorney to call the Examiner’s supervisor or Supervisor’s Supervisor. File the Notice of Appeal and request an appeal conference, to get a second or third opinion on the rejection.

7. Don’t Be Afraid To Appeal.

The official appeal process begins when your attorney files the Brief on Appeal, arguing your position. This filing itself often leads to allowance of at least some of the claims. If the Examiner files the Answer, the dispute will be resolved by the Board of Appeals. Let your attorney request, and present, oral arguments. I believe that showing that you are serious about the outcome greatly increases the chances of success. Also, under recent patent law revisions, if the Board allows one claim, the twenty-year patent term is tolled during the appeal process; any lost term is restored when the patent issues. And, the fact of the matter is that patent claims that have been allowed on appeal are much more difficult to invalidate during litigation. Even if you lose – and of course you won’t – you can refile the application and present further rebuttal evidence or amendments to the Examiner.

I will be presenting this at LifeScience Alley Biotechnology Special Interest Group in Bloomington, MN on June 3rd.

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