Archive for May, 2009

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.

BIO/CHEM/PHARMA CUSTOMER PARTNERSHIP CONTINUES – REPORT FROM 3/3/09 MEETING

Thursday, May 21st, 2009

Although this report (see link below) is of the March meeting, I hope to have current reports of meetings soon after they occur – if they continue to occur. It also gives me a chance to visit memory lane. In the 90′s, the Partnership was made up of a small group of senior PTO Examiners and Officials and a small group of practitioners (e.g, maybe ten of each). If you were a practitioner, you were supposed to attend as a representative of a user group, such as AIPLA or the ABA IP Law Committee. We actually sat across from each other and debated points of PTO policy, such as what does “sequence identity” mean, or how can restriction practice be improved. Practitioners also presented informal training programs to Examiners at lunch meetings. The discussions could get heated (including between practitioners) but these were effective forums to hash out differences face-to-face, without a particular client’s interests at stake.

Later, the Partnership Meetings were thrown open to one and all and became like small one-day conferences, where senior Examiners mainly showed up to “school” the practitioners on their latest positions.

So I stopped attending, although these “semi-inside” reports are still of interest. I hope we get a report from the June 10th meeting, Ray!
Meeting Report 3/3/09.pdf

The Myriad Lawsuit: “Products Of Nature” And “Natural Phenomena” – Turning Back The Clock On Biotech To Erase The Future

Monday, May 18th, 2009

On May 12, 2009, a coalition of interested parties, lead by the Association for Molecular Pathology, and including researchers and breast cancer patients, filed suit in the U.S. District Court for the Southern District of New York to invalidate certain of the claims of seven patents exclusively licensed to Myriad Genetics, Inc. (A copy of the complaint can be found at the end of this blog.) The claims in question are directed to, inter alia, DNA that encodes the BRCA1 and BRCA2 polypeptides and a method for diagnosing a predisposition for breast cancer in a human by comparing his/her BRCA2 DNA sequence with the wild-type BRCA2 DNA sequence wherein an alteration (mutation) in the subject’s BRCA2 DNA sequence indicates a predisposition to said cancer. See U.S. Patent Nos. 5,747,282 and 6,033,857, respectively. (A copy of these patents can be found at the end of the blog.)

The gist of the complaint is that the “DNA claims” are invalid as claiming products of nature and that the diagnosis claims are invalid as claiming abstract ideas. More formally, plaintiffs assert that the challenged claims are invalid under the “patent clause” of the U.S. Constitution and 35 U.S.C. s. 101, since they are products of nature or abstract ideas (“or basic human knowledge and thought”) or, as such, as “unconstitutional under the First and Fourteenth Amendments to the United States Constitution.” Apart from any scholarly analysis of the second cause of action, one witty colleague commented to me at AIPLA that this lawsuit clearly involved “freedom of expression”!

It seems a safe assumption that the plaintiffs were emboldened in this attack on basic biotech patent claiming (that goes at least as far back as the 1980’s) by Justice Breyer’s dissenting opinion in Lab. Corps. of America v. Metabolite Labs., 126 S. Ct. 2511 (2006) in which he began with the statement “There can be little doubt that the correlation between homocysteine and vitamin deficiency set forth in claim 13 is a ‘natural phenomenon.” If you are just joining us, please go back and read my post of Monday April 27, 2009, which proposes a test for deciding whether or not a process claim pre-empts a fundamental principle of nature:

Claims drawn to unpatentable natural phenomena would always be inherently or explicitly anticipated by fundamental natural phenomena.

The claims at issue in the Lab. Corps. case are drawn to “simple” diagnostic tests, wherein a bodily fluid of a subject is tested for total homocysteine and, if it is elevated above a benchmark level, the subject is diagnosed as having a deficiency in cobalamine or folate. I argued that this is not a universal or fundamental principle of nature. Nature may contain correlations but it does not sample or analyze, much less correlate, anything.

It may be a fundamental natural phenomenon that the human genome contains DNA encoding in some form of BRCA1 or BRCA2, so a hypothetical claim pre-empting this phenomenon might be “A human genome comprising DNA encoding BRAC1 containing a mutation at position x.” But this claim would not anticipate diagnostic method claim 2 of U.S. Pat. No. 6033857:

A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, where an alteration in the germline sequence of the BRAC2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.

As I wrote in my April 27, 2009 post, this looks like a diagnostic assay that is a “product of human ingenuity” carried out by “the hand of man,” not like any universal or fundamental principle of nature. Here the plaintiffs argue: “What is patented here is the abstract idea that nature has made the two genes different in a manner that increases the person’s risk of breast cancer.” Period. Being a poet as well as an attorney, I encounter quite a lot of abstract ideas. How about “The love you take is equal to the love you make”? I was going to posit “A penny saved is a penny earned” but that could be characterized as a business method claim that produces a concrete and useful result. Abstract ideas are essentially not subject to confirmation using the scientific method, unlike diagnostic assays that can be objectively demonstrated to be either mostly right or mostly wrong.

Between this post and the April 27th one, I feel that I have said enough about whether or not diagnostic assays are patentable subject matter. However, the drafters of the ‘857 patent (effective filing date asserted: 1995) seem to have anticipated the recent Bilski test for process claims. Claim 4 is similar in direction to claim 2 but recites the laboratory techniques used to carry out the test, such as “observing shifts in electrophoretic mobility of single stranded DNA on non-denaturing polyacrylamide gels.” Is this enough tying to a “particular machine or apparatus” Mr. Federal Circuit Judges? Note that this is not insignificant post-solution activity; it is a step that permits detection of the BRCA2 mutation.

Ironically, this morning, the Minneapolis StarTribune carried an article: “Diagnosing A Minnesota Niche In Medical Marketplace” with the sub-heading: “Though not big in pharmaceuticals, Minnesota is emerging as a center for diagnostics technology that can help speed drugs to market. Experts say the state could be a natural incubator for firms making such technology.” Good luck!

But claims are at issue here that are more basic than the diagnostic claims in the ‘857 patent or in claims at issue in Metabolite Labs. These are the claims to isolated human DNA sequences encoding defined proteins. If these claims are still valid under the new Kubin standard, will they eventually be found to be unpatentable “products of nature”? This, as well as the policy implications of banning research tools and diagnostic assays will be the subject of future posts.
brca1-complaint US5747282 US6033857

BOOK REVIEW: Janice M Mueller, Patent Law, Third Edition, Aspen Publishers (2009), 613 pages, paper.

Monday, May 11th, 2009

I thought I would take time out from my rants about the written description requirement, and patentable subject matter, to let you know about this important addition to IP education tools. In 2003, Professor Mueller, now at the University of Pittsburgh Law School, published the first edition of An Introduction to Patent Law, which was intended to fulfill a need she perceived for an introductory textbook for patent law students that was also rigorous in its analysis of the law, while being manageable in length. The first edition was a mere 398 pages, and a marvel of compression. I used it regularly and felt that, when asked a question, I could confirm or deny my “first impression” of almost any part of 35 U.S.C. with remarkable ease. The new edition has been held to 614 pages, and should be on every patent prosecutor’s shelf, in between Chisum’s (now) three volume Patent Law Digest and, if you are a chem/biotech practitioner, John L. White’s Chemical Patent Practice (a case law summary I still call “The Bible”).

Before issuing this rave review, I thought I would test out the book’s currency in four “hot’ areas of IP law – patentable subject matter, inherent anticipation, obviousness, and the written description requirement. Patent Law is up-to-date in all these areas. Bilski is discussed thoroughly, though Lab. Corps. v. Metabolite Laboratories only rates a footnote. Anticipation by Inherency gets its own subsection in the excellent discussion of section 102, as does KSR in the chapter on obviousness. I need not have worried about the treatment of section 112 issues like enablement and WDR. Professor Mueller has published extensively on WDR and there is a lengthy subsection on what she properly terms “The Written Description of the Invention Requirement.” I would have liked to have seen a bit more on how to logically resolve the “scope of claims” issue under enablement and the WDR but, as I have discussed in an earlier post, the Federal Circuit has just begun to deal with that issue.

A disclaimer is in order, Professor Mueller was “my” law clerk a generation or so back, but, as Patent Law demonstrates, she learned her lessons from me and from my elders (e.g., Judge Giles S. Rich, for whom Mueller also clerked) very well. I would like to close with a quote from her introduction to section 102:

Deceptively straightforward at first reading, when applied, the seven subsections (a) through (g) of 35 U.S.C. s. 102 may seem a rather bewildering Pandora’s box of arcane conventions and obscure terms of art…. First, here are some general recommendations for readers who seek a better understanding of the intricacies of s. 102. It is important to get comfortable with the statute. Post a copy of 35 U.S.C. s. 102 on the wall next to your desk or computer and copy its text into your laptop or PDA. Read the language over every day until you know it by heart.

I think I said something like that 20 years ago, but I can’t be sure. I know I could not have said it better.