Archive for March, 2012

Reaction to Prometheus

March 27, 2012

As expected, after last week’s Supreme Court decision in Mayo v. Prometheus, the Supreme Court issued a GVR order in the Myriad gene patent case.  The Court Granted the petition for certiorari, Vacated the Federal Circuit opinion, and Remanded the case back to that court for a further decision in light of the Supreme Court’s Prometheus opinion.  Prometheus should not have any effect on Myriad, but in light of the Supreme Court’s sweeping language and overly broad decision, who knows.

Guidance from PTO

USPTO Associate Commissioner for Patent Examination Policy Andrew Hirshfeld issued a memo to the examining corps to provide guidance on how to apply the Prometheus decision.  Initially, the memo indicates that the examiners should continue to apply the Interim Bilski Guidance issued July 27, 2010.  The memo continues (emphasis in original):

Examiners must continue to ensure that claims, particularly process claims, are not directed to an exception to eligibility such that the claim amounts to a monopoly on the law of nature, natural phenomenon, or abstract idea itself. In addition, to be patent-eligible, a claim that includes an exception should include other elements or combination of elements such that, in practice, the claimed product or process amounts to significantly more than a law of nature, a natural phenomenon, or an abstract idea with conventional steps specified at a high level of generality appended thereto.

Applicants must explain why such claims are drawn to an application of one of the exceptions and not solely to the law of nature, natural phenomenon, or abstract idea itself.

While the memo does mention product claims, it seems to be directed more toward a Bilski analysis with special emphasis on the law of nature exception to process claims.  In part, this demonstrates what a mess this area of the law is becoming.  It would seem that the PTO is also suggesting that the case does not really apply to product claims, such as those in Myriad.


Supreme Court Continues to Confuse Patentable Subject Matter with Patentability

March 20, 2012

This morning, the PTO has released another decision on patentable subject matter, this time concerning a biomedical invention, Mayo Collaborative Services v. Prometheus Labs., Inc.  In the opinion for the unanimous Court, Justice Breyer writes that the claims at issue are not directed to patentable subject matter.

I have previously covered the details of the claims at issue in this case.  As a reminder, claim 1 of U.S. Patent No. 6,355,623 reads as follows:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8×108

red blood cells red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

In its opinion, the Supreme Court continues to make the all too common mistake of conflating patent eligibility with novelty and obviousness (inventive step) or claim breadth (§ 112):

the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field.

If the Court’s statement is true, the claims should be unpatentable because they lack novelty or are obvious.  There is simply no need to add another step of complexity to the analysis.

The Federal Circuit had determined that the claims were not directed merely to a law of nature, but to a particular application of the law.  The claims recite specific treatment steps and not merely the correlation between metabolite levels and drug efficacy or toxicity.  The Supreme Court disagreed.

Referring to the specific steps of the claims, the Court characterized the “administering” step as simply referring to the relevant audience, doctors.  This step simply picks out the group of individuals that are interested in applying the law of nature.  The Court’s statement about this step again seems to indicate that the step was part of the prior art:

doctors used thiopurine drugs totreat patients suffering from autoimmune disorders long before anyone asserted these claims.

The “wherein” clauses are simply telling the doctors to take laws of nature into account when treating patients.  Finally, the “determining” step tells the doctor to determine the level of metabolite in the blood.  Again, referring to this step as existing in the prior art:

doctors used thiopurine drugs totreat patients suffering from autoimmune disorders long before anyone asserted these claims.

The Court then summarized its conclusion of the claims:

To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of wellunderstood, routine, conventional activity already engaged in by the scientific community; and those steps, whenviewed as a whole, add nothing significant beyond the sum of their parts taken separately.

Finally, the Court went through its precedents regarding patent-eligibility (hardly a study in clarity) and determined that the claims in this case present a weaker case for patent eligibility than those in Diehr, and no stronger than those in Flook.

The Court did attempt to address the issue that I raise in this post.  In an amicus brief, the government argued that other sections of the Patent Act (§§ 102, 103, 112, etc.) can be used to screen claims.  For example, the government argued that the claims at issue in this case are likely not novel.  In addressing this issue, the Court recognized that there may be some overlap between § 101 and § 102, but this won’t always be the case.

And to shift the patent-eligibility inquiry entirely to these later sections riskscreating significantly greater legal uncertainty, while assuming that those sections can do work that they are not equipped to do.

The government’s position (quite a reasonable one) is that laws of nature are by definition part of the prior art.  The Court addressed this issue by suggesting that if that is so, no invention can be patentable because all inventions are applications of laws of nature.  The Court seems to ignore the all-important word application.

Gene Patents

It has been speculated that the Supreme Court was holding the petition for review in the Myriad gene patent case until it released this opinion in Prometheus.  Perhaps the Court will GVR (grant-vacate-remand) that case back to the Federal Circuit for reconsideration in light of this opinion.  The Court scheduled consideration of the Myriad petition over a month ago, so that very well could be what will happen.  Given that the Federal Circuit had already held the method claims in Myriad to be unpatentable, while upholding the claims to isolated genes, this opinion would not seem to have much bearing on Myriad.

Intervening Rights After Reexamination

March 16, 2012

When a patent owner is determining whether to assert a patent against a potential infringer, one of the issues that must be considered is whether the claims of the patent could be in a bit better shape.  Perhaps there is prior art that does not exactly invalidate the claims, but is close enough that it would be good to tighten up the claims a bit.

The patentee could file for a reissue application.  In a reissue, the patent owner must assert that the patent contains one or more mistakes or errors that can be corrected.  These can include that the patent claims too much or too little subject matter to which the patent is otherwise entitled.  Reissue applications seeking to broaden the claims must be filed within 2 years of the patent’s grant.

Another option is to file for reexamination.  In reexamination, the requester (which may be the patent owner) must allege that there is a substantial new question of patentability that is raised by certain patents or printed publications.  The PTO nearly always grants the request.  During reexamination, the patent owner may present claim amendments, new claims, or arguments as to why the patent claims are still patentable over the cited prior art.  At the conclusion of the proceeding, the PTO issues a reexamination certificate showing the changes to the patent during the reexamination or that the patentability of the claims has been confirmed over the cited prior art.

Intervening Rights

A risk to the patentee in either of these scenarios is that third parties may acquire intervening rights based on changes to the claims made during reexamination.  Reissue and reexamination may result in “absolute intervening rights” or “equitable intervening rights.”

Absolute intervening rights permit the third party to sell inventory that would otherwise infringe a claim in the reissued or reexamined patent that would not have infringed such a claim in the original patent, provided that the third party acquired such inventory prior to the issuance of the reissued patent or reexamination certificate.  Thus, if a claim is substantively changed from the original patent, absolute intervening rights may be acquired by third parties.

Equitable intervening rights are rights that can be granted at the discretion of the court based on “substantial preparation” to practice the invention that is later covered by a claim in the reissued or reexamined patent.  This is an equitable remedy that the court may craft to permit continued infringement of the patent claim at issue if the infringer can show that it relied on the original patent claims to make substantial preparations to practice the invention later claimed in the reissued or reexamined patent.

Marine Polymer Techs., Inc. v. Hemcon, Inc.

Yesterday, the Federal Circuit issued an opinion en banc that intervening rights only apply to new or amended claims.

Marine Polymer sued Hemcon for infringement of certain claims of U.S. Patent No. 6,864,245.  While the case was pending, Hemcon filed a request for ex parte reexamination at the PTO.  The PTO granted the request and issued an Office Action rejecting all of the claims.  In response, Marine Polymer canceled some of the dependent claims and argued that the PTO’s interpretation of some of the claim terms was improper.  Instead, the PTO should adopt the interpretation of the district court in the litigation.  None of the claims were amended.

While the reexamination was pending at the PTO, the district court had found that Hemcon infringed certain claims of the patent.  The court issued a permanent injunction against future infringement and awarded $29,410,246 in damages.  After the district court entered final judgment, the PTO issued the reexamination certificate that confirmed the patentability of all of the claims in their original form except those canceled by the amendment filed by Marine Polymer.  The district court never considered the reexamination or its effect on the litigation.

In September 2011, a panel of the Federal Circuit reversed the judgment of the district court holding that Hemcon had acquired intervening rights during the reexamination.  In January 2012, the Federal Circuit agreed to hear the case en banc.

The judgment of infringement by the district court was affirmed by an equally divided Federal Circuit.  Five judges voted to affirm and five judges voted to reverse, with Judges Moore and O’Malley not taking part in the decision, while Judge Gajarsa (senior status) took part in the original panel decision.

By a vote of 6-4, however, the Federal Circuit issued an opinion rejecting the defense of intervening rights in this case.  Hemcon argued that the arguments and cancelation of the dependent claims in this case by Marine Polymers was a substantive change to the claims that permitted intervening rights.

Section 307(b) of the Patent Act covers intervening rights in case of reexamination.  The Federal Circuit concluded that the plain and unambiguous language of the statute recites that it applies only to “amended or new” claims.  Although both Hemcon and the dissenting judges in this case argued that the claims were in effect amended by the argument and cancelation of the dependent claims, the majority of the court held that to “amend” claims has a specific and well understood meaning in patent law.  To expand it to cover situations like this one would render the term in the statute to be meaningless.

Patent Application Costs

March 13, 2012

There are a large number of inventors and companies out there now that want patent work done as cheaply as possible.  Especially since the economy has tanked, many inventors and companies are attempting to low-ball fees for preparing patent applications.  I have seen ads for $1,400 patent applications.  There is simply no way to have a quality patent application prepared for this price.

Another case is where an inventor has prepared his own patent application and has asked me to simply review it to make sure that there are no obvious mistakes.  The reason for preparing the application himself is that the inventor believes that this will save money on preparation costs.  Unfortunately, this is usually not the case, and I tell these clients this fact up front.  Unless the inventor has significant experience with preparing and prosecuting patent applications, the application will undoubtedly need a lot of work on my part.

First, the application may be very brief, perhaps 8-10 pages with a drawing or two.  The invention will often be described in very general terms because the inventor is afraid that specific descriptions will unduly limit the invention.  In this case, I generally have to start over.  One cannot get a patent on a general idea.  One must describe specific implementations of the invention.  This does not mean that the invention must be very specifically claimed.

Otherwise, the inventor may have an application of adequate length for the complexity of the invention, say 30 or so pages, with 10 or so pages of drawings.  In fact, sometimes these inventors don’t understand the difference between a patent application and a research paper, so they will include large amounts of extraneous details ont the background or theory of the invention.  In this situation, it will probably take me just as long or longer to adequately review the entire application, discuss the details with the inventor to fully appreciate and understand the invention, and then make corrections and changes based on my experience in patent law and my adequate understanding of the invention.  This does not save the inventor money.

Another typical situation that I encounter is where an inventor or company sends me a pending patent application and asks me to take over the prosecution because they are dissatisfied with their current counsel.  They believed that the invention would be patentable and that the examiner should be able to be persuaded of this fact quickly.  They have also had commercial success with the invention, but are afraid that if they don’t get a patent, knock-offs will appear that will undercut their prices and knock them out of the market.

Often, I find out that they are correct–certain aspects of the invention are patentable.  When I review the specification, however, I realized that it is only 8 or 10 pages long.  They didn’t want to spend much money when they had their application prepared and filed (often a couple years earlier), so they went with the low-ball price for its preparation.  Now, many of the features that seem to make the invention patentable are not sufficiently described in the specification; I cannot add them to the claims because they would constitute new matter.  I do the best that I can to salvage something from the application for them, but there is a lesson here.  If the description contained more details and was say 15 or even 20 pages long, these aspects of the invention could be added to the claims.  This is not to say that longer applications are always better, but in general this is the case.

What to Do

The best practice is for each invention should be treated as a million dollar invention when the application is being prepared.  At that time, who knows which ones will be?  I always tell clients that patents are speculative investments.  You can’t tell from the start which inventions will be successful and worth the investment; you can’t be certain which will be granted broad patent protection; and, perhaps most importantly, getting a patent doesn’t mean the product will be successful in the marketplace.  If you don’t spend the time and money to prepare an adequate patent application, it doesn’t matter.  The resulting patent, if any, will only be worth what you paid for it.

With a down economy many or most patent attorneys either didn’t raise their rates or even lowered them slightly the past few years, and rightfully so.  The market dictated this event.  When comparing the services of an attorney who charges $800 per hour with one who charges $50 per hour, however, one must realize that the attorney with the low-ball rate would undoubtedly charge a higher rate if the market demanded it.  If he can be just as busy charging $200 or $300 per hour, why would he continue to charge $50 and make less money?

This isn’t to say that a higher rate always gives you a better product.  One should also take referrals and other factors into account when comparison shopping for patent services.  Sometimes a better patent attorney may choose to work for a smaller firm or in a smaller market where rates are lower than those in the big city at the big firm.  His or her work may be just as good or better than the big-firm attorney in New York or DC.  When a price is too good to be true, however, it probably is.

On the point of whether to begin a patent application by preparing the claims or the specification, I have done it both ways.  I generally find, however, that preparing the claims first is advantageous.  In this way, I can confirm with the inventor his or her understanding of what the invention actually is.  I then prepare the written description.  I try to make it as detailed as possible and get the inventor to provide me with as many different implemenations, embodiments, and optional features as I can.  It is indeed an iterative process:  when preparing the description, it is inevitable that I will discover features that that should be claimed, and vice versa.  And yes, all of this takes time; more than $1,400 worth of time.

I will often discover during prosecution that there are features of the invention that I need to add to the claims or that are patentable that were not included in the original claims.  By having an adequate disclosure from the beginning, adding such claims is easy.  If the description is too terse, however, this can’t be done.  New matter cannot be added to a pending application during prosecution.

When a client comes to me with a new idea for a patent application, I try to get all of the details of the invention from them and then provide what I believe to be a fair and realistic estimate of the cost to them based on the time it should take to adequately describe and claim the invention.  Sometimes my estimate is too high and the actual cost is lower; sometimes things happen that raise the costs.  I previously provided some tips and strategies to keep costs down and get better patents.

The bottom line is that in patent preparation and prosecution, like most everything else, you get what you pay for.

Abstractness of Patentable Subject Matter Law

March 2, 2012

The Federal Circuit affirmed the invalidity of the claims at issue in MySpace, Inc. v. GraphOn Corp.  The claims at issue in the case are directed to methods and apparatus that allow a user to create, modify, and search for a database record over a computer network.  The district court granted motions for summary judgment that all of the claims were invalid based on prior art under §§ 102 and 103 of the Patent Act.  The Federal Circuit affirmed.  End of case, right?  Not quite.

Despite the issue not being raised by any party to the litigation, nor being addressed by the district court, Senior Judge Robert Mayer filed a 13 page dissent that the claims were invalid as not being directed to patentable subject matter under § 101.  He argued that subject matter eligibility is an “antecedent question” that must be addressed before the court can consider whether the claims are invalid under §§ 102 or 103.

In response, in the opinion of the court, Senior Judge Plager spends 8 pages arguing against Judge Mayer’s view.  He doesn’t address the § 101 question on the merits.  Instead, he argues that principles of judicial efficiency caution against addressing patent eligibility issues when not raised by the parties and when cases can be more easily decided, as in this case, by other sections of the Patent Act.

He goes on to suggest the complexity of § 101 jurisprudence, comparing it to the activity of  oenologists trying to describe a new wine.  They have numerous adjectives to use, but choosing the correct one is very difficult and subjective.  So too with the current state of § 101 law.  Many courts have written many pages on the subject, but they seem no closer to a resolution of the issue now than at the beginning.

When it comes to explaining what is to be understood by “abstract ideas” in terms that are something less than abstract, courts have been less successful.

Judge Plager advocates § 101 being a “coarse filter” such that if it is very clear that the claim is abstract.  This would be a rather unusual and infrequent circumstance.

If instead, as in this case, the issues under §§ 102 and 103 are clear, there is no need to wade into the morass of § 101 law.

UPDATE: Richard Taranto Confirmation Hearing

March 2, 2012

While they have different views on the hearing, the Legal Times blog and Patently-O provide updates.  LT characterizes the questioning as tough, with the senators asking a number of political questions having little or nothing to do with cases that may be heard by the Federal Circuit.  Patently-O, by contrast, characterizes the hearing as showing that there are no roadblocks to Mr. Taranto’s swift confirmation.  Both note that he discussed his clerkship with former Supreme Court Justice Sandra Day O’Connor prior to beginning his career in private practice.

Other Judges

Chief Judge Randall Rader, 62, has served on the court since 1990 and will be eligible for senior status when he turns 65 in April 2014.

Judge Pauline Newman, 84, has served on the court since 1984 and is currently eligible for senior status.

Judge Alan Lourie, 77, has served on the court since 1990 and is currently eligible for senior status.

Judge William Bryson, 66, has served on the court since 1994 and is currently eligible for senior status.

Judge Richard Linn, 67, has served on the court since 2000 and will be eligible for senior status in April 2012.

Judge Timothy Dyk, 75, has served on the court since 2000 and is currently eligible for senior status.

Judge Sharon Prost, 60, has served on the court since 2001 and will be eligible for senior status in 2016.

Judge Kimberly Moore, 43, has served on the court since 2006.

Judge Kathleen O’Malley, 55, has served on the court since 2010 after having served as a district court judge since 1994.

Judge Jimmie Reyna, 59, has served on the court since 2011.

Judge Evan Wallach, 62, has served on the court since 2011.

In addition, Judges Jay Plager, Raymond Clevenger, Alvin Schall, Robert Mayer, and Arthur Gajarsa all serve on the court as senior judges.