Archive for August, 2010

Another Means-Plus-Function Opinion

August 30, 2010

On Friday, the Federal Circuit issued another in a long line of cases cautioning against the use of means-plus-function language in patent claims.

As previously noted, 35 U.S.C. § 112, sixth paragraph, permits a patent applicant to write a limitation of a patent claim as a means for performing a specific function recited in the claim.  In this way, it is not necessary to actually include the specific structure for performing that function in the claim.

The Federal Circuit has interpreted such claim limitations as being limited to those structures and their equivalents that are specifically linked to the function recited in the claim.  The specification has to provide the link to make it clear what structures from the specification would meet the claim limitation.  If no structure is specifically linked, the claim is invalid as indefinite.

How does one determine if the structure is equivalent to a structure recited in the specification?  The Federal Circuit takes a narrow view of this issue as well.

A structure in the accused device constitutes an equivalent to the corresponding structure in the patent only if the accused structure performs the identical function “in substantially the same way, with substantially the same result.”

The function must be identical to that in the claim and the structure must perform the function “in substially the same way, with substantially the same result.”

General Protecht Group, Inc. v. ITC

In Friday’s opinion, the Federal Circuit was to determine whether the claim limitation “latching means” was infringed by the defendant.  The “latching means” was recited in clause f) of claim 1 of U.S. Patent No. 5,594,398.

1. A ground fault interrupter (gfi) wiring device for connection in an electrical circuit, said device comprising:

a) housing means defining an enclosed space;

b) at least one pair of electrical terminals fixedly supported in spaced relation within said enclosed space;

c) a unitary, electrically conducting mem-ber carrying a pair of spaced electrical contacts;

d) mounting means for said conducting member to permit movement thereof be-tween a first position, wherein said pair of contacts are in respective, circuit-making engagement with said pair of terminals, and a second position, wherein both of said pair of contacts are in spaced, circuit-breaking relation to said pair of terminals;

e) biasing means urging said conducting member toward movement to said second position;

f) latching means releasably retaining said conducting member in said first position; and

g) actuating means for releasing said latching means to permit said biasing means to move said conducting member to said second position in response to a pre-determined fault condition in said electrical circuit.

The structure described in the specification for performing the function of “releasably retaining [the] conducting member in [the] first position” was a pin passing through a hole.  The defendant instead used a magnet to perform this function.  The ITC found the magnet to be an equivalent structure for performing the function.

The Federal Circuit reversed, relying on a previous case, holding as a matter of law that a structure that performs a function mechanically does so in a substantially different way from a structure that accomplishes the function with magnetic force.  Thus, the claim was not infringed by the defendant’s device.

Judge Newman dissented on this issue, correctly pointing out that equivalence is a question of fact, not law as ruled on by the majority.  The ITC’s determination of equivalence was supported by substantial evidence of experts who testified on the known interchangability of the two types of latches at the time of the filing of the ‘398 patent.

This is another case where the court’s opinion, substituting its judgment and understanding of factual evidence for that of the ITC, is difficult to grasp.  There is, however, a definite lesson.  Unless it is very difficult to draft a claim in any other way, avoid means-plus-function claim limitations.  The court has made it clear that it will go out of its way to find such claims invalid or not infringed.  These limitations have very little to no benefit and a very high risk.

Another New Patent Reform Bill is Introduced in the House

August 27, 2010

On July 29, Rep. Frank Wolf (R-VA), along with Rep. Hal Rogers (R-KY), Rep. Rob Wittman (R-VA), Rep. Candice Miller (R-MI), Rep. Daniel Lipinski (D-IL), introduced a bill entitled “Bring Jobs Back to America:  Strategic Manufacturing and Job Repatriation Act.”  Section 8 of the bill relates to changes to the patent system.

The first major change is that the bill seeks to eliminate pre-grant publication of patent applications and instead only publish abstracts.  This provision will be almost universally opposed by the patent community as less than 7% of patent applications are currently not published prior to issuance.  It is difficult to understand the impetus behind this provision.  The recent trend in US patent law has been to increase international harmonization.  The US was one of the last nations in the world to adopt pre-grant publication when it did so about 10 years ago.

Next, the bill seeks to eliminate much of the so-called “secret” prior art by amending § 102(e) to reduce it almost completely to international applications published in English.  No US applications could be used as prior art under this provision any more.  Again, what is the impetus behind this amendment?

Finally, the bill directs the PTO to give priority in examination to applications filed by institutions of higher learning or patent holding companies affiliated with such institutions.

Congress does some rather strange and unpredictable things, but this bill is simply too bizzare to be anything other than a political re-election ploy on the part of the sponsors.  Given the stalemate over patent reform, it seems highly unlikely that anything resembling the provisions in this bill could be passed.

That being said, there are a number of commentators that are predicting that a lame duck session of Congress may take up patent reform after the elections in November.  Stay tuned . . .

Organizations Provide Comments on Proposed Three-Tier Application System

August 24, 2010

The American Intellectual Property Law Association (AIPLA) and the Intellectual Property Owners Association (IPO) have provided comments on the PTO’s proposed three-tier examination system.  While both organizations generally support the ability of applicants to control examination timing, they raise several serious concerns about the proposal.

AIPLA

The Proposal calls for U.S. applications that claim priority to a foreign application to be precluded from entering the examination queue until an office action and an appropriate response to the action as to why the claims are patentable under U.S. law has been filed in the foreign patent office.  AIPLA suggests that the USPTO does not have the authority to implement such a discriminatory regime.  The organization believes it will lead to discrimination of U.S. applicants by foreign patent offices, which would harm U.S. businesses and the U.S. economy.

AIPLA also questions the sense of submitting arguments to a foreign patent office as to why claims would be patentable under U.S. law when the laws and patentability standards of the two countries are likely to be different.  The claims are also likely to be different due to translation and practices before the foreign patent office.

The mandatory delay may lead more applicants to file first in the U.S., which would increase U.S. filings and not decrease the PTO workload.

AIPLA supports the Track I prioritized examination proposal based on paying cost-covering fees.  The organization does question whether a refund will be forthcoming if the PTO does not meet the examination goals of 4 months to a first Office Action and 12 months to final disposition. 

AIPLA is also concerned that Track I may divert resources from Track II examination and cause further delay for applications examined in the normal course.  Small and micro-entities have concerns that the PTO does not have statutory authority to implement a fee reduction for Track I.  Thus, Track I would be primarily used by large entities causing small entities to be at a disadvantage.

AIPLA encourages the PTO to permit more than 4 independent and 20 total claims for Track I applications.  Perhaps a higher fee could be charged for applications with more claims.  Futher, extensions of time and RCEs should not be limited for these applications.

AIPLA has traditionally opposed deferred examination such as set for in Track III.  Requiring publication of all Track III applications at 18 months addresses one concern.  AIPLA is skeptical of the benefits to the PTO workload of deferred examination because it does not believe there are any statistics to bear out the benefit of abandonments prior to examination. 

AIPLA is concerned that delays in examination will cause uncertainty for third parties as to whether a published application is patentable.  At least under the PCT, a search report is obtained earlier to add certainty to the issue.  The organization questions whether third parties could initiate examination of an application by filing the requisite fee with the PTO.

AIPLA agrees that applications with deferred examination should have any patent term adjustment (PTA) offset.  It argues, however, that the PTO needs to clarify these issues, as they are currently too uncertain.  There should be no discrimination against foreign applicants because this will lead to foreign discrimination against U.S. applicants.

IPO

IPO is concerned that Congress will divert fees collected by the PTO to meet the Track I goals.  IPO is also concerned that discrimination against foreign-based applications will violate international treaties to which the U.S. is a party and will lead to discrimination against U.S. applicants by foreign patent offices.

IPO also has concerns about whether prioritized examination will further delay examination of traditional Track II applications and whether refunds will be available if the PTO does not meet the Track I goals.

IPO generally opposes deferred examination because it delays the public’s knowledge of whether an application is patentable.  This can chill competition and harm the U.S. economy.  IPO encourages the PTO to instead implement a refund procedure to refund search and examination fees if an application is expressly abandoned prior to examination.

IPO has similar concerns to AIPLA regarding foreign-originated applications.  The system could be gamed by many applicants who would file first in the U.S. if they wanted faster examination and first in foreign countries if they preferred slower examination.  Any reduction in the U.S. examination queue would be temporary until foreign patent offices begin examining applications.  This would put them right back in the U.S. queue, unless it is expected that many will be abandoned based on the foreign office’s action.  Alternatively, fewer foreign applicants may file U.S. applications, which would reduce PTO revenue.

IPO opposes any automatic deferral of foreign-based applications without awarding corresponding PTA.  PTA should not be reduced for any event outside of the applicant’s control.

Conclusion

Thus, both influential intellectual property organizations generally agree with the PTO’s overall goal of giving applicant’s more control over examination timing, but they oppose many of the proposed features of the Three Track system.  They also have a large number of questions as to how the system would be implemented.

Are You a Small Entity?

August 9, 2010

Under PTO rules, a “Small Entity” is entitled to pay certain PTO fees associated with patent prosecution at a reduced rate, usually 50%.  As the PTO raises filing and post-issuance fees, it is important to determine just who qualifies as a Small Entity.

In the early 1980s, Congress substantially raised many of the PTO fees associated with patent prosecution and introduced some new fees that had not previously been charged, such as issue fees and maintenance fees.  To help off-set the burden this would cause for smaller or non-profit parties, Congress also introduced the Small Entity Status.

PTO rules define a Small Entity as an individual inventor or inventors, a small business concern, or a nonprofit organization.  In order to qualify as one of these three types of entities, none of the rights associated with a patent or patent application may have been assigned or licensed to any party that would not qualify for Small Entity Status, nor must there be any obligation on the part of the small entity to make such an assignment or license.  All of the rights in the patent or patent application must be held by a small entity.

In other words, IBM cannot set up a small holding company for all of its patents in order to qualify for Small Entity Status if it wishes to retain any rights in the patents.  Nor can IBM pay Small Entity Fees and wait until the patent issues to assign it to the company if the inventor(s) had an obligation to assign the invention to the company at the time of filing.

An individual inventor is anyone who has not assigned his patent application to a business or other organization.  The rules define a Small Business Concern as a company having fewer than 500 employees.  The rules define a Nonprofit Organization as a university, 501(c)(3) organization, or a scientific or educational organization under any state law or in a foreign country.  If an individual inventor, small business concern, or nonprofit organization licenses the patent or patent application to a company that doesn’t qualify for Small Entity Status, the full price fees must be paid at the PTO.

Previously, the PTO required the applicant or assignee to sign a verification of Small Entity Status.  Now, the simple written assertion of such status or even the payment of Small Entity Fees is sufficient.  This puts more of the burden on the patent applicant and the patent attorney to verify Small Entity Status.

If a small entity pays large entity fees, the small entity may request a refund of the overpayment.  Conversely, if Small Entity Fees are paid by an entity that is actually a large entity, it can usually be corrected by simply paying the required deficiency, if the incorrect amount was paid in good faith.  The rules do warn, however, that fraudulently paying Small Entity Fees when the applicant is not entitled payment of such fees can result in the resulting patent being held unenforceable due to inequitable conduct.

The PTO notes applicants have a contiuing duty to conduct a thorough investigation of the facts surrounding a claim of Small Entity Status.  The facts should especially be revisited at the times of paying the issue fee and maintenance fees.  For example, a patent issued to a Small Entity may have been licensed to a non-small entity between the time of its issuance and the time to pay a maintenance fee, or the company itself might have grown to more than 500 employees, making Small Entity Status inappropriate.

Micro-Entity

The patent reform bills pending in Congress have provisions for a new entity called a “micro-entity” that would pay certain fees at a 75% reduction of the normal amount.  To qualify as a micro-entity, certain conditions must be met.

For unassigned applications, the entity must not include any inventors that have been named on 5 or more patent applications.  Thus, “micro-entities” are newer inventors.  The application must not be licensed or the inventors must not be legally obligated to license or assign the application.  Each inventor must have an income of less than 2.5 times the average gross income reported by the Department of Labor for the previous calendar year.

For assigned applications, the inquiry is similar.  None of the inventors must be named on 5 or more patent applications.  The application can only be assigned to an entity with 5 or fewer employees.  And the assignee must have an income of less than 2.5 times the average gross income for the previous calendar year.

Thus, micro-entities will be a very small group of applicants, but it can result in significant savings on PTO fees if the new bills pass.

When paying PTO fees, it is important to stay up-to-date on whether the applicant qualifies as a Small Entity.

Judge Dyk’s View on the Patentability of Isolated Genes and DNA

August 5, 2010

Yesterday, the Federal Circuit reversed and remanded an infringement suit based on errors in the district court’s claim construction and infringement analysis.  Intervet, Inc. v. Merial, Ltd.  One of the claims at issue in the case is claim 32 of U.S. Patent No. 6,368,601, which reads:

An isolated DNA molecule comprising a nucleotide sequence encoding an epitope which is specific to PCV-2 and not specific to PCV-1.

The court reversed the claim construction of the “specific to” clause of the claim.  The court specifically noted that neither the district court nor any of the parties had raised the issue of patentable subject matter under § 101 in this case.  That didn’t stop Judge Dyk from addressing the issue in a partially-concurring and partially-dissenting opinion.

Judge Dyk’s Opinion

Judge Dyk agreed with the majority’s construction of claim 32, but was quick to add that

I write separately primarily to make clear that in construing the claims, we are not deciding that the claims as construed are limited to patentable subject matter.

He then argued that claim 32 raises substantial questions as to whether it is directed to patentable subject matter.

That claim is not limited to the use of a particular isolated DNA molecule in a vaccine or other application.

Rather, the claim is simply directed to an isolated DNA molecule.  The question, to him, is whether an isolated DNA molecule, without a particular application, such as a vaccine, is patentable subject matter. 

He argued that neither the Supreme Court nor the Federal Circuit has decided this issue, although he did admit that they have upheld the validity of certain gene patents, this was not in the § 101 context.  Although the PTO recognizes their validity, the issue had not been decided by either court.

Judge Dyk then seemed to follow Judge Sweet’s reasoning of Supreme Court (mess) precedent to hold that, in order for a product occurring in nature to be patentable, the isolated product must be qualitatively different, with “markedly different characteristics from any found in nature.”  He argued that mere isolation of a DNA molecule is not enough, as merely taking a leaf off a plant–the leaf doesn’t occur naturally isolated from the plant–is not enough.

Why?

It is hard to understand why Judge Dyk chose to write about this issue given that it wasn’t raised by either party or addressed by the district court or the majority opinion.  He apparently wants to signal to other parties that the battle is on regarding isolated DNA and gene patents and the side he is on. 

This is not what federal judges are supposed to do.  They are supposed to decide the case before them on the issues raised in that case.  If and when Judge Dyk is a part of a panel or en banc court that gets to address this issue, that would be the proper time for him to do so.  At this point, he is issuing an advisory opinion, contrary to the constitutional mandate that court’s decide “cases and controversies.”  The stakes in the Myriad case may have just gotten a bit higher.

Informing Someone of the Inherent Property of a Method is Not Patentable

August 3, 2010

Yesterday, the Federal Circuit issued an opinion in King Pharms., Inc. v. Eon Labs, Inc. The patent at issue in King Pharms. related to a muscle relaxant for use in treating painful muscle conditions.  The drug itself was discovered and a method for producing it was patented in the 1960s.

The patent owner in this case had received a new patent for a method of increasing the bioavailability of the drug by administering a therapeutically effective amount of the drug with food.  The patent applicant had discovered that the drug worked much better when the patient took it with food.

Several prior art references had suggested taking the drug with food to decrease nausea, but had not suggested that this would increase the drug’s bioavailability.  The district court held, and the Federal Circuit affirmed, that the increased bioavailability was inherent when administered with food.  That is, although the prior art did not recognize this benefit of administration with food, it necessarily occurred when the drug was so administered.  Thus, the prior art that suggested taking the drug with food inherently anticipated claim 1.

Claim 21

The more interesting claim is claim 21 that depends from claim 1.  Claim 21 adds the limitation of “informing the patient” that taking a therapeutically effective amount of the drug with food will increase its effectiveness.  The patent owner argued that this step has the benefits of increasing the likelihood that the patient will ingest the drug with food and increase any potential placebo effect.

The district court found the claim invalid under § 101 because the informing step did not meet Bilski‘s machine-or-transformation test.  The Federal Circuit held on appeal that this was error because any patentable subject matter analysis must focus on the claim as a whole and not on one specific limitation.

The court went on to note that the Supreme Court had sent one of its method of treatment cases back after Bilski, namely Prometheus, but that the King Pharms. case was not the proper vehicle to determine the patent eligibility of method of treatment cases.

The Federal Circuit instead affirmed invalidity of claim 21 on grounds of anticipation.  The step of informing the patient of the benefits of taking the drug with food was not disclosed in the prior art.  The court held that since claim 1 was not novel, the step of informing the patient added no novelty to the claim either.

The court held that simply informing the patient of the benefits of the drug does not transform that process of taking the drug with food.  Whether or not the patient is informed, the method of taking the drug with food is the same.  The step of informing someone of an inherent property of a method does not make an otherwise unpatentable method patentable.


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