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10/14/2009
In its Brief as respondent in Bilski v. Kappos, the Government has taken the position before the Supreme Court that the patentable subject matter must be tethered to technology, and that the Federal Circuit’s test, namely that a patent-eligible process must involve a machine or a transformation of matter. Activities such as means of performing “economic, social, or legal” tasks, are not, in the Government’s estimation, patentable subject matter unless they qualify under the “machine-or-transformation” test. Thus, the Government’s position is that Bilski’s claims are not patentable subject matter under this test.
However, an important position that the Government supports is that software when tied to a general-purpose computer should be in most cases patentable subject matter, basing this position off of the Federal Circuit case In re Alappat from 1994, which developed the legal theory that the installation of software itself onto a general-purpose computer transformed the computer into a specialized machine, thereby satisfying the requirements of the “machine-or-transformation” test.
Thus, as expected, the Government has argued against so-called “pure” business methods (and has generally supported the Federal Circuit’s test), and it will remain to be seen if Bilski’s attorneys and the amicus briefs can persuade the Court otherwise. However, it is extremely important to software companies who wish to patent their inventions that given neither side in the litigation seems to want to prevent software inventions which are patented in association with a general-purpose computer, even if patentable subject matter is restricted to exclude “methods of organizing human activity” (as the Government would prefer), Bilski v. Kappos will almost certainly leave a significant safe harbor for software inventions and most likely business methods which can be reduced to software as well. Thus, the decisions made by the government in the brief may make some inventors considerably more confident about concerns about successfully overcoming 35 U.S.C. § 101 challenges when submitting applications to the USPTO. 9/1/2009
In order to determine how to respond to relevant Supreme Court precedent and In re Bilski’s approaches to 35 U.S.C. § 101, the USPTO has developed a series of instructions for its Examiners. Of course, these instructions have been released with the realization that more stable guidelines will be established once the Supreme Court rules on Bilski v. Kappos. In addition, these are guidelines, since they are only based off of rules and laws, so they are "neither appealable nor petitionable." Overall, they condense the 35 U.S.C. § 101 issues into manageable flowcharts which reflect the current state of the law, but next spring the Supreme Court is very likely to reject the Federal Circuit's “Machine-or-Transformation” test. Therefore, Examiner time will have been wasted which could have been spent on more meaningful prior art issues.
A link to the guidelines is:
http://www.uspto.gov/web/offices/pac/dapp/opla/2009-08-25_interim_101_instructions.pdf
The guidelines consist of a series of steps represented by flowcharts. The first step is to determine if the invention is directed to a statutory class (process, machine, manufacture, or composition of matter), excluding things like a signal or a computer program per se. Next, inventions which encompass a judicial exception, such pre-empting a law of nature or a natural phenomenon, or which consist of a mental process or abstract idea are excluded.
Third, machines, manufactures and compositions of matter must have a practical application. If the invention is a process, it must pass the “machine-or-transformation” test prescribed by the Federal Circuit. Also, it must be a particular machine or a particular article to be transformed, and field-of-use and extra-solution activities are insufficient.
The USPTO’s press release about the guidelines may be found at:
http://www.uspto.gov/web/offices/com/speeches/09-14.htm
The USPTO has requested comments, which may be submitted via e-mail at: AB98.Comments@uspto.gov on or before September 28, 2009.
These guidelines do provide some helpful guidance for the interim, but the ultimate fate of this issue remains to be settled. 8/7/2009
Background on the client--AIPPI
The initials "AIPPI" are taken from the French name of the International Association for the Protection of Intellectual Property (Association Internationale pour la Protection de la Propriété Intellectuelle).
The International Organization
AIPPI is an international organization comprised of business firms, executives, lawyers, educators, patent and trademark agents, intellectual property owners, and other persons interested in the worldwide protection of patents, designs, trademarks, trade names, know how, goodwill, copyright, and other intellectual property rights and the elimination of unfair trade practices.
The international organization is domiciled in Switzerland. AIPPI currently has over 8,000 members. It operates mainly through National Groups, of which the United States group, AIPPI-US, is one. In addition, AIPPI has two regional (multi-national) groups, as well as individual members in countries where no National Groups have yet been formed. The members of AIPPI represent more than 100 countries. The website for the international organization is www.aippi.org.
The US group has a separate website at www.aippi-us.org Nixon Peabody Partner R. Mark Halligan serves on the Executive Committee for the AIPPI-US group.
Team Effort to Obtain AIPPI and AIPPI-US as a Client
On June 1st, the United States Supreme Court granted Bilski's petition for a writ of certiorari in the In Re Bilski case decided by the Federal Circuit. This case involves the so-called "machine-or-transformation" test and the issue is whether the Federal Circuit erred by holding that that a "process" must be tied to a particular machine or apparatus, or transform a particular condition into a different state to be patent-eligible subject matter. The officers and Executive Committee of the AIPPI recognized the importance of filing an amicus brief in the United States Supreme Court before the upcoming deadline for filing of July 23.
Nixon Peabody LLP accepted the challenge and stepped forward in a team effort to prepare the amicus brief utilizing the resources of its stellar IP practice group. Nixon Peabody LLP was approved as counsel on June 26 and the Nixon Peabody team prepared the first draft for further discussions and review by July 3. Since that time the team---Mark Kaufman in Washington DC and Bill Pegg, David McKone and Mark Halligan in Chicago---have worked for weeks completing the amicus brief and obtaining the necessary approvals and sign-offs from both AIPPI-US and AIPPI. Finally, the AIPPI-US/AIPPI brief was filed in the United States Supreme Court.
7/30/2009
In a recent Federal Circuit decision, Blackboard v. Desire2Learn (Fed. Cir. 2009), the Federal Circuit provided some insights about how means-plus-function claiming (as governed by the 6th paragraph of 35 U.S.C. § 112) would be adjudicated. Desire2Learn, who was accused of infringing a patent for educational software, based their argument around the idea that Blackboard’s claims did not include the single login feature that Blackboard claimed they had. However, that depended upon the feature, “means for assigning a level of access in control” which was part of the claim. Because the limitation was written in “means-plus-function” form, it only covered “the corresponding structure…described in the specification and equivalents thereof” 35 U.S.C. § 112 ¶ 6.
The Federal Circuit found that the specification only minimally discussed an “access control manager” (ACM) which managed an “access control list”, and that this description in the specification was an insufficient disclosure. Thus, they ruled under 35 U.S.C. § 112 ¶ 2 that the limitation was indefinite.
As part of their opinion, the Federal Circuit added that even though an person having ordinary skill in the art might have been able to create an access control list which would have yielded the claimed embodiment, that goes to enablement. The issue in this case was whether the means-plus-function claim feature was rendered definite by the specification, which in this case it was held not to be.
The result of the ruling that the claims were indefinite was that Desire2Learn received a judgment in its favor and Blackboard was unable to gain an advantage from its patent. The moral, perhaps, of this story for a patent practitioner is to be reminded of the important relationship between claims and their support in the specification, especially for means-plus-function claims, taking note to drafting applications to ensure that support is there and being aware of the issue in litigation situations. 7/28/2009
According to In re Bilski, the Federal Circuit from decision which was handed down in an en banc decision in 2008, the appropriate test to decide whether a given claim in a patent is patent-eligible subject matter is the machine-or-transformation test, wherein the claim must be tied to a particular machine or apparatus or transform an article into a different state or thing.
Ex parte Dickerson, a decision handed down by the Board this month, has complicated the interpretation of the test. In the Bilski decision, the court said that insignificant post-solution activity was insufficient to allow a claim to pass the test. It based this position on Parker v. Flook. However, Dickerson presents a computerized method claim which generates a solution to a performance metrics problem whose final step is outputting the solution. On the basis of the outputting the solution feature, the Board decided that the claim was statutory subject matter.
Thus, Dickerson suggests that the Board may perhaps now be more lenient about allowing claims that involve an outputting step as a way of tying the rest of the claim language to a machine or apparatus. However, given the risk of having an outputting step dismissed as extrasolution activity, it may still be a good idea to reinforce the role of the machine or apparatus elsewhere in the claim. 6/29/2009
On June 25, Rep. Lofgren reintroduced legislation in the House that except manufacturers and sellers of parts used to repair automobiles from patent infringement liability. H.R. 3059, introduced in the prior Congress as H.R. 5638, is directed primarily at supporting consumers and the insurance industry by allowing the use of "aftermarket" generic parts--as opposed to vehicle manufacturer patented parts--in auto repair. The original bill came in the wake of the International Trade Court's decision in Ford Global Technologies, LLC v. Keystone Automotive Industries, Inc., which held that a U.S. automaker could assert its patents on the ornamental features of vehicles to prevent the importation of foreign-made, generic copies. See ITC Investigation No. 337-TA-557.
Both the IPO and AIPLA strongly opposed the measure last year, arguing, inter alia, that the bill would devalue patent protection by allowing free use of a patented product for some purposes. For current patent holders, implementation of the bill could also run afoul of the Fifth Amendment, which prohibits the taking of private property for public use without just compensation. Further, despite its apparent focus on protecting consumers from pricey automobile repair, the bill uses broad language (applying the provision to "any article of manufacture that itself constitutes a component part of another article of manufacture") that could affect patent holders across multiple industries.
H.R. 3059 has been referred to the House's Committee on the Judiciary for further consideration. 6/24/2009
In January, 2007, Every Penny Counts (EPC), a Florida company, sued Bank of America (BofA) over the bank's "Keep the Change" savings program. Under the "Keep the Change" program, BofA rounds up debit card purchases to the nearest dollar and deposits the extra amount into customers' savings accounts.
EPC argued that the BofA program infringed on a patent, US 6,112,191, obtained in 2000 by EPC. The Patent, titled, "Method and system to create and distribute excess funds from consumer spending transaction" is commonly known as the "rounder patent." Every Penny Counts stated that it spoke with Bank of America in 2004 and 2005 about licensing its "rounder patent." However, Bank of America launched "Keep the Change" on its own.
BofA argued that the patent claim at the heart of EPC's suit over BofA's “Keep the Change” program is invalid in light of the U.S. Court of Appeals for the Federal Circuit's (CAFC) ruling in In re Bilski.
In an order signed Wednesday in the U.S. District Court for the Middle District of Florida, Judge Paul A. Magnuson granted Bank of America's motion for summary judgment, and denied EPC's motion, concluding that the patent claim at issue refers to a process, not a machine, and would therefore be an unpatentable method claim under the Bilski standard.
The EPC rounder patent claim at the heart of the lawsuit reads as:
15. A system, comprising:
a network;
entry means coupled to said network for entering into the network an amount being paid in a transaction by a payor;
identification entering means in said entry means and coupled to said network for entering an identification of the payor;
said network including computing means having data concerning the payor including an excess determinant established by the payor for the accounts;
said computing means in said network being responsive to said data and said identification entering means for determining an excess payment to the basis of the determinant established by the payor, and
said computing means in said network being responsive to the excess payment
for apportioning at least a part of the excess payment among said accounts on the basis of the excess determined and established by the payor and on the basis of commands established by the payor and controlled by other than the payee.
EPC said that the “computing means” was not “simply an off-the-shelf computer,” but a specific machine that must be combined and configured with the other components of the claim to practice the invention.
The company argued that even if its patent could be considered a process rather than a machine claim, the patent meets the “machine-or-transformation test” for patentability under Bilski.
But Judge Magnuson sided with BofA, ruling that simply because the process at issue requires machines or computers to work does not mean that the process or system is a machine.
“Because it is beyond question that the patented process is not tied to a particular computer or other devices, the process embodied by the 191 patent is invalid,” the court wrote.
For details, see "Bilski Kills Patent In 'Keep The Change' Suit V. BofA," by Morgan Bettex, at IPLaw360, May 29, 2009
6/22/2009
On Thursday, June 18, 2009, the White House announced its intent to nominate David Kappos as the next Director of the USPTO. Kappos, whose official title will be Under Secretary of Commerce for Intellectual Property, has over 20 years of patent experience and is currently serving as the Vice President and Assistant General Counsel for Intellectual Property Law and Strategy at the IBM Corporation. He is also on the Board of Directors of the Intellectual Property Owners Association, and is active within AIPLA.
Kappos has been a strong proponent of patent reform efforts and has most recently testified before the Senate Committee on the Judiciary to voice his support of S. 515, the Patent Reform Act of 2009. Specifically, Kappos advocated for post-grant review, enhanced inter partes reexamination proceedings, and pre-issuance submission of information. He also proposed a balanced approach to damages valuation provisions that would incorporate Quanta's "essential features" standard and provide for strengthened judicial gatekeeping. David S. Resnick and Ronald I. Eisenstein, Nixon Peabody LLP
Another front has been opened in the war against biotechnology, particularly personalized medicine intellectual property. On May 12, 2009 the American Civil Liberties Union (ACLU), the Public Patent Foundation, a not-for-profit organization affiliated with Benjamin N. Cardozo School of Law (PUBPAT), and a group of patients, physicians, academic researchers and medical societies joined the attack and filed a lawsuit against the U.S. Patent and Trademark Office, Myriad Genetics and the University of Utah Research Foundation challenging patents on two human genes associated with breast and ovarian cancer claiming such patents stifle research that could lead to cures and limit women’s options regarding their medical care. (Association for Molecular Pathology et al. v. U.S. Patent and Trademark Office, Myriad Genetics et al. 09-cv-04515-RWS; District Court for the Southern District of New York.)
The challenged patents cover the genes, known as BRCA1 and BRCA2, which are responsible for many cases of hereditary breast and ovarian cancers, as well as their application in diagnostic tests. While this complaint focused on Myriad’s patents, the ACLU has indicated that their real target are the patents that cover human genes and their application. For example, in paragraph 103 of the complaint, plaintiffs argue that “[b]ecause human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought, the challenged claims are invalid under Article 1, section 8, clause 8 of the United States Constitution and 35 U.S.C. § 101.” Article 1, section 8 is the “IP clause” which authorizes Congress to enact patent laws. Section 101 of the patent statute defines patent eligible subject matter. This ignores the fact that the U.S. Supreme Court has held microorganisms patentable as long as they are isolated from nature.
Plaintiffs also claim in paragraph 103 of the complaint that “[a]ll of the challenged claims represent patents on abstract ideas or basic human knowledge and/or thought and as such are unconstitutional under the First and Fourteenth Amendments to the United States Constitution.” A rationale given for the First Amendment argument is that such patents prevent medical professionals from speaking about the patent’s mutational status for fear of being sued. That’s absurd! A second rationale is that these patents limit who may give the test and thus limit the availability of different places where people can get the test. Such a position would say that there should be no medical related patents, e.g., pharmaceuticals, because it impacts medical care.
The complaint identifies the following U.S. Patents: Nos. 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; and 6,033,857. They are assigned to Myriad Genetics, the University of Utah Research Foundation, and the National Institutes of Health (the '282, '001 and '441 patents); Myriad Genetics, Centre de Recherche du Chul, and the Japanese Cancer Institute (the '473 and 999 patents); and Myriad Genetics, Endo Recherche, HCS R&D Ltd. Partnership, and the University of Pennsylvania (the '492 and '857 patents).
In their “Prayer for Relief” the plaintiffs ask the Court to:
1. Declare invalid and/or unenforceable
a. Claim 1, 2, and 5, 6, 7 and 20 of patent 5,747,282
b. Claims 1, 6, and 7 of patent 5,837,492
c. Claim 1 of patent 5,693,473
d. Claim 1 of patent 5,709,999
e. Claim 1 of patent 5,710,001
f. Claim 1 of patent 5,753,441
g. Claims 1 and 2 of patent 6,033,857;
The claims of the '282 patent expressly called out in the complaint read as follows:
1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.
5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2.
7. An isolated DNA selected from the group consisting of:
- a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having T at nucleotide position 4056;
- a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having an extra C at nucleotide position 5385;
- a DNA having the nucleotide sequence set forth in SEQ ID NO: 1 having G at nucleotide position 5443; and, (d) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having 11 base pairs at nucleotide positions 189-199 deleted.
20. A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.
The inclusion of claim 20 shows the draconian nature of the attack. The claim is directed to a method of screening using cells expressing a recombinant expression construct encoding an altered BRCA1 gene.
The claims recited in the complaint for the remaining patents relate to isolated DNA molecules and diagnostics testing methods.
The '492 patent:
1. An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2.
6. An isolated DNA molecule coding for a mutated form of the BRCA2 polypeptide set forth in SEQ ID NO:2, wherein said mutated form of the BRCA2 polypeptide is associated with susceptibility to cancer.
7. The isolated DNA molecule of claim 6, wherein the DNA molecule comprises a mutated nucleotide sequence set forth in SEQ ID NO:1.
The '473 patent:
1. An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1.
The '999 patent:
1. A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.
The '001 patent:
1. A method for screening a tumor sample from a human subject for a somatic alteration in a BRCA1 gene in said tumor which comprises gene comparing a first sequence selected form the group consisting of a BRCA1 gene from said tumor sample, BRCA1 RNA from said tumor sample and BRCA1 cDNA made from mRNA from said tumor sample with a second sequence selected from the group consisting of BRCA1 gene from a nontumor sample of said subject, BRCA1 RNA from said nontumor sample and BRCA1 cDNA made from mRNA from said nontumor sample, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said tumor sample from the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA from said nontumor sample indicates a somatic alteration in the BRCA1 gene in said tumor sample.
The '441 patent:
1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.
The '857 patent:
1. A method for identifying a mutant BRCA2 nucleotide sequence in a suspected mutant BRCA2 allele which comprises comparing the nucleotide sequence of the suspected mutant BRCA2 allele with the wild-type BRCA2 nucleotide sequence, wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.
2. 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, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.
Claims directed to the use of antibodies to detect altered BRCA1 proteins and cells lines carrying DNA encoding BRCA proteins were not recited in the complaint.
It is clear from the review of the asserted claims that the plaintiffs’ offensive is directed to the patentability of not just genes per se and use of those gene sequences in diagnostic methods, but also to the entire pharmaceutical field. 6/1/2009
The Supreme Court has granted certiorari today in Bilski v. Doll, formerly In re Bilski, a significant case on whether business methods can be patentable subject matter. Despite opposition from the Solicitor General, the Court will hear the case and decide whether the Federal Circuit's holding that a "machine-or-transformation" test is the appropriate test to use to determine whether inventions in areas such as business methods, computer software, and related areas, constitute patentable subject matter. The appellate court held that a process claim must be tied to a particular machine, or must transform an article to a different state or thing.
The petition presents two questions:
Whether the Federal Circuit erred by holding that a “process” must be tied to a particular machine or apparatus, or transform a particular article into a different state or thing (“machine-or-transformation” test), to be eligible for patenting under 35 U.S.C. §101, despite this Court's precedent declining to limit the broad statutory grant of patent eligibility for “any” new and useful process beyond excluding patents for “laws of nature, physical phenomena, and abstract ideas.”
Whether the Federal Circuit's “machine-or-transformation” test for patent eligibility, which effectively forecloses meaningful patent protection to many business methods, contradicts the clear Congressional intent that patents protect “method[s] of doing or conducting business.” 35 U.S.C. §273.
Now that the Supreme Court has granted certiorari, it will rule in due course and provide a more definite answer to which inventions are patent-eligible. | Check Effective Permissions | | /patents/_layouts/SecurityReportAccount.aspx?id={ItemId}&List={ListId}&Type=ListItem | 0x40000000 | 0x0 | ContentType | 0x01 | 10 |
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