Patent Baristas

In In re Crish, No. 04-1075 (Fed Cir. December 21, 2004), Crish filed a patent application for purified DNA molecules having promoter activity for the human involucrin gene (hINV). The Federal Circuit held that the claims were anticipated by two other publications that disclosed the complete structure of hINV.

The claimed invention relates to purified DNA molecules having promoter activity for the human involucrin gene (hINV). The outermost layers of the skin and other stratifying squamous epithelia are composed of dead cells densely packed with a fibrous protein called keratin. Involucrin is a protein that interacts with keratin and other intracellular proteins to form a cross-linked envelope within the dead cells to strengthen the plasma membrane of the cells.

As the name indicates, the involucrin gene contains the DNA sequence that codes for involucrin. Crish?s application discloses that Crish has isolated and sequenced the promoter sequence of hINV from plasmid pSP64 ? I-3 H6B using standard molecular biology techniques. Crish determined that the hINV promoter sequence was approximately 2.5 kb (kilobases) in size. Crish?s application also identified and numbered each nucleotide in the hINV promoter sequence and designated it as SEQ ID NO:1.

During prosecution, the examiner rejected the claims as being anticipated by a Crish publication  and a Welter publication. The Crish publication lists James Crish, coinventor on the ?509 application, as a coauthor. The Crish publication analyzed the phenotype (physical appearance) of mice pups that had hINV (including the promoter region) microinjected into them at the embryonic stage. The microinjected hINV was isolated from the same plasmid pSP64 ? I-3 H6B referenced in Crish?s patent application. The Crish publication also disclosed the complete structure of hINV (the promoter region of hINV used in the Crish publication, however, was not sequenced), including the approximate size (2.5 kb) of the promoter region, and referenced an earlier publication 4 disclosing how the plasmid pSP64 ? I-3 H6B was obtained.

The Welter publication, which also lists James Crish as a coauthor, identified five protein-binding sites on the promoter region of hINV. The publication also confirmed that protein binding on two of those sites was necessary for the cell to begin transcribing the DNA coding region. The hINV that was used for this study was from plasmid pSP64 ? I-3 H/Hc. Although plasmids pSP64 ? I-3 H6B and pSP64 ? I-3 H/Hc are not identical, the PTO contends that the promoter regions of hINV contained in both plasmids are identical.

Crish argued that the Crish and Welter publications cannot anticipate his claims because the prior art does not provide any information regarding nucleotide sequences. According to Crish, the fact that Crish?s application references a prior art plasmid is irrelevant; the pending claims cover a specified novel DNA sequence, not the starting materials. Secondly, Crish asserts that even if the Crish and Welter publications are relevant, a person of ordinary skill in the art starting with the plasmid disclosed in the Crish and Welter publications would not necessarily obtain SEQ ID NO:1. Crish explains that different DNA sequencing techniques, for example, using different restriction enzymes, may result in workers obtaining different DNA sequences.

However, since the promoter region of hINV was not new, the court found the only arguable contribution to the art that Crish?s application makes is the identification of the nucleotide sequence of the promoter region of hINV. However, just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.

The court rejected Crish?s argument that the claims are not anticipated because the Crish publication did not sequence the promoter region of hINV:

While the PTO?s position that the discovery of new properties of a known material does not make claims reciting those properties novel is correct, and we agree with the PTO as to its conclusion, we differ with its characterization of the nucleotide sequence of the gene as a property of that gene. The sequence is the identity of the structure of the gene, not merely one of its properties. The gene may have functional, biological properties, and it may have physical properties, but its structure is its identity, not merely one of its properties. A long line of cases confirms that one cannot establish novelty by claiming a known material by its properties. E.g., In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) material plasmid, is unsound. The starting material plasmid necessarily contains the gene of interest, including the promoter region, and once we have affirmed the PTO?s construction of the claims as ?comprising? more than the recited numbered nucleotides, the claims necessarily encompass the gene incorporated in the starting material plasmid. Accordingly, Crish?s pending claims encompassing the gene plus other nucleotides are anticipated by the starting material plasmid, which consists of the gene plus other nucleotides. .

The court found that it was irrelevant whether other workers used the same plasmid as Crish and obtained a different sequence for the promoter region of hINV:

Crish is claiming what Crish earlier disclosed, and we presume that Crish correctly sequenced the promoter region of the hINV gene from plasmid pSP64 ? I-3 H6B, as he has described in his application on appeal. Crish cannot rely upon the inability of another worker to correctly sequence the promoter region of the hINV gene from plasmid pSP64 ? I-3 H6B when he has sequenced it accurately himself. His own work, as recited in his application, is better evidence than Lopez-Bayghen?s work. Finally, we address Crish?s argument that the Board improperly assumed that the plasmid referenced in Crish?s application is the same plasmid used in the Crish publication. We have previously explained that when the prior art evidence reasonably allows the PTO to conclude that a claimed feature is present in the prior art, the evidence ?compels such a conclusion if the applicant produces no evidence or argument to rebut it.? Spada, 911 F.2d at 708 n.3. Here, the Board reasonably concluded that the plasmids used in Crish?s application and the Crish publication were the same. Several facts support the reasonableness of the Board?s assumption. First, Crish is both an inventor on the subject application and an author of the prior art publication. Secondly, both the application and the publication refer to the promoter region as approximately 2.5 kb in size. Third, both the application and the publication refer to the same source for plasmid pSP64 ? I-3 H6B, a publication by Eckert et al.

The court also noted that Crish did not argue that the portions of the plasmid not consisting of the involucrin gene are not nucleotides, nor did he argue that the preamble term purified has any operative meaning in this appeal. It will be interesting to see if these are argued in subsequent appeals.

I want to wish everyone a Happy Festivus. In case you don’t remember the history of Festivus from the show "Seinfeld," Frank Costanza went to buy a doll for his son one Christmas. He went to reach for the last one at the same time as another man and as Frank rained blows upon him, he thought there could be another way. The doll was destroyed, but out of that, a new holiday was born. He named it Festivus.

Festivus takes place during the last few weeks in December, families and friends gather at the dinner table and have "The Airing of Grievances". Durning this time, family and friends share all the ways they have disappointed each other during the past year.

After the Airing of Grievances, the "Feats of Strength" takes place. This is where the head of the household tests his/her strength with another friend or family member. Festivus is not over until the head of the household is pinned.

Finally, the house is decorated with the Festivus Pole, not a tree. It is a metal pole with no decorations. Frank Costanza believed that tinsel is very distracting. The pole is tall and silver.

Cincinnati Children’s Hospital Medical Center will begin making investments in biotech companies built around technologies originally developed at the medical center. Cincinnati Children’s Tomorrow Fund will provide early-stage angel and seed capital to new Cincinnati-based companies to develop to the point where traditional venture capital and other funding is attainable.

The Tomorrow Fund received $500,000 from the State of Ohio’s Third Frontier Validation Fund and Seed Fund Initiative.  Start-up companies that receive investments from the Tomorrow Fund will use the investment capital to further develop their technology, hire employees and management, and refine their commercialization strategy.

Any returns on investment received by Cincinnati Children’s will be used for future Tomorrow Fund investments. Cincinnati Children’s CEO James Anderson said the primary goal of the Tomorrow Fund is to move hospital-owned technologies into the market, where they can become medical products to treat patients around the world.

U.S. District Court Judge Gregory M. Sleet ended the stem cell patent suit by PharmaStem Therapeutics, Inc. against CorCell, Inc. and numerous private umbilical cord blood banks for infringement of its patents 5,004,681 and 5,192,553. Judge Sleet stated that, "There was no legally sufficient evidentiary basis for a reasonable jury to find that all, or any specific number, of the defendants cord blood units infringe the ’681 patent." This judgment follows a Sept. 14, 2004 ruling by Judge Sleet stating that the defendants did not infringe on the ’553 patent, the first of two PharmaStem patents in question. The earlier judgment overturned a $7 million award to PharmaStem.

Earlier, the Court held that CorCell is not, and cannot be, liable for patent infringement because they do not sell, or offer for sale umbilical cord blood. The Federal Court’s decision decisively rejects PharmaStem’s effort to prevent CorCell from processing and storing umbilical cord blood for families. The implication of this ruling is that ostetricians and other healthcare providers who simply collect umbilical cord blood for cryopreservation, cannot be liable for contributory infringement of any PharmaStem patent. The Court also declared that a child’s family owns the child’s umbilical cord blood and the private blood banks provide a service, processing and preserving the cord blood for the families.

Earlier, the Court overturned a ruling against ViaCell ruling that the cord blood is owned by the family and because ViaCell only provides services to assist the family, it does not infringe meaning that any individual, corporation or institution providing services to assist a family in preserving the Cord Blood does not infirnge PharmaStem’s patents.

I just tried out FreshPatents.Com, a patent keyword monitoring offered as a free service. You can monitor just your niche, for example, under the category "Drug, bio-affecting and body treating compositions" with recently published patent applications available by RSS feed and e-mail. The listing format includes USPTO National Class full category number, link to abstract/description, and title of the patent application. You have to register to get set up but it offers a good way to monitor certain classifications. There is even a patent highlights feed.

Cool feature:  Click on the button at the type labeled "Agents" and you can see all the applications that published by law firm name.

The recently enacted Cooperative Research and Technology Enhancement (CREATE) Act of 2004, amends Federal patent law in an effort to promote collaborative research, particularly between scientists at separate universities and between industry and university scientists. This new law provides that sharing of confidential information under a joint research agreement that was in effect on or before the date the claimed invention was made will not be the basis of an obviousness determination under patent law. 

During the course of collaborative research, patent applications may be filed which arise from the research.  The filing of these patent applications can become unforeseen prior art when these patent applications or resulting patents become prior art against subsequent patent applications coming out of the collaborative research.

To take advantage of its provisions, you should take steps to: 

1. prior to entering into a collaborative agreement, consider whether you are willing to potentially give up the opportunity to separately enforce your patent;
2. review any pending patent applications which may have come out of a collaborative research agreement;
3. review all collaborative agreements to determine if the agreement will satisfy the criteria set forth in the Act;
4. amend any relevant pending patent applications or issued patents to include the names of the parties to the agreement;
5. consider filing a Certificate of Correction to amend patents that have issued as a result of collaborative works; and
6. record all collaborative research agreements with the United States Patent and Trademark Office.

More details can be found here.

Carnegie Mellon University scientists have developed a new way to introduce peptide nucleic acid (PNA) directly into live mammalian cells, including human embryonic stem (ES) cells. The work, published online December 2 in Chemical Communications, holds considerable promise in genetic engineering, diagnostics and therapeutics.

Until now, getting PNAs into living cells has been difficult. While other laboratories have developed ways to shuttle PNAs into cells, these methods remain largely ineffective and limited to small-scale experimental setups. Messenger RNA (mRNA) is the current preferred target of antisense therapy.

The U.S. Congress passed a bill raising patent-filing fees in the Consolidated Appropriations Act, 2005 enacted on December 8, 2004.  The new system’s basic filing fee, search fee and examination fee add up to more costs for applicants, but the most significant change may be the fee hike for each claim beyond the first 20 claims.  The increase from $18 to $50 for each additional claim will particularly hit biotechnology patent applications since even run-of-the-mill applications are now filed with 100-200 pages and as many as 100 claims.

The maintenance fees during the patent’s lifetime have also increased substantially.  This, on top of current efforts by the U.S. Patent and Trademark Office to step up pressure on applicants to reduce the number of claims and pages.  This does not address the fact the one broad claim can cause more searching work for an Examiner than 50 relatively straight-forward and focused claims.  It is worth noting here that what is disclosed in a patent but not claimed is dedicated to the public.  To get around this limitation in the case of applications having both broad scope and broad disclosure, a patentee will need to file additional applications with terminal disclaimers subjecting themselves to multiple maintenance fees.

Of course, the big issue for patentees is that a lot of the money is going into the general government fund and not staying at the patent office to improve efficiency and the quality of prosecution. According to the Intellectual Property Owners Association in Washington, D.C., the federal government has diverted three-quarters of a billion dollars in fees from the patent office since 1992.

The AIPLA has this nice desciption here.

More from the USPTO here.