As a result of a recent change to the Public PAIR (Patent Application Information Retrieval),  most provisional applications that are relied upon for their earlier filing dates in U.S. patent application publications or U.S. patents are now available to the public over the Internet. Exceptions mainly include provisional applications with filing dates prior to 1997.

Anyone wishing to view and/or print a copy of a provisional application relied upon by an examiner to give prior art effect under 35 U.S.C. 102(e) to a reference applied in a rejection, may do so using the Public PAIR website.

It will be interesting to see how this effects patentability opinions whenever the earlier-filed provisional substantially deviates from the substance of the later-filed regular patent application.  Obviously, for there to be a published provisional patent application, a non-provisional patent application must have been filed claiming priority to the earlier provisional.  More info here.

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The Food and Drug Administration will publish draft guidelines today that would encourage companies to submit voluntary safety evaluations of bioengineered food crops that sometimes drift and cross-pollinate with
plants in nearby fields.

The biotech industry welcomed the new approach, but environmental and food-safety advocates called it a poor substitute for the rigorous testing they have sought before the planting of scientifically engineered crops that could enter the nation’s food supply.

Under the new FDA guidelines, which are to be published in the Federal Register, companies also would be asked to conduct a voluntary safety evaluation and submit it to the agency. Critics of bioengineered crops have called instead for full-scale, mandatory safety testing and prohibiting the introduction of new biotech foods without detailed FDA certification that they are safe.

More from the Washington Post.

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Without comment, the Supreme Court has declined to review a Federal Circuit decision on a University of Rochester patent involving the discovery of a separate cox-2 gene and related biological processes.  The University had petitioned the Court to hear the case after a three-judge panel of the federal appeals court, in February, upheld a lower court ruling that declared the University’s patent invalid on the grounds that it did not provide sufficient information to meet what the court described as a "written description" requirement.  In July, the federal appeals court had denied, on a 7 to 5 vote, a request by the University for an en banc hearing.

While the fact was uncontested that the University’s discovery of a gene and biological process enabled companies to create new drugs, the federal appeals court in effect imposed a second hurdle for such patents by saying that the Rochester patent was invalid because it did not include the precise chemical formula for such a compound.

The school committed more than $10 million in legal costs to defend the patent for a new cyclo-oxygenase enzyme that causes inflammation.  Pharmaceutical companies later codeveloped lucrative cox-2 inhibitor drugs, such as Celebrex, and the school hoped to recoup royalties and fees ranging from $3 billion to $30 billion.  The University is not anticipating any further legal steps at this time.

See Rochesters Reply Brief.

The Rochester decision, and other recent precedent, is sending a message that the Federal Circuit does not intend to limit the written description requirement solely to cases involving issues of priority or DNA structure.  Rather, Rochester holds that the written description requirement applies when a patentee seeks to claim an aspect of an invention in terms of functionality rather than structure.

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Now that we’re all stuffed with turkey, I thought it was timely to note an AP article on the research into perfecting the turkey.  Most turkeys have been selectively bred for their white meat for so long that even walking can be a problem for many of the big-breasted birds and sex is no longer possible.  A research team is now hoping to come to the rescue, employing the latest in biotechnology to chart the turkey’s genetic map to eventually alleviate the breeding problems.  The idea is to identify specific genes that produce desirable traits such as salmonella resistance, strong leg muscles and, of course, big breasts.

That would do away with much of the guesswork involved in traditional breeding methods as farmers try to match birds that appear to have the sought-after qualities.  With just $1 million in funding from the U.S. Department of Agriculture and two commercial poultry interests, the researchers hope to publish by year’s end a guide to roughly 300 turkey genes, and have twice that many by next Thanksgiving, far short of the turkey’s 25,000 genes.  Animal rights activists believe this is not enough since turkeys will still be treated as commodities and more is needed to alleviate suffering.

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Of note for those of us that regularly deal with university inventions, and inventors, a Chemistry professor has filed a lawsuit against the University of Pennsylvania alleging that it deprived him of profits from technology he developed. Professor Michael Therien accuses the University of failing to live up to its obligation to commercialize his technology, which led to 10 patents in fields ranging from telecommunications to medical imaging and diagnostics. The suit alleges that Therien suffered lost profits and damages to his reputation exceeding $100,000.

The University has filed a motion to dismiss the case, which is currently pending in the Pennsylvania Eastern District Court. In a response filed with the court, University officials said Therien has "no right" to the technology and the University has "discretion" over whatever technology its employees develop.

Since I was previously the Interim Director of a tech transfer office, I will be particularly interested in seeing how this plays out.   See the entire article here.

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For everyone who’s wished they had a patent on something ubiquitous, there was a recent article on Bill Holloway who has a patent on a formula for water – and four more pending. About this point, you’re thinking: "Isn’t the formula H20?" Apparently, the company Penta is the leading pure-water company at health food stores.

Holloway claims "Our water is purified with a unique molecular structure that has been proven to be absorbed by human cells faster and more effectively than other water.  Simply put, Penta will help your body stay healthy and function like it’s supposed to."  Holloway claims the water formula even saved his life. Some years ago, he was diagnosed with Fibromyalgia, a chronic fatigue immune dysfunction syndrome, and he began researching ways to combat the disease, working on the simple fact that water is the conduit that delivers and manages the recovery of damaged cells in the body.

So, Holloway set about figuring out how to purify ordinary city water with a new method of reverse osmosis. The resulting highly purified water caused him to feel better and to lead a relatively normal life. He claims that Penta is the only formula utilizing a natural physics process instead of chemicals to restructure water. It’s this process that they’ve patented. The patent, U.S. Pat. No. 6,521,248, entitled "Micro-cluster liquids and methods of making and using them" is described as:

Abstract

The invention provides novel micro-cluster liquids and methods for manufacturing and using them. The micro-cluster liquids comprise fractionized or micro-cluster liquids, (e.g. water, such as oxygenated micro-cluster water). The methods comprise causing cavitation of a liquid to form cavitation bubbles under a first pressure followed by depressurization to a second pressure to cause implosion and explosion of the cavitation bubbles such that acoustical energy shockwaves are created.  The micro-cluster water (e.g., oxygenated micro-cluster water) is used to deliver hydration, oxygenation, or agents, such as nutritional agents or medications, and increasing overall cellular performance and exchanging liquids in the cell within minutes of consumption.

1. A process for producing a micro-cluster liquid, comprising: subjecting a liquid to cavitation such that dissolved entrained gases in the liquid form a plurality of cavitation bubbles; and subjecting the liquid containing the plurality of cavitation bubbles to a reduced pressure, wherein the reduction in pressure causes breakage of large liquid molecule matrices into smaller liquid molecule matrices, thereby producing a micro-cluster liquid.

33. A micro-cluster liquid produced by the process of claim 1 or 16.

44. A method for modulating a cellular performance comprising contacting a cell with a micro-cluster water made by the process of claim 1 or claim 16.

He said cancer chemotherapy patients seem to be at the top of the list of people drinking the water, along with teenagers suffering from acne and people with cirrhosis and congenital heart disease.  He said that with chemo patients, as with people with arthritis, his water helps to reduce swelling.

I have to wonder how much is attributable to the fact that most people could stand to drink some extra water.  No word yet on whether or not the micro-cluster water could be used for cold fusion.

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The USPTO clarified its position concerning the treatment of petitions to withdraw a holding of abandonment that are not timely filed because the applicant failed to exercise reasonable diligence in monitoring the status of the application. The USPTO receives petitions under 37 CFR 1.181(a) to withdraw holdings of abandonment (based on non-receipt of an Office action, or upon non-receipt or loss of a reply by the applicant). Some of these petitions are filed years after the application is held abandoned, causing extensive prosecution delays. To prevent these delays from inappropriately extending the term of any patent issued from the application, the USPTO is clarifying its position concerning the treatment of petitions to withdraw holdings of abandonment that are not timely filed because the applicant failed to exercise reasonable diligence in monitoring the status of the application.

Utility and Plant Applications Filed on or after May 29, 2000.

The term of a patent issuing from a utility or plant application filed on or after June 8, 1995, ends on the date that is twenty years from the filing date of the application, or the earliest filing date for which a benefit is claimed under 35 U.S.C. 120, 121, or 365(c). Utility and plant applications filed on or after May 29, 2000, however, are eligible for patent term adjustment under the American Inventors Protection Act of 1999 (AIPA). Therefore, if a petition to withdraw a holding of abandonment is not filed within two months from the mailing date of the notice of abandonment, any patent term adjustment will be reduced under the provisions of 37 CFR 1.704(c)(4).

If applicant does not receive the notice of abandonment, any patent term adjustment may be reduced under the provisions of 37 CFR 1.704(a) by a period equal to the period of time during which the applicant "failed to engage in reasonable efforts to conclude prosecution" (processing or examination) of the application, in which case any period of adjustment shall be reduced by the number of days, if any, beginning on the day after the date that is twelve months from the date of applicant’s filing or submission of correspondence with the USPTO for which further action by the USPTO can reasonably be expected and ending on the filing date of a grantable petition to withdraw the holding of abandonment.

Utility and plant applications filed on or after June 8, 1995, but before May 29, 2000

Utility and plant applications filed on or after June 8, 1995, but before May 29, 2000, are eligible for patent term extension under the Uruguay Round Agreements Act (URAA). The URAA provides for patent term extension only if issuance of the patent was delayed due to: (1) an interference proceeding; (2) imposition of a secrecy order; or (3) successful appellate review. See 35 U.S.C. 154(b) (1994). Unless an application is held abandoned during one of these three periods, the untimely filing of a petition to withdraw a holding of abandonment will not operate to extend the term of the patent because the USPTO has no authority to grant patent term extension under the URAA for other administrative delays. If a petition to withdraw a holding of abandonment is not filed within two months from the mailing date of the notice of abandonment during a period of appellate review, any patent term extension accrued under 37 CFR 1.701(a)(3) (extension due to successful appellate review) may be reduced under the "due diligence" provisions of 37 CFR 1.701(d)(2).

Design Applications, Utility Applications Filed Before June 8, 1995, and Plant Applications Filed Before June 8, 1995

(A) Applicant Receives Notice of Abandonment. In any utility or plant application filed before June 8, 1995, and in any design application, if applicant receives a notice of abandonment, any petition to withdraw the holding of abandonment that is not filed within two months of the mail date of the notice of abandonment will not (absent extraordinary circumstances) be treated on its merits unless accompanied by a terminal disclaimer under 37 CFR 1.321(a), and the required fee set forth in 37 CFR 1.20(d). The period to be disclaimed is the terminal part of the term of any patent granted on the application, or of any patent granted on any utility or plant application that claims the benefit of the filing date of the application under 35 U.S.C. 120, 121, or 365(c), equivalent to the period between:

  1. the date that is two months after the mail date of the notice of abandonment; and
  2. the filing date of a grantable petition to withdraw the holding of abandonment.

(B) Applicant Does Not Receive Notice of Abandonment. In any utility or plant application filed before June 8, 1995, and in any design application, if applicant never receives the notice of abandonment, any petition to withdraw the holding of abandonment that is not filed within twelve months from the date of applicant’s filing (or date of submission, if the correspondence was never received by the USPTO) of correspondence with the USPTO for which further action by the USPTO can reasonably be expected, will not (absent extraordinary circumstances) be treated on its merits unless accompanied by a terminal disclaimer under 37 CFR 1.321(a), and the required fee set forth in 37 CFR 1.20(d). The period to be disclaimed is the terminal part of the term of any patent granted thereon, or of any patent granted on any utility or plant application that claims the benefit of the filing date of the application under 35 U.S.C. 120, 121, or 365(c), equivalent to the period between:

  1. the date that is twelve months from the date of applicant’s filing or submission of correspondence with the USPTO, for which further action by the USPTO can reasonably be expected; and
  2. the filing date of a grantable petition to withdraw the holding of abandonment.

Petitions to revive an abandoned application for unavoidable or unintentional delay under 37 CFR 1.137(a) or (b) are also subject to a terminal disclaimer requirement of 37 CFR 1.137(d). According to the USPTO, "Since practitioners and pro se applicants can monitor the status of their applications using the USPTO?s PAIR and IFW systems, the failure to receive a notice of abandonment (or any other USPTO notification) will not excuse an unreasonable delay in filing a petition to withdraw the holding of abandonment. A status inquiry is in order once six months have elapsed with no response from the USPTO."

Read the full document here.

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US District Court Judge Mark Wolf dismissed patent claims filed by several biotechnology companies (including Genzyme Corp. and Biogen Idec Inc.) against Columbia University that alleged the New York school was improperly trying to extend its rights to a process widely used to engineer new drugs. Columbia had collected several hundred million dollars over the years from its patents on the drug-making process but the school recently pledged not to seek further royalties, so the judge in the case dismissed firms’ claims.

The patents are based on research from the 1970s by Columbia professor Richard Axel, who this year was co-winner of the Nobel Prize for Medicine. Axel and two colleagues created a way to splice bits of DNA into living cells to create human proteins, a basic technique used to produce many of today’s best-selling biotechnology products such as Genzyme’s Cerezyme for Gaucher disease and Biogen Idec’s multiple-sclerosis drug Avonex.

The patents expired in 2000, but in 2002 Columbia received a new patent derived from its previous patents with 17 more years of protection and Columbia expected continuing royalties based on the new patent. The companies stopped paying and filed various suits against Columbia the next year.

In dismissing the claims, Wolf let stand Columbia’s patent itself, which the school is having reexamined by the US Patent and Trademark Office. David I. Gindler, an attorney at the firm of Irell & Manella LLP in Los Angeles who represents Columbia, said Wolf’s ruling leaves open the possibility of a future decision by the government agency that would extend the school’s rights after all.

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