
Mike Selvon asked:
In 2000, just four years before his death, “Superman” actor Christopher Reeves wrote in TIME Magazine: “It is our responsibility to do everything possible to protect the quality of life of the present and future generations. A critical factor will be what we do with human embryonic stem cells.” He went on to note the potential for treating Alzheimer’s, heart disease, Lou Gehrig’s disease and spinal cord injuries like he had with a simple, basic embryonic stem cell; “the body’s repair kit.” While controversy proliferated during the George Bush presidency, millions suffered. Today, there is a more liberal policy regarding stem cell research funding.
“The likelihood of something going wrong is pretty high,” warns Arnold Kriegstein of UC San Francisco’s Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research. “Something like tumors are probably going to happen. This is an area where the risks are great. The public has to be prepared.” He points to a recent story of a teenage boy who traveled from Israel to Russia to undergo stem cell therapies only to find he had little more than a brand new brain tumor four years later. Embryonic stem cell research is far from perfect, Kriegstein admits, and it could take many years before taxpayers see a return on their $3 billion investment.
Even though $3 billion has been allocated for stem cell research funding, the cost of embryonic stem cell research is high. A human clinical trial, for instance, could cost hundreds of millions of dollars. Nothing is more substantive than a successful human trial, of course, yet what if it doesn’t work? “We all want the same thing – we want to see regenerative medicine work,” said Bruce Conklin at the J. David Gladstone Institutes. “Although there’s $2 billion left to give out, that’s actually a very small amount of money. Now, if that’s all spent on clinical trials that don’t tell us anything because they don’t work, that’s a missed opportunity.”
Despite the limitations of the embryonic stem cell, there have been some significant discoveries in recent years. For instance, Japanese scientist Shinya Yamanaka found that adult stem cells could be transformed into pluripotent stem cells, which carry an infinite potential for transforming into other cells. It was also found that the human body tends to accept these new adult cells more than embryonic cells. The added significance is that an embryo needn’t be destroyed to advance science, which is what many pro-lifers had against stem cell research.
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Michael Callen asked:
Stem Cell Update
Stem cell differences. Stem cells are different from other cells of the body in that they have the ability to differentiate into other cell/tissue types. This ability allows stem cells to replace cells that have been damaged or died. With this ability, they have been used in therapies to replace cells/tissues in patients who have certain diseases or defects.
Focus changes from genes to stem cells. During the 1990’s, the research for many debilitating diseases was focused on gene therapy, which involves putting certain genes into cells in a patient. In the 21st century, the focus has shifted from gene therapy to stem cell therapy.
Stem cell therapy offers promises. Stem cell therapy offers the promises that gene therapy held, without the difficulty and expense. Because stem cells are the body’s master cells – having the ability to become other kinds of cells – theory and results hold that the difficult work of gene therapy can be done by the stem cell itself.
Stem Cell Debate. Is There A Solution? Stem Cell research and stem cell therapy are two subjects about which nearly everyone has an opinion. The crux of the issue is that there are two main sources of stem cells: stem cell donors or stem cell patients.
The donors can be from living humans or fetal tissue, and this is typically where the main argument comes in to play. Those who are opposed to abortion do not want the by-product of an abortion (in this case – embryotic stem cells) to become a cottage industry. This is understandable.
On the other hand, adult stem cells can be extracted from the bone marrow of the patient or a living donor, and then cultured, and finally injected into the patient. While this kind of therapy seems to be quite effective, it is a very expensive procedure that is out of reach for most people.
Fortunately, there is a third option that is simple, safe, and affordable for everyone; and best of all – it is not objectionable to parties on either side of the stem cell debate. This stem cell therapy alternative involves a natural botanical extract that has been shown to stimulate the release of adult stem cells within the patient.
Triple-blind clinical trials show that one gram of this botanical stem cell enhancer increases the number of adult stem cells in circulation by 25 – 30% for several hours.
Stem Cell Enhancers – A Breakthrough. Scientists have identified a breakthrough, natural botanical extract that supports wellness by helping your body maintain healthy stem cell physiology. Available without a prescription, this product is from the latest phytoceutical product category called “stem cell enhancers”.
What are Stem Cell Enhancers? Recent scientific developments have revealed that stem cells derived from the bone marrow, travel throughout the body, and act to support optimal organ and tissue function. Stem cell enhancers are products that support the natural role of adult stem cells.
How can Stem Cell Enhancers Benefit You? As you age, the number and quality of stem cells that circulate in your body gradually decrease, leaving your body more susceptible to injury and other age-related health challenges. Just as antioxidants are important to protect your cells from “free radical” damage, stem cell enhancers are equally important to support your stem cells in maintaining proper organ and tissue functioning in your body.
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Rosy Vohra asked:
Gene is the structural and functional unit of life. These basic entities are the vehicles that carry entire genetic information encoding for every function of the body. This it does so by encoding for specific amino acids. Several amino acids team up to build proteins. It is these proteins which will then be an integral part of hormones, enzymes and other essential components which will regulate the body mechanisms. In most cases one gene codes for one amino acid and several amino acids make for a single protein. Thus in the built up of a single protein which can serve as enzyme or hormone is made up by the instructions coming from a group of inter-related genes.
It is essential to understand that in the event of any alteration in the structure of gene, defective commands will be given causing the formation of wrong structure of protein. The alteration takes place by way of mutation caused due to natural aging process, environmental factors, radioactive components, ultra violet rays and others of the kind. This altered protein will not be similar to the protein desired and needed by the body to perform the required function. This means the metabolism is faulty and not taking place as required. This is externally manifested by way of a disease.
The natural corollary of this would be that correction in the defective make up of the gene would automatically lead to normal functioning of the body. The current motto is ‘To repair what you can and replace all that what you cannot repair’. This is now being taken care of by the break through in stem cell research and gene therapy. The repair and replacement therapy is taken care of by way of stem cell and gene therapy. It is aimed to restore the original functions and restore back to the disease-free state.
• Stem cells are primarily taken up because they are still at the threshold of adolescence. They are active, vigorous and have the potential of being transformed into mature cells of the desired type such as the nerve cell, blood or any other tissue. The acquire forms similar to the neighboring cells in whose vicinity they fall.
• Practically this is undertaken by first boosting the production of stem cells in the bone marrow and in the connective tissue around blood vessels of the umbilical cord and the placenta. These stem cells are harvested and then injected in the organ that requires the repair. For example stem cells from the bone marrow after harvesting are injected into failing heart helps replenish its lost properties. Stem cells have helped in curing leukemia, Parkinson’s disease, lymphoma, cancers and other rare ailments.
• Another repair and replacement technique is the gene therapy. Genetics have learnt to cut, splice and insert genes using the genetic scissors and genetic glue. Genetic scissors are the enzyme endonuclease and glue is the enzyme ligase which is capable of artificial synthesis in the laboratory.
• The defective gene is cut using endonuclease and removed. Simultaneously the counterpart gene functioning normally is extracted in the similar fashion from another organism particularly from bacterium E.coli. The normal gene is inserted in the diseased organ and fixed using ligase. Soon the normal gene is integrated in the genome which now behaves as normal. The major bonus with this technology is that the incurable genetic disease being transcending hereditarily is cured for ever. The next generation will receive the customary gene and shall be disease free.
• Gene replacement has helped cure diabetes, color blindness, severe combined immunodeficiency (SCID), cosmic enhancement, anti-aging and several such times programmed by genetic coding and timing. Gene and stem cell therapy are the modern elixirs to eternal youth and facilitators to a disease free-ageless body.
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Mike Martinez asked:
We hear much controversy concerning the ethical nature of Stem Cell reasearch. In particular embryonic stem cells. The reason is clear, embryonic stem cells are taken from a developing embryo, thus destroying it.
Yet Stem Cell research continues because they have shown to have the potential to develop or transform themselves in almost any cell in the human body. This means a rejuvenation of damaged or injured organs. Many of todays so called degenerative diseases, which we currently have little if any effective therapies, could in fact be alleviated or healed. Advocates of Stem Cell research argue that Stem Cells could hold the key to curing diseases like cancer, AIDS, Alzheimer and multiple sclerosis, just to name a few. Facinating science.
However what most people have not heard about is Adult Stem Cells. These Stem Cells are found in the human body, mainly in the bone marrow. Recent research shows that Adult Stem Cells also have the ability to renew damaged organs and tissue within the body.
In fact, while embryonic Stem Cells have not been used in even one human therapy, Adult Stem Cells have already been used successfully in numerous patients. Jay Lefkowitz, a former adviser to President Bush on Stem Cell policy says, “Adult Stem cells are really where the real progress is being made.”
The key difference with Stem Cells is that they can divide, regenerate and actually become different organ cells. Research has conclusively shown Stem Cells can become liver cells, blood cells, pancrea cells, heart cells, and even brain cells. Almost any cell or tissue in the body.
For decades now Adult Stem Cells have been used very successfully in bone marrow transplants to treat certain cases of blood disorders and leukemia. A massive amount of research, which is still in it’s early stage but none the less very promising, shows impressive results for heart damage due to heart attacks, liver disease, bone and cartilage diseases and brain disorders.
In a landmark experiment, Professor Saul J. Sharkis of John Hopkins University was able to convert bone-marrow Adult Stem Cells from animal donors into healthy liver cells. He says, “It is mind blowing stuff. I never would have thought this would be possible.”
In another landmark experiment carried out by scientist at Yale University in 2001, Adult Stem Cells taken from the bone marrow of male mice were injected into female mice whose own marrow was destroyed by radiation irradation. Eleven months later, the male stem cells (identified through the Y chromosome) were found not only in the females’ bone marrow, but also in their blood, guts, lungs and skin tissue.
While there is still much to learn about the magic of Adult Stem Cells, we can rest assure that a breakthrough in health is right around the corner.
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Maria Leonora Albino asked:
More than same-sex marriage and pedophile priests molesting choir boys, what tears the Christian Church apart is its own followers’ biases and prejudices against each other.
As Christians, we tend to focus too much on our diversity that we forget what it is that unites us: our faith in Jesus Christ, his death for sins, burial, resurrection and our desire to follow His teachings.
But is it possible to have unity in the Christian Church? The answer is yes. Love, understanding and praying for unity are what we need to break down denominational walls in the Church.
With two billion followers, Christianity is the world’s most widely practiced religion. If a family consisting of a father, a mother and their two children may not always see eye to eye, how much more such a huge number of people? Dissension cannot be avoided and there will always be disagreements. It is when we begin to ask, “Whose views are more superior?” that judgment starts. This leads to alienation, and alienation is what creates disunity among us.
Wracked by issues as child sexual molestation by the clergy, contraception, abortion, stem cell research and divorce, the moral authority of the Christian Church is continuously under scrutiny. Also, some denominations within the Christian Church openly support homosexuality and gay marriage even among male priests and consecration of openly gay bishops. This triggers denouncement from other Christian groups which perceive these practices as blasphemous to the Church’s doctrines and damaging to the already fragile image of the Christian faith.
Another issue that has drawn criticisms from both Christians and non-Christians alike is the growing number of churches being established in areas in close proximity of each other. One example of this is a particular town in Texas which only has a population of around 20,000 but 51 churches were built in the area. It seems the Christian Church is taking the words, “Go forth and multiply” too literally. With the problems hounding it, it seems that the Church’s response is to build more churches much like social networking sites sprouting on the internet instead of unifying the members of the existing ones.
Instead of addressing these glaring problems within the organization, church leaders hurl blame against each other. Different denominations preoccupy themselves arguing about non-essential matters like worship styles, Arminianism, Calvinism, etc., instead of uniting on the foundation of Christianity. This somehow proves what most people fear all along, that the Christian Church is the Church of the Disunited.
How can the Christian Church summon enough credibility (and focus as obviously its energies are scattered) to continue to preach the word of God? How can it defend itself from the attacks of other religions when a war is raging within the Church itself? Division and bickering is like a disease that attacks the Christian Church from within, much like an auto immune disease.
How differences can be healthy
A little dose of differences among the members of the Christian Church can be healthy because it leads to dynamism. “For there must also be factions among you, in order that those who are approved may have become evident among you,”(1 Cor. 11:19).
According to Romans 14:1-12, we may have differing opinions, but we should not judge each other because “To his own master he stands or falls; and stand he will, for the Lord is able to make him stand. One man regards one day above another, another regards every day alike. Let each man be fully convinced in his own mind…” God himself will be the judge.
Not one denomination of the Christian Church should consider itself superior and regard the other groups with contempt. Christians may operate under different names, but it should not matter because God gave us no name but his under which to rally.
Unity in the Christian Church is possible
Unity is not achieved by ramming one’s opinions down someone else’s throat and the other person blindly conforming to these. We need to recognize that our differences of opinions and worship styles are fine, but we need to constantly work and pray for unity.
What is important is for us to practice God’s loving and accepting attitude across denominational barriers. When we reject others whom Christ has accepted, it conflicts with the very nature of the Christian faith which preaches about love, forgiveness, self sacrifice, humility, and unity. What God truly meant for us to do is to practice His teachings and spread His word, not sit as judge of the other person.
Would it not be a good way to preach to the world about Christianity if the Christian Church is able to unite despite its differences? Would it not please God if Christians, regardless of denominations, are able to accept and love each other?
Love, acceptance, and praying for unity
Love, acceptance, and praying for unity are the perfect unifying bond for the Christian Church, and these should be tightly woven into the spiritual and moral fiber of the Christian faith. The unity of the Christian Church begins with individuals praying for unity.
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Lawrence Ebert asked:
In March 2006, there was renewed concern about the patent system, manifested not only in discussion of the NTP v. RIM (BlackBerry) case, which settled for $612.5 million but also on the fate of the use of injunctions in patent infringement cases, to be reviewed by the Supreme Court in eBay v. MercExchange. The Wall Street Journal wrote that U.S. patent law is “deterring research and penalizing innovation,” and that the patent system is “fast becoming a detriment to U.S. competitiveness, not to mention basic fairness.” The idea that patents are not central to innovation can also be found in the philosophy of some venture capitalists, who will directly tell you “patents are not why we are investing.”
Although some people, such as Adam B. Jaffe, and Josh Lerner, suggest the patent problems are of recent origin, with changes in the last 20 years which have led to a decline in patent quality but a strengthening in patent rights, the empirical evidence for this is thin. Many of the issues we see now have been around for a long time.
In the following, aspects in the history of the light bulb are discussed. Consistent with the viewpoint of the VCs, J.P. Morgan invested in Edison, the man, before Edison’s key patent
issued. To attract attention of the influential, Edison set up the first commercial electric power plant near Wall Street, much as RIM (BlackBerry) has attained impact through the opulence of
its customers. After a commercial beachhead was established, the patent wars began. Edison’s final success in the patent wars was established both offensively and defensively, and was greatly
assisted by his high profile. It is suggested that certain legal issues that confronted Thomas Edison in the 19th century will soon appear before stem cell workers in the 21st century. [Of various suggestions that Edison was troll-like in his behavior in not making product, one observes that Edison himself obtained the funds from investors to set up the first electric power plant, and then created the power plant. He made product. Whether he was actually the inventor of the light bulb is a different story.]
DID EDISON INVENT THE LIGHT BULB?
Although not widely discussed, the application for Edison’s famous US Patent No. No. 223,898, granted January 27, 1880, was involved in an interference with competing inventors Sawyer and
Man and Edison lost on the contested point.
Following up, the successors to Sawyer and Man challenged Edison’s patent. The basic claim of Edison read: An electric lamp for giving light by incandescence, consisting of a filament of carbon of high resistance, made as described, and secured to metallic wires, as set forth. The trial court noted that Edison “was the first to make a carbon of materials and by a process which was especially designed to impart high specific resistance to it; the first to make a carbon in the special form for the special purpose of imparting to it high total resistance; and the first to combine such a burner with the necessary adjuncts of lamp construction to prevent its disintegration and give it sufficiently long life.” The trial court also noted, somewhat
cryptically, “There are many adjudicated cases in which it appears that the inventor builded better than he knew; where a patent has been sustained for an invention the full significance of which was not appreciated by the inventor when it was made. In the case of the Bell telephone patent there was great room for doubt whether the speaking telephone had been thought of by Mr. Bell when he filed his application for a patent, but the court said: ‘It describes apparatus which was an articulating telephone, whether Bell knew it or not.’” Edison’s patent survived. A problem with the court’s analysis is that the distinctly long life of Edison’s filaments arose from the use of
bamboo, which was not disclosed in Edison’s patent.
In a case that went all the way to the Supreme Court, the relevant patent of Sawyer and Man, asserted against the interests of Edison, did not survive. The first claim of U.S. Patent No.
317,076 (related to patent 205,144 ) read: An incandescing conductor for an electric lamp, of carbonized fibrous or textile material and of an arch or horseshoe shape, substantially as
hereinbefore set forth. The Supreme Court noted: “It is admitted that the lamp described in the Sawyer and Man patent is no longer in use, and was never a commercial success; that it does not
embody the principle of high resistance with a small illuminating surface.” Getting to the broadness of the Sawyer/Man claim, the Supreme Court stated: “But if woods generally were not adapted to the purpose, and yet the patentee had discovered a wood ossessing certain qualities, which gave it a peculiar fitness for such purpose, it would not constitute an infringement for another to discover and use a different kind of wood, which was found to contain similar or superior qualities.” The court further noted that Sawyer/Man “made a broad claim for every fibrous or textile material, when in fact an examination of over six thousand vegetable growths showed that none of them possessed the peculiar qualities that fitted them for that purpose. Was everybody then precluded by this broad claim from making further investigation? We think not.”
The court noted that Edison “found suitable for his purpose only about three species of bamboo.” After discussing the amount of work Edison did with bamboo, the court asked: The question
really is whether the imperfectly successful experiments of Sawyer and Man, with carbonized paper and wood carbon, conceding all that is claimed for them, authorize them to put under
tribute the results of the brilliant discoveries made by others.”The court brought up the “infringement if later, anticipation if earlier” argument: “if the patent were infringed by the use of any such material, it would be anticipated by proof of the prior use of any such material.”
Although the Supreme Court did not address the issue, there were allegations by Edison at trial that Sawyer/Man had amended their application to conform to Edison’s work: “no such invention
was set forth in the original application, but was introduced for the first time more than four years after it was filed, and after the same material had been used by Edison, and claimed by
him in an application for a patent.” The trial court agreed, saying “after Edison’s inventions on this subject had been published to the world, there was an entire change of base on the part of Sawyer and Man, and that the application was amended to give it an entirely different direction and purpose from what it had in its original form …. [Testimony] shows that the idea of claiming carbons made from fibrous and textile materials was an after-thought, and was no part of the purpose of the original application.”
Of the issue of inventorship, text within the court cases manifests diffidence as to whether Edison was, or was, not the inventor of the light bulb. In 1875, Henry Woodward and Matthew
Evans patented a light bulb, the rights for which were purchased by Edison. In 1878, Joseph Wilson Swan invented a light bulb whose lifetime was about 13.5 hours. Edison’s bulbs in 1880, derived using a filament derived from bamboo, lasted 1200 hours.
The issues in the 1895 case are not unrelated to those in LizardTech v. Earth Resource Mapping, 433 F.3d 1373; 2006 U.S. App. LEXIS 137; 77 U.S.P.Q.2D 1391 (CAFC 2006) and are not
unrelated to issues in the current discussion of alterations in the practice of continuing applications.
[Endnote 13, which appears here in the text, states: 71 Fed. Reg. 48 (Jan. 3, 2006). Abuses of applicants while awaiting developments in similar or parallel technology caused by amending the pending application to cover developments. If the
amendments are covered by the disclosure, this practice is allowed. PIN/NIP, 304 F.3d 1235.]
STEM CELLS
The situation faced by the courts in the 1880’s, in trying to figure out who made the step-out invention with the light bulb, will soon be faced by the courts of the 21st century, in trying to figure out who has made the step-out invention in embryonic stem cells. Although there are presently numerous patent applications on somatic cell nuclear transfer [SCNT] in various phases of generating embryonic stem cells, there are presently questions of scope of invention and of enablement, just as there were in the 19th century. Although many people are now claiming
large, with perhaps limited enablement and written description, the ultimate winner will be the person, who both identifies the insight to make the entire system happen and obtains patent
protection thereon.
UPDATE TO “YOU ONLY LOOK TWICE”
In the November 2005 issue of Intellectual Property Today, I presented some data on continuing applications for FY 2004 from the PTO, and noted the USPTO is evaluating the possibility
of limiting continuations, which crystallized in the Federal Register in January 2006. Two readers from Chicago, Kevin Noonan and Paul Reinfelds, sent along data for FY 2005, and noted, with the small number of “second” continuing applications, that the PTO proposal limiting continuing applications, even if effected, would not likely solve the problem faced by the PTO.
[Endnote 18 stated of the data for FY 2005: There were 63,000 continuing applications, which included 44,500 cons/cips and 18,500 divisionals. Of these, 11,800 were second, or subsequent, applications. Separately, there were 52,000 RCEs, of which 10,000 were second, or subsequent. Thus, 21,800 applications of
384,228, were second or subsequent, which is 5.7%. As for FY2004, RCEs were the single most abundant “continuing” form, 52,000 of 384,228 [13.5%]. All “continuing” forms combined
constituted 115,000 of 384,228 [30%]. The contents of Endnote 18 were cited in comments made to the USPTO about proposed rulemaking in the area of continuing applications:
www.uspto.gov/web/offices/pac/dapp/opla/comments/fpp_continuation/ebert.pdf.
The comments referred to my April 2006 article in Intellectual Property Today, which unknown to me at the time of the comments, was not actually published by Intellectual Property Today. These comments to the USPTO objected to the proposed limitations on second, and subsequent, continuing applications on the basis that, even if implemented, the proposed limitations would NOT resolve the application backlog problem AND separately would adversely impact many reasonable uses of continuing application practice.]
Of Carhart’s book, “Lost Triumph,” the publisher is Putnam, not Putman. Two other reviewers have discussed the novelty of the book, even though the theory about J.E.B. Stuart’s possible
role had been published years before Carhart’s book.
[After March 2006, the Supreme Court decided the case eBay v. MercExchange. Therein, the Supreme Court made clear that entities such as universities and individual inventors, who don't make product, could satisfy the four-factor test and obtain permanent injunctions to bar infringement of their patents.]
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