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Life-work in Engineering of Improved Heart Valve

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Atherogenic Processes & Pathology, Bio Instrumentation in Experimental Life Sciences Research, Bioengineering & reverse engineering design, Biomedical Measurement Science, Cardiac & Vascular Repair Tools Subsegment, Cardiac and Cardiovascular Surgical Procedures, Computational Biology/Systems and Bioinformatics, Discovery process, Ecosystems & Industrial Concentration in the Medical Device Sector, Experimental validation, Frontiers in Cardiology and Cardiovascular Disorders, Historical relevance, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Patents, Personal Health Applications: Tech Innovations serves HealhCare, Technology Advance Assessment of, Valves & Tools, tagged aortic valve leaflets, Percutaneous aortic valve replacement, reverse engineering, TAV, TAVI, Transcatheter Aortic Valve Replacement (TAVR), working life of mechanical implant on July 15, 2014| Leave a Comment »

Life-work in Engineering of Improved Heart Valve

Curator and Reporter: Larry H Bernstein, MD, FCAP

 

An authority and author of the book on cardiovascular valve devices is challenged by patient’s mother to go beyond what is available.  The results are splendid after re-engineering the design to the problem.

 

Reverse Engineering A Human Heart Valve

By Jim Pomager

aortic valve – a remarkable piece of biomechanical engineering

 

 

 

The aortic valve is a remarkable piece of biomechanical engineering. On any given day, the leaflets (or cusps) of a healthy aortic valve will open and close 100,000+ times, allowing the proper amount of blood to flow from the heart to the rest of the body. Over a lifetime, a healthy valve endures more than 3.4 billion heartbeats.

Unfortunately, the aortic valve doesn’t always remain healthy. (What organ does?) According to the American Heart Association, up to 1.5 million people in the United States suffer from aortic stenosis (AS), a calcification of the aortic valve that narrows its opening and restricts blood flow. In the early stages, the disease is often asymptomatic, but as it progresses, it can cause chest pain, weakness, and difficulty breathing. And in approximately 300,000 people worldwide, the condition develops into severe AS, which has a one-year survival rate of approximately 50 percent, if left untreated.

Fortunately, there are treatment options.  The most common and successful is aortic valve replacement (AVR), wherein a mechanical or tissue-based valve is substituted for the diseased valve. For decades, replacement valves were implanted via open heart surgery, which involves an extended hospital stay and months of recovery. But in recent years, a promising new approach has emerged: transcatheter aortic valve implementation (TAVI), also known as transcatheter aortic valve replacement (TAVR). In TAVI, a tissue-based artificial valve is delivered into the diseased heart valve via a blood vessel, rather than through a large incision in the chest.

TAVI has many benefits, the most obvious (and compelling) of which is its noninvasiveness, which means shorter recovery times and faster attainment of quality-of-life outcomes for the patient. Replacement of a transcatheter aortic valve (TAV) can also be a minimally invasive exercise — a second TAV can simply be implanted within the first.

On the other hand, the use of TAVI procedures in U.S. hospitals is not yet widespread (though it is growing rapidly). The longevity of current-generation TAVs also remains unknown because it is an emerging technology, compared to evidence of 15+ years for surgically implanted heart valves. Plus, TAVI is only approved in the U.S. for use in AS patients who are either ineligible for surgical valve replacement or at high risk. (TAVI has been available in Europe since 2007, and clinical trials are underway in the U.S. for its use in intermediate-risk patients.)

What’s really needed is an improved TAV — one that outperforms current transcatheter valves, is as durable as a surgical valve, and operates more like … well, a healthy human aortic valve. Such a valve would open the door to TAVI’s use in the hundreds of thousands of lower-risk (and generally younger) AS patients whose only current option is a surgically implanted valve, and who would rather not have their chest opened.

Now, a man who has dedicated his professional career to studying the aortic valve has invented a new artificial valve design that he says will revolutionize TAVI. And if everything goes according to plan, his TAV will reach European patients in 2015 and U.S. patients soon after. How did he and his startup company design such technology? By reverse engineering the aortic valve.

The Man Behind The Valve

Mano Thubrikar

 

 

 

Mano Thubrikar, quite literally wrote the book on heart valves and heart disease — two of them, in fact. His The Aortic Valve (1989) and Vascular Mechanics and Pathology (2007) are leading textbooks in cardiovascular studies, and the former is widely used as a guide in the design of bioprosthetic heart valves.

After earning an undergraduate degree in metallurgy, a master’s in materials science, and a Ph.D. in biomedical engineering, Dr. Thubrikar spent the first 30 years of his career exclusively in academic research. He studied the aortic valve and bioprostheses from almost every conceivable angle while working at the University of Virginia (UVA) and at the Carolinas Medical Center and the University of North Carolina (UNC) at Charlotte.

But in 2003, Dr. Thubrikar received a phone call that would change the trajectory of his career and set him on the path to develop a novel TAV technology. A woman contacted him to discuss her son, a 35-year-old athlete with a calcified aortic valve. The condition was the result of a bicuspid valve, a congenital condition where the aortic valve has two cusps, rather than the customary three. The man needed a valve replacement, and his only choice was to have a mechanical heart valve surgically implanted. However, the surgical valve meant he would have to stay on anticoagulants for the rest of his life, effectively ending his athletic pursuits. Dr. Thubrikar informed the mother that there just weren’t any treatments available that would allow her son to continue his active lifestyle.

“Didn’t you write the book on the aortic valve?” she asked. “Why didn’t you make a valve that my son could use?”

The conversation and question deeply affected the researcher. “I went home and was so disturbed,” he told me during a recent visit to his office. “I talked to my wife and said, “You know what? Years of research, writing papers, and giving presentations — that’s done. I now need to make a heart valve.”

Soon after, Dr. Thubrikar left Carolinas Medical Center to embark on his new mission. He joined artificial heart valve pioneer Edwards Lifesciences as a Distinguished Scientist, but left after it became clear that the company’s plans for him didn’t align with his own.

So in 2007 — coincidentally, the same year Edwards launched the first commercially available TAV device — Dr. Thubrikar returned to academia, joining the staff at the South Dakota School of Mines & Technology. There he spent the next three years working on a new artificial valve design — one based on decades of research on the physics behind the human aortic valve.

Looking To The Human Body For Design Output
According to Dr. Thubrikar’s research, the natural aortic valve follows four strong design principles for maximum longevity and optimal hemodynamic performance. Those criteria are:

1. A specific coaptation height — When the valve’s three leaflets come together to close the valve, there is some surface-to-surface contact between the leaflets, rather than an edge-to-edge seal. This safety margin helps prevent against blood leakage back into the left ventricle.

2. No folds in the leaflets — Natural aortic valve cusps flex without folding. Folds would crease the tissue and cause unwanted stress on the leaflets, negatively impacting durability.

3. Minimum overall height — Extra height would produce dead space, which can lead to a variety of issues.

4. Minimum leaflet flexion — The human aortic valve manages to open completely with the leaflets moving only 70 degrees, not the 90 degrees you might expect. Again, this improves the valve’s longevity.

“You almost need to be a solid geometry design engineer to understand the math and the equations behind these principles,” he explained. “With these criteria, however, you have design parameters for the aortic valve. The mathematical equations give you the output of how an artificial valve should be designed.”

Dimensions of the natural aortic valve

Dimensions of the natural aortic valve

 

 

Based on these four principles, Dr. Thubrikar reverse engineered the aortic heart valve, developing a new artificial valve design that mimics the aortic valve’s precise geometry. In October 2010, he launched a startup company called Thubrikar Aortic Valve, Inc. to commercialize his new creation, which he calls Optimum TAV and touts as “nature’s valve by design.”

“When someone asks me, ‘How does your valve compare with Edwards’?’ or ‘How does your valve compare with Medtronic’s?’, I say ‘We don’t compare our valve to them,'” Dr. Thubrikar told me. “We compare our valve with the natural aortic valve.”

On the surface, Optimum TAV looks similar to other artificial heart valves on the market, with three leaflets of bovine pericardium tissue mounted on a metal stent-frame. (In fact, the design is often mistaken for another widely used surgical valve.) But according to Dr. Thubrikar, it has a unique combination of features that will help it overcome the major design limitations of current-generation TAVs (if we’re going to compare). Those design limitations include:

• Suture holes in the leaflet body — While all TAVs (including Optimum TAV) are constructed by sewing animal tissue to a metal frame, piercing the flexion zone of the leaflets leads to potential wear. Optimum TAV does not have a single suture hole in the working portion of the leaflet body.
• Blood flow through frame — Some TAV frames are as tall as 5 cm in height, extending up into the aorta once implanted. As a result, blood must pass through the frame to enter the coronary arteries. Proteins in the blood will accumulate on the frame, and can eventually break loose and cause thromboembolisms (blood clots).  Optimum TAV is only 2 cm in height. (Related, the low height of the Thubrikar valve also makes it less likely to require a pacemaker.)
• Thick outer frame — The thicker the frame, the smaller the valve opening will be, allowing less blood to pass through. This opening is referred to as the valve’s EOA, or effective orifice area. The average EOA of a surgical valve is around 1.9 cm², and some TAVs have EOAs as small as 1.5 cm²(technically, a mild form of stenosis). In bench tests, Optimum TAV’s EOA was 2.3 to 2.4 cm². (A healthy aortic valve has an EOA of approximately 2.7 cm².)
• Clipped calcified leaflets — Some current TAVs are anchored to the patient’s original valve using a paper-clip like mechanism. In this design, there is the potential that the TAVs leaflets will come into contact with the old, calcified leaflets during the operation, causing wear. Optimum TAV’s design eliminates the possibility of contact between the leaflets and native valve.
• Paravalvular leakage — In some cases, a space forms between the outside of a TAV and the surrounding heart tissue, and blood can leak through. Optimum TAV has a high skirt to prevent this type of gap from developing. In addition, Optimum TAV’s novel frame architecture allows it to conform to and seal off either a round or elliptical annulus (the ring-shaped base of the original valve). This is particularly helpful in minimizing or eliminating leakage in bicuspid patients, who often have an irregularly shaped annulus.
• Balloon expansion — TAV frames made of stainless steel must be forced open by a balloon. The TAV’s tissue can get caught between the balloon and the frame and potentially tear. Optimum TAV’s frame is made of nitinol, which automatically expands once deployed from the catheter.

 

optimum TAV

 

 

Optimum TAV

“Other technologies have built-in issues,” Dr. Thubrikar said. “To be able to avoid those problems in a comprehensive fashion is no small feat.”

Trial By Fire
During the two and a half years following the establishment of Thubrikar Aortic Valve, Optimum TAV seemed to be moving steadily toward market. The company raised enough funding to get started, primarily from friends, family, physicians, entrepreneurs, and technology industry executives. Patent applications were filed, suppliers were selected, valves were painstakingly produced (by hand, over one-and-a-half to two days each), and preclinical testing began.

Members of the Thubrikar Aortic Valve team

 

 

Members of the Thubrikar Aortic Valve team (left to right): Deodatt Wadke, member of the board of directors and cofounder; Samir Wadke, executive director of business development and cofounder; Dr. Mano Thubrikar, president and founder; Samuel Evans, research engineer II; and Nikhil Heble, counsel, secretary, and cofounder

But the fledgling company was dealt a major setback in April 2013, when a fire destroyed the Horsham, Pa. office building to which the Thubrikar Aortic Valve laboratory had recently relocated (from South Dakota). All of its equipment was destroyed and needed to be replaced. The company had to relocate to nearby Norristown, Pa. Not an ideal scenario for a startup trying to make the most of extremely limited resources.

The company was undeterred by the fire, and the last year has been a successful one for Thubrikar. The company completed most of its preclinical testing (including implants in 12 animals and two diseased human cadaver hearts), reached design freeze on Optimum TAV, filed a provisional patent application for its proprietary delivery catheter, and achieved almost $2 million in total funding. Perhaps the biggest milestone came in August 2013, when Optimum TAV met the International Organization for Standardization’s (ISO’s) durability requirements by surpassing 200 million cycles in a third-party ISO certified laboratory.

The durability testing has continued, and Optimum TAV continues to function beyond 390 million cycles, which approximates 11 years in vivo. Surgical valves typically last anywhere from 12 to 18 years, and Thubrikar expects his valve to last at least that long.

“I would not be surprised if it surpasses the longevity of even the surgical valve,” he said.

The company also received its first institutional investment, from Delaware Crossing Investor Group (DCIG), in 2014. The primary DCIG investor, Marv Woodall, led the commercialization of the world’s first stents as president of Johnson & Johnson Interventional Systems (now Cordis) and was on the board of director of the first TAV company, Percutaneous Valve Technologies (PVT, now part of Edwards Lifesciences). Thubrikar has recruited him as its business advisor.

What Lies Ahead
Like many other developers of novel medical devices, Thubrikar Aortic Valve has decided to take its product to market through Europe initially, given European regulators’ comfort level with TAV and the FDA’s steep requirement for clinical trials. “We have spoken to the FDA and will continue to do so on a regular basis,” according to Dr. Thubrikar. “But they asked for a lot more preclinical testing than the European Notified Bodies to start a clinical trial.”

The company is now working to raise an additional $2 million to $10 million, and expects the granting of its patent for Optimum TAV in 2014. The finances will enable Thubrikar to not only conduct a first-in-human (FIH) feasibility study in up to 15 patients this year, but also to expand to a full European clinical trial of about 65 additional patients in 2015. If all goes well, a 2015 CE Mark for Optimum TAV isn’t out of the question.

However, trial success is vital, since today’s investors — and large companies in search of technology acquisitions — wait for significant clinical data to accumulate before backing a medical device. “We realize that until we actually implant the valve in a patient, other companies will think, ‘You don’t know what can go wrong,'” Dr. Thubrikar explained. “We had one big company say, ‘We will pay you four times as much once the product is in a patient.’ They want you to de-risk everything, to work out all the bugs yourself on your own dime.”

Yet Dr. Thubrikar thinks its only a matter of time until his life’s work finally arrives in the hands of interventional cardiologists, who he said have been “knocking at his door” since he first presented a paper on the technology in 2012. Since then, he has spoken at several of the largest interventional cardiology conferences, and word continues to spread about Optimum TAV. Like many other researchers-turned-entreprenuers, he steadfastly believes that his invention will eventually reach the market, where it can begin helping patients — like the one whose mother contacted him a decade ago.

“If hell freezes over, if we don’t get any money, I don’t care,” he said. “I don’t care how it happens. We are going to make a heart valve. That’s the only mission in my life.”

For more information on Thubrikar Aortic Valve and Optimum TAV, visit http://tavi.us/.

 

 

 

 

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USPTO Guidance On Patentable Subject Matter

Posted in Academic Publishing, Advanced Drug Manufacturing Technology, Bio Instrumentation in Experimental Life Sciences Research, Biomarkers & Medical Diagnostics, Biomedical Measurement Science, Cancer Screening, Cardiac & Vascular Repair Tools Subsegment, Clinical Diagnostics, Computational Biology/Systems and Bioinformatics, Curation, Diagnostic Immunology, Drug Delivery Platform Technology, Ecosystems & Industrial Concentration in the Medical Device Sector, Experimental validation, FDA Regulatory Affairs, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Health Law & Patient Safety, HealthCare IT, Imaging-based Cancer Patient Management, Immunodiagnostics, Infectious Disease Immunodiagnostics, Innovation in Immunology Diagnostics, Innovations in Neurophysiology & Neuropsychology, Intellectual Property, Innovations, Commercialization, Investment in technological breakthrough, International Global Work in Pharmaceutical, ISO 10993 for Product Registration: FDA & CE Mark for Development of Medical Devices and Diagnostics, Mass automation of plasma proteins, Mechanical Assist Devices: LVAD, RVAD, BiVAD, Artificial Heart, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Mitral Valve: Repair and Replacement, Monoclonal Immunotherapy, Nanotechnology for Drug Delivery, Open Access Journals, Patents, PCI, Pharmaceutical Discovery, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Pharmacotherapy of Cardiovascular Disease, Prescription Drugs Costs, Rapid automation of plasma protein pools, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Statistical Methods for Research Evaluation, Stents & Tools, Technology Advance Assessment of, Technology Capital Expenses, Technology Transfer: Biotech and Pharmaceutical, Valves & Tools, tagged Clinical trial, FDA, FDA innovation route, gene, gene expression, gene patents, genomics, Innovation, Innovation Act, innovative applications, mutation, nanotechnology, research, science, tachnology protection, Therapeutic innovations, US Supreme Court, USPTO on July 3, 2014| Leave a Comment »

USPTO Guidance On Patentable Subject Matter

Curator and Reporter: Larry H Bernstein, MD, FCAP

LH Bernstein

 

 

 

 

 

 

Revised 4 July, 2014

http://pharmaceuticalintelligence.com/2014/07/03/uspto-guidance-on-patentable-subject-matter

 

I came across a few recent articles on the subject of US Patent Office guidance on patentability as well as on Supreme Court ruling on claims. I filed several patents on clinical laboratory methods early in my career upon the recommendation of my brother-in-law, now deceased.  Years later, after both brother-in-law and patent attorney are no longer alive, I look back and ask what I have learned over $100,000 later, with many trips to the USPTO, opportunities not taken, and a one year provisional patent behind me.

My conclusion is

(1) that patents are for the protection of the innovator, who might realize legal protection, but the cost and the time investment can well exceed the cost of startup and building a small startup enterprize, that would be the next step.

(2) The other thing to consider is the capability of the lawyer or firm that represents you.  A patent that is well done can be expected to take 5-7 years to go through with due diligence.   I would not expect it to be done well by a university with many other competing demands. I might be wrong in this respect, as the climate has changed, and research universities have sprouted engines for change.  Experienced and productive faculty are encouraged or allowed to form their own such entities.

(3) The emergence of Big Data, computational biology, and very large data warehouses for data use and integration has changed the landscape. The resources required for an individual to pursue research along these lines is quite beyond an individuals sole capacity to successfully pursue without outside funding.  In addition, the changed designated requirement of first to publish has muddied the water.

Of course, one can propose without anything published in the public domain. That makes it possible for corporate entities to file thousands of patents, whether there is actual validation or not at the time of filing.  It would be a quite trying experience for anyone to pursue in the USPTO without some litigation over ownership of patent rights. At this stage of of technology development, I have come to realize that the organization of research, peer review, and archiving of data is still at a stage where some of the best systems avalailable for storing and accessing data still comes considerably short of what is needed for the most complex tasks, even though improvements have come at an exponential pace.

I shall not comment on the contested views held by physicists, chemists, biologists, and economists over the completeness of guiding theories strongly held.  Only history will tell.  Beliefs can hold a strong sway, and have many times held us back.

I am not an expert on legal matters, but it is incomprehensible to me that issues concerning technology innovation can be adjudicated in the Supreme Court, as has occurred in recent years. I have postgraduate degrees in  Medicine, Developmental Anatomy, and post-medical training in pathology and laboratory medicine, as well as experience in analytical and research biochemistry.  It is beyond the competencies expected for these type of cases to come before the Supreme Court, or even to the Federal District Courts, as we see with increasing frequency,  as this has occurred with respect to the development and application of the human genome.

I’m not sure that the developments can be resolved for the public good without a more full development of an open-access system of publishing. Now I present some recent publication about, or published by the USPTO.

DR ANTHONY MELVIN CRASTO

Dr. Melvin Castro – Organic Chemistry and New Drug Development

 

 

 

 

 

 

 

 

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• patentimages.storage.goog…
• organic-chemistry.org/abs…
• google.co.in/patents/US75…

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USPTO Guidance On Patentable Subject Matter: Impediment to Biotech Innovation

Joanna T. Brougher, David A. Fazzolare J Commercial Biotechnology 2014 20(3):Brougher

jcbiotech-patents

 

 

 

 

 

 

 

 

 

 

 

Abstract In June 2013, the U.S. Supreme Court issued a unanimous decision upending more than three decades worth of established patent practice when it ruled that isolated gene sequences are no longer patentable subject matter under 35 U.S.C. Section 101.While many practitioners in the field believed that the USPTO would interpret the decision narrowly, the USPTO actually expanded the scope of the decision when it issued its guidelines for determining whether an invention satisfies Section 101.

The guidelines were met with intense backlash with many arguing that they unnecessarily expanded the scope of the Supreme Court cases in a way that could unduly restrict the scope of patentable subject matter, weaken the U.S. patent system, and create a disincentive to innovation. By undermining patentable subject matter in this way, the guidelines may end up harming not only the companies that patent medical innovations, but also the patients who need medical care.  This article examines the guidelines and their impact on various technologies.

Keywords:   patent, patentable subject matter, Myriad, Mayo, USPTO guidelines

Full Text: PDF

References

35 U.S.C. Section 101 states “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

” Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 566 U.S. ___ (2012)

Association for Molecular Pathology et al., v. Myriad Genetics, Inc., 569 U.S. ___ (2013).

Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95, 103 (C.C.S.D.N.Y. 1911)

USPTO. Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products.

http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf

Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948)

USPTO. Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products.

http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf

Courtney C. Brinckerhoff, “The New USPTO Patent Eligibility Rejections Under Section 101.” PharmaPatentsBlog, published May 6, 2014, accessed http://www.pharmapatentsblog.com/2014/05/06/the-new-patent-eligibility-rejections-section-101/

Courtney C. Brinckerhoff, “The New USPTO Patent Eligibility Rejections Under Section 101.” PharmaPatentsBlog, published May 6, 2014, accessed http://www.pharmapatentsblog.com/2014/05/06/the-new-patent-eligibility-rejections-section-101/

DOI: http://dx.doi.org/10.5912/jcb664

 

Science 4 July 2014; 345 (6192): pp. 14-15  DOI: http://dx.doi.org/10.1126/science.345.6192.14

• IN DEPTH

INTELLECTUAL PROPERTY

Biotech feels a chill from changing U.S. patent rules

1. Kelly Servick*

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A 2013 Supreme Court decision that barred human gene patents is scrambling patenting policies.

PHOTO: MLADEN ANTONOV/AFP/GETTY IMAGES

A year after the U.S. Supreme Court issued a landmark ruling that human genes cannot be patented, the biotech industry is struggling to adapt to a landscape in which inventions derived from nature are increasingly hard to patent. It is also pushing back against follow-on policies proposed by the U.S. Patent and Trademark Office (USPTO) to guide examiners deciding whether an invention is too close to a natural product to deserve patent protection. Those policies reach far beyond what the high court intended, biotech representatives say.

“Everything we took for granted a few years ago is now changing, and it’s generating a bit of a scramble,” says patent attorney Damian Kotsis of Harness Dickey in Troy, Michigan, one of more than 15,000 people who gathered here last week for the Biotechnology Industry Organization’s (BIO’s) International Convention.

At the meeting, attorneys and executives fretted over the fate of patent applications for inventions involving naturally occurring products—including chemical compounds, antibodies, seeds, and vaccines—and traded stories of recent, unexpected rejections by USPTO. Industry leaders warned that the uncertainty could chill efforts to commercialize scientific discoveries made at universities and companies. Some plan to appeal the rejections in federal court.

USPTO officials, meanwhile, implored attendees to send them suggestions on how to clarify and improve its new policies on patenting natural products, and even announced that they were extending the deadline for public comment by a month. “Each and every one of you in this room has a moral duty … to provide written comments to the PTO,” patent lawyer and former USPTO Deputy Director Teresa Stanek Rea told one audience.

At the heart of the shake-up are two Supreme Court decisions: the ruling last year in Association for Molecular Pathology v. Myriad Genetics Inc. that human genes cannot be patented because they occur naturally (Science, 21 June 2013, p. 1387); and the 2012 Mayo v. Prometheus decision, which invalidated a patent on a method of measuring blood metabolites to determine drug doses because it relied on a “law of nature” (Science, 12 July 2013, p. 137).

Myriad and Mayo are already having a noticeable impact on patent decisions, according to a study released here. It examined about 1000 patent applications that included claims linked to natural products or laws of nature that USPTO reviewed between April 2011 and March 2014. Overall, examiners rejected about 40%; Myriad was the basis for rejecting about 23% of the applications, and Mayo about 35%, with some overlap, the authors concluded. That rejection rate would have been in the single digits just 5 years ago, asserted Hans Sauer, BIO’s intellectual property counsel, at a press conference. (There are no historical numbers for comparison.) The study was conducted by the news service Bloomberg BNA and the law firm Robins, Kaplan, Miller & Ciseri in Minneapolis, Minnesota.

USPTO is extending the decisions far beyond diagnostics and DNA?

The numbers suggest USPTO is extending the decisions far beyond diagnostics and DNA, attorneys say. Harness Dickey’s Kotsis, for example, says a client recently tried to patent a plant extract with therapeutic properties; it was different from anything in nature, Kotsis argued, because the inventor had altered the relative concentrations of key compounds to enhance its effect. Nope, decided USPTO, too close to nature.

In March, USPTO released draft guidance designed to help its examiners decide such questions, setting out 12 factors for them to weigh. For example, if an examiner deems a product “markedly different in structure” from anything in nature, that counts in its favor. But if it has a “high level of generality,” it gets dinged.

The draft has drawn extensive criticism. “I don’t think I’ve ever seen anything as complicated as this,” says Kevin Bastian, a patent attorney at Kilpatrick Townsend & Stockton in San Francisco, California. “I just can’t believe that this will be the standard.”

USPTO officials appear eager to fine-tune the draft guidance, but patent experts fear the Supreme Court decisions have made it hard to draw clear lines. “The Myriad decision is hopelessly contradictory and completely incoherent,” says Dan Burk, a law professor at the University of California, Irvine. “We know you can’t patent genetic sequences,” he adds, but “we don’t really know why.”

Get creative in using Draft Guidelines!

For now, Kostis says, applicants will have to get creative to reduce the chance of rejection. Rather than claim protection for a plant extract itself, for instance, an inventor could instead patent the steps for using it to treat patients. Other biotech attorneys may try to narrow their patent claims. But there’s a downside to that strategy, they note: Narrower patents can be harder to protect from infringement, making them less attractive to investors. Others plan to wait out the storm, predicting USPTO will ultimately rethink its guidance and ease the way for new patents.

 

Public comment period extended

USPTO has extended the deadline for public comment to 31 July, with no schedule for issuing final language. Regardless of the outcome, however, Stanek Rea warned a crowd of riled-up attorneys that, in the world of biopatents, “the easy days are gone.”

 

United States Patent and Trademark Office

Today we published and made electronically available a new edition of the Manual of Patent Examining Procedure (MPEP). Manual of Patent Examining Procedure uspto.gov http://www.uspto.gov/web/offices/pac/mpep/index.html Summary of Changes

PDF Title Page
PDF Foreword
PDF Introduction
PDF Table of Contents
PDF Chapter 600 –
PDF   Parts, Form, and Content of Application Chapter 700 –
PDF    Examination of Applications Chapter 800 –
PDF   Restriction in Applications Filed Under 35 U.S.C. 111; Double Patenting Chapter 900 –
PDF   Prior Art, Classification, and Search Chapter 1000 –
PDF  Matters Decided by Various U.S. Patent and Trademark Office Officials Chapter 1100 –
PDF   Statutory Invention Registration (SIR); Pre-Grant Publication (PGPub) and Preissuance Submissions Chapter 1200 –
PDF    Appeal Chapter 1300 –
PDF   Allowance and Issue Appendix L –
PDF   Patent Laws Appendix R –
PDF   Patent Rules Appendix P –
PDF   Paris Convention Subject Matter Index 
PDF Zipped version of the MPEP current revision in the PDF format.

Manual of Patent Examining Procedure (MPEP)Ninth Edition, March 2014

The USPTO continues to offer an online discussion tool for commenting on selected chapters of the Manual. To participate in the discussion and to contribute your ideas go to:
http://uspto-mpep.ideascale.com.

Manual of Patent Examining Procedure (MPEP) Ninth Edition, March 2014
The USPTO continues to offer an online discussion tool for commenting on selected chapters of the Manual. To participate in the discussion and to contribute your ideas go to: http://uspto-mpep.ideascale.com.

Note: For current fees, refer to the Current USPTO Fee Schedule.
Consolidated Laws – The patent laws in effect as of May 15, 2014. Consolidated Rules – The patent rules in effect as of May 15, 2014.  MPEP Archives (1948 – 2012)
Current MPEP: Searchable MPEP

• See the user manual or quick reference guide for help with search features (e.g., default operators, proximity searches, and wild cards) and navigation.

The documents updated in the Ninth Edition of the MPEP, dated March 2014, include changes that became effective in November 2013 or earlier.
All of the documents have been updated for the Ninth Edition except Chapters 800, 900, 1000, 1300, 1700, 1800, 1900, 2000, 2300, 2400, 2500, and Appendix P.
More information about the changes and updates is available from the “Blue Page – Introduction” of the Searchable MPEP or from the “Summary of Changes” link to the HTML and PDF versions provided below. Discuss the Manual of Patent Examining Procedure (MPEP) Welcome to the MPEP discussion tool!

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We have some great news! Chapters 1300, 1500, 1600 and 2400 of the MPEP are now available for discussion. Please submit any ideas and comments you may have on these chapters. Also, don’t forget to vote on ideas and comments submitted by other users. As before, our editorial staff will periodically be posting proposed new material for you to respond to, and in some cases will post responses to some of the submitted ideas and comments.Recently, we have received several comments concerning the Leahy-Smith America Invents Act (AIA). Please note that comments regarding the implementation of the AIA should be submitted to the USPTO via email t aia_implementation@uspto.gov or via postal mail, as indicated at the America Invents Act Web site. Additional information regarding the AIA is available at www.uspto.gov/americainventsact  We have also received several comments suggesting policy changes which have been routed to the appropriate offices for consideration. We really appreciate your thinking and recommendations!

• 800 Restriction in Applications Filed Under 35 U.S.C. 111; Double Patenting
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• 1100 Statutory Invention Registration (SIR); Pre-Grant Publication (PGPub) and Preissuance Submissions
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• 1300 Allowance and Issue

FDA Guidance for Industry:Electronic Source Data in Clinical Investigations

Electronic Source Data

 

 

 

 

 

 

 

The FDA published its new Guidance for Industry (GfI) – “Electronic Source Data in Clinical Investigations” in September 2013.
The Guidance defines the expectations of the FDA concerning electronic source data generated in the context of clinical trials. Find out more about this Guidance.
http://www.gmp-compliance.org/enews_4288_FDA%20Guidance%20for%20Industry%3A%20Electronic%20Source%20Data%20in%20Clinical%20Investigations
_8534,8457,8366,8308,Z-COVM_n.html

After more than 5 years and two draft versions, the final version of the Guidance for Industry (GfI) – “Electronic Source Data in Clinical Investigations” was published in September 2013. This new FDA Guidance defines the FDA’s expectations for sponsors, CROs, investigators and other persons involved in the capture, review and retention of electronic source data generated in the context of FDA-regulated clinical trials.In an effort to encourage the modernization and increased efficiency of processes in clinical trials, the FDA clearly supports the capture of electronic source data and emphasizes the agency’s intention to support activities aimed at ensuring the reliability, quality, integrity and traceability of this source data, from its electronic source to the electronic submission of the data in the context of an authorization procedure. The Guidance addresses aspects as data capture, data review and record retention. When the computerized systems used in clinical trials are described, the FDA recommends that the description not only focus on the intended use of the system, but also on data protection measures and the flow of data across system components and interfaces. In practice, the pharmaceutical industry needs to meet significant requirements regarding organisation, planning, specification and verification of computerized systems in the field of clinical trials. The FDA also mentions in the Guidance that it does not intend to apply 21 CFR Part 11 to electronic health records (EHR). Author: Oliver Herrmann Q-Infiity Source: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM328691.pdf Webinar: https://collaboration.fda.gov/p89r92dh8wc

 

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