Posts Tagged ‘Innovation’

USPTO Guidance On Patentable Subject Matter

USPTO Guidance On Patentable Subject Matter

Curator and Reporter: Larry H Bernstein, MD, FCAP

LH Bernstein

LH Bernstein







Revised 4 July, 2014



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. Melvin Castro - Organic Chemistry and New Drug Development

Dr. Melvin Castro – Organic Chemistry and New Drug Development









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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














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


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.


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.


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


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

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


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:

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

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!

We have received many thoughtful ideas on Chapters 100-600 and 1800 of the MPEP as well as on how to improve the discussion site. Each and every idea submitted by you, the participants in this conversation, has been carefully reviewed by the Office, and many of these ideas have been implemented in the August 2012 revision of the MPEP and many will be implemented in future revisions of the MPEP. The August 2012 revision is the first version provided to the public in a web based searchable format. The new search tool is available at http://mpep.uspto.gov. We would like to thank everyone for participating in the discussion of the MPEP.

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!

FDA Guidance for Industry:Electronic Source Data in Clinical Investigations

Electronic Source Data

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.

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/
Webinar: https://collaboration.fda.gov/p89r92dh8wc


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Tycho Brahe, where art thou? Today’s Renaissance of the Self-Funded Scientist!

Curator: Stephen J. Williams, Ph.D.

Every scientist usually can describe an event or an admired historical figure as their pivotal point of inspiration which led them to embark on a scientific career.

I will admit there were two points of inspiration: the first was Jacques Cousteau while watching his program Undersea World of Jacques Cousteau.

The other (and please don’t laugh) was reading about the intellectual duel and collaboration between two of the greats in astronomy and mathematics: Tycho Brahe and Johannes Kepler, two historical figures responsible for our modern-day understanding of the universe and planetary motion.  For some reason I had romanticized the study of science, envisioning days in the laboratory wearing renaissance garb while striking medieval vogue poses (just kidding). But back then, accurately determining planetary motions and mapping the stars was a real big deal, as trade ships would rely on the positioning of stars as their heavenly GPS system.  Otherwise you might be trying to establish a new trade route to India and wind up somewhere… say America.


Tycho Brahe (1546-1601; born Tyge Ottesen Brahe) was a Danish nobleman and scientist who made the most accurate measurement of planetary motion and positioning of the stars, which enabled another great astronomer, Johannes Kepler, to deduce the laws of planetary orbits.  His measurements allowed Kepler to prove Copernicus’s sun centered theory (Earth revolves around the sun). An interesting history of Brahe, The crazy life and crazier death of Tycho Brahe, history’s strangest astronomer, gives some in-depth look at this intriguing historical figure.

Now back then science, as is the case now, costs money; and the two ways to get that money was either find a wealthy backer (like a king) or have a rich uncle who leaves a great inheritance.  Well Tycho did have a rich uncle who left him a lot of money, but instead of just sitting around spending it on jewelry, he used a great portion of his inheritance to build his 1st observatory to make his important measurements and also discover a supernova (published in De Nova Stella), breaking the dogma at the time that stars never changed their appearance or position.

(Photo Credit: Wikipedia)

There have been other examples of self-funded scientists including:

i.            Luther Burbank (b:1845) who led the way for plant genetics.  After developing the Burbank potato he used the money from his nursery business to buy a farm to conduct plant breeding experiments

ii.            Dr. Edward Jenner who used his own funds to develop the first smallpox vaccine and later awarded money from Parliament for his development

iii.            Ritu Levi Montalcini, M.D.:  Dr. Montalcini discovered nerve growth factor together with Stanley Cohen (both awarded Nobel Prize).  After earning an MD in Turin, Italy in 1938 she was unable to work as Mussolini banned Jews from holding professional positions.  So she moved to Belgium but when the Nazi’s took over she fled back to Turin and made a secret lab to study the development of neurons in chick embryos.

Now as many government science budgets are tightening some scientist are returning to self-funding and alternative models in order to continue their research.

The Ronin Institute

One such example is the Ronin Institute, founded by Dr. Jon Wilkins, Ph.D., where scientists who may not have institutional support, band together in a sort of virtual Institute which supports publication and grantsmanship.  The mission and values of the Ronin Institute (which can be found here) includes creating new models for the conducting, funding, collaboration, and dissemination of scholarly research to get researchers back to what they do best: RESEARCH.

A wonderful and inspiring article, written by Samuel Arbesman and co-authored by Jon Wilkens, can be found in Wired magazine.

The following is an excerpt from the article about independent researchers:

One of us (Jon Wilkins), has set out to promote and support independent scholarly research through the founding of the Ronin Institute. The Ronin Institute acts as an aggregator for the fractional scholars of the world, providing an institutional affiliation, connection with other fractional scholars, and support for conference travel and grant applications.

When people are doing something that they are passionate about, they work harder and produce a better product. Thus, underemployed scholars represent in some sense a good that is currently trading well below its actual value. By providing a mechanism for those who wish to conduct research, we can allow these people to engage in their passions while growing the base of scholarly knowledge, which in turn has the potential to create further economic growth.

Through the Ronin Institute, we will be harnessing the skills and talents of thousands of underemployed researchers.

Some more articles on the Ronin Institute can be found on their site at http://ronininstitute.org/press/

Two other great articles on “gentlemen scientists” or self-funding scientists can be found at the Singular Scientist blog post entitled “Self-Funding in Science” and a 1998 Science article by Jon Cohen entitled Scientists Who Fund Themselves.  In each case, scientists felt freed up from the financial overhead accompanied with big institutions and realized more time for their research.

Alternate Funding Source: CROWDSOURCING

The passage of the JOBS act has relieved some of the pressures off obtaining funding for companies through crowdfunding mechanisms.  Scientists are also turning to crowdsourcing mechanisms to fund their research.  An article in the Washington Times (Scientists discover ‘crowdfunding’ as a way of replacing research grants) highlights some of the successes and science-related crowdfunding sites that exist.

Science-related Crowdfunding sites include:

i.            Rockethub

ii.            SciFund Challenge

iii.            Microryza

iv.            Kickstarter

v.            Petridish.org

Digital Tools and Lab Space for the Self-Funding Scientist

Dr. Elizabeth Iorns, breast cancer researcher and founder and CEO of Science Exchange, an online marketplace for ordering science experiments from various nationwide and worldwide labs, explains in a three-part Nature blog post “Research 2.0.1: The future of research funding” how the traditional government-based grant-funding model may transition into a more crowdfunding model.  For example Science Exchange allows you to order common laboratory procedures (for example immunohistochemistry or bioinformatics analysis or gene sequencing) from a list of participating labs in the marketplace.  Prices are usually reasonably priced.

Finding Lab Space: Biohacker Labs

The last piece of the puzzle is finding rented space and equipment to do research.  A new type of laboratory space, small, nimble, and priced and equipped to fit the independent researcher is cropping up.  Termed biohacker labs or hackubators, these small rented communal spaces are different from the traditional bio-incubators or science centers which sprang up decades ago to foster the biotech revolution.  This phenomenon is explained quite nicely in a Science article by Virginia Gewen “Biotechnology: Independent Streak”.  These spaces can go for $100-400 a month, much less than $900 a month for incubator space. Most of the investigators highlighted in the article get funds through crowdsourcing.

One such hackubator lab is Bio, Tech and Beyond, a DIY lab in San Diego which supports numerous projects using 3D printing, cell culture, and sequencing.  These type of DIY biolabs are springing up all over, based on the idea from tech hacker DIY labs, although before the expense seemed to be the limiting factor.  Now it appears the internet is once again revolutionizing another industry, namely that of the independent bio researcher

…. Sans the 16th century fashion (what a shame!)

Other posts on this site about Science Funding, Crowdsourcing, and Open Innovation include:

10 heart-focused apps & devices are crowdfunding for American Heart Association’s open innovation challenge

Importance of Funding Replication Studies: NIH on Credibility of Basic Biomedical Studies

Digital Health: SXSW Interactive 2014, March 9, 2014, Startup Village, Hilton Austin Downtown, 4th Floor


Fourth Annual QPrize Competition to Fund the World’s Next Groundbreaking Startups by Qualcomm Ventures

Gamification of Genomics and Proteomics Research

Collaborations and Open Access Innovations – CHI, BioIT World, 4/29 – 5/1/2014, Seaport World Trade Center, Boston

The Fatal Self Distraction of the Academic Publishing Industry: The Solution of the Open Access Online Scientific Journals

e-Recognition via Friction-free Collaboration over the Internet: “Open Access to Curation of Scientific Research”

Investing and inventing: Is the Tango of Mars and Venus Still on

2013 Genomics: The Era Beyond the Sequencing of the Human Genome: Francis Collins, Craig Venter, Eric Lander, et al.

conceived: NEW Definition for Co-Curation in Medical Research

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Innovation: Drug Discovery, Medical Devices and Digital Health

Curator:  Larry H. Bernstein, MD, FCAP

The following discussuions are related to postings presenting on innovation by Dr. Aviva Lav-Ari.   It is painfull on this week that the Federal Funding for research necessary for maintaining a fruitful and dominant position of US universities and scientific organizations is hanging on the vine.  What resources will be available to ripen the fruit?  Despite the serious fracturing of serious issues debated in the republican “Tea Parrty” led House of Representatives, The actual productivity of scientific discovery has increased with falling budgets since the Vietnam War, mainly because of great postdocs and great mentoring – in both “ivy league”, fluorishing non-ivy league (Duke, Vanderbilt, University of Chicago),  and strong state and land-grant universities.  The difference now is that states are struggling with budgets and the decline of municipalities, and research is no longer an individual exploring an idea because of the need for many scientists with different technologies and different approaches to collaborate, across worldwide and state borders.  Michelangelo as an example.  3-D printing revolution.

This Will Save Us Years — Lean LaunchPad for Life Science Oct 14, 2013

Steve Blank
Part 1 of this post described the issues in the drug discovery. Part 2 covered medical devices and digital health. Part 3 described what we’re going to do about it.

This is post is a brief snapshot of our progress.

Vitruvian is one of the 28 teams in the class. The team members are:

Dr. Hobart Harris Chief of General Surgery, Vice-Chair of the Department of Surgery, and a Professor of Surgery at UCSF. Dr. Harris is also a Principal Investigator in the UCSF Surgical Research Laboratory at San Francisco General Hospital.
Dr. David Young, Professor of Plastic Surgery at UCSF. His area of expertise includes wound healing, microsurgery, and reconstruction after burns and trauma. His research interests include the molecular mechanisms of wound healing and the epidemiology and treatment of soft tissue infections.
Sarah Seegal is at One Medical.  Sarah is interested in increasing the quality and accessibility of healthcare services. Sarah worked with Breakthrough.com to connect individuals with professional therapists for online sessions.
Cindy Chang is an Enzymologist investigating novel enzymes involved in biofuel and chemical synthesis in microbes at LS9

Vitruvian’s first product, MyoSeal, promotes wound repair via biocompatible microparticles plus a fibrin tissue sealant that has been shown to prevent incisional hernias through enhanced wound healing. The team believed that surgeons would embrace the product and pay thousands to use it. In week 2 of the class 14 of their potential customers (surgeons) told the team otherwise.
Watch and find out how the Lean LaunchPad class saved them years.

10d0de1 Vitruvian Man by Leonardo da Vinci
Image: A derived drawing from Vitruvian Man by Leonardo da Vinci, via Wikimedia Commons

Lessons Learned – Get out of the building
Read more Steve Blank posts at http://www.steveblank.com

What Michelangelo Can Teach Us about Innovation and Competition

Daniel Burrus  Oct 14, 2013

On a recent trip to Italy I had the opportunity to visit both Florence and Rome, and to see the work of some of history’s greatest artists, including Michelangelo.
In Florence, I saw David, Michelangelo’s amazing sculpture. I also refreshed my memory about the history of that sculpture which is a great story of innovation, courage, and reinvention. Historians have well documented the fact that Michelangelo was very competitive with other artists. When other sculptures looked at the large piece of marble that was selected for this sculpture that was being commissioned, they decided it was not a good piece of marble and would be too difficult to work with. So they passed on it.
But not Michelangelo. He said he could do it and he took it on. At that moment, he began to separate himself from the competition and he began his strategy to redefine sculpting. Therefore, he became the competition.
And that’s what business needs to do. In Michelangelo’s case, all of the depictions of David in the David and Goliath story, up to that point, depicted David as a very young boy. And, of course, he was clothed. Additionally, all of the sculptures up to that point were human-sized or slightly bigger. They weren’t overly large.
So Michelangelo did something very different from his peers. He did the opposite and created a 17-foot tall David, made him an adult, and kept him unclothed. The only thing he had with him was his slingshot to get Goliath.
After working each day on David, he would study cadavers to learn more of how the human body worked. Taking what he learned and applying it to his work, he became the first sculptor to show veins and arteries and detailed muscle structures.
The result, of course, was absolute mastery. Anyone who has ever seen David understands that.
Michelangelo changed everyone’s view. He redefined what sculpting was about and set a new standard. In other words, he went beyond the competition.
Years passed and Michelangelo had done some drawings and some paintings, but he considered himself, first and foremost, a sculptor. However, the Pope decided that he wanted Michelangelo to paint the ceiling of the Sistine Chapel. Interestingly, Michelangelo didn’t want to do it because he considered himself a sculptor. In a note to the Pope, Michelangelo even signed it, “The Sculptor, Michelangelo,” pointing out the fact that he wasn’t a painter; he was a sculptor. When the Pope wouldn’t take “no” for an answer, Michelangelo left Rome.
The Pope sent guards to get him and bring him back, essentially forcing him into painting the Sistine Chapel. So Michelangelo reluctantly agreed.
At that time, all of his competition was painting pictures in 2D. In other words, paintings were flat with no depth to them.
Anyone who has ever seen the ceiling of the Sistine Chapel knows that Michelangelo, once again, redefined what art was by putting in amazing—even by today’s standards—depth and 3D effects. Essentially, he once again went beyond the competition. As a matter of fact, while he was working on the Sistine Chapel, other great artists of the day would sneak in during Michelangelo’s breaks just to look at his techniques. They were floored, literally, by what he was doing. And from that point on, other artists started to incorporate depth and 3D techniques into their paintings.
So what’s the moral of the story? Look at what your competition is doing … and don’t do that. Why? Because they are already doing it.
Instead, raise the bar. Look at what the best of the best are doing … and then go beyond them. Think bigger. Don’t compete. Create. Innovate.
DANIEL BURRUS is considered one of the world’s leading technology forecasters and innovation experts, and is the founder and CEO of Burrus Research, a research and consulting firm that monitors global advancements in technology driven trends to help clients understand how technological, social and business forces are converging to create enormous untapped opportunities. He is the author of six books including The New York Times best seller Flash Foresight.

3D Printing Is Turning the Impossible Into the Possible

Daniel Burrus      Aug 22, 2013

1299592  3-D Printing

Thanks to 3D Printing, you can!
I have been covering 3D Printing (also called Additive Manufacturing) for over 20 years in my Technotrends Newsletter,and at first the technology was used for rapid prototyping. Over the past few years, however, rapid advances in processing power, storage, and bandwidth have catapulted this technology into a tool for manufacturing finished products that include jewelry, shoes, dresses, car dashboards, parts for jet engines, jawbones for humans, replacement parts for synthesizers, and much more.
When people first hear that you can manufacture something by printing it, they have a hard time visualizing it. Think of it this way:
  • 3D printers build things by depositing material, typically plastic or metal, layer by layer, until the prototype or final product is finished.
  • When the design is downloaded into the printer, a laser creates a layer of material and fuses it.
  • Then it adds another layer and fuses it…and then another and another…until the object is completed.
For example, a Belgian company, LayerWise, used 3D printing to create a jawbone that was recently implanted into an 83-year-old woman. An Australian company, Inventech, has created what they call their 3D BioPrinters to print tissue structures using human tissue. And Bespoke Innovations is using 3D printing to create prosthetic limb castings.
This amazing technology can also be used for on-demand printing of spare parts—something the U.S. military is already doing in the field. Knowing this,
  • it is not hard to see that in the future, a manufacturer could sell a machine or system to a company, and as part of their maintenance and support contract they can put their 3D printer on-site with the licensed software to print replacement parts as needed.
On a smaller level, it is easy to see that service mechanics will have portable 3D printers in their vans or at their main office. Original equipment manufacturers (OEM) will most likely sell and license these printers to their dealer network.
In addition, there are already a number of companies including Shapeways and Quirky that will use their 3D printers to print the design you send them, and then they’ll ship the final product to you. It’s not hard to see that at some point Amazon will provide this service too.
3D printing will definitely become more commonplace in the near future thanks to its many benefits, including the ability to print the complete part without assembly and the ability to print complex inner structures too difficult to be machined. Additionally, the entire process produces much less waste than traditional manufacturing where large amounts of material have to be trimmed away from the usable part.
Whether you call it 3D Printing or Additive Manufacturing, it is advancing quickly on a global level and offers something that up until recently was impossible: On-demand, anytime, anywhere, by anyone manufacturing.

Related references at Pharmaceutical Intelligence:

Healthcare Startups Accelerator is Reaching Out: Deadline November 11, 2013
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24 New MacArthur Fellows: 13 men and 11 women — Now so-called “Geniuses”
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Biopharma Industry: The Leaders are Massachusetts-based
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Emerging Clinical Applications for Cardiac CT: Plaque Characterization, SPECT Functionality, Angiogram’s and Non-Invasive FFR
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Fractional Flow Reserve (FFR) & Instantaneous wave-free ratio (iFR): An Evaluation of Catheterization Lab Tools for Ischemic Assessment
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Participatory Healthcare: A New Trend in Research?

 Author: Dr Anayo Unachukwu, MBBS, LLM


When the great innovation appears, it will almost certainly be in muddled, incomplete and confusing form….For any speculation which does not at first glance look crazy, there is no hope”

Freeman Dyson

Healthcare by its very nature is complex. It comprises of not just one single integrated system, but consists of a large number of interrelated systems.[1] Risk[2] is inherent in the system. As a result of its complexity, it is also prone to errors due to concatenation of multiple small failures.[3] Given the fore-goings, it is unsurprising that a patient care pathway can be complex as regards the nature of care delivered and in the number of organisations that contribute to the care.[4] In parallel to this is the mounting cost of healthcare, emergence of post approval hurdle-pricing reimbursement and health technology assessments-that are more stringent.

Risk in general lacks precision both in definition and the impact it presents. There appears to be an inverse relationship between the tolerance of risk in a given society and its level of affluence. However, most affluent society seeks change in the delivery of service. This is to make for faster, efficient and effective delivery of quality services taking advantage of new technologies. The paradox is that change is front-loaded with uncertainty and it is inherently risky. In the National Health Service-as in many public organisations in developed societies that are involved in healthcare-change is influenced by the public choice theory[5] and market theory principles.[6] The government is increasingly relying on effective partnership to deliver on broad outcome measures[7] which is the nature of Public Service Agreement (PSA). Of note, it recognises that good risk management is integral to delivery of successful partnership.[8] Collaboration, co-invention and partnership have now become the buzz words in the pharmaceutical industries as part of to optimise on their research and development efforts, reduce redundant capacity and adoption of Darwinian approach to portfolio management.

The development of risk assessment and management is largely due to trends in the wider society, technological advances in health care, and the paradigm shift from paternalism to autonomy, consumerism, and clinical negligence litigation.[9] Further, in post-Vioxx world, the regulatory environment in the industry has become more challenging resulting in robust risk management and label restrictions. The political and economic trends and impacts on risk assessment and management are now more ubiquitous; and conflate and complicate the perception of risks.

Given this background, wholesale or partial significant changes in healthcare or a significant change in direction must be done circumspectly whilst factoring in inter alia: the complexity of the sector, risk management and resource reallocation among the various competing influences. According to Le Chatelier’s principle[10] which can be roughly stated as:

“Any change in status quo within a closed system will result in an opposing reaction in the responding system”.

At this stage in this discourse, it may be pertinent to look at the practical applications of change particularly with respect to research in healthcare as recently advocated by some healthcare leaders.

In December 2012, Lucien Engelen, director Raboud REshape and Innovation Centre at Raboud University Njimegen Medical Centre communicated his ‘Big Ideas 2013:The ideas include a launch of an initiative where patients together with their family and informal carers will come up with research-ideas and patients will also try to raise the money for chosen research ideas’. According to Mr Engelen, ‘This will start a new movement”.

Mr Engelen’s qualities as a visionary leader (his innovation centre is the second largest Academic Medical Centre in the Netherlands) and indeed enthusiasm are never in doubt. Neither is his honest intention to make healthcare truly participatory with patient at the very heart of service delivery. In principle participatory healthcare is laudable, given that patients come into such partnership/relationship better informed and able to negotiate better and take active part in management of their health.

However, it may be of some concern when ‘Big Ideas’ are bandied around with a complete disconnect between fundamental research and applied research. His idea of research needless to say is informed by the wisdom of the crowd and successes in other fields-art and culture, new technology etc. Healthcare is unique in more ways than one and attempts to extrapolate from other unrelated sector may have the unintended consequences that have far reaching implications.

Bold initiatives and innovation are laudable in all human efforts and endeavours, be it healthcare, other sectors, etc. The problem with the big ideas in research as advanced by Mr Englene is that it is emotive-and I dare say-has a whiff of personal imprimatur in his attempt to vivify research. Further, big ideas by its very nature, generally have at stake self beliefs, ego and personal ambitions, etc; “outcomes”[11] (as it is said torture data long enough it will confess to anything) become everything. The new game will be the end justifies the means and as a result ‘Lance Armstronging’[12] investigative studies will not be off the radar of the “researchers,” given that the vocal minority backing the effort will be banking on immediate positive outcomes. This cannot by any stretch of definition be called a scientific quest for truth. Call it by any other name-by all means-but not research. Research in healthcare is complex and is beset with vicissitudes of life. Serendipity is integral to any serious research effort and certainly it has changed lives. Part of the reasons why pharmaceutical industries have not had as many successes as previously-apart from the fact that previous research efforts have picked the low hanging fruits-is the ‘sanitised’ funding that leaves little room for serendipity. I am pleased to note that The Dean of the University where Mr Englene is based, Paul Smits, although he likes the idea-‘it brings science into the living room’-however cautioned that care ought to be exercised that the big ideas are not pursued at the expense of fundamental research.

We have to accept that certain endeavours are more difficult than others, no matter how much other disciplines may attempt to borrow from science or even language up what they do to imbricate scientific investigations. The output will be at best a pseudoscientific pretender. Einstein’s wise words are instructive: “Everything should be made as simple as possible, but not simpler”.


[1] Ellie Scrivens, Quality, Risk And Control in Health Care. Open University Press 2005. p. 8

[2] HM Treasure. The Orange Book Management of Risk-Principle and Concepts (October 2004).

[3] Ibid.

[4] Sheila Peskett, “The challenges of commissioning healthcare: a discussion paper,” Int J Health Plann Mgmt 2009; 24: 95-112.

[5] This take the view that publicly provided services are prone to be less efficient, less productive and less focused on their customers than privately provided services.

[6] Competition amongst providers will drive up quality, innovation and productivity whilst containing costs.

[7] This applies not only in the  health sector and other public sectors.

[8] HM TREASURY. Managing risks with delivery partners. Office of Government Commerce (OGC).

[9] Department of Health Making Amends: A Consultation Paper Setting out proposals for Reforming the Approach to Clinical Negligence in the NHS (2003); the cost of compensating patients jumped 400 per cent in the course of the 1970s and 750 per cent in the 1990s.

[10] This principle is native to chemistry and  in its original form states that in a closed system-a chemical system-if it experiences a change in concentration, temperature, volume or pressure, the new equilibrium is achieved to counteract the imposed change.

[11] Who is measuring; always bear in mind Hawthorn’s effect

[12] One is not talking about being dishonest to achieve a success, but going to an inordinate extraordinary length to see that success is ensured without counting the cost in the long term.

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