Friday, August 29, 2014

USPTO Conspiracy II


Pursuing a balance with NATURE

_____________________________________________________________

Hydrology Breakthrough vs. USPTO Conspiracy


"Violation of science: bad apples and/or systems failure?"

Why Bad Apples Spoil the Barrel?


The Conspiracy – USPTO is running a broad Reinvention Scheme that let Lawyers writing scientific patents and allowing IP rights of issues they are not known in the art!


‘...  If you have a point to make about my treatment of hydrological concepts, I ask that you take the time to explain your specific points of disagreement.  I note that my work is better represented in my publications (available at http://www.stroockgroup.org/home/publicationsthan in patents, as the lawyers have been translated the latter into legalese that I do not understand.

Food for thought – If an inventor PhD from Harvard can have USPTO issued patents to protect his intellectual property rights but he does NOT understand it, how much the Patent Attorney and Patent Examiner knows about the issue granted protection by US Government. If it holds true, it means that Lawyers know about science more than scientists doAmazing! I just imagine Albert Einstein trying to get patents with his scientific papers .. . It means that those guys in the patenting affairs would handle Theory of Relativity more than him . . . Now I understand why Americans are the leaders of the world . . . awesome, this is simply magical. Mayday Mr. Snowden .  . .mayday mother nature!

My ‘scientific breakthrough’ deals deeply with Hydrogeology/Soil Physics/Hydrology. When I took classes at the Pennsylvania State University of such disciplines during my PhD in Soil Science I remember seeing no single Law student as classmate.

If my patent was being violated I had simple questions to pursue:

·       Was it a casual violation or a clear biased trend?
·       Had the examiner already cited my patent earlier?
·       Did the inventors and examiner have technical-scientific background in the issue?
·       Was the violator a wealthy party?
·       Was the examiner citing my patent to be sure he was granting new claims not claimed before?
·   Why my issued patent was being randomly cited for irrelevant patents and ignored when violated blatantly? 
-------------------



This is the tip of the iceberg as of what lies  bellow, clearly points out distorted conceptions and beliefs on human culture WHEN LAWS OF MAN IGNORE LAWS OF NATURE.


From: Moulis, Thomas <
Thomas.Moulis@uspto.gov>
 
Date: Fri, Aug 7, 2015 at 12:40 PM 
Subject: RE: Conspiracy and Brainwashing III – USPTO is preaching to their Patent Examiners that they do not need to be known in the art for judging and allowing IP rights when issuing patents! 
To: Elson Silva, PhD <tubarc@gmail.com>

You are a fool--- 

If you can’t understand legal or technical writing, you have no business blogging about it 

Wicking” is a term of art---fluid will travel in any direction via the fibers—regardless of gravity

-------------------

"Wick/wicking is in the patent classification system but not on HYDROLOGY textbooks."


LEGAL WICKING as the term of the art regardless of gravity confirms USPTO long standing bias ignoring hydrology on conductivity parameters of issued patents (11/30/23):


Thermal/Heat Conductivity                       176.074 pat.

Electric/Electrical Conductivity                139.254 pat.

Hydraulic Conductivity                                  1.329 pat.

Unsaturated Hydraulic Conductivity                  38 pat.

Wick/wicking                                                      66.415 pat.


The US Government states that LEGAL WICKING is not technical, being inert to gravity LAW, meaning that LEGAL OIL LAMPS and LEGAL CANDLES can work upsided down. This sort of deceiving is behind the Economic Melting Down of 2008 burning about 41 trillion dollars, also dumping 1,1 million American as the leader of the COVID-19 pandemic catastrophe that  took around 7 million lives world widely. In addition, obesity and sedentarism letting human beings miss brain capacity by becoming grumpier and dumber on neurogenesis effect.

Science is our understanding on nature functioning. Humans learn to respect nature early as babies on the first steps taming gravity for walking and running. Soon we understand the consequences of missteping and falling down. Therefore, all issued patents dealing with wick/wicking are CERTAINLY frauded because PATENT EXAMINERS ignored their homework from the beginning of their lives - GRAVITY

Sir Isaac Newton defined the Law of Universal Gravitation in 1687. He was inspired to formulate his theory of gravitation by watching the fall of an apple from a tree.

---------------------------------
De: Owen, Steven [mailto:steven.owen@uconn.edu]
Enviada em: quarta-feira, 5 de outubro de 2011 11:36
Para: Elson Silva, PhD
Assunto: RE: {SPAM?} Protecting Hydrology Science from REINVENTION

Mr. Silva, has anyone ever called you a nutcase

Are people out to get you? 

Are you having some trouble keeping up with your medications?


---------------------------------
Steven V. Owen
University Professor Emeritus
Educational Psychology

---------------------------------

Dr. Owen, my medicine is a bit bitter than that one swallowed by Albert Einstein by just stretching his tongue:

http://youtu.be/E3d-JRg28p8

https://youtu.be/czv2OiiC5wA


_____________________________________________________________


This email from an Emeritus Faculty of Educational Psychology provided valuable insights and feedback showing how deep the academic community is compromised on scientific affairs in the US.They were supposed to know that Darcy’s Law on Hydraulic Conductivity is not written in the US constitution, but endorsed by Mother Nature.


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Nobel Prize is IMPORTANT TO HUMAN KIND, as 50% is business, 40% politics, 5% bad science and 5% good science from an educated abstraction. Nobel Prize Nomination of Economic Science was introduced to pretend that Human Business could overlap nature functioning. THE US AS THE FIRST ECONOMIC POWER IN THE WORLD GRABBED TWO-THIRDS (411/621) OF NOBEL PRIZE NOMINATIONS FOR SCIENCE. Exploratory Analysis shows that the American scientific community has been violating Hydrology science in the Patenting System more than a century, leaving a gap huge enough for a new science Hydrotechnology.  It seems that working with the Chemistry of explosives is far more profitable than the Hydrology of self-watering flower pots. Mr. Alfred Nobel, Arms Dealer, Merchant of Death, and Father of Dynamite, got 355 patents and Albert Einstein got 50 issued patents to portray top scientists claiming intellectual property rights. Obesity, Economic Melt Dow, COVID-19 tragedies, and now Reinvention Policy by USPTO are important evidence of American negligence to science misbalance with Nature.

How much NATURE endorses the Economy and Politics? Sunlight and rain come to us FREE OF CHARGE, regardless of BOUNDARIES, making the Economy not a science, but a distorted human affair as basic Laws of offer and demand is being replaced by GREED and FEAR. Likewise,  recent wars in Ukraine and Israel show us that Politics can’t be science, but a wicked manipulation on human issues wasting innocent lives and spoiling the landscape for weaponry industry profit and disguised interest as Homo sapiens misses simple rationality.

In my neighborhood, I saw the Scientific Police taking pictures of swings I installed on trees for children in the Park during the COVID-19 pandemic lock down. Society try to employ the word SCIENCE for POWER, but there is a misunderstanding as scientific principles claim TRANSPARENCY and HONESTY. Nature is in charge of SCIENCE as there is no POLICE to enforce Nature LAWS. Even religion try to use Scientology for credibility. I like the simple conception that God = Nature. However, Nature writes no books, promises no lands, no life after death, no war or death in name of a divine. In around 4 billions of years of our planet, it seems that we got no aliens to affect our evolution. Most probable we are not leaving our home until the end in 4 to 6 billions of years. Human challenge is to keep nuclear weapons safe, cropping soils, mining our minerals and preserve our home in balance with nature functioning, making our blue planet good for all humans. 

What we see in the universe is just for light travelling.

It seems that few scientists do understand the meaning of their titles PhD as Philosophy Doctor coming from Philosophy of Science (Epistemology, Metaphysics, Logics, and History of Science).

_____________________________________________________________



Who cares?

I got my PhD at Penn State Univ. a famous place that let boys be raped in the locker rooms more than a decade. Bill Clinton then President was on my commencement saying we would be inventing new technologies never imagined before. He did not mention about facing government conspiracy violating science by a USPTO despicable reinvention policy! While money was pouring and fame was high at Happy Valley Joe Pa and Graham Spanier did not budge to protect a sound functioning of society as it seems to be a major trend around spoiling American credibility far beyond their imagination. . . after all who cares about disadvantaged boys and even less for science and technological development?

The country I got my PhD changed so abruptly!

Now my ‘scientific breakthrough’ is facing the same treat as those boys got in the academic facilities – shameful rape by Law Firms, Corporations, and Institutions in a conspiracy scheme letting wealthy parties pillage on granted patents by reinvention with lousy patents from lay inventors and corrupt Lawyers . Wealthy Corporations and top educational Institutions are crossing the boundaries flunking the content of their libraries, ethics, respect, and dishonoring edifying principles by shamefully disregarding the Law.

I am curious if they are considering that Hydrology might vanish from libraries!

Conspiracy is the best description for this ongoing plot (Law: An agreement between two or more persons to commit a crime or accomplish a legal purpose through illegal action. 3. a group of persons for a secret, unlawful, or evil purpose.) They are not smart as I happen to be not an inventor, but a scientist that understand how science works and how humans behave.

Early 2011 I told Mr. Obama not to dishonor Hydrology this way . . .  http://hydrotechnology.blogspot.com.br/


Outcome - Inventors owning US patents only collect money if they can afford court fees suing violators reinventing their ideas over and over sometimes by flawed patents from lay inventors and wealthy parties.

What does it means?
It means that inventions granted American patents might collect rewards if the inventor can afford 2 to 5 million dollars for suing a continuous reckless patent infringement from wealthy parties colluding with US Officials.

American patents are becoming useless if the inventor cannot afford steep court fees on continuous litigations.

Who takes advantages by the Reinvention Policy?
US government and Law Firms profit high by reinvention policy spoiling the patenting system and harming inventors that cannot feed such swindle.

Who are the Patent Examiners and what is their technical-scientific background?
USPTO confirmed having no single Patent Examiner with background in Hydrology among around 6,000 examiners. So, Hydrology has been examined by lay Patent Examiners not known in the art for judging it!

USPTO Conspiracy - Reinventing by Wealthy Corporation

Roche employs about 67,000 people around the world and has about 44 billion dollars revenue annually. In the last decade a group of researchers at Roche Diagnostics was filing dozens of patent applications trying to develop the spatial geometry of a channel on lancets to conduct blood for glucose test.

This left figure shows that Roche does not employ any Hydrologist or Soil Scientist to understand the deep functioning of fluids moving on porous systems, even less the rounding geometry. So, they learned with my patent (US 6 ,766,817), copied it and poorly reinvented it certainly bribing and corrupting US officials, as well as ignoring my pleas for HONESTY under the Law. The violation is so despicable that the Patent Examiner Mr. Max Hindenburg allowing the violation had already cited my patent earlier allowing 7,377,904 on May 27, 2008 and the technical background is so poorly handled that the Hydrology scientific community is going to become mesmerized by such nuisance

What is going on at USPTO? Conspiracy?

I told Roche and put more than 4,000 of their emails on my blog (http://roche-tubarc.blogspot.com ) that If they have this power to bribe US officials on money making, they should be smarter and bribe people at the Treasure Office by printing the bills. Stealing my invention poorly is just impossible as knowledge cannot be recreated even less by those ones not known in the art missing critical background and expertise. 



It is unlikely that a pharmaceutical company would hire Geologists or Soil Scientists. So, they have no handle on the Hydrodynamic properties to address the core issue. They never gauged Unsaturated Hydraulic Conductivity, have no idea about Hydraulic Zones, anisotropic unsaturated flow, vertical hydraulic gradient potential, molecular connectivity, self-sustaining reversible flow, molecular drainage, void ratio, pore connectivity, porosity geometry self-cleaning filtering, inertial/rotating energy addiction/subtraction, etc. 

‘This sort of conspiracy makes me feel appalled like when a thug that steals my car, but just at the time of getting away with my belonging he discovers not being able to drive it!’


Carefusion Corporation employs around 16,650 people and has an annual budget of about 4 billion dollars revenue. It filed seven patents poorly claiming the same geometry of Tubarc. The same geometry of tubarc (US ,766,817), was allowed on May 27, 2014 by US 8,733,348, a lousy patent from lay inventors and wealthy party.)

US 20130255672 - TRANSPORTING LIQUID IN A RESPIRATORY COMPONENT 
 Abstract
A respiratory component coupled with a breathing circuit, the respiratory component including at least one groove disposed upon a surface of the respiratory component, wherein the respiratory component is not a heater wire.
Claims
1. A respiratory component comprising: a liquid transporting device configured for transporting a liquid from a first region to a second region, wherein said liquid transporting device is disposed on a surface of said respiratory component and is not disposed on a heater wire.

2. The respiratory component of claim 1, wherein said liquid transporting device comprises: at least one groove disposed upon said surface of said respiratory component, wherein said at least one groove is configured for wicking up liquid from said first region and transporting said liquid to said second region. 



Illumina, Inc.They got the same geometry as Tubarc twice. As a scientist I am glad to have created something that is really good and important to human kind, but I was expecting a reward from it so I could invest in my research project. It means that the Intellectual Property system is failing to scientists and inventors on their dedication and hardship.
            - Illumina, Inc. poorly reinvented the same geometry of tubarc (US ,766,817) twice:




Abstract
A fluidic device for conveying liquid to a well of a microplate. The device includes a support structure configured to be mounted along the microplate. The device also includes a microfluidic tube coupled to the support structure. The tube has an inlet, an outlet, and an open-sided channel that extends longitudinally therebetween. The tube has a cross-section that includes an interior contour with a gap therein. The gap extends at least partially along a length of the tube. The tube is configured to convey liquid to the well of the microplate when the tube is held in a dispensing orientation.

Claims
1. A fluidic device for conveying liquid to a well of a microplate, the device comprising: a support structure configured to be mounted along the microplate; and a microfluidic tube coupled to the support structure, the tube having an inlet, an outlet, and an open-sided channel that extends longitudinally therebetween, the tube having a cross-section that includes an interior contour with a gap therein, the gap extending at least partially along a length of the tube, the tube being configured to convey liquid to the well of the microplate when the tube is held in a dispensing orientation. 



Sour Reality – Lawyers are messing with science on intellectual property affairs as they have no handle on it.
So, collusion with USPTO is unleashing a wave of flawed patents like this one more below:





The ‘wick’ 34 cannot work below the water table reference.
The device 34 is just a porous drain and never a wick.
Wick is a device on oil lamps that takes fuel toward the flame inside the Unsaturated Hydraulic Zone (Negative Pressure).
Lay people employing wicking terminology does not understand oil lamps and the functioning of wicks.

From my patent US Pat. 6,766,817

BACKGROUND OF THE INVENTION  


(3rd paragraph)
A fluid that possesses a positive pressure can be generally defined in the field of hydrology as saturated fluid. Likewise, a fluid that has a negative pressure (i.e., or suction) can be generally defined as an unsaturated fluid. Fluid matric potential can be negative or positive. For example, water standing freely at an open lake, can be said to stand under a gravity pull. The top surface of the liquid of such water accounts for zero pressure known as the water table or hydraulic head. Below the water table, the water matric potential (pressure) is generally positive because the weight of the water increases according to parameters of force per unit of area. When water rises through a capillary tube or any other porosity, the water matric potential (e.g., conventionally negative pressure or suction) is negative because the solid phase attracts the water upward relieving part of its gravitational pull to the bearing weight. The suction power comes from the amount of attraction in the solid phase per unit of volume in the porosity.

(7th paragraph)
Specialized scientific literature about unsaturated zones also recognizes this shortcoming. For example: "Several differences and complications must be considered. One complication is that concepts of unsaturated flow are not as fully developed as those for saturated flow, nor are they as easily applied." (See Dominico & Schwartz, 1990. Physical and Chemical Hydrogeology. Pg. 88. Wiley). Concepts of unsaturated flow have not been fully developed to date, because the "capillary action" utilized to measure the adhesion-cohesion force of porosity is restrained by capillary tube geometry conceptions. The term "capillary action" has been wrongly utilized in the art as a synonym for unsaturated flow, which results in an insinuation that the tube geometry conception captures this phenomenon when in truth it does not.

(16th paragraph)
The present inventor has thus discovered that the dynamics between saturated and unsaturated conditions as expressed in the fluid matric potential can be utilized to harness the unsaturated flow of fluid using the macrostructure of reversible unsaturated siphons for a variety of purposes, such as irrigation and drainage, fluid recharging and filtration, to name a few. The present inventor has thus designed unique methods and systems to recover or prevent interruption in liquid unsaturated flow in both multidirectional and reversible direction by taking advantage of the intrinsic relationship between unsaturated and saturated hydrological zones handling a vertical fluid matric gradient when working under gravity conditions. The present inventor has thus designed an enhanced microporosity called tubarc, which is a tube like geometric figure having continuous lateral flow in all longitudinal extension. The tubarc porosity offers a high level of safe interconnected longitudinally, while providing highanisotropy for fluid movement and reliability for general hydrodynamic applications.


My Demand to USPTO

It is not that hard to argue at the Court of the Law that Hydrological issues should be examined by Hydrologists.
My demand to USPTO is the same as the first letter sent on Oct. 2006:

1. Hire Examiners with background in Hydrogeology and/or Soil Physics so that they have full comprehension of fluids moving on porosity;
2. Cancel issued patents with scientific flaws. Obsolete patents are cancelled naturally by becoming outdated;
3. Make a public statement about Hydrology negligence hurting all Hydrological community as well as my project that needs experts in Hydrology to protect the content of my issued claims.
4. Compensate for my losses since as an inventor filing patents I was not expecting lay people handling hydrology in the examination process by USPTO.
5. Since USPTO is failing to protect my IP rights my patents should be eligible for time extension of their expiration dates (new demand).
6. Issue a bill requiring Hydrology be handled by Hydrologists preventing laypeople from harming standing common knowledge in the scientific literature (new demand).
7. Make people accountable for breaking the Law regarding my complaints (new demand).
_______________________________________________________________________________

Understanding the bias – The size of the Hydrological Gap

Wick/wicking is not a word found on my Hydrology textbooks but it is in the patent classification system at USPTO guiding lay inventors and lay Patent Examiners pretending they are known in the art.

In 1856 Henry Darcy proposed an equation Law to address fluids moving on porosity for Hydraulic Conductivity. Afterwards in 1907 Edward Buckingham suggested a change to address negative pressure flow for Unsaturated Hydraulic Flow (wick/wicking).

Today Aug 18, 2014 searching at USPTO:

Thermal/Heat Conductivity is mentioned in                                                                97,870 issued patents
Electrical/Electric Conductivity is mentioned in                                                          74,465 issued patents
Hydraulic Conductivity mentioned in only                                                                          721 issued patents
Unsaturated Hydraulic Conductivity (wicking for lay people) is mentioned in only                  27 issued patents 
Wick/wicking (Unsaturated Flow if not flawed) is mentioned in                                    32,774 issued patents

_______________________________________________________________________________
The Conspiracy

Abraham Duncan Stroock
Dept: Chemical and Biomolecular Engineering
Title: Associate Professor

Education

Ph.D., Harvard University, Chemical Physic (2002)
M.S., University Paris VI and XI,Solid State Physics (1997)
B.A. Cornell UniversityPhysics (1995)


De: Abraham Duncan Stroock [mailto:abe.stroock@cornell.edu]
Enviada em: terça-feira, 22 de abril de 2014 22:20
Para: Elson Silva, PhD
Assunto: RE: [06856] Protecting Hydrology Science from REINVENTION by corrupt LAY PEOPLE colluding with USPTO - US Pat 8,701,469

Dear Dr. Silva,
‘...  If you have a point to make about my treatment of hydrological concepts, I ask that you take the time to explain your specific points of disagreement.  I note that my work is better represented in my publications (available at http://www.stroockgroup.org/home/publicationsthan in patentsas the lawyers have been translated the latter into legalese that I do not understand.

Best regards,

Abe
___________________________________________________________
De: Elson Silva, PhD [mailto:el_silva@uol.com.br]
Enviada em: terça-feira, 22 de abril de 2014 23:40
Para: 'Abraham Duncan Stroock'
Cc: cko3@cornell.edu; TDO1@cornell.edu; MGS22@cornell.edu; SBW11@cornell.edu; el_silva@uol.com.br
Assunto: RES: [06856] Protecting Hydrology Science from REINVENTION by corrupt LAY PEOPLE colluding with USPTO - US Pat 8,701,469
Prioridade: Alta

Abe,

You are so naive.

‘…Are you sure you got your PhD at Harvard? ‘

Lawyers learn nothing about Hydrology in Law School.

As far as I know no Law School provides Hydrology teaching . . . No Lawyer could discuss Hydrology having no expertise in the subject!

This is funny!
You do not give your scientific papers to Lawyers, so why are your patents different?
(By the way, was it a Lawyer who wrote your PhD thesis?)
Also, Lawyers are illiterate on the functioning of science, besides most scientists have no idea about Epistemology, Metaphysics, Logics, and History of Science (Philosophy of Science).

USPTO is a sham system allowing reinvention sometimes by flawed lazy patents from wealthy parties letting Lawyers step over boundaries beyond their background in Law Schools….’


Academic Pillage on Hydrology Science

UCONN III, …, XIV




SUNNY IIIIIIIV


UC Santa Barbara IIIIII






The ONGOING Conspiracy


8,814,808  Body fluid sampling device, by Calasso; Irio Guiseppe (Arth, CH), Griss; Patrick (Zurich, CH), Sarofim; Emad (Hagendorn, CH), Jaeggi; Rainer (Wohlen, CH), Kraemer; Uwe(Ilvesheim, DE), Hasker; Dave (San Jose, CA), Zimmer; Volker (Laumersheim, DE), Schmid; Wilifried (Mannheim, DE), Fuerst; Otto (Viernheim,DE), List; Hans (Hesseneck-Kailbach, DE), Haar; Hans-Peter (Wiesloch, DE), Arnitz; Theo (Waghaeusel, DE), Roe; Steven N. (San Mateo, CA) , assigned to Roche Diagnostics Operations, Inc. (Indianapolis, IN), August 26, 2014

Abstract
Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid. In one embodiment, the collection zone includes a plurality of holes, e.g., 3 or more holes, or 50 to 100 holes. The hole size may be small, e.g., having a diameter of 0.01 to 0.5 mm. The holes may or may not extend through the lancet. In some embodiments, the holes have a depth of 50 to 500 .mu.m. In other embodiments, the collection zone is porous, or is a roughened area. The collection zone can take up a very small volume of body fluid, e.g., 3 to 10 nL, in a very short time period, e.g., less than 0.5 seconds. In other embodiments, the device further comprises a fluid receiving means spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially.

Claims



1. A body fluid system, comprising: a skin-piercing element having a sharpened end for piercing tissue and a collection zone for receiving body fluid from the tissue, wherein the thickness of the skin-piercing element is below 500 .mu.m and the collection zone comprises 3 or more blind holes open to the environment for receiving the body fluid; and a test zone for receiving body fluid from the collection zone of said skin-piercing element.


5. A testing system comprising: a lancet having a sharpened end adapted to penetrate the skin surface and obtain a sample of body fluid, the lancet including a plurality of blind holes open to the environment and forming a collection zone, wherein the diameter of each hole is 0.01 mm (millimeters) to 0.5 mm (millimeters); and a test zone for receiving body fluid from the collection zone of said lancet.

10. A testing system comprising: a lancet having a sharpened end adapted to penetrate a skin surface to obtain a sample of body fluid, the lancet including a collection zone adapted to hold a sample of bodily fluid as the lancet is withdrawn from the skin, wherein the collection zone includes a plurality of blind holes open to the environment and having diameters of 0.01 mm to 0.5 mm; and a test zone for receiving body fluid from the collection zone of said lancet.
17. A testing system comprising: a lancet having a sharpened end adapted to penetrate a skin surface to obtain a sample of body fluid, the lancet including a collection zone adapted to hold a sample of bodily fluid as the lancet is withdrawn from the skin, wherein the collection zone includes a plurality of blind holes open to the environment and having depths of 50 to 500 .mu.m; and a test zone for receiving body fluid from the collection zone of said lancet.


Systems for sampling body fluids are already known in the prior art in which body fluid is taken up into a disposable element. Blood collection and analytical systems are known from document EP 0 199 484 for example which comprises a disposable unit with a capillary to collect body fluid and to transport the body fluid into a detection area. The further development of this concept is described in WO 97/42888. The arrangement described in this document is particularly suitable for collecting relatively small amounts of body fluids which is primarily accomplished by pressing a ring onto the area surrounding a collection site and applying a pump movement. A system for analysis based on small amounts of interstitial fluid is known from EP 0 723 418. For this purpose a very thin hollow needle is inserted into the dermis and interstitial fluid is conveyed through the needle to a test zone by applying pressure to the area surrounding the puncture site. A highly miniaturized arrangement which also utilizes a hollow needle to withdraw body fluid is known from U.S. Pat. No. 5,801,057. A particular advantage of this arrangement is the extremely thin needle which can be inserted into the arm region of a patient essentially without any pain.

The prior art sampling and testing devices describe embodiments where sample from a capillary channel is directly transferred to a testing zone which is in fluidic contact with the channel. Contrary to that the present invention proposes body fluid sampling and testing devices where the collection zone in a phase in which sample is taken up is out of fluidic contact with a testing zone. In a second phase, after having taken up a fluid sample into the collection zone, at least a portion of the collection zone is being transferred in a second position in which at least a portion of the collection zone comes into contact with a fluid receiving means that receives fluid from the collection zone. Alternatively the fluid receiving means can be moved or both, the fluid receiving means as well as the collection zone may be moved.

According to an embodiment of the prior art the transport means comprises e.g. capillary reaching from the collection zone to the fluid receiving means (e.g. EP 1 360 931). The body fluid is taken up at the test zone and is transferred to contact the fluid receiving means by capillary actuation, i.e. the subsequently picked up body fluid pushes the sample to the fluid receiving means. This additionally needed fluid volume, the so-called dead volume, serves as transport means to transfer the fluid used for the analysis to contact the fluid receiving means. This means that by principle more body fluid volume has to be collected than is needed for the measurement and this dead volume increases with increasing transfer distance. According to the present invention contrary to the prior art there is no dead volume needed. Ideally the whole sample volume that is collected in the collection zone is transferred to the fluid receiving means to be used for the measurement. Of course, it is likely that some sample remains in the collection zone, as it is the case by using a capillary. Furthermore, according to the present invention the body fluid volume needed to be sampled for measurement does not necessarily increase with increasing distance between collection zone and fluid receiving means.

A skin-piercing element for withdrawing small amounts of body fluid according to the present invention has a protruding portion with a sharpened end for piercing skin. Within at least a region of the protruding portion a collection zone is located which has the ability to collect body fluid. This in particular can be achieved by a capillary activity. At least a part of the body fluid receiving structure is open. capillary structure is understood within the scope of the invention as a body which transports body fluid as a result of capillary forces. In case of a capillary channel fluid is transported towards the proximal end of the skin-piercing element when the distal area is contacted with body fluid. With regard to this embodiment the capillary structure according to the invention is similar to the open needle structures described in US 2003/0018282 and US 2003/0028125 to which reference is made herewith. However, an important difference is that these documents describe microneedles where the capillary channel is in fluidic contact with a test zone so that body fluid received in the capillary channel is directly applied to the test zone and hence initiates reaction.

Capillary structures in the collection zone may be manufactured by photolithographic methods like those described in the document U.S. Pat. No. 5,801,057 and which are known from the field of semiconductor technology. It is also possible to provide channels, grooves, holes etc. which are open to the outside in solid needles by milling, etching and such like. Such structures are preferably generated by etching processes as photochemical milling (PCM). PCM is based on optical pattern transfer and etch processes. It is known to be a micromachining technology.

In addition to the already mentioned methods for incorporating capillary structures into surfaces, it is also possible to generate the capillary channels by assembling bodies in a way that capillary gaps are created. Thus it is for example possible to fasten two or more solid needles together for example by welding such that the contact areas of the solid needles form capillary channels. In a corresponding manner it is also possible to twist wires or fibres together in the form of a stranded wire such that numerous contact areas are formed which generate the capillary channels. The wires or fibres might be made of metal, glass or carbon, and can be solid or hollow, for example it can be necessary to grind a lancet surface to achieve open capillaries. It is also possible that the capillary is not open to the environment for the whole time, e.g. it may be opened only during the skin-piercing step to collect the body fluid. Further skin-piercing elements with fluid pathways can be created by applying one or more layer of materials (e.g. laminated foils) onto a flat needle in a way that a capillary gap is created between the layers or is provided in one such layer.

The capillary structures according to the present invention are, however, not restricted to capillary channels leading from a distal to a proximal end of the skin-piercing element. Also porous structures or holes may be employed to sample fluid. With the present invention it is not essential that capillaries transport fluid over a macroscopic distance to achieve wetting of a test zone. Instead the collection zone and fluid receiving means are moved into proximity.

As already stated above it is advantageous that the capillary channels are open to the outside such that they can take up body fluid while the capillary structure is inserted into the body.

Preferably, the fluid receiving means has a higher capillarity than the collection zone of the skin-piercing element so that during contact fluid is automatically taken up, i.e. the capillarity difference serves as contacting means. In this regard the fluid receiving means can be made from a fleece or fabric material that has a high capillarity and is hydrophilic (at least in areas for fluid take-up). The fluid receiving means may have a particular region which comprises such material of high capillarity or the whole area of the fluid receiving means can act as receiving means for fluid from the fluid channel. The fluid receiving means may be a test zone in itself which can be covered with a fabric or woven material or the fluid receiving means may be more complex and allows for pre-processing of sample fluid and/or transport of fluid to a sensor/test zone. Pre-processing may comprise filtration of fluid sample and/or a mixing with reagents. Alternatively or to support the capillary force as contacting means a mechanical force can be applied pressing collection zone and receiving element together, or overpressure on the side of the collection zone and/or under pressure, e.g. vacuum, on the receiving side may be applied. In particular at collection zones comprising through holes overpressure on one end of the holes may be used to ensure that at least a portion of the sample leaves the collection zone through the other end and contacts the fluid receiving means. Mechanical compressing means or ultrasound, (e.g. in sawtooth operation), are also possible contacting means to transfer the fluid sample to the receiving means.

The fluid receiving means comprises a test zone with at least one chemistry layer that contains a reagent for detecting an analyte. The reagent undergoes a detectable change due to reaction with the analyte to be detected. Typical reagents for detecting glucose are based for example on glucose oxidase in conjunction with a chromogenic redox system. Reagents are well known in the prior art for optical evaluation which form a colour with glucose from the body fluid. Furthermore reagents are also known from the field of blood sugar test strips which allow electrochemical detection of analytes. The reagent mixtures that are used are usually in a solid state and, due to their constituents (e.g. aluminium oxide, kieselguhr and such like), have such a high capillarity that they can take up body fluid from the capillary channel. Since these detection systems are well-known from the prior art they are not described in more detail herein but reference is made to U.S. Pat. Nos. 5,762,770 and 36,268.

A further decisive factor which is important for an efficient uptake of body fluid is the wettability of the collection zone. When capillary structures made of silicon are used, these are usually adequately wettable due to a silicon oxide layer on the surface. If metals are used for the capillary structure, these are often relatively difficult to wet. This can be counteracted by a number of different hydrophilisation measures such as silication of the surface. The wettability is usually adequate when the liquid in the capillaries has a concave meniscus which is the case when the wetting angle is less than 90.degree..

In a preferred embodiment of a body fluid collection system the volume of the fluid sample is very small, i.e. less than 0.5 .mu.l, preferably 3 to 10 mL. Such a small volume can be collected very fast, e.g. using very small holes of for example 20 .mu.m in diameter generating high capillary forces for rapid filling. The time to receive sufficient amount of body fluid sample can be less than 0.1 s, e.g. 1 to 10 ms. Accordingly the interaction time between the skin-piercing element and the body while the skin-piercing element remains in the body and sufficient amount of body fluid sample is received may be less than 0.5 s, e.g. about 10 ms. Preferably the body fluid sample is collected in the body so that virtually no blood is visible on the skin. According to the invention the geometry of the collection zone and hence the body fluid volume that is collected is defined precisely, e.g. the risk of over- or underdosing of the fluid receiving means is significantly reduced.

FIG. 13 shows a skin-piercing element (14) which has a collection zone (9) which runs in an elongated portion of the skin-piercing element. This portion is connected to a holder (32) in form of a frame. The elongated portion has a protruding portion (33) which protrudes from the holder portion (32). At the front end of the protruding portion a sharpened tip (3) is located. The sharpened tip (3) enables penetration of the skin surface during pricking with the skin-piercing element. The collection zone (9) is located in the front end region of the protruding portion. The collection zone is an open capillary channel which permits body fluid which contacts the channel in the region of the protruding portion to move into the moveable portion of the collection zone (34) by means of capillary action. As depicted in FIG. 13 protruding portion (33), moveable portion (34) and frame portion (32) of the skin-piercing element (14) are formed integrally. The skin-piercing element (14) can be made by etching processes. As well known in silicon manufacturing processes a wafer of silicon material can be etched to provide devices comprising tips and capillary channels. For mass production it is however advantageous to produce the skin-piercing elements by etching of thin metal plates. It is particularly advantageous that the sharpened tip (3) of the protruding portion (33) can be formed during the etching process as well so as to avoid separate grinding steps. As can be seen from FIG. 13 there is no reagent or sensor contacting the fluid channel which would receive body fluid immediately after the collection zone has been filled with sample fluid. The present invention proposes to locate a test zone or sensor separately on a fluid receiving means.

FIG. 14 shows the skin-piercing element (14) of FIG. 13 together with a fluid receiving means (10) including a test zone (35). The fluid receiving means (10) is shown schematically. The fluid receiving means (10) is located on the upper side of the skin-piercing element (14) on which side the fluid channel (9) is open to the environment. The fluid receiving means (10) is, however, initially spaced from the collection zone (9) so that sample fluid within the collection zone does not contact the fluid receiving means. Therefore no fluid transfer from the collection zone onto the fluid receiving means occurs in this geometry of the fluid sampling device. In the depicted embodiment the fluid receiving means essentially consists of a holding structure (11) which provides proper orientation and spacing of the fluid receiving means relative to the skin-piercing element and the test zone (35). In the depicted embodiment the test zone includes a reagent which produces an optical signal based on the concentration of analyte in the body fluid. Due to the incorporation of porous materials as e.g. kieselghur or titanium dioxide, the reagent already has high capillarity that sucks fluid from capillary channel (9). The reagent is applied to a carrier surface. After fluid has been received in the collection zone and has filled the moveable section (34) the body fluid sampling device is primed for measurement. By means of mechanical actuation the moveable section (34) can be bent in direction of the sensor (35) so that body fluid located in the collection zone (9) contacts the test zone (35) and wets the reagent. This mode of contacting the sensor with sample fluid has several advantages over the prior art devices.

A first advantage over the prior art is that measurement can be initiated at a specific point in time. This means that the time between wetting of the test zone and measurement of the final signal can be chosen at will. The time period, however, is shorter than the drying time of blood in the capillary. Knowing or controlling the time of reaction improves accuracy of the measurement. Further a signal can be measured beginning directly after wetting which allows to monitor reaction kinetics. Evaluation of this early signals can be used to improve accuracy of the measurement result as well.

FIG. 18 shows a skin piercing element having two parts (70, 70') which can be moved relative to one another. In FIG. 18a the parts (70, 70') are aligned to form a capillary channel into which sample is received. The filled device (FIG. 18b) is rearranged as shown in FIG. 18c. At one end of the channel the parts are moved apart and hence the sample is concentrated in the region (71) where the parts are still close together.


I would like to invite people around the world to send messages to those 6,311 emails below pledging USPTO Examiners  to be honest and stop violating intellectual property rights allowing huge corporations and UNIVERSITIES to reinvent issued patents shamefully dishonoring HYDROLOGY SCIENCE and breaking the Law.


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