Treatment of tumors using implanted radiation sources; Cianna Medical, Inc.; U.S. Pat. No. 7,736,292

July 5, 2010 Leave a comment

U.S. Patent No. 7,736,292, issued on June 15, 2010 to Cianna Medical, Inc. of Aliso Viejo, CA, discloses a device and method for treating breast cancer or prostate cancer using radiation sources implanted in the body (brachytherapy).

In low-dose rate (LDR) brachytherapy, multiple radiation sources or “seeds” (e.g., each about the size of a grain of rice) are implanted via needles within or near a tumor and/or surrounding tissue that may contain cancerous cells  to deliver a measured and localized dose of radiation for extended periods of time.  The lower radioactivity of LDR seeds provides benefits as compared to high-dose rate (HDR) brachytherapy, including less stringent safety procedures for healthcare workers, less damage of normal tissue during treatment, and fewer visits by the patient to the healthcare facility.  However, there are potential drawbacks of LDR brachytherapy, such as the implanted seeds are generally not removable or repositionable, can move or migrate within the body, and need to be manipulated individually at the time of implantation, which can be a time-consuming process.  The ’292 patent discloses a method and apparatus that prevents or substantially limits movement of the LDR seeds, allows removal of the seeds after treatment, and uses pre-arranged seed packages to facilitate implantation.

According to its website, Cianna Medical is “a women’s health company dedicated to the innovative treatment of early-stage breast cancer.”  The website includes alot of information on Cianna’s SAVI® applicator for targeting radiation “to sculpt dose away from the skin and chest wall without sacrificing overall treatment coverage.”  The SAVI® applicator appears to be compatible with some of aspects of the technology disclosed by the ’292 patent.

According to the USPTO database, Cianna has two issued U.S. patents, including the ’292 patent, and four pending U.S. patent applications.  However, Cianna likely has other intellectual property protection besides these two U.S. patents.  For example, a March 2009 press release by Cianna touted U.S. Patent Nos. 7,497,819 and 7,497,820 as being “directly related to its SAVI multi-catheter brachytherapy device for the treatment of breast cancer.”  Yet these two patents were issued to Theragenics Corp., not Cianna.   Presumably, Cianna obtained a license to these two patents from Theragenics, a hypothesis supported by the fact that Theragenics’ 2009 Annual Report states that in May 2008, the company “entered into an exclusive license agreement for the rights to certain intellectual property related to an expandable brachytherapy delivery system developed by us.”  The report did not identify Cianna as the licensee, but gave some information regarding the license including the minimum annual royalties.      

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TechAmerica OC’s “High-Tech Innovation” Awards and Finalists; Clarient

June 6, 2010 Leave a comment

On June 2, 2010, I attended the 17th Annual High-Tech Innovation Awards presented by TechAmerica OC.  A number of my firm’s clients were finalists for awards in the various categories, and I was happy to see that a few of them picked up awards in areas including medical technology and “green” technology.

I had the pleasure of sitting at a table with Ronnie Andrews, CEO of Clarient, Inc. of  Aliso Viejo, CA, and a few members of his team.   Clarient develops innovative cancer diagnostic technologies, and was a finalist in the medical technology category.  From our conversation, it was clear that they see patent protection as an important part of Clarinet’s success, and that they are on top of the latest developments in patent law as they relate to Clarient’s business.  

According the USPTO database, Clarient’s most recent U.S. patent issued in March 2010 as U.S. Pat. No. 7,678,581 for a method of ”Correlating chemical and spatial data within pathology samples.”

 

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Bariatric surgery through the esophagus: US Pat. No. 7,703,459

May 11, 2010 Leave a comment

U.S. Patent No. 7,703,459, issued on April 27, 2010 to USGI Medical, Inc. of San Clemente, CA, discloses a system and method for performing gastrointestinal surgery.

As described by the patent, gastrointenstinal (GI) surgical techniques for treating morbidly obese patients can be challenging.  For example, laparoscopy can be hampered by the fat layers needed to be traversed by accessing the stomach from outside the torso, and open surgical procedures have numerous post-operative complications.  The patent discloses a system and method of accessing the stomach endoluminally (i.e., through the esophagus) and performing GI surgery (e.g., bariatric surgery) to reduce the patient’s stomach volume while promoting the patient’s wound healing response.

 USGI’s website touts their “breakthrough capability to reliably and durably fixate and plicate GI tract tissue without an incision” by “[o]perating through the body’s natural orifices.”    According to the USPTO database, USGI has 23 U.S. issued patents, including seven in 2009 and four in 2010 (so far).

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In the news: SenoRx

May 6, 2010 Leave a comment

According to an Orange County Business Journal article yesterday, SenoRx Inc. of Irvine, CA, a developer of minimally-invasive medical devices used in the diagnosis and treatment of breast cancer, is being acquired for about $213 million by C.R. Bard, Inc., a multinational medical device company with yearly sales of more than $2.5 billion.

In January, SenoRx was awarded U.S. Patent No. 7,651,505, which was the subject of an earlier blogpost of mine.  The same day, SenoRx was also awarded U.S. Patent No. 7,651,467, directed to a method of removing a tissue specimen from a target site within a patient’s body. 

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Parabolic contact lens: US Pat. No. 7,682,020

March 29, 2010 Leave a comment

U.S. Patent No. 7,682,020, issued on March 23, 2010 to Natural Focus LLC of Santa Ana, CA, discloses a contact lens designed to reshape the cornea.

According to the patent, as practiced since the 1970′s, orthokeratology is a method which uses a rigid contact lens to exert pressure on selected portions of the cornea to modify its shape, which it retains for a period of time once the contact lens is removed.  A retainer lens is then worn on a part-time basis to prevent the cornea from returning to its former shape.  Since the corneal shape affects how light is refracted through the cornea, this technique seeks to modify the shape of the cornea to focus light onto the retina, thereby correcting the patient’s vision. 

The patent discloses a parabolic contact lens designed to reshape the cornea by epithelium and stromal tissue growth to correct the patient’s vision after the lens has been worn for a sufficient amount of time.  The resulting corrections are described as lasting several days before a retainer lens is required.

Natural Focus’ website touts their proprietary “Corneal Reshaping Therapy” as having advantages over current laser refraction surgical techniques (e.g., LASIK).  I got a smile out of the realization that Natural Focus was lucky enough to receive U.S. Pat. No. 7682020 for their contact lens.

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Antibodies for serum PTH levels: US Pat. No. 7,670,805

March 8, 2010 Leave a comment

U.S. Patent No. 7,670,805, issued on March 2, 2010 to Immutopics, Inc. of San Clemente, CA, discloses a method of producing isolated antibodies useful for determining PTH levels in blood.

 

Parathyroid hormone (PTH) is involved in the body’s regulation of blood calcium ion levels by releasing stored calcium when serum calcium levels decrease.  Serum PTH levels can be important to monitor for patients suffering from various conditions, including osteoporosis, but it is normally present at extremely low levels, and in the form of various fragments, making reliable measurements difficult.

According to the patent, the disclosed methods produce antibodies with an improved binding affinity to PTH at higher yields, thereby allowing more cost-effective and reliable assays of serum PTH levels.

 According to its website, Immutopics specializes in innovative assays for assessing bone health, including their “Human BioActive PTH (1-84) ELISA kit.”  The USPTO database lists three previous U.S. patents for Immutopics, two of which also deal with producing antibodies for PTH assays.

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Electrodes for implantable defibrillator: US Pat. No. 7,657,322

February 7, 2010 Leave a comment

U.S. Patent No. 7,657,322, issued on February 2, 2010 to Cameron Health, Inc. of San Clemente, CA, discloses an electrode assembly for a defibrillator implanted subcutaneously outside the patient’s ribcage. 

According to the patent, the electrodes of conventional  implantable cardioverter/defibrillators (ICDs) are directly applied to heart tissue (e.g., via a catheter that passes through the superior vena cava and into one or more endocardial areas of the heart).  Conversely, as described by the patent, the subcutaneous ICD and electrodes can be implanted without exposing heart tissue during the implantation process, and can avoid the expensive implantation techniques and complications of conventional ICDs. 

Cameron Health was also issued two other U.S. patents on the same day as the ’322 patent (U.S. Pat. Nos. 7,657,311 and 7,655,014), both directed to methods of implanting subcutaneous ICDs and their electrodes.  According to the USPTO database, Cameron Health has received 67 U.S. patents, with 11 issued in 2009, 12 in 2008, and 11 in 2007.  With these three U.S. patents in February 2010, the company seems to be on track to have an equally successful 2010, patent-wise.

In 2004, Boston Scientific made an equity investment in Cameron Health, and secured an exclusive option to purchase the company.  In 2006, as part of the approval of Boston Scientific’s acquisition of Guidant Corp., the FTC required Boston Scientific to reform certain contractual rights between Boston Scientific and Cameron Health to limit Boston Scientific’s control over certain Cameron actions and the sharing of nonpublic information about Cameron’s ICD product.

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Prosthetic knee: US Pat. No. 7,655,050

February 4, 2010 Leave a comment

U.S. Patent No. 7,655,050, issued on February 2, 2010 to Freedom Innovations, LLC of Irvine, CA, discloses a prosthetic knee device that is computer-controlled. 

The patent explains that previous prosthetic knees with computer-controlled actuators were complex and heavy, and that the prosthetic knee disclosed in the patent provides the gait speed adaptability and safety of a computer-controlled knee while being relatively lightweight and simple in design.

Freedom Innovations markets the Plié™ MPC Knee, which is described as a microprocessor-controlled knee that utilizes a proprietary technology to provide a smooth, secure, and natural gait — at any speed, angle, or incline. 

According to their website, the company has 13 U.S. patents and uses their innovative technologies to provide “top-quality, high performance prothetic devices for individuals with lower limb amputations.”  Their website also includes an admirable  mission statement and a set of values that would be well adopted by all businesses. 

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In the News: NeoMend

February 1, 2010 Leave a comment

Last week, socaltech.com reported that NeoMend, Inc. of Irvine, CA has raised $30M in a Series D funding round.  According to their website, NeoMend markets a patented hydrogel technology for use in wound sealing, prevention of post-surgical adhesions, and site-specific sustained drug delivery.  NeoMend’s patents include U.S. Patent No. 7,351,249, issued on April 1, 2008.

The ’249 patent describes a biocompatible material which can be used to seal a puncture site in a blood vessel and to seal a suture knot.  According to the USPTO database, NeoMend is listed as the assignee for fourteen U.S. patents, including the one featured here.  Earlier this month, NeoMend also received pre-market approval from the FDA for its ProGEL™ Pleural Air Leak Sealant, for use in lung surgery. 

 

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Biopsy site marker delivery device: US Pat. No. 7,651,505

January 31, 2010 1 Comment

U.S. Patent No. 7,651,505, issued on January 26, 2010 to SenoRx, Inc. of Irvine, CA, discloses a delivery tube for introducing markers into a patient’s body at desired locations to be used as reference points in ultrasound, x-ray, MRI, or other medical imaging devices.

For small cancerous lesions in the body (e.g., in the breast), it can be difficult to direct surgical or radiation treatment to the exact location from which a biopsy was taken, often weeks earlier.  The patent discloses a device to precisely place biopsy site markers to indiate the location where the biopsy was taken, thereby identifying the location of the lesion for later treatment.

SenoRx is a publicly owned company (NASDAQ: SENO), having completed its initial public offering of common stock in March 2007.  According to their website, SenoRx places a high priority on maintaining and growing a strong portfolio of intellectual property in the area of  minimally invasive devices for the diagnosis and treatment of breast cancer.  The USPTO database shows that SenoRx is the assignee of 68 issued U.S. patents, seven of which were issued in 2009 and ten of which were issued in 2008. 

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Delivering oxygen-supersaturated solutions to the body: US Pat. No. 7,641,628

January 6, 2010 4 Comments

U.S. Patent No. 7,641,628, issued on January 5, 2010 to TherOx, Inc. of Irvine, CA, discloses a system and method for generating a gas-supersaturated fluid and delivering it at high pressures without bubble formation.

 

An oxygen-supersaturated solution can be infused into a patient to provide oxygen to regions or systems of the patient’s body in need of oxygen (e.g., blood downstream of a balloon angioplasty site).  The patent discloses a way to generate this high-pressure solution and to controllably deliver it at a specified rate and pressure to prevent bubble formation. 

This patent provides a good example of mining a single patent application to obtain multiple patents with claims of varying scope.  But first, a bit of background:  Most of the time, in a first office action from the USPTO, the examiner will reject some or all of the claims of the application for not satisfying the legal requirements for patentability in an “office action.”  The applicant then has the opportunity to file a response which (i) explains how the rationale of the rejection is legally flawed, (ii) amends the claims to address the rejection, or both.  If the examiner is convinced by this response, the examiner will allow the patent to issue.  If the examiner remains unconvinced, a subsequent office action will be sent out by the USPTO.  This office action may be deemed to be a “Final Office Action” by the USPTO, but there are still opportunities to respond or perhaps to appeal the examiner’s rejection to continue pursuing the allowance of the application.

In this case, back in 1998, the examiner reviewed the original patent application, and instead of rejecting the application in an office action, the USPTO sent out a “Notice of Allowance,” and a first U.S. patent was issued in 1999.  Such “first-action allowances” are good news to the applicant; after all, the patent issued without having to argue with the examiner or amending the claims to satisfy the examiner’s view of patentability.  However, it’s possible that the examiner would have allowed even broader claims to issue.  By receiving the first-action allowance and not a rejection, the applicant doesn’t get information regarding the examiner’s view of how broad is too broad.

To avoid leaving money on the table, as it were, by having the issued claims more narrow than what might have been obtainable, a “continuation” application can be filed to pursue additional claims.  The scope of these claims can be different from those of the original patent application, but they must be fully supported by the specification as originally filed.  (There can be other reasons to file a continuation application, which I won’t discuss now.)  In this case, two continuation applications were subsequently filed, resulting in a second U.S. patent issuing in 2000 and a third U.S. patent issuing in 2001. 

We’re not done yet, though.  If the examiner reviews the claims of a patent application and determines that there are actually multiple inventions being claimed, the examiner will issue a “Restriction Requirement,” which requires that the applicant identify which of the multiple inventions they wish to pursue in the application.  The other inventions can be pursued in one or more “divisional” applications.  In this case, three divisional applications were subsequently filed, resulting in a fourth U.S. patent issuing in 2004, a fifth U.S. patent issuing in 2006, and a sixth U.S. patent (the subject of this blog post).  So the original patent application filed in 1997 resulted in six issued U.S. patents, all claiming priority to the original 1997 filing date.

TherOx is a private, venture-financed medical device company that flirted with an IPO in late 2008, but withdrew its filing in early 2009.  In March 2009, in a 9-5 split decision, an FDA advisory committee recommended against approval of TherOx’s Downstream oxygen delivery system for patients after percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) but sought further clinical trial data.  I presume that TherOx has since begun to gather additional data to bring back to the FDA, but in my internet searching, I haven’t found any reference to such efforts.

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Detecting botulinum or tetanus toxins: US Pat. No. 7,638,294

January 3, 2010 Leave a comment

U.S. Patent No. 7,638,294, issued on December 29, 2009 to Allergan, Inc. of Irvine, CA, discloses a fluorescence-based assay to determine the presence or activity of clostridial toxins, such as botulinum and tetanus toxins.

Botulism and tetanus are caused by highly potent neurotoxins produced by bacteria of the genus Clostridium.  For example, the presence of nanograms of botulinum neurotoxin can be fatal, which, surprisingly to me, hasn’t prevented people from injecting it into their faces (Allergan’s Botox® cosmetic injections) .  The patent discloses a way to test for the presence and activity of such toxins in the food and pharmaceutical industries while avoiding drawbacks of current methods (e.g., a mouse lethality test). 

Allergan, a global, $3 billion multi-specialty health care company, is the assignee of about 60 U.S. patents that issued in 2009 about 72 in 2008, and about 55 in 2007.  Allergan is currently suing the FDA, alleging that the ban on off-label marketing to health-care professionals of Botox®, namely the dissemination of safety data on its use to treat muscle spasticity, violates the company’s free speech rights.

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