Categories: Interferences Date: May 20, 2014 Title: Tobinick v. Olarmarker: Written Description Analysis in Interference Proceeding
|Title||Tobinick v. Olarmarker, No. 2013-1499 (Fed. Cir. May 19, 2014).|
|Issue||[T]he parties dispute the meaning of “administered locally” and whether Tobinick’s patent application contains written description support for this claim limitation. |
Tobinick at *2.
|Holding||We find that Tobinick’s application contains sufficient written description support for local administration because it describes administering the relevant therapeutic compound to the epidural space adjacent to a herniated spinal disc, which is the site where the com- pound “is intended to act” and “the location where the nucleus pulposus is causing the symptoms of the nerve disorder.”|
Id. at *2.
|Procedural History||This appeal arises out of an interference proceeding before the Patent Trial and Appeal Board (“Board”) at the United States Patent and Trademark Office (“PTO”) relating to drug treatments for spinal nerve injuries. The Board construed “administered locally” as administering the claimed therapeutic compound “directly to the site where it is intended to act, that is, to the location where the nucleus pulposus is causing the symptoms of the nerve disorder.” Based on this construction, the Board found that Edward Tobinick’s (“Tobinick”) patent application did not contain written description support for the interference count. Without written description support for the count, Tobinick lacked standing to bring the interference, and the Board dismissed.|
Tobinick at *2.
|Legal Reasoning (Lourie, Reyna, Wallach)|
|Patents at Issue in Interference||On December 15, 2011, Tobinick requested an interference by copying claims from the ’995 and ’990 patents in Tobinick’s patent application 12/714,205 (“’205 application”). These claims covered methods of treating spinal nerve injuries by locally or epidurally administering a TNF-α inhibitor.|
Tobinick at *4.
|Claim 68: A method of treating or alleviating one or more symptoms of a nerve disorder mediated by nucleus pulposus in a mammal in need of such treatment comprising the step of administering a therapeutically effective amount of a TNF-α inhibitor to the mammal, wherein said TNF-α inhibitor is an antibody that blocks TNF-α activity, wherein the antibody is administered locally.|
Id. at *4.
|Claim 69: The method of claim 68, wherein the antibody is administered epidurally to the mammal.|
’205 application ¶ 37 (emphasis added).
Id. at *4.
|Claim Construction of '995 Patent|
|Intrinsic Evidence||The ’995 patent[…] discloses “a method for treating nerve disorders . . . by administering . . . a TNF inhibitor.” […] The goal of the method is to treat back pain caused by TNF-α’s irritation of nerve endings. […] The ’995 patent contrasts local and systemic administration. Regarding local administration, the patent provides an example in which the inhibitor is applied directly to the nucleus pulposus. |
Tobinick at *6 (internal citations omitted).
Battle of the Experts
|Olmarker’s witness, Dr. Andersson, relied on dictionary evidence to contrast the definition of “local,” as “restricted to or pertaining to one spot; not general,” Dorland’s Illustrated Medical Dictionary 552 (23d ed. 1957), with that of “general,” as “affecting many parts or all parts of the organism, not local,” id. at 772. Based on these definitions, Dr. Andersson defined “local administration” as administration “directly to the site where the medicine is intended to act,” whereas he defined “systemic administration” as administration in which “medicine is broadly distributed before reaching the site of action, such as being carried . . . by the vascular system.”|
Id. at *7.
|Tobinick’s expert witness, Dr. Richardson, also relied on dictionary evidence, which defined “local” in essentially the same way as Dr. Andersson. See Stedman’s Medical Dictionary for the Health Professions and Nursing 982 (7th ed. 2012). Dr. Richardson also discussed more re- mote administration techniques. For example, Dr. Richardson testified that a steroid can be injected up to about ten centimeters away from the site of the nerve injury and still remain effective.|
Id. at *7.
|Construction Upheld||The Board’s conclusion that the disputed claims cover the administration of TNF-α inhibitor “directly to” the site of the nerve injury is supported by the specification and the medical definitions of “local” presented by both sides. Contrary to Tobinick’s argument, the Board’s construction does not exclude administration “adjacent to disc herniation.” Because leakage of nucleus pulposus from a herniated disc affects the nerve roots of adjacent discs, a site of nerve injury “adjacent to disc herniation” may well be where the inhibitor “is intended to act.” |
Id. at *8.
|Written Description of '205 Patent|
|Legal Standard||The written description determination depends on “the nature and scope of the claims and on the complexity and predictability of the relevant technology.” […] Accordingly, we must determine whether the disclosure of the ’205 application “reasonably conveys to those skilled in the art” that Tobinick “had possession” of the claimed local administration. […]|
Tobinick at *9 (internal citations omitted).
|Support in '205 Application||The ’205 application discloses “methods for treating neurological . . . disorders in humans by administering a [TNF-α inhibitor].” ’205 application ¶ 31. The specification distinguishes between local and systemic delivery of TNF-α inhibitor and lists several unique benefits of local administration. […] The disclosure lists perispinal administration as a preferred form of localized administration of a TNF-α inhibitor. […] The specification defines perispinal administration as including a number of different administration techniques. One such technique is an epidural injection adjacent to the site of disc herniation. […]|
Id. at *10.
|Adequate Description||A person of ordinary skill in the art would understand this type of epidural injection to be an injection into the location where the TNF-α is injuring spinal nerves. As explained above, nucleus pulposus leaks from an injured spinal disc into the epidural space, where spinal nerve roots are located. The ’995 specification recognizes that TNF-α in the epidural space harms adjacent nerve roots. […] Thus, an epidural injection adjacent to the site of disc herniation will administer the drug “directly to the site where it is intended to act, that is, to the location where the nucleus pulposus is causing the symptoms of the nerve disorder.”|
Id. at *10-11 (internal citations omitted).
|For the above reasons, we conclude that the Board’s finding of lack of adequate written description is not supported by substantial evidence. Accordingly, we reverse the Board’s decision to dismiss the interference and remand for further proceedings.|
Tobinick at *12.