Panchev v. Kappos
| Decision Date | 25 June 2013 |
| Docket Number | Civil Action No. 1:12-cv-641 (GBL/IDD) |
| Court | U.S. District Court — Eastern District of Virginia |
| Parties | VLADIMIR PANCHEV, el al., Plaintiffs, v. DAVID KAPPOS, Director, United States Patent and Trademark Office, Defendant. |
THIS MATTER is before the Court on Defendant's Motion for Summary Judgment. (Doc. 20.) This case concerns Plaintiffs' United States Patent Application 10/496,322 ("the '322 Application"), which seeks the issuance of a patent with claims directed at a method for treating tumors with formic acid. (See Administrative R. Al (hereinafter Admin. R.], Doc. 13-3.) This case presents three issues.
The first issue is claim construction. Plaintiffs assign error to the United States Patent and Trademark Office's ("USPTO") construction of their claim term "tumor" to encompass warts. Upon de novo review, the Court construes Plaintiffs' term language to encompass any and all abnormal growths, including warts. The Court reaches this construction for two reasons. First, the Court's construction is consistent with the ordinary and customary meaning of the term as it is used in the claim language and correlates with contemporaneous dictionary definitions, including those to which Plaintiffs cited during prosecution. Second, the Court's construction isconsistent with Plaintiffs' intent, as evidenced by the use of the term in the specification. For these reasons, the Court construes "tumor" to mean any abnormal growth.
The second issue is whether the Director of the USPTO is entitled to summary judgment as to Plaintiffs' claim that the USPTO erred in concluding that their claimed method was obvious over two prior art references, Agholme and Schwartz. The Court concludes that Plaintiffs' Application is obvious over the cited references for two reasons. First, construing "tumor" to encompass warts, Plaintiffs' Application would have been obvious because the treatment of warts, a benign tumor, with formic acid is taught by the Agholme reference. Second, the germicidal properties referenced in Schwartz, which teaches the addition of iodine for its antiseptic benefits, would have been an obvious combination with the ablation of undesirable tissue taught by Agholme. As a result, the Court finds no material issue with respect to the obviousness of Plaintiffs' claims and the Court grants the Director summary judgment on this count.
The third issue is whether the Director is entitled to summary judgment as to Plaintiffs' claim that the USPTO erred in concluding that their specification's disclosure fails to enable their claims. The Court grants the Director's Motion for Summary Judgment on this claim because Plaintiffs' specification fails to provide the requisite specificity to fully disclose how to use the novel aspects of their claims sufficient to enable one of ordinary skill in the art to practice the claimed method without undue experimentation. Further, the Court's tie novo review of Plaintiffs' newly admitted, post-filing evidence does not alter this conclusion because the scientific abstracts and the experimental data of a single treatment remain inadequate to surmount the deficiencies of Plaintiffs' Application insofar as the specification fails to explain how its teaching could be implemented to treat all types of tumors. Therefore, Plaintiffs' claimsfail for lack of enablement and the Court grants the Director's Motion for Summary Judgment on this count.
This case concerns Plaintiffs Vladimir Panchev, Marieta Pancehva, and Adelina Pancheva's '322 Application entitled, "Medium for Radical Treatment of Tumors, Inflammatory Processes, Fungal Infections and other Affections of the Tissues, Diagnostic and Prophylactic and Method of its Implementation." (Admin. R. Al.) Plaintiffs are Bulgarian citizens, proceeding pro se, seeking review of the USPTO's rejection of their claims pursuant to 35 U.S.C. § 145.
Plaintiffs filed the '322 Application on May 20, 2004, seeking claim priority to an earlier Bulgarian application filed on December 12, 2001.1 Specifically, Plaintiffs seek method claims generally directed to treating tumors with formic acid based on their alleged discovery that the more permeable blood vessels of diseased tissues, such as tumors, are uniquely penetrable, such that the blood coagulation properties of formic acid are able to penetrate the vascular system to necrotize the targeted diseased tissue. In other words, Plaintiffs' Application seeks a patent for a method applying a known chemical to abnormal growths, in which Plaintiffs purport that the method kills the growth by restricting its blood supply while preserving the surrounding healthytissue. Plaintiffs' Application, therefore, seeks a patent on a method of treating all benign and malignant tumors.
Plaintiffs assert their field of invention as "the treatment of tumor[s] and other diseased tissues with increased permeability of their blood vessels." (Admin. R. A260, Doc. 13-4.) The method of treatment claimed is "based on the different degree of protection that ensure [sic] that blood vessels of healthy and of the tumor tissue against [sic] the influence of blood-coagulation enhancing substances . . . ." (Admin. R. A261.) Plaintiffs propose their method based on (1) the "[a]typicity of the tumor tissue . . . in direct proportion of its malignity[;]" (2) the superior vascular protection of healthy tissue; (3) the blood coagulation properties of formic acid; (4) the reduced risk of side effects from formic acid exposure; and (5) the rapid absorption rate of formic acid's water solutions, which Plaintiffs purport allow for the treatment of internal tumors without the need of syringe, sound, or surgical intervention. (Admin. R. A262.)
The specification of Plaintiffs' Application generally provides that their invented method can be used to treat tumors with formic acid, to which iodine may be added to accelerate absorption. (Admin. R. A263.) Plaintiffs qualify their method by stating that their method is case dependent and depends on the treating physician's qualifications but that generally a 10% solution with the addition of a 5% iodine concentration is sufficient for malignant tumors. (Id.) The treatment of Plaintiffs' method consists of rubbing the concentrated medium directly on the tumor or an accessible surface of the contiguous healthy tissue. (Id.) Repeated application and monitored absorption is instructed, such that the tumor is sufficiently saturated with formic acid solution and the tumor is necrotized. (Id.) Plaintiffs warn of a "caustic effect" on tissues, however, with too high of a concentration resulting in toxicity. (Id.) For benign tumors, Plaintiffs' Application teaches the mechanical irritation of the tissue. (Id.)
Additionally, the Plaintiffs' specification provides details of one example of the method of treatment. Specifically, Plaintiffs mention the treatment of a 52-year-old woman, Plaintiffs' relative, with "two side fibrous mastopathy" three times a day over the course of ten days. However, Plaintiffs' specification provides no other details of treatment, nor does Plaintiffs' Application specify how to use its claimed method beyond its fibrous mastopathy reference. Notwithstanding Plaintiffs' sparse specification, Plaintiffs purport that their method opens "unlimited possibilities for tumor treatment in other organs" through inhalation, puncture, and by surgical reach. (Admin. R. A265.)
Plaintiffs' Application claims:
On June 28, 2007, and following preliminary exchanges with the USPTO Examiner, Plaintiffs amended claims 1-3. These claims were originally directed to the "treatment, diagnostic and prophylactic of benign and malignant tumors, inflammatory disease states, pathologically affected tissues, fungal infections, and blood stopping . . . ." (Admin. R. A195. Doc. 13-3.) Ultimately, claims 1-3 were amended to state "treatment for benign and...
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