Ex Parte ShaferDownload PDFBoard of Patent Appeals and InterferencesJun 10, 201111000856 (B.P.A.I. Jun. 10, 2011) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte LISA L. SHAFER __________ Appeal 2010-008771 Application 11/000,856 Technology Center 1600 __________ Before DONALD E. ADAMS, ERIC GRIMES, and STEPHEN WALSH, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to methods of treating a stroke in a subject. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The Specification discloses methods “to promote recovery o[f] damaged CNS tissue by making use of the endogenous (not-implanted) stem cell[] populations” (Spec. 5, ¶ 14) by “combining electrical and chemical Appeal 2010-008771 Application 11/000,856 2 therapies to optimize the proliferation, differentiation, migration, and integration of endogenous stem cells” (id.). Claims 4-10, 18, 19, 33, 36-38, 41, 46, 47, and 55 are on appeal. Claim 4 is representative and is directed to a method of treating stroke that comprises, among other steps, implanting a “first therapy delivery element” (either a catheter or a lead) in the subject and “positioning the therapy delivery region of the first therapy delivery element in a first CNS region containing endogenous stem cells selected from the group consisting of a subventricular zone of a lateral ventricle, a central canal of a spinal cord, [and] a subgranular zone of the hippocamupus [sic],” then applying a first therapy that is either an electrical signal or one of several specified therapeutic agents, where the delivered signal or agent “promote[s] the endogenous stem cells to proliferate, migrate, or differentiate.” The full text of claim 4 is reproduced in Appellant’s Claims Appendix (Appeal Br. 18- 19). All of the claims on appeal stand rejected under 35 U.S.C. § 103(a) both in view of John,1 Finklestein,2 Wiessner,3 and Gliner,4 and in view of John, Hartlaub,5 and Gliner. 1 John, US 6,066,163, issued May 23, 2000. 2 Finklestein et al., WO 01/12236 A3, published Feb. 22, 2001. 3 Wiessner et al., Anti-Nogo-A Antibody Infusion 24 Hours After Experimental Stroke Improved Behavioral Outcome and Corticospinal Plasticity in Normotensive and Spontaneously Hypertensive Rats, 23 J. CEREBRAL BLOOD FLOW & METABOLISM 154-165 (2003). 4 Gliner et al., US 2003/0088274 A1, issued May 8, 2003. 5 Hartlaub, US 2002/0042597 A1, issued Apr. 11, 2002. Appeal 2010-008771 Application 11/000,856 3 I. Issue The Examiner has rejected all of the claims on appeal as being obvious in view of John, Finklestein, Wiessner, and Gliner. The Examiner finds that John discloses a method of treating, e.g., stroke “by a first therapy that is an electrode to generate a[n] electric signal and a second therapy that is [an] infusion of [a] neurotrophic or therapeutic agent” (Answer 5). With regard to the limitation of claim 4 requiring positioning a therapy delivery element in one of three specific CNS regions, the Examiner finds that John discloses the infusion of “pharmacological agonists/antagonists or neurotrophic factors … through [the] lateral ventricle…. The lateral ventricle encompasses the subventricular zone.” (Id. at 6-7.) Appellant contends that it would not have been obvious to position a therapy delivery element in the recited CNS regions because the cited references do not discuss providing therapy to endogenous stem cells or suggest positioning a therapy delivery element in any of the recited regions that contain endogenous stem cells (Appeal Br. 10-12). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that it would have been obvious to one of ordinary skill in the art, in view of the cited references, to position a catheter portion or an electrode lead in a subventricular zone of a lateral ventricle? Findings of Fact 1. The Specification discloses that a “subventricular zone includes a mediolateral wall of a lateral ventricle” (Spec.16, ¶ 64). Appeal 2010-008771 Application 11/000,856 4 2. Figure 5 of the Specification is shown below: The figure shows a catheter with an electrode 5 may be positioned in a region containing endogenous stem cells. The catheter with an electrode 5 is positioned at the lateral walls of the ventricles. At step 1, a stem cell enhancing agent may be delivered via the catheter with the electrode 5 to the lateral walls of the ventricles. At step 2, an electrical signal may also be applied to the lateral walls of the ventricles. (Spec. 20, ¶ 82.) 3. John discloses a “brain stimulation system and method … which aids in the rehabilitation of patients from traumatic brain injury, coma, or other brain dysfunction. After a direct brain stimulator is implanted in a brain region of a patient, the patient is stimulated according to a set of stimulation parameters.” (John, abstract.) Appeal 2010-008771 Application 11/000,856 5 4. John discloses that “a second area of the brain is stimulated when stimulation of the first brain area produces a desired effect, thereby reinforcing the prior response of the brain” (id.). 5. John discloses that “instead of electrical stimulation, stimulation can utilize pharmacological means such as systemic injection or local microinjection of psychostimulants (amphetamine) or other and functional agonists or antagonists which can be routed directly into a specific brain area or into a lateral ventricle” (id. at col. 12, ll. 58-63). 6. John discloses that an infusion apparatus can provide a supply of pharmacological antagonists, or agonists such as psycho stimulants which can move the brain or an area of the brain into a more active state, or provide a supply of therapeutic agents such as neurotropic substances that will work either independently or in conjunction with the electrical stimulation to produce beneficial results. (Id. at col. 10, ll. 60-66.) Analysis We agree with Appellant that the Examiner has not adequately shown that the cited references would have made obvious to position a therapy delivery element in any of the regions that are recited in claim 4 (Appeal Br. 10-12). As discussed above (FFs 3-6), John only discloses administering therapeutic agents to a lateral ventricle itself. A ventricle, as shown in the Specification’s Figure 5 (FF 2) is a (fluid-filled) empty space. Claim 4, by contrast, requires positioning the therapy delivery element in the subventricular zone of the ventricle, which, as described in the Specification (FFs 1, 2), is the wall of the ventricle; i.e., the tissue that defines the boundary of the ventricle. Appeal 2010-008771 Application 11/000,856 6 The Examiner reasons that therapeutic agents “delivered into a lateral ventricle would diffuse and reach the SVZ [subventricular zone] of the lateral ventricle. Thus intraventricular delivery of neurogenesis-enhancing agents into the lateral ventricle as taught by [John] does equate to delivery of the agents to the SVZ of a lateral ventricle.” (Answer 16.) We do not agree that this adequately supports the rejection. Claim 4 does not recite “delivery of the agents” to the subventricular zone of the lateral ventricle, as the Examiner states. Claim 4 expressly recites “positioning the therapy delivery region of the first therapy delivery element” in a subventricular zone of a lateral ventricle. Although the Specification discloses that this step can be met by a “catheter with an electrode 5 … positioned at the lateral walls of the ventricles” (FF 2), the broadest reasonable interpretation of the claims does not read on simply delivering an agent to the lateral ventricle itself, whether or not an agent so delivered would also reach the subventricular zone. The Examiner also reasons that John discloses electric stimulation of the hippocampus and the cortex, which contain endogenous stem cells in the “subgranular zone of the hippocampus” and the “subventricular zone of a lateral ventricle,” respectively (Answer 17). This reasoning is not persuasive because it impermissibly ignores claim limitations: positioning a therapy delivery element in the hippocampus or the cortex is not the same as positioning it in the subgranular zone of the hippocampus or in a subventricular zone of a lateral ventricle. Appeal 2010-008771 Application 11/000,856 7 Independent claims 41 and 55, like claim 4, require positioning the infusion section of a catheter (claim 41) or an electrode lead (claim 55) in a subventricular zone of a lateral ventricle, a central canal of a spinal cord, or a subgranular zone of the hippocampus. Thus, the rejection of claims 4, 41, and 55, and dependent claims 5-10, 18, 19, 46 and 47, is reversed for the reasons discussed above Independent claim 33 is similar to claim 4 in requiring the positioning of both an electrode lead and an infusion section of a catheter “in communication with a … subventricular zone of a lateral ventricle, a central canal of a spinal cord, a subgranular zone of the hippocamupus [sic].” Claim 33 also requires that the electrical stimulation and therapeutic agent promote proliferation, migration, or differentiation of the endogenous stem cells. Since none of the cited references disclose or suggest an electrode lead or an infusion element in any of the recited regions, the Examiner has not adequately explained why one of skill in the art would expect that the application of electric stimulation or therapeutic agents to portions of the brain, other than those recited in the claim, would result in the proliferation, migration, or differentiation of the endogenous stem cells from the claimed regions. Thus, the rejection of claim 33, and dependent claims 34-36, is reversed. Conclusion of Law The evidence of record does not support the Examiner’s conclusion that it would have been obvious to position a catheter portion or an electrode lead in a subventricular zone of a lateral ventricle. Appeal 2010-008771 Application 11/000,856 8 II. The Examiner has rejected all of the claims on appeal under 35 U.S.C. § 103(a) as being obvious in view of John, Hartlaub and Gliner. The Examiner finds that Hartlaub discloses treating a stroke patient by “implanting an infusion system in the patient to deliver a medicament composition” (Answer 11). The Examiner relies on John and Gliner as for the rejection discussed above. The Examiner concludes that it would have been obvious to one of ordinary skill in the art to combine the teachings of John, Hartlaub and Gliner “to apply neurotrophic factors to the CNS to rescue neuronal death and simultaneously to apply an electric signal by an implantable electrode to the CNS to treat … stroke … since neurotrophic factors and electric stimulation have been shown to stimulate neurogenesis of neural stem cells” (id. at 14). As with the previously discussed rejection, Appellant argues that it would not have been obvious to position a therapy delivery element in any of the recited regions because none of the cited references disclose or suggest providing therapy to endogenous stem cells or suggest positioning a therapy delivery element in the specified regions (Appeal Br. 16). We agree with Appellant that the Examiner has not adequately shown that the cited references would have made obvious the claims on appeal. The Examiner reasons that John discloses the treatment or stimulation of the hippocampus and the cortex and the “hippocampus and cortex are known … regions that contain endogenous stem cells,” i.e. in the subgranular zone of the hippocampus and in the subventricular zone of a lateral ventricle, respectively (Answer 22). The Examiner further reasons Appeal 2010-008771 Application 11/000,856 9 that in Gliner the “brain regions to be treated or stimulated by electrodes include regions containing endogenous stem cells, such as the hippocampus, which is the damaged brain region of Alzheimer's disease” (id. at 21). The Examiner does not cite Hartlaub for any disclosure relating to the brain areas specified in the claims (see id. at 11, 21). As discussed above, however, the Examiner has not adequately explained why the disclosure of treating a larger brain portion such as the cortex or the hippocampus would have made obvious positioning a catheter portion or an electrode lead in a smaller part of those areas, specifically, the subventricular zone of a lateral ventricle or the subgranular zone of the hippocampus. Thus, the rejection of independent claims 4, 41 and 55, and their associated dependent claims is reversed. Further, as discussed above for claim 33, the Examiner has not adequately explained why one of skill in the art would expect that the application of electric stimulation or therapeutic agents to portions of the brain, other than those recited in the claims, would result in the proliferation, migration, or differentiation of the endogenous stem cells from the claimed regions. Thus, the rejection of independent claim 33, and its dependent claims, is reversed. SUMMARY We reverse the rejection of claims 4-10, 18, 19, 33, 36-38, 41, 46, 47 and 55 under 35 U.S.C. § 103(a). REVERSED Appeal 2010-008771 Application 11/000,856 10 EG SW DEA cdc Copy with citationCopy as parenthetical citation