Ex Parte ElbornoDownload PDFPatent Trial and Appeal BoardSep 4, 201412258317 (P.T.A.B. Sep. 4, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/258,317 10/24/2008 Ahmed A. Elborno 1362009-2103.1 8790 50638 7590 09/04/2014 Boston Scientific Neuromodulation Corp. c/o Lowe Graham Jones 701 Fifth Avenue Suite 4800 Seattle, WA 98104 EXAMINER DIETRICH, JOSEPH M ART UNIT PAPER NUMBER 3762 MAIL DATE DELIVERY MODE 09/04/2014 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte AHMED A. ELBORNO __________ Appeal 2012-005245 Application 12/258,317 Technology Center 3700 __________ Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. Opinion for the Board filed by Administrative Patent Judge PAULRAJ. Opinion Dissenting-in-Part filed by Administrative Patent Judge GRIMES. PAULRAJ, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to methods for treating essential tremor and restless leg syndrome using spinal cord stimulation. The Examiner rejected the claims on obviousness grounds. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.2 1 Appellant identifies the Real Party in Interest as Boston Scientific Neuromodulation Corporation (see App. Br. 3). 2 We also decide a related appeal, Appeal 2012-005243 (Application No. 12/180,924), concurrently with this decision. Appeal 2012-005245 Application 12/258,317 2 STATEMENT OF THE CASE Background “The present invention is directed to the area of implantable spinal cord stimulation systems and methods of making and using the systems,” and “is also directed to the use of implantable spinal cord stimulation systems for treating Parkinsonism, essential tremor, or restless leg syndrome” (Spec. 1:9-13). According to the Specification, essential tremor and restless leg syndrome are progressive neurological diseases with no known cures (id. at 2-3). The Specification states that a method for treating essential tremor or restless leg syndrome includes “implanting a lead near a spinal cord of a patient,” and providing electrical signals “from a control module coupled to the lead to stimulate a portion of the spinal cord of the patient using at least one of the electrodes” in order to “reduce, alleviate, or eliminate at least one adverse effect” of the disease (id. at 4). The Claims Claims 1, 3-6, 9, 12, 14-17, 20, and 23-32 are on appeal. Independent claim 1 is representative, and reads as follows: 1. A method for treating essential tremor using spinal cord stimulation, the method comprising: implanting a lead near a spinal cord of a patient, the lead comprising a plurality of electrodes disposed on a distal end of the lead and electrically coupled to at least one contact terminal disposed on a proximal end of the lead, wherein the lead is implanted near the patient’s spinal cord such that at least one of the plurality of electrodes is disposed near at least one of the patient’s C4-coccygeal spinal cord segments, wherein the at least one spinal cord segment that the at least one of the plurality of electrodes is implanted near is selected such that at least one peripheral nerve attaches to the at least one spinal cord segment; and Appeal 2012-005245 Application 12/258,317 3 providing electrical signals, from a control module coupled to the lead, to stimulate a portion of the spinal cord of the patient at the spinal cord segment that the at least one of the plurality of electrodes is implanted near using at least one of the plurality of electrodes, wherein the electrical signals reduce, alleviate, or eliminate at least one adverse effect of essential tremor. Independent claim 12 is similar to claim 1, except it is directed to the treatment of restless leg syndrome using the same spinal cord stimulation method (Cl. 12). The Issues The Examiner has rejected the claims as follows: I. Claims 1, 3-6, 9, and 23-27 under 35 U.S.C. § 103(a) as being unpatentable over Cameron.3 II. Claims 12, 14-17, 20, and 28-32 under 35 U.S.C. § 103(a) as being unpatentable over the combination of Cameron and Kim.4 FINDINGS OF FACT FF1. Cameron is directed to a “method of using spinal cord stimulation to treat neurological disorders or conditions,” comprising “surgically implanting an electrical stimulation lead that is in communication with spinal nervous tissue associated with a first, second, or third cervical vertebral segment to result in spinal nervous tissue stimulation” (Cameron, Title, Abstract). FF2. Cameron discloses that “[t]he use of electrical stimulation for treating neurological disease, including . . . essential tremor . . . has been widely discussed in the literature” (Cameron ¶ 5). 3 Cameron et al., US 2007/0060954 A1, published Mar. 15, 2007. 4 Kim et al., US 2006/0052856 A1, published Mar. 9, 2006. Appeal 2012-005245 Application 12/258,317 4 FF3. Cameron discloses: According to one aspect of the invention, a neurological stimulation system is provided for electrically stimulating a subject’s spinal nervous tissue associated with a C1, C2, or C3 cervical vertebral segment to treat one or more neurological disorders. The system includes an electrode or stimulation portion adapted for implantation into a subcutaneous area in communication with the spinal nervous tissue associated with a C1, C2, or C3 cervical vertebral segment. The stimulation portion includes one or more stimulation electrodes adapted to be positioned in the subcutaneous area associated with a C1, C2, or C3 vertebral segment to deliver electrical stimulation pulses to the neuronal tissue. The system also includes a pulse generation source to stimulate the one or more electrodes. (Id. ¶ 10). FF4. Cameron discloses: [a]s another example, in certain embodiments, electrical stimulation of the spinal nervous tissue associated with a C1, C2, or C3 cervical vertebral segment may be delivered to treat localized, diffuse, or other pain in any one or more regions of the body below the head, such as pain in the neck, shoulders, upper extremities, torso, abdomen, hips, and lower extremities. (Id. ¶ 13). Cameron further discloses: “in certain embodiments, electrical stimulation of the spinal nervous tissue associated with a C1, C2, or C3 cervical vertebral segment may be provided to effectively treat lack of coordination in the upper or lower extremities (e.g., gait problems).” (Id. ¶ 14). FF5. Cameron discloses: Those of skill in the art are aware that the spinal cord and tissue associated therewith are associated with cervical, Appeal 2012-005245 Application 12/258,317 5 thoracic, and lumbar vertebrae. In the present invention, the spinal cord or spinal tissue that is stimulated is associated with at least one or more of the cervical vertebra. See also FIGS. 3A and 3B. As used herein, C1 refers to cervical vertebral segment 1 or the first vertebral segment, C2 refers to cervical vertebral segment 2 or the second vertebral segment, C3 refers to cervical vertebral segment 3 or the third vertebral segment, C4 refers to cervical vertebral segment 4 or the fourth vertebral segment, C5 refers to cervical vertebral segment 5 or the fifth vertebral segment, C6 refers to cervical vertebral segment 6 or the sixth vertebral segment, and C7 refers to cervical vertebral segment 7 or the seventh vertebral segment, unless otherwise specifically noted. (Id. ¶ 47). FF6. Cameron discloses that [i]n general terms, stimulation system 10 includes an implantable pulse generation portion (e.g., electrical stimulation source) 12 and an implantable stimulation portion (e.g., electrical stimulation lead, or electrode) 14 for applying the stimulation signal to the target the spinal cord. In operation, both of these primary components are implanted in the person’s body. (Id. ¶ 52). FF7. Cameron teaches that “[i]n a preferred embodiment, two or more laminotomy leads are positioned within the epidural space of C1, C2, or C3, or both. The leads may assume any relative position to one another” (id. ¶ 69). FF8. Kim is directed to “stimulation systems and components for selective stimulation and/or neuromodulation of one or more dorsal root ganglia through implantation of an electrode on, in or around a dorsal root ganglia” (Kim, Abstract). Appeal 2012-005245 Application 12/258,317 6 FF9. Kim discloses essential tremor and restless leg syndrome (RLS) as neuromuscular disorders that may be treated using pharmacological agents alone or in combination with electrical stimulation (id. ¶ 148, Fig. 24). FF10. Figure 3B of Kim is reproduced below: “FIG. 3B relates the spinal nerve roots to their respective vertebral spinal levels.” (Id. ¶ 87). “The letter C designates nerves and vertebrae in the cervical levels. The letter T designates vertebrae and nerves in the thoracic levels. The letter L designates vertebrae Appeal 2012-005245 Application 12/258,317 7 and nerves in the lumbar levels. The letter S designates vertebrae and nerves in the sacral levels.” (Id.). FF11. Figure 3C of Kim is reproduced below: “FIG. 3C illustrates the various dermatomes of the body related to their respective nerve roots using the designations in FIG. 3B.” (Id. ¶ 87). FF12. The Specification states that the “spinal cord 302 is typically divided into thirty-one different segments. . . . There are typically eight cervical segments (C1-C8) 304, twelve thoracic segments (T1-T12) 306, five lumbar segments (L1-L5) 308, five sacral segments (S1-S5) 310, and a coccygeal segment 312.” (Spec. 10:6-11). Appeal 2012-005245 Application 12/258,317 8 FF13. The Specification states: Each segment of the spinal cord 302 sends and receives signals corresponding to muscle movement, such as skeletal muscle movement at different locations of a patient’s body. For example, muscles used to control movement of the head and neck typically connect to the spinal cord 302 at C1-C3; muscles used to control movement of the hands typically connect to the spinal cord 302 at T1; muscles used to control movement of the wrists and elbows typically connect to the spinal cord 302 at C6-C7; muscles used to control movement of the hips typically connect to the spinal cord 302 at L2; muscles used to control movement of the quadriceps typically connect to the spinal cord 302 at L3; muscles used to control movement of the hamstrings and knees typically connect to the spinal cord 302 at L4-L5; and muscles used to control movement of the feet and knees typically connect to the spinal cord 302 at L4-S1. (Spec. 10:12-22). PRINCIPLES OF LAW “Section 103(a) forbids issuance of a patent when ‘the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.”’ KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting 35 U.S.C. § 103(a)). “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” Id. at 416. “[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize Appeal 2012-005245 Application 12/258,317 9 that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Id. at 417. “Obviousness [under 35 U.S.C. § 103] does not require absolute predictability of success . . . all that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988) (citations omitted). ANALYSIS Claims 1 and 12 Claim 1 is directed to a method of treating essential tremor comprising implanting a lead so that an electrode “is disposed near at least one of the patient’s C4-coccygeal spinal cord segments” (Cl. 1). Based on the Specification’s description of cervical (C1-C8) and coccygeal segments of the spinal cord (FF12), we interpret claim 1’s reference to “C4-coccygeal spinal cord segments” to mean any spinal cord segment between and including the C4 cervical segment and the coccygeal segment. The Examiner finds that Cameron renders claim 1 obvious based on its teaching of a method for treating neurological disorders by “implanting electrodes [ ] and stimulating the C1, C2, and/or C3 vertebral segments,” which the Examiner considers to be “near” the C4 spinal cord segment (Ans. 4; see FF1-3). The Examiner further takes official notice that “essential tremor is a well known movement disorder,” and thus concludes: Appeal 2012-005245 Application 12/258,317 10 [i]t would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the treated movement disorders (i.e., Parkinson’s and tremor) as taught by Cameron with treating essential tremor as is known in the art, since such a modification would provide the predictable results of improving the well being of a patient suffering from movement disorders. (Ans. 4). The Examiner alternatively finds that “Cameron mentions that any of the cervical vertebra, including the C4 segment can be stimulated,” and concludes: [i]t would have been obvious to modify the embodiment that stimulates the C1, C2, and/or C3 segments as taught in paragraph 14 of Cameron with stimulating the C4 segment as taught in paragraph 47 of Cameron, since all patients react differently to different stimulations, and such a modification would provide the predictable results of determining the best location for optimum therapy. (Id. at 4-5; see FF5). With respect to claim 12, although Cameron does not disclose treating restless leg syndrome, the Examiner finds that “Kim teaches it is well known to treat restless leg syndrome through stimulation of the spinal cord,” and concludes that [i]t would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the treated movement disorders (i.e. Parkinson’s and tremor) as taught by Cameron with treating restless leg syndrome as taught by Kim, since such a modification would provide the predictable results of improving the well being of a patient suffering from a large number of movement disorders. (Id. at 6; see FF8-9). Appeal 2012-005245 Application 12/258,317 11 We agree with the Examiner that a prima facie case of obviousness has been established based on the cited prior art. We have considered Appellant’s arguments, but are not persuaded otherwise. Appellant’s primary argument is that “Cameron does not teach or suggest implanting a lead near at least one of the patient’s C4-coccygeal spinal cord segments and stimulating the patient’s spinal cord at that at least one spinal cord segment (i.e., at the selected C4-coccygeal spinal cord segment)” (App. Br. 12). Appellant asserts that “Cameron does not teach surgically implanting an electrical stimulation lead in proximity to any other spinal cord segments, other than C1, C2, and C3,” and “there is no teaching in Cameron that the disclosed stimulation method could be applied to any other spinal cord segments” (id.). Citing MPEP § 2112(IV), Appellant contends that “[s]timulation of the C1, C2, and/or C3 spinal cord segments does not necessarily stimulate the C4-coccygeal spinal cord segments” (App. Br. 13). We disagree with Appellant’s characterization of the Cameron reference. Cameron explicitly teaches that “[i]n the present invention, the spinal cord or spinal tissue that is stimulated is associated with at least one or more of the cervical vertebra,” which it then defines to include the C1-C7 cervical vertebral segments (FF5). Although the embodiments disclosed in Cameron focus on the C1-C3 segments, “[a]ll the disclosures in a reference must be evaluated, including nonpreferred embodiments . . ., and a reference is not limited to the disclosure of specific working examples.” In re Mills, 470 F.2d 649, 651 (CCPA 1972) (citations omitted). As such, we find that Cameron teaches that spinal cord or spinal tissue associated with other Appeal 2012-005245 Application 12/258,317 12 cervical vertebral segments (C4-C7) may also be stimulated according to the “invention” disclosed therein. Moreover, even if one were to focus on the specific embodiments of Cameron, the problem with Appellant’s arguments is that there is nothing in the claims that requires the purposeful stimulation of the C4-coccygeal spinal cord segments. While the claims require “stimulat[ing] a portion of the spinal cord of the patient at the spinal cord segment . . . ,” that does not necessarily require stimulating one of the C4-coccygeal segments itself, as opposed to stimulating any other spinal cord segment that is also “near” the implanted electrodes. We therefore determine that the broadest reasonable interpretation of the claims would encompass stimulating other nearby spinal cord segments. In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000) (“[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the specification.”). Regardless of what other spinal cord segments might qualify as “near,” we find that requirement satisfied by Cameron’s disclosure of stimulating the C3 segment, which is directly adjacent to the C4 segment (see FF5; Cameron, Fig. 3). Appellant asserts that “the Specification describes ‘near’ as being in the epidural space and close enough to a nerve of interest to contact that nerve with stimulation pulses equal to or above a minimum therapeutic stimulation level” (App. Br. 15, citing Spec. ¶ 66). The cited portions of the Specification are described only for “at least some embodiments” relating to the treatment of Parkinsonism, and therefore do not clearly define the term “near” to preclude stimulation of other spinal cord segments adjacent to the C4 segment for the claimed methods of treating essential tremor or restless Appeal 2012-005245 Application 12/258,317 13 leg syndrome. The claims do not require the C4-coccygeal segments to be stimulated at or above any particular level; rather, they only require that “the electrical signals reduce, alleviate, or eliminate at least one adverse effect” of essential tremor or restless leg syndrome. Furthermore, we find nothing in the Specification identifying any unexpected results or criticality associated with stimulating the C4-coccygeal spinal cord segments for the treatment of essential tremor or restless leg syndrome. Indeed, other than a general statement that “[t]here are typically eight cervical segments (C1- C8),” the Specification does not mention the C4 spinal cord segment at all (Spec. 10). As such, we find that Cameron’s general disclosure that “the spinal cord or spinal tissue that is stimulated is associated with at least one or more of the cervical vertebra” (FF5), in combination with the specific embodiment wherein electrical leads may be implanted in the epidural space of the C3 segment (i.e., “near” the C4 segment) (FF6-7), renders the method of claim 1 obvious. We therefore affirm the rejection of claim 1. We also accordingly conclude that Cameron’s disclosure, in combination with Kim’s disclosure that restless leg syndrome can be treated using pharmacological agents in combination with electrical stimulation (FF9), renders obvious the method of claim 12. Appellant does not make separate arguments for dependent claims 3, 4, 6, 9, 14, 15, 17, 20, 23, 24, 26, 28, and 29; therefore, those claims fall with their respective independent claims. 37 C.F.R. § 41.37(c)(1)(vii). Claims 5 and 16 Dependent claims 5 and 16 require that “at least one of the plurality of electrodes is disposed near a portion of the spinal cord with at least one Appeal 2012-005245 Application 12/258,317 14 peripheral nerve extending to a lower extremity” (Cls. 5, 16). With respect to these claims, Appellant additionally argues that “[o]ne of skill in the art would recognize that peripheral nerves do not extend between the C1-C3 spinal cord segments and the lower extremities,” and that “the portions of the spinal cord with at least one peripheral nerve extending to a lower extremity include the lumbar and sacral spinal cord segments” (App. Br. 17- 18). As noted by the Examiner, Cameron specifically teaches that the electrical stimulation disclosed therein may affect lower extremities (Ans. 7; FF4). With regard to this teaching, Appellant argues that “[o]ne of skill in the art would recognize that C1-C3 have nerve roots that extend to the head and the neck, and that none of C1-C3 have nerve roots that extend to lower extremities” (App. Br. 19). Appellant also argues that were a medical practitioner to contact the lumbar and sacral spinal cord segments with stimulation pulses equal to or above a minimum therapeutic stimulation level while being located in communication with the C1-C3 spinal cord segments (as suggested by the Final Office Action), the stimulation amplitude may need to be at a level that is sufficiently high enough to be detrimental to patient tissue on or around the C1- C3 spinal cord segments. (Id.). As discussed above, Cameron generally discloses that spinal nervous tissue associated with any of the cervical vertebral segments (C1-C7) may be stimulated (FF5). Although we recognize that the cervical spinal cord segments are not typically associated with peripheral nerves extending to a lower extremity, the reference nonetheless states that lower extremities may be affected as a result of the stimulation (FF4). Furthermore, there is Appeal 2012-005245 Application 12/258,317 15 nothing in the claim language or the Specification that requires any particular degree of proximity between the implanted electrode and the portion of the spinal cord with the peripheral nerve extending to the lower extremity, other than simply being “near” one another. Other than the broad requirement in the independent claims that “the electrical signals reduce, alleviate, or eliminate at least one adverse effect” of essential tremor or restless leg syndrome, claims 5 and 16 do not further require that the peripheral nerve extending to the lower extremity be stimulated with the nearby electrode at any particular level. As with the independent claims, the term “near” is broad enough to encompass disposing an electrode directly adjacent to other spinal cord segments even if those portions of the spinal cord do not themselves have a peripheral nerve extending to a lower extremity. The dissent states that the term “near” is “reasonably interpreted to encompass a spinal cord segment adjacent to one of the specific spinal cord segments required by the claims,” but finds that “interpreting segment C7 to be ‘near’ segment L1 requires an unreasonably broad interpretation of the claim language” (Dissent 2-3). Certainly, the C7 segment is closer than other cervical segments to the L1 segment (FF10). Given that we give claims “their broadest reasonable interpretation consistent with the specification,” Hyatt, 211 F.3d at 1372, and the fact that Appellant’s Specification does not clearly suggest otherwise, we find no basis to draw an arbitrary line as to which segments can qualify as “near a portion of the spinal cord with at least one peripheral nerve extending to a lower extremity.”5 We find that interpretation to be 5 The term “near” is a relative term. Because Appellant is in the best position to bring clarity to the scope of his claims, we find it reasonable to Appeal 2012-005245 Application 12/258,317 16 consistent with the language of the independent claim requiring that “at least one of the plurality of electrodes is disposed near at least one of the patient’s C4-coccygeal spinal cord segments.” Claims 5 and 16 therefore encompass electrodes disposed “near” the C4-C7 cervical vertebral segments that are also “near” a portion of the spinal cord with at least one peripheral nerve extending to a lower extremity. Appellant does not explain why the stimulation would be detrimental to tissue around the C1-C3 segments but not the other cervical segments within the scope of the claim. Indeed, Cameron’s disclosure also encompasses the stimulation of spinal cord or tissue associated with the C4, C5, C6, and C7 segments, which are even closer to the lumbar and sacral spinal cord segments that have peripheral nerves extending to a lower extremity. We therefore affirm the obviousness rejections of claim 5 and 16. Claims 25, 27, and 30-32 Claim 25 requires “providing electrical signals to the T1 spinal cord segment . . . to reduce, alleviate, or eliminate at least one adverse effect of essential tremor in the patient’s hands” (Cl. 25). Claims 27 and 32 require “providing electrical signals to at least one of the L4, L5, or S1 spinal cord segment . . . to reduce, alleviate, or eliminate at least one adverse effect of broadly interpret the claims to encompass the stimulation of non-adjacent spinal cord segments. See In re Zletz, 893 F.2d 319, 321-22 (Fed. Cir. 1989) (“During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.”). Appeal 2012-005245 Application 12/258,317 17 [essential tremor or restless leg syndrome] in at least one of the patient’s feet or knees” (Cls. 27, 32). Likewise, claims 30 and 31 require “providing electrical signals to the L3 spinal cord segment” (claim 30) or “at least one of the L4 or L5 spinal cord segment” (claim 31) “to reduce, alleviate, or eliminate at least one adverse effect of restless leg syndrome” in the patient’s quadriceps, hamstrings, or knees (Cls. 30, 31). With respect to these dependent claims, the Examiner takes official notice that “it is well known that muscles used to control the hands typically connect to the T1 spinal cord segment, . . . muscles used to control feet and knees typically connect to the L4, L5, or S1 spinal cord segments,” “that muscles used to control the quadriceps typically connect to the L3 spinal cord segment, and muscles used to control the hamstrings or knees typically connect to the L4 or L5 spinal cord segments” (Ans. 5-6). Appellant does not dispute those facts, which are corroborated by both Appellant’s Specification (FF13) and the disclosure in Kim (FF10-11). In making a rejection, . . . an examiner may “take notice of facts beyond the record which, while not generally notorious, are capable of such instant and unquestionable demonstration as to defy dispute.’” In re Ahlert, 424 F.2d 1088, 1091 (CCPA 1970). Because Appellant does not dispute those facts, we assume them to be true in our consideration of the obviousness rejection of these dependent claims. See In re Fox, 471 F.2d 1405, 1407 (CCPA 1973) (affirming rejection based on official notice where “appellant has not denied the existence of the facts on which the examiner rested his obviousness rejection nor the added facts of which the board took judicial notice”). Appeal 2012-005245 Application 12/258,317 18 Appellant argues that “there is no suggestion in Cameron to stimulate other regions of the spinal cord to treat lack of coordination in the upper or lower extremities when Cameron already teaches that the upper and lower extremities are treatable by stimulation of C1, C2, and C3” (App. Br. 23). However, given Cameron’s disclosure that “[t]hose of skill in the art are aware that the spinal cord and tissue associated therewith are associated with cervical, thoracic, and lumbar vertebrae” (FF5), and the undisputed known correlation between spinal cord segments and the affected portions of the body (dermatomes) (FF11, FF13), we find that one skilled in the art would have a reasonable expectation of success in treating nervous disorders associated with the upper or lower extremities (e.g., essential tremor or restless leg syndrome) by providing electrical signals to the spinal cord segments that contain peripheral nerves extending to those specific portions of the body. Appellant argues that “were a medical practitioner to contact the Tl, L3, L4, L5, or S1 spinal cord segments with stimulation pulses equal to or above a minimum therapeutic stimulation level while being located in communication with the C1-C3 spinal cord segments (as suggested by the Final Office Action), the stimulation amplitude may need to be at a level that is sufficiently high enough to be detrimental to patient tissue on or around the C1-C3 spinal cord segments” (App. Br. 22). Appellant further argues that “the T1, L3, L4, L5, and/or S1 spinal cord segments are located too far away from the C1-C3 spinal cord segments to be reachable during an implantation procedure at the C1-C3 spinal cord segments” (Reply Br. 18). Appeal 2012-005245 Application 12/258,317 19 Contrary to the premise of Appellant’s arguments, the rejection is not based only on Cameron’s embodiments wherein the C1-C3 spinal cord segments are stimulated. Rather, the Examiner finds it would have been obvious to modify stimulating the cervical segments [as taught by Cameron] with stimulating the T1, L4, L5, and/or S1 segments as are well known in the art, since such a modification would stimulate the part of the spinal cord that is related to the patient's extremities that are affected by essential tremor and/or restless leg syndrome. (Ans. 8). At least the T1 spinal cord segment is directly adjacent to the spinal cord tissue associated with the C7 vertebral segment, which as stated above, is within the scope of Cameron’s disclosure (FF4; Cameron, Fig. 3). Other than unsupported attorney argument, Appellant presents no evidence that stimulation of the T1, L3, L4, L5, or S1 spinal cord segments would necessarily be detrimental to tissue around the cervical vertebral segments. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of evidence.”). Nor do the claims suggest that electrodes could not be disposed near both areas of the spinal cord. 6 We therefore affirm the obviousness rejection of claims 25 and 27 based on Cameron, and the rejection of claims 30-32 based on the combination of Cameron and Kim. 6 The dissent notes that claims 25, 27, and 30–32 require providing electrical signals specifically “to,” not “near,” one of the T1, L3, L4, L5, or S1 spinal cord segments (Dissent 3). While true, these claims do not require providing electrical signals to only those particular spinal cord segments, nor do they further limit the placement of the electrodes beyond the requirements of the independent claims. Appeal 2012-005245 Application 12/258,317 20 SUMMARY We affirm the claim rejections under 35 U.S.C. § 103(a). No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED bar UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte AHMED A. ELBORNO __________ Appeal 2012-005245 Application 12/258,317 Technology Center 3700 __________ Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. GRIMES, Administrative Patent Judge, dissenting-in-part. I agree with the majority that claims 1 and 12—which recite implanting an electrode near, for example, the C4 spinal cord segment— encompass implanting an electrode at the C3 spinal cord segment, and therefore read on the methods made obvious by Cameron alone or by Cameron and Kim. I part ways with the majority, however, with respect to claims 5, 16, 25, 27, and 30-32. Claims 5 and 16 require implanting a lead so that an electrode is “disposed near a portion of the spinal cord with at least one peripheral nerve extending to a lower extremity” (Appeal Br. 25, 27 (Claims App’x)). Kim’s Figure 3C shows that the peripheral nerves extending to the legs and feet originate at spinal cord segments L1–L5, S1, and S2 (FF11). Thus, claims 5 and 16 require implanting an electrode near one of spinal cord segments L1– L5, S1, and S2. Appeal 2012-005245 Application 12/258,317 2 Cameron’s disclosed method is limited to providing electrical stimulation to one of the C1–C3 cervical vertebral segments (see FF3, FF4). Although Cameron states broadly that, “[i]n the present invention, the spinal cord or spinal tissue that is stimulated is associated with at least one or more of the cervical vertebra” (FF5), it does not describe any actual method that provides electrical stimulation at a vertebral segment other than C1–C3. The majority notes that Cameron states that its method can affect the lower extremities (ante at 14), but that statement at best would have led a skilled artisan to stimulate one of the C1–C3 vertebral segments in order to affect the legs or feet. That disclosure does not address the structural requirement of claims 5 and 16 of implanting an electrode near a portion of the spinal cord with a peripheral nerve extending to a lower extremity; i.e., one of spinal cord segments L1–L5, S1, and S2. The majority also reasons that claims 5 and 16 read on the method made obvious by the prior art because the Specification does not define the term “near,” and thus “the term ‘near’ is broad enough to encompass disposing an electrode directly adjacent to other spinal cord segments even if those portions of the spinal cord do not themselves have a peripheral nerve extending to a lower extremity” (ante at 15). I agree that “near” is reasonably interpreted to encompass a spinal cord segment adjacent to one of the specific spinal cord segments required by the claims. I do not agree with the majority’s conclusion that Cameron discloses stimulating any of cervical segments C1–C7, but even assuming it does, claims 5 and 16 require stimulating a spinal cord segment near one of L1–L5, S1, and S2. Segment C7 is separated from segment L1 by all twelve of the thoracic spinal cord segments (see FF10). In my opinion, interpreting segment C7 to Appeal 2012-005245 Application 12/258,317 3 be “near” segment L1 requires an unreasonably broad interpretation of the claim language, and effectively reads the term “near” out of the claims entirely. For the above reasons, I respectfully dissent from the majority’s conclusion that the cited references would have made obvious the methods defined by claims 5 and 16. Claims 25, 27, and 30–32 require providing electrical signals specifically “to,” not “near,” one of the T1, L3, L4, L5, or S1 spinal cord segments (Appeal Br. 28-29 (Claims App’x)). The majority concludes that it would have been obvious to modify Cameron’s method to include stimulation of those spinal cord segments because it was known that they connect to nerves in the hands and the lower extremities (ante at 16-17). I respectfully disagree with this conclusion. In my view, Cameron’s disclosed method is limited to providing stimulation to the C1–C3 segments, but even assuming it would have suggested providing stimulation to any of the C1–C7 cervical segments, the majority points to no suggestion in the cited references that would lead a skilled artisan to provide stimulation to any of the thoracic, lumbar, or sacral spinal cord segments. The knowledge that peripheral nerves controlling the hands and legs connect to the T1, L3, L4, L5, and S1 spinal cord segments does not, in my mind, provide the required reason to modify the prior art as required by the claims. As Appellant has pointed out (Appeal Br. 23), Cameron discloses that stimulation of the C1–C3 spinal cord segments can effectively treat the upper and lower extremities (FF4). Cameron also expressly states that “[i]n the present invention, the spinal cord or spinal tissue that is stimulated is Appeal 2012-005245 Application 12/258,317 4 associated with at least one or more of the cervical vertebra” (FF5, emphasis added). In my view, the majority’s conclusion that a skilled artisan would have considered it obvious to modify Cameron’s method as required by claims 25, 27, and 30-32, in order to accomplish what Cameron describes as a result of stimulating the C1–C3 spinal cord segments, is based on hindsight rather than on the teachings of the prior art. In summary, I agree with the majority’s analysis with regard to claims 1, 3, 4, 6, 9, 12, 14, 15, 17, 20, 23, 24, 26, 28, and 29, but dissent with respect to the analysis of claims 5, 16, 25, 27, and 30–32. 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