The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wasserman et al. (US Patent Pub. No. 2021/0031031) in view of Llinas et al. (US Patent Pub. No. 2009/0192569), further in view of Osorio et al. (US Patent No. 7,006,859), as evidenced by either one of Russell (US Patent Pub. No. 2008/0312716) and Lowry et al. (US Patent Pub. No. 2004/0102828).
Regarding claim 1, Wasserman discloses that tumors inside a person’s head can be treated using tumor treating fields (TTFields) by positioning capacitively coupled electrodes on opposite sides of the tumor, and applying an AC voltage between the electrodes (see Abstract and Figure 1; reads on “An apparatus for delivering alternating electric fields to a target region in a subject’s brain”, see preamble of claim 1). “Unlike the conventional approach (in which all of the electrodes are positioned on the person's scalp) at least one of the electrodes is implemented using an implanted apparatus” (see Abstract), which improves the problem of prior art devices which place electrodes on the scalp which leads to “attenuation of the electric field introduced by the skull and scalp, [leading to] the voltage and current that is applied to the transducer arrays must be relatively high” (see paragraph 18). As shown in Figures 3 and 4, a skull implant 10 as taught by Wasserman may comprise at least two conductive plates 32 on the inside of the implant. And as shown in Figure 1, these skull implants 10 may be positioned on the left and right sides and the anterior and posterior sides of the patient’s skull/head. Therefore, this teaches “a plurality of first electrode assemblies configured for positioning … on a first side of the target region” (see lines 3-4 of claim 1) and “a plurality of second electrode assemblies configured for positioning … on a second side of the target region” (see lines 20-21 of claim 1). However, these are via a single hole each, and “each of the plurality of first/second electrode assemblies” is not comprised of “a shaft”, “a flange”, “a conductive electrode” and “a conductive wire”.
Llinas teaches a cortical electrode array and method for stimulating brain activity (see Title). As shown in Figure 1, an electrode device of Llinas includes “a plurality of electrode assemblies, each with at least one electrode lead, extending from a common base. The base is configured to be positioned on an outside of the patient's cranium with each electrode assembly projecting individually through a hole in the patient's cranium such that the electrode lead is in the vicinity of the brain… Each of the electrode assemblies are placed in their respective holes in order to stimulate” (see Abstract). “This interface may be, for example, in the form of conductive traces 72 on the base 12 (FIG. 5) providing electrical contact to each electrode… The conductive traces 72 or wires 74 interconnect with an interface such as a cable or connector 76 for further connection to external electronics” (see paragraph 34). Also, Figure 4 illustrates that “electrode lead 22 may be positioned on a distal tip of the electrode assembly 34” (see paragraph 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize the electrode array with electrodes extending through holes, as taught by Llinas, in place of the skull implant of Wasserman because Llinas teaches that a craniotomy surgery is “intensive, involves health risks and includes an extended healing time” (see paragraph 5 of Llinas) as opposed to the improvement presented with the system and methods of use of the electrodes of Llinas (i.e., “without requiring an extensive craniotomy or the removal of a portion of the cranium”, see paragraph 6 of Llinas).
By the combination of Wasserman with Llinas, the Llinas reference reads on “a plurality of first/second electrode assemblies configured for positioning through a respective plurality of first/second holes in the subject’s skull on a first/second side of the target region (since Figure 2 illustrates a single array having electrodes extending through holes of the skull, and Wasserman already taught multiple electrode arrays at four opposing locations of the head), wherein each of the plurality of first electrode assemblies has: a first/second shaft having a longitudinal axis, an inner end, and an outer end (see Figure 2 of Llinas), wherein the first shaft is shaped and dimensioned to traverse a respective one of the first/second holes (see Figure 2 of Llinas), and Figures 5 and 6 of Llinas illustrates “connector 76 for further connection to external electronics” (see paragraph 34), which reads on “at least one port” as recited in the last 7 paragraphs of claim 1.
It is noted that Llinas does not teach that each of the plurality of firs/second electrode assemblies have… “a first flange…”, “a first conductive electrode element…” and “a first conducive wire…”.
Osorio teaches a unitized electrode. Figure 9 illustrates one embodiment with an array of electrode assemblies on a common surface, in the same manner as illustrated in Figure 1 of Llinas. Also, like Llinas, Osorio teaches that its design “obviates, in certain cases, the need to expose the brain through … craniotomy thereby minimizing the risk of damage to the cortex, hemorrhage, infection and reducing surgical and anesthesia time” (see column 5, lines 41-44) by utilizing smaller holes (see column 15, lines 26-31). Osorio also teaches an alternative embodiment to that of the array on a single substrate, in which individual electrodes contain a shaft portion 24, a flange (see disk portion 22), a conductive electrode element disposed at the inner end of the shaft (see at least Fig. 7, element 62 at the distal, bottom end; note also that Llinas was taught as illustrating and teaching an electrode element at the distal end), and a conductive wire having a first portion in electrical contact with the electrode element (see conductor 69 contacting element 62 at the bottom end in Figure 7; also “Conductors or wires 26 may also be used to convey control signals from control units (or stimulation units) to selected ones of the contact surfaces”, see column 12, lines 1-8). Osorio teaches that this device may be anchored to the skull (see column 10, lines 10-15), and that “the presence of disk portion 22 provides supporting and anchoring capabilities to the shaft portion 24 and prevents undue movement of the shaft portion 24” (see column 11, lines 12-15; also see column 10, lines 60-64).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use individual electrode structures having a disk portion used for improved anchoring on the skull, as taught by Osorio, as a functional equivalent to an unitary array as taught by both Osorio (see Figure 9) and Llinas (see Figure 1) as such a modification amounts to substitution of known equivalents to provide multiple electrodes to the brain and the substitution yields predictable results (KSR v. Teleflex).
With regard to “wherein the first/second electrode element has an inner face that is within 10o of perpendicular to the longitudinal axis of the first/second shaft”, it is noted that the distal end of the shafts in both Llinas and Osorio comprise rounded distal ends. As such, at least the distal most point of each will be “within 10o of perpendicular to the longitudinal axis of the shaft”.
With regard to “wherein the inner face of the first/second electrode element has an area of at least 5 mm2”, it is noted that Llinas teaches that “the electrode assemblies may each be on the order of 1.5 mm in diameter” (see paragraph 20). Additionally, Osorio teaches that “the shaft portion 24 has a diameter between approximately 0.1-1.0 mm” (see column 10, lines 45-50). However, this passage from Osorio continues by stating, “it is to be understood, however, that the disk portion 22 and the shaft portion 24 may have other dimensions as necessary for a particular application.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize an electrode with a shaft with a wider diameter than that expressly taught by Osorio or Llinas, such as a diameter that would produce an inner face of an area of at least 5 mm2, if and when it is deemed “necessary for a particular application” required by a doctor. To this end, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), and that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233)). Additionally, the specification of the instant application provides no criticality to this range of at least 5 mm2. As evidence that this is obvious, Russell teaches that “the diameter of the electrode shaft is sufficiently small, e.g. about 5 mm or less, to preclude the need for a full craniotomy” (see paragraph 67); and Lowry teaches that “The dimensions of the electrode 100 can be varied to meet various design objectives… For most applications, shafts 110 having diameters (typically excluding the width of the threads 112) of no greater than 4 mm will suffice. Shaft diameters of about 14 mm are likely, with diameters of 1.5-2.5 mm being well suited for most applications” (see paragraph 49).
As stated earlier, Figures 5 and 6 of Llinas illustrate “connector 76 for further connection to external electronics” (see paragraph 34), which reads on “at least one port” as recited in the last 7 paragraphs of claim 1. Figure 7 illustrates the wiring running under the skin to an interface 80 (see paragraph 35). However, paragraph 35 also states that “the communications interface 80 may be provided at the patient's cranium by way of a connector provided in the vicinity of the electrode array.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that if and when the communications interface 80 is “provided at the patient’s cranium” as stated in paragraph 35 that it would be affixed to the cranium in order to secure the interface under the skin, thereby preventing movement and/or discomfort to the patient if movement were to occur (i.e., improving safety and patient compliance with the system). Furthermore, by the combination of Wasserman with Llinas, it would be obvious that the connectors 76 from multiple arrays (which would be required by the combination to create the arrangement taught in Wasserman) would all be connected to the interface 80, which would require at least one port per array/connector 76.
Regarding claims 2 and 8, it is noted that Wasserman teaches treatment by capacitively coupled electrodes (see Abstract). “The conductive plate 22 and the dielectric layer 24 form a capacitor, and using a higher capacitance improves the coupling of the electric field into the tumor. One approach for achieving a high capacitance is to use a ceramic dielectric material with a dielectric constant of at least 10,000 for implementing the dielectric layer 24” (see paragraph 22). It can be seen in Figures 2-4 that the dielectric layer is placed between the electrode (i.e., conductive plate 22) and the patient’s tissue. A dielectric constant of at least 10,000 as taught by Wasserman reads on the claimed “a dielectric constant of at least 10”.
Regarding claims 3 and 9, Wasserman teaches that “In some embodiments of the first apparatus, the dielectric layer comprises a flexible thin layer of high dielectric polymer” (see paragraph 5). It is noted that the specification of the instant application states in each instance in which it is described that “a polymer layer having a thickness of less than 50 μm” (e.g., paragraphs 6, 11, 16 and 33 o the PGPUB 2025/0108204 of the instant application), it teaches that the this would result in “a dielectric constant of at least 10” (e.g., from paragraph 11, “Optionally, in the instances described in the previous paragraph, each of the first layers of insulating material and each of the second layers of insulating material comprises a polymer layer having a thickness of less than 50 μm.”). In other words, the thickness is given no criticality at all, other than to provide the dielectric constant as stated in claim 2 of “at least 10”. Since claim 2 was rejected immediately prior to this rejection of claim 3 by the teachings of Wasserman, and Wasserman also teaches the use of a polymer, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use a dielectric polymer having a thickness within the range claimed. In this regard, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), and that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233)).
Regarding claims 4 and 10, Wasserman teaches that “the dielectric layer comprises a ceramic layer with a dielectric constant of at least 10,000” (see paragraph 5).
Regarding claims 5 and 11, Llinas teaches that “Each electrode assembly includes an electrode lead either in direct contact or in the vicinity of tissue inside the patient's cranium such as brain tissue or dura mater” (see paragraph 7).
Regarding claims 6 and 12, it is re-iterated that Llinas teaches that “the electrode assemblies may each be on the order of 1.5 mm in diameter” (see paragraph 20). Additionally, Osorio teaches that “the shaft portion 24 has a diameter between approximately 0.1-1.0 mm” (see column 10, lines 45-50). However, this passage from Osorio continues by stating, “it is to be understood, however, that the disk portion 22 and the shaft portion 24 may have other dimensions as necessary for a particular application.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize an electrode with a shaft with a wider diameter than that expressly taught by Osorio or Llinas, such as a diameter that would produce an inner face of an area of at least 5 mm2, if and when it is deemed “necessary for a particular application” required by a doctor. To this end, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), and that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233)). Additionally, the specification of the instant application provides no criticality to this range of 5-20 mm2.
As further evidence that this is obvious, Russell teaches that “the diameter of the electrode shaft is sufficiently small, e.g. about 5 mm or less, to preclude the need for a full craniotomy” (see paragraph 67); and Lowry teaches that “The dimensions of the electrode 100 can be varied to meet various design objectives… For most applications, shafts 110 having diameters (typically excluding the width of the threads 112) of no greater than 4 mm will suffice. Shaft diameters of about 14 mm are likely, with diameters of 1.5-2.5 mm being well suited for most applications” (see paragraph 49).
With regard to claims 7 and 13, it is noted that all of claim 7 is identical to that of claim 1 until the last three lines. Additionally, claim 7 is a method and recites “positioning” the “plurality of first [and second] electrode assemblies”. To this end, it is noted that the rejection of claim 1 teaches a combination in which the structure is present and where the structures, as claimed and rejected, would be positioned on the head of a patient. With regard to the last three lines of claim 7, Wasserman teaches that “Tumor Treating Fields, or TTFields, are low intensity (e.g., 1-3 V/cm) alternating electric fields within the intermediate frequency range (e.g., 100-500 kHz) that inhibit cancer cell growth” (see paragraph 2). And Wasserman states in the Abstract that “Tumors inside a person's head (e.g., brain tumors) can be treated using tumor treating fields (TTFields) by positioning capacitively coupled electrodes on opposite sides of the tumor, and applying an AC voltage between the electrodes.” Therefore, this teaches the frequency range of an AC voltage being applied between the varied electrode arrays.
Claims 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Osorio in view of Lowry and Wasserman.
Osorio discloses a unitized electrode. Figures 6A and 6B illustrate an apparatus for delivering alternating electric fields to a target region of a subject’s brain, comprising:
A shaft (see numeral 24) having a longitudinal axis , an upper end (see top end), and a lower end (see bottom distal end), wherein the shaft has a length of 4-10 mm (note that Osorio teaches that “The length of the shaft portion 24 may have any desired length depending on the location as required for a particular application”, see column 10, lines 50-52, and also that the device many be anchored to the skull, see column 10, lines 11-12) and an outer diameter of 2-15 mm (note that Osorio teaches that “the shaft portion 24 has a diameter between approximately 0.1-1.0 mm”, see column 10, lines 46-47);
A flange disposed at the upper end of the shaft (see disk portion 22), wherein the flange has a diameter that is at least 2 mm larger than the outer diameter of the shaft (note that Osorio teaches that “the disk portion 22 has a diameter between approximately 1-25 mm”, see column 10, lines 45-46, which is at least 2 mm larger than the explicitly disclosed diameter of the shaft);
A conductive electrode element disposed at the lower end of the shaft (see numeral 63 in Figure 7).
It is noted that the teaching that the device may be anchored to the skull and may be of any desired length depending on location, and that it would extend all the way through the skull implies that the length would obviously be in the range as that claimed, since the claimed invention extends from the skull into the region of the brain just as Osorio teaches, and that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233)).
It is noted that Osorio illustrates in at least Figure 9 that a stimulating surface 95 may reside at the distal end, there is not explicit teaching of the end face of the distal end, and there is no insulative material at the distal end. Furthermore, the length and diameters taught by Osorio are not explicitly as claimed.
Lowry teaches methods and systems employing intracranial electrodes for neurostimulation (see Title). As illustrated in most figures, there is an electrode that extends from through the skull to the brain (i.e., to the patient’s dura mater 20). Lowry teaches that “the threaded shaft 110 is only slightly longer than the skull thickness at the intended treatment site. Lengths on the order of 4-50 mm, for example, may be appropriate in certain applications. The diameter of the head 102 and the threaded shaft 110 may also be varied. For most applications, shafts 110 having diameters (typically excluding the width of the threads 112) of no greater than 4 mm will suffice” (see paragraph 49). This teaches that the length of such an electrode to extend through the skull would be “on the order of 4-50 mm” and diameters of such electrodes may be on the order of up to 4 mm in diameter. This explicitly reads on the shaft dimensions as claimed. Additionally, Figures 2A, 3A, 4A, 5,6A, 7, 9 and 12-14 illustrate various different shaped distal ends, most of which have a slight curvature while some are flat. This reads on “where the electrode element has a lower face that is within 10o of perpendicular to the longitudinal axis of the shaft”, since the curvature will inherently at some point along its curve be at such an angle. Additionally, if the diameter of the shaft meets the limitation of 2-15 mm, and the electrode resides at the bottom of the shaft (which the figures of the instant application illustrate the electrode 13 extending the full diameter of the shaft at the bottom edge), then these dimensions of Osorio as combined with Lowry meets the limitations of having an area of at least 5 mm2.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application that the length of an electrode that extends through the skull would be of a length of between 4-50 mm, as disclosed by Lowry, and that the electrode(s) taught by Osorio would similarly be this length, since they too extend through the skull. Similarly, it would be obvious to use an electrode having a slightly larger diameter than that of Osorio, as Lowry teaches that slightly wider electrodes are common within the art, and there would be no unexpected result by changing this size. To this end, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), and that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233)).
However, Osorio combined with Lowry still fails to teach a layer of insulating material disposed on the lower face of the electrode element.
Wasserman teaches that “[i]n many situations, it is preferable to capacitively couple the electric field into the target region. The conductive plate 22 and the dielectric layer 24 form a capacitor, and using a higher capacitance improves the coupling of the electric field into the tumor. One approach for achieving a high capacitance is to use a ceramic dielectric material with a dielectric constant of at least 10,000 for implementing the dielectric layer 24” (see paragraph 22). It is noted that a dielectric constant of at least 10,000 is within the range of the claimed “dielectric constant of at least 10”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to capacitively couple the electric field into the target region, as taught by Wasserman, within the system and methods taught by Osorio as combined with Lowry, because “using a higher capacitance improves the coupling of the electric field into the tumor” (see paragraph 22).
Regarding claim 15, Figure 6A of Osorio illustrates conductors/wires 26 running down and into the shaft of the device. Additionally, Osorio teaches that “Electrode 20 is constructed of biocompatible materials, such as polyurethane covered as appropriate with thin sheets or coatings of noble metals, such as platinum or other suitable material” (see column 11, lines 41-44).
Regarding claim 16, Wasserman teaches that “In some embodiments of the first apparatus, the dielectric layer comprises a flexible thin layer of high dielectric polymer” (see paragraph 5). It is noted that the specification of the instant application states in each instance in which it is described that “a polymer layer having a thickness of less than 50 μm” (e.g., paragraphs 6, 11, 16 and 33 o the PGPUB 2025/0108204 of the instant application), it teaches that the this would result in “a dielectric constant of at least 10” (e.g., from paragraph 11, “Optionally, in the instances described in the previous paragraph, each of the first layers of insulating material and each of the second layers of insulating material comprises a polymer layer having a thickness of less than 50 μm.”). In other words, the thickness is given no criticality at all, other than to provide the dielectric constant as stated in claim 2 of “at least 10”. Since claim 2 was rejected immediately prior to this rejection of claim 3 by the teachings of Wasserman, and Wasserman also teaches the use of a polymer, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use a dielectric polymer having a thickness within the range claimed. In this regard, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), and that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233)).
Regarding claim 17, Wasserman teaches that “the dielectric layer comprises a ceramic layer with a dielectric constant of at least 10,000” (see paragraph 5).
Regarding claim 18, it is re-iterated that Llinas teaches that “the electrode assemblies may each be on the order of 1.5 mm in diameter” (see paragraph 20). Additionally, Osorio teaches that “the shaft portion 24 has a diameter between approximately 0.1-1.0 mm” (see column 10, lines 45-50). However, this passage from Osorio continues by stating, “it is to be understood, however, that the disk portion 22 and the shaft portion 24 may have other dimensions as necessary for a particular application.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize an electrode with a shaft with a wider diameter than that expressly taught by Osorio or Llinas, such as a diameter that would produce an inner face of an area of at least 5 mm2, if and when it is deemed “necessary for a particular application” required by a doctor. To this end, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)), and that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 105 USPQ 233)). Additionally, the specification of the instant application provides no criticality to this range of 5-20 mm2.
Regarding claim 19, it is illustrated in the plurality of figures of Osorio that the shaft has a cylindrical outer surface.
Regarding claim 20, Figures 2A, 3A, 4A, 5,6A, 7, 9 and 12-14 of Lowry illustrate various different shaped distal ends, most of which have a slight curvature while some are flat. This reads on “where the lower face of the electrode element is within 2o of perpendicular to the longitudinal axis of the shaft”, since the curvature will inherently at some point along its curve be at such an angle. Additionally, the instant application fails to teach any criticality to a lower face being off-axis from perpendicular to the longitudinal axis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAMES KISH/ Primary Examiner, Art Unit 3792
Prosecution Insights