DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/28/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 04/28/2026. As directed by the amendment: Claims 20 have been amended, claims 1-19, 21-22, 27-29, 32-37, and 42-50 have been cancelled, and no claims have been added. Claims 25-26, 38, and 40-41 were previously withdrawn due to a Restriction Requirement. Thus, claims 20, 23-24, and 30-31 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 04/28/2026, with respect 35 U.S.C. 112(a) for the claim(s) have been considered but are not persuasive. Applicant argues on pages 6-7 that support for the claims can be found in [0094], and [00101]-[00102] since the metallic vertebral interbody device can have appropriate stimulate frequencies that are tuned for different physiological responses, and asserts on [0094] that the pulse generator is fully capable of generating more than one frequency or programmable therapy, which one skilled in the art would readily recognize, so the metallic vertebral interbody device can deliver more than one frequency stimulation.
Examiner disagrees because in the instant specification fails to disclose the second stimulation parameter to the metallic vertebral interbody device, as the aforementioned frequencies that are capable of treating different pain reliefs of [00101] of the instant specification are not disclosed to be used in combination.
A subgenus is not necessarily implicitly described by a genus encompassing it and a species upon which it reads, see In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972).
Disclosure of a genus and species of subgenus within that genus is not sufficient description of subgenus to satisfy description requirement of 35 U.S.C. 112, unless there are specific facts which lead to determination that subgenus is implicitly described. Ex parte Westphal, 26 USPQ2d (BPAI 1993). In re Smith 173 USPQ 679 (CCPA 1972).
Limitation of a class, generically disclosed, to a subgenus without any teaching of the subgenus is new matter unsupported by the specification. Ex parte Batchelder, 131 USPQ 38, 39 (1960).
[00102] of the instant specification nominally recites the capability of combinational therapy but fails to disclose a species of combinations. For example, the “combinational therapy” nominally recited in [00102] could be directed to the combination of the first and second leads, and may not even be referring to multiple frequency stimulations for the metallic vertebral interbody device. Such genus language is insufficient to satisfy the written description required for the specific requirement of multiple frequencies tuned to be delivered by the metallic vertebral interbody device.
Applicants arguments that one skilled in the art would readily recognize the pulse generator being fully capable of generating more than one frequency or programmable therapy cannot be applied to a new matter rejection.
Obviousness is not the standard for the addition of new limitations to the disclosure as filed. It is noted that entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed. Lockwood v. American Airlines Inc., 41 USPQ2d 1961 (Fed. Cir. 1977). New Matter is a written description issue.
Examiner notes that the third electrical neurostimulation therapy, although may be obvious to have another frequency for stimulation, is not the standard for the new matter rejection because obviousness is under a different statutory rejection. Furthermore, Examiner further notes that there is lack of disclosure for a combinational treatment using the first and second lead with the multiple frequencies since the specification fails to disclose a combinational treatment.
Examiner further notes that [0094] of the instant specification fails to disclose the generating of more than one frequency or programmable therapy, as asserted by Applicant. Therefore, the rejection of record is maintained.
Applicant’s arguments, see pages 8-9, filed 04/28/2026, with respect to 35 U.S.C. 112(b) have been fully considered and are persuasive. The amendments obviate the rejection of record. The rejection of the claims has been withdrawn.
Applicant’s arguments, see pages 10-14, filed 04/28/2026, with respect 35 U.S.C. 103 with respect to the claim(s) have been considered but are not persuasive. Applicant argues on page 12 that “Zellmer does not teach the implant body being fully conductive and serving as the active portion of a lead, configured to deliver electrical energy to the target. Instead, Zellmer teaches discrete electrodes within the implant body that are configured to stimulate distinct regions of a target. In this sense, Zellmer actually teaches away from the claimed invention which uses the entire metallic vertebral interbody device as an active portion of a lead, i.e., the metallic vertebral interbody device is functioning as an electrode to deliver electrical energy to the target region as a whole, not only to distinct regions.”
Examiner disagrees because Applicant fails to describe the structure of the metallic vertebral interbody device in the claim. No where in the claim does the entire metallic body of the interbody device is claimed to be conductive and functioning as an electrode, or that the entire interbody device is metallic.
Applicant further argues on page 12 that “It is also unclear what purpose partial conductivity of the implant body lends to Zellmer since all embodiments require the integrated electrode sites. Zellmer itself does not disclose or suggest that purpose. However, what is clear is that Zellmer does not teach or suggest a metallic implant body that does not require additional electrodes.
The claimed system does not require integrated electrode sites within the metallic vertebral interbody device. Instead, the metallic vertebral interbody device is the electrode. Thus, the structure is significantly different, but the results will also be significantly different as Zellmer delivers energy via a plurality of electrodes to associate distinct regions, which implies that certain regions are untreated, while the claimed structure comprises a single body that delivers energy to a much broader region with fuller treatment coverage and without treatment gaps. In turn, it will be appreciated that the stimulated bone cell and/or collagen growth will be uniform and full, without gaps using the claimed system as opposed to distinct, non-uniformly covered regions with gaps of stimulated bone cell and/or collagen growth using the Zellmer device.”
Examiner notes that the partial conductivity of Zellmer has nothing to do with what is claimed because Zellmer’s device has metallic components, which is what is claimed. The claims fail to describe that the metallic vertebral interbody device is the electrode. Applicant fails to provide structure in the claim to distinguish the prior art.
Applicant then argues on page 13 that “Removing the distinct sites of integrated electrodes from a partially conductive body of Zellmer, then energizing that partially conductive body isn't taught or suggested by Zellmer, nor is it obvious to try based on Zellmer and/or Molnar's disclosure.
There is simply no teaching or suggestion within Zellmer that would serve to move the artisan to convert Zellmer's partially conductive body with discrete integrated active electrode sites into a fully conductive body with no integrated active electrode sites. The result is a completely different structure with a significantly different therapeutic result compared with the Zellmer disclosure. In this regard, Applicant asserts that the Examiner is using impermissible hindsight to modify Zellmer's device into something that is non-obviously different than the disclosed subject matter.”
As noted above, the claims fail to distinguish between the prior art’s interbody device because the claims do not claim structure to distinguish between the devices. The claims require the targeting of the vertebral bones and implanted bone graft, which is taught by Molnar in [0097]. Zellmer can be substitute with the leads of Molnar with the interbody device to induce bone growth.
Examiner does not that Applicant admits on page 7 that one skilled in the art would readily recognize that the pulse generator is fully capable of generating more than one frequency or programmable therapy.
Therefore, the rejection of record is updated to the amendments and maintained.
Claim Objections
Claim 20 is objected to because of the following informalities: regarding the phrase “wherein the first and second sets of therapy parameters are different than the third set of therapy parameters of the third electrical neurostimulation therapy” is not grammatically clear if Applicant is trying to claim if the first and second sets are individually different than the third set or if the first and second set in combination differs collectively from the thirds set. Appropriate clarification is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20, 23-24, and 30-31 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 20 has been added to include the limitation, " wherein the first and second sets of therapy parameters are different than the third set of therapy parameters of the third electrical neurostimulation therapy". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for a metallic vertebral interbody device that can have appropriate stimulation delivered at a specific frequency to induce bone cell growth and repair from a graft ([00102]). However, the specification does not provide support for multiple electrical neurostimulation energy pulses sent from the metallic vertebral interbody device, let alone a third electrical neurostimulation energy therapy. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, "wherein the first and second sets of therapy parameters are different than the third set of therapy parameters of the third electrical neurostimulation therapy”. Therefore, the new claim limitations introduce new matter.
Claims 20, 23-24, and 30-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. For some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. See MPEP 2163 (II)(2).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. See MPEP 2163(III)(a)(ii).
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998)(holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species). See MPEP 2163(III)(a)(ii).
Claim 20 fails to sufficiently describe the metallic vertebral interbody device that delivers a first neurostimulation energy therapy and a second lead electrode that delivers a second neurostimulation energy therapy and the third neurostimulation energy therapy in enough detail for one skilled in the art to have possession of the claimed representative species. The instant specification discloses for the possibility of combinational frequencies given, [00101] of the instant specification only discloses the combination of applying 88 Hz, 7 Hz, and 4.5 Hz for treating arthritis. However, this disclosure fails to disclose 1) which lead, the first or second lead, is applying which frequency, 2) if the frequencies disclosed are the neurostimulation energy therapy that are claimed, and 3) which lead is delivering the third neurostimulation energy therapy. The instant specification fails to disclose any type of combinational therapy of frequencies for a specific treatment. The instant specification only defines the frequency treatment for arthritis ([00101]). No where in the instant specification is there a disclosure where the metallic vertebral interbody device delivers a first neurostimulation energy therapy and a second lead electrode delivers a second neurostimulation energy therapy and there being a third neurostimulation energy therapy. The instant specification fails to disclose any other embodiment/species, and therefore does not have a representative number of species, as instantly claimed. Therefore, claims 20, 23-24, and 30-31 do not provide sufficient detail for a person skilled in the art to have been in possession of the invention as claimed.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20, 23-24, and 30-31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation "the metallic interbody device" in line 12. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests to amend to recite “the metallic vertebral interbody device” to fall in line with the scope.
Claim 20 recites the limitation "the third set of therapy parameters of the third electrical neurostimulation therapy" in line 23-24. There is insufficient antecedent basis for this limitation in the claim.
The term “therapeutic proximity” in claim 20 is a relative term which renders the claim indefinite. The term “therapeutic proximity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what is the therapeutic proximity required for the positioning of the electrodes in relation to the second target. [0108] of the instant specification distinguishes between “at”, “near”, and “therapeutic proximity” but fails to define what the “therapeutic proximity” distance may be.
Claims 23-24 and 30-31 are rejected for being dependent on claim 20.
Claim Interpretation
Regarding the first, second, and third electrical neurostimulation energy therapy of claim 20, in view of the instant specification [00101], Examiner will interpret different frequencies that may be delivered to specified targets to define the first, second, and third sets of therapy parameters.
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.
Claim(s) 20, 23-24, and 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Molnar et al. (US 20200222692)(IDS)(Hereinafter Molnar) in view of Zellmer et al. (US 20200108252)(Hereinafter Zellmer) and Yakovlev et al. (US 20170095667)(IDS)(Hereinafter Yakovlev).
Regarding claim 20, Molnar teaches An implantable system for delivering electrical stimulation therapy to at least two spinal targets, wherein one of the at least two spinal targets comprises an implanted bone graft material comprising bone cells, ([0008] “The neuromodulation procedure includes the placement of one or more neurostimulation leads at one or more target spinal levels, and more specifically, at one or more nerve targets or other anatomical targets at or near the spinal treatment site.” [0097] “The leads of any of the embodiments of FIGS. 7-10 may alternatively be positioned in the lateral gutters of the spine or may be positioned in both the interbody space and the lateral gutters in any combination desirable for the stimulation of bone growth. The lateral gutters may additionally be packed with corticocancellous bone graft on and around the leads placed therein, as may be the interbody space. The leads can be designed and positioned to maximize contact with live bone both on the lateral gutters and/or in the interbody space so as to maximize effectiveness of the neuromodulation therapy.”) the system comprising:
a first lead comprising an active portion that is a metallic vertebral interbody device configured to be implanted within a spinal interbody space and further configured to deliver neurostimulation energy to a first target within, or adjacent to, the spinal interbody space (Claim 1 “a second lead having a lead body including a proximal portion electrically coupled to the implantable pulse generator and a distal portion positionable in therapeutic proximity to a target nerve and having one or more electrodes capable of delivering the neuromodulation energy to a second anatomical target;” Claim 3 “wherein the second anatomical target is an interbody space.” [0092] “The interbody space 410 may have an outer periphery 412 defined by the outer periphery of each of the adjacent vertebral levels [spine] 430, 432” [0090] “The proximal portion 404 of the lead 402 is electrically coupled to the implantable pulse generator 408 to enable delivery of the neuromodulation therapy to the target interbody space 410 via the electrodes 403.”), the first target comprising vertebral bones that are adjacent to the spinal interbody space, and the implanted bone graft material ([0097] “The leads of any of the embodiments of FIGS. 7-10 may alternatively be positioned in the lateral gutters of the spine or may be positioned in both the interbody space and the lateral gutters in any combination desirable for the stimulation of bone growth. The lateral gutters may additionally be packed with corticocancellous bone graft on and around the leads placed therein, as may be the interbody space. The leads can be designed and positioned to maximize contact with live bone both on the lateral gutters and/or in the interbody space so as to maximize effectiveness of the neuromodulation therapy.”);
a second lead having an active portion that is a set of one or more electrodes, the one or more electrodes configured to be positioned in therapeutic proximity to a second target comprising a dorsal root ganglion (Claim 1 “a first lead having a lead body including a proximal portion electrically coupled to the implantable pulse generator and a distal portion positionable in therapeutic proximity to a target nerve and having one or more electrodes capable of delivering the neuromodulation energy to a first anatomical target;” Claim 2 “wherein the first anatomical target is a dorsal root ganglion at a spinal treatment site.”);
an electrical stimulation pulse generator electrically coupled to the metallic interbody device, and electrically coupled to the second lead, the electrical stimulation pulse generator configured to generate a first electrical neurostimulation energy therapy delivered to the first target via the metallic vertebral interbody device to stimulate bone cell growth and/or collagen production in the vertebral bones and the implanted bone graft material of the first target, and a second electrical neurostimulation energy therapy delivered to the second target via the second lead to modulate pain (Claim 1 “an implantable pulse generator capable of providing a neuromodulation energy source” [0049] “system 20 having a first lead 26 having a unilateral lead pathway defined by the lead body 15 that extends from an implantable pulse generator 24 positioned at the spinal treatment site 22 to a unilateral target nerve 34 at a first spinal level 40 and a second lead 28 having a unilateral lead pathway defined by the lead body 15 that extends from the implantable pulse generator 24 to a second spinal level 42 such that the distal portion 30 of first lead 26 and second lead 28 are capable of delivering a neuromodulation therapy to a nerve target 34 that innervates the corresponding facet joint 44.” [0127] “the lead may be connected to the implantable pulse generator by the various means of connecting described with reference to FIGS. 12A-12C and the implantable pulse generator may be anchored to the interspinous device via the fixation elements described above with reference to FIG. 13 and may include, as desired, any other elements described in the embodiments above.” [0051] “FIG. 3 illustrates a facet joint pain neuromodulation system 20… the lead may be positioned on the second portion 63 of the facet joint 44 that is distal to the dorsal root 62.” [0097] “The leads of any of the embodiments of FIGS. 7-10 may alternatively be positioned in the lateral gutters of the spine or may be positioned in both the interbody space and the lateral gutters in any combination desirable for the stimulation of bone growth. The lateral gutters may additionally be packed with corticocancellous bone graft on and around the leads placed therein, as may be the interbody space. The leads can be designed and positioned to maximize contact with live bone both on the lateral gutters and/or in the interbody space so as to maximize effectiveness of the neuromodulation therapy.”).
However, Molnar does not teach a metallic interbody device that provides electrical stimulation to the interbody space. Zellmer, in the same field of endeavor, teaches the use of electrodes/leads in the interbody space of the spine for electrical stimulation for bone growth (Abstract), in the spine ([0027]), and further teaches metallic vertebral interbody device to deliver neurostimulation energy to a first spinal target within the spinal interbody space (See Fig. 4 and 5 of implant body 100 with interior and exterior electrodes 112 and 114 found in between the vertebras. [0025] “an implant may be implanted in the space between two vertebrae” [0049] “The electrode sites are distributed across the geometry of the implant body 100 in such a way as to facilitate the osteoinduction and osteolysis in desired bone growth regions during a controlled stimulation mode.” [0041] “The spinal cage is preferably composed of a non-conductive polymer, such as PEEK, but may be made of engineered, natural or synthetic bone material, titanium [metallic] and/or other suitable material or combinations thereof.”) to enhance desired bone growth behavior ([0026]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Molnar, with the active portion of the first lead having a form factor of an interbody cage of Zellmer, because such a modification would allow to enhance desired bone growth behavior.
Molnar in view of Zellmer do not teach the first electrical neurostimulation therapy comprises a first set of therapy parameters that are different than a second set of therapy parameters of the second electrical neurostimulation therapy and the first and second sets of therapy parameters are different than the third set of therapy parameters of the third electrical neurostimulation therapy. Yakovlev, in the same field of endeavor, teaches the neuromodulation of nerves, including the ganglion nerve and spinal cord for pain relief (Abstract and [0018]-[0020]), and further teaches wherein the first electrical neurostimulation therapy comprises a first set of therapy parameters that are different than a second set of therapy parameters of the second electrical neurostimulation therapy ([0075] “The electrical stimulation parameters can be configured to have the following parameters: frequency in the range between 40 and 150 Hz [first set of therapy parameters]… The electrical stimulation parameters can be configured to have the following parameters: frequency in the range between 2 and 20 kHz [second set of therapy parameters]”), and
wherein the first and second sets of therapy parameters are different than the third set of therapy parameters of the third electrical neurostimulation therapy ([0075] “The electrical stimulation parameters can be configured to have the following parameters: frequency in the range between 1 Hz and 50 kHz [third set of therapy parameters]” The range between 1-39 Hz and 21 kHz-50 kHz is different than the first and second therapy parameters.) to treat pain management ([0199]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Molnar in view of Zellmer, with the first electrical neurostimulation therapy comprises a first set of therapy parameters that are different than a second set of therapy parameters of the second electrical neurostimulation therapy and the first and second sets of therapy parameters are different than the third set of therapy parameters of the third electrical neurostimulation therapy of Yakovlev, because such a modification would allow to treat pain management.
Although Molnar in view of Zellmer do not explicitly teach that the IPG electrically couples to the metallic interbody device, for a person of ordinary skill in the art, making such modifications would have required nothing more than a predictable application of a known technique to a known device ready for improvement. See KSR, 550 U.S. at 416-417. A skilled artisan would have understood how to modify Zellmer to use leads to the implant to control the stimulation of the two leads simultaneously from a singular controller (Molnar [0071]). The IPG electrically coupling to the metallic interbody device would not have been “uniquely challenging or difficult for one of ordinary skill in the art” or “represented an unobvious step over the prior art” to modify Molnar in view of Zellmer as discussed above. Leapfrog Enters., Inc. v. Fisher- Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (citing KSR, 550 U.S. at 418-19).
Regarding claims 23-24, claim 20 is obvious over Molnar and Zellmer. However, Molnar does not teach the active portion of the first lead having a form factor of an interbody cage. Zellmer, in the same field of endeavor, teaches an teaches the use of electrodes/leads in the interbody space of the spine for electrical stimulation for bone growth (Abstract), in the spine ([0027]), and further teaches wherein the metallic vertebral interbody device comprises an interbody cage…wherein the active portion of the first lead is directly electrically connected with the interbody cage (See Fig. 4 and 5 of implant body 100 with interior and exterior electrodes 112 and 114 found in between the vertebras. [0049] “The electrode sites are distributed across the geometry of the implant body 100 in such a way as to facilitate the osteoinduction and osteolysis in desired bone growth regions during a controlled stimulation mode.”) to enhance desired bone growth behavior ([0026]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Molnar, with the active portion of the first lead having a form factor of an interbody cage of Zellmer, because such a modification would allow to enhance desired bone growth behavior.
Although Molnar in view of Zellmer do not explicitly teach that the first lead is directly electrically coupled to the metallic interbody device and the active portion of the first lead is directly electrically connected with the interbody cage, for a person of ordinary skill in the art, making such modifications would have required nothing more than a predictable application of a known technique to a known device ready for improvement. See KSR, 550 U.S. at 416-417. A skilled artisan would have understood how to modify Zellmer to use leads to the implant to control the stimulation of the two leads simultaneously from a singular controller (Molnar [0071]). The first lead is directly electrically coupled to the metallic interbody device and the active portion of the first lead is directly electrically connected with the interbody cage would not have been “uniquely challenging or difficult for one of ordinary skill in the art” or “represented an unobvious step over the prior art” to modify Molnar in view of Zellmer as discussed above. Leapfrog Enters., Inc. v. Fisher- Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (citing KSR, 550 U.S. at 418-19).
Regarding claim 30-31, claim 20 is obvious over Molnar and Zellmer. Molnar in view of Zellmer do not teach the first electrical neurostimulation therapy has a frequency of about 88 Hz, and wherein the third electrical neurostimulation therapy comprises a frequency of 7 and 15 Hz. Yakovlev, in the same field of endeavor, teaches the neuromodulation of nerves, including the ganglion nerve and spinal cord for pain relief (Abstract and [0018]-[0020]), and further teaches wherein the first electrical neurostimulation therapy has a frequency of about 88 Hz, and wherein the third electrical neurostimulation therapy comprises a frequency of 7 and 15 Hz ([0075] “The electrical stimulation parameters can be configured to have the following parameters: frequency in the range between 40 and 150 Hz [first set of therapy parameters]… The electrical stimulation parameters can be configured to have the following parameters: frequency in the range between 2 and 20 kHz [second set of therapy parameters]… The electrical stimulation parameters can be configured to have the following parameters: frequency in the range between 1 Hz and 50 kHz [third set of therapy parameters]”) to treat pain management ([0199]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Molnar in view of Zellmer, with the first electrical neurostimulation therapy has a frequency of about 88 Hz, and wherein the third electrical neurostimulation therapy comprises a frequency of 7 and 15 Hz of Yakovlev, because such a modification would allow to treat pain management.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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