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 .
Response to Arguments
Applicant’s arguments, see page 5, filed 09/26/2025, with respect Double Patenting the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see pages 5-7, filed 09/26/2025, with respect 35 U.S.C. 102/103 with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see pages 7-8, filed 09/26/2025, with respect Double Patenting the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Election/Restrictions
Applicant’s election without traverse of a(i), the first electrical stimulation/neurostimulation therapy at frequency about 88 Hz, the second electrical stimulation/neurostimulation therapy at frequency about 15 Hz, the third electrical stimulation/neurostimulation therapy at frequency about 1 Hz, in the reply filed on 02/10/2026 is acknowledged.
Claims 25-26, 38, and 40-41 (neurostimulation/stimulation at a frequency of 1 Hz, when the election specified at 15 Hz) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and election, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/10/2026.
Response to Amendment
This Office Action is responsive to the amendment filed on 02/10/2026. As directed by the amendment: Claims 20, 29-31, and 38, 40-41 have been amended, claims 27-28, 32-37, and 42-47 have been cancelled, and claims 48-50 have been added. Claims 25-26, 38, and 40-41 are withdrawn due to a Restriction Requirement. Thus, claims 20-24, 29-31, and 48-50 are presently under consideration in this application.
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 29-31 and 50 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 50 has been added to include the limitation, " wherein the electrical stimulation pulse generator is configured to generate a third electrical neurostimulation energy via the first lead to stimulate bone cell growth and/or collagen production within the first spinal target". 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. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, "wherein the electrical stimulation pulse generator is configured to generate a third electrical neurostimulation energy via the first lead to stimulate bone cell growth and/or collagen production within the first spinal target”. Therefore, the new claim limitations introduce new matter.
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 23-24, 29-31, and 48-49 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 21 recites the broad recitation that the first lead is electrically coupled to the metallic interbody device, but claim 20 also recites that the first lead comprises an active portion that is a metallic interbody device which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. It is not possible for the first lead to comprise the metallic interbody device, while the first lead also directly electrically connected to itself.
Claim 23 recites the limitation "the metallic vertebral interbody device" in line 12. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests to amend to recite “the metallic interbody device” to fall in line with the scope.
Regarding claim 24, it is unclear how “bone cells” are within the first spinal target within the spinal interbody space. It is unclear where these “bone cells” are located.
The term “about” in claims 30-31 is a relative term which renders the claim indefinite. The term “about” 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. Regarding claims 30 and 31, the term “about” will be interpreted as about a 5 Hz above and below the given value because the instant specification fails to define what Applicant defines the term for “about”.
Regarding claim 48, it is unclear how the first spinal target is the vertebral bone but the first spinal target is within the spinal interbody space, which means that the first spinal target will have to be the space between 2 vertebras.
Regarding claims 29 and 49, it is unclear how the first spinal target further comprises a bone graft when the first spinal target is within the spinal interbody space because a bone graft is not a human anatomical part.
Regarding claim 49, it is unclear if the bone cells of the graft of claim 49 is the same or different than the bone cells of the vertebral bones of claim 48.
Claim Interpretation
Regarding claim 20, the phrase “the electrical stimulation pulse generator configured to generate a first electrical neurostimulation energy therapy delivered to the first spinal target via the first lead to stimulate bone cell growth or collagen production, and a second electrical neurostimulation energy therapy delivered to the second spinal target via the second lead to modulate pain” is intended use. The structure of Molnar teaches the claimed structure of the device because the neurostimulation of the interbody space using the metallic interbody device and the neurostimulation of the DRG by the electrodes of Molnar are capable of stimulating bone cell growth and modulate pain, respectively, even without the recitation bone cell growth and pain modulation in [0038], [0089], and claim 3.
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) 20-21 and 23-24 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).
Regarding claim 20, Molnar teaches An implantable system for delivering electrical stimulation therapy to at least two spinal targets ([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.”) the system comprising:
a first lead comprising an active portion that is a metallic interbody device configured to be implanted within a spinal interbody space and further configured to deliver neurostimulation energy to a first spinal target within 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.”);
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 spinal 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 spinal target via the first lead to stimulate bone cell growth or collagen production, and a second electrical neurostimulation energy therapy delivered to the second spinal 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.”).
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 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 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.
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 21 and 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 first lead is directly electrically coupled to the metallic interbody device…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 48, Molnar teaches wherein the first spinal target comprises vertebral bones comprising bone cells within the first spinal target within the spinal interbody space, wherein the first electrical neurostimulation therapy is configured to induce the bone cells of the vertebral bones to grow ([0085] “Neuromodulation of the Interbody Space for Stimulation of Bone Growth” [0095] “FIG. 8 or 9 such that the distal portion 406 of the lead 402 is capable of delivering a neuromodulation therapy to an outer periphery 412 of the interbody space 410 for the stimulation of bone growth.” [0092] “The interbody space 410 may have an outer periphery 412 defined by the outer periphery of each of the adjacent vertebral levels 430, 432, and further defines an inner periphery 414 defined as the area proximal to the spinal cord 440 relative to the outer periphery 412.”).
Regarding claim 49, Molnar teaches wherein the first spinal target further comprises bone graft comprising bone cells, wherein the bone graft is disposed within the spinal interbody space, wherein the first electrical neurostimulation therapy is configured to induce the bone cells of the bone graft to grow ([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.” Examiner further notes that the bone graft is not actively recited.).
Regarding claim 50, Molnar teaches wherein the electrical stimulation pulse generator is configured to generate a third electrical neurostimulation energy via the first lead to stimulate bone cell growth and/or collagen production within the first spinal target ([0103] “The therapy may be delivered periodically, one or more times per day for a specified period of time, and repeated one or more days, weeks, or months for a specified number of days, weeks or months. Such therapy delivery schedule may, of course, include intermittent or periodic changes in the therapy delivery timing and attributes.” [0099] “It is further understood that the method and system for the above embodiments relating to neurostimulation of the interbody space can be implanted and implemented in combination with other neuromodulation therapies such as those described previously, and those described below.” [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.” [0089] “FIG. 7 illustrates a neuromodulation system 420 for targeting the interbody space 410 for the stimulation of bone growth.”).
Regarding claim 29, Molnar teaches wherein the first spinal target comprises a bone graft comprising bone cells, the bone graft disposed within the vertebral fusion site, wherein the third stimulation therapy is configured to stimulate the bone cells of the bone graft within the first spinal target ([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.” Examiner further notes that the bone graft is not actively recited. Stimulating bone cells within the bone graft is intended use.).
Claim(s) 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 Puryear et al. (US 10117580)(Hereinafter Puryear).
Regarding claim 30-31, claim 20 is obvious over Molnar and Zellmer. Molnar in view of Zellmer do not teach the wherein the first electrical neurostimulation therapy has a frequency of about 88 Hz, and wherein the third electrical neurostimulation therapy comprises a frequency of about 7 and 15 Hz. Puryear, in the same field of endeavor, teaches the implantable device placed in the interspinous space for electrical stimulation (Cols. 1 and 2), 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 about 7 and 15 Hz (Col. 7 lines 7-14 “a programmable continuous or pulsed stimulation current in the 10 Hz to 1000 Hz range, and a probe in the form of electrode-bearing leads, connected to the implanted receiver and routed to the sites of therapy. The receiver may be implanted at sites in the spinal column local to the site of the pain. An example implant site is between and alongside of the interspinous processes.” Examiner notes that the first and third frequencies fall in the range of 10-1000 Hz, and that either frequencies may be chosen for the neurostimulation therapies provided by Molnar.) to enhance bone growth (Col. 2 lines 27-30). 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 frequency range between 15-88 of Puryear, because such a modification would allow to enhance bone growth.
Claim(s) 22 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), Puryear et al. (US 10117580)(Hereinafter Puryear) and Yakovlev et al. (US 20170095667)(IDS)(Hereinafter Yakovlev).
Regarding claim 22, claim 20 is obvious over Molnar and Zellmer. Molnar in view of Zellmer do not teach the first electrical neurostimulation therapy comprises a first set of therapy parameters. Puryear, in the same field of endeavor, teaches the implantable device placed in the interspinous space for electrical stimulation (Cols. 1 and 2), 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 (Col. 7 lines 7-14 “a programmable continuous or pulsed stimulation current in the 10 Hz to 1000 Hz range, and a probe in the form of electrode-bearing leads, connected to the implanted receiver and routed to the sites of therapy. The receiver may be implanted at sites in the spinal column local to the site of the pain. An example implant site is between and alongside of the interspinous processes.”) to enhance bone growth (Col. 2 lines 27-30). 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 of Puryear, because such a modification would allow to enhance bone growth.
Molnar in view of Zellmer and Puryear do not teach the second set of therapy parameters of the second 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;” Examiner notes that 40 Hz is within the range of 1-40 Hz.) 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 and Puryear, with the second set of therapy parameters of the second electrical neurostimulation therapy of Yakovlev, because such a modification would allow to treat pain management.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796