DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
3. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
4. Claims 2-11 are rejected under 35 U.S.C. 103 as being unpatentable over , Pellegrino U.S. 2019/0038345 (herein referred to as “Pellegrino”) and in view of Non-Patent Literature, Percutaneous Radiofrequency Hip Joint Denervation by Saiz-Sapena (herein referred to as “Saiz-Sapena”).
5. Regarding Claims 2-4, Pellegrino teaches a minimally invasive method of modulating a nerve branch to treat joint pain in a subject (para 0035, “the energy is configured to heat tissue within bone (e.g., a vertebral body) sufficient to modulate (e.g., denervate, ablate) intraosseous nerves (e.g., basivertebral nerves or other nerves located partially or fully within bone)… the energy is configured to treat tissue outside the spine, for example in non-spinal joints… and or their surrounding nerves”), the method comprising:
a. imaging the joint using at least one of ultrasound or fluoroscopy to identify anatomical landmarks (Fig. 3; para 0116, “the target region may be identified or determined by pre-operative imaging, such as from MRI or CT images”; para 0129, “target treatment location T is identified prior to the introduction of the trocar 20 by magnetic resonance (MR) imaging, computed tomography (CT) imaging, or other imaging modalities. The introduction of the trocar 20, curved cannula 50, treatment device, and/or other instruments can be visualized in real time using fluoroscopic or other imaging to ensure proper introduction and orientation within the target treatment location”);
b. percutaneously inserting a treatment device to a first point determined by the anatomical landmarks until a distal end of the treatment device contacts bone (Fig. 4A, ref num 20 advanced to ref num 128; para 0119; para 0120, “the assembly (trocar 20 and straight stylet 80) is advanced through soft tissue to the surface of the bone. Once the proper alignment is determined, the assembly may be advanced through the cortical shell of pedicle 138 and into the cancellous interior 124 of the bone”);
c. extending a stylet out of a needle body of the treatment device (Fig. 4B, 4D, ref num 50/56 is extended out of ref num 20; Fig. 4E, ref num 90/94 also extended out of the needle body; para 0125, “advancing the curved cannula 50 and stylet 60 beyond the distal opening of trocar 20”), wherein extending the stylet comprises sliding the stylet along the bone to a second point (para 0125, “para 0125, “advancing the curved cannula 50 and stylet 60 beyond the distal opening of trocar 20 to generate a curved path in the cancellous bone region 124”; this also leads ref num 90 to be advanced to the desired target; para 0127, “The tip 94 of the channeling stylet 90 may be advanced beyond the end 54 of the curved cannula 50 towards the intended target treatment zone”),
d. imaging using at least one of ultrasound or fluoroscopy to confirm a first location of the treatment device relative to the anatomical landmarks (para 0129, “the target treatment location T is identified prior to introduction of the trocar 20 by magnetic resonance (MR) imaging, computed tomography (CT) imaging, or other imaging modalities. The introduction of the trocar 20, curved cannula 50, treatment device, and/or other instruments can be visualized in real time using fluoroscopic or other imaging to ensure proper introduction and orientation within the target treatment location”);
e. applying bipolar radiofrequency energy to a first electrode and a second electrode to ablate first tissue between the first point and the second point (para 0130, “ the active element 102 is delivered to the treatment site and activated to deliver therapeutic treatment energy. In various embodiments, the treatment device comprises a probe, catheter, antenna, wire, tube, needle, cannula, sleeve, or conduit. The treatment device may comprise an RF delivery probe having bipolar electrodes 106 and 108 that deliver a therapeutic level of heating (e.g., thermal dose) to modulate (e.g., stimulate or ablate) at least a portion of the nerve 122”),
f. retracting the stylet into the needle body; g. retracting the treatment device out of the subject (para 0140, “once the treatment is complete, the probe 100 may be withdrawn. The curved cannula 50 may then be withdrawn into the needle trocar 20. The needle trocar 20 with the curved cannula 50 may then be removed and the access site may be closed as prescribed by the physician or other medical professional”).
While Pellegrino fails to specifically teach the following:
h. percutaneously inserting the treatment device to a third point determined by the anatomical landmarks until the distal end of the treatment device contacts the bone;
i. extending the stylet out of the needle body of the treatment device, wherein extending the stylet comprises sliding the stylet along the bone to a fourth point;
j. imaging using at least one of ultrasound or fluoroscopy to confirm a second location of the first electrode and the second electrode relative to the anatomical landmarks;
k. applying bipolar radiofrequency energy to the first electrode and the second electrode to ablate second tissue between the third point and the fourth point,
l. retracting the stylet into the needle body; and
m. retracting the treatment device out of the subject,
and fails to teach the steps repeated in Claims 3 and 4, Pellegrino does discuss that the treatment may be performed at different locations of target tissue sequentially (para 0129, “the treatment (e.g., neuromodulation) can be performed at multiple levels of vertebrae (simultaneously or sequentially with one, two, three or more treatment devices). The levels may be adjacent or spaced apart”) in order to achieve the desired effect (para 0129). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pellegrino to have repeated the method of treating various nerve branches as described above in order to achieve the desired modulation of the target locations.
Pellegrino fails to specifically teach modulating an articular nerve branch to treat hip joint pain; the needle body comprising a first electrode and the stylet comprising a second electrode; the first tissue including an articular branch nerve of a sciatic nerve; the second tissue including an articular branch nerve of a cranial gluteal nerve.
Pellegrino discusses a first and second electrode being spaced apart in order to provide bipolar modulation (para 0036). These electrodes may be placed on different structures/probes of the instrument (para 0044). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pellegrino to have the first electrode on the needle body and the second electrode on the stylet, because this produces the same expected result of creating a line of ablation for modulating the target location of tissue.
Saiz-Sapena teaches a method of analogous art, wherein the method includes modulating an articular nerve branch to treat hip joint pain, including an articular branch nerve of a sciatic nerve and an articular branch nerve of a cranial gluteal nerve (Section 5.3 – Nerve Targets). By applying the method as taught by Pellegrino to the desired areas, such as treating a hip, this reduces hip pain in the subject (Section 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pellegrino to target the hip nerves in order to treat hip joint pain and achieve the desired result as described.
6. Regarding Claim 5, Pellegrino teaches the subject is a quadruped (para 0217, “In conducting initial animal experiments with a dual probe embodiment”; para 0290).
7. Regarding Claim 6, Pellegrino teaches a minimally invasive method of modulating a nerve branch to treat joint pain in a subject (para 0035, “the energy is configured to heat tissue within bone (e.g., a vertebral body) sufficient to modulate (e.g., denervate, ablate) intraosseous nerves (e.g., basivertebral nerves or other nerves located partially or fully within bone)… the energy is configured to treat tissue outside the spine, for example in non-spinal joints… and or their surrounding nerves”), the method comprising:
a. percutaneously inserting a treatment device to a first point until a distal end of the treatment device contacts bone (Fig. 4A, ref num 20 advanced to ref num 128; para 0119; para 0120, “the assembly (trocar 20 and straight stylet 80) is advanced through soft tissue to the surface of the bone. Once the proper alignment is determined, the assembly may be advanced through the cortical shell of pedicle 138 and into the cancellous interior 124 of the bone”);
b. extending a stylet out of a needle body of the treatment device (Fig. 4B, 4D, ref num 50/56 is extended out of ref num 20; Fig. 4E, ref num 90/94 also extended out of the needle body; para 0125, “advancing the curved cannula 50 and stylet 60 beyond the distal opening of trocar 20”), wherein extending the stylet comprises sliding the stylet along the bone to a second point (para 0125, “para 0125, “advancing the curved cannula 50 and stylet 60 beyond the distal opening of trocar 20 to generate a curved path in the cancellous bone region 124”; this also leads ref num 90 to be advanced to the desired target; para 0127, “The tip 94 of the channeling stylet 90 may be advanced beyond the end 54 of the curved cannula 50 towards the intended target treatment zone”),
c. applying bipolar radiofrequency energy to a first electrode and a second electrode to ablate first tissue between the first point and the second point (para 0130, “ the active element 102 is delivered to the treatment site and activated to deliver therapeutic treatment energy. In various embodiments, the treatment device comprises a probe, catheter, antenna, wire, tube, needle, cannula, sleeve, or conduit. The treatment device may comprise an RF delivery probe having bipolar electrodes 106 and 108 that deliver a therapeutic level of heating (e.g., thermal dose) to modulate (e.g., stimulate or ablate) at least a portion of the nerve 122”),
d. retracting the stylet into the needle body (para 0140, “once the treatment is complete, the probe 100 may be withdrawn. The curved cannula 50 may then be withdrawn into the needle trocar 20. The needle trocar 20 with the curved cannula 50 may then be removed and the access site may be closed as prescribed by the physician or other medical professional”).
Pellegrino fails to specifically teach modulating an articular nerve branch to treat hip joint pain; the needle body comprising a first electrode and the stylet comprising a second electrode; the first tissue including an articular branch nerve of a sciatic nerve, a cranial gluteal nerve, a femoral nerve, or an obturator nerve.
Pellegrino discusses a first and second electrode being spaced apart in order to provide bipolar modulation (para 0036). These electrodes may be placed on different structures/probes of the instrument (para 0044). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pellegrino to have the first electrode on the needle body and the second electrode on the stylet, because this produces the same expected result of creating a line of ablation for modulating the target location of tissue.
Saiz-Sapena NPL teaches a method of analogous art, wherein the method includes modulating an articular nerve branch to treat hip joint pain, including an articular branch nerve of a sciatic nerve and an articular branch nerve of a cranial gluteal nerve (Section 5.3 – Nerve Targets). By applying the method as taught by Pellegrino to the desired areas, such as treating a hip, this reduces hip pain in the subject (Section 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pellegrino to target the hip nerves in order to treat hip joint pain and achieve the desired result as described.
8. Regarding Claims 7-10, while Pellegrino fails to teach repeating the method of Claim 6 for various target areas, they does discuss that the treatment may be performed at different locations of target tissue sequentially (para 0129, “the treatment (e.g., neuromodulation) can be performed at multiple levels of vertebrae (simultaneously or sequentially with one, two, three or more treatment devices). The levels may be adjacent or spaced apart”) in order to achieve the desired effect (para 0129). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pellegrino to have repeated the method of treating various nerve branches as described above in order to achieve the desired modulation of the target locations.
As for the first and second tissues being of different articular branches, Saiz-Sapena teaches a method of analogous art, wherein the method includes modulating an articular nerve branch to treat hip joint pain, including an articular branch nerve of a sciatic nerve and an articular branch nerve of a cranial gluteal nerve (Section 5.3 – Nerve Targets). By applying the method as taught by Pellegrino to the desired areas, such as treating a hip, this reduces hip pain in the subject (Section 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pellegrino to target the hip nerves in order to treat hip joint pain and achieve the desired result as described.
9. Regarding Claim 11, Pellegrino teaches the subject is a quadruped (para 0217, “In conducting initial animal experiments with a dual probe embodiment”; para 0290).
10. Claims 12, 16, 17, 19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Donovan U.S. 2024/0148455 (herein referred to as “Donovan”) and in view of Bowling U.S. 9,480,534 (herein referred to as “Bowling”).
11. Regarding Claim 12, Donovan teaches a minimally invasive method of modulating an articular nerve branch to treat hip joint pain of a subject (para 00877), wherein the method comprises:
a. identifying an articular branch nerve emanating from a nerve innervating the hip joint (para 0138, “The registration system may include multiple computing devices (e.g., processors and computer-readable memory for storing instructions to be executed by the processor(s)). The registration may involve identification of natural landmarks”)
b. percutaneously modulating the articular branch nerve (para 0145, “A treatment device 501 can then be inserted through the introducer assembly to modulate (e.g., ablate or stimulate) nerves”).
c. wherein after modulating the articular branch nerve the hip joint pain is reduced (para 0059).
Donovan fails to teach wherein identifying the articular branch nerve comprises: d.1 acquiring a hip joint reference point corresponding to a radiographically identifiable anatomical feature of the hip joint; and d.2 generating coordinates for a target treatment site as a function of a calculated distance from the reference point.
12. Regarding Claim 16, Donovan teaches wherein modulating the articular branch nerve comprises ablating the articular branch nerve at a target site (abstract).
13. Regarding Claim 17, Donovan teaches the target site is external to the hip joint (para 0077).
14. Regarding Claim 19, Donovan teaches the target site comprises a portion of the articular branch nerve proximate a terminus of the articular branch nerve (para 0076).
15. Regarding Claim 21, Donovan teaches percutaneously inserting a treatment device to a first point (Fig. 3H), extending a stylet out of a needle body of the treatment device (Fig. 3H, ref num 501), and applying energy to the treatment device to ablate tissue including the articular branch nerve (para 0098). While Donovan fails to teach the needle body comprising a first electrode and the stylet comprising a second electrode, they discuss the electrodes being a bipolar pair of electrodes that are spaced apart from one another, such as one is at the tip, i.e., ref num 501 (para 0101). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Donovan to have the first electrode on the needle body and the second electrode on the stylet, because this produces the same expected result of creating a line of ablation for modulating the target location of tissue.
16. Regarding Claims 22 and 23, Donovan teaches applying the energy comprises radiofrequency energy that is bipolar (para 0101).
17. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Donovan and Bowling, and further in view of Saiz-Sapena.
18. Regarding Claim 15, Donovan fails to teach the nerve comprises at least one of the cranial gluteal nerve, femoral nerve, sciatic nerve, or obturator nerve.
Saiz-Sapena teaches a method of analogous art, wherein the method includes modulating an articular nerve branch to treat hip joint pain, including an articular branch nerve of a sciatic nerve and an articular branch nerve of a cranial gluteal nerve (Section 5.3 – Nerve Targets). By applying the method as taught by Pellegrino to the desired areas, such as treating a hip, this reduces hip pain in the subject (Section 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Donovan to target the hip nerves in order to treat hip joint pain and achieve the desired result as described.
Bowling teaches a method of analogous art (Col. 2, lines 52-67 – Col. 3, lines 1-3), such that identifying the target site comprises: acquiring a reference point corresponding to a radiographically identifiable anatomical feature of the target; and generating coordinates for a target treatment site as a function of a calculated distance from the reference point (Col. 26, lines 4-29). This provides feedback to the user in order to position the instrument and control the movement of the instrument as desired (Col. 28, lines 17-22). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Donovan to have identified the articular branch nerve as described above in order to manipulate and position the instrument at the target location for treatment.
19. Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Donovan and Bowling, and further in view of Non-Patent Literature, Thermal radiofrequency ablation of the saphenous nerve in dogs with pain from naturally-occurring stifle osteoarthritis by Boesh (herein referred to as “Boesh”).
20. Regarding Claims 25 and 26, Donovan fails to teach the subject is a quadruped, and wherein the subject has osteoarthritis or degenerative joint disease, and that the subject is a canine.
Boesch teaches ablating nerves of analogous art (abstract), wherein the subject is a quadruped, and wherein the subject has osteoarthritis or degenerative joint disease, and that the subject is a canine (abstract). This still produces the same expected result of reducing hip pain (abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Donovan to treat the desired subject, as this produces the same expected result of reducing hip joint paint.
Conclusion
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794