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 .
Continued Examination Under 37 CFR 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 After-Final submission filed on 08/17/26 (“08/17/26 Amendment") has been entered, and fully considered [by the filing of the 08/26/26 RCE].
Response to Amendment
3. In the 08/17/26 Amendment, claims 1, 2, 5, 6, 9, 10, 13, 16, 17, 21-23, & 25 were amended. No claims were cancelled or newly added. Therefore, claims 1-25 are now pending in the application.
4. The 08/17/26 Amendment has overcome the claim objections and the claim rejections under § 112(b) previously set forth in the Final Office Action mailed 06/03/26 (“06/03/26 Action”).
5. New grounds of rejection under § 112(b) are set forth herein, necessitated by Applicant’s Amendment.
6. The prior rejection of independent claim 1 under § 103 has been updated to address the new limitation, and maintained, along with the remainder of the prior § 103 rejections.
7. Applicant's arguments are addressed in detail below in the "Response to Arguments"
section.
Claim Rejections - 35 USC § 112
8. 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.
9. Claim 9 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
10. Claim 9 (which was amended to depend from claim 8) recites the limitation “a cutting section” in line 2, and “a drill member” in lines 2-3. These recitations render the claim indefinite, as it is not clear whether the recited “a cutting section” and “a drill member” are intended to comprise the same “cutting section” and “drill member” previously recited in claim 8 (from which claim 9 now depends), or a separate/additional cutting section and drill member. As such, the structure required by the claim is not clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
Claim Rejections - 35 USC § 103
11. 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.
12. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
13. Claims 1-4, 7, 14, 16-18, & 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2018/01039064 to Patel et al. (“Patel”) in view of U.S. 2019/0343575 to Carter et al. (“Carter”), and further in view of U.S. 2019/0269469 to Bush, JR. et al. (“Bush”).
14. Regarding claim 1, Patel teaches a set of surgical tools [system or kit (10) - ¶¶ [0111], [0155], [0235]] for spinal facet therapy for alleviating spinal pain for minimally invasive spinal facet joint or capsular treatment and/or surgery using mechanical ablation and electromagnetic ablation and/or coagulation, comprising:
a first tool for performing mechanical ablation [e.g., ¶[0135] (“treatment may be effected by any mechanical destruction and or removal means capable of severing or denervating the basivertebral nerve. For example, a cutting blade, bur, electrocautery knife or mechanically actuated cutter may be used”); & ¶[0231]] of a part of a target spinal facet joint or capsular…,
a second tool using electromagnetic waves for ablation [e.g., ¶[0034] (“the energy delivery device is configured to deliver radiofrequency energy, microwave energy, light energy, thermal energy, ultrasonic energy, and/or other forms of electromagnetic energy, and/or combinations of two or more thereof”); see also RF probe (100) - ¶[0111]; FIG. 2] of tissue and/or nerves and/or parts of the target spinal facet joint or capsular and/or coagulation of tissue and/or parts of the target spinal facet joint or capsular, and
a sleeve [e.g., cannula (50) - ¶[0111]; FIG. 1] configured to be inserted into an incision provided on a back of a patient over a guide wire and/or a dilator until the sleeve reaches the target spinal facet joint or capsular [cannula (50) is capable of performing this claimed function] and to provide a working channel [central lumen of curved cannula (50) - see ¶[0120]], the working channel configured to separately receive each of the first tool and the second tool therein [the central lumen of cannula (50) in Patel is capable of separately receiving different tools therein - see, e.g., ¶[0127] (“a treatment device fed through the cannula 50”); ¶[0141] (“the treatment device 100 may be deployed into the bone through the curved cannula 50”); ¶[0112] (“The surgical devices and surgical systems described may be used to deliver numerous types of treatment devices to varying regions of the body”); NOTE: “separately” is being interpreted herein according to its plain and ordinary meaning – i.e., independently or distinctly; not at the same time or not in the same place; apart in space or time); in Patel, the first and second tools are separate tools, that are used separately (i.e., not simultaneously); see also the "Response to Arguments" section herein (below)],
wherein the sleeve [(50)] comprises a shaft extending longitudinally along a length of the sleeve [as broadly as claimed, the body of cannula (50) comprises a shaft that extends in the longitudinal direction - e.g., FIG. 1].
A. HAND-HELP GRIP OF FIRST TOOL
While Patel teaches that the first tool may comprise a cutting blade, bur, electrocautery knife, mechanically actuated cutter, or any mechanical destruction and or removal means capable of severing or denervating the basivertebral nerve (as noted above), Patel does not explicitly teach:
the first tool configured to be driven by a hand-held grip.
However, the use of hand-held grips for driving tools when performing procedures for treating/alleviating back pain was well known in the art, before the effective filing date of the claimed invention.
As one example, Carter, in a similar field of endeavor, teaches a spinal facet debridement surgical tool kit [¶[0180]; FIG. 12] comprising, inter alia, a spinal facet therapy delivery tool (e.g., “debrider” tool) (10) having a head (15) that contacts target tissue and is rotatable for denudement of the target tissue [¶[0112]; FIGS. 2, 7A, 7C] (i.e., a “mechanical ablation”).
Tool (10) includes a handle (or hand-held grip) [FIGS. 2, 7A, 7C] with a push button for driving/controlling the debrider tool [¶[0112]; FIGS. 2, 7A, 7C].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Patel such that the first tool for performing mechanical ablation be configured to be driven by a hand-held grip, as was well known in the art as demonstrated by Carter, since such a modification would facilitate the procedure for a surgeon by providing easily-accessible and manipulatable device controls directly at the fingertips of the surgeon.
B. FIXATION SECTION
Finally, while Patel further teaches that the cannula can have a sharp distal end or tip configured to penetrate bone tissue [e.g., ¶[0029]], the combination of Patel and Carter does not explicitly teach the following emphasized claim limitations:
wherein the sleeve comprises a shaft extending longitudinally along a length of the sleeve and a fixation section for fixing or securing the sleeve on the target spinal face joint or capsular, the fixation section being situated at a distal portion of the shaft.
Bush, in a similar field of endeavor, teaches tool assemblies, system, and methods for manipulating tissue and methods for performing a surgical procedure on a vertebral body adjacent soft tissue [Abstract].
Bush teaches an elongate sleeve (72), advanced within an incision (¶[0081]), to provide a working channel for a tool [¶[0084]]. Bush further teaches that it was known to provide the elongate sleeve with a fixation element at the distal end thereof for securing the sleeve to bone and preventing unintended movement thereof during a procedure [e.g., ¶[0085] (“With reference to FIGS. 8A and 8C, the elongate sleeve 72 may comprise teeth, spikes, or other anti-skid features to prevent lateral movement of the elongate sleeve 72 relative to the bony anatomy B. In the version shown, the elongate sleeve 72 comprises bone penetrating spikes 93 fixed to the distal end of the elongate sleeve 72. Once the elongate sleeve 72 is pushed through the soft tissue T into contact with the bony anatomy B, then the elongate sleeve 72 may be further advanced distally to be partially embedded within the bony anatomy B′ by driving the spikes 93 into the bony anatomy B. In some cases, a mallet or other device may be used to impact the elongate sleeve 72 to embed the spikes 93 into the bony anatomy B. The embedding of the elongate sleeve 72 within the bony anatomy B provides the working channel through an entirety of the overlying soft tissue T, and may further prevent unintended lateral movement of the tool assembly 40 relative to the bony anatomy B (e.g., to prevent skiving of the working section 68 upon contact with the bony anatomy B′)”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel & Carter such that the sleeve comprise a fixation section for fixing or securing the sleeve on a target location, the fixation section being situated at a distal portion of the shaft, since such a modification would provide the benefit/advantage of securing the sleeve in place to prevent unintended movement of the sleeve (as well a tool inserted through the working channel thereof) during a procedure, as taught by Bush.
15. Regarding claim 2, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Claim 2 further recites the limitations:
further comprising the guidewire and the dilator,
wherein the guide wire is a K-wire configured to be inserted into the incision provided on the back of the patient until it reaches the target spinal facet joint or capsular; and,
wherein the sleeve is configured to be inserted into the incision provided on the back of the patient over the guide wire and the dilator, the dilator is configured to be put on or over the guide wire and guided by the guide wire towards the target spinal facet joint or capsular.
Carter teaches that it was known in the art to provide a guide wire (a K-wire) that is configured to be inserted into an incision until it reaches the target spinal facet joint or capsular, as well as to provide a dilator configured to be put on or over the guide wire and guided by the guide wire towards the target spinal facet joint or capsular, such that the sleeve can than be inserted into the incision provided on the back of the patient over the guide wire and the dilator [see Carter, e.g., ¶’s [0019] (“The introducing step can be carried out by first inserting a k-wire or pin into the patient into bone at the target spinal facet joint, then inserting a dilation tube over the k-wire or pin into the patient, then inserting the guide cannula over the dilation tube”); [0133], [0134], [0142], & [0152]; see also guide wire (k-wire or pin) (20), dilation tube (50), and cannula (sleeve) (30) as illustrated in FIG. 10B (reproduced below)].
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It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, & Bush to include the guidewire and the dilator, such that the guide wire is a K-wire configured to be inserted into the incision provided on the back of the patient until it reaches the target spinal facet joint or capsular, and, wherein the sleeve is configured to be inserted into the incision provided on the back of the patient over the guide wire and the dilator, the dilator is configured to be put on or over the guide wire and guided by the guide wire towards the target spinal facet joint or capsular, all as taught by Carter, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results [i.e., introduction of a sleeve to establish a working channel enabling access (for tools) to a target spinal facet joint or capsular] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
16. Regarding claim 3, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Patel further teaches an endoscope configured to be insertable into the working channel [diagnostic device, e.g., camera - see ¶[0239]] and used for visualizing the target spinal facet joint or capsular before and/or after performing mechanical ablation and/or using electromagnetic waves for ablation.
17. Regarding claim 4, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
Patel was modified above (in the rejection of claim 1) such that the sleeve [(50)] include the fixation section of Bush. Bush further teaches wherein the fixation section is provided at or in a lateral surface of the shaft so as to extend along part of a circumference of the shaft [Bush, ¶[0085]].
18. Regarding claim 7, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 4 for the reasons set forth in detail (above) in the Office Action.
Patel was modified above (in the rejection of claim 1) such that the sleeve [(50)] include the fixation section of Bush. Bush further teaches wherein the fixation section includes at least one fixing pin [“spike” - ¶[0085]] provided on the lateral surface of the shaft so as to extend along a longitudinal direction of the sleeve, wherein the at least one fixing pin protrudes from an end face of the sleeve at a distal end [¶[0085]].
The combination of Patel, Carter, & Bush does not explicitly teach:
wherein the fixing pin protrudes in a range of 0.2 mm to 2 mm.
However, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, & Bush such that the at least one spike [fixing pin] protrude in a range of whatever distance was desired, including, e.g., in a range of 0.2 mm to 2 mm, since it has been held that selection of relative dimensions is an example of a common practice which the court has held normally requires only ordinary skill in the art, and is hence considered a routine expedient. See Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), wherein the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
19. Regarding claim 14, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Patel further teaches wherein the second tool includes an electromagnetic probe or radiofrequency (RF) probe or a cautery element [e.g., ¶’s [0003], [0005], [0111], [0129]], and
wherein the second tool is provided with an electrosurgical generator [e.g., ¶[0128]] supplying power to the electromagnetic probe, the RF probe or the cautery element.
20. Regarding claim 16, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Patel further teaches a method for treating back pain [e.g., ¶[0031]] by carrying out a minimally invasive spinal treatment and/or surgery using mechanical ablation [e.g., ¶’s [0135], [0231]] and electromagnetic ablation and/or coagulation [e.g., ¶’s [0034], [0111], [0282]] using the set of surgical tools according to claim 1 [see the rejection of claim 1 set forth above, which is incorporated herein], the method comprising the steps of:
advancing the first tool for performing mechanical ablation [¶’s [0135], [0231]]…, and/or
advancing the second tool using electromagnetic waves for ablating tissue [e.g., ¶’s [0034], [0039], [0046], [0111]] and/or nerves and/or parts of a target spinal facet joint or capsular and/or coagulating tissue and/or parts of the target spinal facet joint or capsular.
Carter further teaches a method for treating back pain including advancing a first tool for performing mechanical ablation of a target spinal facet joint or capsular [e.g., ¶’s [0102], [0105], [0112]].
Carter additionally teaches that different treatment modalities [mechanical and cauterization] may be used during treatment at a target spinal facet joint, either serially or concurrently [e.g., ¶’s [0013], [0189], [0205]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, & Bush such that the first tool of Patel be advanced for performing mechanical ablation of the target spinal facet joint, since such a particular known technique (used for alleviating back pain) was recognized as part of the ordinary capabilities of one skilled in the art, as demonstrated by Carter, and one of ordinary skill in the art would have been capable of applying this known technique to the known device/method of Patel, Carter, & Bush, and the results would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Further, in Patel, the first and second tools are separate tools, that are used separately (i.e., not simultaneously). Hence, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, & Bush such that use of the tools [for denuding and cauterization] occurs “one after the other,” depending on desired clinical objectives.
21. Regarding claim 17, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Claim 17 further includes limitations regarding use of the first and second tools for ablating, or shaving, and coagulating tissue and/or nerves of the target spinal facet joint. As noted above in the rejection of claim 16, Patel/Carter/Bush teaches these limitations, and the order of use would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, depending on desired clinical objectives.
22. Regarding claim 18, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Patel/Carter/Bush further teaches wherein before and/or after the use of the first tool and/or the second tool an endoscope is used for inspecting [Patel, e.g., ¶[0239]] and/or recording the target spinal facet joint or capsular or a conducted treatment and/or surgical area.
23. Regarding claim 23, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Carter further teaches:
at first a guide wire [(20)] is inserted into the incision [e.g., ¶’s [0133], [0142]; FIG. 10B] based on an angle of approach [e.g., ¶’s [0191]-[0192]] required to reach the target spinal facet joint or capsular,
the guide wire [(20)] is advanced into the incision until it reaches the target spinal facet joint or capsular [e.g., ¶[0133]], and then
the guide wire is tapped into the target spinal facet joint or capsular [e.g., ¶[0133]].
24. Regarding claim 24, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 23 for the reasons set forth in detail (above) in the Office Action.
Carter further teaches wherein after the guide wire [(20)] is positioned and a position of the guide wire has been confirmed via fluoroscopy [e.g., ¶[0128]], a dilator [dilation tube (50) - ¶’s [0134], [0142]; FIG. 10B] is advanced over the guide wire [(20)] towards the target spinal facet joint or capsular and a position of the guide wire [(20)] and the dilator [(50)] is confirmed via fluoroscopy [e.g., ¶[0128]].
25. Regarding claim 25, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 24 for the reasons set forth in detail (above) in the Office Action.
The combination of Patel, Carter, & Bush teaches the fixation section provided on the sleeve [taught by Bush as detailed in the rejection of independent claim 1 (above)].
Carter further teaches:
inserting and advancing the sleeve [guide cannula (30)] including the working channel over the dilator [(50)] and the guide wire [(20)] towards the target spinal facet joint [see ¶’s [0106], [0134], [0142]; FIG. 10B] or capsular and fixate the sleeve at the target spinal facet joint or capsular.
26. Claims 5 & 6 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Patel, Carter, & Bush, and further in view of U.S. 2021/0015529 to Fenton, Jr. et al. ("Fenton").
27. Regarding claim 5, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 4 for the reasons set forth in detail (above) in the Office Action.
While Bush further teaches that the fixation section may comprise teeth, spikes, or other anti-skid features [¶[0085]], the combination of Patel, Carter, & Bush does not teach:
wherein the fixation section includes at least one cut that extends from a distal end of the sleeve for a predetermined distance along a longitudinal direction of the sleeve towards a proximal end of the sleeve.
Fenton, in a similar field of endeavor, teaches that it was known in the art for a cannula (340) to include a fixation section including at least one cut [broadly, formed by threads (345)] that extends from the distal end of the cannula (340) for a predetermined distance along a longitudinal direction of the cannula (340) towards a proximal end of the cannula (340) for securing the distal end of the cannula to bone [e.g., ¶[0118]; FIG. 26].
Given Bush’s express contemplation of different kinds of fixation features (noted above), it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, & Bush such that the fixation section includes at least one cut that extends from a distal end of the sleeve for a predetermined distance along a longitudinal direction of the sleeve towards a proximal end of the sleeve, since such a modification amounts merely to the simple substitution of one known fixation element for another, yielding predictable results [fixing or securing the sleeve to bone] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
28. Regarding claim 6, the combination of Patel, Carter, Bush, & Fenton teaches all of the limitations of claim 5 for the reasons set forth in detail (above) in the Office Action.
The combination of Patel, Carter, Bush, & Fenton does not explicitly teach:
wherein the at least one cut, has a length of 1 to 4 mm, and a width of 1 to 3 mm.
However, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, Bush, & Fenton such that the at least one cut, has whatever dimensions were desired, including, e.g., a length of 1 to 4 mm, and a width of 1 to 3 mm, since it has been held that selection of relative dimensions is an example of a common practice which the court has held normally requires only ordinary skill in the art, and is hence considered a routine expedient. See Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), wherein the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
29. Claims 8-12, 15, 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Patel, Carter, & Bush, and further in view of U.S. 2014/0012261 to Nita et al. ("Nita").
30. Regarding claim 8, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
While Patel teaches that treatment may be effected by any mechanical destruction or removal means including, e.g., a cutting blade, bur, electrocautery knife, or mechanically actuated cutter [e.g., ¶[0135]], Patel does not explicitly teach that the tool includes a drill member. As such the combination of Patel, Carter, & Bush does not explicitly teach:
wherein the first tool for performing mechanical ablation includes a drill member having a cutting section for cutting bone, said cutting section being situated at a distal end of the drill member.
Nita, in a similar field of endeavor, teaches methods and apparatus for removal of tissue or bone from the lateral recess, neural foramina and central spinal canal areas [e.g., ¶[0001]], and teaches that it was known in the art to cut and remove a portion of a structure using a variety of different modification devices including, e.g., a cautery device, a laser, a rasp, a rongeur, a grasper, a burr, a sander, a drill, a shaver, an abrasive device, and a probe [Nita, e.g., claim 19].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, & Bush such that the first tool for performing mechanical ablation includes a drill member having a cutting section for cutting bone, said cutting section being situated at a distal end of the drill member, since such a modification amounts merely to the simple substitution of one known mechanical tissue modification device for another, yielding only predictable results (the cutting of bone or tissue) to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
31. Regarding claim 9, the combination of Patel, Carter, Bush, & Nita teaches all of the limitations of claim 8 for the reasons set forth in detail (above) in the Office Action.
Claim 9 further requires the limitation:
wherein a cutting section comprises a plurality of cutting edges provided on a front surface of a drill member and extending radially outward.
As best understood [see the rejection under § 112(b) above], it is noted that Patel was modified (in the rejection of claim 8) above to include the drill member of Nita. Nita further teaches that the drill comprises a plurality of cutting edges provided on a front surface extending radially outward [e.g., FIG. 19].
32. Regarding claim 10, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Patel was modified (in the rejection of claim 1 above) to include the handle (or hand-held grip) of Carter. As such, Patel/Carter/Bush further teaches that the hand-held grip of the first tool for performing mechanical ablation includes a handle situated at a proximal end of [the tool] [Carter, FIGS. 2, 3, 7A, 7C] wherein the handle has a spherical or curved shape to fit comfortably in a hand of a surgeon or an operator [e.g., FIGS. 2-3].
While Patel teaches that treatment may be effected by any mechanical destruction or removal means including, e.g., a cutting blade, bur, electrocautery knife, or mechanically actuated cutter [e.g., ¶[0135]], Patel does not explicitly teach that the tool includes a drill member. As such the combination of Patel, Carter, & Bush does not explicitly teach:
wherein the hand-held grip of the first tool for performing mechanical ablation includes a handle situated at a proximal end of a drill member of the first tool, wherein the handle has a spherical or curved shape to fit comfortably in a hand of a surgeon.
Nita, in a similar field of endeavor, teaches methods and apparatus for removal of tissue or bone from the lateral recess, neural foramina and central spinal canal areas [e.g., ¶[0001]], and teaches that it was known in the art to cut and remove a portion of a structure using a variety of different modification devices including, e.g., a cautery device, a laser, a rasp, a rongeur, a grasper, a burr, a sander, a drill, a shaver, an abrasive device, and a probe [Nita, e.g., claim 19].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, & Bush such that the first tool for performing mechanical ablation includes a drill member, since such a modification amounts merely to the simple substitution of one known mechanical tissue modification device for another, yielding only predictable results (the cutting of bone or tissue) to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
33. Regarding claim 11, the combination of Patel, Carter, Bush, & Nita teaches all of the limitations of claim 10 for the reasons set forth in detail (above) in the Office Action.
Patel was modified (in the rejection of claim 1 above) to include the handle (or hand-held grip) of Carter. As such, Patel/Carter/Bush/Nita further teaches wherein the handle has a spherical or curved portion [broadly, the portion comprising the motor “M” shown in FIG. 7A of Carter is a curved portion] followed by a straight portion [the portion comprising control circuit “C” and battery pack “B” in FIG. 7A of Carter is a straight portion], both portions being hollow [so as to enable the accommodation of the interior components, as shown in FIG. 7A of Carter], wherein the spherical or curved portion [broadly, the portion comprising the motor “M” shown in FIG. 7A of Carter is a curved portion] includes through-holes [at proximal and distal ends of the motor section “M” as seen in FIG. 2 - note also the hole at the distal end allows for passage of shaft (18)/barrel (10b) (FIG. 7A)] and the straight portion [the portion comprising control circuit “C” and battery pack “B” in FIG. 7A of Carter is a straight portion] includes on the outer circumference notches [FIGS. 2-3, formed by latch - ¶[0117]].
34. Regarding claim 12, the combination of Patel, Carter, Bush, & Nita teaches all of the limitations of claim 10 for the reasons set forth in detail (above) in the Office Action.
Patel was modified (in the rejection of claim 1 above) to include the handle (or hand-held grip) of Carter. As such, Patel/Carter/Bush/Nita further teaches wherein the handle has at least partially a spherical or curved shape [broadly, the portion comprising the motor “M” shown in FIG. 7A of Carter has a curved shape].
The combination of Patel, Carter, Bush, & Nita, however, does not explicitly teach:
wherein the handle has at least partially a spherical or curved shape with a radius in the range of 25 mm to 40 mm.
However, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, Bush, & Nita such that the handle has at least partially a spherical or curved shape with a radius of whatever dimension was desired, including, e.g., a radius in the range of 25 mm to 40 mm, since it has been held that selection of relative dimensions is an example of a common practice which the court has held normally requires only ordinary skill in the art, and is hence considered a routine expedient. See Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), wherein the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
35. Regarding claim 15, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
Patel further teaches that an inner diameter of the working channel of the sleeve [(50)] is such that it can accommodate a wide variety of tools [e.g., ¶’s [0034], [0035], [0112], [0135]], including e.g., a bur [which is a rotary tool].
While Patel teaches that treatment may be effected by any mechanical destruction or removal means including, e.g., a cutting blade, bur, electrocautery knife, or mechanically actuated cutter [e.g., ¶[0135]], Patel does not explicitly teach that the tool includes a drill member. As such the combination of Patel, Carter, & Bush does not explicitly teach:
wherein an inner diameter of the working channel of the sleeve is such that when a drill member of the first tool is inserted or received, the first tool or the drill member is rotatable.
Nita, in a similar field of endeavor, teaches methods and apparatus for removal of tissue or bone from the lateral recess, neural foramina and central spinal canal areas [e.g., ¶[0001]], and teaches that it was known in the art to cut and remove a portion of a structure using a variety of different modification devices including, e.g., a cautery device, a laser, a rasp, a rongeur, a grasper, a burr, a sander, a drill, a shaver, an abrasive device, and a probe [Nita, e.g., claim 19].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, & Bush such that the first tool includes a drill member, since such a modification amounts merely to the simple substitution of one known mechanical tissue modification device for another, yielding only predictable results (the cutting of bone or tissue) to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
As modified, the inner diameter of the working channel of the sleeve would be such that when a drill member of the first tool is inserted or received, the first tool or the drill member is rotatable [just as the sleeve of Patel already accommodates a bur (which is a rotary tool)].
36. Regarding claim 19, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 18 for the reasons set forth in detail (above) in the Office Action.
The combination of Patel, Carter, & Bush does not, however, teach:
wherein the second tool is provided or advanced through a working channel of the endoscope, under vision provided by the endoscope.
Nita, in a similar field of endeavor, teaches methods and apparatus for removal of tissue or bone from the lateral recess, neural foramina and central spinal canal areas [e.g., ¶[0001]], and that it was known to advance tools through a working channel of an endoscope [e.g., ¶’s [0083-[0085]] to enable direct visualization of a targeted area of the spine with minimally invasive techniques.
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, & Bush such that the second tool is provided or advanced through a working channel of the endoscope, under vision provided by the endoscope, since such a modification would provide the benefit or advantage of enabling direct visualization of a targeted area of the spine with minimally invasive techniques, as explicitly taught by Nita.
37. Regarding claim 20, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 18 for the reasons set forth in detail (above) in the Office Action.
Patel teaches use of a bipolar RF probe [e.g., ¶[0109]].
The combination of Patel, Carter, & Bush does not, however, teach:
wherein the endoscope is used for water irrigation of the target spinal facet joint or capsular, thereby providing fluid for a bipolar RF probe.
Nita, in a similar field of endeavor, teaches methods and apparatus for removal of tissue or bone from the lateral recess, neural foramina and central spinal canal areas [e.g., ¶[0001]], and that it was known to advance tools through a working channel of an endoscope [e.g., ¶’s [0083-[0085]] to enable direct visualization of a targeted area of the spine with minimally invasive techniques. Nita further teaches that the endoscope may be used for irrigation [e.g., ¶[0085]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, & Bush such that an endoscope is used, since such a modification would provide the benefit or advantage of enabling direct visualization of a targeted area of the spine with minimally invasive techniques, as explicitly taught by Nita. Further, the use of irrigation fluid would provide the benefit/advantage of keeping the device cool to avoid any unintended thermal damage to the device and/or treatment site.
38. Regarding claim 21, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
The combination of Patel, Carter, & Bush does not, however, teach:
wherein the first tool and/or the second tool and the endoscope are configured to be used simultaneously, such that the first tool and/or the second tool and the endoscope are configured to be inserted together into the working channel of the sleeve, for visualization of the target spinal facet joint or capsular or treatment and/or surgical area before and/or during ablation via the first tool and/or the second tool.
Nita, in a similar field of endeavor, teaches methods and apparatus for removal of tissue or bone from the lateral recess, neural foramina and central spinal canal areas [e.g., ¶[0001]], and teaches that it was known to use an endoscope with a device [e.g., ¶[0085]] to enable direct visualization of a targeted area of the spine with minimally invasive techniques.
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, & Bush such that the first tool and/or the second tool and the endoscope can be used simultaneously since such a modification would provide the benefit or advantage of enabling direct visualization of a targeted area of the spine with minimally invasive techniques, as explicitly taught by Nita.
39. Regarding claim 22, the combination of Patel, Carter, & Bush teaches all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Patel further teaches wherein…. the first tool advances into a pathological tissue such that the pathological tissue is removed [e.g., ¶’s [0135], [0231]].
While Patel teaches that treatment may be effected by any mechanical destruction or removal means including, e.g., a cutting blade, bur, electrocautery knife, or mechanically actuated cutter [e.g., ¶[0135]], Patel does not explicitly teach that the tool includes a drill member. As such the combination of Patel, Carter, & Bush does not explicitly teach:
wherein a drill element of the first tool advances into a pathological tissue such that the pathological tissue is removed.
Nita, in a similar field of endeavor, teaches methods and apparatus for removal of tissue or bone from the lateral recess, neural foramina and central spinal canal areas [e.g., ¶[0001]], and teaches that it was known in the art to cut and remove a portion of a structure using a variety of different modification devices including, e.g., a cautery device, a laser, a rasp, a rongeur, a grasper, a burr, a sander, a drill, a shaver, an abrasive device, and a probe [Nita, e.g., claim 19].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, & Bush such that the first tool includes a drill member, since such a modification amounts merely to the simple substitution of one known mechanical tissue modification device for another, yielding only predictable results (the cutting of bone or tissue) to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
40. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Patel, Carter, Bush, & Nita, as applied to claim 10 above, and further in view of U.S. 2021/0052320 to Holmberg ("Holmberg").
41. Regarding claim 13, the combination of Patel, Carter, Bush, & Nita teaches all of the limitations of claim 10 for the reasons set forth in detail (above) in the Office Action.
The combination of Patel, Carter, Bush, & Nita does not, however, teach:
wherein the handle is configured to provide the surgeon or the operator with a haptic feedback with regard to an introduced force and/or torque.
Holmberg, in a similar field of endeavor, teaches that it was known in the art for a device handle to incorporate haptic feedback to indicate force exerted at a treatment site [e.g., ¶[0035]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Patel, Carter, Bush, & Nita such that the handle is configured to provide the surgeon or the operator with a haptic feedback with regard to an introduced force and/or torque, since such a modification would provide the benefit/advantage of facilitating a procedure for a surgeon by enabling the surgeon to receive immediate, tactile feedback regarding the application of force at the treatment site, which can improve the overall accuracy and effectiveness of the procedure.
Response to Arguments
42. As noted above, the 08/17/26 Amendment has overcome the claim objections and the claim rejections under § 112(b) previously set forth in the 06/03/26 Action.
43. New grounds of rejection under § 112(b) are set forth herein, necessitated by Applicant’s Amendment.
44. The prior rejection of independent claim 1 under § 103 has been updated to address the new limitation, and maintained.
45. In the 08/17/26 Amendment, independent claim 1 was amended to further require the limitation:
...the working channel configured to separately receive each of the first tool and the second tool therein,
46. Concerning this new limitation, Applicant argues as follows:
However, none of the cited references teach or suggest a set of surgical tools for spinal facet therapy in which the sleeve is configured to separately receive each of the first tool and the second tool in a working channel therein.
On the other hand, in the set of surgical tools set forth in amended claim 1, the sleeve is configured to separately receive each of the first tool and the second tool. In conjunction with the fixation section of the shaft of the sleeve, such a configuration enables each of the first and second tools to be utilized at the same point on the target spinal facet joint or capsular. This coordinated interaction between the sleeve and the first and second tools provides a less traumatic spinal therapy.
None of Patel, Carter, nor Bush, alone or in any motivated combination, teach or suggest a set of surgical tools including a sleeve configured to separately receive each of a first mechanical ablation tool and a second electromagnetic ablation tool through a working channel thereof to provide improve spinal facet therapy, as set forth in amended claim 1.
08/17/26 Amendment, pgs. 9-10.
47. This argument is not persuasive. First, the term “separately” is being interpreted herein according to its plain and ordinary meaning – i.e., independently or distinctly; not at the same time or not in the same place; apart in space or time.
In Patel, the first and second tools are separate tools, that are used separately (i.e., not simultaneously).
As the updated rejection makes clear, the working channel in Patel [the central lumen of cannula (50)] is clearly capable of receiving a tool therein [see, e.g., ¶[0127] (“a treatment device fed through the cannula 50”); ¶[0141] (“the treatment device 100 may be deployed into the bone through the curved cannula 50”)].
Patel further teaches that numerous types of treatment devices may be delivered to varying regions of the body [e.g., ¶[0112] (“The surgical devices and surgical systems described may be used to deliver numerous types of treatment devices to varying regions of the body”)].
As such, the working channel [the central lumen of cannula (50)] in Patel is clearly configured in the manner claimed (i.e., it can separately receive treatment devices one at a time), and therefore satisfies the new claim limitation.
For this reason, the rejection of independent claim 1 under § 103 based on the combination of Patel, Carter, & Bush has been maintained.
Conclusion
48. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Bradford C. Blaise whose telephone number is (571) 272-5617. The Examiner can normally be reached on Monday - Friday, 8:30 AM - 4:30 PM MST.
Examiner Interviews are available via a variety of formats. See MPEP § 713.01. 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, Joanne M. Rodden, can be reached at telephone number 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADFORD C. BLAISE/Primary Examiner, Art Unit 3794
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