DETAILED ACTION
This action is in response to applicant’s amendment received on August 11th, 2026.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 5-6, 9-12, and 14-23 are rejected under 35 U.S.C. 103 as being unpatentable over Teisen (U.S. Publication 2013/0331840) in view of Sasaki (U.S. Publication 2016/0051306).
Regarding claims 1, 3-6, 9-15, and 22:
Teisen discloses a device (for example see Figures 1 and 5) comprising:
(claim 1) a cannula (104) including
(claim 2) a hub (146)
(claim 1) a cutting obturator (102)
(claim 1) wherein the cutting obturator is connectable to the cannula
(claim 14) wherein the cutting obturator is receivable through an internal bore of the cannula
(claim 1) wherein the cutting obturator includes
(claim 2) a handle (140)
(claim 2) wherein the handle engage the hub
(claim 1) a cylindrical body (106)
(claim 1) a cutting tip (the distal end of 106 and element 108) having
(claim 1) a cylindrical body (108)
(claim 1) a plurality of cutting blades (the elements formed at the distal end of 106 are cutting blades)
(claim 1) wherein the cutting blades protrude radially outwardly from an outer surface of the cylindrical body (the cutting blades extend from the surface of 108)
(claim 9) wherein the cutting blades are equidistantly circumferentially spaced about the outer surface of the cylindrical body
(claim 10) wherein opposed outer sides of the plurality of cutting blades extend longitudinally and are parallel to one another
(claim 1) wherein each of the cutting blades include
(claim 1) a knife edge (a sharp edge of the cutting blades) configured to penetrate and dilate, i.e. cut/drill an opening, tissue during use
(claim 1) wherein the knife edge is located at a leading edge of the cutting blades
(claim 4) wherein the knife edge is a tapered knife edge
(claim 4) wherein the tapered knife edge extends at a sloped angle relative to a proximal body portion of the cutting blade
(claim 22) wherein the cutting blades define a plurality of flutes (122) projecting outwardly relative to the outer surface of the cylindrical body to allow removal of cut portions of tissue while maintaining stiffness at the cutting tip
(claim 3) wherein at least a portion of the cutting tip protrudes beyond a distal end of the cannula when connected to the cannula (for example see Figure 2)
(claim 6) wherein the cutting tip is integrally formed with a distal portion of the tubular body
(claim 12) a guidewire (paragraph 51)
Teisen fails to disclose the device wherein the cutting obturator includes a hollow tubular body and a hollow cylindrical cutting tip, i.e. the cutting obturator includes a lumen through the body and the cutting tip. Sasaki teaches a device (for example see Figures 11 and 12) comprising a cannula (24) and an obturator (54), wherein the obturator includes a cannulated body and a cannulated tip, i.e. the obturator includes a lumen (66) extending through the length of the obturator (claim 21), in order to allow a guidewire to pass through the obturator. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Teisen wherein the cutting obturator includes a hollow tubular body and a hollow cutting tip, i.e. the obturator includes a lumen extending the full length of the obturator, in view of Sasaki in order to allow a guidewire to pass through the obturator.
Regarding claims 11-13, the device of Teisen as modified by Sasaki discloses the device wherein tubular body and the hollow cylindrical body of the cutting tip establish an inner lumen that extends the entire length of the tubular body, wherein the guidewire is receivable within the inner lumen.
Regarding claim 15:
The invention of Teisen as modified by Sasaki discloses a method of using the device discussed above comprising:
(claim 15) inserting a guidewire into a joint space (for example see paragraph 65; the vertebral bodies are part of the spinal joint)
(claim 15) inserting the device discussed above over the guidewire
(claim 15) rotating the device until the cutting tip of the obturator and a distal end of the cannula are positioned within the joint space (for example see paragraph 49)
(claim 15) wherein the knife edge of the cutting blades penetrates and dilates, i.e. creates an opening, tissue overlaying the joint space as the device is rotated
Regarding claims 16-19 and 21:
Teisen discloses a device (for example see Figures 1 and 5) comprising:
(claim 16) a cannula (104) including
(claim 16) an internal bore
(claim 16) a cutting obturator (102)
(claim 16) wherein the cutting obturator is capable of being inserted through the internal bore of the cannula
(claim 16) wherein the cutting obturator includes
(claim 16) a cylindrical body (106)
(claim 16) a cutting tip (the distal end of 106 and element 108)
(claim 16) wherein the cutting tip includes
(claim 16) a cylindrical body (108)
(claim 16) two or more cutting blades (the elements formed at the distal end of 106 are cutting blades)
(claim 16) wherein the cutting blades protrude radially outwardly from an outer surface of the cylindrical body (the cutting blades extend from the surface of 108)
(claim 16) wherein the cutting blades include
(claim 16) a knife edge (a sharp edge of the cutting blades) configured to penetrate and dilate, i.e. cut/drill an opening, tissue during use into a joint space
(claim 16) wherein the knife edge is at a leading end of the cutting blade
(claim 16) wherein the knife edge extends at a sloped angle relative to a proximal body portion of the cutting blade
(claim 17) wherein the knife edge is a tapered knife edge that extends at a sloped angle relative to a proximal body portion of the cutting blade
(claim 18) wherein the tapered knife edge is disposed proximal to a distal-most end of the cutting tip
(claim 21) wherein the cutting blades define a plurality of flutes (122) projecting outwardly relative to the outer surface of the cylindrical body to allow removal of cut portions of tissue while maintaining stiffness at the cutting tip
(claim 19) wherein the device is capable of percutaneously inserting a device, such as a drill (the surgical device is functionally recited in the preamble of claim 16; therefore the details of the surgical device do not need to be disclosed in the references and device only needs to be capable of performing the function)
Teisen fails to disclose the device wherein the cutting obturator includes a hollow tubular body, a hollow cylindrical cutting tip, and an inner lumen, i.e. the cutting obturator includes an inner lumen extending through the body and the cutting tip. Sasaki teaches a device (for example see Figures 11 and 12) comprising a cannula (24) and an obturator (54), wherein the obturator includes a cannulated body and a cannulated tip, i.e. the obturator includes an inner lumen (66) extending through the length of the obturator (claim 21), in order to allow a guidewire to pass through the obturator. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Teisen wherein the cutting obturator includes a hollow tubular body, a hollow cutting tip, and an inner lumen, i.e. the obturator includes an inner lumen extending the full length of the obturator, in view of Sasaki in order to allow a guidewire to pass through the obturator.
Regarding claim 16 and 19, the device of Teisen as modified by Sasaki discloses the device wherein tubular body and the hollow cylindrical body of the cutting tip include an inner lumen that extends the entire length of the tubular body, wherein a guidewire is receivable within the inner lumen.
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Regarding claim 23:
Teisen discloses a device (for example see Figures 1 and 5) comprising:
(claim 23) a cannula (104) extending along a longitudinal axis including
(claim 23) an internal bore
(claim 23) a cutting obturator (102)
(claim 23) wherein the cutting obturator is capable of being inserted through the internal bore of the cannula
(claim 23) wherein the cutting obturator is capable of being connected to the cannula (for example element 140 connects to element 146)
(claim 23) wherein the cutting obturator includes
(claim 23) a cylindrical body (the portion of 106 proximal the distal tip)
(claim 23) a cutting tip integrally formed with a distal portion of the cylindrical body (the distal tip of 106 and element 108)
(claim 23) wherein the cutting tip includes
(claim 23) a cylindrical body
(claim 23) a plurality of cutting blades (the elements formed at the distal end of 106 are cutting blades)
(claim 23) wherein the cutting blades protrude radially outwardly from an outer surface of the cylindrical body (the cutting blades extend from the surface of 108)
(claim 23) wherein each of the cutting blades include
(claim 23) a knife edge (a sharp edge of the cutting blades) providing a dilating insertion technique to penetrate and dilate, i.e. cut/drill an opening, tissue during use into a joint space
(claim 23) wherein the knife edge is at a leading end of the cutting blade
(claim 23) wherein the knife edge extends at a sloped angle relative to a proximal body portion of the cutting blade
(claim 23) wherein opposed outer sides of the plurality of cutting blades extend longitudinally and are parallel to one another
(claim 23) wherein the plurality of cutting blades define a plurality of flutes (122) projecting outwardly relative to the outer surface of the cylindrical body to allow removal of cut tissue while maintaining stiffness at the cutting tip
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Teisen fails to disclose the device wherein the cutting obturator includes a tubular body, a hollow cylindrical cutting tip, and an inner lumen, i.e. the cutting obturator includes an inner lumen extending through the body and the cutting tip. Sasaki teaches a device (for example see Figures 11 and 12) comprising a cannula (24) and an obturator (54), wherein the obturator includes a cannulated body and a cannulated tip, i.e. the obturator includes an inner lumen (66) extending through the length of the obturator (claim 21), in order to allow a guidewire to pass through the obturator. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Teisen wherein the cutting obturator includes a hollow tubular body, a hollow cutting tip, and an inner lumen, i.e. the obturator includes an inner lumen extending the full length of the obturator, in view of Sasaki in order to allow a guidewire to pass through the obturator.
The device of Teisen as modified by Sasaki discloses the device wherein tubular body and the hollow cylindrical body of the cutting tip include an inner lumen that extends the entire length of the tubular body, wherein a guidewire is receivable within the inner lumen.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Teisen (U.S. Publication 2013/0331840) in view of Sasaki (U.S. Publication 2016/0051306) further in view of Sasaki (U.S. Publication 2016/0051306) and further in view of Akerfeldt (U.S. Patent 5,423,824).
The device of Teisen as modified by Sasaki discloses the invention as claimed except for the cannula being made from a transparent material and the hub of the cannula having a first thread portion adapted to engage a second thread portion of a handle of the cutting obturator.
Regarding the cannula being made from a transparent material, Sasaki teaches a device comprising a cannula (24) and an obturator (54), wherein the cannula is as least partially made from a transparent material in order to view into the passageway during use (paragraph 27). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Teisen as modified by Sasaki wherein the cannula is made from transparent material in view of Sasaki in order to view into the passageway during use.
Regarding the hub of the cannula including a first threaded portion and the handle including a second threaded portion, the invention of Teisen as modified by Sasaki discloses the invention as claimed, see above, wherein the hub of the cannula includes a first connection element (paragraph 47) and the handle includes a second connecting element (paragraph 47), wherein the connecting elements form a connection, i.e. the handle engages the hub via the connection, in order to connect the cannula to the cutting obturator. Akerfeldt teaches a device (for example see Figure 8) comprising a cannula (8) including a hub (4) having a first threaded connection element and a cutting obturator (needle tip 17) including a handle (6) including a second threaded connection element, wherein the first connection element and the second connection element form a connection in order to connect the cannula and the cutting obturator. Because both the device of Teisen as modified by Sasaki and the device of Akerfeldt disclose a device comprising a cannula including a hub with a first connection element and a cutting obturator including a handle with a second connection element, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to substitute one second of connection elements with the other set of connection elements in order to achieve the predictable results of connecting the cannula and the cutting obturator.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Teisen (U.S. Publication 2013/0331840) in view of Sasaki (U.S. Publication 2016/0051306) further in view of Courvoisier (U.S. Publication 2006/0008771).
The invention of Teisen as modified by Sasaki discloses the invention as claimed, see above, except for the cutting tip being a separate piece from the tubular body with an inner shaft received within the tubular body. Courvoisier teaches a device comprising a cutting obturator including a tubular body (12) and cutting tip (20; see Figure 4) including an inner shaft (22) received within the tubular body (paragraphs 9-14). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Teisen as modified by Sasaki wherein the cutting tip is a separate piece including an inner shaft inserted into the tubular body in view of Courvoisier, since it has been held that constructing formerly integral structure into various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USQP 177, 179.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Teisen (U.S. Publication 2013/0331840) in view of Sasaki (U.S. Publication 2016/0051306) further in view of Courvoisier (U.S. Publication 2006/0008771) further in view of Burchette (U.S. Patent 5,057,082).
The invention of Teisen as modified by Sasaki as further modified by Courvoisier discloses the invention as claimed except for the tubular body being made from a plastic material and the cutting tip being made from a metallic material. Burchette teaches a device comprising a cutting obturator including a body (16) made from a polymeric material and a cutting tip (22) made from a metal (column 3 lines 36-40). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Teisen as modified by Sasaki as further modified by Courvoisier wherein the tubular body is made from a plastic material and the cutting tip is made from a metal in view of Burchette, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Response to Arguments
Applicant's arguments filed August 11th, 2026 have been fully considered but they are not persuasive. The applicant’s argument that the Teisen reference fails to disclose tissue dilation while penetrating the tissue during insertion of the device is not persuasive. As discussed above, the Teisen reference discloses a cutting obturator (102) including a cutting tip (for example see Figure 5) having a plurality of cutting blades that protrude radially outwards, wherein the cutting blades include tapered knife edges extending at a sloped angle configured to penetrate and dilate tissue during insertion of the device. The tapered shape of the cutting blades would allow the cutting tip to cut and expand the tissue, i.e. dilate the tissue, while forming a hole in the tissue during insertion. Therefore, the reference discloses the limitation of the apparatus claims (for example claims 1 and 16) as presented. Regarding the method claims, the functional limitation is inherent due to the tapered shape of the cutting tip and as the instrument is inserted into the tissue the tapered and radially expanding cutting blades would penetrate and expand the tissue, i.e. dilate, while forming a hole in the tissue. Therefore, the limitations of the method claims (for example claim 15) are disclosed as presented. The applicant’s argument that the rationale for modifying Teisen with the teachings of Sasaki are not provided in the Sasaki reference is not persuasive. The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale to modify may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). The applicant’s argument that the modification is structurally incompatible is not persuasive. The test for obviousness is not whether the features of one reference may be bodily incorporated into the other to produce the claimed subject matter but simply what the combination of references makes obvious to one of ordinary skill in the pertinent art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
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 Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
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