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 1-4 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta U.S. 7,905,840 (herein referred to as “Pimenta”), and in view of Raulerson U.S. 5,509,902 (herein referred to as “Raulerson”) and Cantwell U.S. 2019/0261875 (herein referred to as “Cantwell”).
5. Regarding Claim 1, Pimenta teaches a dilator clip for neurological monitoring during continuous real-time electromyography (Figs. 1, 16, 41-45), comprising:
a. a first member and a second member (Fig. 16, ref nums 26 and 28), comprising a first member handle region (Fig. 16, ref num 31), a second member handle region (Fig. 16, ref num 33), a first member pressure region, and second member pressure region (Fig. 16, ref nums 18 and 16)
b. a central hinge connecting the first member and the second member (Fig. 1, ref num 30); Col. 8, lines 51-53, “first and second arm members 26, 28 hingedly coupled via coupling mechanism shown generally at 30”), the central hinge comprising a mechanical force element that applies mechanical force to drive the first member pressure region and the second member pressure region together (see Figs. 1 and 16, it is understood that there is a mechanical force element between ref nums 26 and 28 that force them together/apart; Col. 9, lines 1-4, “Through the use of handle extenders 31, 33 (FIG. 8), the arms 26, 28 may be simultaneously opened such that the cephalad-most and caudal-most retractor blades 16, 18 move away from one another”);
d. an electrode within the second member pressure region (Fig. 1, ref num 39; Col. 8, lines 21-25, “any or all of the retractor blades 12, 16, 18, the shim element 22 and/or the retractor extenders 24/25 may be provided with one or more electrodes 39 (preferably at their distal regions) equipped for use with a nerve surveillance system”), wherein the electrode is configured to contact a tubular dilator (as shown in Fig. 13, ref nums 16 and 18 are in contact with ref num 54, the dilator; therefore, if the electrode is at the distal end of ref num 16/18 as indicated above, they would be in contact with the dilator, ref num 54).
Pimenta fails to teach (c) a compression band secured through an opening on the first member pressure region and the second member pressure region; and (d) the electrode being embedded in the second member pressure region.
Raulerson teaches an instrument clip of analogous art (Figs. 1-3), wherein the clip comprises a first member with a pressure region (Fig. 3, ref num 13 with pressure region on interior side, ref num 24) and a second member with a pressure region (Fig. 3, ref num 14 with pressure region on interior side, ref num 24). The clip also comprises a compression band (Fig. 3, ref num 48) that is secured through an opening of the first and second pressure regions (Fig. 3, ref nums 46 on each side, ref num 50 through the first region and ref num 52 through the second region; Col. 8, lines 52-56, “A first end 50 of the connecting material 48 is drawn through and tied to the suture hole 46 in one arcuate member 13, and a second end 52 of the connecting material 48 is drawn through and tied to the suture hole 46 in the other arcuate member 14”). The compression band tightens around the instrument once inserted in order to secure the tool between the pressure regions (Col. 8, lines 59-67). 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 Pimenta to include a compression band in order to improve securing the tool within the pressure regions.
Cantwell teaches a clip of analogous art (Fig. 1), wherein the clip comprises a first member with a pressure region (Fig. 2, ref num 18a with interior surface as pressure region) and a second member with a pressure region (Fig. 2, ref num 18b with interior surface as pressure region). The clip also comprises an electrode (Fig. 2, ref num 12) within the second member pressure region (see Fig. 2, ref num 12 resides on the pressure region of ref num 18b). The electrode is embedded within the second member pressure region (see Fig. 4, ref num 12 is embedded; para 0033). The electrode provides recording and stimulating functions (para 0034). 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 Pimenta to embed the electrode, as this provides the same expected result of recording and stimulating functions as taught in Pimenta.
6. Regarding Claim 2, Pimenta fails to teach the compression band is comprised of an elastic band.
Raulerson teaches the compression band (Fig. 2, ref num 48) is an elastic band (Col. 9, lines 47-50, “connecting material 48 may be… nylon suture material”; it is well known that nylon is elastic). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the compression band be elastic, 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.
7. Regarding Claim 3, Pimenta fails to teach a housing structure within the second member with a cavity for housing a lead wire to the embedded electrode.
Cantwell teaches the second member (Fig. 2, ref num 18b) with the embedded electrode (Fig. 2, ref num 12), wherein the second member has a housing structure within it (Fig. 4, ref num 22). The housing structure comprises a cavity (Fig. 4, ref num 50) for a lead wire to the embedded electrode (Fig. 4, ref num 60 to the electrode, ref num 12). The lead wire provides electrical connection to the electrode (para 0039, “the lead wire assembly 60 can further support electrical connections to the electrode 12”). 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 Pimenta to include a housing with a lead wire to the embedded electrode, since this provides electrical connection to the electrode which allows the electrode to provide the same expected result of recording and stimulating functions as taught in Pimenta.
8. Regarding Claim 4, Pimenta fails to teach the lead wire is soldered to the embedded electrode.
Cantwell teaches the lead wire (Fig. 4, ref num 60) and the electrode (Fig. 4, ref num 12), such that the lead wire is attached to the electrode (para 0035, “the first channel 49a is positioned within the domed portion 46 and can be crimped to the exposed wire core 66 proximate the top 42 using a single point crimp”). While Cantwell fails to explicitly teach that the lead wire is soldered, it is well known that crimping and soldering are both well-known means of connection between lead wires and electrodes (see John U.S. 2019/0038438, para 0164). 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 further modified Pimenta to solder the lead wire to the electrode, as this is a well-known means of connection within the art.
9. Regarding Claim 11, Pimenta teaches a method of acquiring signals from a dilator clip (Fig. 1; Col. 8, lines 21-25), comprising:
a. providing a first member and a second member (Fig. 16, ref nums 26 and 28), comprising a first member handle region (Fig. 16, ref num 31), a second member handle region (Fig. 16, ref num 33), a first member pressure region, and second member pressure region (Fig. 16, ref nums 18 and 16), and central hinge connecting the first member and the second member (Fig. 1, ref num 30); Col. 8, lines 51-53, “first and second arm members 26, 28 hingedly coupled via coupling mechanism shown generally at 30”), the central hinge comprising a mechanical force element that applies mechanical force to drive the first member pressure region and the second member pressure region together (see Figs. 1 and 16, it is understood that there is a mechanical force element between ref nums 26 and 28 that force them together/apart; Col. 9, lines 1-4, “Through the use of handle extenders 31, 33 (FIG. 8), the arms 26, 28 may be simultaneously opened such that the cephalad-most and caudal-most retractor blades 16, 18 move away from one another”); and an electrode within the second member pressure region (Fig. 1, ref num 39; Col. 8, lines 21-25, “any or all of the retractor blades 12, 16, 18, the shim element 22 and/or the retractor extenders 24/25 may be provided with one or more electrodes 39 (preferably at their distal regions) equipped for use with a nerve surveillance system”), wherein the electrode is configured to contact a tubular dilator (as shown in Fig. 13, ref nums 16 and 18 are in contact with ref num 54, the dilator; therefore, if the electrode is at the distal end of ref num 16/18 as indicated above, they would be in contact with the dilator, ref num 54)
b. applying a pinching pressure to the first member handle region and the second member handle region causing the central hinge to move the first member pressure region and the second member pressure region to an open state (Col. 9, lines 1-2, “Through the use of handle extenders 31, 33 (FIG. 8), the arms 26, 28 may be simultaneously opened”);
c. placing the first member pressure region and the second member pressure region around the tubular dilator (Figs. 13, 16, and 42; Col. 15, lines 46-52); and
d. releasing pressure on the first member handle region and the second member handle region causing the central hinge to decompress and force the first member pressure region and the second member pressure region into a closed state (Figs. 13-18; Col. 9, lines 61-67 – Col. 10, lines 1-13).
Pimenta fails to teach a compression band secured through an opening on the first member pressure region and the second member pressure region; and the electrode being embedded in the second member pressure region.
Raulerson teaches an method and clip of analogous art (Figs. 1-3), wherein the clip comprises a first member with a pressure region (Fig. 3, ref num 13 with pressure region on interior side, ref num 24) and a second member with a pressure region (Fig. 3, ref num 14 with pressure region on interior side, ref num 24). The clip also comprises a compression band (Fig. 3, ref num 48) that is secured through an opening of the first and second pressure regions (Fig. 3, ref nums 46 on each side, ref num 50 through the first region and ref num 52 through the second region; Col. 8, lines 52-56, “A first end 50 of the connecting material 48 is drawn through and tied to the suture hole 46 in one arcuate member 13, and a second end 52 of the connecting material 48 is drawn through and tied to the suture hole 46 in the other arcuate member 14”). The compression band tightens around the instrument once inserted in order to secure the tool between the pressure regions (Col. 8, lines 59-67). 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 Pimenta to include a compression band in order to improve securing the tool within the pressure regions.
Cantwell teaches a clip of analogous art (Fig. 1), wherein the clip comprises a first member with a pressure region (Fig. 2, ref num 18a with interior surface as pressure region) and a second member with a pressure region (Fig. 2, ref num 18b with interior surface as pressure region). The clip also comprises an electrode (Fig. 2, ref num 12) within the second member pressure region (see Fig. 2, ref num 12 resides on the pressure region of ref num 18b). The electrode is embedded within the second member pressure region (see Fig. 4, ref num 12 is embedded; para 0033). The electrode provides recording and stimulating functions (para 0034). 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 Pimenta to embed the electrode, as this provides the same expected result of recording and stimulating functions as taught in Pimenta.
10. Regarding Claim 12, Pimenta as modified teaches acquiring electrical signals through the embedded electrode (Col. 8, lines 21-25, “any or all of the retractor blades 12, 16, 18, the shim element 22 and/or the retractor extenders 24/25 may be provided with one or more electrodes 39 (preferably at their distal regions) equipped for use with a nerve surveillance system”; Col. 6, lines 45-52, “this nerve surveillance system is capable of detecting the existence of (and optionally the distance and/or direction to) neural structures during the distraction and retraction of tissue by detecting the presence of nerves by applying a stimulation signal to such instruments and monitoring the evoked EMG signals from the myotomes associated with the nerves being passed by the distraction and retraction systems of the present invention”).
11. Regarding Claim 13, Pimenta fails to teach a housing structure within the second member with a cavity for housing a lead wire to the embedded electrode.
Cantwell teaches the second member (Fig. 2, ref num 18b) with the embedded electrode (Fig. 2, ref num 12), wherein the second member has a housing structure within it (Fig. 4, ref num 22). The housing structure comprises a cavity (Fig. 4, ref num 50) for a lead wire to the embedded electrode (Fig. 4, ref num 60 to the electrode, ref num 12). The lead wire provides electrical connection to the electrode (para 0039, “the lead wire assembly 60 can further support electrical connections to the electrode 12”). 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 Pimenta to include a housing with a lead wire to the embedded electrode, since this provides electrical connection to the electrode which allows the electrode to provide the same expected result of recording and stimulating functions as taught in Pimenta.
12. Regarding Claim 14, Pimenta fails to teach the lead wire is soldered to the embedded electrode.
Cantwell teaches the lead wire (Fig. 4, ref num 60) and the electrode (Fig. 4, ref num 12), such that the lead wire is attached to the electrode (para 0035, “the first channel 49a is positioned within the domed portion 46 and can be crimped to the exposed wire core 66 proximate the top 42 using a single point crimp”). While Cantwell fails to explicitly teach that the lead wire is soldered, it is well known that crimping and soldering are both well-known means of connection between lead wires and electrodes (see John U.S. 2019/0038438, para 0164). 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 further modified Pimenta to solder the lead wire to the electrode, as this is a well-known means of connection within the art.
13. Claims 5, 7, 9, 15, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta, Raulerson, and Cantwell, and further in view of Santangelo U.S. 2009/0221153 (herein referred to as “Santangelo”).
14. Regarding Claim 5, Pimenta fails to teach the compression band further comprises conductive material to acquire and/or deliver electrical signals.
Santangelo teaches a clip of analogous art (Fig. 5, ref num 26) wherein the clip comprises a compression band (Fig. 5, ref nums 74 and 76), such that the compression band comprises conductive material to acquire and/or deliver electrical signals (para 0037, “the elongate members 74, 76 are made from an electrically conductive material and contact the shaft of a surgical tool received within the housing 60. The elongate members 74, 76 provide an electrical connection between the electrical conduit 20 and the tool shaft”). This provides electrical signals to the tool shaft that the clip is clamped to (para 0037). 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 further modified Pimenta to have the compression band comprise of conductive material to deliver electrical signals, in order to provide the electrical signals to the tool/dilator that the clip is attached to.
15. Regarding Claim 7, Pimenta fails to teach the compression band is coated with a layer of lubricant to have a low friction coefficient to allow for rotation about a central axis of the tubular dilator.
Santangelo teaches a clip of analogous art (Fig. 5, ref num 26) wherein the clip comprises a compression band (Fig. 5, ref nums 74 and 76). The compression band is configured to have a low friction coefficient to allow for rotation about a central axis of a tool (para 0060). This is to ensure that the tool is retained but still allows for rotation of the tool (para 0060). While Santangelo fails to teach that the compression band is coated with a layer of lubricant, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the compression coated with a lubricant, 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.
16. Regarding Claim 9, Pimenta fails to teach a plurality of compression bands.
Santangelo teaches a plurality of compression bands (Fig. 5, ref nums 74 and 76). Multiple compression bands provides accommodation for tool shafts of varying diameters, in order to secure said tool (para 0038, “permits the elongate members 74, 76 to accommodate tool shafts of varying diameters while providing a secure connection between the housing 60 and the tool”). 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 further modified Pimenta to have a plurality of compression bands in order to improve the dynamic fitting of different size tools and provide the same expected result of securing the tool.
17. Regarding Claim 15, Pimenta fails to teach the compression band further comprises conductive material to acquire and/or deliver electrical signals.
Santangelo teaches a clip of analogous art (Fig. 5, ref num 26) wherein the clip comprises a compression band (Fig. 5, ref nums 74 and 76), such that the compression band comprises conductive material to acquire and/or deliver electrical signals (para 0037, “the elongate members 74, 76 are made from an electrically conductive material and contact the shaft of a surgical tool received within the housing 60. The elongate members 74, 76 provide an electrical connection between the electrical conduit 20 and the tool shaft”). This provides electrical signals to the tool shaft that the clip is clamped to (para 0037). 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 further modified Pimenta to have the compression band comprise of conductive material to deliver electrical signals, in order to provide the electrical signals to the tool/dilator that the clip is attached to.
18. Regarding Claim 17, Pimenta fails to teach the compression band is coated with a layer of lubricant to have a low friction coefficient to allow for rotation about a central axis of the tubular dilator.
Santangelo teaches a clip of analogous art (Fig. 5, ref num 26) wherein the clip comprises a compression band (Fig. 5, ref nums 74 and 76). The compression band is configured to have a low friction coefficient to allow for rotation about a central axis of a tool (para 0060). This is to ensure that the tool is retained but still allows for rotation of the tool (para 0060). While Santangelo fails to teach that the compression band is coated with a layer of lubricant, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the compression coated with a lubricant, 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.
19. Regarding Claim 19, Pimenta fails to teach a plurality of compression bands.
Santangelo teaches a plurality of compression bands (Fig. 5, ref nums 74 and 76). Multiple compression bands provides accommodation for tool shafts of varying diameters, in order to secure said tool (para 0038, “permits the elongate members 74, 76 to accommodate tool shafts of varying diameters while providing a secure connection between the housing 60 and the tool”). 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 further modified Pimenta to have a plurality of compression bands in order to improve the dynamic fitting of different size tools and provide the same expected result of securing the tool.
20. Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta, Raulerson, and Cantwell, and further in view of Carroccio U.S. 11,628,277 (herein referred to as “Carroccio”).
21. Regarding Claim 6, Pimenta fails to teach the central hinge is comprised of a pin that integrates with a torsion spring that forces the first member pressure region and the second member pressure region into a closed state by applying pressure to the first member pressure region and the second member pressure region.
Carroccio teaches a clip of analogous art (Figs. 1 and 2), wherein the clip comprises a first and second member (Fig. 1, ref num 101 and 102) each comprising a pressure member (Fig. 1, ref nums 101 and 102 each have interior surface that is a pressure member). The clip also comprises a central hinge (Fig. 2, ref num 105) that is comprised of a pin that integrates with a torsion spring (see Fig. 2, ref num 140 is disposed about a pin; Col 6, lines 42-43). This forces the first pressure region and second pressure region into a closed state by applying pressure (Col. 6, lines 42-47, “the torsion spring 140 is disposed about the hinge 105. The torsion spring 140 provides a force to close the first jaw 101 and the second jaw 102 automatically when the first lever 107 and the second lever 108 are released. The torsion spring 140 biases the first jaw 101 and second jaw 102 in the closed position shown in FIG. 3”). This provides the same expected result of forcing the first and second members together, like taught in Pimenta. 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 Pimenta to have a pin that integrates with a torsion spring in order to provide the same expected result of forcing the first and second pressure regions towards one another.
22. Regarding Claim 16, Pimenta fails to teach the central hinge is comprised of a pin that integrates with a torsion spring that forces the first member pressure region and the second member pressure region into a closed state by applying pressure to the first member pressure region and the second member pressure region.
Carroccio teaches a clip of analogous art (Figs. 1 and 2), wherein the clip comprises a first and second member (Fig. 1, ref num 101 and 102) each comprising a pressure member (Fig. 1, ref nums 101 and 102 each have interior surface that is a pressure member). The clip also comprises a central hinge (Fig. 2, ref num 105) that is comprised of a pin that integrates with a torsion spring (see Fig. 2, ref num 140 is disposed about a pin; Col 6, lines 42-43). This forces the first pressure region and second pressure region into a closed state by applying pressure (Col. 6, lines 42-47, “the torsion spring 140 is disposed about the hinge 105. The torsion spring 140 provides a force to close the first jaw 101 and the second jaw 102 automatically when the first lever 107 and the second lever 108 are released. The torsion spring 140 biases the first jaw 101 and second jaw 102 in the closed position shown in FIG. 3”). This provides the same expected result of forcing the first and second members together, like taught in Pimenta. 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 Pimenta to have a pin that integrates with a torsion spring in order to provide the same expected result of forcing the first and second pressure regions towards one another.
23. Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta, Raulerson, and Cantwell, and further in view of Andino U.S. 9,694,130 (herein referred to as “Andino”).
24. Regarding Claim 8, Pimenta fails to teach the dilator clip is comprised of a semi-rigid polymeric material.
Andino teaches a clip of analogous art (Fig. 1, ref num 40), wherein the clip is comprised of a semi-rigid polymeric material (Col. 8, lines 26-36). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the clip be made of a semi-rigid polymeric material, 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.
25. Regarding Claim 18, Pimenta fails to teach the dilator clip is comprised of a semi-rigid polymeric material.
Andino teaches a clip of analogous art (Fig. 1, ref num 40), wherein the clip is comprised of a semi-rigid polymeric material (Col. 8, lines 26-36). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the clip be made of a semi-rigid polymeric material, 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.
26. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Pimenta, Raulerson, and Cantwell, and further in view of Bozich U.S. 7,914,350 (herein referred to as “Bozich”).
27. Regarding Claim 10, Pimenta fails to teach the central hinge is comprised of a compression spring.
Bozich teaches a clip of analogous art (Figs. 3A-3E) wherein the clip comprises a first and second member (Fig. 3A, ref nums 304 and 306) and a central hinge (Fig. 3D, ref num 344) that connects the first and second members (Col. 19, lines 44-47, “A biasing element 344 is coupled to the first contact element 304 and the second contact element 306 to bias the first contact element 304 and the second contact element 306 towards each”). The central hinge is comprised of a compression spring (see Fig. 3D, ref num 344 is a spring; Col 19, line 57, “the biasing element 344 is a spring”). This provides the same expected result of driving the first and second member towards one another (Col. 19, lines 61-65). 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 Pimenta to have the central hinge comprised of a compression spring, as this is a well-known structure in the art that performs the same expected result of biasing the first and second member towards one another.
28. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Pimento, Raulerson, and Cantwell, and further in view of Mire U.S. 2013/0103103 (herein referred to as “Mire”).
29. Regarding Claim 20, Pimenta teaches removing the dilator clip (Col. 16, lines 22-24).
Pimenta fails to teach removing the clip by compressing the first member handle region and the second member handle region and moving the first member pressure region and the second member pressure region away from the tubular dilator.
Mire teaches a method of analogous art (Figs. 1-4; para 0051, 0058), wherein the method comprises removing a dilator clip by compressing the first member handle region and the second member handle region and moving the first member pressure region and the second member pressure region away from the tubular dilator (para 0058, “Upon desired positioning of dilator 32 adjacent the surgical site, dilator 32 may be moved from the first, non-expanded configuration to the second, expanded configuration… Upon desired positioning of dilator 32 adjacent the surgical site, dilator 32 may be moved from the first, non-expanded configuration to the second, expanded configuration”; see Fig. 4 and para 0052). The removal of the clip is done once the tubular dilator is in the desired position (para 0058). 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 Pimenta to remove the clip by compressing the handle members together, since the clip would not be needed once the dilator is in the proper position.
Conclusion
30. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794