DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on 12/22/2025 has been entered.
Response to Amendment
The amendment filed on 12/22/2025 has been entered. Claims 1-19 and 21-23 remain pending the application.
Response to Arguments
Applicant's arguments filed on 12/22/2025 have been fully considered but they are not persuasive or are moot.
Applicant argues on pages 7-9 that Burney requires that the ramp be two separate components and therefore cannot be modified by Giasolli to be a single unitary structure. However, Burney states that this is “preferably” done this way as seen in the Applicant’s citation. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See MPEP 2123. Accordingly, a person having ordinary skill in the art would have been motivated to modify Burney in the disclosed manner. Accordingly, this argument is not persuasive.
Claim Rejections - 35 USC § 103
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.
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, 4, 11-12, 14-16, 18, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Burney et al. (US20010001811, hereafter Burney) and Giasolli et al. (US20180200491, hereafter Giasolli).
Regarding claim 1, Burney discloses in Figures 1-12 an access needle (biopsy assembly 10), comprising:
a needle housing (hub 40);
a needle shaft (cannula 20) having a portion disposed within the needle housing (Burney, Figures 1-11 showing this) (Burney, Para 56; “the invention includes a hub 40 attached to the second end 22 of the cannula 20 as depicted in FIG. 2. Referring also to FIG. 6, hub 40 defines a channel 45 for delivering a biopsy needle to the cannula 20. The channel 45 includes a first end 46 and a second end 47. The first end 46 of the channel 45 surrounds the second end 22 of the cannula 20 and is in communication with the aperture 23.), the needle shaft integrally include a needle tip (tip 30) a distal end (first end 21) of the needle shaft (Burney, Para 48; “A tip 30 which closes the lumen 25 is disposed at the first end 21 of the cannula 20.”) (Burney, Figure 3; showing this);
a lumen (lumen 25) within the needle shaft (Burney, Para 48; “The cannula 20 defines a lumen 25 which extends between the first end 21 and the second end 22 of the cannula 20 as shown more clearly in FIG. 3.”);
an entry port (aperture 23) at a proximal end (second end 22) of the needle shaft (Burney, Para 48; “The cannula 20 defines an aperture 23 at the second end 22 of the cannula 20. The aperture 23 is in communication with the lumen 25 and is sized and configured to receive a biopsy needle 11 for passage into the lumen”) (Burney, Figure 3; showing this);
an exit port (lateral opening 24) on a sidewall of the needle shaft, wherein the exit port is disposed nearer the distal end of the needle shaft than the proximal end, and wherein the lumen extends from the entry port to the exit port (Burney, Para 49; “The cannula 20 also defines a lateral opening 24 which is in communication with the lumen 25. The lateral opening 24 is preferably adjacent the first end 21 of the cannula 20. The lateral opening 24 is sized and configured to allow exit of a biopsy needle from the cannula as it is advanced through the lumen 25”) Burney, Para 48; “The aperture 23 is in communication with the lumen 25 and is sized and configured to receive a biopsy needle 11 for passage into the lumen”); and
a ramp region disposed within the exit port and extending from the exit port toward a distal end of the needle tip, the ramp region including an upwardly sloped exit surface (ramp 35) that transitions to a transition surface (see annotated Figure 4 below), wherein the transition surface transitions to a downwardly sloped ramp surface that tapers to the distal end of the needle tip (see annotated Figure 4 below), wherein the ramp region is at least partially coupled to an interior of the needle shaft (Burney, Para 51; “ramp 35 disposed within the cannula 20 at an end 36 of the lateral opening 24 adjacent the first end 21 of the cannula 20. The ramp 35 is inclined toward the lateral opening 24. In the operation of the biopsy assembly 10, a biopsy needle 11 will be deflected through the lateral opening 24 as it is advanced through the lumen 25 and exits the cannula 20. The ramp 35 provides controlled exit of the biopsy needle 11. The slope of the ramp may be altered to obtain a desired angle of deflection of the needle 11 as it exits the lateral opening 24.”) (Burney, Figures 3-5, 9, and annotated Figure 4 showing this).
PNG
media_image1.png
347
627
media_image1.png
Greyscale
Burney does not clearly and explicitly disclose wherein the ramp region is a separate, unitary structure that is attached to the needle shaft.
In an analogous inserted medical device in a patient field of endeavor Giasolli discloses wherein a ramp region is a separate, unitary structure that is attached to a medical device (Giasolli, Para 199; “Ramps may be produced with UV glues using repeat deposition and curing steps in a series of laying down and building up layers until a ramp is produced as seen in FIG. 25N.1.”).
The use of the techniques of forming a separate unitary ramp region from UV glue taught by Giasolli in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the ramp region is a separate, unitary structure that is attached to the needle shaft as taught by Giasolli in order to increase manufacturing speed which reduces costs.
Regarding claim 4, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney further discloses wherein the exit surface of the ramp region comprises: a first angled surface angled upward from a bottom of the needle shaft towards the exit port (Burney, Para 51; “ramp 35 disposed within the cannula 20 at an end 36 of the lateral opening 24 adjacent the first end 21 of the cannula 20. The ramp 35 is inclined toward the lateral opening 24. In the operation of the biopsy assembly 10, a biopsy needle 11 will be deflected through the lateral opening 24 as it is advanced through the lumen 25 and exits the cannula 20. The ramp 35 provides controlled exit of the biopsy needle 11. The slope of the ramp may be altered to obtain a desired angle of deflection of the needle 11 as it exits the lateral opening 24.”) (Burney, Figures 3-5 and annotated Figure 4 showing this).
Regarding claim 11, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney further discloses wherein the ramp region comprises: the exit surface form of a first angled surface angled upward from a bottom of the needle shaft towards the exit port; the transition surface formed of a second planar surface contiguous with the first angled surface in a vicinity of the exit port; the ramp surface formed of a third angled surface angled downward from the second planar surface towards the needle tip (Burney, Figure 9 and annotated Figure 4 showing a this, a configuration similar to instant application figure 9 which corresponds to this claim limitation).
Regarding claim 12, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney does not clearly and explicitly disclose wherein the ramp region is coupled to the needle shaft via gluing.
In an analogous inserted medical device in a patient field of endeavor Giasolli discloses wherein a ramp region is coupled to a device via glue (Giasolli, Para 199; “Alternatively, ramps maybe prefabricated into the desired shape and then bonded to the surface with cyanoacrylate, UV glue”).
The use of the techniques of gluing the ramp region to the device taught by Giasolli in the invention of a ramp region for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the ramp region is coupled to the needle shaft via gluing as taught by Giasolli in order to use a known secure and reliable method of assembling a medical device.
Regarding claim 14, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney does not clearly and explicitly disclose wherein the ramp region is formed by molding ultraviolet glue.
In an analogous inserted medical device in a patient field of endeavor Giasolli discloses wherein a ramp region is formed by molding ultraviolet glue (Giasolli, Para 199; “Ramps may be produced with UV glues using repeat deposition and curing steps in a series of laying down and building up layers until a ramp is produced”).
The use of the techniques of making a ramp region for a medical device by molding UV glue taught by Giasolli in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the ramp region is formed by molding ultraviolet glue as taught by Giasolli in order to use a known secure and reliable method of assembling a medical device.
Regarding claim 15, Burney as modified by Giasolli above discloses all of the limitations of claim 14 as discussed above.
Burney does not clearly and explicitly disclose wherein the ramp region is coupled to the needle shaft with ultraviolet glue.
In an analogous inserted medical device in a patient field of endeavor Giasolli discloses wherein a ramp region is coupled to a device via UV glue (Giasolli, Para 199; “Alternatively, ramps maybe prefabricated into the desired shape and then bonded to the surface with cyanoacrylate, UV glue”).
The use of the techniques of gluing the ramp region to the device via UV glue taught by Giasolli in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the ramp region is coupled to the needle shaft with ultraviolet glue as taught by Giasolli in order to use a known secure and reliable method of assembling a medical device.
Regarding claim 16, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney further discloses wherein a length of the exit port is greater than a height of the ramp (Burney, Figures 8-9 showing this).
Regarding claim 18, Burney discloses in Figures 1-12 an access needle (biopsy assembly 10), comprising:
a handle (handle 71) having a rotatable connector coupled thereto (Burney, Para 65; “As shown in FIG. 7, the invention also contemplates a biopsy needle stylet 70. The biopsy stylet 70 facilitates guiding the biopsy needle 11 through the lateral opening 24. The biopsy needle stylet 70 includes a handle 71”) (Burney, Para 50; “The introducer 15 can be rotated so that the lateral opening 24 will be exposed to different areas within the sampling zone, so that a biopsy needle 11 can be directed into these different areas”);
a needle housing coupled to the handle (hub 40);
a needle shaft (cannula 20) having a portion disposed within the needle housing (Burney, Figures 1-11 showing this) (Burney, Para 56; “the invention includes a hub 40 attached to the second end 22 of the cannula 20 as depicted in FIG. 2. Referring also to FIG. 6, hub 40 defines a channel 45 for delivering a biopsy needle to the cannula 20. The channel 45 includes a first end 46 and a second end 47. The first end 46 of the channel 45 surrounds the second end 22 of the cannula 20 and is in communication with the aperture 23.), the needle shaft integrally include a needle tip (tip 30) a distal end (first end 21) of the needle shaft (Burney, Para 48; “A tip 30 which closes the lumen 25 is disposed at the first end 21 of the cannula 20.”) (Burney, Para 52; “the solid tip 30 is preferably a separate component which is secured to the first end 21 of the cannula 20 as shown in FIGS. 2-5.”) (Burney, Figure 3; showing this) (Burney, Para 52; “the solid tip 30 is preferably a separate component which is secured to the first end 21 of the cannula 20 as shown in FIGS. 2-5.”);
a lumen (lumen 25) within the needle shaft (Burney, Para 48; “The cannula 20 defines a lumen 25 which extends between the first end 21 and the second end 22 of the cannula 20 as shown more clearly in FIG. 3.”);
an entry port (aperture 23) at a proximal end (second end 22) of the needle shaft (Burney, Para 48; “The cannula 20 defines an aperture 23 at the second end 22 of the cannula 20. The aperture 23 is in communication with the lumen 25 and is sized and configured to receive a biopsy needle 11 for passage into the lumen”) (Burney, Figure 3; showing this);
an exit port (lateral opening 24) on a sidewall of the needle shaft, wherein the exit port is disposed nearer the distal end of the needle shaft than the proximal end, and wherein the lumen extends from the entry port to the exit port (Burney, Para 49; “The cannula 20 also defines a lateral opening 24 which is in communication with the lumen 25. The lateral opening 24 is preferably adjacent the first end 21 of the cannula 20. The lateral opening 24 is sized and configured to allow exit of a biopsy needle from the cannula as it is advanced through the lumen 25”) Burney, Para 48; “The aperture 23 is in communication with the lumen 25 and is sized and configured to receive a biopsy needle 11 for passage into the lumen”);
a ramp region disposed within the exit port and extending from the exit port toward a distal end of the needle tip, the ramp region including an upwardly sloped exit surface (ramp 35) that transitions to a transition surface (see annotated Figure 4 below), wherein the transition surface transitions to a downwardly sloped ramp surface that tapers to the distal end of the needle tip (see annotated Figure 4 below),
wherein the ramp region is at least partially coupled to an interior of the needle shaft (Burney, Para 51; “ramp 35 disposed within the cannula 20 at an end 36 of the lateral opening 24 adjacent the first end 21 of the cannula 20. The ramp 35 is inclined toward the lateral opening 24. In the operation of the biopsy assembly 10, a biopsy needle 11 will be deflected through the lateral opening 24 as it is advanced through the lumen 25 and exits the cannula 20. The ramp 35 provides controlled exit of the biopsy needle 11. The slope of the ramp may be altered to obtain a desired angle of deflection of the needle 11 as it exits the lateral opening 24.”) (Burney, Figures 3-5, 9, and annotated Figure 4 showing this); and
PNG
media_image1.png
347
627
media_image1.png
Greyscale
wherein rotation of the rotatable connector causes rotation of the needle tip without causing rotation of the needle housing (Burney, Para 79; “The cannula 120 of the guide 100 can be adjusted coaxially or rotated to change the direction of the lateral opening 124.”) (Burney, Para 50; “The introducer 15 can be rotated so that the lateral opening 24 will be exposed to different areas within the sampling zone, so that a biopsy needle 11 can be directed into these different areas”).
Burney does not clearly and explicitly disclose wherein the ramp region is a separate, unitary structure that is attached to the needle shaft.
In an analogous inserted medical device in a patient field of endeavor Giasolli discloses wherein a ramp region is a separate, unitary structure that is attached to a medical device (Giasolli, Para 199; “Ramps may be produced with UV glues using repeat deposition and curing steps in a series of laying down and building up layers until a ramp is produced as seen in FIG. 25N.1.”).
The use of the techniques of forming a separate unitary ramp region from UV glue taught by Giasolli in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the ramp region is a separate, unitary structure that is attached to the needle shaft as taught by Giasolli in order to increase manufacturing speed which reduces costs.
Regarding claim 21, Burney as modified by Giasolli discloses all of the limitations of claim 1 as discussed above.
Burney further discloses wherein the ramp region extends to a distal most end of the needle shaft (Burney, Figures 3-5, 9, and annotated Figure 4 show this).
Regarding claim 22, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney does not clearly and explicitly disclose wherein the needle tip, the exit port, and the needle shaft are all formed as a first component, and the ramp region is a second component that is attached to the first component.
Giasolli further discloses wherein a ramp region is a separate, unitary structure that is attached to a medical device (Giasolli, Para 199; “Ramps may be produced with UV glues using repeat deposition and curing steps in a series of laying down and building up layers until a ramp is produced as seen in FIG. 25N.1.”).
The use of the techniques of forming a separate unitary ramp region from UV glue taught by Giasolli in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the needle tip, the exit port, and the needle shaft are all formed as a first component, and the ramp region is a second component that is attached to the first component as taught by Giasolli in order to increase manufacturing speed which reduces costs.
Regarding claim 23, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney further discloses wherein the ramp region is at least partially positioned on an exterior surface of the needle shaft (Burney, Figure 4; showing this, Burney is also interpreted as disclosing this because this is similar to applicant’s Figure 9).
PNG
media_image1.png
347
627
media_image1.png
Greyscale
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Burney and Giasolli as applied to claim 1, and in further view of Sapir et al. (US20160100859, hereafter Sapir).
Regarding claim 2, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney does not clearly and explicitly disclose wherein the ramp region is formed from ultraviolet (UV) glue, and wherein the distal end of the needle shaft is formed from nitinol.
Giasolli further discloses in Figure 25N wherein a ramp region is formed from ultraviolet (UV) glue (Giasolli, Para 199; “Ramps may be produced with UV glues using repeat deposition and curing steps in a series of laying down and building up layers until a ramp is produced as seen in FIG. 25N.1.”).
The use of the techniques of using a ramp region formed from UV glue taught by Giasolli in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the ramp region is formed from ultraviolet (UV) glue as taught by Giasolli in order to use a fast curing material that forms strong bonds and is extremely versatile which results in higher speed manufacturing and assembly.
In an analogous access needle field of endeavor Sapir discloses wherein a distal end of a needle shaft is formed from nitinol (Sapir, Para 64-66; “hollow needle comprising: a proximal portion having an outer diameter between 0.7 and 3 mm, a length between 650 and 1200 mm, and a wall thickness between 0.1 and 0.3 mm; and a distal portion at least partially made of nitinol”) (Sapir, Para 117; “distal portion 88 comprises a portion that is at least partially made of nitinol […] The nitinol provides flexibility to distal portion 88”).
The use of the techniques of using a needle distal end comprising nitinol taught by Sapir in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a flexibly tipped access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the distal end of the needle shaft is formed from nitinol in order to use a flexible material as taught by Sapir (Sapir, Para 117) which allows for more precise placement and navigation through narrow spaces within the body.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Burney and Giasolli as applied to claim 1 above, and in further view of Goldrath (US5501691).
Regarding claim 3, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney does not clearly and explicitly disclose wherein the ramp region is formed from epoxy resin.
In an analogous hollow needle with an exit port field of endeavor Goldrath discloses wherein a ramp region is formed from epoxy resin (Goldrath, Col 5, lines 26-33; “Various embodiments of the angled channel guide of the present invention are shown in FIGS. 3, 4 and 5. In FIG. 3, the angled channel guide is formed by filling the tip end of the probe with a filler material 14, such as epoxy resin. The filler 14 is allowed to harden at an angle to form the angled channel guide”).
The use of the techniques of using a ramp formed from epoxy resin taught by Goldrath in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the ramp region is formed from epoxy resin as taught by Goldrath in order to use a material which is strong, durable, biocompatibility, and the ability to withstand sterilization processes which increases reliability of the device.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Burney and Giasolli as applied to claim 4 above, and in further view of Johnson et al. (US20140276037, hereafter Johnson).
Regarding claim 5, Burney as modified by Giasolli above discloses all of the limitations of claim 4 as discussed above.
Burney does not clearly and explicitly disclose wherein the first angled surface is angled at 10°-45° from a central longitudinal axis of the needle shaft.
In an analogous access needle field of endeavor Johnson discloses wherein a first angled surface of a ramp is angled at 10°-45° from a central longitudinal axis of a needle shaft (Johnson, Para 32; “Tapered proximal end (242) forms an included angle with the longitudinal axis of lumen (15) (included angle with a horizontal line in FIG. 2) of about 45 degrees, while ramp surface (212) forms an included angle with the longitudinal axis of about 30 degrees.”).
The use of the techniques of using a ramp at about 30 degrees taught by Johnson in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the first angled surface is angled at 10°-45° from a central longitudinal axis of the needle shaft as taught by Johnson in order to increase the ease of pushing things through the exit port.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Burney and Giasolli as applied to claim 1 above, and in further view of Malandain et al. (US20070123889, hereafter Malandain), and Sapir et al. (US20160100859, hereafter Sapir).
Regarding claim 6, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney does not clearly and explicitly disclose wherein the ramp region is formed from stainless steel. and wherein the distal end of the needle shaft is formed form nitinol.
In an analogous inserted medical device in a patient field of endeavor Malandain discloses wherein a ramp region is formed from stainless steel (Malandain, Para 33; “The ramp can be made of any of a plurality of materials including stainless steel, nickel-titanium alloys (such as NITINOL), other metal alloys, polymeric materials, rubber, or any other material that is structurally suited to facilitating the articulation of the blade and/or tip.”).
The use of the techniques of using a ramp formed from stainless steel taught by Malandain in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the ramp region is formed from stainless steel in order to facilitate easier articulation of tools or objects through the exit port as taught by Malandain (Malandain, Para 33).
In an analogous access needle field of endeavor Sapir discloses wherein a distal end of a needle shaft is formed from nitinol (Sapir, Para 64-66; “hollow needle comprising: a proximal portion having an outer diameter between 0.7 and 3 mm, a length between 650 and 1200 mm, and a wall thickness between 0.1 and 0.3 mm; and a distal portion at least partially made of nitinol”) (Sapir, Para 117; “distal portion 88 comprises a portion that is at least partially made of nitinol […] The nitinol provides flexibility to distal portion 88”).
The use of the techniques of using a needle distal end comprising nitinol taught by Sapir in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a flexibly tipped access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the distal end of the needle shaft is formed from nitinol in order to use a flexible material as taught by Sapir (Sapir, Para 117) which allows for more precise placement and navigation through narrow spaces within the body.
Claims 7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Burney and Giasolli as applied to claim 1 above, and in further view of Kohm et al. (US20080086142, hereafter Kohm).
Regarding claim 7, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney does not clearly and explicitly disclose wherein a radius of curvature of a bottom of the ramp region matches a radius of curvature of the interior of the needle shaft.
In an analogous access needle field of endeavor Kohm discloses wherein a radius of curvature of a bottom of a ramp region matches a radius of curvature of an interior of a needle shaft (Kohm, Para 196; “The insertable part may comprise a sloped surface that ranges in slope from about 2 degree to 90 degrees, or from about 5 degrees to about 80 degrees, or from about 10 degrees to about 70 degrees, or from about 10 degrees to about 60 degrees, or from about 15 degrees to about 50 degrees, or from about 20 degrees to about 35 degrees, or from about 20 degrees to about 30 degrees. [...] Also, the base of the insertable part may be tapered, or may be substantially squared off, to be flush with the internal circumference of the access member.”).
The use of the techniques of using a ramp region with a radius of curvature of a bottom of the ramp region matching a radius of curvature of the interior of the needle shaft taught by Kohm in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an access needle without a corner to get a tool stuck in; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein a radius of curvature of a bottom of the ramp region matches a radius of curvature of the interior of the needle shaft as taught by Kohm in order to reduce the chance of a tool getting stuck.
Regarding claim 9, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney does not clearly and explicitly disclose wherein the ramp region comprises a plurality of smooth angled guide surfaces for preventing snagging of a guide wire.
The limitation for preventing snagging of a guide wire is interpreted as a recitation of intended result.
In an analogous access needle field of endeavor Kohm discloses in Figures 6J-6L wherein a ramp region comprises a plurality of smooth angled guide surfaces for preventing snagging of a guide wire (Kohm, Para 17; “FIG. 6 illustrates different structures for insertion into an access member in accordance with alternate embodiments of the present invention including a flat angled step (panels A-C); a concave ramp having a squared-off end (panels D-F); multiple steps (panels G-I); a plurality of convex and concave surfaces comprising a wave-type shape (panels J-L); and a concave ramp having a tapered proximal end (panels M-O).”).
The use of the techniques of using a ramp region comprising a plurality of smooth angled guide surfaces taught by Kohm in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an access needle without a corner to get a tool stuck in; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the ramp region comprises a plurality of smooth angled guide surfaces for preventing snagging of a guide wire as taught by Kohm in order to smoothly guide thing out of the exit port.
Regarding claim 10, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney further discloses wherein a second portion of the exit port is formed by an end of an angled surface of the ramp (Burney, Figures 3-4 showing this) (Burney, Para 75; “a ramp 135 disposed within the cannula 120 at an end 136 of the lateral opening 124”).
Burney does not clearly and explicitly disclose wherein a first portion of the exit port is formed by a U-shaped cutout in a top of the needle shaft.
In an analogous access needle field of endeavor Kohm discloses in Figure 15A wherein a first portion of the exit port is formed by a U-shaped cutout in a top of a needle shaft (Kohm, Figure 15A, port 42 showing this).
The use of the techniques of using an exit port formed with a u-shape cutout taught by Kohm in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an exit port with a smooth surface; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein a first portion of the exit port is formed by a U-shaped cutout in a top of the needle shaft as taught by Kohm in order to increase usability by reducing the number of corners in the device which can trap debris and other unwanted things.
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Burney and Giasolli above, and in further view of Palushi et al. (US20190069959, hereafter Palushi).
Regarding claim 8, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney does not clearly and explicitly disclose wherein a height of the needle shaft is greater than a height of the ramp region by a predetermined distance.
In an analogous access needle field of endeavor Palushi discloses in Figure 4A wherein a height of a needle shaft is greater than a height of the ramp region by a predetermined distance (Palushi, Figure 4A showing this).
The use of the techniques of using an exit port with ends of differing heights resulting in a height of a needle shaft is greater than a height of the ramp region by a predetermined distance taught by Palushi in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of an exit port in an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein a height of the needle shaft is greater than a height of the ramp region by a predetermined distance as taught by Palushi in order to use a tapered access needle which is easier to manipulate within a patient’s body.
Regarding claim 17, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney does not clearly and explicitly disclose wherein a height of a first end of the exit port is greater than a height of a second end of the exit port.
In an analogous access needle field of endeavor Palushi discloses in Figure 4A wherein a height of a first end of an exit port is greater than a height of a second end of the exit port (Palushi, Figure 4A showing this).
The use of the techniques of using an exit port with ends of differing heights taught by Palushi in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of an exit port in an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein a height of a first end of the exit port is greater than a height of a second end of the exit port as taught by Palushi in order to use a tapered access needle which is easier to manipulate within a patient’s body.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Burney and Giasolli as applied to claim 1 above, and in further view of Fueglister (US20130253532).
Regarding claim 13, Burney as modified by Giasolli above discloses all of the limitations of claim 1 as discussed above.
Burney does not clearly and explicitly disclose wherein the ramp region is coupled to the needle shaft via laser welding.
In an analogous access needle field of endeavor Fueglister discloses wherein a guide tube is coupled to a needle shaft via laser welding (Fueglister, Para 198; “the helical guide tube 744 […]is affixed [..] by means of laser spot welding”).
The use of the techniques of attaching the a guide tube to a medical device via laser welding taught by Fueglister in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of a ramp in an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the ramp region is coupled to the needle shaft via laser welding as taught by Fueglister in order to use a known fast and precise method of assembling a medical device.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Burney and Giasolli as applied to claim 18 above, and in further view of Hong et al. (US20100331677, hereafter Hong).
Regarding claim 19, Burney as modified by Giasolli above discloses all of the limitations of claim 18 as discussed above.
Burney does not clearly and explicitly disclose wherein the rotatable connector comprises a number of radial marks for identifying a rotation angle of the rotatable connector.
In an analogous access needle field of endeavor Hong discloses wherein a rotatable connector comprises a number of radial marks for identifying a rotation angle of the rotatable connector (Hong, Para 44; “The second vertical section 1C first deploys the marker out of the side opening 4A and into tissue. The second horizontal section 1D corresponds to the rotation of the needle 3 by a specified angle, for example 72 degrees to deploy 5 markers. After the second vertical track 1C, each successive vertical section corresponds to deployment of one marker, whereas each successive horizontal section corresponds to the rotation of the needle by the specified angle”).
The use of the techniques of using a number of radial marks for identifying a rotation angle taught by Hong in the invention of a ramp for an access needle would have comprised only application of a known technique to a known device ready for improvement to yield the predictable result of knowing the rotation of an access needle; and similar modifications have previously been held to involve only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Burney wherein the rotatable connector comprises a number of radial marks for identifying a rotation angle of the rotatable connector as taught by Hong in order to use a tapered access needle which is easier to manipulate within a patient’s body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John Li whose telephone number is (313)446-4916. The examiner can normally be reached Monday to Thursday; 5:30 AM to 3:30 PM Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN D LI/Primary Examiner, Art Unit 3798