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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 20, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on March 13, 2025 are accepted.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-20, 28 and 30-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clancy et al., US 2010/0317963 A1, hereinafter Clancy.
Claim 16. Clancy teaches in FIGS. 4-7 a system ([0009]: the system preferably includes an echogenic cannula element that may include an echogenically-enhanced cannula and/or an echogenically-enhanced stylet) for accessing a biliary duct ([0004]: stent devices are known and used for maintaining the patency of the biliary tree, or common bile duct, and for treatment of other ailments related to the biliary tee; FIG.1: the common bile duct 102), comprising:
an access cannula (210, 310, 410) extending longitudinally (412) from a proximal end to a distal end and including a channel (418) extending therethrough ([0025]: echogenic needle assemblies 210, 310; [0032]: An echogenic needle assembly 410 extends through the sheath lumen 404. The echogenic needle assembly 410 includes a flexible body length 412 with bevel-tipped distal needle 414 attached to and extending distally from it. The distal needle 414 includes a textured surface 416 with a needle lumen 418),
a distal portion of the access cannula including an echogenic pattern defined via echogenic segments (216) ([0026]: FIG.5, the distal portion of the needle structure 210 includes a beveled needle 214 that is constructed of metal and that includes a textured irregular surface region 216 along its cannula shaft illustrated here as being dimpled. The dimpled region 216 is configured to enhance the echogenicity of the needle 214; and [0031]: The distal portion of the needle structure 310 includes a rounded needle 314 that includes an irregular surface region 316 illustrated here as being ribbed. The ribbed region 316 is configured to enhance the echogenicity of the needle 314. In other embodiments, the needle 314 may have dimples, edged ridges, knurling, and/or regular or irregular other surface texturing or details on an internal and/or external surface to provide enhanced echogenicity, and may be constructed of any appropriate material),
each of which are separated from one another via a space so that the echogenic pattern is configured to produce alternating bright and dark regions, when visualized under ultrasound guidance (FIGS.5-6: the dimpled portions and the ribs are spaced from their neighboring dimples and ribs, respectively; and [0022]: the term “echogenic” is defined as having enhanced echogenicity. Specifically, it is used to refer to materials or portions of materials that are constructed or are treated to have greater reflectivity of ultrasonic waves than standard materials) – as the dimpled portions and the ribs are spaced from their neighboring ones, this configuration produces “alternating bright and dark regions” as claimed – the neighboring dimpled portions and the ribs are bright, and the spaces in between the neighboring ones are dark; and
a needle (420) extending longitudinally from a proximal end to a distal end, and sized, shaped and configured to be received within the channel of the access cannula (418) ([0032]: A stylet 420 extends through the needle lumen 418),
the distal end of the needle including a sharp tip (see FIG.7) producing a localized bright spot (422), under an ultrasound guidance, that is distinguishable from the bright and dark regions created via the echogenic pattern of the access cannula ([0032]: The stylet 420 is also shown as including an echogenicity-enhancing surface…that is patterned with a series of circumferential scallops 422 that may alternatively be embodied as another texture, shape, pattern, or a coating material that would enhance echogenicity of the stylet 420 whether or not it is used with an echogenic needle).
Claim 17. Clancy further teaches that
each of the echogenic segments include a plurality of markings extending along a portion of a length of an exterior surface of the access cannula (FIG.5: the dimpled portion 216 and FIG.6: the ribs 316) – each of the dimples or the ribs, or any number of a group of dimples or the ribs is considered the “echogenic segment” as claimed.
Claim 18. Clancy further teaches that
each of the markings is configured as a circumferential ring extending about the access cannula (FIG.6: each rib is considered a circumferential ring, and the ribs as illustrated in FIG.6 extend about the access cannula).
Claim 19. Clancy further teaches that
each of the markings is configured as a depression extending into the exterior surface along a curve (FIG.5: each dimpled portion is considered a depression, and the dimpled portions as illustrated in FIG.5 extent along the curvature of the exterior surface of the cannula).
Claim 20. Clancy further teaches that
each of the markings is configured as a roughened portion along the exterior surface (FIG.5: the dimples on the exterior surface make the exterior surface not smooth, hence create a roughened portion).
Claim 28. Clancy teaches in FIGS.4-7 an endoscopic device (200, 400) ([0038]: the ultrasound-visualizable endoscopic stent-placement system 200; and [0032]: FUG,7 shows a distal-end detail longitudinal section view of a stent-placement system 400 with an outer sheath 402. The overall structure of the system may generally be similar to the needle assembly 200), comprising:
an access cannula sized (210, 310, 410), shaped and configured to be inserted through a working channel of an endoscope ([0031]: The outer sheath 402 includes a sheath lumen 404. An echogenic needle assembly 410 extends through the sheath lumen 404),
the access cannula extending along a longitudinal axis (412) from a proximal end to a distal end ([0025]: echogenic needle assemblies 210, 310; [0032]: An echogenic needle assembly 410 extends through the sheath lumen 404. The echogenic needle assembly 410 includes a flexible body length 412 with bevel-tipped distal needle 414 attached to and extending distally from it. The distal needle 414 includes a textured surface 416 with a needle lumen 418) and including
an echogenic pattern along a distal portion thereof, the echogenic pattern defined via echogenic segments (216) ([0026]: FIG.5, the distal portion of the needle structure 210 includes a beveled needle 214 that is constructed of metal and that includes a textured irregular surface region 216 along its cannula shaft illustrated here as being dimpled. The dimpled region 216 is configured to enhance the echogenicity of the needle 214; and [0031]: The distal portion of the needle structure 310 includes a rounded needle 314 that includes an irregular surface region 316 illustrated here as being ribbed. The ribbed region 316 is configured to enhance the echogenicity of the needle 314. In other embodiments, the needle 314 may have dimples, edged ridges, knurling, and/or regular or irregular other surface texturing or details on an internal and/or external surface to provide enhanced echogenicity, and may be constructed of any appropriate material),
each of which are separated from one another via a space so that the echogenic pattern is configured to produce alternating bright and dark regions, when visualized under ultrasound guidance (FIGS.5-6: the dimpled portions and the ribs are spaced from their neighboring dimples and ribs, respectively; and [0022]: the term “echogenic” is defined as having enhanced echogenicity. Specifically, it is used to refer to materials or portions of materials that are constructed or are treated to have greater reflectivity of ultrasonic waves than standard materials) – as the dimpled portions and the ribs are spaced from their neighboring ones, this configuration produces “alternating bright and dark regions” as claimed – the neighboring dimpled portions and the ribs are bright, and the spaces in between the neighboring ones are dark; and
a needle (420) sized, shaped and configured to be slidably received within a channel of the access cannula (418) ([0033]: A stylet 420 extends through the needle lumen 418),
the needle extending longitudinally from a proximal end to a sharp distal tip which produces a localized bright spot (422), when visualized under an ultrasound guidance, so that the sharp distal tip is distinguishable from the bright and dark regions created via the echogenic pattern of the access cannula ([0032]: The stylet 420 is also shown as including an echogenicity-enhancing surface…that is patterned with a series of circumferential scallops 422 that may alternatively be embodied as another texture, shape, pattern, or a coating material that would enhance echogenicity of the stylet 420 whether or not it is used with an echogenic needle).
Claim 30. Clancy further teaches that
the access cannula is formed of a first echogenic material defining the echogenic segments and a second non-echogenic material defining the spaces therebetween ([0026]: FIG.5, the distal portion of the needle structure 210 includes a beveled needle 214 that is constructed of metal and that includes a textured irregular surface region 216 along its cannula shaft illustrated here as being dimpled. The dimpled region 216 is configured to enhance the echogenicity of the needle 214; and [0031]: The distal portion of the needle structure 310 includes a rounded needle 314 that includes an irregular surface region 316 illustrated here as being ribbed. The ribbed region 316 is configured to enhance the echogenicity of the needle 314. In other embodiments, the needle 314 may have dimples, edged ridges, knurling, and/or regular or irregular other surface texturing or details on an internal and/or external surface to provide enhanced echogenicity, and may be constructed of any appropriate material) – the dimpled portions and the ribs are the “first echogenic material” as claimed. The space between the dimpled portion and the ribs are the “second non-echogenic material” as claimed.
Claim 31. Clancy teaches in FIGS.4-8, and claims 8&20 a method for accessing a biliary duct ([0035]: FIG.8 shows a system for using the presently-described method, using the same needle assembly 200 as shown in FIG.4; and ([0004]: stent devices are known and used for maintaining the patency of the biliary tree, or common bile duct, and for treatment of other ailments related to the biliary tee; FIG.1: the common bile duct 102; and claim 8: a method for ultrasound-guided delivery of a stent device to a target site), comprising:
inserting an endoscope to target area within a stomach; inserting an access cannula, with a needle received therein, through a working channel of the endoscope to a target area within a body (claim 20: a cannula assembly extending through the sheath lumen, the cannula assembly including a distal cannula configured for longitudinal extension from the distal sheath end and including a longitudinal cannula lumen therethrough; a flexible body length extending proximately from the distal cannula through the sheath lumen; a stylet extending through the body length and the cannula lumen), under an endoscopic ultrasound image guidance (EUS) ([0036]: a method for endoscopic, ultrasound-guided delivery of a stent device to a target site is described with reference to FIGS. 4, 5, 8 and 9A-9B. The target site preferably is a location in or near the GI tract)) – “in or near the GI tract” is considered reading on the “target are within a stomach” as claimed;
pressing a distal end of the access cannula against a portion of a wall of the stomach adjacent a target wall of a target duct to be accessed so that a sharp tip of the needle pierces the stomach wall ([0028]: the distal tip 222 of the stylet 220 preferably aligns with the beveled end of the needle 214 such that the needle has enhanced structural support and can penetrate tissue),
the sharp tip of the needle visible as a localized bright spot under the EUS (claim 8: providing ultrasound visualization of the echogenic cannula portion and the target site); moving the access cannula and the needle toward the target wall of the target duct and puncturing the target wall of the target duct via the sharp tip of the needle (claim 8: directing the echogenic cannula portion and the overlaying stent to a location near a target site),
the access cannula visually distinguishable from the sharp tip via an echogenic pattern extending along a distal portion of the access cannula (FIGS.5-6: the dimpled portions and the ribs are spaced from their neighboring dimples and ribs, respectively; and [0022]: the term “echogenic” is defined as having enhanced echogenicity. Specifically, it is used to refer to materials or portions of materials that are constructed or are treated to have greater reflectivity of ultrasonic waves than standard materials; claim 20: an echogenic cannula portion disposed immediately adjacent a distal cannula end, the echogenic cannula portion comprising a dimpled surface configured to enhance reflection of ultrasound for visual resolution of the cannula); and
moving the access cannula distally over the sharp tip so that the distal end of the access cannula passes through the puncture to be received within the target duct (claim 8: directing the echogenic cannula portion and the overlaying stent to a location near a target site; directing the distal cannula to a location nearer th target site where it is desired to place the stent device; and moving at least one of the distal sheath end and the body length relative to the other of the distal sheath end and the body length to deploy the stent device into a desired location).
Claim 32. Clancy further teaches that
the echogenic pattern is defined via echogenic segments ([0026]: FIG.5, the distal portion of the needle structure 210 includes a beveled needle 214 that is constructed of metal and that includes a textured irregular surface region 216 along its cannula shaft illustrated here as being dimpled. The dimpled region 216 is configured to enhance the echogenicity of the needle 214; and [0031]: The distal portion of the needle structure 310 includes a rounded needle 314 that includes an irregular surface region 316 illustrated here as being ribbed. The ribbed region 316 is configured to enhance the echogenicity of the needle 314. In other embodiments, the needle 314 may have dimples, edged ridges, knurling, and/or regular or irregular other surface texturing or details on an internal and/or external surface to provide enhanced echogenicity, and may be constructed of any appropriate material),
each of which are separated from one another via a space so that the echogenic pattern is configured to produce alternating bright and dark regions, when the access cannula is visualized under EUS (FIGS.5-6: the dimpled portions and the ribs are spaced from their neighboring dimples and ribs, respectively; and [0022]: the term “echogenic” is defined as having enhanced echogenicity. Specifically, it is used to refer to materials or portions of materials that are constructed or are treated to have greater reflectivity of ultrasonic waves than standard materials).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Clancy et al., US 2010/0317963 A1, hereinafter Clancy, in view of Schmidt et al., US 2021/0001085 A1, hereinafter Schmidt.
Claim 21. Clancy teaches all the limitations of claim 17.
Clancy does not teach a distal-most one of the echogenic segments is offset from the distal end of the access cannula via a length of at least 3.0mm.
However, in an analogous ultrasound echogenic needle assembly configuration field of endeavor, Schmidt teaches
a distal-most one of the echogenic segments is offset from the distal end of the access cannula via a length of at least 3.0mm ([0031]: Echogenic member may be positioned any suitable distance from distal end 25 of catheter 20 to enable a clinician to determine the relative position of distal end 25…In other examples, echogenic member 21 may be greater than 2 mm proximal to distal end 25) – greater than 2 mm is considered reading on the claimed length of at least 3.0 mm in view of the obviousness consideration below.
In regard to the distance from the distal end to the echogenic segment to be a length of at least 3.0 mm, it is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an alternate configuration is considered merely changes in size/proportion, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients. It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP 2144.04.IV.A.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the echogenic member of the access cannular of Clancy employ such a feature of being offset from the distal end of the access cannula via a length of at least 3.0mm as taught in Schmidt as an exemplary dimension suitable for its intended utility, as suggested in Schmidt, [0031].
Claim 23. Clancy teaches all the limitations of claim 16.
Clancy does not teach that the space extending between each of the echogenic segments extends along a length of between 2.0mm and 12.0mm of the access cannula.
However, in an analogous ultrasound echogenic needle assembly configuration field of endeavor, Schmidt teaches
the space extending between each of the echogenic segments extends along a length of between 2.0mm and 12.0mm of the access cannula ([0037]: In some examples, a catheter may include more than one echogenic member. FIGS. 2A and 2B are conceptual diagrams illustrating an example catheter 400 including…echogenic members 404A and 404B; and [0041]: echogenic member 404B may be space apart from echogenic member 404A a distance within a range from about 1 mm to about 30 mm, such as about 5 mm to about 25 mm or about 10 mm to about 20 mm) – these taught ranges of apart-space is considered reading on the claimed range between 2.0 mm and 12.0 mm in view of the obviousness consideration below.
In regard to the space extending between each of the echogenic segments extends along a length of between 2.0mm and 12.0mm of the access cannula, it is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an alternate configuration is considered merely changes in size/proportion, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients. It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP 2144.04.IV.A.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the echogenic members of the access cannular of Clancy employ such a feature of having a space extending in between 2.0mm and 12.0mm of the access cannula as taught in Schmidt as an exemplary dimension suitable for its intended utility, as suggested in Schmidt, [0031].
Claim 24. Clancy teaches all the limitations of claim 17.
Clancy does not teach that the distal end of the access cannula is tipped to include a tapered surface which produces a bright region, when visualized under the ultrasound guidance.
However, in an analogous ultrasound echogenic needle assembly configuration field of endeavor, Schmidt teaches
the distal end of the access cannula is tipped to include a tapered surface which produces a bright region, when visualized under the ultrasound guidance ([0028]: Echogenic member 21 may include any suitable shape. For example, echogenic member 21 may include…a tapered shape…In examples in which the echogenic member includes a tapered shape, the tapered shape may vary in radius of curvature and/or shape between its principal axes, such as, for example, a frustum, a cone, or an ellipse that is tapered on one end; and [0031]: Echogenic member may be positioned any suitable distance from distal end 25 of catheter 20 to enable a clinician to determine the relative position of distal end 25. In some example, echogenic member 21, e.g., a distal end of the echogenic member, may be within a range from about 0mm (e.g., a distal end of echogenic member 21 may be flush or nearly flush within manufacturing tolerances relative to distal end 25 of catheter 20) to about 2 mm proximal to distal end 25) – a 0 mm distance between the tapered echogenic member and the distal end of the catheter is considered “the distal end being tipped to include a tapered surface that produces a bright region” as claimed.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the distal end of the access cannular of Clancy employ such a feature of being tipped to include a tapered surface which produces a bright region, when visualized under the ultrasound guidance as taught in Schmidt for the advantage of “enabling a clinician to determine the relative position of distal end”, as suggested in Schmidt, [0031].
Claims 22, 29 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Clancy et al., US 2010/0317963 A1, hereinafter Clancy, in view of McWeeney et al., US 2015/0012008 A1, hereinafter McWeeney.
Claim 22. Clancy teaches all the limitations of claim 17.
Clancy does not teach the dimension of the echogenic member.
However, in an analogous ultrasound echogenic needle assembly configuration for bile duct utility field of endeavor, McWeeney teaches that
the echogenic segments extend along a length of between 2.5mm and 12.5mm of the access cannula ([0135]: FIG.40 is a side view of another embodiment of a distal section of an access catheter…The metallic tip 228 may be thermally bounded to the distal end 208 of the catheter 200…The tip 228 may vary in length between 2 and 30 mm. In one embodiment, the tip 228 may have a length in the range of 2 to 10 mm. The outer surface of the metallic tip 228 enhanced echogenicity or acoustic reflection).
In regard to the length of the echogenic segment to be between 2.5 mm and 12.5 mm, it is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an alternate configuration is considered merely changes in size/proportion, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients. It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP 2144.04.IV.A.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the echogenic member of the access cannular of Clancy employ such a feature of having a length between 2.5 mm and 12.5 mm as taught in McWeeney as an exemplary dimension suitable for its intended utility, as suggested in McWeeney, [0135].
Claims 29 and 33. Clancy teaches all the limitations of claim 28.
Clancy further teaches that
each of the echogenic segments include a plurality of circumferential rings etched into an exterior surface of the access cannula (FIG.6: each rib is considered a circumferential ring, and the ribs as illustrated in FIG.6 extend about the access cannula) – a group of the ribs is considered one “echogenic segment” as claimed.
Clancy does not teach that the ribs are etched into an exterior surface of the access cannula.
However, in an analogous ultrasound echogenic needle assembly configuration for bile duct utility field of endeavor, McWeeney teaches that
the exterior surface of the access cannula is etched to create the echogenic signature ([0135]: the echogenic enhanced pattern is imparted to the needle via a micro-blasting process which roughens the surface of the needle over a specific length…the echogenically enhanced region of the needle is achieved through the removal of material from the surface of the needle to provide greater reflectivity and strengthened reflected signal) – a “micro-blasting process to remove the material from the surface” is considered an “etching” process as claimed.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the echogenic pattern on the surface of the access cannular of Clancy employ such a feature of being etched into the surface as taught in McWeeney for the advantage of “provide greater reflectivity and strengthened reflected signal”, as suggested in McWeeney, [0135].
Claims 25 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Clancy et al., US 2010/0317963 A1, hereinafter Clancy, in view of Finch et al., US 2011/0071624 A1, hereinafter Finch.
Claims 25 and 34. Clancy teaches all the limitations of claims 16 and 31, respectively, including the access cannular formed of a material as a base (210, 310, 410) and the echogenic segments that are separated from one another and formed along the base (216) ([0022]; [0025]; [0026]; [0031]; [0032]; FIGS.5-6).
Clancy does not teach that the echogenic pattern is formed via a first echogenic material that is one of swaged and reflowed along an exterior surface of a second non- echogenic material forming a base.
However, in an analogous ultrasound echogenic needle assembly configuration field of endeavor, Finch teaches that
the echogenic pattern is formed via a first echogenic material that is one of swaged and reflowed along an exterior surface of a second non- echogenic material forming a base ([0323]: echogenic markers 118a, 118b, 119a, 119b can be swaged, riveted, adhered, or otherwise placed and secured into the bores and dimensioned to be flush with the contours of the segments).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the echogenic material of Clancy employ such a feature of the echogenic pattern being formed via a first echogenic material that is one of swaged and reflowed along an exterior surface of a second non-echogenic material forming a base as taught in Finch for the advantage of “the echogenic markers to be properly secured to the base, as suggested in Finch, [0323].
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Clancy et al., US 2010/0317963 A1, hereinafter Clancy, in view of Finch et al., US 2011/0071624 A1, hereinafter Finch, further in view of Cage et al., US 2012/0226144 A1, hereinafter Cage.
Claim 26. Clancy and Finch combined teaches all the limitations of claim 25.
Neither Clancy nor Finch teaches that the first echogenic material is a glass-filled polymer and the second non-echogenic material is a polymer extrusion.
However, in an analogous ultrasound echogenic needle assembly configuration field of endeavor, Cage teaches that
the first echogenic material is a glass-filled polymer and the second non-echogenic material is a polymer extrusion ([0036]: A non-limiting example of an echogenic material that may be incorporated in this manner is glass spheres. Glass spheres are frequently used to enhance echogenicity, and in this case, the spheres may be readily incorporated into the polymer during the extrusion process).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the first echogenic material of Clancy and Finch combined employ such a feature of being a glass-filled polymer and the second non-echogenic material is a polymer extrusion as taught in Cage for the advantage of “providing sufficient echogenicity for visualization under ultrasound without further need to add other materials to enhance echogenicity”, as suggested in Cage, [0036].
Claims 27 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Clancy et al., US 2010/0317963 A1, hereinafter Clancy, in view of Gupta et al., US 2022/0354454 A1, hereinafter Gupta.
Claims 27 and 35. Clancy teaches all the limitations of claims 16 and 31, respectively.
Clancy further teaches that the access cannula is formed of an echogenic material ([0025]: FIG.5, the distal portion of the needle structure 210 includes a beveled needle 214 that is constructed of metal and that includes a textured irregular surface region…Needles for use with the present method may be constructed of a polymer or metal material, and preferred embodiments may be constructed of a nickel-titanium alloy and/or stainless steel; and [0032]: Metal alloys, various polymers, and other materials generally include inherent echogenicity).
Clancy does not teach that the spaces between echogenic segments formed via one of a non-echogenic heat shrink and jacket wrapped around portions of the access cannula.
However, in an analogous ultrasound echogenic needle assembly configuration field of endeavor, Gupta teaches that
the spaces between echogenic segments formed via one of a non-echogenic heat shrink and jacket wrapped around portions of the access cannula ([0053]: the catheter 200 can include a non-echogenic layer 206 along a portion of the length of the catheter 200 such that the echogenicity of the echogenic layer 204 is much less compared to the echogenicity of the echogenic layer 204. For instance, the non-echogenic layer 206 can include a non-echogenic polymer film wrapped between the echogenic layer 204).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the access cannula of Clancy employ such a feature of having the spaces between echogenic segments formed via one of a non-echogenic heat shrink and jacket wrapped around portions of the access cannula as taught in Gupta for the advantage of “creating specific images during imaging, which can help to identify the location of the catheter within a body”, as suggested in Gupta, [0053].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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