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 .
Response to Arguments
Applicant’s arguments in regard to the teaching of Clancy have been fully considered and they are persuasive. The prior art rejections to claims 16-35 are now withdrawn. After reconsideration, new ground of rejection to claims 16-35 under 35 U.S.C. 103 are now made. This Office action hence is a non-final Office action.
In the new ground of rejection, the newly cited prior art Khalaj is relied upon for the teaching of the echogenic region on the cannular being pattered as segments with spaces in between that is visualized as alternating bright and dark in the ultrasound image. Further, another newly cited prior art Massengale is relied upon for the teaching of the sharp tip of the needle being echogenic, resulting in a “localized bright spot” as the need tip is a short tip.
Claims 16-35 remain rejected.
Claim Objections
Claims 1 and 28 are objected to because of the following informalities:
In claims 1 and 28, the term “ultrasound guidance” is recited twice in each claim. The first recitation should be corrected to –an ultrasound guidance--, and the second recitation should be corrected to –the ultrasound guidance--.
Claims 21-23 recites 3.0mm, 2.5mm, 12.5mm, 2.0mm, and 12.0mm. A space should be inserted between the value and the mm, i.e., for example, --3.0 mm--.
Appropriate correction is required.
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 16-20, 28 and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Clancy et al., US 2010/0317963 A1, hereinafter Clancy, in view of Khalaj et al., US 2018/0177980 A1, hereinafter Khalaj, further in view of Massengale et al., US 2012/0095404 A1, hereinafter Massengale.
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 (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) – the ribbing that provides echogenicity is the “echogenic pattern” as claimed,
the echogenic pattern is configured to produce a bright region, when visualized under ultrasound guidance ([0031]: The ribbed region 316 is configured to enhance the echogenicity of the needle 314; and [0032]: the textured surface may alternatively be…ribbed…in a manner configured to enhance reflection of ultrasound waves, thereby providing echogenicity); 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), and
the distal end of the needle including a sharp tip (see FIG.7) producing brightness under an ultrasound guidance ([0031]: the needle 314 may have dimples, edged ridges, knurling, and/or regular or irregular other surface texturing or details…to provide enhanced echogenicity).
Clancy does not teaches that (1) the echogenic pattern on the access cannula is defined via echogenic segments, 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, and (2) the sharp tip producing a localized bright spot, under an ultrasound guidance, that is distinguishable from the bright and dark regions created via the echogenic pattern of the access cannula.
In regard to (1), in an analogous echogenic catheter assembly configuration field of endeavor, Khalaj teaches that
the echogenic pattern on the access cannula is defined via echogenic segments ([0044]: FIG.5: the echogenic catheter assembly 10 may include a plurality of echogenic members 30 configured with the catheter 14), each of which are separated from one another via a space (FIG.5 – the spaces between the segments 30) so that the echogenic pattern is configured to produce alternating bright and dark regions ([0044]: the echogenic members 30 provides enhanced ultrasonic imaging to the catheter assembly) – as shown in the ultrasound images of FIGS.14-17, only the echogenic member 30 is bright in the image. The configuration of the sectioned echogenic members 30 in FIG.5 would results in alternative bright (catheter 14 that is covered by the echogenic members 30) and dark regions (catheter 14 that is not covered by the echogenic member 30, particularly the regions in between any two echogenic members 30).
Therefore, it would have been obvious for one of ordinary skilled in the art at the time of the invention to substitute one continuous section of the echogenic region of Clancy (the ribbed region 316) with a plurality of echogenic region of Khalaj (the multiple regions 30), as the substitution of one known echogenic configuration (one section) with another (multiple sections with spaces in between) yields predictable results to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
The function of the echogenic sections on, within, or embedded in the catheter is to enable the catheter to be visible under an ultrasound imaging so that that the location and position of the catheter may be properly tracked. Either a configuration of one section or an alternative configuration with multiple sections may be designed and manufactured in order for the catheter or the cannula to be suitable for particular applications as desired. It would have been obvious for one of ordinary skills in the art at the time of invention to have alternatives of the number and size of the echogenic member to be one long section as shown in Clancy, multiple shorter sections spaced apart as shown in Khalaj. Either configuration would achieve the same functionality of making the catheter or the cannular visible in an ultrasound image. The configuration of multiple sections provides additional advantage to “provide enhanced ultrasonic imaging to the catheter assembly without compromising the inherent flexibility of the catheter 14”, as suggested in Khalaj, [0044].
In regard to (2), though Clancy teaches that the needle may have edged ridges to provide enhanced echogenicity, neither Clancy nor Khalaj teaches that the sharp tip of the needle produces a localized bright spot, under an ultrasound guidance, that is distinguishable from the bright and dark regions created via the echogenic pattern of the access cannula.
However, in an echogenic medical device configuration field of endeavor, Massengale teaches that
the sharp tip of the needle produces a localized bright spot, under an ultrasound guidance ([0049]: FIG.1, the echogenic needle 10 has a distal end 12 composed of an echogenic needle tip 14).
Since the needle is echogenic, the needle tip would be echogenic too. The brightness resulted from the needle tip would be a localized bring spot since the sharp needle tip occupies a localized volume.
When Clancy, Khalaj and Massengale are combined, since the needle tip and the cannula, or more specifically, the echogenic members and the space in between on the cannular, are at different positions, when under an ultrasound guidance, each of the needle tip (echogenic, hence bright at the very tip), the echogenic members (bright, not at the tip), and the spaces in between the members (dark, between the brights) would be distinguishable from each other.
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 needle of Clancy and Khalaj combined employ such a feature associated with the sharp tip of the needle producing a localized bright spot, under an ultrasound guidance as taught in Massengale for the advantage of providing the sharp tip of the needle to be visible under ultrasound imaging such that the needle advancement may be more precisely monitored and navigated.
Claim 17. Khalaj 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.7: the discontinuities 40 along the length 35; and [0043]: the echogenic member 30 may include a cylindrical body 32 defining an exterior surface 38 extending between a first end 34 and a second end 36…the exterior surface 38 may include a plurality of discontinuities 40…[that] may be arranged in a predetermined pattern…[that] may include organized rows and/or columns of discontinuities)
Claim 18. Khalaj further teaches that
each of the markings is configured as a circumferential ring extending about the access cannula (FIG.7: the discontinuities 40 along the circumference of 30; [0043]: the echogenic member 30 may include a cylindrical body 32 defining an exterior surface 38 extending between a first end 34 and a second end 36…the exterior surface 38 may include a plurality of discontinuities 40…[that] may be arranged in a predetermined pattern…[that] may include organized rows and/or columns of discontinuities).
Claim 19. Khalaj further teaches that
each of the markings is configured as a depression extending into the exterior surface along a curve ([0045]: the discontinuities 40 may include at least one or more of the following: indentations, grooves, notches, recesses, threads, protrusions, or similar).
Claim 20. Khalaj further teaches that
each of the markings is configured as a roughened portion along the exterior surface ([0045]: the discontinuities 40 may include at least one or more of the following: indentations, grooves, notches, recesses, threads, protrusions, or similar) – the discontinuity results in 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 material (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) - the ribbing that provides echogenicity is the “echogenic pattern” as claimed,
the echogenic pattern is configured to produce a bright region, when visualized under ultrasound guidance ([0031]: The ribbed region 316 is configured to enhance the echogenicity of the needle 314; and [0032]: the textured surface may alternatively be…ribbed…in a manner configured to enhance reflection of ultrasound waves, thereby providing echogenicity); 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 (see FIG.7) producing brightness, when visualized under an ultrasound guidance ([0031]: the needle 314 may have dimples, edged ridges, knurling, and/or regular or irregular other surface texturing or details…to provide enhanced echogenicity).
Clancy does not teaches that (1) the echogenic pattern on the access cannula is defined via echogenic segments, 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, and (2) the sharp tip producing a localized bright spot, under an ultrasound guidance, that is distinguishable from the bright and dark regions created via the echogenic pattern of the access cannula.
In regard to (1), in an analogous echogenic catheter assembly configuration field of endeavor, Khalaj teaches that
the echogenic pattern on the access cannula is defined via echogenic segments ([0044]: FIG.5: the echogenic catheter assembly 10 may include a plurality of echogenic members 30 configured with the catheter 14), each of which are separated from one another via a space (FIG.5 – the spaces between the segments 30) so that the echogenic pattern is configured to produce alternating bright and dark regions ([0044]: the echogenic members 30 provides enhanced ultrasonic imaging to the catheter assembly) – as shown in the ultrasound images of FIGS.14-17, only the echogenic member 30 is bright in the image. The configuration of the sectioned echogenic members 30 in FIG.5 would results in alternative bright (catheter 14 that is covered by the echogenic members 30) and dark regions (catheter 14 that is not covered by the echogenic member 30, particularly the regions in between any two echogenic members 30).
Therefore, it would have been obvious for one of ordinary skilled in the art at the time of the invention to substitute one continuous section of the echogenic region of Clancy (the ribbed region 316) with a plurality of echogenic region of Khalaj (the multiple regions 30), as the substitution of one known echogenic configuration (one section) with another (multiple sections with spaces in between) yields predictable results to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
The function of the echogenic sections on, within, or embedded in the catheter is to enable the catheter to be visible under an ultrasound imaging so that that the location and position of the catheter may be properly tracked. Either a configuration of one section or an alternative configuration with multiple sections may be designed and manufactured in order for the catheter or the cannula to be suitable for particular applications as desired. It would have been obvious for one of ordinary skills in the art at the time of invention to have alternatives of the number and size of the echogenic member to be one long section as shown in Clancy, multiple shorter sections spaced apart as shown in Khalaj. Either configuration would achieve the same functionality of making the catheter or the cannular visible in an ultrasound image. The configuration of multiple sections provides additional advantage to “provide enhanced ultrasonic imaging to the catheter assembly without compromising the inherent flexibility of the catheter 14”, as suggested in Khalaj, [0044].
In regard to (2), though Clancy teaches that the needle may have edged ridges to provide enhanced echogenicity, neither Clancy nor Khalaj teaches that the sharp tip of the needle produces a localized bright spot, under an ultrasound guidance, that is distinguishable from the bright and dark regions created via the echogenic pattern of the access cannula.
However, in an echogenic medical device configuration field of endeavor, Massengale teaches that
the sharp tip of the needle produces a localized bright spot, under an ultrasound guidance ([0049]: FIG.1, the echogenic needle 10 has a distal end 12 composed of an echogenic needle tip 14).
Since the needle is echogenic, the needle tip would be echogenic too. The brightness resulted from the needle tip would be a localized bring spot since the sharp needle tip occupies a localized volume.
When Clancy, Khalaj and Massengale are combined, since the needle tip and the cannula, or more specifically, the echogenic members and the space in between on the cannular, are at different positions, when under an ultrasound guidance, each of the needle tip (echogenic, hence bright at the very tip), the echogenic members (bright, not at the tip), and the spaces in between the members (dark, between the brights) would be distinguishable from each other.
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 needle of Clancy and Khalaj combined employ such a feature associated with the sharp tip of the needle producing a localized bright spot, under an ultrasound guidance as taught in Massengale for the advantage of providing the sharp tip of the needle to be visible under ultrasound imaging such that the needle advancement may be more precisely monitored and navigated.
Claim 30. Khalaj 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 ([0044]: FIG.5: the echogenic catheter assembly 10 may include a plurality of echogenic members 30 with spaces in between; [0044]: the echogenic members 30 provides enhanced ultrasonic imaging to the catheter assembly) – as shown in the ultrasound images of FIGS.14-17, only the echogenic member 30 is bright in the image. The echogenic members hence are formed by a first echogenic material, and the space in between that is non-echogenic is formed by a second non-echogenic material.
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 needle is visible as bright 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 region 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).
Clancy does not teaches that (1) the echogenic region has an echogenic pattern extending along a distal portion of the access cannula, and (2) the sharp tip of the needle is visible as a localized bright spot under the utlrasound.
In regard to (1), in an analogous echogenic catheter assembly configuration field of endeavor, Khalaj teaches that
the echogenic region has an echogenic pattern extending along a distal portion of the access cannula ([0044]: FIG.5: the echogenic catheter assembly 10 may include a plurality of echogenic members 30 configured with the catheter 14) – the repeating echogenic members 30 is the pattern.
Therefore, it would have been obvious for one of ordinary skilled in the art at the time of the invention to substitute one continuous section of the echogenic region of Clancy (the ribbed region 316) with a plurality of echogenic region of Khalaj (the multiple regions 30), as the substitution of one known echogenic configuration (one section) with another (multiple sections with spaces in between) yields predictable results to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
The function of the echogenic sections on, within, or embedded in the catheter is to enable the catheter to be visible under an ultrasound imaging so that that the location and position of the catheter may be properly tracked. Either a configuration of one section or an alternative configuration with multiple sections may be designed and manufactured in order for the catheter or the cannula to be suitable for particular applications as desired. It would have been obvious for one of ordinary skills in the art at the time of invention to have alternatives of the number and size of the echogenic member to be one long section as shown in Clancy, multiple shorter sections spaced apart as shown in Khalaj. Either configuration would achieve the same functionality of making the catheter or the cannular visible in an ultrasound image. The configuration of multiple sections provides additional advantage to “provide enhanced ultrasonic imaging to the catheter assembly without compromising the inherent flexibility of the catheter 14”, as suggested in Khalaj, [0044].
In regard to (2), though Clancy teaches that the needle may have edged ridges to provide enhanced echogenicity, neither Clancy nor Khalaj teaches that the sharp tip of the needle is visible as a localized bright spot under the ultrasound.
However, in an echogenic medical device configuration field of endeavor, Massengale teaches that
the sharp tip of the needle produces a localized bright spot, under the guidance ([0049]: FIG.1, the echogenic needle 10 has a distal end 12 composed of an echogenic needle tip 14).
Since the needle is echogenic, the needle tip would be echogenic too. The brightness resulted from the needle tip would be a localized bring spot since the sharp needle tip occupies a localized volume.
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 needle of Clancy and Khalaj combined employ such a feature associated with the sharp tip of the needle producing a localized bright spot, under the guidance as taught in Massengale for the advantage of providing the sharp tip of the needle to be visible under ultrasound imaging such that the needle advancement may be more precisely monitored and navigated.
Claim 32. Khalaj further teaches that
the echogenic pattern is defined via echogenic segments ([0044]: FIG.5: the echogenic catheter assembly 10 may include a plurality of echogenic members 30 configured with the catheter 14),
each of which are separated from one another via a space (FIG.5 – the spaces between the segments 30) so that the echogenic pattern is configured to produce alternating bright and dark regions, when the access cannula is visualized under the ultrasound ([0044]: the echogenic members 30 provides enhanced ultrasonic imaging to the catheter assembly) – as shown in the ultrasound images of FIGS.14-17, only the echogenic member 30 is bright in the image. The configuration of the sectioned echogenic members 30 in FIG.5 would results in alternative bright (catheter 14 that is covered by the echogenic members 30) and dark regions (catheter 14 that is not covered by the echogenic member 30, particularly the regions in between any two echogenic members 30).
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 Khalaj et al., US 2018/0177980 A1, hereinafter Khalaj, further in view of Massengale et al., US 2012/0095404 A1, hereinafter Massengale, further in view of Schmidt et al., US 2021/0001085 A1, hereinafter Schmidt.
Claim 21. Clancy, Khalaj and Massengale combined teaches all the limitations of claim 17.
Neither of Clancy, Khalaj and Massengale 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 3.0 mm.
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 3.0 mm ([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, Khalaj and Massengale combined 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, Khalaj and Massengale combined teaches all the limitations of claim 16.
Neither of Clancy, Khalaj and Massengale teaches 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, Khalaj and Massengale combined 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, Khalaj and Massengale combined teaches all the limitations of claim 16.
Neither of Clancy, Khalaj and Massengale teaches 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, Khalaj and Massengale combined 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 Khalaj et al., US 2018/0177980 A1, hereinafter Khalaj, further in view of Massengale et al., US 2012/0095404 A1, hereinafter Massengale, further in view of McWeeney et al., US 2015/0012008 A1, hereinafter McWeeney.
Claim 22. Clancy, Khalaj and Massengale combined teaches all the limitations of claim 16.
Neither of Clancy, Khalaj and Massengale teaches 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, Khalaj and Massengale combined 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, Khalaj and Massengale combined teaches all the limitations of claims 16 and 31, respectively.
Khalaj further teaches that
each of the echogenic segments include a plurality of circumferential rings on an exterior surface of the access cannula (FIG.7: each group of the discontinuities 40 along the circumference of 30 of the same height is considered one circumferential ring; [0043]: the echogenic member 30 may include a cylindrical body 32 defining an exterior surface 38 extending between a first end 34 and a second end 36…the exterior surface 38 may include a plurality of discontinuities 40…[that] may be arranged in a predetermined pattern…[that] may include organized rows and/or columns of discontinuities).
Neither of Clancy, Khalaj and Massengale teaches that the rings of the echogenic markings 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, Khalaj and Massengale combined 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 Khalaj et al., US 2018/0177980 A1, hereinafter Khalaj, further in view of Massengale et al., US 2012/0095404 A1, hereinafter Massengale, further, further in view of Finch et al., US 2011/0071624 A1, hereinafter Finch.
Claims 25 and 34. Clancy, Khalaj and Massengale combined teaches all the limitations of claims 16 and 31, respectively, including the access cannular formed of a material as a base (Clancy: 210, 310, 410; and Khalaj: 14) and the echogenic segments that are separated from one another and formed along the base (Clancy: [0022]; [0025]; [0026]; [0031]; [0032]; FIGS.5-6; Khalaj: 14, 30, FIG.5).
Neither of Clancy, Khalaj and Massengale 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.
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, Khalaj and Massengale combined 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 Khalaj et al., US 2018/0177980 A1, hereinafter Khalaj, further in view of Massengale et al., US 2012/0095404 A1, hereinafter Massengale, further, further 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, Khalaj, Massengale and Finch combined teaches all the limitations of claim 16.
Neither of Clancy, Khalaj, Massengale and 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, Khalaj, Massengale 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 Khalaj et al., US 2018/0177980 A1, hereinafter Khalaj, further in view of Massengale et al., US 2012/0095404 A1, hereinafter Massengale, further in view of Gupta et al., US 2022/0354454 A1, hereinafter Gupta.
Claims 27 and 35. Clancy, Khalaj and Massengale combined 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).
Neither of Clancy, Khalaj and Massengale 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.
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, Khalaj and Massengale combined 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
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
