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 Amendment
Currently claims 1-2, 4, 7-13, and 21-31 are pending.
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 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 1, 2, 23, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over McFarland (US20220096116A1) in view of Paul (US20200000545A1) and in further view Cook et al., (US20220218881A1) with a teaching reference Mayes et al., (US20200121415A1).
Regarding claim 1, Barbagli teaches a medical system useful in performing treatment under magnetic resonance imaging comprising ([0004] MRI are used with these medical instruments[0108] the stylet can be used with MRI):
a first medical device formed of a first material (fig. 2 stylet 14 is made of nitinol [0082]), the first material having a first magnetic susceptibility (teaching reference Mayes teaches that nitinol has a Magnetic Susceptibility of .000000297 (m3kg-1) see page 5 Table 1), the first medical device comprising a stylet (fig. 2 stylet 14 [0082])
a second medical device comprising an elongate member having a lengthwise axis and formed of a second material, the second material comprising a metal having a second magnetic susceptibility (fig. 2 needle 12 has a length wise axis, and can be made of nitinol[0082]; teaching reference Mayes teaches that nitinol has a Magnetic Susceptibility of .000000297 (m3kg-1) see page 5 Table 1) the second medical device comprising a needle (fig. 4 instrument 406 is a needle [0054]).
However, the McFarland of references still fail to explicitly disclose a plurality of markers disposed on the second medical device, a marker of the plurality of markers formed of a third material that is different than the first material and the second material, the third material having a third magnetic susceptibility that is different than the first magnetic susceptibility and the second magnetic susceptibility, each marker of the plurality of markers having a width along the lengthwise axis of the second medical device between 0.6 millimeters and 1.2 millimeters.
In the same MRI field of endeavor, Paul teaches a plurality of markers disposed on the second medical device (fig. 2 markers 222 are disposed on the body member 210), a marker of the plurality of markers formed of a third material (fig. 2 the markers are made of stainless steel [0075]) that is different than the first material and the second material (the markers are made of work hardened stainless steel while the first and second material are made of nitinol), the third material having a third magnetic susceptibility that is different than the first magnetic susceptibility and the second magnetic susceptibility (as taught by teaching reference Mayes, work hardened stainless steel such as 301 (55% cold worked) stainless steel has a magnetic susceptibility of .00165 which is different than nitinol’s susceptibility of .000000297), each marker of the plurality of markers having a width along the lengthwise axis of the second medical device between 0.6 millimeters and 1.2 millimeters ([0067] the marker can have a length of 1mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the needle and stylet system of modified McFarland with the MRI markers of Paul, as both inventions relate to systems under MRI imaging, would yield the predictable result of a needle that incorporates markers to one of ordinary skill in the art. One of ordinary skill would be able to perform such a combination, and the results of modified Barbagli using markers for MRI imaging are reasonably predictable.
However, the combination of references are silent regarding the plurality of markers electroplated onto the elongate member, the third material comprising nickel.
In the same MRI field of endeavor, Cook teaches plurality of markers electroplated onto the elongate member ([0037] the marker can be electroplated onto the medical device), the third material comprising nickel ([0051] marker can be electroplated).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified McFarland with the marker of Cook, as this would provide an improved device in performing treatment under MRI (see Cook [0006]).
Regarding 2, modified McFarland teaches the system of claim 1, but fails to explicitly disclose wherein Paul further teaches wherein the third magnetic susceptibility is greater than the first magnetic susceptibility and the second magnetic susceptibility.
In the same MRI field of endeavor, Paul teaches wherein the third magnetic susceptibility is greater than the first magnetic susceptibility and the second magnetic susceptibility (as taught by teaching reference Mayes, work hardened stainless steel such as 301 (55% cold worked) stainless steel has a magnetic susceptibility of .00165 which is greater than nitinol’s susceptibility of .000000297),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the needle and stylet system of modified McFarland with the MRI markers of Paul, as both inventions relate to systems under MRI imaging, would yield the predictable result of a needle that incorporates markers to one of ordinary skill in the art. One of ordinary skill would be able to perform such a combination, and the results of modified Barbagli using markers for MRI imaging are reasonably predictable.
Regarding claim 23, modified McFarland teaches the system of claim 1, wherein McFarland further teaches wherein the elongate member has a main body with a circumference (fig. 2 is a needle that comprises an elongate member, and therefore has a circumference [0082]), but is silent regarding wherein each marker of the plurality of markers is disposed around a portion of the circumference of the main body of the elongate member.
However, in the same MRI field of endeavor, Paul teaches wherein each marker of the plurality of markers is disposed around a portion of the circumference of the main body of the elongate member (fig. 2 the plurality of markers 222 are disposed circumferentially around the body member 210 [0073]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified McFarland with the markers and material of Paul, as this would fill the need for a device with markers that is less labor intensive and easy to reproduce consistently, thereby making them more reliable (see Paul [0003]).
Regarding claim 27, modified McFarland teaches the system of claim 1, but fails to explicitly disclose wherein the plurality of markers is provided on one of the first medical device and the second medical device.
However in the same MRI field of endeavor, Paul teaches wherein the plurality of markers is provided on one of the second medical device (fig. 2 markers 222 are disposed on the body member 210).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the needle and stylet system of modified McFarland with the MRI markers of Paul, as both inventions relate to systems under MRI imaging, would yield the predictable result of a needle that incorporates markers to one of ordinary skill in the art. One of ordinary skill would be able to perform such a combination, and the results of modified Barbagli using markers for MRI imaging are reasonably predictable.
Regarding claim 7, modified McFarland teaches the system of claim 1, but fails to explicitly disclose comprises a first subset of markers, a second subset of markers, and a third subset of markers, wherein each marker in the first subset of markers form of the third material.
However in the same MRI field of endeavor, Paul teaches wherein the plurality of markers comprises a first subset of markers, a second subset of markers, and a third subset of markers (fig. 2 markers 224, 226, and 228 [0075]), wherein each marker in the first subset of markers form of the third material ([0075] the marker 224 are made from work hardened stainless steel, which is known to produce useful visual artifacts in MRI ([0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of McFarland with the markers and material of Paul, as this would fill the need for a device with markers that is less labor intensive and easy to reproduce consistently, thereby making them more reliable (see Paul [0003]).
However the combination of references are still silent regarding each marker in the second subset of markers formed of a fourth material, and each marker in the third subset of markers formed of a fifth material, the fourth material having a fourth magnetic susceptibility that is different than the first magnetic susceptibility and the second magnetic susceptibility, the fifth material having a fifth magnetic susceptibility that is different than the first magnetic susceptibility and the second magnetic susceptibility.
However in the same MRI device field of endeavor, Cook teaches each marker in the second subset of markers formed of a fourth material, and each marker in the third subset of markers formed of a fifth material, the fourth material having a fourth magnetic susceptibility that is different than the first magnetic susceptibility and the second magnetic susceptibility, the fifth material having a fifth magnetic susceptibility that is different than the first magnetic susceptibility and the second magnetic susceptibility (fig. 2 markers 152, 154, and 156 can all differ from each other in terms of magnetic susceptibility, therefore each respective marker may be made of a third, fourth, and fifth material that have different magnetic susceptibilities than the first and second magnetic susceptibilities [0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the markers of modified McFarland to be those of different magnetic susceptibilities as taught by Cook, as this would provide an ability to distinguish the markers of a plurality of markers (see Cook [0060]).
Regarding claim 9, modified McFarland teaches the system of claim 7, but is silent regarding each marker in the first subset of markers is formed of a material comprising nickel.
In the same MRI field of endeavor, Cook teaches each marker in the first subset of markers is formed of a material comprising nickel ([0051] marker can be electroplated).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the markers of modified McFarland with nickel as taught by Cook, as this would allow for visualization of the main body in a magnetic resonance image and for device conspicuity without obscuring target tissue during treatment (see Cook [0051]).
Regarding claim 13, modified McFarland teaches the system of claim 7, but is silent regarding each marker in the first subset of markers is formed of a stainless steel.
However in the same MRI field of endeavor, Paul teaches each marker in the first subset of markers is formed of a stainless steel (fig. 2 marker 224 comprises work hardened stainless steel [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of McFarland with the markers and material of Paul, as this would fill the need for a device with markers that is less labor intensive and easy to reproduce consistently, thereby making them more reliable (see Paul [0003]).
However, the combination of references fails to explicitly disclose wherein each of the first material and the second material is titanium wherein each marker in the second subset markers is formed of a first cobalt chromium alloy; and wherein each marker in the third subset of markers is formed of a second cobalt chromium alloy that is different than the first cobalt chromium alloy.
In the same MRI device field of endeavor, Cook teaches wherein each of the first material and the second material is titanium ([0050] the main body may be made of titanium) and wherein each marker in the second subset markers is formed of a first cobalt chromium alloy ([0051] the markers can be made of a cobalt chromium); and wherein each marker in the third subset of markers is formed of a second cobalt chromium alloy that is different than the first cobalt chromium alloy ([0051] the markers may also be made of a cobalt chromium alloy that is different than cobalt chromium).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the material of the subset of markers of modified McFarland with the cobalt chromium and cobalt chromium alloys of Cook, as both inventions relate to devices that include markers visible in MRI systems, and would the yield the predictable result of a MRI device with a subset of markers being made of cobalt chromium and a second subset of markers being made of a cobalt chromium allow to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of modified Barbagli having the material of the first subset of markers being cobalt chromium and the second subset of markers being a cobalt chromium are reasonably predictable. Since the main body of modified Barbagli is made of titanium and includes the rods 216 and connectors 218 (see Paul [0073]) this would therefore result in the first and second material being made of titanium.
Regarding claim 29, modified McFarland teaches the system of claim 1, but fails to explicitly disclose wherein the elongate member has a proximal end, a distal end, and a midpoint; and wherein the marker of the plurality of markers disposed between the proximal end and the midpoint.
In the same MRI field of endeavor, Paul teaches wherein the elongate member has a proximal end, a distal end, and a midpoint (see annotated fig. 2); and wherein the marker of the plurality of markers disposed between the proximal end and the midpoint (see annotated fig. 2, there is a marker 222 that is between the proximal end and the midpoint).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of McFarland with the markers of Paul, as this would fill the need for a device with markers that is less labor intensive and easy to reproduce consistently, thereby making them more reliable (see Paul [0003]).
Regarding claim 30, modified McFarland teaches the system of claim 1, but fails to explicitly disclose wherein the elongate member has an outer surface; and wherein the marker of the plurality of markers is disposed on the outer surface.
However in the same MRI field of endeavor, Park teaches wherein the elongate member has an outer surface (fig. 2 medical device has an outer surface); and wherein the marker of the plurality of markers is disposed on the outer surface ([0073] the markers are disposed circumferentially around the rods).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the markers of modified McFarland with the markers of Park, as this would render the medical devices more effective and desirable (see Park [0058]).
Regarding claim 31, Barbagli teaches a medical system useful in performing treatment under magnetic resonance imaging comprising ([0004] MRI are used with these medical instruments[0108] the stylet can be used with MRI):
a first medical device formed of a first material (fig. 2 stylet 14 is made of nitinol [0082]), the first material having a first magnetic susceptibility (teaching reference Mayes teaches that nitinol has a Magnetic Susceptibility of .000000297 (m3kg-1) see page 5 Table 1), the first medical device comprising a cannula (fig. 2 stylet 14 [0082])
a second medical device comprising an elongate member having a lengthwise axis and formed of a second material, the second material comprising a metal having a second magnetic susceptibility (fig. 2 needle 12 has a length wise axis, and can be made of nitinol[0082]; teaching reference Mayes teaches that nitinol has a Magnetic Susceptibility of .000000297 (m3kg-1) see page 5 Table 1) the second medical device comprising a needle (fig. 4 instrument 406 is a needle [0054]).
However, the McFarland of references still fail to explicitly disclose a plurality of markers disposed on the second medical device, a marker of the plurality of markers formed of a third material that is different than the first material and the second material, the third material having a third magnetic susceptibility that is different than the first magnetic susceptibility and the second magnetic susceptibility, each marker of the plurality of markers having a width along the lengthwise axis of the second medical device between 0.6 millimeters and 1.2 millimeters.
In the same MRI field of endeavor, Paul teaches a plurality of markers disposed on the second medical device (fig. 2 markers 222 are disposed on the body member 210), a marker of the plurality of markers formed of a third material (fig. 2 the markers are made of stainless steel [0075]) that is different than the first material and the second material (the markers are made of work hardened stainless steel while the first and second material are made of nitinol), the third material having a third magnetic susceptibility that is different than the first magnetic susceptibility and the second magnetic susceptibility (as taught by teaching reference Mayes, work hardened stainless steel such as 301 (55% cold worked) stainless steel has a magnetic susceptibility of .00165 which is different than nitinol’s susceptibility of .000000297), each marker of the plurality of markers having a width along the lengthwise axis of the second medical device between 0.6 millimeters and 1.2 millimeters ([0067] the marker can have a length of 1mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the needle and stylet system of modified McFarland with the MRI markers of Paul, as both inventions relate to systems under MRI imaging, would yield the predictable result of a needle that incorporates markers to one of ordinary skill in the art. One of ordinary skill would be able to perform such a combination, and the results of modified Barbagli using markers for MRI imaging are reasonably predictable.
However, the combination of references are silent regarding the plurality of markers electroplated onto the elongate member, the third material comprising nickel.
In the same MRI field of endeavor, Cook teaches plurality of markers electroplated onto the elongate member ([0037] the marker can be electroplated onto the medical device), the third material comprising nickel ([0051] marker can be electroplated).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified McFarland with the marker of Cook, as this would provide an improved device in performing treatment under MRI (see Cook [0006]).
Claims 4, 10, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable McFarland in view of Paul, Mayes, and Cook as applied to claim 1 and 7, and further in view of Jahnke et al., (US20080004689A1).
Regarding claim 4, modified McFarland teaches the system of claim 1, wherein McFarland further teaches wherein the first material and the second material are the same ([0082] stylet and needle are made of nitinol)but fails to explicitly disclose wherein the third material is an alloy that includes less than 1% of iron by weight.
In the same device usable with MRI field of endeavor [0031], Jahnke teaches wherein the third material is an alloy that includes less than 1% of iron by weight (fig. 1 marker bands 30 may be nonferrous and magnet opaque, and would since it is non-ferrous it would have less than 1% iron by weight[0031] ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the third material of modified McFarland with the non-ferrous material of the marker band of Jahnke, as both inventions relate to devices that include markers visible in MRI systems, and would the yield the predictable result of the marker of modified Barbagli being made of a non-ferrous material to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of modified Paul having a marker made of a non-ferrous material are reasonably predictable.
Regarding claim 10, modified McFarland teaches the system of claim 7, but fails to explicitly disclose wherein each marker in the second subset markers is formed of a first alloy that includes less than 1% of iron by weight.
In the same MRI device field of endeavor, Jahnke teaches wherein each marker in the second subset markers is formed of a first alloy that includes less than 1% of iron by weight (fig. 1 marker bands 30 may be nonferrous and magnet opaque, and would since it is non-ferrous it would have less than 1% iron by weight[0031] ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the material of the second subset markers of modified McFarland with the non-ferrous material of the marker band of Jahnke, as both inventions relate to devices that include markers visible in MRI systems, and would the yield the predictable result of the second subset markers of modified Barbagli being made of a non-ferrous material to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of modified Paul having a second subset markers made of a non-ferrous material are reasonably predictable.
Regarding claim 11, modified McFarland teaches the system of claim 7, but fails to explicitly disclose wherein each marker in the second subset markers is formed of a first alloy that includes less than 1% of iron by weight.
In the same MRI device field of endeavor, Jahnke teaches wherein each marker in the second subset markers is formed of a first alloy that includes less than 1% of iron by weight (fig. 1 marker bands 30 may be nonferrous and magnet opaque, and would since it is non-ferrous it would have less than 1% iron by weight[0031] ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the material of the second subset markers of modified McFarland with the non-ferrous material of the marker band of Jahnke, as both inventions relate to devices that include markers visible in MRI systems, and would the yield the predictable result of the second subset markers of modified McFarland being made of a non-ferrous material to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of modified Barbagli having a second subset markers made of a non-ferrous material are reasonably predictable.
Regarding claim 12, modified McFarland teaches the system of claim 7, wherein McFarland further teaches the first material and second material is titanium ([0082] the stylet and needle can be made of titanium) but fails to explicitly disclose each marker in the first subset of markers is formed of a stainless steel.
However, in the same MRI field of endeavor, Paul teaches each marker in the first subset of markers is formed of a stainless steel (fig. 2 marker 224 comprises work hardened stainless steel [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of McFarland with the markers and material of Paul, as this would fill the need for a device with markers that is less labor intensive and easy to reproduce consistently, thereby making them more reliable (see Paul [0003]).
However the combination of references are still silent regarding wherein each marker in the second subset markers is formed of a first alloy that includes less than 1% of iron by weight; and wherein each marker in the third subset of markers is formed of a second alloy that includes less than 1% of iron by weight.
In the same MRI device field of endeavor, Jahnke teaches wherein each marker in the second subset markers is formed of a first alloy that includes less than 1% of iron by weight (fig. 1 marker bands 30 may be nonferrous and magnet opaque, and would since it is non-ferrous it would have less than 1% iron by weight[0031] ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the material of the second subset markers of modified McFarland with the non-ferrous material of the marker band of Jahnke, as both inventions relate to devices that include markers visible in MRI systems, and would the yield the predictable result of the second subset markers of modified Barbagli being made of a non-ferrous material to one of ordinary skill in the art. One of ordinary skill would be able to perform such a substitution, and the results of modified McFarland having a second subset markers made of a non-ferrous material are reasonably predictable. One of ordinary skill would recognize that this substitution would also apply to each marker in the third subset of markers, resulting in the teaching of the limitation “wherein each marker in the second subset markers is formed of a first alloy that includes less than 1% of iron by weight; and wherein each marker in the third subset of markers is formed of a second alloy that includes less than 1% of iron by weight.”
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable McFarland in view of Paul, Mayes, and Cook as applied to claim 7, and further in view of Curry et al., (US20120078087A1).
Regarding claim 8, modified McFarland teaches the system of claim 7, but fails to explicitly disclose wherein each of the first material and the second material is Inconel 625.
In the same device useable with MRI field of endeavor, Curry teaches wherein each of the first material and the second material is Inconel 625 ([0010] the localizing obturator and localizing wire are both made of Inconel 625).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the first and second material of modified McFarland with the Inconel 625 of Curry, as both inventions relate to medical devices usable with MRI, and would yield the predictable result of the system of modified Barbagli having a first material and second material of Inconel 625 to one of ordinary skill. One of ordinary skill would be able to make such a substitution, and the results of the system of modified McFarland having a first material and second material of Inconel 625 are reasonably predictable.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable McFarland in view of Paul, Mayes, and cook as applied to claim 1, and further in view of Quick et al., (US 20040167428 A1).
Regarding claim 21, modified McFarland teaches the system of claim 1, but fails to explicitly disclose wherein each marker of the plurality of markers is formed of nickel.
However, in the same MRI field of endeavor, Quick teaches each marker of the plurality of markers is formed of nickel ([0047] the distal end of the biopsy device includes markers made of nickel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified McFarland with the markers of Quick, as this would provide enhanced visualization to the eye (see Quick [0047]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable McFarland in view of Paul, Mayes, and Cook as applied to claim 1, and further in view of Nguyen et al., (US 20120083877 A1).
Regarding claim 22, modified McFarland teaches the system of claim 1, McFarland further teaches wherein the elongate member has a main body with a circumference (fig. 4 instrument 406 is a needle, and therefore has a circumference [0054]), but is silent regarding wherein each marker of the plurality of markers is disposed around the entire circumference of the main body of the elongate member.
However, in the same MRI field of endeavor, Nguyen teaches wherein each marker of the plurality of markers is disposed around the entire circumference of the main body of the elongate member (fig. 37 the marker 112 can extend around the entire circumference of sheath 100 [0132]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the size of the marker of modified McFarland with the size of the marker of Nguyen, as both inventions relate to markers used to track interventional devices, and would yield the predictable result of the needle of biopsy device with a marker that covers an entire circumference of an elongate member to one of ordinary skill in the art. One of ordinary skill in the art would be able to perform such a substitution, and would the results of the system of McFarland having markers that cover an entire circumference are reasonably predictable.
Claims 24 is rejected under 35 U.S.C. 103 as being unpatentable over McFarland in view of Paul and Mayes as applied to claim 1, and further in view of teaching reference Cross, William B., Anthony H. Kariotis, and Frederick J. Stimler. Nitinol characterization study. No. GER-14188. NASA, 1969. (hereinafter “Cross”).
Regarding claim 24, modified McFarland teaches the system of claim 1, wherein McFarland further teaches wherein the second material comprises a nickel alloy ([0082] the needle can be nitinol, which is a nickel alloy ) and the second material has a magnetic susceptibility between 237 ppm and 2268 ppm (the teaching reference Mayes teaches that nitinol has a magnetic mass susceptibility of .000000297 (m3kg-1) and the teaching reference Cross teaches nitinol has a density of about 6477.09 kg/m3. Therefore, converting mass susceptibility to volume susceptibility by multiplying them equates to .0019237, and then converting that to ppm equates to 1923.7 ppm, which is between 237 ppm and 2268 ppm).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable McFarland in view of Paul, Mayes, and Cook as applied to claim 1, and further in view of Park et al., (US 20190192124 A1).
Regarding claim 25, modified McFarland teaches the system of claim 1, but fails to explicitly disclose wherein the second material comprises a nickel-chromium based alloy.
In the same needle field of endeavor, Park teaches wherein the second material comprises a nickel-chromium based alloy ([0042] the needle can be made of a nickel-chromium-molybdenum alloy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the material of the needle of modified McFarland with the nickel chromium based alloy of Park, as both inventions relate to needle inventions and would yield the predictable result of a needle made of a nickel chromium based alloy to one of ordinary skill. One of ordinary skill would be able to perform such a substitution, and the results of modified McFarland using a nickel chromium based alloy are reasonably predictable.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable McFarland in view of Paul and Mayes as applied to claim 1, and further in view of Kocaturk et al., (US 20210247472 A1).
Regarding claim 26, modified McFarland teaches the system of claim 1, but fails to explicitly disclose wherein the marker of the plurality of markers comprises multiple layers of the third material on the second material.
In the same MRI field of endeavor, Kocaturk teaches wherein the marker of the plurality of markers comprises multiple layers of the third material on the second material ([0093] the markers may be formed by depositing multiple layers on the needle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified McFarland with the markers of Kocaturk, as this would allow for more distinct active visualization markers on interventional devices (see Kocaturk [0091]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable McFarland in view of Paul, Mayes, and Cook as applied to claim 1, and further in view of Chin (US 20030187461 A1).
Regarding claim 28, modified McFarland teaches the system of claim 1, but fails to explicitly disclose an etched marker on the second medical device.
In the same needle field of endeavor, Chin teaches an etched marker on the second medical device ([0039] the marker can a series of rings etched in the needle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the needle system of modified McFarland with the etched markers of Chin, as this would provide both visual and tactile feedback to the user (see Chin [0039]).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Instead, Cook has been used to teach the amended portions of claim 1, and, in combination of McFarland, Paul, and Mayes, teaches the limitations of claim 1.
The remaining claims are rejected for substantially the same reasons as above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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