DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/15/26 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4-14, and 18-25 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.
As detailed in infra rejections: claims 1-2, 4-10, 18, and 22-25 are rejected over the combination of Deckman, Patel, Weber, and Basar; claims 11-14 are rejected over the combination of Deckam, Patel, Weber, Basar, and Wakikaido; claim 19 is rejected over the combination of Deckman, Patel, Weber, Basar, and Wakikaido; claim 20 is rejected over the combination of Deckman, Patel, Weber, and Basar; and claim 21 is rejected over the combination of Deckman, Patel, Weber, Basar, and Peeters.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-10, 18, and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Deckman (U.S. Pub. No. 2005/0021002), hereinafter “Deckman,” in further view of Patel et al. (U.S. Pub. No. 2016/0051384), hereinafter “Patel,” in further view of Weber (U.S. Patent No. 5,908,410), hereinafter “Weber,” in further view of Basar et al. (“Segmented nitinol guidewires with stiffness-matched connectors for cardiovascular magnetic resonance catheterization: preserved mechanical performance and freedom from heating” 2015), hereinafter “Basar.”
Regarding claim 1, Deckman discloses a medical device useful in interventional procedures performed under magnetic resonance imaging (interventional catheter-based system comprising a blunt dissection catheter and a sheath catheter, Abstract; note the limitation “useful in interventional procedures performed under magnetic resonance imaging” is merely a purpose and/or intended use for the claimed “medical device” and therefore does not have patentable weight as it does not result in a structural difference, MPEP 2111.02 II. and 2114 II.), said medical device comprising:
a body member (dissection catheter, Abstract; sheath introducer/dissection catheter, [0112], Figs. 1, 4a-4c; see also placement of a guide wire through the sheath catheter, [0064]); and
a first marker and a second marker attached to the body member (marker is attached via swaging to the sheath introducer; [0110]-[0112], [0116], Figs. 4a-4c; marker comprises a band-like shape having an outer surface and a marker lumen within which the sheath introducer passes through the marker, [0110]-[0112], [0116], Figs. 4a-4c; a plurality of marker bands, [0074], [0104], [0105], [0106]), the first marker and second marker comprising work-hardened stainless steel (marker is work-hardened using swaging for attachment to the shaft of the sheath introducer, [0110]-[0112], [0116], Figs. 4a-4c; marker comprises stainless steel, [0076], [0084], [0104]; a plurality of marker bands, [0074], [0104], [0105], [0106]).
However, while Deckman discloses that the first marker and second marker comprises work-hardened stainless steel, Deckman does not appear to disclose the first marker and second marker having an ultimate tensile strength between about 100 KSI and about 225 KSI; and the first marker spaced from the second marker by a distance that results in non-overlapping visual artifacts in magnetic resonance imaging.
However, in the same field of endeavor of imaging markers, Patel teaches the first marker and second marker having an ultimate tensile strength between about 100 KSI and about 225 KSI (marker formed by a swaging or crimping process for attachment to a separate medical device, [0023]-[0025]; marker comprises stainless steel material, Ex. 103-105 on P.15; marker has an average ultimate tensile strength of about 100-310 KSI, [0029]; a plurality of marker bands spaced at defined distances from one another that results in visibility in MRI images, [0048]), the first marker spaced from the second marker by a distance that results in visual artifacts in magnetic resonance imaging (a plurality of marker bands spaced at defined distances from one another that results in visibility in MRI images, [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Patel’s known technique of using a stainless steel alloy as a MRI marker with an average ultimate tensile strength of about 100-310 KSI attached to a medical device using crimping/swaging to Deckman’s known apparatus using stainless steel as an imaging marker attached to a sheath catheter using a swaging process to achieve the predictable result that such a stainless steel alloy material for the marker reduces or prevents microcrack formation and/or breaking of the marker when the marker is crimped/swaged for attachment to the body of another medical device. See, e.g., Patel, [0023]. See also MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
However, Deckman in further view of Patel does not appear to explictly teach the first marker is spaced from the second marker by a distance that results in non-overlapping visual artifacts in magnetic resonance imaging.
However, in the same field of endeavor of imaging markers, Weber teaches the first marker is spaced from the second marker by a distance that results in non-overlapping visual artifacts in magnetic resonance imaging (a plurality of magnetic radiation imaging markers in which the first marker is spaced apart from the second marker such that each marker produces its own independent visual image which is unaffected by an adjacent marker, Col. 2, lines 54-62; see also Col. 2, line 63 – Col. 3, line 2; see also Col. 4, lines 44-59).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Weber’s known technique of spacing a first marker from a second marker by a distance resulting in non-overlapping visual artifacts in magnetic resonance imaging to Deckman in further view of Patel’s known apparatus having a first marker spaced from a second marker by a distance that results in visual artifacts in magnetic resonance imaging to achieve the predictable result that the minimum distance between a first marker and a second marker to achieve separate/distinct MRI visualization may be determined as desired in accordance with the concentration/density of paramagnetic/ferromagnetic material of each marker. See, e.g., Weber, Col. 4, lines 44-59. See also MPEP 2144.04 IV. A. Changes in Size/Proportion, MPEP 2144.04 VI. C. Rearrangement of Parts, and MPEP 2144.05 II. Routine Optimization.
However, while Deckman in further view of Patel in further view of Weber teaches an elongate member, it does not appear to teach the elongate member comprising a plurality of rods, each rod of the plurality of rods being non-resonant in magnetic resonance imaging.
However, in the same field of endeavor of imaging markers, Basar teaches an elongate member comprising a plurality of rods, each rod of the plurality of rods being non-resonant in magnetic resonance imaging (a segmented guidewire comprising a plurality of rods, each rod of the plurality of rods being non-resonant in magnetic resonance imaging, P.1, ¶2-5; P.2, ¶3 – P.3, ¶1; Figs. 1-3; see also markers attached to the rods of the segmented guidewire, P.1, ¶2, 5, P.2, ¶3, P.2, ¶6 – P.3, ¶1, Fig. 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Basar’s known technique of using a segmented guidewire comprising a plurality of rods, each rod being non-resonant in MRI as an elongate member to Deckman in further view of Patel in further view of Weber’s known apparatus comprising an outer sheath member and an elongate member slidably disposed within the outer sheath member to achieve the predictable result that an elongate member such as a segmented guidewire that comprises a plurality of rods configured to prevent standing wave formation in MRI provides an intrinsically safe device for magnetic resonance catheterization by preventing radiofrequency induced heating while providing mechanical properties comparable to high-performance commercial guidewires. See, e.g., Basar, P.1, ¶1-5, P.2, ¶3.
Regarding claim 2, Deckman discloses the first marker comprises a tubular member having an outer surface and defining a marker lumen (marker comprises a band-like shape having an outer surface and a marker lumen within which the sheath introducer passes through the marker, [0110]-[0112], [0116], Figs. 4a-4c; a plurality of marker bands, [0074], [0104], [0105], [0106]); and
the marker lumen defines a substantially circular cross-sectional shape (marker comprises a band-like shape having an outer surface and a marker lumen within which the sheath introducer passes through the marker, [0110]-[0112], [0116], Figs. 4a-4c; a plurality of marker bands, [0074], [0104], [0105], [0106]).
Regarding claim 4, while Deckman discloses the first marker is swaged on the body member (marker is attached via swaging to the sheath introducer; [0110]-[0112], [0116], Figs. 4a-4c; marker comprises a band-like shape having an outer surface and a marker lumen within which the sheath introducer passes through the marker, [0110]-[0112], [0116], Figs. 4a-4c; a plurality of marker bands, [0074], [0104], [0105], [0106]), Deckman does not appear to disclose the marker is crimped on the body member.
However, in the same field of endeavor of imaging markers, Patel teaches the first marker is crimped on the body member (tubular marker may be crimped or swaged onto a separate medical device, [0023]-[0025]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Patel’s known technique of using a stainless steel alloy as a MRI marker with an average ultimate tensile strength of about 100-310 KSI attached to a medical device using crimping/swaging to Deckman’s known apparatus using stainless steel as an imaging marker attached to a sheath catheter using a swaging process to achieve the predictable result that such a stainless steel alloy material for the marker reduces or prevents microcrack formation and/or breaking of the marker when the marker is crimped/swaged for attachment to the body of another medical device. See, e.g., Patel, [0023]. See also MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
Regarding claim 5, Deckman discloses the first marker is swaged on the body member (marker is attached via swaging to the sheath introducer; [0110]-[0112], [0116], Figs. 4a-4c; marker comprises a band-like shape having an outer surface and a marker lumen within which the sheath introducer passes through the marker, [0110]-[0112], [0116], Figs. 4a-4c; a plurality of marker bands, [0074], [0104], [0105], [0106]).
Regarding claim 6, while Deckman discloses that the marker comprises work-hardened stainless steel (marker is work-hardened using swaging for attachment to the shaft of the sheath catheter, [0074], [0101], [0105]-[0107]; marker comprises stainless steel, [0076], [0084], [0104]), Deckman does not appear to disclose the marker has an ultimate tensile strength between about 150 KSI and about 200 KSI.
However, in the same field of endeavor of imaging markers, Patel teaches the marker has an ultimate tensile strength between about 150 KSI and about 200 KSI (marker formed by a swaging or crimping process for attachment to a separate medical device, [0023]-[0025]; marker comprises stainless steel material, Ex. 103-105 on P.15; marker has an average ultimate tensile strength of about 100-310 KSI, [0029]; see also MRI imaging of the marker, [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Patel’s known technique of using a stainless steel alloy as a MRI marker with an average ultimate tensile strength of about 100-310 KSI attached to a medical device using crimping/swaging to Deckman’s known apparatus using stainless steel as an imaging marker attached to a sheath catheter using a swaging process to achieve the predictable result that such a stainless steel alloy material for the marker reduces or prevents microcrack formation and/or breaking of the marker when the marker is crimped/swaged for attachment to the body of another medical device. See, e.g., Patel, [0023]. See also MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
Regarding claim 7, while Deckman discloses that the marker comprises work-hardened stainless (marker is work-hardened using swaging for attachment to the shaft of the sheath catheter, [0074], [0101], [0105]-[0107]; marker comprises stainless steel, [0076], [0084], [0104]), Deckman does not appear to disclose the marker has an ultimate tensile strength between about 170 KSI and about 200 KSI.
However, in the same field of endeavor of imaging markers, Patel teaches the marker has an ultimate tensile strength between about 170 KSI and about 200 KSI (marker formed by a swaging or crimping process for attachment to a separate medical device, [0023]-[0025]; marker comprises stainless steel material, Ex. 103-105 on P.15; marker has an average ultimate tensile strength of about 100-310 KSI, [0029]; see also MRI imaging of the marker, [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Patel’s known technique of using a stainless steel alloy as a MRI marker with an average ultimate tensile strength of about 100-310 KSI attached to a medical device using crimping/swaging to Deckman’s known apparatus using stainless steel as an imaging marker attached to a sheath catheter using a swaging process to achieve the predictable result that such a stainless steel alloy material for the marker reduces or prevents microcrack formation and/or breaking of the marker when the marker is crimped/swaged for attachment to the body of another medical device. See, e.g., Patel, [0023]. See also MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
Regarding claim 8, while Deckman discloses that the marker comprises work-hardened stainless steel (marker is work-hardened using swaging for attachment to the shaft of the sheath catheter, [0074], [0101], [0105]-[0107]; marker comprises stainless steel, [0076], [0084], [0104]), Deckman does not appear to disclose the marker has an ultimate tensile strength between about 172 KSI and about 197 KSI.
However, in the same field of endeavor of imaging markers, Patel teaches the marker has an ultimate tensile strength between about 172 KSI and about 197 KSI (marker formed by a swaging or crimping process for attachment to a separate medical device, [0023]-[0025]; marker comprises stainless steel material, Ex. 103-105 on P.15; marker has an average ultimate tensile strength of about 100-310 KSI, [0029]; see also MRI imaging of the marker, [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Patel’s known technique of using a stainless steel alloy as a MRI marker with an average ultimate tensile strength of about 100-310 KSI attached to a medical device using crimping/swaging to Deckman’s known apparatus using stainless steel as an imaging marker attached to a sheath catheter using a swaging process to achieve the predictable result that such a stainless steel alloy material for the marker reduces or prevents microcrack formation and/or breaking of the marker when the marker is crimped/swaged for attachment to the body of another medical device. See, e.g., Patel, [0023]. See also MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
Regarding claim 9, while Deckman discloses that the marker comprises work-hardened stainless steel (marker is work-hardened using swaging for attachment to the shaft of the sheath catheter, [0074], [0101], [0105]-[0107]; marker comprises stainless steel, [0076], [0084], [0104]), Deckman does not appear to disclose the marker has an ultimate tensile strength between about 187 KSI and about 191 KSI.
However, in the same field of endeavor of imaging markers, Patel teaches the marker has an ultimate tensile strength between about 187 KSI and about 191 KSI (marker formed by a swaging or crimping process for attachment to a separate medical device, [0023]-[0025]; marker comprises stainless steel material, Ex. 103-105 on P.15; marker has an average ultimate tensile strength of about 100-310 KSI, [0029]; see also MRI imaging of the marker, [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Patel’s known technique of using a stainless steel alloy as a MRI marker with an average ultimate tensile strength of about 100-310 KSI attached to a medical device using crimping/swaging to Deckman’s known apparatus using stainless steel as an imaging marker attached to a sheath catheter using a swaging process to achieve the predictable result that such a stainless steel alloy material for the marker reduces or prevents microcrack formation and/or breaking of the marker when the marker is crimped/swaged for attachment to the body of another medical device. See, e.g., Patel, [0023]. See also MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
Regarding claim 10, while Deckman discloses that the marker comprises work-hardened stainless steel (marker is work-hardened using swaging for attachment to the shaft of the sheath catheter, [0074], [0101], [0105]-[0107]; marker comprises stainless steel, [0076], [0084], [0104]), Deckman does not appear to disclose the marker has an ultimate tensile strength about 189 KSI.
However, in the same field of endeavor of imaging markers, Patel teaches the marker has an ultimate tensile strength about 189 KSI (marker formed by a swaging or crimping process for attachment to a separate medical device, [0023]-[0025]; marker comprises stainless steel material, Ex. 103-105 on P.15; marker has an average ultimate tensile strength of about 100-310 KSI, [0029]; see also MRI imaging of the marker, [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Patel’s known technique of using a stainless steel alloy as a MRI marker with an average ultimate tensile strength of about 100-310 KSI attached to a medical device using crimping/swaging to Deckman’s known apparatus using stainless steel as an imaging marker attached to a sheath catheter using a swaging process to achieve the predictable result that such a stainless steel alloy material for the marker reduces or prevents microcrack formation and/or breaking of the marker when the marker is crimped/swaged for attachment to the body of another medical device. See, e.g., Patel, [0023]. See also MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
Regarding claim 18, Deckman discloses an outer sheath member (sheath catheter serves as a conduit for the dissection catheter, Abstract; see also placement of a guide wire through the sheath catheter, [0064]); and
the body member (dissection catheter, Abstract; sheath introducer/dissection catheter, [0112], Figs. 1, 4a-4c; see also placement of a guide wire through the sheath catheter, [0064]) is slidably disposed within the outer sheath member (sheath catheter serves as a conduit for the dissection catheter within which the dissection catheter freely advances and retracts, Abstract; see also sheath catheter serves as a conduit for the guide wire within which the guide wire freely advances and retracts, [0064], [0071]).
Regarding claim 22, Deckman discloses the first marker has a length of about 0.4 mm (the marker bands can have a length between 0.05 mm and 3 mm, [0104]).
Regarding claim 23, while Deckman in further view of Patel in further view of Weber teaches the first marker is spaced from the second marker by a distance as detailed above, Deckman in further view of Patel in further view of Weber does not appear to disclose a distance of between about 5 cm and about 10 cm.
However, in the same field of endeavor of imaging markers, Basar teaches a first marker is spaced from a second marker by a distance of between about 5 cm and about 10 cm (each of the markers are placed at 10 cm intervals, P.2, ¶4 - P.3, ¶1, Figs. 1-2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Basar’s known technique of using a segmented guidewire comprising a plurality of rods, with markers spaced at about 10 cm intervals to Deckman in further view of Patel in further view of Weber’s known apparatus comprising an outer sheath member and an elongate member slidably disposed within the outer sheath member to achieve the predictable result that an elongate member such as a segmented guidewire that comprises a plurality of nitinol rods and markers configured to prevent standing wave formation in MRI provides an intrinsically safe device for magnetic resonance catheterization by preventing radiofrequency induced heating while providing mechanical properties comparable to high-performance commercial guidewires and imparting passive visibility for real-time MRI. See, e.g., Basar, P.1, ¶1-5, P.2, ¶3. See also MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
Regarding claim 24, Deckman in further view of Patel in further view of Weber does not appear to teach the first marker is attached to a first rod of the plurality of rods; and the second marker is attached to a second rod of the plurality of rods.
However, in the same field of endeavor of imaging markers, Basar teaches a first marker is attached to a first rod of the plurality of rods; and a second marker is attached to a second rod of the plurality of rods (each of the rods are 10 cm in length and each marker is placed at 10 cm intervals, i.e., each rod has a respective marker attached thereto, wherein a first marker is attached to a first rod of the plurality of rods and a second marker is attached to a second rod of the plurality of rods, P.2, ¶4 - P.3, ¶1, Figs. 1-2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Basar’s known technique of using a segmented guidewire comprising a plurality of rods, each rod being non-resonant in MRI and having a respective marker as an elongate member to Deckman in further view of Patel in further view of Weber’s known apparatus comprising an outer sheath member and an elongate member slidably disposed within the outer sheath member to achieve the predictable result that an elongate member such as a segmented guidewire that comprises a plurality of nitinol rods and markers configured to prevent standing wave formation in MRI provides an intrinsically safe device for magnetic resonance catheterization by preventing radiofrequency induced heating while providing mechanical properties comparable to high-performance commercial guidewires and imparting passive visibility for real-time MRI. See, e.g., Basar, P.1, ¶1-5, P.2, ¶3.
Regarding claim 25, Deckman in further view of Patel in further view of Weber does not appear to teach each rod of the plurality of rods is formed of nitinol.
However, in the same field of endeavor of imaging markers, Basar teaches each rod of the plurality of rods is formed of nitinol (each rod of the plurality of rods is formed of nitinol, P.1, ¶2, P.2, ¶4-5, Figs. 1-3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Basar’s known technique of using a segmented guidewire comprising a plurality of rods, each rod being non-resonant in MRI and formed of nitinol as an elongate member to Deckman in further view of Patel in further view of Weber’s known apparatus comprising an outer sheath member and an elongate member slidably disposed within the outer sheath member to achieve the predictable result that an elongate member such as a segmented guidewire that comprises a plurality of nitinol rods configured to prevent standing wave formation in MRI provides an intrinsically safe device for magnetic resonance catheterization by preventing radiofrequency induced heating while providing mechanical properties comparable to high-performance commercial guidewires. See, e.g., Basar, P.1, ¶1-5, P.2, ¶3.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Deckman in further view of Patel in further view of Weber in further view of Basar as applied to claim 2 above, and further in view of Wakikaido et al. (U.S. Pub. No. 2005/0149009), hereinafter “Wakikaido.”
Regarding claim 11, Deckman in further view of Patel in further view of Weber in further view of Basar does not appear to teach the first marker has a mass of between about 0.05 mg and about 2.74 mg.
However, in the same field of endeavor of imaging markers, Wakikaido teaches the first marker has a mass of between about 0.05 mg and about 2.74 mg (stainless steel marker with a mass of 1-10 mg, [0038]; plurality of marker members at different positions along the body, [0039]; see also MRI imaging of the marker, [0008]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Wakikaido’s known technique of providing a stainless steel alloy MRI marker with a mass of 1-10 mg to Deckman in further view of Patel in further view of Weber in further view of Basar’s known apparatus of a stainless steel alloy MRI marker to achieve the predictable result that the material and the mass of the marker may be determined as desired in accordance with the size of the MRI monitoring imaging artifact desired. See, e.g., Wakikaido, [0038]. See also MPEP 2144.05 I. Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions and MPEP 2144.05 II. Routine Optimization.
Regarding claim 12, Deckman in further view of Patel in further view of Weber in further view of Basar does not appear to teach the first marker has a mass of between about 0.1 mg and about 1.37 mg.
However, in the same field of endeavor of imaging markers, Wakikaido teaches the first marker has a mass of between about 0.1 mg and about 1.37 mg (stainless steel marker with a mass of 1-10 mg, [0038]; plurality of marker members at different positions along the body, [0039]; see also MRI imaging of the marker, [0008]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Wakikaido’s known technique of providing a stainless steel alloy MRI marker with a mass of 1-10 mg to Deckman in further view of Patel in further view of Weber in further view of Basar’s known apparatus of a stainless steel alloy MRI marker to achieve the predictable result that the material and the mass of the marker may be determined as desired in accordance with the size of the MRI monitoring imaging artifact desired. See, e.g., Wakikaido, [0038]. See also MPEP 2144.05 I. Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions and MPEP 2144.05 II. Routine Optimization.
Regarding claim 13, while Deckman discloses that the first marker comprises work-hardened stainless steel (marker is attached via swaging to the sheath introducer; [0110]-[0112], [0116], Figs. 4a-4c; marker comprises a band-like shape having an outer surface and a marker lumen within which the sheath introducer passes through the marker, [0110]-[0112], [0116], Figs. 4a-4c; a plurality of marker bands, [0074], [0104], [0105], [0106]; marker comprises stainless steel, [0076], [0084], [0104]), Deckman does not appear to disclose the first marker has an ultimate tensile strength between about 150 KSI and about 200 KSI.
However, in the same field of endeavor of imaging markers, Patel teaches the first marker has an ultimate tensile strength between about 150 KSI and about 200 KSI (marker formed by a swaging or crimping process for attachment to a separate medical device, [0023]-[0025]; marker comprises stainless steel material, Ex. 103-105 on P.15; marker has an average ultimate tensile strength of about 100-310 KSI, [0029]; see also MRI imaging of the marker, [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Patel’s known technique of using a stainless steel alloy as a MRI marker with an average ultimate tensile strength of about 100-310 KSI attached to a medical device using crimping/swaging to Deckman’s known apparatus using stainless steel as an imaging marker attached to a sheath catheter using a swaging process to achieve the predictable result that such a stainless steel alloy material for the marker reduces or prevents microcrack formation and/or breaking of the marker when the marker is crimped/swaged for attachment to the body of another medical device. See, e.g., Patel, [0023]. See also MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
However, Deckman in further view of Patel in further view of Weber in further view of Basar does not appear to teach the first marker has a mass of between about 0.1 mg and about 1.37 mg.
However, in the same field of endeavor of imaging markers, Wakikaido teaches the first marker has a mass of between about 0.1 mg and about 1.37 mg (stainless steel marker with a mass of 1-10 mg, [0038]; plurality of marker members at different positions along the body, [0039]; see also MRI imaging of the marker, [0008]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Wakikaido’s known technique of providing a stainless steel alloy MRI marker with a mass of 1-10 mg to Deckman in further view of Patel in further view of Weber in further view of Basar’s known apparatus of a stainless steel alloy MRI marker to achieve the predictable result that the material and the mass of the marker may be determined as desired in accordance with the size of the MRI monitoring imaging artifact desired. See, e.g., Wakikaido, [0038]. See also MPEP 2144.05 I. Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions and MPEP 2144.05 II. Routine Optimization.
Regarding claim 14, while Deckman discloses that the marker comprises work-hardened stainless steel (marker is attached via swaging to the sheath introducer; [0110]-[0112], [0116], Figs. 4a-4c; marker comprises a band-like shape having an outer surface and a marker lumen within which the sheath introducer passes through the marker, [0110]-[0112], [0116], Figs. 4a-4c; a plurality of marker bands, [0074], [0104], [0105], [0106]; marker comprises stainless steel, [0076], [0084], [0104]), Deckman does not appear to disclose the marker has an ultimate tensile strength between about 170 KSI and about 200 KSI.
However, in the same field of endeavor of imaging markers, Patel teaches the marker has an ultimate tensile strength between about 170 KSI and about 200 KSI (marker formed by a swaging or crimping process for attachment to a separate medical device, [0023]-[0025]; marker comprises stainless steel material, Ex. 103-105 on P.15; marker has an average ultimate tensile strength of about 100-310 KSI, [0029]; see also MRI imaging of the marker, [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Patel’s known technique of using a stainless steel alloy as a MRI marker with an average ultimate tensile strength of about 100-310 KSI attached to a medical device using crimping/swaging to Deckman’s known apparatus using stainless steel as an imaging marker attached to a sheath catheter using a swaging process to achieve the predictable result that such a stainless steel alloy material for the marker reduces or prevents microcrack formation and/or breaking of the marker when the marker is crimped/swaged for attachment to the body of another medical device. See, e.g., Patel, [0023]. See also MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
However, Deckman in further view of Patel in further view of Weber in further view of Basar does not appear to teach the marker has a mass of between about 0.1 mg and about 1.37 mg.
However, in the same field of endeavor of imaging markers, Wakikaido teaches the marker has a mass of between about 0.1 mg and about 1.37 mg (stainless steel marker with a mass of 1-10 mg, [0038]; plurality of marker members at different positions along the body, [0039]; see also MRI imaging of the marker, [0008]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Wakikaido’s known technique of providing a stainless steel alloy MRI marker with a mass of 1-10 mg to Deckman in further view of Patel in further view of Weber in further view of Basar’s known apparatus of a stainless steel alloy MRI marker to achieve the predictable result that the material and the mass of the marker may be determined as desired in accordance with the size of the MRI monitoring imaging artifact desired. See, e.g., Wakikaido, [0038]. See also MPEP 2144.05 I. Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions and MPEP 2144.05 II. Routine Optimization.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Deckman in further view of Patel in further view of Weber in further view of Basar as applied to claim 1 above, and further in view of Peeters et al. (“Development and testing of passive tracking markers for different field strengths and tracking speeds” 2006), hereinafter “Peeters.”
Regarding claim 21, Deckman in further view of Patel in further view of Weber in further view of Basar does not appear to teach the marker has a mass of less than about 1 mg.
However, in the same field of endeavor of imaging markers, Peeters teaches the marker has a mass of less than about 1 mg (stainless steel alloy marker with a density of 7.7x103 kgm-3 and a volume between 2.1x10-3 mm3 and 16x10-3 mm3, i.e., a mass between 0.01617 and 0.1232 mg, P.N130, ¶2; Fig. 2; Table 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Peeter’s known technique of providing a stainless steel alloy MRI marker with a mass less than 1 mg to Deckman in further view of Patel in further view of Weber in further view of Basar’s known apparatus of a stainless steel alloy MRI marker to achieve the predictable result that the material, volume, and mass of the marker may be determined as desired in accordance with the desired size of the MRI susceptibility artifact and/or the volume applicable to an interventional device. See, e.g., Peeters, P.N127, ¶1, P.N128, ¶2, and P.N135, ¶3 - P.N136, ¶3. See also MPEP 2144.05 I. Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions and MPEP 2144.05 II. Routine Optimization.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Deckman in further view of Patel in further view of Weber in further view of Basar in further view of Wakikaido.
Regarding claim 19, Deckman discloses a medical device useful in interventional procedures performed under magnetic resonance imaging (interventional catheter-based system comprising a blunt dissection catheter and a sheath catheter, Abstract; note the limitation “useful in interventional procedures performed under magnetic resonance imaging” is merely a purpose and/or intended use for the claimed “medical device” and therefore does not have patentable weight as it does not result in a structural difference, MPEP 2111.02 II. and 2114 II.), said medical device comprising:
an outer sheath member (sheath catheter serves as a conduit for the dissection catheter, Abstract; see also placement of a guide wire through the sheath catheter, [0064]);
an elongate member (dissection catheter, Abstract; sheath introducer/dissection catheter, [0112], Figs. 1, 4a-4c; see also placement of a guide wire through the sheath catheter, [0064]) slidably disposed within the outer sheath member (sheath catheter serves as a conduit for the dissection catheter within which the dissection catheter freely advances and retracts, Abstract; see also sheath catheter serves as a conduit for the guide wire within which the guide wire freely advances and retracts, [0064], [0071]); and
a first tubular marker and a second tubular marker attached to one of the outer sheath member (marker attached via swaging methods to the sheath catheter, [0074], [0101], [0105]-[0107], Figs. 3b-3e; marker comprises a band-like shape having an outer surface and a marker lumen within which the dissection catheter/sheath introducer passes through the marker, [0074], [0101], [0105]-[0107], Figs. 3b-3e; a plurality of marker bands, [0074], [0104], [0105], [0106]) and the elongate member (marker is attached via swaging to the sheath introducer; [0110]-[0112], [0116], Figs. 4a-4c; marker comprises a band-like shape having an outer surface and a marker lumen within which the sheath introducer passes through the marker, [0110]-[0112], [0116], Figs. 4a-4c; a plurality of marker bands, [0074], [0104], [0105], [0106]) and each of the first tubular marker and the second tubular marker comprising work-hardened stainless steel (marker is work-hardened using swaging for attachment to the shaft of the sheath catheter, [0074], [0101], [0105]-[0107]; marker is work-hardened using swaging for attachment to the shaft of the sheath introducer, [0110]-[0112], [0116], Figs. 4a-4c; marker comprises stainless steel, [0076], [0084], [0104]; a plurality of marker bands, [0074], [0104], [0105], [0106]).
However, while Deckman discloses that the marker comprises work-hardened stainless steel, Deckman does not appear to disclose the marker has an ultimate tensile strength between about 100 KSI and about 225 KSI; and the first tubular marker spaced from the second tubular marker by a distance that results in non-overlapping visual artifacts in magnetic resonance imaging.
However, in the same field of endeavor of imaging markers, Patel teaches each of the first tubular marker and the second tubular marker has an ultimate tensile strength between about 100 KSI and about 225 KSI (tubular marker formed by a swaging or crimping process for attachment to a separate medical device, [0023]-[0025]; marker comprises stainless steel material, Ex. 103-105 on P.15; marker has an average ultimate tensile strength of about 100-310 KSI, [0029]; a plurality of marker bands spaced at defined distances from one another that results in visibility in MRI images, [0048]), the first tubular marker spaced from the second tubular marker by a distance that results in visual artifacts in magnetic resonance imaging (a plurality of marker bands spaced at defined distances from one another that results in visibility in MRI images, [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Patel’s known technique of using a stainless steel alloy as tubular MRI markers with an average ultimate tensile strength of about 100-310 KSI attached to a medical device using crimping/swaging to Deckman’s known apparatus using stainless steel as tubular imaging markers attached to a sheath catheter using a swaging process to achieve the predictable result that such a stainless steel alloy material for the marker reduces or prevents microcrack formation and/or breaking of the marker when the marker is crimped/swaged for attachment to the body of another medical device. See, e.g., Patel, [0023]. See also MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
However, while Deckman in further view of Patel teaches a first tubular marker and a second tubular marker, Deckman in further view of Patel does not appear to explictly teach the first tubular marker is spaced from the second tubular marker by a distance that results in non-overlapping visual artifacts in magnetic resonance imaging.
However, in the same field of endeavor of imaging markers, Weber teaches the first marker is spaced from the second marker by a distance that results in non-overlapping visual artifacts in magnetic resonance imaging (a plurality of magnetic radiation imaging markers in which the first marker is spaced apart from the second marker such that each marker produces its own independent visual image which is unaffected by an adjacent marker, Col. 2, lines 54-62; see also Col. 2, line 63 – Col. 3, line 2; see also Col. 4, lines 44-59).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Weber’s known technique of spacing a first marker from a second marker by a distance resulting in non-overlapping visual artifacts in magnetic resonance imaging to Deckman in further view of Patel’s known apparatus having a first tubular marker spaced from a second tubular marker by a distance that results in visual artifacts in magnetic resonance imaging to achieve the predictable result that the minimum distance between a first marker and a second marker to achieve separate/distinct MRI visualization may be determined as desired in accordance with the concentration/density of paramagnetic/ferromagnetic material of each marker. See, e.g., Weber, Col. 4, lines 44-59. See also MPEP 2144.04 IV. A. Changes in Size/Proportion, MPEP 2144.04 VI. C. Rearrangement of Parts, and MPEP 2144.05 II. Routine Optimization.
However, while Deckman in further view of Patel in further view of Weber teaches an elongate member, it does not appear to teach the elongate member comprising a plurality of rods, each rod of the plurality of rods being non-resonant in magnetic resonance imaging.
However, in the same field of endeavor of imaging markers, Basar teaches an elongate member comprising a plurality of rods, each rod of the plurality of rods being non-resonant in magnetic resonance imaging (a segmented guidewire comprising a plurality of rods, each rod of the plurality of rods being non-resonant in magnetic resonance imaging, P.1, ¶2-5; P.2, ¶3 – P.3, ¶1; Figs. 1-3; see also markers attached to the rods of the segmented guidewire, P.1, ¶2, 5, P.2, ¶3, P.2, ¶6 – P.3, ¶1, Fig. 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Basar’s known technique of using a segmented guidewire comprising a plurality of rods, each rod being non-resonant in MRI as an elongate member to Deckman in further view of Patel in further view of Weber’s known apparatus comprising an outer sheath member and an elongate member slidably disposed within the outer sheath member to achieve the predictable result that an elongate member such as a segmented guidewire that comprises a plurality of rods configured to prevent standing wave formation in MRI provides an intrinsically safe device for magnetic resonance catheterization by preventing radiofrequency induced heating while providing mechanical properties comparable to high-performance commercial guidewires. See, e.g., Basar, P.1, ¶1-5, P.2, ¶3.
However, while Deckman in further view of Patel in further view of Weber in further view of Basar teaches a first tubular marker and a second tubular marker it does not appear to teach each of the first tubular marker and the second tubular marker has a mass of between about 0.1 mg and about 1.37 mg.
However, in the same field of endeavor of imaging markers, Wakikaido teaches each of the first marker and the second marker has a mass of between about 0.1 mg and about 1.37 mg (stainless steel marker with a mass of 1-10 mg, [0038]; plurality of marker members at different positions along the body, [0039]; see also MRI imaging of the marker, [0008]; see also cylindrical marker member, [0042]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Wakikaido’s known technique of providing a plurality of stainless steel alloy tubular MRI markers with a mass of 1-10 mg to Deckman in further view of Patel in further view of Weber in further view of Basar’s known apparatus of a plurality of stainless steel alloy MRI marker to achieve the predictable result that the material and the mass of the markers may be determined as desired in accordance with the size of the MRI monitoring imaging artifact desired. See, e.g., Wakikaido, [0038]. See also MPEP 2144.05 I. Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions and MPEP 2144.05 II. Routine Optimization.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Deckman in further view of Patel in further view of Weber in further view of Basar.
Regarding claim 20, Deckman discloses a medical device useful in interventional procedures performed under magnetic resonance imaging (interventional catheter-based system comprising a blunt dissection catheter and a sheath catheter, Abstract; note the limitation “useful in interventional procedures performed under magnetic resonance imaging” is merely a purpose and/or intended use for the claimed “medical device” and therefore does not have patentable weight as it does not result in a structural difference, MPEP 2111.02 II. and 2114 II.), said medical device comprising:
an outer sheath member (sheath catheter serves as a conduit for the dissection catheter, Abstract; see also placement of a guide wire through the sheath catheter, [0064]);
an elongate member (dissection catheter, Abstract; sheath introducer/dissection catheter, [0112], Figs. 1, 4a-4c; see also placement of a guide wire through the sheath catheter, [0064]) slidably disposed within the outer sheath member (sheath catheter serves as a conduit for the dissection catheter within which the dissection catheter freely advances and retracts, Abstract; see also sheath catheter serves as a conduit for the guide wire within which the guide wire freely advances and retracts, [0064], [0071]); and
a first marker attached to the outer sheath member (marker attached via swaging methods to the sheath catheter, [0074], [0101], [0105]-[0107], Figs. 3b-3e; marker comprises a band-like shape having an outer surface and a marker lumen within which the dissection catheter/sheath introducer passes through the marker, [0074], [0101], [0105]-[0107], Figs. 3b-3e; a plurality of marker bands, [0074], [0104], [0105], [0106]), the first marker comprising work-hardened stainless steel (marker is work-hardened using swaging for attachment to the shaft of the sheath catheter, [0074], [0101], [0105]-[0107]; marker comprises stainless steel, [0076], [0084], [0104]; a plurality of marker bands, [0074], [0104], [0105], [0106]), the first marker defining a first marker lumen (marker comprises a band-like shape having an outer surface and a marker lumen within which the dissection catheter/sheath introducer passes through the marker, [0074], [0101], [0105]-[0107], Figs. 3b-3e); and
a third marker attached to the elongate member (marker is attached via swaging to the sheath introducer; [0110]-[0112], [0116], Figs. 4a-4c; marker comprises a band-like shape having an outer surface and a marker lumen within which the sheath introducer passes through the marker, [0110]-[0112], [0116], Figs. 4a-4c; a plurality of marker bands, [0074], [0104], [0105], [0106]), the third marker comprising work-hardened stainless steel (marker is work-hardened using swaging for attachment to the shaft of the sheath catheter, [0074] [0101], [0105]-[0107]; marker is work-hardened using swaging for attachment to the shaft of the sheath introducer, [0110]-[0112], [0116], Figs. 4a-4c; marker comprises stainless steel, [0076], [0084], [0104]).
However, while Deckman discloses a plurality of markers, including a first marker and a third marker, comprising work-hardened stainless steel, Deckman does not appear to disclose the plurality of markers have an ultimate tensile strength between about 100 KSI and about 225 KSI; a second marker; and the first marker is spaced from the second marker by a distance that results in non-overlapping visual artifacts in magnetic resonance imaging.
However, in the same field of endeavor of imaging markers, Patel teaches a first marker and a second marker, each of the first marker and the second marker having an ultimate tensile strength of between about 100 KSI and about 225 KSI (marker formed by a swaging or crimping process for attachment to a separate medical device, [0023]-[0025]; marker comprises stainless steel material, Ex. 103-105 on P.15; marker has an average ultimate tensile strength of about 100-310 KSI, [0029]; a plurality of marker bands spaced at defined distances from one another that results in visibility in MRI images, [0048]), the first marker spaced from the second marker by a distance that results in visual artifacts in magnetic resonance imaging (a plurality of marker bands spaced at defined distances from one another that results in visibility in MRI images, [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Patel’s known technique of using a stainless steel alloy as tubular MRI markers with an average ultimate tensile strength of about 100-310 KSI attached to a medical device using crimping/swaging to Deckman’s known apparatus using stainless steel as tubular imaging markers attached to a sheath catheter using a swaging process to achieve the predictable result that such a stainless steel alloy material for the marker reduces or prevents microcrack formation and/or breaking of the marker when the marker is crimped/swaged for attachment to the body of another medical device. See, e.g., Patel, [0023]. See also MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions. See also MPEP 2144.04 VI. Duplication of Parts.
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Patel’s known technique of using a stainless steel alloy for a plurality of MRI markers each with an average ultimate tensile strength of about 100-310 KSI and attached to a medical device using crimping/swaging (marker formed by a swaging or crimping process for attachment to a separate medical device, Patel, [0023]-[0025]; marker comprises stainless steel material, Ex. 103-105 on Patel, P.15; marker has an average ultimate tensile strength of about 100-310 KSI, Patel, [0029]; a plurality of marker bands spaced at defined distances from one another that results in visibility in MRI images, Patel, [0048]) to Deckman’s known apparatus using stainless steel as tubular imaging markers, including a third marker attached to an elongate sheath introducer using a swaging process (marker comprises a band-like shape having an outer surface and a marker lumen within which the dissection catheter/sheath introducer passes through the marker, Deckman, [0074], [0101], [0105]-[0107], Figs. 3b-3e; a plurality of marker bands, Deckman, [0074], [0104], [0105], [0106]; marker is work-hardened using swaging for attachment to the shaft of the sheath catheter, Deckman, [0074], [0101], [0105]-[0107], Figs, 3b-3e; marker comprises stainless steel, Deckman, [0076], [0084], [0104]), to achieve the predictable result that such a stainless steel alloy material for the third marker reduces or prevents microcrack formation and/or breaking of the third marker when the third marker is crimped/swaged for attachment to the body of another medical device. See, e.g., Patel, [0023]. See also MPEP 2144.05 Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions.
However, while Deckman in further view of Patel teaches a first marker and a second marker Deckman in further view of Patel does not appear to explictly teach the first marker is spaced from the second marker by a distance that results in non-overlapping visual artifacts in magnetic resonance imaging.
However, in the same field of endeavor of imaging markers, Weber teaches the first marker is spaced from the second marker by a distance that results in non-overlapping visual artifacts in magnetic resonance imaging (a plurality of magnetic radiation imaging markers in which the first marker is spaced apart from the second marker such that each marker produces its own independent visual image which is unaffected by an adjacent marker, Col. 2, lines 54-62; see also Col. 2, line 63 – Col. 3, line 2; see also Col. 4, lines 44-59).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Weber’s known technique of spacing a first marker from a second marker by a distance resulting in non-overlapping visual artifacts in magnetic resonance imaging to Deckman in further view of Patel’s known apparatus having a first marker spaced from a second marker by a distance that results in visual artifacts in magnetic resonance imaging to achieve the predictable result that the minimum distance between a first marker and a second marker to achieve separate/distinct MRI visualization may be determined as desired in accordance with the concentration/density of paramagnetic/ferromagnetic material of each marker. See, e.g., Weber, Col. 4, lines 44-59. See also MPEP 2144.04 IV. A. Changes in Size/Proportion, MPEP 2144.04 VI. C. Rearrangement of Parts, and MPEP 2144.05 II. Routine Optimization.
However, while Deckman in further view of Patel in further view of Weber teaches an elongate member, it does not appear to teach the elongate member comprising a plurality of rods, each rod of the plurality of rods being non-resonant in magnetic resonance imaging.
However, in the same field of endeavor of imaging markers, Basar teaches an elongate member comprising a plurality of rods, each rod of the plurality of rods being non-resonant in magnetic resonance imaging (a segmented guidewire comprising a plurality of rods, each rod of the plurality of rods being non-resonant in magnetic resonance imaging, P.1, ¶2-5; P.2, ¶3 – P.3, ¶1; Figs. 1-3; see also markers attached to the rods of the segmented guidewire, P.1, ¶2, 5, P.2, ¶3, P.2, ¶6 – P.3, ¶1, Fig. 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Basar’s known technique of using a segmented guidewire comprising a plurality of rods, each rod being non-resonant in MRI as an elongate member to Deckman in further view of Patel in further view of Weber’s known apparatus comprising an outer sheath member and an elongate member slidably disposed within the outer sheath member to achieve the predictable result that an elongate member such as a segmented guidewire that comprises a plurality of rods configured to prevent standing wave formation in MRI provides an intrinsically safe device for magnetic resonance catheterization by preventing radiofrequency induced heating while providing mechanical properties comparable to high-performance commercial guidewires. See, e.g., Basar, P.1, ¶1-5, P.2, ¶3.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Paul et al. (U.S. Pub. No. 2019/0167952) discloses tubular stainless steel MRI markers that are crimped or swaged onto a body member.
Roth et al. (U.S. Pub. No. 2019/0046684) discloses tubular stainless steel MRI markers that are crimped or swaged onto a body member.
Shuffler et al. (U.S. Pub. No. 2014/0005647) discloses stainless steel markers formed as tubular rings that are crimped or swagged to a body member.
Miki et al. (U.S. Pub. No. 2005/0240165) discloses stainless steel markers formed as tubular rings that are crimped or swagged to a body member.
Tan-Malecki et al. (U.S. Pub. No. 2013/0165942) discloses stainless steel markers formed as tubular rings that are crimped or swagged to a body member.
Wang et al. (U.S. Pub. No. 2005/0215874) discloses stainless steel markers formed as tubular rings that are crimped or swagged to a body member.
Malek et al. (U.S. Pub. No. 2020/0069927) discloses stainless steel markers formed as tubular rings that are crimped or swagged to a body member.
Yribarren et al. (U.S. Pub. No. 2008/0097404) discloses stainless steel markers formed as tubular rings that are crimped or swagged to a body member.
Lee et al. (U.S. Pub. No. 2003/0167052) discloses stainless steel markers formed as tubular rings that are crimped or swaged to a body member.
Dorn et al. (U.S. Pub. No. 2004/0199240) discloses stainless steel markers formed as tubular rings that are crimped or swagged to a body member.
Lenker et al. (U.S. Pub. No. 2018/0289388) discloses stainless steel markers formed as tubular rings that are crimped or swagged to a body member.
Furst (U.S. Pub. No. 2006/0200048) discloses stainless steel markers formed as tubular rings that are crimped or swaged to a body member.
Shireman et al. (U.S. Pub. No. 2004/0167442) discloses stainless steel markers formed as tubular rings that are crimped or swaged to a body member.
Clark et al. (U.S. Patent No. 6,613,002) discloses metallic markers formed as tubular rings that are crimped or swaged to a body member at spacings of 5-10 cm.
Agostinelli et al. (U.S. Pub. No. 2019/0223975) discloses a tubular MRI marker attached to an elongated body, the marker having a mass of less than 2 mg.
Pacetti (U.S. Pub No. 2003/0120148) discloses metallic marker bands attached to the shaft of a body member at spacings of 10 cm.
Kocaturk et al. (U.S. Pub. No. 2017/0239450) discloses a segmented guidewire comprising a plurality of rods, each rod of the plurality of rods being non-resonant in magnetic resonance imaging and having MRI markers attached thereon.
Lederman et al. (U.S. Pub. No. 2018/0243530) discloses a segmented guidewire comprising a plurality of rods, each rod of the plurality of rods being non-resonant in magnetic resonance imaging and having MRI markers attached thereon.
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/Johnathan Maynard/Examiner, Art Unit 3798
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