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
Applicant’s amendments, filed 9 April 2026, are acknowledged. Claims 1, 12, 13, 15, 18, 20, and 21 are amended. Claim 3 was previously cancelled. Claims 1, 2 and 4-21 are pending in the instant application.
Response to Arguments
Applicant’s arguments, filed 9 April 2026, with respect to the interpretation under 35 USC 112(f) and subsequent rejection under 35 USC 112(b) of claims 12, 13-19 and 21 have been fully considered and are persuasive in light of the amendments. The interpretation under 35 USC 112(f) and subsequent rejection under 35 USC 112(b) of claims 12, 13-19 and 21 has been withdrawn.
Applicant's arguments, with respect to the 35 USC 103 rejection of claim 1, have been fully considered but they are not persuasive. Examiner agrees that Wang discloses “avoiding forming a closed conductive circuit along the circumference of the ring”, the markers are “noncircumferentially conducting”, that markers "do not form a continuous conducting circuit in a plane that is perpendicular to the longitudinal axis of the medical device" and the conductivity of the marker "along its circumference is interrupted by isolating parts." Wang also discloses the marker can form a closed ring as previously cited and the inner ring (Figure 4, Paragraphs [0041]-[0042]) formed of one or more of gold, silver, or titanium (Paragraph [0033], Figure 4, first fluoroscopic imaging layer “56”)). Claim 1, as written does not require the inner ring to consist of only gold, silver, or titanium, nor does it require the ring to form a continuous conducting circuit or closed conductive circuit, nor does the claim, as written, prevent the inner ring from comprising isolating parts. The use of “formed of” does not preclude the use of isolating parts. As Wang discloses the inner ring can be a closed ring, while comprising gold, silver, or titanium, while the closed ring is not noncircumferentially conducting, it would require isolating parts. A solid inner ring comprising isolating parts and gold, silver, or titanium, would read on “an inner ring having a closed ring shape formed of one or more of copper, brass, gold, silver, or titanium;”. To advance prosecution, Examiner acknowledges if claim 1 is amended to limit the inner ring to just the materials of copper, brass, gold, silver, or titanium, claim 1 would overcome the prior art of Wang.
As Wang discloses the inner ring is an annular ring that can be a closed ring while comprising gold, silver, or titanium and isolating parts to prevent circumferentially conducting, the modification to the toroidal ring of Efthimion is merely a shape change of the ring. The specification does not cite the criticality of the toroidal ring design over other ring designs to include annular. As such, Efthimion discloses a marker for a medical instrument, a fiducial marker, a POSITA looking for a design of a marker for a medical instrument would look to Efthimion.
Applicant’s arguments, with respect to the 35 USC 103 rejection of claim 18, have been fully considered and are persuasive in light of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Wang (US 20050215874 A1) and further in view of Efthimion (US 20180126189 A1) and De Vries (US20160166328A1).
Regarding claim 20, Applicant does not provide arguments against the combination of Wang (US20050215874A1) in view of Efthimion (US20180126189A1) and further in view of Ravi (WO2019075548A1), beyond that Ravi does not cure the failure of the Wang/Efthimion combination to suggest the claimed structure, which was addressed in claim 1, supra.
In light of the amendments to claims 12 and 21, the 35 USC 103 rejections to claims 12-17 and 21 have been withdrawn. Upon further consideration, a new ground(s) of rejection of claims 12-17 and 21 is made in view of Wang (US 20050215874 A1) and further in view of Efthimion (US 20180126189 A1), Ravi (WO 2019075548 A1) and De Vries (US20160166328A1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20050215874 A1) in view of Efthimion (US 20180126189 A1).
Regarding claim 1, Wang discloses a marker for a medical instrument (Abstract), the marker comprising an inner ring (Figure 4, Paragraphs [0041]-[0042]) formed of or more of gold, silver, or titanium (Paragraph [0033], Figure 4, first fluoroscopic imaging layer “56”) the use of “formed of” does not preclude isolating portions being part of the closed ring); an outer coating comprising one or more of nickel or iron oxide (Paragraph [0034], Figure 4, MRI layer “58”), wherein a thickness of the outer coating is about 1 μm to about 30 μm (Paragraph [0035]); and a central opening, wherein a diameter of the central opening is about 0.50 mm to about 3.00 mm (Paragraph [0035]) and wherein the marker is electrically conductive (Paragraph [0010], “The marker is noncircumferentially conducting”) and detectable bv an electromagnetic sensor (Paragraph [0034] An MRI is an EM sensor).
Wang discloses the marker has a ring shape (Figure 4, Paragraphs [0041]-[0042]) but does not disclose the marker has a toroidal shape. Efthimion disclose using a marker with a toroidal shape (Paragraph [0077]) for a marker for a medical instrument (Abstract). As the disclosure does not cite the criticality of the toroidal shape, it would have been obvious before the effective filing date of the claimed invention to modify the annular shape of Wang with the toroidal shape of Efthimion as the shape of the marker does not change its performance and is merely an aesthetic design change (MPEP 2144.04.I.)
Regarding claim 4, Wang discloses an outer diameter of the marker is about 1.00 mm to about 5.50 mm (Paragraph [0035]).
Regarding claim 5, Wang discloses the thickness of the outer coating is about 4 μm to about 20 μm (Paragraph [0012]).
Regarding claim 6, Wang discloses the diameter of the central opening is about 0.75 mm to about 2.25 mm (Paragraph [0035]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20050215874 A1) ) in view of Efthimion (US 20180126189 A1), as applied to claim 1 above, and further in view of Gertner (US 20090161827 A1).
Regarding claim 2, modified Wang, as disclosed in claim 1, discloses using gold, silver, or titanium as a marker in fluoroscopy, but does not disclose copper or brass. Gertner discloses using copper as a radiographic contrasting material in markers. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the marker as taught by modified Wang, with using copper as an alternative material for contrasting in fluoroscopy as taught by Gertner, since such a modification would provide the predictable results of providing the same results as expected from modified Wang while using an alternative material. As the applicant does not disclose why copper is preferred over the other options of gold, silver, or titanium, it would have been obvious to try an alternative material.
Claim(s) 7-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20050215874 A1) in view of Efthimion (US 20180126189 A1), as applied to claim 1 above, and further in view of Ravi (WO 2019075548 A1).
Regarding claims 7-9, modified Wang as disclosed in claim 1, teaches the marker for a medical instrument but fails to teach the brachytherapy devices. Ravi teaches using an MRI visible marker with an interventional device (Paragraphs [0025]-[0026]) for the purposes of positioning the interventional device (Paragraph [0025]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the marker as taught by modified Wang, for use with a brachytherapy applicator, needle or catheter as taught by Ravi, since such a modification would provide the predictable results of allowing a practitioner to see the interventional device’s position in an MR image.
Regarding claim 11, modified Wang teaches the marker, as disclosed in claim 1, is visible under MR imaging (Abstract). Ravi teaches using an MRI visible marker with an interventional device (Paragraphs [0025]-[0026]) so that the marker generates an artifact when the interventional device is imaged using MRI (Paragraph [0036]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the marker as taught by modified Wang, for use with an interventional device to generate an artifact in an MR image as taught by Ravi, since such a modification would provide the predictable results of allowing a practitioner to see the interventional device’s position in an MR image and adjust according to the treatment plan.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20050215874 A1) in view of Efthimion (US 20180126189 A1) as applied to claim 1 above, and further in view of De Vries (US 20160166328 A1).
Regarding claim 10, modified Wang as disclosed in claim 1, teaches the marker for a medical instrument but fails to teach the brachytherapy device. De Vries discloses a position verification system for brachytherapy systems to verify the positioning of the transfer tube (Paragraph [0001]). De Vries further discloses a marker for the position verification system, wherein the marker is coupled to a distal region of a brachytherapy transfer tube (Figure 2, ring “2a”, Abstract, Paragraph [0049]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the marker as taught by modified Wang, with the marker being coupled to a distal region of a brachytherapy transfer tube as taught by De Vries, since such a modification would provide the predictable results of confirming the placement of conduits within the patient ensuring proper radiation treatment (Paragraphs [0006] and [0010]).
Claim(s) 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20050215874 A1) in view of Efthimion (US 20180126189 A1) and Ravi (WO 2019075548 A1), as applied to claim 11 above, and further in view of De Vries (US 20160166328 A1).
Regarding claim 12, Wang, as modified in claim 11, discloses the inner ring and the outer coating of the marker are configured to create an artifact (See claim 11 rejection supra). Modified Wang does not explicitly disclose that the artifact created in the magnetic resonance image is configured to facilitate adjustment of a location of the brachytherapy instrument within a patient, and wherein the marker is included in a brachytherapy system. De Vries discloses a position verification system for brachytherapy systems to verify the positioning inside of a transfer tube (Paragraph [0001]). De Vries further discloses the artifact created in the magnetic resonance image is configured to facilitate adjustment of a location of the brachytherapy instrument within a patient (Paragraph [0045]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the marker as taught by modified Wang, with using the artifact from an MR image to facilitate adjustment of a location of the brachytherapy instrument within a patient, and wherein the marker is included in a brachytherapy system as taught by De Vries, since such a modification would provide the predictable results of detecting human error in transfer tube connection, and/or for promoting accurate radiotherapy source positioning (Paragraph [0010]).
Regarding claim 13, De Vries discloses the brachytherapy system, as disclosed in claim 12, further comprises an afterloader configured to insert an afterloader cable within the brachytherapy instrument, wherein the afterloader cable includes an electromagnetic sensor configured to detect the marker (Paragraph [0013]).
Regarding claim 14, De Vries discloses the afterloader cable is a dummy cable (Paragraph [0066], “check cable”).
Regarding claim 15, De Vries discloses the afterloader is further configured to insert a source cable into the brachytherapy instrument and to position a radioactive source relative to the artifact (Paragraph [0066]).
Regarding claim 16, De Vries discloses the source cable includes a second electromagnetic sensor (Paragraph [0066]).
Regarding claim 17, De Vries discloses the electromagnetic sensor is a coil (Paragraph [0013]).
Claim(s) 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20050215874 A1) and further in view of Efthimion (US 20180126189 A1) and De Vries (US 20160166328 A1).
Regarding claim 18, Wang discloses a marker for a medical instrument (Abstract), the marker comprising an inner ring (Figure 4, Paragraphs [0041]-[0042]) formed of or more of gold, silver, or titanium (Paragraph [0033], Figure 4, first fluoroscopic imaging layer “56”) the use of “formed of” does not preclude isolating portions being part of the closed ring); an outer coating comprising one or more of nickel or iron oxide (Paragraph [0034], Figure 4, MRI layer “58”), wherein a thickness of the outer coating is about 1 μm to about 30 μm (Paragraph [0035]); wherein the inner ring and the outer coating of the marker are configured to create an artifact in a magnetic resonance image when the magnetic resonance image is generated (Paragraph [0010]) and a central opening, wherein a diameter of the central opening is about 0.50 mm to about 3.00 mm (Paragraph [0035]) and wherein the marker is electrically conductive (Paragraph [0010], “The marker is noncircumferentially conducting”) and detectable by an electromagnetic sensor (Paragraph [0034] An MRI is an EM sensor).
Wang discloses the marker has a ring shape (Figure 4, Paragraphs [0041]-[0042]) but does not disclose the marker has a toroidal shape. Efthimion disclose using a marker with a toroidal shape (Paragraph [0077]) for radiation therapy (Abstract). As the disclosure does not cite the criticality of the toroidal shape, it would have been obvious before the effective filing date of the claimed invention to modify the annular shape of Wang with the toroidal shape of Efthimion as the shape of the marker does not change its performance and is merely an aesthetic design change (MPEP 2144.04.I.)
Wang, as modified by Efthimion, does not disclose the marker is included in a brachytherapy system, wherein the artifact created in the magnetic resonance image is configured to facilitate adjustment of a location of the brachytherapy instrument within a patient, the brachytherapy system comprising an afterloader configured to insert an afterloader cable within the brachytherapy instrument, wherein the afterloader cable includes an electromagnetic sensor configured to detect the marker, wherein the afterloader is further configured to insert a source cable into the brachytherapy instrument, and wherein the afterloader is further configured to position a radioactive source relative to the artifact. De Vries discloses a position verification system for brachytherapy systems to verify the positioning inside of a transfer tube (Paragraph [0001]). De Vries further discloses the artifact created in the magnetic resonance image is configured to facilitate adjustment of a location of the brachytherapy instrument within a patient (Paragraph [0045]), the brachytherapy system comprising an afterloader configured to insert an afterloader cable within the brachytherapy instrument (Paragraphs [0013]-[0014] and [0066]), wherein the afterloader cable includes an electromagnetic sensor configured to detect the marker (Paragraphs [0013]-[0014] and [0066]) wherein the afterloader is further configured to insert a source cable into the brachytherapy instrument (Paragraphs [0013]-[0014] and [0066]), and wherein the afterloader is further configured to position a radioactive source relative to the artifact (Paragraphs [0013]-[0014] and [0066]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the marker as taught by modified Wang, with the marker being included in a brachytherapy system, wherein the artifact created in the magnetic resonance image being configured to facilitate adjustment of a location of the brachytherapy instrument within a patient, the brachytherapy system comprising an afterloader configured to insert an afterloader cable within the brachytherapy instrument, wherein the afterloader cable includes an electromagnetic sensor configured to detect the marker, wherein the afterloader is further configured to insert a source cable into the brachytherapy instrument, and wherein the afterloader is further configured to position a radioactive source relative to the artifact as taught by De Vries, since such a modification would provide the predictable results of detecting human error in transfer tube connection, and/or for promoting accurate radiotherapy source positioning (Paragraph [0010]).
Regarding claim 19, modified Wang, as modified by De Vries in claim 19, further discloses the marker is coupled to a brachytherapy applicator, a brachytherapy needle, a brachytherapy catheter, or a distal region of a brachytherapy transfer tube (Abstract and Paragraph [0043]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20050215874 A1) in view of Efthimion (US 20180126189 A1) and further in view of Ravi (WO 2019075548 A1).
Regarding claim 20, Wang discloses a marker for a medical instrument (Abstract), the marker comprising an inner ring (Figure 4, Paragraphs [0041]-[0042]) formed of or more of gold, silver, or titanium (Paragraph [0033], Figure 4, first fluoroscopic imaging layer “56”) the use of “formed of” does not preclude isolating portions being part of the closed ring); an outer coating comprising one or more of nickel or iron oxide (Paragraph [0034], Figure 4, MRI layer “58”), wherein a thickness of the outer coating is about 1 μm to about 30 μm (Paragraph [0035]); and a central opening, wherein a diameter of the central opening is about 0.50 mm to about 3.00 mm (Paragraph [0035]) and wherein the marker is electrically conductive (Paragraph [0010], “The marker is noncircumferentially conducting”) and detectable bv an electromagnetic sensor (Paragraph [0034] An MRI is an EM sensor).
Wang discloses the marker has a ring shape (Figure 4, Paragraphs [0041]-[0042]) but does not disclose the marker has a toroidal shape. Efthimion disclose using a marker with a toroidal shape (Paragraph [0077]) for radiation therapy (Abstract). As the disclosure does not cite the criticality of the toroidal shape, it would have been obvious before the effective filing date of the claimed invention to modify the annular shape of Wang with the toroidal shape of Efthimion as the shape of the marker does not change its performance and is merely an aesthetic design change (MPEP 2144.04.I.)
Wang, as modified by Efthimion, does not disclose using the marker with a brachytherapy instrument. Ravi teaches using an MRI visible marker with an interventional device (Paragraphs [0025]-[0026]) so that the marker generates an artifact when the interventional device is imaged using MRI (Paragraph [0036]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the marker as taught by modified Wang, with use with an interventional device to generate an artifact in an MR image to allow a practitioner to adjust the location of the interventional device as taught by Ravi, since such a modification would provide the predictable results of allowing a practitioner to see the interventional device’s position in an MR image and adjust according to the treatment plan.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20050215874 A1) in view of Efthimion (US 20180126189 A1) and Ravi (WO 2019075548 A1), as applied to claim 20 above, and further in view of De Vries (US 20160166328 A1).
Regarding claim 21, Wang, as modified in claim 20, does not disclose the marker is included in a brachytherapy system, wherein the artifact created in the magnetic resonance image is configured to facilitate adjustment of a location of the brachytherapy instrument within a patient, the brachytherapy system comprising an afterloader configured to insert an afterloader cable within the brachytherapy instrument, wherein the afterloader cable includes an electromagnetic sensor configured to detect the marker, wherein the afterloader is further configured to insert a source cable into the brachytherapy instrument, wherein the afterloader is further configured to position a radioactive source relative to the artifact and the afterloader cable is a dummy cable, wherein the source cable includes a second electromagnetic sensor, and wherein at least one of the electromagnetic sensor or the second electromagnetic sensor is a coil. De Vries discloses a position verification system for brachytherapy systems to verify the positioning inside of a transfer tube (Paragraph [0001]). De Vries further discloses the artifact created in the magnetic resonance image is configured to facilitate adjustment of a location of the brachytherapy instrument within a patient (Paragraph [0045]), the brachytherapy system comprising an afterloader configured to insert an afterloader cable within the brachytherapy instrument (Paragraphs [0013]-[0014] and [0066]), wherein the afterloader cable includes an electromagnetic sensor configured to detect the marker (Paragraphs [0013]-[0014] and [0066]) wherein the afterloader is further configured to insert a source cable into the brachytherapy instrument (Paragraphs [0013]-[0014] and [0066]), and wherein the afterloader is further configured to position a radioactive source relative to the artifact (Paragraphs [0013]-[0014] and [0066]) and the afterloader cable is a dummy cable (Paragraph [0066]), wherein the source cable includes a second electromagnetic sensor (Paragraph [0066]), and wherein at least one of the electromagnetic sensor or the second electromagnetic sensor is a coil (Paragraph [0013]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the marker as taught by modified Wang, with the marker being included in a brachytherapy system, wherein the artifact created in the magnetic resonance image being configured to facilitate adjustment of a location of the brachytherapy instrument within a patient, the brachytherapy system comprising an afterloader configured to insert an afterloader cable within the brachytherapy instrument, wherein the afterloader cable includes an electromagnetic sensor configured to detect the marker, wherein the afterloader is further configured to insert a source cable into the brachytherapy instrument, wherein the afterloader is further configured to position a radioactive source relative to the artifact and the afterloader cable is a dummy cable, wherein the source cable includes a second electromagnetic sensor, and wherein at least one of the electromagnetic sensor or the second electromagnetic sensor is a coil as taught by De Vries, since such a modification would provide the predictable results of detecting human error in transfer tube connection, and/or for promoting accurate radiotherapy source positioning (Paragraph [0010]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marc D Honrath whose telephone number is (571)272-6219. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791
Prosecution Insights