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 amendment, filed 14 October 2025, is acknowledged. Claims 1, 12, 13, 15, and 18-21 are amended. Claim 3 is cancelled.
Claims 1, 2, and 4-21 are pending in the instant application.
Response to Arguments
Applicant’s arguments, filed 14 October 2025, with respect to 35 USC 112(b) rejection of claims 12-19 and 21 with respect to the scope mismatch, have been fully considered and are persuasive in light of the amendments. The 35 USC 112(b) rejection of claims 12-19 and 21 with respect to the scope mismatch has been withdrawn.
Applicant's arguments, with respect to the 35 USC 112(b) rejection of claims 12-15 with respect to the invocation of 35 USC 112(f) the have been fully considered but they are not persuasive. The amendment of “a member configured to” still invokes 35 USC 112(f) since the term is considered a generic placeholder. Upon further consideration, terms in claims 18 and 21 also invoke 35 USC 112(f).
Applicant’s arguments, with respect to the rejection(s) of claim(s) 1, 18 and 20 under 35 USC 102 and 35 USC 103 have been fully considered and are persuasive in light of the amendment. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection of claim 1 is made in view of Wang (US 20050215874 A1) in view of Efthimion (US20180126189A1), a new ground(s) of rejection of claim 18 is made in view of Wang (US 20050215874 A1) in view of Efthimion (US20180126189A1) and further in view of Ravi (WO2019075548A1), Woudstra (US20160339267A1) and Shen (US20110201923A1), and a new ground(s) of rejection of claim 20 is made in view of Wang (US 20050215874 A1) in view of Efthimion (US20180126189A1) and further in view of Ravi (WO2019075548A1).
Examiner acknowledges that Wang teaches a C-shaped marker, but Wang also teaches a looped band, wherein the layers are prepared such that they do not form a continuous conducting circuit in a plane that is perpendicular to the longitudinal axis of the medical device (Figure 4, Paragraph [0041]). The claim as written does not require the copper, brass, gold, silver, or titanium to be a closed ring, merely the inner layer comprising the copper, brass, gold, silver, or titanium. Wang does teach the marker is electrically conducting, just not circumferentially conducting (Paragraph [0010], “The marker is noncircumferentially conducting.“). Wang explicitly discloses an inner fluoroscopic imaging material gold, platinum, tungsten, tantalum, rhenium, bismuth, silver, iridium and mixtures, compounds, complexes and mixtures thereof in paragraph [0010]. Wang explicitly discloses an outer MRI material layer comprising nickel, iron, magnesium, cobalt and alloys, oxides and mixtures thereof, and gadolinium, dysprosium, terbium and alloys and oxides thereof, in paragraph [0010]. Wang teaches and MRI visible marker and a POSITO would recognize that and MRI is inherently an electromagnetic sensor, so a marker visible in an MRI would have to be detectable by an electromagnetic sensor.
As Wang teaches a closed looped band and the criticality of the toroidal shape is not disclosed by the applicant, a POSITA would look to Efthimion for other marker designs.
As the remaining arguments rely on Applicant’s argued failings of Wang, which the examiner has traversed, the remaining rejections stand.
Examiner notes that Woudstra was published on 24 November 2016. Applicant has not disclosed priority tying the instant application to Woudstra and since Woudstra was published outside of the 1 year grace period of the instant application, the cited art having the same applicant is moot.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 12 recites “an adjustment member” which is a generic placeholder.
Claim 13 recites “an insertion member” and “a detection member” which are generic placeholders.
Claim 15 recites “a second insertion member” and “a positioning member” which are generic placeholders.
Claim 18 recites “an adjustment member” and “a device configurable” which are generic placeholders.
Claim 21 recites “an adjustment member” and “a device configurable” which are generic placeholders.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12, 13, 15, 18 and 21 recite the following limitations:
“an adjustment member configured to adjust a location” in claim 12
“an insertion member configured to insert an afterloader cable” in claim 13
“a detection member configured to detect the marker” in claim 13
“a second insertion member configured to insert means for inserting a source cable” in claim 15
“a positioning member configured to position a radioactive source” in claim 15
“an adjustment member configured to adjust a location” in claim 18
“a device configurable to insert an afterloader cable” in claim 18
“a device configurable to detect” in claim 18
“a device configurable to insert a source cable into the brachytherapy instrument” in claim 18
“a device to position a radioactive source” in claim 18
“an adjustment member configured to adjust a location” in claim 21
“a device configurable to insert an afterloader cable” in claim 21
“a device configurable to detect” in claim 21
“a device configurable to insert a source cable into the brachytherapy instrument” in claim 21
“a device to position a radioactive source” in claim 21
The limitations invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The limitations of claims 12, 13, 15, 18 and 21 are described in a method in the specification as steps to be completed by a practitioner. The specification does not describe the structure that is used to accomplish the function claimed. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 14, 16, 17 and 19 inherit the same deficiencies.
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]) comprising one or more of gold, silver, or titanium (Paragraph [0033], Figure 4, first fluoroscopic imaging layer “56”)); 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.)
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 11-12 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 claims 11 and 12, 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]). Further Ravi discloses using the marker to adjust the location of the interventional device from the MRI image (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 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]).
Claims 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20050215874 A1), Efthimion (US 20180126189 A1) and Ravi (WO 2019075548 A1) as applied to claim 12, in view of Woudstra (US 20160339267 A1) and further in view of Shen (US 20110201923 A1).
Regarding claims 13-17, Wang, as modified in claim 12, does not disclose an afterloader comprising an afterloader cable within the brachytherapy instrument, wherein the afterloader cable is a dummy cable and further comprising an insertion member configured to insert a source cable into the brachytherapy instrument; and a positioning member configured to position a radioactive source relative to the artifact. The use of an afterloader with a source and a dummy cable are common in the art as disclosed by Woudstra. Woudstra discloses a system for transporting a source for brachytherapy that may include a source guide, a detector, and a controller (Abstract). Woudstra further discloses an afterloader (Paragraphs [0048] and [0052]) with a dummy afterloader cable (Paragraph [0051]) and a source cable (Paragraphs [0018] and [0019]) and a brachytherapy instrument (Paragraph [0011]). Further Woudstra discloses using electromagnetic field transmitter (Paragraph [0020]) for accurate positioning of the source (Paragraph [0024] This would be the positioning member configured to position a source relative to the artifact.) As the use of an afterloader with an afterloader cable within the brachytherapy instrument, wherein the afterloader cable is a dummy cable and further comprising a second insertion member configured to insert a source cable into the brachytherapy instrument; and a positioning member configured to position a radioactive source relative to the artifact are commonly known in the art, 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 further comprising an afterloader with an afterloader cable within the brachytherapy instrument, wherein the afterloader cable is a dummy cable and further comprising an insertion member configured to insert a source cable into the brachytherapy instrument and a positioning member configured to position a radioactive source relative to the artifact as taught by Woudstra, since such a modification would provide the predictable results of accurate source positioning and improved treatment (Paragraph [0024]).
Modified Wang, further modified by Woudstra, discloses the use of electromagnetic tags for determining the position of the dummy or source cable within the brachytherapy instrument (Woudstra, Paragraphs [0020] and [0024]), but does not disclose the afterloader cable includes an electromagnetic sensor, a detection member configured to detect the marker using the electromagnetic sensor and the source cable includes a second electromagnetic sensor. Shen discloses tracking system for target internal anatomy of a patient (Abstract) where the system includes a needle and an electromagnetic sensor coil insertable into the needle for determining the position of the coil and needle (Paragraph [0020]). The induced current in the coil changes as the coil changes in orientation to markers (Paragraph [0021]). As the marker of modified Wang would have the same induced current changes in the coil, 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 afterloader cable including an electromagnetic sensor, a detection member configured to detect the marker using the electromagnetic sensor and the source cable including a second electromagnetic sensor as taught by Woudstra, since such a modification would provide the predictable results of accurately placing surgical devices in target anatomy (Paragraph [0004]).
Claims 18 and 19 are 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), Woudstra (US20160339267A1) and Shen (US20110201923A1).
Regarding claim 18, Wang discloses a marker for a medical instrument (Abstract), the marker comprising an inner ring (Figure 4, Paragraphs [0041]-[0042]) comprising one or more of gold, silver, or titanium (Paragraph [0033], Figure 4, first fluoroscopic imaging layer “56”)); 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 using the marker with a brachytherapy instrument and an adjustment member configurable to adjust a location of the brachytherapy instrument within a patient based on the artifact created in the magnetic resonance image. 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]). Further Ravi discloses using the marker to adjust the location of the interventional device from the MRI image (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 practioner to adjust the location of the interventional device as taught by Ravi, since such a modification would provide the predictable results of allowing a practioner to see the interventional device’s position in an MR image and adjust according to the treatment plan.
Modified Wang, further modified by Ravi, does not disclose a device configurable to insert an afterloader cable within the brachytherapy instrument, a device configurable to insert a source cable into the brachytherapy instrument, and a device to position a radioactive source relative to the artifact. The use of an afterloader with a source and a dummy cable are common in the art as disclosed by Woudstra. Woudstra discloses a system for transporting a source for brachytherapy that may include a source guide, a detector, and a controller (Abstract). Woudstra further discloses an afterloader (Paragraphs [0048] and [0052]) with a dummy afterloader cable (Paragraph [0051]) and a source cable (Paragraphs [0018] and [0019]) and a brachytherapy instrument (Paragraph [0011]). Further Woudstra discloses using electromagnetic field transmitter (Paragraph [0020]) for accurate positioning of the source (Paragraph [0024] This would be the means for positing a source relative to the artifact.) As the use of an afterloader with an afterloader cable within the brachytherapy instrument, wherein the afterloader cable is a dummy cable and further comprising a means for inserting a source cable into the brachytherapy instrument; and means for positioning a radioactive source relative to the artifact are commonly known in the art, 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 further comprising an afterloader with an afterloader cable within the brachytherapy instrument, wherein the afterloader cable is a dummy cable and further comprising a means for inserting a source cable into the brachytherapy instrument and a means for positioning a radioactive source relative to the artifact as taught by Woudstra, since such a modification would provide the predictable results of accurate source positioning and improved treatment (Paragraph [0024]).
Modified Wang, further modified by Woudstra, discloses the use of electromagnetic tags for determining the position of the dummy or source cable within the brachytherapy instrument, but does not disclose the afterloader cable includes an electromagnetic sensor, or a device for detecting the marker using the electromagnetic sensor. Shen discloses tracking system for target internal anatomy of a patient (Abstract) where the system includes a needle and an electromagnetic sensor coil insertable into the needle for determining the position of the coil and needle (Paragraph [0020]). The induced current in the coil changes as the coil changes in orientation to markers (Paragraph [0021]). As the marker of Wang would have the same induced current changes in the coil, 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 afterloader cable including an electromagnetic sensor and a means for detecting the marker using the electromagnetic sensor as taught by Woudstra, since such a modification would provide the predictable results of accurately placing surgical devices in target anatomy (Paragraph [0004]).
Regarding claim 19, Wang, as modified in claim 18, discloses the interventional device includes a brachytherapy applicator, a brachytherapy needle, or a brachytherapy catheter (Ravi, Paragraph [0025]).
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]) comprising one or more of gold, silver, or titanium (Paragraph [0033], Figure 4, first fluoroscopic imaging layer “56”)); 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 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 Woudstra (US20160339267A1) and Shen (US20110201923A1).
Regarding claim 21, Wang, as modified in claim 20, does not disclose using the marker with a brachytherapy instrument and an adjustment member configurable to adjust a location of the brachytherapy instrument within a patient based on the artifact created in the magnetic resonance image. 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]). Further Ravi discloses using the marker to adjust the location of the interventional device from the MRI image (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 practioner to adjust the location of the interventional device as taught by Ravi, since such a modification would provide the predictable results of allowing a practioner to see the interventional device’s position in an MR image and adjust according to the treatment plan.
Modified Wang, further modified by Ravi, does not disclose a device configurable to insert an afterloader cable within the brachytherapy instrument, a device configurable to insert a source cable into the brachytherapy instrument, and a device to position a radioactive source relative to the artifact. The use of an afterloader with a source and a dummy cable are common in the art as disclosed by Woudstra. Woudstra discloses a system for transporting a source for brachytherapy that may include a source guide, a detector, and a controller (Abstract). Woudstra further discloses an afterloader (Paragraphs [0048] and [0052]) with a dummy afterloader cable (Paragraph [0051]) and a source cable (Paragraphs [0018] and [0019]) and a brachytherapy instrument (Paragraph [0011]). Further Woudstra discloses using electromagnetic field transmitter (Paragraph [0020]) for accurate positioning of the source (Paragraph [0024] This would be the means for positing a source relative to the artifact.) As the use of an afterloader with an afterloader cable within the brachytherapy instrument, wherein the afterloader cable is a dummy cable and further comprising a means for inserting a source cable into the brachytherapy instrument; and means for positioning a radioactive source relative to the artifact are commonly known in the art, 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 further comprising an afterloader with an afterloader cable within the brachytherapy instrument, wherein the afterloader cable is a dummy cable and further comprising a means for inserting a source cable into the brachytherapy instrument and a means for positioning a radioactive source relative to the artifact as taught by Woudstra, since such a modification would provide the predictable results of accurate source positioning and improved treatment (Paragraph [0024]).
Modified Wang, further modified by Woudstra, discloses the use of electromagnetic tags for determining the position of the dummy or source cable within the brachytherapy instrument, but does not disclose the afterloader cable includes an electromagnetic sensor, or a device for detecting the marker using the electromagnetic sensor. Shen discloses tracking system for target internal anatomy of a patient (Abstract) where the system includes a needle and an electromagnetic sensor coil insertable into the needle for determining the position of the coil and needle (Paragraph [0020]). The induced current in the coil changes as the coil changes in orientation to markers (Paragraph [0021]). As the marker of Wang would have the same induced current changes in the coil, 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 afterloader cable including an electromagnetic sensor and a means for detecting the marker using the electromagnetic sensor as taught by Woudstra, since such a modification would provide the predictable results of accurately placing surgical devices in target anatomy (Paragraph [0004]).
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791