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 .
Election/Restrictions
Applicant's election without traverse of Invention I and with traverse of Species 1 in the reply filed on 5/6/2026 is acknowledged.
Applicant argues that a showing of lack of unity of invention was not demonstrated for the species groupings as the analysis did not specify claim groupings corresponding to the species groupings.
As recited in the claim set filed 8/6/2024, claims 8-12 are specific to the embodiment of Figs. 1-5 (Species 1), claim 13 is specific to the embodiment of Fig. 6 (Species 2), and claim 14-16 are specific to the embodiment of Fig. 7 (Species 3).
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Species 1 and 2 lack unity of invention because even though the invention of these groups require the technical features of claim 1, these technical features are not special technical features as they do not make a contribution over the prior art in view of Cunningham et al. (U.S. Pub. No. 2012/0310080), hereinafter “Cunningham.”
Cunningham discloses a medical system useful in performing treatment under magnetic resonance imaging (a tracking device to be coupled to an interventional instrument tracked by a magnetic resonance imaging system, Abstract) comprising:
a first medical device having a first passive marker, the first passive marker formed of a first material having a first magnetic susceptibility (a second tracking member having a second passive component, the second passive component formed of a second material having a second magnetic susceptibility, [0009]); and
a second medical device having a second passive marker, the second passive marker formed of a second material having a second magnetic susceptibility, the second passive marker creating an image artifact under MRI (a first tracking member having a first passive component, the first passive component formed of a first material having a first magnetic susceptibility, the first passive component creating an image artifact under MRI, [0008]-[0011], [0032]-[0033], [0044]-[0045]);
wherein the image artifact created by the second passive marker is altered under MRI when the first passive marker overlaps the second passive marker (the magnetic field disturbance in the image created by the first passive component is altered under MRI when the second passive component is axially aligned with the first passive component, [0008]-[0011], [0032]-[0033], [0044]-[0045]).
Species 1 and 3 lack unity of invention because even though the invention of these groups require the technical features of claim 1, these technical features are not special technical features as they do not make a contribution over the prior art in view of Cunningham as set forth above.
Species 2 and 3 lack unity of invention because even though the invention of these groups require the technical features of claim 1, these technical features are not special technical features as they do not make a contribution over the prior art in view of Cunningham as set forth above.
Additionally, Applicant is on notice that amendments to the claims to introduce subject matter such that the claims recite the subject matter of the embodiment of Figure 8 (Species 4) or the embodiment of Figs. 9 and 10 (Species 5) would lack unity of invention with those of the embodiment of Figs. 1-5 and claims 8-12 (Species 1) as elected by the Applicant.
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-20 are withdrawn from consideration and claims 1-12 are under consideration in this Office Action.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cunningham et al. (U.S. Pub. No. 2012/0310080), hereinafter “Cunningham.”
Regarding claim 1, Cunningham discloses a medical system useful in performing treatment under magnetic resonance imaging (a tracking device to be coupled to an interventional instrument tracked by a magnetic resonance imaging system, Abstract) comprising:
a first medical device having a first passive marker, the first passive marker formed of a first material having a first magnetic susceptibility (a second tracking member having a second passive component, the second passive component formed of a second material having a second magnetic susceptibility, [0009]); and
a second medical device having a second passive marker, the second passive marker formed of a second material having a second magnetic susceptibility, the second passive marker creating an image artifact under MRI (a first tracking member having a first passive component, the first passive component formed of a first material having a first magnetic susceptibility, the first passive component creating an image artifact under MRI, [0008]-[0011], [0032]-[0033], [0044]-[0045]);
wherein the image artifact created by the second passive marker is altered under MRI when the first passive marker overlaps the second passive marker (the magnetic field disturbance in the image created by the first passive component is altered under MRI when the second passive component is axially aligned with the first passive component, [0008]-[0011], [0032]-[0033], [0044]-[0045]).
Regarding claim 2, Cunningham discloses the first magnetic susceptibility is the same as the second magnetic susceptibility (the tracking device can have a first passive component with the same magnetic susceptibility as a second passive component, [0063]-[0064]).
Regarding claim 3, Cunningham discloses the image artifact created by the second passive marker is amplified when the first passive marker overlaps the second passive marker (the magnetic susceptibility is increased when the first passive component and the second passive component overlap as the magnetic susceptibility of the first passive component and the second passive component are each positive, e.g., paramagnetic, [0063]-[0064]).
Regarding claim 4, Cunningham discloses the first magnetic susceptibility is different than the second magnetic susceptibility (the second magnetic susceptibility is different than the first magnetic susceptibility, [0009]).
Regarding claim 5, Cunningham discloses the image artifact created by the second passive marker is attenuated when the first passive marker overlaps the second passive marker (the magnetic field disturbance in the image created by the first passive component is attenuated when the second passive component is axially aligned with the first passive component, [0008]-[0011], [0032]-[0033], [0044]-[0045]).
Regarding claim 6, Cunningham discloses the first material is the same as the second material (the tracking device can have a first passive component formed of a first material that is the same as the second material of the second passive component, [0063]-[0064]).
Regarding claim 7, Cunningham discloses the first material is different than the second material (the tracking device can have a first passive component formed of a first material that is different from the second material of the second passive component, [0009]).
Regarding claim 8, Cunningham discloses the first medical device comprises an elongate member, the first passive marker is disposed on the elongate member of the first medical device (the second tracking member comprises a first elongate annular sheath, the second passive component is disposed on the first elongate annular sheath of the second tracking member, [0008]-[0011], [0046]-[0047], Figs 2-3); and
the second medical device comprises an elongate member, the second passive marker is disposed on the elongate member of the second medical device (the first tracking member comprises a second elongate annular sheath, the first passive component is disposed on the second elongate annular sheath of the first tracking member, [0008]-[0011], [0046]-[0047], Figs 2-3).
Regarding claim 12, Cunningham discloses the first medical device and the second medical device can be used coaxially (the first tracking member and the second tracking member are disposed co-axially/concentrically, [0011]).
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 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Cunningham as applied to claim 8 above, and further in view of Paul et al. (U.S. Pub. No. 2020/0000545), hereinafter “Paul.”
Regarding claim 9, Cunningham does not appear to disclose the elongate member of the first medical device is formed of a third material that is different than the first material.
However, in the same field of endeavor of MRI tracking of interventional instruments, Paul teaches the elongate member of the first medical device is formed of a third material that is different than the first material (the elongate body of the outer sheath member is formed of a third material, titanium alloy/Nitinol, that is different than the first material, stainless steel, of the marker attached to the outer sheath member, [0048]-[0050], [0074]-[0075], [0077]).
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 Paul’s known technique of using a different material for the first elongate member than for the shorter first passive marker attached thereto to Cunningham’s known apparatus having a second elongated member comprising a second passive marker to achieve the predictable result that reducing the length of the markers compared to the length of the elongate member can prevent dephasing of blood. See, e.g., Paul, [0067].
Regarding claim 10, Cunningham does not appear to disclose the elongate member of the second medical device is formed of a fourth material that is different than the second material.
However, in the same field of endeavor of MRI tracking of interventional instruments, Paul teaches the elongate member of the second medical device is formed of a fourth material that is different than the second material (the elongate body of the core member is formed of a fourth material, titanium alloy/Nitinol, that is different than the second material, stainless steel, of the marker attached to the core member, [0048]-[0050], [0074]-[0075], [0077]).
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 Paul’s known technique of using a different material for the second elongate member than for the shorter second passive marker attached thereto to Cunningham’s known apparatus having a first elongated member comprising a first passive marker to achieve the predictable result that reducing the length of the markers compared to the length of the elongate member can prevent dephasing of blood. See, e.g., Paul, [0067].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Cunningham in further view of Paul as applied to claim 10 above, and further in view of Popowski (U.S. Pub. No. 2023/0414967), hereinafter “Popowski.”
Regarding claim 11, Cunningham does not appear to disclose the third material and the fourth material are titanium.
However, in the same field of endeavor of MRI tracking of interventional instruments, Paul teaches the third material and the fourth material comprise titanium (the elongate body of the outer sheath member has a third material and the elongate body of the core member has a fourth material formed of a titanium alloy, Nitinol, [0048]-[0050], [0074]-[0075], [0077]).
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 Paul’s known technique of using a different material for the first and second elongate member than for the shorter first and second passive markers attached respectively thereto to Cunningham’s known apparatus having a first elongate member comprising a first passive marker and a second elongate member comprising a second passive marker to achieve the predictable result that reducing the length of the markers compared to the length of the elongate member can prevent dephasing of blood. See, e.g., Paul, [0067].
However, Cunningham in further view of Paul does not appear to teach the third material and the fourth material are titanium.
However, in the same field of endeavor of MRI tracking of interventional instruments, Popowski teaches using titanium as a material for an elongate member (effector shaft is an elongate member formed of titanium, [0176], [0179], [0181]; see also imaging marker formed of a material different from the elongate member, [0131])
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 Popowski’s known technique of using titanium as a material for an elongate member to Cunningham in further view of Paul’s known apparatus comprising a first elongate member and a second elongate member to achieve the predictable result that selecting titanium as the material for the first elongate member and the second elongate member provides for biocompatibility of the elongate members when inserted into the body. See, e.g., Popowski, [0176] and [0179].
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 a plurality of MRI markers attached to an elongated member.
Cunningham et al. (U.S. Pub. No. 2012/0268127) discloses a plurality of MRI markers attached to an elongated member including paramagnetic and diamagnetic MRI markers.
Mareci et al. (U.S. Pub. No. 2012/0133363) discloses an MRI marker attached to an elongated member including paramagnetic and diamagnetic MRI markers.
Udale et al. (U.S. Pub. No. 2025/0025260) discloses an MRI marker attached to an elongated member including paramagnetic and diamagnetic MRI markers.
Udale et al. (U.S. Pub. No. 2025/0255693) discloses an MRI marker attached to an elongated member including paramagnetic and diamagnetic MRI markers.
Udale et al. (U.S. Pub. No. 2024/0310462) discloses an MRI marker attached to an elongated member including paramagnetic and diamagnetic MRI markers.
Van Vaals (U.S. Patent No. 6,430,429) discloses a plurality of MRI markers attached to an elongated member including paramagnetic MRI markers.
Wang et al. (U.S. Pub. No. 2005/0215874) discloses a plurality of MRI markers attached to an elongated member including paramagnetic MRI markers.
Weber et al. (U.S. Patent No. 5,728,079) discloses a plurality of MRI markers attached to an elongated member including paramagnetic MRI markers.
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/Johnathan Maynard/Examiner, Art Unit 3798
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