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
The amendment filed on 08/07/2026 has been entered. Claims 1-13 have been amended. Claim 14 is cancelled. Claims 15-21 are newly presented. Thus, claims 1-13 and 15-21 remain pending in the application.
Claim Objections
Claims 9 and 21 are objected to because of the following informalities: The claims state “the inner metal tube has inner diameter dimensions of 0.81mm and the outer metal tube has outer diameter dimensions of 1.62mm”. However, because there is only a singular dimension listed for both the inner diameter and the outer diameter, the examiner suggests modifying the claims to fix issues of plurality. The examiner suggests rewriting the claims to state, “the inner metal tube has an inner diameter dimensionan outer diameter dimension. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: The word “provide” in the first line of the claim should be modified to “provides” for proper grammar as it follows the singular “at least one tracking coil”.
Claim 20 is objected to because of the following informalities: The status of the claim is incorrectly listed as “(Currently Amended)” where it should have been listed as “(New)”.
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, 5-8, 13, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins et al. (WIPO International Publication No. WO 2010/148083 A2; herein, Jenkins), and further in view of Fill et al. (United States Patent Application Publication No. US 2015/0305770 A1; herein, Fill), Mitsuhashi et al. (United States Patent Application Publication No. US 2017/0071568 A1; herein, Mitsuhashi), and Sabbah (United States Patent Application Publication No. US 2009/0259210 A1).
Regarding claim 1, Jenkins discloses a magnetic resonance imaging (MRI) tracked injection needle device (medical device 100) comprising: an injection needle (FIG. 8, injection needle is made up of an elongated sheath 112, an elongated dilator 120, and an elongated needle 130) comprising a shaft (FIG. 4 to FIG. 9A, shaft is the main body of the elongated sheath 112, elongated dilator 120, and elongated needle 130 that stretches between one end and another) having a needle distal end (FIG. 9A, distal end 130a) and a needle proximal end (FIG. 7, proximal end 130b), the shaft comprising concentric tubes (FIG. 10, needle 130 and dilator 120 are concentric) comprising an inner tube (FIG. 10, elongated needle 130) and an outer metal tube (FIG. 10, dilator 120), the needle proximal end coupled to the electrical adaptor (FIG. 16, proximal parts of the elongated needle and shaft assembly connect to an electrical connector interface 168) and the needle distal end terminating at a tip (FIG. 9A, needle tip 130t) and comprising one or more tracking coils (RF tracking coils 150). Parts of the tracking coils can also be found between the outer diameter of the inner tube and the outer diameter of the outer tube (FIG. 9B and FIG. 10, pg. 27 lines 21-22, Dilator wall 123 is between the outer edge of elongated needle 130 and outer edge of dilator 120. The RF tracking coils are typically embedded within the dilator wall, which is interpreted by the examiner as being arranged between the inner and outer tube).
Jenkins does not explicitly disclose a luer syringe; an electrical connector that is at least partially housed in an interior space of a distal end of the luer syringe; an electrical adaptor coupled to the electrical connector; and the concentric inner and outer tubes being made of metal, and the tracking coils being arranged between the inner metal tube and the outer metal tube at the needle distal end.
However, Fill teaches an injection needle (FIG. 13, entirety of tool 200) with concentric tubes (FIG. 13, needle 10 and sheath 26 are concentric, with needle 10 acting as the inner tube and sheath 26 acting as the outer tube) and comprising one or more tracking coils (tracking coil 20) arranged between the inner tube and the outer tube at the needle distal end (FIG. 13, [0080], tracking coil 20 is arranged between the sheath 26 and needle 10 and is located at the distal end of the tool 200 near the needle tip). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the MRI-tracked injection needle device as disclosed by Jenkins to locate the tracking coil between the inner tube and outer tube at the distal end of the device as taught by Fill in order to secure the tracking coil and enhance tracking accuracy by placing the tracking coil relative to the distal end ([0080]).
Jenkins in view of Fill still does not explicitly disclose a luer syringe; an electrical connector that is at least partially housed in an interior space of a distal end of the luer syringe; an electrical adaptor coupled to the electrical connector; and the concentric inner and outer tubes being made of metal.
However, Mitsuhashi teaches a luer syringe (FIG. 1, syringe S); an electrical connector (FIG. 4, connector unit 165) that is at least partially housed in an interior space of a distal end of the luer syringe (FIG. 4); an electrical adaptor coupled to the electrical connector (annotated on FIG. 4 below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the MRI-tracked injection needle device as disclosed by Jenkins to include a syringe as taught by Mitsuhashi in order to supply the system with a liquid that supports the medical imaging process ([0054]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the MRI-tracked injection needle device as disclosed by Jenkins to include an electrical connector and adaptor as taught by Mitsuhashi in order to mechanically and electrically connect to an external imaging apparatus ([0046]).
Jenkins in view of Fill and Mitsuhashi still does not explicitly disclose the concentric inner and outer tubes being made of metal.
However, Sabbah teaches the inner and outer tubes being made of metal (Fig. 2E, [0062], [0067], outer tube 40 and inner tube 50 are concentric and both tubes may be made of metal). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner and outer tubes of the MRI-tracked injection needle device as disclosed by Jenkins to be made of metal as taught by Sabbah in order to provide a desired balance of longitudinal stiffness and torsional rigidity for the outer tube ([0062]) and to be advanced and withdrawn through the outer lumen and to communicate fluid for the inner tube ([0067]).
Regarding claim 5, in the modified device of Jenkins, Jenkins discloses cables connected to one or more tracking coils (coaxial cables 160).
The primary embodiment of Jenkins does not explicitly disclose the needle distal end further comprising flexible printed circuit board connected by cables.
However, an alternative embodiment of Jenkins teaches the needle distal end further comprising flexible printed circuit board (pg. 20 lines 12-33, tuning circuit 83 can reside on the intrabody device 80) connected by cables (FIG. 32, pg. 20 lines 12-33, coaxial cable connects circuit to tracking coil at one end, and other end of circuit connects to MRI Scanner). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the MRI-tracked injection needle device as disclosed by the modified Jenkins to include a flexible printed circuit board connected to the tracking coils by cables as taught by the alternative embodiment of Jenkins in order to help stabilize the tracking signal for faster system identification of spatial coordinates (pg. 20 lines 13-14).
Regarding claim 6, in the modified device of Jenkins, Jenkins discloses the one or more tracking coils provide electrical tracking signals representative of location information of the tip (pg. 27 lines 30-33, RF tracking coils 150 provide signals of dilator distal end 120a).
The primary embodiment of Jenkins does not explicitly disclose the flexible printed circuit board transmits the electrical tracking to a receiver of a MRI scanner.
However, an alternative embodiment of Jenkins teaches the flexible printed circuit board transmits the electrical tracking to a receiver of a MRI scanner (pg. 20 lines 12-33, tracking coil data passes through tuning circuit back to MR Scanner). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the MRI-tracked injection needle device as disclosed by the modified Jenkins to include a flexible printed circuit board that transmits tracking signals to a MRI scanner as taught by the alternative embodiment of Jenkins in order to help stabilize the tracking signal for faster system identification of spatial coordinates (pg. 20 lines 13-14).
Regarding claim 7, in the modified device of Jenkins, Jenkins discloses the needle distal end further comprising a protective heat shrink to provide water insulation for the one or more tracking coils and cables (FIG. 8, sheath 112).
Regarding claim 8, in the modified device of Jenkins, Jenkins does not explicitly disclose the concentric metal tubes are composed of titanium.
However, Sabbah teaches the concentric metal tubes are composed of titanium ([0062], [0067], Outer tube 40 and inner tube 50 may be made of nitinol, which contains titanium. The examiner interprets the use of “composed of” in the claim to be interpreted in the same manner of “consisting essentially of”, meaning the scope of the claim is limited to the specified materials and materials that do not materially affect the basic and novel characteristics of the claimed invention (MPEP 2111.03)). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner and outer tubes of the MRI-tracked injection needle device as disclosed by Jenkins to be comprised of titanium as taught by Sabbah in order to provide a desired balance of longitudinal stiffness and torsional rigidity for the outer tube ([0062]) and to be advanced and withdrawn through the outer lumen and to communicate fluid for the inner tube ([0067]). Further, it is known in the art that nitinol is considered MR compatible due to its non-ferromagnetic nature.
Regarding claim 13, Jenkins discloses a method for fabricating a magnetic resonance imaging (MRI)-tracked injection needle device (medical device 100): the injection needle (FIG. 8, injection needle is made up of an elongated sheath 112, an elongated dilator 120, and an elongated needle 130) comprising a shaft (FIG. 4 to FIG. 9A, shaft is the main body of the elongated sheath 112, elongated dilator 120, and elongated needle 130 that stretches between one end and another) having a needle distal end (FIG. 9A, distal end 130a) and a needle proximal end (FIG. 7, proximal end 130b), the shaft comprising concentric metal tubes (FIG. 10, needle 130 and dilator 120 are concentric) comprising an inner tube (FIG. 10, elongated needle 130) and an outer tube (FIG. 10, dilator 120), the needle proximal end coupled to the electrical adaptor (FIG. 16, proximal parts of the needle and shaft assembly connect to an electrical connector interface 168) and the needle distal end terminating at a tip (FIG. 9A, needle tip 130t); disposing at least one tracking coil of electrical conductor (RF tracking coils 150); and providing an electrical output to the at least one tracking coil (FIG. 16). Parts of the tracking coils can also be found between the outer diameter of the inner tube and the outer diameter of the outer tube (FIG. 9B and FIG. 10, pg. 27 lines 21-22, Dilator wall 123 is between the outer edge of elongated needle 130 and outer edge of dilator 120. The RF tracking coils are typically embedded within the dilator wall, which is interpreted by the examiner as being arranged between the inner and outer tube).
Jenkins does not explicitly disclose attaching an injection needle to a syringe, the concentric inner and outer tubes being made of metal, and the tracking coils being between the inner metal tube and the outer metal tube at the needle distal end.
However, Fill teaches an injection needle (FIG. 13, entirety of tool 200) with concentric tubes (FIG. 13, needle 10 and sheath 26 are concentric, with needle 10 acting as the inner tube and sheath 26 acting as the outer tube) and disposing at least one tracking coil of electrical conductor (tracking coil 20) between the inner tube and the outer tube at the needle distal end (FIG. 13, [0080], tracking coil 20 is arranged between the sheath 26 and needle 10 and is located at the distal end of the tool 200 near the needle tip). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the MRI-tracked injection needle device as disclosed by Jenkins to locate the tracking coil between the inner tube and outer tube at the distal end of the device as taught by Fill in order to secure the tracking coil and enhance tracking accuracy by placing the tracking coil relative to the distal end ([0080]).
Jenkins in view of Fill still does not explicitly disclose attaching an injection needle to a syringe, the concentric inner and outer tubes being made of metal
However, Mitsuhashi teaches attaching an injection needle to a syringe (FIG. 1, syringe S connects at port 162 which attaches on the same hub 160 as diagnostic imaging catheter 100). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of fabricating an MRI-tracked injection needle device as disclosed by the Jenkins to attach a syringe as taught by Mitsuhashi in order to supply the system with a liquid that supports the medical imaging process ([0054]).
Jenkins in view of Fill and Mitsuhashi still does not explicitly disclose the concentric inner and outer tubes being made of metal.
However, Sabbah teaches the inner and outer tubes being made of metal (Fig. 2E, [0062], [0067], outer tube 40 and inner tube 50 are concentric and both tubes may be made of metal). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner and outer tubes of the MRI-tracked injection needle device as disclosed by Jenkins to be made of metal as taught by Sabbah in order to provide a desired balance of longitudinal stiffness and torsional rigidity for the outer tube ([0062]) and to be advanced and withdrawn through the outer lumen and to communicate fluid for the inner tube ([0067]).
Regarding claim 18, in the modified method of Jenkins, Jenkins discloses cables connected to one or more tracking coils (coaxial cables 160).
The primary embodiment of Jenkins does not explicitly disclose providing a flexible printed circuit board in the needle distal end that is connected by cables to the at least one tracking coil.
However, an alternative embodiment of Jenkins teaches providing a flexible printed circuit board in the needle distal end (pg. 20 lines 12-33, tuning circuit 83 can reside on the intrabody device 80) that is connected by cables to the at least one tracking coil (FIG. 32, pg. 20 lines 12-33, coaxial cable connects circuit to tracking coil at one end, and other end of circuit connects to MRI Scanner). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method for fabricating a MRI-tracked injection needle device as disclosed by the modified Jenkins to include a flexible printed circuit board connected to the tracking coils by cables as taught by the alternative embodiment of Jenkins in order to help stabilize the tracking signal for faster system identification of spatial coordinates (pg. 20 lines 13-14).
Regarding claim 19, in the modified device of Jenkins, Jenkins discloses at least one tracking coil provides electrical tracking signals representative of location information of the tip (pg. 27 lines 30-33, RF tracking coils 150 provide signals of dilator distal end 120a).
The primary embodiment of Jenkins does not explicitly disclose the flexible printed circuit board transmits the electrical tracking to a receiver of a MRI scanner.
However, an alternative embodiment of Jenkins teaches the flexible printed circuit board transmits the electrical tracking to a receiver of a MRI scanner (pg. 20 lines 12-33, tracking coil data passes through tuning circuit back to MR Scanner). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method for fabricating a MRI-tracked injection needle device as disclosed by the modified Jenkins to include a flexible printed circuit board that transmits tracking signals to a MRI scanner as taught by the alternative embodiment of Jenkins in order to help stabilize the tracking signal for faster system identification of spatial coordinates (pg. 20 lines 13-14).
Regarding claim 20, in the modified method of Jenkins, Jenkins discloses forming a protective heat shrink to the needle distal end to provide water insulation for the at least one tracking coil and cables (FIG. 8, pg. 22 lines 31-34, sheath 112 is sealed around device).
Claims 2, 10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins in view of Fill, Mitsuhashi, and Sabbah as applied to claims 1 and 13 above, and further in view of Jacobs (United States Patent No. US 6,402,677 B1).
Regarding claim 2, in the modified device of Jenkins, Jenkins does not explicitly disclose the needle distal end further comprising two holes cut into the outer metal tube to permit MRI signals to be obtained from more than one orientation of the injection needle.
However, Jacobs teaches the needle distal end further comprising two holes cut into the outer metal tube to permit MRI signals to be obtained from more than one orientation of the injection needle (Fig. 14, slots 230B, 230C). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the MRI-tracked injection needle device as disclosed by the modified Jenkins to include two holes on the needle distal end as taught by Jacobs in order to prevent the user from having to orient the needle in a particular way to visualize (col. 6 lines 36-48).
Regarding claim 10, in the modified device of Jenkins, Jenkins does not explicitly disclose the outer metallic tube contains groves of defined dimensions and at specific locations in order to increase or decrease the trajectory linearity or deviation when the injection needle is inserted into a specific tissue.
However, Jacobs teaches the outer metallic tube contains groves of defined dimensions and at specific locations in order to increase or decrease the trajectory linearity or deviation when the injection needle is inserted into a specific tissue (Fig. 14, slots 230A, 230B, 230C). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the MRI-tracked injection needle device as disclosed by the modified Jenkins to include grooves on the outer tube as taught by Jacobs in order to prevent the user from having to orient the needle in a particular way to visualize (col. 6 lines 36-48), which would help support positioning based on the intended trajectory.
Regarding claim 15, in the modified method of Jenkins, Jenkins does not explicitly disclose forming two holes in the outer metal tube at the needle distal end to permit MRI signals to be obtained from more than one orientation of the injection needle.
However, Jacobs teaches forming two holes in the outer metal tube at the needle distal end to permit MRI signals to be obtained from more than one orientation of the injection needle (Fig. 14, slots 230B, 230C). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method for forming a MRI-tracked injection needle device as disclosed by the modified Jenkins to include two holes on the needle distal end as taught by Jacobs in order to prevent the user from having to orient the needle in a particular way to visualize (col. 6 lines 36-48).
Claims 3, 4, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins in view of Fill, Mitsuhashi, and Sabbah as applied to claims 1 and 13 above, and further in view of Ibragimov (United States Patent Application Publication No. US 2015/0305769 A1).
Regarding claim 3, in the modified device of Jenkins, Jenkins does not explicitly disclose the tip is a beveled tip.
However, Ibragimov teaches the tip is a beveled tip (FIG. 6, [0054], straight beveled tip 220). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the MRI-tracked injection needle device as disclosed by the modified Jenkins to include a bevel tip as taught by Ibragimov in order to support the trajectory of the device by penetrating necessary soft tissue ([0042]).
Regarding claim 4, in the modified device of Jenkins, Jenkins does not explicitly disclose the beveled tip has a 30° bevel. However, Ibragimov teaches a bevel of the tip between 10°- 40° [0054]. Ibragimov does not explicitly disclose the beveled tip being 30° bevel. Yet, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bevel of Ibragimov from between 10°-40° to 30° since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” (MPEP 2144.05 (I)). Further, applicant appears to have placed no criticality on the claimed bevel. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the MRI-tracked injection needle device as disclosed by the modified Jenkins to include a 30° bevel tip as taught by Ibragimov in order to support the trajectory of the device by penetrating necessary soft tissue ([0042]).
Regarding claim 16, in the modified method of Jenkins, Jenkins does not explicitly disclose the tip is a beveled tip.
However, Ibragimov teaches the tip is a beveled tip (FIG. 6, [0054], straight beveled tip 220). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method for fabricating a MRI-tracked injection needle device as disclosed by the modified Jenkins to include a bevel tip as taught by Ibragimov in order to support the trajectory of the device by penetrating necessary soft tissue ([0042]).
Regarding claim 17, in the modified method of Jenkins, Jenkins does not explicitly disclose the beveled tip has a 30° bevel. However, Ibragimov teaches a bevel of the tip between 10°- 40° [0054]. Ibragimov does not explicitly disclose the beveled tip being 30° bevel. Yet, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bevel of Ibragimov from between 10°- 40° to 30° since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” (MPEP 2144.05 (I)). Further, applicant appears to have placed no criticality on the claimed bevel. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method for fabricating a MRI-tracked injection needle device as disclosed by the modified Jenkins to include a 30° bevel tip as taught by Ibragimov in order to support the trajectory of the device by penetrating necessary soft tissue ([0042]).
Claims 9 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins in view of Fill, Mitsuhashi, and Sabbah as applied to claims 1 and 13 above, and further in view of Ragg (United States Patent Application Publication No. US 2018/0169294 A1).
Regarding claim 9, in the modified device of Jenkins, Jenkins does not explicitly disclose the inner metal tube has inner diameter dimensions of 0.81mm and the outer metal tube has outer diameter dimensions of 1.62mm. However, Ragg teaches the inner diameter of the inner tube is between 0.3-1.6 mm, more preferably 0.4-1.0 mm and even more preferably 0.5-0.8 mm ([0054],[0060]). Ragg also teaches the outer diameter of the outer tube is between 1.3 mm and 3.3 mm ([0054],[0061]). Ragg does not explicitly disclose the inner metal tube has inner diameter dimensions of 0.81mm and the outer metal tube has outer diameter dimensions of 1.62mm. Yet, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dimensions of Ragg from between 0.3mm-1.6mm for the inner diameter of the inner tube and 1.3mm-3.3mm for the outer diameter of the outer tube to 0.81mm for the inner tube and 1.62mm for the outer tube since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” (MPEP 2144.05 (I)). Further, applicant appears to have placed no criticality on the claimed dimensions. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner and outer tubes of the MRI-tracked injection needle device as disclosed by modified Jenkins for the inner tube to have an inner diameter dimension of 0.81mm and the outer metal tube to have an outer diameter dimension of 1.62mm as taught by Ragg in order to properly fit within designated soft tissue or veins (Figure 2a).
Regarding claim 21, in the modified method of Jenkins, Jenkins does not explicitly disclose the inner metal tube has inner diameter dimensions of 0.81mm and the outer metal tube has outer diameter dimensions of 1.62mm. However, Ragg teaches the inner diameter of the inner tube is between 0.3-1.6 mm, more preferably 0.4-1.0 mm and even more preferably 0.5-0.8 mm ([0054],[0060]). Ragg also teaches the outer diameter of the outer tube is between 1.3 mm and 3.3 mm ([0054],[0061]). Ragg does not explicitly disclose the inner metal tube has inner diameter dimensions of 0.81mm and the outer metal tube has outer diameter dimensions of 1.62mm. Yet, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dimensions of Ragg from between 0.3mm-1.6mm for the inner diameter of the inner tube and 1.3mm-3.3mm for the outer diameter of the outer tube to 0.81mm for the inner tube and 1.62mm for the outer tube since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” (MPEP 2144.05 (I)). Further, applicant appears to have placed no criticality on the claimed dimensions. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner and outer tubes of the MRI-tracked injection needle device as disclosed by modified Jenkins for the inner tube to have an inner diameter dimension of 0.81mm and the outer metal tube to have an outer diameter dimension of 1.62mm as taught by Ragg in order to properly fit within designated soft tissue or veins (Figure 2a).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Jenkins in view of Fill, Mitsuhashi, and Sabbah as applied to claim 1 and over Jenkins in view of Fill, Mitsuhashi, Sabbah, and Jacobs as applied to claim 10 above, and further in view of Schmidt et al. (WIPO International Publication No. WO 2019/040395 A1; herein, Schmidt).
Regarding claim 11, in the modified device of Jenkins, Jenkins does not explicitly disclose an insulator layer arranged on an exterior surface of the outer metal tube.
However, Schmidt teaches an insulator layer arranged on an exterior surface of the outer metal tube (FIG. 5E, [0059], outer layer 506 formed from an insulator). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the MRI-tracked injection needle device as disclosed by the modified Jenkins to include an insulator exterior to the outer tube as taught by Schmidt in order to protect the solenoid from electrical problems and damage ([0059]).
Regarding claim 12, in the modified device of Jenkins, Jenkins does not explicitly disclose the shaft further comprises a loosely wound solenoid that is connected in series to a thin film capacitor that is separated by an insulator layer with one end of the solenoid and one end of the thin film capacitor connected to the outer metal tube to reduce MRI radio-frequency induced heating of the shaft.
However, Schmidt teaches the shaft further comprises a loosely wound solenoid (FIG. 2C, FIG. 5E, leaky solenoidal coil 508) that is connected in series to a capacitor (FIG. 5E, capacitor 510) that is separated by an insulator layer (FIG. 5E, [0059], outer layer 506 formed from an insulator) with one end of the solenoid and one end of the capacitor connected to the outer metal tube to reduce MRI radio-frequency induced heating of the shaft ([0059], entire device is for MRI radio frequency amelioration). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the MRI tracked injection needle device as disclosed by the modified Jenkins to include an insulator exterior to the outer tube wrapped in a loosely wound solenoid connected to a capacitor as taught by Schmidt in order to provide amelioration of MRI radio-frequency induced heating for metallic catheters ([0003]).
Jenkins in view of Fill, Mitsuhashi, Sabbah and further in view of Schmidt still does not disclose the capacitor is a thin film capacitor.
However, an alternative embodiment of Schmidt teaches a thin film capacitor (FIG. 7F, thin film capacitor). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the capacitor taught by the primary embodiment of Schmidt in MRI-tracked injection needle device as disclosed by the modified Jenkins to specify the capacitor as a thin film capacitor as taught by the alternative embodiment Schmidt in order to allow the entire tracking coil to have a thickness of ~0.2 mm, which is required in order to maintain the smaller outer diameter of the guidewire ([0064]).
Response to Arguments
Applicant’s arguments, see pages 7-12 of Applicant’s Remarks, with respect to claims 1 and 13 have been considered but are moot because the arguments do not apply in view of the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new grounds 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 Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
Prosecution Insights