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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
FIGS. 3C and 3E: Although these figures include the label 891, this label is not found in the specification.
FIG. 11F: Although this figure includes the labels 120S and 121S, these labels are not found in the specification.
FIG. 25: Although this figure includes the label 244, this label is not found in the specification (see objection to paragraph [0158] below).
FIG. 26: Although this figure includes the label 248, this label is not found in the specification.
FIGS. 44C and 45C: Although these figures include the label 81C, this label is not found in the specification.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
FIGS. 2I and 2J: Although the specification states “With reference now to FIGS. 2I and 2J […] The proximal most edge portion 19 has a thickness, the distal-most edge portion 19D has a thickness, the first lateral-most edge portion 19R has a thickness, and the second lateral-most edge portion 33L has a thickness, where such edge portion thicknesses are less than the maximum thickness of the marker 19B” [0121], the label 33L does not appear within these figures.
FIG. 11A: Although the specification states “Referring now to FIG. 11A, shown is another embodiment of a medical device 100A […] The stylet 102 has a hub member 104 and an elongate member 106. The elongate member 106 has a proximal end 108, a distal end 110, an outer surface 112, and a main body 114 that defines a solid member with a distal tapered tip 116 with a cutting edge 118. The elongate member 106 includes a single marker 120 that extends along the entire length of the elongate member 106” [0198], this figure does not include the label 106.
FIGS. 27-30: Although the specification states “As shown in FIGS. 27 through 30, the first medical device 250 includes a first pattern of markers 273 and the second medical device includes a second pattern of markers 275” [0169], these figures do not include the labels 273 or 275.
FIG. 39C: Although the specification states “Shown in FIG. 39C is an embodiment in which the marker 81 is a tapered thickness marker 81B as discussed above, and in which the adjunct material layer 289 is in the form of an adjunct material layer 289B having a thickness that decreases from a larger maximum thickness, occurring within its peripheral edges, toward its peripheral edges having a smaller thickness” [0182], this figure does not include the label 289B.
FIG. 40A: Although the specification states “FIGS. 40A-C illustrate embodiments having an adjunct material layer 290 overtop a marker 81” [0183], FIG. 40A does not include the label 290, rather it includes the label 289.
FIGS. 44A-C: Although the specification states “FIGS. 44A-C illustrate embodiments in which a depression, for example a circumferential groove, has been formed within the elongate member 16 or 56 to receive the band marker 78. In certain forms as shown, the outer surface of the band member 78 can be flush with the outer surface portions of the elongate member 16 or 56 adjacent to the depression” [0189], these figures do not include the label 78, rather they include the label 81.
FIGS. 45A-C: Although the specification states “FIGS. 45A-C illustrate embodiments in which a depression, for example a circumferential groove, has been formed within the elongate member 16 or 56 to receive the band marker 78 and the adjunct layer 297” [0190], these figures do not include the label 78, rather they include the label 81.
FIG. 46: Although the specification states “By way of illustration, FIG. 46 shows an embodiment of device 50B in the form of a stylet 52. Device 50B can have the same features as device 50 and/or device 50A discussed above, except as otherwise described herein” [0195], this figure does not include the label 50B, rather it includes the label 58B.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0101]: As written it reads “materials (e.g., stainless steel) having a hardness of about 192 KSI […] PEEK, carbon-filled PEEK”. However, this is the first indication of the terms KSI and PEEK in the specification, therefore, the terms should be spelled out to provide clarity.
[0107]: As written it reads “typically in the range of about 500 ppm to about 1,000,000 and more preferably in the range of about 7000 ppm to about 100,000 (these values will be understood as positive values)”. However, the examiner believes there should be a unit (i.e. ppm) after 1,000,000 and 100,000.
[0149]: As written it reads “[…] Pebax, polyolefins, PEEL, FEP, or TFE […]”. However, this is the first indication of the terms PEEL, FEP, and TFE in the specification, therefore, the terms should be spelled out to provide clarity.
[0158]: As written it reads “In this example, the medical device 240 is an alternative embodiment of a cannula 242 that can be included in a medical system. The medical device 240 includes a first portion 242 formed as an outer lubricious layer, a second portion 242 formed as an intermediate layer and third portion 246 formed as an inner layer. The first portion 240 is formed of a first material, the second portion 242 is formed of a second material, and the third portion 246 is formed of a third material”. In this case, the label 242 is used to describe a cannula, a first portion and a second portion. The examiner would recommend utilizing different labels for each of these parts. Furthermore, the examiner believes that “a second portion 242” should be “a second portion 244” to match the labeling shown in FIG. 25. Additionally, the first portion has two different labels: 240 and 242. The examiner would recommend maintaining the same label for each instance of the term “first portion”.
[0158]: As written it reads “For example, the first material can be a polymer, the second material can be PFTE that includes magnetically susceptible particles (e.g., stainless steel powder), and the third material can be a polymer”. However, this is the first instance of the term PFTE therefore the term should be spelled out to provide clarity.
[0192]: As written it reads “Echogenic marker 298 in the illustrated form overlaps the passive MRI marker 17 and includes a plurality of dimples (see e.g. dimples 298a-298f) in the outer surface of the passive MRI marker 17 and elongate body 16”. However, the examiner believes “298f” should be “298h” in order to account for dimples 298g and 298h in FIG. 48C.
[0203]: As written it reads “The outer side surfaces of the medical device that will contact and travel against patient tissue, for example provided by outer side surfaces the elongate member and surfaces of the MRK marker(s) and/or when present surfaces of an adjunct material layer positioned over the passive MRI marker(s), can be coated with the lubricant film”. The examiner believes the term “MRK” is a typo which should instead be “MRI”.
[0252]: As written it reads “For example, a vascular procedure may be best performed with one sequence type during device tracking (e.g., rapid frame rate, lower resolution, enhancement of certain tissue characteristics) and another sequence type once the interventional devices have been advanced to the target site (e.g., higher resolution, enhancement of different tissue characteristics to detect lesions, such as inflammation, ADC)”, however this is the first indication of the term ADC therefore, the term should be spelled out to provide clarity.
Appropriate correction is required.
Claim Objections
Claims 1, 5, 25 and 26 are objected to because of the following informalities:
Regarding claim 1, as written it reads “at least one passive MRI marker, the at least one passive MRI marker comprising a second material, wherein the second material has a second magnetic susceptibility greater than the first magnetic susceptibility”. However, this is the first indication of the term “MRI” in the claims, therefore, the term should be spelled out to provide clarity.
Regarding claim 5, as written it reads “The medical device of claim 1 wherein the layer has edges with a thickness less than a maximum thickness of the layer”. However, the examiner notes that the term “a layer” is first introduced in claim 2. Therefore, the examiner recommends updating the dependency of claim 5 to be dependent from claim 2 to avoid antecedent basis issues.
Regarding claim 25, as written it reads “wherein the at least one passive MRI marker includes at least first and second said passive MRI markers longitudinally spaced from one another along the length of the elongate member”. However, the examiner believes that the word “markers” should be included after the phrase “first and second” (underlined above).
Regarding claim 26, the claim reads “wherein the at least one MRI marker is configured to […]”. However, claim 1, on which this claim depends, recites “at least one passive MRI marker”. Therefore, the examiner would recommend amending claim 26 to recite “[…] at least one passive MRI marker”.
Appropriate correction is required.
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.
Claims 4, 10, 21 and 73 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 4, as written it reads “wherein the second material is a metal comprising nickel; optionally, wherein the metal is nickel”. However, due to the term “optionally”, it is unclear what the second material actually requires nickel. The examiner recommends clarifying what metal is used as the second material and/or deleting the phrase “optionally, wherein the metal is nickel”.
Regarding claim 10, as written it reads “wherein the first material is a first metal, optionally wherein the first metal is an allow containing nickel and chromium”. However, due to the term “optionally”, it is unclear what the first material actually includes. Should the first metal require an allow containing nickel and chromium, the examiner would recommend deleting the term “optionally”.
Regarding claim 21, as written it reads “The medical device of claim 3, which is a cannula, stylet or needle”. However, it is unclear what is being referred to in this limitation. For example, it could be referring to: 1) the medical device as a whole, 2) the elongate member (see claim 2), or 3) the distal tapered tip of the elongate member (see claim 2). The examiner recommends clarifying what is meant by this limitation.
Regarding claim 73, as written it reads “[…] the second magnetic susceptibility that is different than, preferably greater than, the first magnetic susceptibility” However, due to the term “preferably” it is unclear whether the second magnetic susceptibility must be greater than the first magnetic susceptibility. The term “different than” encompasses magnetic susceptibility values that are less than the first magnetic susceptibility. The examiner recommends clarifying the value of the second magnetic susceptibility.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4, 6-7, 20, 73, and 80 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Van Vaals WO 00/33099 “Van Vaals”.
Regarding claim 1, Van Vaals teaches “A medical device, comprising:” (“Fig. 4 is a diagrammatic representation, in the form of a partly cut-away side elevation, of a second embodiment of the interventional instrument according to the invention. The indicator element of the interventional instrument shown in Fig. 4 includes a plurality of passive segments 53 and a plurality of active segments 54. The active segments are preferably made from a material having a magnetic susceptibility which deviates significantly from the magnetic susceptibility of the holder 2; for example, the active segments are made from a paramagnetic material, for example copper, manganese, chromium, nickel or notably gadolinium or dysprosium. The passive elements are made from a material having a very low magnetic susceptibility, such as plastic or a ceramic material” [Page 9, Lines 8-16]. Therefore, Van Vaals describes a medical device (i.e. interventional instrument).);
“an elongate member formed of a first material, the elongate member having a proximal end, a distal end, a length, an outside diameter, and an outer surface, wherein the first material has a first magnetic susceptibility” (See FIG. 4 and “The invention can be used for a solid interventional instrument as well as a hollow interventional instrument. Such a hollow interventional instrument includes a holder 2 in which a cylindrical cavity 3 is recessed so as to extend along the axis of the holder. […] The holder terminates as a needle-shaped tip at a distal end 6. […] The holder 2 is preferably made from a material having a very low magnetic susceptibility; for example, the holder 2 is made from plastic or a ceramic material” [Page 8, Lines 2-6, and 12-14]. As shown in FIG. 4, the interventional instrument 1 (i.e. medical device) includes an elongate member (i.e. holder 2) formed of a first material (i.e. plastic or ceramic), the elongate member having a proximal end (i.e. opposite to distal end 6), a distal end (i.e. 6), a length (i.e. between distal end and proximal end), an outside diameter (i.e. see larger portion of cylindrical cavity 3) and an outer surface (i.e. outside of holder 2), wherein the first material has a first magnetic susceptibility (i.e. very low magnetic susceptibility).);
“at least one passive MRI marker, the at least one passive MRI marker comprising a second material, wherein the second material has a second magnetic susceptibility greater than the first magnetic susceptibility” (See [Page 9, Lines 8-16] above and “With the exception of the indicator element of the interventional instrument, the components, such as the holder, preferably have a magnetic susceptibility which does not influence or only hardly influences the magnetic resonance image, whereas the indicator element has a magnetic susceptibility which is capable of strongly influencing the magnetic resonance image. It has been found that the interventional instrument can be clearly and accurately tracked in the magnetic resonance images when use is made of such an indicator element” [Page 4, Lines 12-18]; “The indicator element preferably includes a number of segments of different magnetic susceptibility. For example, the indicator element includes strips with segments in the form of parts of the strip of different materials with a different magnetic susceptibility” [Page 4, Lines 32-34]. Therefore, since the interventional instrument includes an indicator element with a number of segments of different magnetic susceptibility for use in clearly and accurately tracking the interventional instrument in magnetic resonance images, the interventional device includes at least one passive MRI marker, the at least one passive MRI marker comprising a second material, wherein the second material has a second magnetic susceptibility greater than the first magnetic susceptibility (i.e. differs significantly from magnetic susceptibility of the holder 2).).
Regarding claim 4, Van Vaals discloses all features of the claimed invention as discussed with respect to claim 1 above, and Van Vaals further teaches “wherein the second material is a metal comprising nickel; optionally, wherein the metal is nickel” (“The interventional instrument 1 is also provided with the indicator element 5 in the form of two paramagnetic strips 5 which are provided transversely of the axis of the lumen and in the vicinity of the distal end of the interventional instrument. The paramagnetic strips 5 are, for example strips 5 of a plastic compound such as polyurethane or nylon in which a paramagnetic material is included. Such a paramagnetic material is, for example copper, manganese, chromium, nickel or notably gadolinium or dysprosium” [Page 8, Lines 15-20]. Therefore, the second material is a metal comprising nickel; optionally, wherein the metal is nickel.).
Regarding claim 6, Van Vaals discloses all features of the claimed invention as discussed with respect to claim 1 above, and Van Vaals further teaches “also comprising a directly visible marker associated with the passive MRI marker” (See [Page 9, Lines 8-16] as discussed with respect to claim 1 above. Therefore, the medical device also comprises a directly visible marker (i.e. active segment 54) associated with the passive MRI marker (i.e. passive segments 53).).
Regarding claim 7, Van Vaals discloses all features of the claimed invention as discussed with respect to claim 6 above, and Van Vaals further teaches “wherein the directly visible marker at least partially co-extends with the passive MRI marker along the length of the elongate member and/or wherein the directly visible marker has a longitudinal length along the elongate member that is greater than that of the passive MRI marker” (See FIG. 4. As shown in FIG. 4, the passive segments 53 and active segments 54 (i.e. directly visible markers) extend along the length of the indicator element 5 included within the holder 2 (i.e. the elongate member). Therefore, the directly visible marker at least partially co-extends with the passive MRI marker along the length of the elongate member.).
Regarding claim 20, Van Vaals discloses all features of the claimed invention as discussed with respect to claim 1 above, and Van Vaals further teaches “wherein the passive MRI marker contains a volume of the second material not exceeding 1 mm3” (See [Page 9, Lines 8-16]. Since the passive segments 53 are made from material having a very low magnetic susceptibility, such as plastic or ceramic material, by definition these passive segments 53 (i.e. passive MRI marker) contain a volume of the second material not exceeding 1 mm3.).
Regarding claim 73, Van Vaals teaches “A method for making a medical device, comprising:” (See FIG. 4. In order to create the interventional instrument shown in FIG. 4, for example, a method had to have been followed. Therefore, Van Vaals inherently provides a method for making a medical device.);
“providing an elongate member formed of a first material, the elongate member having a proximal end, a distal end, a length, an outside diameter, and an outer surface, wherein the first material has a first magnetic susceptibility” (See FIG. 4; [Page 9, Lines 8-16]; [Page 8, Lines 2-6, and 12-14]. As shown in FIG. 4, the interventional instrument 1 (i.e. medical device) includes an elongate member (i.e. holder 2) formed of a first material (i.e. plastic or ceramic), the elongate member having a proximal end (i.e. opposite to distal end 6), a distal end (i.e. 6), a length (i.e. between distal end and proximal end), an outside diameter (i.e. see larger portion of cylindrical cavity 3) and an outer surface (i.e. outside of holder 2), wherein the first material has a first magnetic susceptibility (i.e. very low magnetic susceptibility). Therefore, the method involves providing an elongate member (i.e. holder) formed of a first material (i.e. plastic or ceramic), the elongate member having a proximal end (i.e. opposite to distal end 6), a distal end (i.e. 6), a length (i.e. between distal end and proximal end), an outside diameter (i.e. see larger portion of cylindrical cavity 3) and an outer surface (i.e. outside of holder 2), wherein the first material has a first magnetic susceptibility (i.e. very low magnetic susceptibility).).;
“forming at least one passive MRI marker on the elongate member, wherein the forming includes attaching a volume of a second material to the elongate member within a longitudinal length of no more than about 10 mm along the elongate member, the second material having a second magnetic susceptibility that is different than, preferably greater than, the first magnetic susceptibility” (See [Page 4, Lines 12-18]; and [Page 4, Lines 32-34]. Therefore, since the interventional instrument includes an indicator element with a number of segments of different magnetic susceptibility for use in clearly and accurately tracking the interventional instrument in magnetic resonance images, the interventional device includes at least one passive MRI marker, the at least one passive MRI marker comprising a second material, wherein the second material has a second magnetic susceptibility greater than the first magnetic susceptibility (i.e. differs significantly from magnetic susceptibility of the holder 2). Thus, the method involves forming at least one passive MRI marker on the elongate member, wherein the forming includes attaching a volume of a second material to the elongate member within a longitudinal length of no more than 10 mm along the elongate member, the second material having a second magnetic susceptibility that is different than, preferably greater than, the first magnetic susceptibility.).
Regarding claim 80, Van Vaals discloses all features of the claimed invention as discussed with respect to claim 1 above, and Van Vaals further teaches “A method for taking a tissue biopsy from a patient, comprising:” (“The interventional instrument may also be constructed as a biopsy needle for the removal of pieces of tissue from the body of the patient” [Page 8, Lines 11-12]. Therefore, since the interventional instrument may be constructed as a biopsy needle for removing a piece of tissue from the body of the patient, the interventional instrument carries out a method for taking a tissue biopsy from a patient.).
“positioning a cannula in a patient tissue volume, the cannula defining a lumen”; “causing a sample of tissue from the patient tissue volume to enter the lumen of the cannula”; “inserting a stylet into the lumen of the cannula; (See [Page 8, Lines 11-12] above, and “The invention can be used for a solid interventional instrument as well as a hollow interventional instrument. Such a hollow interventional instrument includes a holder 2 in which a cylindrical cavity 3 is recessed so as to extend along the axis of the holder. The cylindrical cavity 3 is referred to as the "lumen". The holder terminates as a needle-shaped tip at a distal end 6. The interventional instrument 1 is thus formed as a hollow needle. Thin cables or rods can be guided through the lumen; such cables or rods serve for the electrical or mechanical operation of a surgical instrument which can be coupled to the distal end of the interventional instrument”. [Page 8, Lines 2-9]. In order for the interventional instrument to be able to remove a piece of tissue from a patient, it had to have been positioned in a patient tissue volume. Therefore, the method involves positioning a cannula (i.e. cylindrical cavity 3) in a patient tissue volume, the cannula defining a lumen, causing a sample of tissue (i.e. piece of tissue) from the patient tissue volume to enter the lumen of the cannula and inserting a stylet (i.e. surgical instrument connected to cables or rods which are all guided through the lumen) into the lumen of the cannula.); and
“acquiring and displaying real-time or near real-time MR images including the patient tissue volume during said positioning and/or said causing” (“For example, magnetic resonance images are formed during the introduction of the interventional instrument, the interventional instrument then influencing the magnetic resonance images to a substantial degree so that the interventional instrument can be readily tracked in the magnetic resonance images. As a result, the interventional instrument is clearly reproduced in the magnetic resonance image so that the interventional instrument can be tracked within the body of the patient without being directly visible. The interventional instrument can thus be safely guided through the body of the patient without unnecessary damaging of tissue” [Page 2, Line 31-Page 3, Line 4]. Therefore, since magnetic resonance images are formed during the introduction of the interventional instrument such that its position can be readily tracked and safely guided through the body, the method involves acquiring and displaying real-time or near real-time MR images including the patient tissue volume during said positioning and/or said causing.).
“wherein at least one of the cannula and the stylet is a medical device according to claim 1” (See [Page 9, Lines 8-16]; [Page 8, Lines 2-6, and 12-14]; [Page 4, Lines 12-18]; [Page 4, Lines 32-34] as discussed with respect to claim 1 above.).
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Van Vaals WO 00/33099 “Van Vaals” as evidenced by University of British Columbia: Department of Earth, Ocean and Atmospheric Sciences “UBC EOAS”, "Part 2 Interpretation-Room temperature susceptibility", pages 36-44 (2026) “UBC EOAS”.
Regarding claim 8, Van Vaals discloses all features of the claimed invention as discussed with respect to claim 1 above, and Van Vaals further teaches “wherein the second material has a magnetic susceptibility of at least 7000 ppm” (See [Page 9, Lines 8-16] as discussed with respect to claim 1. Therefore, the active segments 54 are made of a second material made from copper, manganese, chromium, nickel, gadolinium or dysprosium. As evidenced by UBC EOAS, see specifically Table 2.2 Minerals and magnetic susceptibility, the mass specific magnetic susceptibility of nickel is 68,850 10-6 m3 Kg-1, wherein 10-6 m3 Kg-1 represents ppm (i.e. 68850 x 10-6 = 0.068850 m3 Kg-1; 1m3/Kg = 1 ppm when density is neglected, so 0.068850 x 106 = 68,850 ppm). Therefore, the second material has a magnetic susceptibility of at least 7000 ppm.).
Regarding claim 9, Van Vaals discloses all features of the claimed invention as discussed with respect to claim 8 above, and Van Vaals further teaches “wherein the first material has a magnetic susceptibility of less than 3000 ppm” (See [Page 9, Lines 8-16] and [Page 8, Lines 2-6, and 12-14] as discussed with respect to claim 1. Therefore, the passive elements 53 and the holder 2 are made of a first material comprising plastic or ceramic. As evidenced by UBC EOAS, see specifically Table 2.2 Minerals and magnetic susceptibility, the mass specific magnetic susceptibility of plastic is -0.005 10-6 m3 Kg-1, wherein 10-6 m3 Kg-1 represents ppm (i.e. -0.005 x 10-6 = -0.000000005 m3 Kg-1; 1m3/Kg = 1 ppm when density is neglected, so -0.000000005 x 106 = -0.005 ppm). Therefore, the second material has a magnetic susceptibility of at less than 3000 ppm.).
Claim Rejections - 35 USC § 103
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.
Claim(s) 2-3, 21, 25, 30, 67, 69, and 71-72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Vaals WO 00/33099 “Van Vaals” as applied to claim 1 above, and further in view of Gross et al. US 2022/0218392 A1 “Gross”.
Regarding claim 2, Van Vaals discloses all features of the claimed invention as discussed with respect to claim 1 above, and Van Vaals further teaches “wherein: the elongate member has a distal tapered tip with a cutting edge” (See FIGS. 2 and 4, as well as [Page 8, Lines 11-12] as discussed with respect to claim 80 above. As shown in FIGS. 2 and 4, the distal end 6 is a tapered tip (i.e. has a diameter which is less than the diameter of the proximal end. In order to perform a biopsy to remove a piece of tissue, it is necessary to perform a cut. Therefore, the tapered tip (see FIGS. 2 and 4) inherently includes a cutting edge to enable a biopsy to be performed.);
“the second material is a passive MRI marker-forming metal” (see [Page 9, Lines 8-16] as discussed with respect to claim 1 above. Since the material used in the active segments 54 can be made from paramagnetic material such as copper, manganese, chromium, nickel, gadolinium or dysprosium, the second material is a passive MRI marker forming metal.).
However, Van Vaals does not teach that “the passive MRI marker includes a layer of the passive MRI marker-forming metal over the outer surface of the elongate member”.
Gross is within the same field of endeavor as the claimed invention because it involves access devices, treatment devices and kits useful in performing treatment under magnetic resonance imaging (see [Abstract]).
Gross teaches that “the passive MRI marker includes a layer of the passive MRI marker-forming metal over the outer surface of the elongate member” (“In the illustrated embodiment, the elongate tubular member 12 is formed of an MRI compatible metal and has a plurality of passive markers 30 disposed along the axial length 17 of the elongate tubular member 12 and at the distal end 16 that allow for visualization of the elongate tubular member 12 in a magnetic resonance image and for device conspicuity without obscuring target tissue during treatment (e.g., biopsy, removal). […] Markers of the plurality of passive markers 30 are advantageously formed of a magnetically susceptible material, such as a paramagnetic material or a ferromagnetic material” [0038]. As shown in FIGS. 1 and 2, the passive markers 30 are over the outer surface of the elongate tubular member 12 (i.e. elongate member). Since the passive markers are formed of a magnetically susceptible material such as a paramagnetic material or ferromagnetic material (i.e. paramagnetic materials including copper, manganese, chromium, nickel, gadolinium or dysprosium, see Van Vaals: [Page 9, Lines 8-16]), the passive MRI marker includes a layer of the passive MRI marker-forming metal over the outer surface of the elongate member.).
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 medical device of Van Vaals such that the passive MRI marker includes a layer of the passive MRI marker-forming metal over the outer surface of the elongate member as disclosed in Gross in order to allow for visualization of the elongate tubular member in the magnetic resonance image (See Gross: [0038]). Including a passive marker on the outside of an elongate member is one of a finite number of techniques which can be used to visualize the elongate member with a reasonable expectation of success. Thus, modifying the medical device of Van Vaals such that the passive MRI marker includes a layer of the passive MRI marker-forming metal over the outer surface of the elongate member as disclosed in Gross would yield the predictable result of allowing for visualization of the elongate tubular member in the magnetic resonance image.
Regarding claim 3, Van Vaals in view of Gross discloses all features of the claimed invention as discussed with respect to claim 2 above, and Gross further teaches “wherein: the layer of the passive MRI marker-forming metal has a thickness not exceeding about 0.03 mm; and/or the layer of the passive MRI marker-forming metal is a plated layer of the passive MRI marker-forming metal” (See Gross: [0038] as discussed with respect to claim 2 above. As shown in FIGS. 1 and 2, the passive markers 30 are included on the outer surface of the elongate tubular member 12 (i.e. elongate member). In order to attach the passive markers 30 (i.e. which are formed of a paramagnetic material (i.e. nickel, see Van Vaals: [Page 9, Lines 8-16])) to the elongate tubular member 12, the passive markers 30 must be plated to the elongate tubular member 12. Therefore, the layer of the passive MRI marker-forming metal (i.e. passive marker 30) is a plated layer of the passive MRI marker-forming metal.).
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 medical device of Van Vaals such that the layer of the passive MRI-marker-forming metal is a plated layer of the passive MRI marker-forming metal as disclosed in Gross in order to allow for visualization of the elongate tubular member in the magnetic resonance image (See Gross: [0038]). Including a passive marker made of a passive MRI marker-forming metal which is a plated layer of passive MRI marker-forming metal (i.e. such as nickel, see Van Vaals: [Page 9, Lines 8-16]) on the outer surface of an elongate member is one of a finite number of techniques which can be used to visualize the elongate member with a reasonable expectation of success. Thus, modifying the medical device of Van Vaals such that the layer of the passive MRI-marker-forming metal is a plated layer of the passive MRI marker-forming metal as disclosed in Gross would yield the predictable result of allowing for visualization of the elongate tubular member in the magnetic resonance image.
Regarding claim 21, Van Vaals in view of Gross discloses all features of the claimed invention as discussed with respect to claim 3 above, and Van Vaals further teaches “which is a cannula, stylet or needle” (“The holder terminates as a needle-shaped tip at a distal end 6. The interventional instrument 1 is thus formed as a hollow needle” [Page 8, Lines 6-7]. Therefore, the interventional instrument (i.e. medical device) is a cannula/needle.).
Regarding claim 25, Van Vaals in view of Gross discloses all features of the claimed invention as discussed with respect to claim 21 above, and Van Vaals further teaches “wherein the at least one passive MRI marker includes at least first and second said passive MRI markers longitudinally spaced from one another along the length of the elongate member” (See FIGS. 2 and 4. As shown in FIG. 2, the segments 51 and 52 are longitudinally spaced from one another along the length of the elongate member (i.e. the indicator element 5 included within the holder 2). As shown in FIG. 4, the passive segments 53, as well as the active segments 54, are longitudinally spaced from one another along the length of the elongate member (i.e. the indicator element 5 included within the holder 2).);
“wherein the first passive MRI marker contains a greater volume of the second material than the second passive MRI marker” (See FIG. 2 and “For example, the indicator element is a paramagnetic strip which may include several segments of different magnetic susceptibility” [Abstract]); “Such a paramagnetic material is, for example copper, manganese, chromium, nickel or notably gadolinium or dysprosium” [Page 8, Lines 19-20]. As shown in FIG. 2, the segments 51 are wider and longer than the segments 52, thus the segments 51 contain a greater volume of the second material (i.e. paramagnetic material) than the segments 52 (i.e. second passive MRI marker). Therefore, the first passive MRI marker (i.e. segments 51) contains a greater volume of the second material than the second passive MRI marker (i.e. segments 52).).
Regarding claim 30, Van Vaals discloses all features of the claimed invention as discussed with respect to claim 1 above, and Van Vaals further teaches “wherein the second material is [...] of nickel” (See Van Vaals: [Page 9, Lines 8-16] as discussed with respect to claim 1. Therefore, since the active segments are made from paramagnetic material such as nickel. The second material is nickel.).
However, Van Vaals does not teach that the second material “is a plated layer” “on the outer surface of the elongate member”.
Gross teaches that the second material “is a plated layer” “on the outer surface of the elongate member” (See Gross: [0038] as discussed with respect to claim 2 above. As shown in FIGS. 1 and 2, the passive markers 30 are included on the outer surface of the elongate tubular member 12 (i.e. elongate member). In order to attach the passive markers 30 (i.e. which are formed of a paramagnetic material (i.e. nickel, see Van Vaals: [Page 9, Lines 8-16])) to the elongate tubular member 12, the passive markers 30 must be plated to the elongate tubular member 12. Therefore, the second material is a plated layer on the outer surface of the elongate member.).
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 medical device of Van Vaals such that the second material is a plated layer of nickel on the outer surface of the elongate member as disclosed in Gross in order to allow for visualization of the elongate tubular member in the magnetic resonance image (See Gross: [0038]). Including a passive marker made of plated layer of nickel on the outer surface of an elongate member is one of a finite number of techniques which can be used to visualize the elongate member with a reasonable expectation of success. Thus, modifying the medical device of Van Vaals such that the second material is a plated layer of nickel on the outer surface of the elongate member as disclosed in Gross would yield the predictable result of allowing for visualization of the elongate tubular member in the magnetic resonance image.
Regarding claim 67, Van Vaals in view of Gross discloses all features of the claimed invention as discussed with respect to claim 21 above, and Van Vaals further teaches “A medical system, comprising a stylet which is a medical device according to claim 21, and a cannula having a lumen for receiving the stylet” (See [Page 8, lines 2-9] as discussed with respect to claim 80 above. Therefore, Therefore, Van Vaals discloses a medical system comprising a stylet (i.e. surgical instrument connected to cables/rods) which is a medical device according to claim 21 and a cannula (i.e. cylindrical cavity 3), the cannula having a lumen for receiving the stylet (i.e. surgical instrument).
Regarding claim 69, Van Vaals in view of Gross discloses all features of the claimed invention as discussed with respect to claim 21 above, and Van Vaals further teaches “A medical system, comprising a cannula which is a medical device according to claim 21, and a stylet, the cannula having a lumen for receiving the stylet” (See [Page 8, lines 2-9] as discussed with respect to claim 80 above. Therefore, Van Vaals discloses a medical system comprising a cannula (i.e. cylindrical cavity 3) which is a medical device according to claim 21 and a stylet (i.e. surgical instrument connected to cables/rods), the cannula having a lumen for receiving the stylet (i.e. surgical instrument).).
Regarding claim 71, Van Vaals in view of Gross discloses all features of the claimed invention as discussed with respect to claim 69 above, and Van Vaals further teaches “wherein the stylet is free from any passive MRI marker” (See [Page 8, Lines 2-9] as discussed in claim 80 above. In this case the surgical instrument represents the stylet. Since the cables or rods connected to the surgical instrument (i.e. stylet) are used for electrical or mechanical operation and travel through the lumen of the cylindrical cavity 3 (i.e. wherein the indicator elements 5 (i.e. 51/52 in FIG. 2, 53-54 in FIG. 4) are outside the cylindrical cavity 3), the stylet is free from any passive MRI marker.).
Regarding claim 72, Van Vaals discloses all features of the claimed invention as discussed with respect to claim 1 above, Van Vaals teaches “the system of claim 69” (See [Page 8, lines 2-9] as discussed with respect to claim 80 above.)
However, Van Vaals does not teach “A medical kit, including a package containing the system of claim 69”.
Gross teaches “A medical kit, including a package containing the system of claim 69” (“FIG. 15 illustrates an exemplary kit 700 comprising an access device 702 according to an embodiment, such as access device 10 illustrated in FIGS. 1 and 2; a first treatment device 704 according to an embodiment, such as treatment device 110 illustrated in FIGS. 3 and 4; a second treatment device 706 according to an embodiment, such as treatment device 210 illustrated in FIGS. 5 and 6; a third treatment device 708 according to an embodiment, such as treatment device 310 illustrated in FIGS. 7 and 8; and instructions for use 710” [0105]; “While kit 700 has been illustrated as including one access device 702 and three treatment devices 704, 706, and 708, any suitable number, and type, of access devices and/or treatment devices can be included in a kit. Selection of a suitable number of access devices and/or treatment devices to include in a kit according to a particular embodiment can be based on various considerations, such as the treatment intended to be performed.” [0106]. Therefore, Gross describes a medical kit including a package containing various access devices and treatment devices for use in performing an MRI guided treatment.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the system disclosed in Van Vaals into the kit described in Gross in order to allow a user to have the option of using the system of Van Vaals when performing a treatment within a patient. Accessing a kit with a variety of devices included therein is one of a finite number of techniques which can be used to simplify the treatment process by allowing a user to select devices based on the desired treatment. Thus, incorporating the system (see claim 69) of Van Vaals into the kit described in Gross would yield the predictable result of allowing a user the option of utilizing the system of Van Vaals when performing a treatment within a patient.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Vaals WO 00/33099 “Van Vaals” as applied to claim 1 above, and further in view of McHale et al. US 7,972,350 B2 “McHale”.
Regarding claim 5, Van Vaals discloses all features of the claimed invention as discussed with respect to claim 1 above, however Van Vaals does not teach “wherein the layer has edges with a thickness less than a maximum thickness of the layer; and wherein the edges include at least a proximally-facing edge and a distally-facing edge, the proximally-facing edge and distally-facing edge each having a thickness less than the maximum thickness of the layer”.
McHale is within a related field of endeavor to the claimed invention because it involves a catheter tip which includes markers such as radiopaque markers and MRI markers (see [Abstract]).
McHale teaches “wherein the layer has edges with a thickness less than a maximum thickness of the layer; and wherein the edges include at least a proximally-facing edge and a distally-facing edge, the proximally-facing edge and distally-facing edge each having a thickness less than the maximum thickness of the layer” (See FIG. 2 and “Markers 32 may comprise radiopaque markers, MRI markers, and the like. Markers 32 may be of any suitable shape and desirably comprise circumferential bands, as depicted in FIGS. 2 and 3” [Column 5, Lines 24-27]; “MRI markers 32 may be any suitable material, and desirably a ferro-magnetic, superparamagnetic or paramagnetic material in such a quantity that the magnetic field surrounding the catheter tip 20 is disturbed enough to visualize the marker 32 on a magnetic resonance imaging system, such as gadolinium, iron or manganese containing alloys” [Column 5, Line 62-Column 6, Line 1]; “A balloon 44 generally includes a proximal waist portion 54 and a distal waist portion 56. A balloon 44 can be coupled at its proximal waist portion 54 to an outer catheter shaft 40, and at its distal waist portion 56 to the catheter tip 20 distal shaft portion 42. The length of the balloon 44 may be substantially coextensive with the catheter tip 20 main shaft portion” [Column 4, Line 56-62].
As shown in FIG. 2, the markers 32 are included within the balloon 44 and the balloon 44 has a proximal waist portion 54 and distal waist portion 56 (i.e. edges) which have thicknesses which are less than a maximum thickness of the balloon 44 (i.e. middle of the balloon 44). Therefore, the balloon represents a layer that has edges with a thickness less than a maximum thickness of the layer; and wherein the edges include at least a proximally-facing edge (i.e. proximal waist portion 54) and a distally-facing edge (i.e. distal waist portion 56), the proximally-facing edge and distally-facing edge each having a thickness less than the maximum thickness of the layer.).
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 layer over the at least one passive MRI marker of Van Vaals such that the layer has edges with a thickness less than a maximum thickness of the layer and wherein the edges include at least a proximally-facing edge and a distally-facing edge, the proximally-facing edge and distally-facing edge having a thickness less than the maximum thickness of the layer as disclosed in McHale in order to protect the passive MRI marker(s). A balloon/layer is one of a finite number of techniques which can be used to protect a passive MRI marker included within a catheter with a reasonable expectation of success. Thus, modifying the layer over the at least one passive MRI marker of Van Vaals such that the layer has edges with a thickness less than a maximum thickness of the layer and wherein the edges include at least a proximally-facing edge and a distally-facing edge, the proximally-facing edge and distally-facing edge having a thickness less than the maximum thickness of the layer as disclosed in McHale would yield the predictable result of protecting the passive MRI marker(s) as the catheter moves through the body of a patient.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Vaals WO 00/33099 “Van Vaals” as applied to claim 1 above, and further in view of Gross et al. US 2022/0218392 A1 “Gross” as evidenced by McClements, Dean; Austenitic Stainless Steel: Definition, Composition, Types, Grades, Properties and Applications; (August, 18, 2023), Xometry “McClements”.
Regarding claim 10, Van Vaals discloses all features of the claimed invention as discussed with respect to claim 1 above, however Van Vaals does not teach “wherein the first material is a first metal, optionally wherein the first metal is an alloy containing nickel and chromium”.
Gross teaches “wherein the first material is a first metal, optionally wherein the first metal is an alloy containing nickel and chromium” (“Examples of MRI compatible materials considered suitable to form an elongate tubular member, elongate member, and/or a tubular member include biocompatible materials, materials that can be made biocompatible, metals, electrically insulating materials, electrically non-conducting materials, non-magnetic materials, shape memory alloys, including nickel-titanium alloys such as Nitinol, stainless steel, including Austenitic stainless steel, stainless steel containing Iron, stainless steel including Inconel, 316 stainless steel, cobalt chromium, cobalt chromium alloys, Inconel, titanium, thermoplastics, polymers, PEEK, carbon-filled PEEK, ceramics, the materials described herein, combinations of the described herein, and any other material considered suitable for a particular embodiment” [0057].
According to McClements, austenitic stainless steel includes Iron (Fe) which is enhanced with often significant portions of key elements including chromium (i.e. accounting for between 16% and 26% of the steel by mass) and nickel (i.e. accounting for 6% to 22% of the steel by mass) (see McClement: [Page 3: What is Austenitic Stainless Steel made of?]). Furthermore, McClements discloses that 316 Stainless steel is composed of chromium (16-18%), nickel (10-14%) and molybdenum (2-3%) and is widely used in medical instruments (see McClements: [Page 5: 2. 316 Stainless Steel]).
Therefore, since the elongate tubular member, elongate member, and/or a tubular member can be constructed of a biocompatible metal such as stainless steel including Austenitic stainless steel and 316 stainless steel (i.e. which contain nickel and chromium) the first material is a first metal, optionally wherein the first metal is an alloy containing nickel and chromium.).
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 first material included in the elongate member of Van Vaals such that it is a first metal, such as an allow that contains nickel and chromium as disclosed in Gross and as evidenced by McClements) in order to allow the elongate member to be both tough and ductile (i.e. flexible) as well as hygienic and easy to clean (as evidenced by McClements: [Page 5: 2. 316 Stainless Steel]: “Stainless steel 316 is non-magnetic in the annealed condition, offers superior corrosion resistance compared to 304, exhibits good high-temperature strength and creep resistance, retains its toughness and ductility at low temperatures and is hygienic and east to clean”).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Vaals WO 00/33099 “Van Vaals” as applied to claim 1 above, and further in view of McErlean et al. US 2022/0160427 A1 “McErlean”.
Regarding claims 11, Van Vaals discloses all features of the claimed invention as discussed with respect to claim 1 above, however Van Vaals does not teach “also comprising an adjunct material layer on the elongate member at least partly positioned over the passive MRI marker”.
McErlean is within a related field of endeavor to the claimed invention because it involves passive markers which are covered with any radiopaque material (See [0181]).
McErlean teaches the medical device “also comprising an adjunct material layer on the elongate member at least partly positioned over the passive MRI marker” (“A passive marker can be covered with any material preferably any radiopaque material” [0181]. Therefore, since a radiopaque material is provided to cover a passive marker, the medical device also comprises an adjunct material layer on the elongate member at least partially over the passive MRI marker.).
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 medical device of Van Vaals such that it further comprises an adjunct material layer (i.e. radiopaque material) on the elongate member at least partially positioned over the passive MRI marker as disclosed in McErlean in order to allow for the passive marker to be easily visualized. A radiopaque marker is one of a finite number of devices which can be incorporated into a device to make it easily viewable with a reasonable expectation of success. Thus, modifying the medical device of Van Vaals such that it further comprises an adjunct material layer (i.e. radiopaque material) on the elongate member at least partially positioned over the passive MRI marker as disclosed in McErlean would yield the predicable result of enabling the elongate member containing the passive markers to be easily viewed when a magnetic resonance image is obtained.
Regarding claim 12, Van Vaals in view of McErlean discloses all features of the claimed invention as discussed with respect to claim 11 above, and McErlean further teaches “wherein the adjunct material layer is configured to provide a directly visible marker” (See [0181] as discussed with respect to claim 11 above. The radiopaque material represents an adjunct material layer which is configured to provide a directly visible marker.).
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 medical device of Van Vaals such that it further comprises an adjunct material layer (i.e. radiopaque material) on the elongate member at least partially positioned over the passive MRI marker, wherein the adjunct material layer is configured to provide a directly visible marker, as disclosed in McErlean in order to allow for the passive marker to be easily visualized. A radiopaque marker is one of a finite number of devices which can be incorporated into a device to make it easily viewable with a reasonable expectation of success. Thus, modifying the medical device of Van Vaals such that it further comprises an adjunct material layer (i.e. radiopaque material) on the elongate member at least partially positioned over the passive MRI marker as disclosed in McErlean would yield the predicable result of enabling the elongate member containing the passive markers to be easily viewed when a magnetic resonance image is obtained.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Vaals WO 00/33099 “Van Vaals” and Gross et al. US 2022/0218392 A1 “Gross” as applied to claim 2 above, and further in view of Toth et al. US 2017/0209389 A1 “Toth” as evidenced by AB Technology Group; "Silicone Oils/Fluid", (2014).
Regarding claim 17, Van Vaals in view of Gross discloses all features of the claimed invention as discussed with respect to claim 2 above, and Gross further teaches “also comprising a lubricant film providing an outermost surface over the elongate member” (“Optionally, an elastic polymeric sleeve or jacket can be positioned on an outer surface of the elongate tubular member that is moveable with the elongate tubular member between a first, unexpanded configuration and a second, expanded configuration. The polymeric sleeve can extend the along the entire axial length of the elongate tubular member, or along a portion of the axial length of the elongate tubular member. […] Optionally the polymeric sleeve can be coated with a lubricious agent to reduce friction during use, as described herein” [0037]. Therefore, since an elastic polymeric sleeve coated with a lubricious agent is positioned on an outer surface over the elongate member, the medical device also comprises a lubricant film providing an outermost surface over the elongate member.).
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 medical device of Van Vaals such that it also comprises a lubricant film providing an outermost surface over the elongate member (i.e. elastic polymeric sleeve with a lubricous agent, see Gross: [0037]) as disclosed in Gross in order to reduce the amount of friction that the elongate member experiences as it travels through a patient. Including a lubricous agent on the outermost surface of an elongate member is one of a finite number of techniques which can be used to reduce friction with a reasonable expectation of success. Thus, modifying the medical device of Van Vaals such that it also comprises a lubricant film providing an outermost surface over the elongate member (i.e. elastic polymeric sleeve with a lubricous agent, see Gross: [0037]) as disclosed in Gross would yield the predictable result of reducing the amount of friction that the elongate member experiences as it travels through a patient.
Van Vaals in view of Gross does not teach “wherein the lubricant film comprises a non-drying oil”.
Toth is within a related field of endeavor to the claimed invention because it involves an elongate member which is provided with a lubricating substance (see [0219], [0226]).
Toth teaches “wherein the lubricant film comprises a non-drying oil” (“In aspects, one or more regions of a probe or elongate member in accordance with the present disclosure may be coated with a substance and/or treated so as to be lubricious in the presence of water. Some non-limiting examples of such coatings include a hydrophilic coating, a silicone coating, a PTFE coating, parylene, a ceramic, PEBAX, a hydrogel, etc.” [0219]; “The catheter 226 is shown with a lumen 242 running substantially the length thereof, for delivery of a composition there through. A wall of the lumen 242 may be lubricated, and may include a lubricating substance (e.g., a PTFE liner, a silicone oil fluid, a hydrophilic layer, etc.) so as to help with passage of the composition there along during delivery to a target site in a body” [0226]. By definition, a non-drying oil is an oil that does not harden, polymerize or form a solid film when exposed to air.
As evidenced by AB Technology Group; "Silicone Oils/Fluid", (2014), silicone oil represents a non-drying oil because it is non-reactive and thermally stable (i.e. experiences minimum change in physical properties over a broad temperature range) (See [Page 2: US-O-150]). Therefore, since the elongate member may be coated with a substance such as a silicone coating and a silicone oil fluid is an example of a silicone coating, the lubricant film comprises a non-drying oil.).
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 lubricant film (i.e. lubricant agent) of Gross such that it is a non-drying oil, such as silicone oil, as disclosed in Toth, as evidenced by AB Technology Group; "Silicone Oils/Fluid", (2014), in order to effectively lubricate the elongate body such that it moves easily through a patient’s body. A non-drying oil, such as silicone oil, is one of a finite number of lubricants which can be applied to an elongate member such that it moves easily through tissue with a reasonable expectation of success. Thus, modifying the lubricant film (i.e. lubricant agent) of Gross such that it is a non-drying oil, such as silicone oil, as disclosed in Toth would yield the predictable result of effectively lubricating the elongate body such that it moves easily through a patient’s body.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Vaals WO 00/33099 “Van Vaals” and Gross et al. US 2022/0218392 A1 “Gross” as applied to claim 2 above, and further in view of Fearnot et al. US 2022/0218389 A1 “Fearnot”.
Regarding claim 18, Van Vaals in view of Gross discloses all features of the claimed invention as discussed with respect to claim 2 above, however, Van Vaals and Gross do not teach “wherein the second material is in the form of a layer that extends completely around a circumference of the elongate member”.
Fearnot is within the same field of endeavor as the claimed invention because it involves a medical device for performing treatment under magnetic resonance imaging (See [Abstract]).
Fearnot teaches “wherein the second material is in the form of a layer that extends completely around a circumference of the elongate member” (“The cannula 112 includes a plurality of markers 144. In the illustrated embodiment, a first marker 146 of the plurality of makers 144 is disposed between the proximal end 120 and the distal end 122 of the cannula 112 and a second marker 148 of the plurality of markers 144 is disposed between the first marker 146 and the proximal end 120 of the cannula 112. Each marker of the plurality of markers 144 is attached to the cannula 112 and is formed of a magnetically susceptible material, such as a paramagnetic material or a ferromagnetic material. The first marker 146 is disposed circumferentially about main body 124 of the cannula 112 and comprises a stainless steel marker band” [0051]. Therefore, since the first marker 146 is formed of a paramagnetic or ferromagnetic material such as a stainless steel marker band which is disposed circumferentially about main body 124 (i.e. elongate body), the second material is in the form of a layer that extend completely around a circumference of the elongate member.).
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 second material of Van Vaals such that it is in the form of a layer that extends completely around a circumference of the elongate member as disclosed in Fearnot in order to allow the elongate member to be viewable in any direction. When a passive marker is in the form of a layer that extends completely around a circumference of the elongate member, the elongate member can be viewed no matter what orientation it is in relative to an imager being used. Thus, modifying the second material of Van Vaals such that it is in the form of a layer that extends completely around a circumference of the elongate member as disclosed in Fearnot would yield the predictable result of enabling the elongate member to be viewable in any direction relative to the location of an imager being used.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Vaals WO 00/33099 “Van Vaals” and Gross et al. US 2022/0218392 A1 “Gross” as applied to claim 21 above, and further in view of Arnholt et al. US 2023/0218894 A1 “Arnholt”.
Regarding claim 26, Van Vaals in view of Gross discloses all features of the claimed invention as discussed with respect to claim 1 above, however, the combination does not teach “wherein the at least one MRI marker is configured to create a visible artifact having a maximum dimension (i) in the range of about 1.5 times to about 50 times the outside diameter of the elongate member; and/or (i) of about 0.5 cm to about 3 cm”.
Arnholt is within a related field of endeavor to the claimed invention because it involves implantable electrodes with reduced MRI artifacts (see [Title]).
Arnholt teaches “wherein the at least one MRI marker is configured to create a visible artifact having a maximum dimension (i) in the range of about 1.5 times to about 50 times the outside diameter of the elongate member; and/or (i) of about 0.5 cm to about 3 cm” (“The presence of metals in implanted medical devices can also contribute to artifacts in MRI signals collected to monitor a course of treatment, leading to visual distortion of the images obtained at or near the site of the implantable medical device components. MRI artifacts in data signals can confound the data analysis process when determining progression or regression of a cancerous tumor” [0004]; “the one or more electric field generating electrodes can be configured to reduce metal-induced magnetic resonance imaging artifacts” [0008]; “Various electrode structures are described herein that are configured to reduce the thickness of metal in the electrode, and thus reduce the extent of the MRI artifact at the cancerous tumor site to allow for more accurate visualization of the tumor structures near the implantable electrodes” [0062]; “In various embodiments, the electrodes suitable for reducing metal-induced magnetic resonance imaging artifacts can include those such as a ribbon wire, a walled tube, or a sputter metallic electrode as will be discussed in reference to FIGS. 9-20, which show cross-sectional views of the distal most electrode 108 of the various leads embodied herein” [0081]; “The first ribbon segments 902 and second ribbon segments 1002 can have a ribbon segment thickness 904 (or a thickness in a radial direction with respect to the lead body) and a ribbon segment width 906. While not intending to be bound by theory, the thickness 904 directly impacts the size of the MRI or imaging artifact. As such, in various embodiments, the thickness 904 can be sufficiently small to avoid significantly sized MRI or imaging artifacts allowing for a better view of the tissue and/or cancerous tumor within the patient” [0085]; “The length of the entire electrodes 108 created with ribbon wires can be greater than or equal to 0.5 centimeters (cm) to 5 cm. In some embodiments, the length of the can be greater than or equal to 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 2.5 cm, 3.0 cm, 3.5 cm, 4.0 cm, 4.5 cm, or 5.0 cm, or can be an amount falling within a range between any of the foregoing. In some embodiments, the length can be from 1 cm to 3 cm. In some embodiments, the electrodes 108 created with ribbon wires can have a length of about 2 cm” [0088].
As shown in FIG. 9, the electrode 108 includes ribbon segments 902 with a ribbon segment thickness 904 that directly impacts the size of the MRI or imaging artifact (see [0085]), wherein the length of the entire electrode 108 created with the ribbon wires (i.e. ribbon segments 902) is within the range of 0.5 cm-5 cm (i.e. amount falling within a range between any of the foregoing, 0.5-3 cm, see [0088]). Therefore, since the length of the electrode 108 may be within the range of 0.5 cm-5 cm (i.e. 0.5-3 cm, see [0088]) and the thickness (i.e. 904) of the ribbon segments 902 included within the electrode 108 have a thickness that is sufficiently small to avoid significantly sized MRI or imaging artifacts, the electrode 108 represents at least one MRI marker which is configured to create a visible artifact having a maximum dimension of about 0.5 cm to about 3 cm.).
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 at least one passive MRI marker of Van Vaals is configured to create a visible artifact having a maximum dimension of about 0.5 cm to about 3 cm as disclosed in Arnholt in order to reduce the extent of the MRI artifact at a cancerous tumor site/tissue to allow for more accurate visualization of a tumor structures/a better view of tissue (see Arnholt: [0062], [0085]). Including at least one passive MRI marker sized to create a visible artifact having a maximum dimension of about 0.5 cm to about 3 cm is one of a finite number of techniques which can be used to allow for visualization of the marker while also viewing tissue with a reasonable expectation of success. Thus, modifying the at least one passive MRI marker of Van Vaals is configured to create a visible artifact having a maximum dimension of about 0.5 cm to about 3 cm as disclosed in Arnholt would yield the predictable result of reducing the extent of the MRI artifact at a cancerous tumor site/tissue to allow for more accurate visualization of tumor structures/a better view of tissue (see Arnholt: [0062], [0085]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wenstrom JR. et al. US 2012/0041442 A1 “Wenstrom” is pertinent to the applicant’s disclosure because it discloses “As previously stated, the device 10 also includes a cutting element 18 that is formed on a distal portion 13 of the elongate member 12. The cutting element 18, which is shown in more detail in FIGS. 2A-2C, can have any configuration and it can be disposed anywhere on the elongate member, but it should be effective to remove bone to form a notch adjacent to or within an opening of a bone tunnel” [0028].
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