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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/28/2026 has been entered.
Response to Arguments
Applicant’s arguments in Applicant’s responses filed 07/28/2026 with respect to the rejections of claims 17, 29 and 33 under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Specifically, newly found prior art Bellinson, S., US 5135006 A, which teaches the amended limitations, has been applied in combination with prior art Herman, et al., US 20200113646 A1 to teach all the limitations of all the claims.
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.
Claims 17, 19-24, 28-30, and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Herman, et al., US 20200113646 A1 in view of Bellinson, S., US 5135006 A.
Regarding claim 17, Herman teaches a hook-wire for localization (tracking wire flexible tracking wire 932 of fig. 9 and [0252] as part of a “slidable delivery control” configuration [0202] of a tissue localization device 900) of a tumor in a breast (Herman teaches the intended use, stating in [0312] that “IG. 18A illustrates that the localization element 930 deployed into the tissue 1800 of a patient can encircle or radially surround at least part of a suspect tissue mass 1802. For example, the tissue 1800 can include breast tissue or lung tissue”), comprising:
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an elongate member with a proximal end and a distal end (Reproduced fig. 9 above shows the tracking wire 932 including a proximal end and a distal end);
at least one hook (localization element 930 shown in reproduced fig. 9 above) at the distal end of the elongate member (see reproduced fig. 9 above. [0252] also states that “The tissue localization device 900 can also include a localization element 930 and a flexible tracking wire 932 coupled to the localization element 930. The tracking wire 932 can have a wire distal segment 934 including a wire distal end 936 and a wire proximal segment 938 including a wire proximal end 940”), configured for insertion in a constrained state into a needle and expansion when exiting said needle ([0020] states that “The localization element can be constrained into a first configuration when within the needle lumen. The localization element can transform into a second configuration when deployed out of the delivery needle. The second configuration can be a circular shape. The second configuration can also be a half-circle shape, a crescent shape, a falciform shape, or a sickle-shape”) in order to anchor the tumor in said breast ([0312] states that “IG. 18A illustrates that the localization element 930 deployed into the tissue 1800 of a patient can encircle or radially surround at least part of a suspect tissue mass 1802. For example, the tissue 1800 can include breast tissue or lung tissue”);
wherein the elongate member and the at least one hook are formed by at least two metal wires which are twisted around each other continuously from the proximal end to the distal end and terminating each at said distal end ([0320] states that “FIG. 20A illustrates that the tracking wire 932 can be fabricated from a cable that is composed of a number of filaments 2000. For example, the cable of the tracking wire 932 can comprise or be composed of a multi-filament (e.g., 19-filament) wire, where each filament is composed of stainless steel, tungsten, or other material”) with a free curved portion forming the at least one hook (the curved localization element 930, see fig. 9 above, forms a hook at the end of the tracking wire 932); and
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a sheathing on the elongate member ([0277] states that “A polymer jacketing 1132 can cover or ensheath at least part of the tracking wire 932. The polymer jacketing 1132 can also cover or ensheath the attachment site 1130”) forming a reading surface with indicia, said reading surface extending over at least 70% of a length of the elongate member between the proximal end and the distal end ([0322] states that “The polymer jacketing 1132 can also be used to identify lengths of the tracking wire 932. For example, an additional layer of the polymer jacketing 1132 can be disposed around an approximately 3 cm long portion of the tracking wire 932 at a distal end of the wire 932. The additional layer of jacketing 1132 can change the feel of the wire 932 to a surgeon using the tracking wire 932 to locate a target tissue site, identifying to the surgeon when he/she is approaching the distal end of the tracking wire 932. Additional layers of the jacketing 1132 may be disposed at other locations along the tracking wire 932, such as every 2 cm along its length. One or more metallic ferrules (e.g. stainless steel, tantalum) may be placed at one or more locations along the length of the tracking wire 932 (e.g. beneath the polymer jacketing) to signify various levels of proximity to the localization element 930. Other depth marking methods may include printing or the use of different colored polymer segments”. That is, the polymer jacketing forms a reading surface with the change in feel of the wire 932 to signify when the surgeon’s approach to the distal end AND also as the depth markings at 2cm intervals),
wherein the indicia are distributed along the elongated member at fixed intervals ([0322] states that “Additional layers of the jacketing 1132 may be disposed at other locations along the tracking wire 932, such as every 2 cm along its length”), wherein the indicia are colored with a different color ([0322] further states that “One or more metallic ferrules (e.g. stainless steel, tantalum) may be placed at one or more locations along the length of the tracking wire 932 (e.g. beneath the polymer jacketing) to signify various levels of proximity to the localization element 930. Other depth marking methods may include printing or the use of different colored polymer segments”).
While Herman does not explicitly indicate that the coloring is after each two intervals, Herman states in [0278] that “Additional layers of the jacketing 1132 may alternatively be disposed at other locations along the tracking wire 932, such as every 2 cm along its length. Alternatively, one or more metallic ferrules (e.g. stainless steel, tantalum) may be placed at one or more locations along the length of the tracking wire 932 (e.g. beneath the polymer jacketing) to signify various levels of proximity to the localization element 930. Other depth marking methods may include printing or the use of different colored polymer segments”. That is, Herman recognizes different indicia marking methods or configurations for identifying and demarcating the location or boundary (e.g. the posterior margin) of the suspect tissue mass 1802 for further analysis or excision [0269].
Furthermore, such modification would be applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. See MPEP 2143(I)(D). That is, one of ordinary skill in the art would have recognized that providing the coloring after each two intervals would also improve the visibility of the indicia and hence improve their identification.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Herman such that the coloring is after each two intervals, as such modification would improve the identification of lengths of the tracking wire 932 to locate the target tissue site ([0278]).
Herman fails to teach wherein the indicia further comprise Arabic numbers distributed over the colored indicia; and wherein the indicia comprise a first colored interval at a distal end of the sheathing, followed by a repeating pattern of an Arabic numeral over a colored hatching interval and an Arabic numeral over a colored interval, and wherein intervals beyond the repeating pattern comprise blank intervals alternating with Arabic numerals.
However, within the same field of endeavor, Bellinson teaches a method and apparatus for monitoring the location of a fetus in a birth canal during labor using conductors of a fetal monitor probe, such as a fetal heartbeat monitor electrode, that are marked with calibration means corresponding to predetermined distances from a babyward end of the probe (see abstract and reproduced figs. 2 and 3 below). Col. 2, lines 1-13 notes that the wires could be encased in a jacket of sufficient thickness to print actual numbers on. Thus, the jacketing could be graduated in centimeters similarly to a meter stick. Alternatively, thin marks could be made on the conductor means in a coded system. Another approach would be to apply colored or distinctively sized silicone beads to the conductors. A conventional probe could be calibrated in the delivery-room by slipping a calibrated sheath over the conductors. A moveable clip could also be used to mark the starting position at the vaginal introitus. Col. 3, lines 53-58 disclose that As in FIG. 3, probe 2 is depicted stretched along these marks from probe end 11 at mark 200 past mark 220. Numerals 300-320 designate the distances from probe end 11 by Arabic numbers "0-20" printed upon marks 200-220. Words 321 are also printed on the legend, describing the colors. As depicted in fig. 3, the indicia further comprise Arabic numbers distributed over the colored indicia; and the indicia comprise a first colored interval at a distal end of the sheathing, followed by a repeating pattern of an Arabic numeral over a colored hatching interval and an Arabic numeral over a colored interval, and wherein intervals beyond the repeating pattern comprise blank intervals alternating with Arabic numerals.
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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 invention to configure Herman, wherein the indicia further comprise Arabic numbers distributed over the colored indicia; and wherein the indicia comprise a first colored interval at a distal end of the sheathing, followed by a repeating pattern of an Arabic numeral over a colored hatching interval and an Arabic numeral over a colored interval, and wherein intervals beyond the repeating pattern comprise blank intervals alternating with Arabic numerals, as taught by Bellinson, such modification would allow precise assessment of region of interest and its location and improve patient outcomes (col. 1, lines 30-44).
Regarding claim 19, Herman in view of Bellinson teaches all the limitations of claim 17.
While the “slidable delivery control” configuration relied upon above disclose in [0270] that “The localization element 930 can be a flexible length of metal or wire, a flexible length of polymer, a flexible length of shape-memory material, or combinations thereof. The localization element 930 can take on an arcuate, curvilinear, or looping shape when deployed out of the delivery needle 906”, it does not teach wherein the at least one hook includes at least two hooks, and wherein the at least two hooks, in the expended state, are evenly angularly distributed around a main axis of the elongate member.
However, in a modification to the “slidable delivery control” of the localization element 930 above, Herman further discloses a “branched distal segment” configuration (see reproduced annotated fig. 17 below) which teaches wherein the at least one hook includes at least two hooks, and wherein the at least two hooks, in the expended state, are evenly angularly distributed around a main axis of the elongate member ([0325] states that “the delivery needle 906 can be rotated about a longitudinal axis of the delivery needle 906 (e.g., to achieve a desired deployment path for the localization element 930), and the localization element 930 can be redeployed out of the delivery needle 906 into the tissue”, hence when [0311] states that “FIG. 17 illustrates that the localization element 930 can have a branched distal segment 1700. As shown in FIG. 17, the branched distal segment 1700 can be an instance of the locator distal end 1102 having two or more sharpened locator tips 1104. For example, when the branched distal segment 1700 has two sharpened locator tips 1104, the two sharpened locator tips 1104 can diverge at an angle away from one another”, the diverging of the two tips 1104 (see reproduced fig. 17 below) is occurring from the longitudinal axis, that is, main axis, of the delivery needle 906. Of note, the flexible tracking wire 932 shares this longitudinal axis, since the wire 932 is threading within a lumen of the delivery needle 906).
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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 invention to configure “slidable delivery control” configuration of Herman ([0270]) wherein the at least one hook includes at least two hooks, and wherein the at least two hooks, in the expended state, are evenly angularly distributed around a main axis of the elongate member, as taught by the “branched distal segment” configuration, to allow the localization element 930 to more securely anchor into the tissue of the patient, and also can more fully delineate the tissue site in three dimensions ([0311]), with a reasonable expectation of success, as the “slidable delivery control” configuration of Herman also strives to accurately and removably place a localization or marking device into a patient to demarcate a region of tissue for subsequent surgical removal ([0006]).
Regarding claim 20, Herman in view of Bellinson teaches all the limitations of claim 17.
While the “slidable delivery control” configuration relied upon above disclose in [0270] that “The localization element 930 can be a flexible length of metal or wire, a flexible length of polymer, a flexible length of shape-memory material, or combinations thereof. The localization element 930 can take on an arcuate, curvilinear, or looping shape when deployed out of the delivery needle 906”, it does not teach wherein the at least one hook includes at least two hooks, and wherein the free curved portion of each of the at least two hooks forms, from the distal end of the elongate member to a free end of said hook, a quarter of a circle.
However, in a modification to the “slidable delivery control” of the localization element 930 above, Herman further discloses a “branched distal segment” configuration (see reproduced annotated fig. 17 above) which teaches wherein the at least one hook includes at least two hooks, and wherein the free curved portion of each of the at least two hooks forms, from the distal end of the elongate member to a free end of said hook, a quarter of a circle (see annotated reproduced fig. 17 above that shows the distal tips 1104 and 1106 negotiating a quarter of a circle turn from along the longitudinal axis to an axis perpendicular to the longitudinal axis).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure the “slidable delivery control” configuration of Herman ([0270]) wherein the at least one hook includes at least two hooks, and wherein the free curved portion of each of the at least two hooks forms, from the distal end of the elongate member to a free end of said hook, a quarter of a circle, as taught by the “branched distal segment” configuration, to allow the localization element 930 to more securely anchor into the tissue of the patient, and also can more fully delineate the tissue site in three dimensions ([0311]), with a reasonable expectation of success, as the “slidable delivery control” configuration of Herman also strives to accurately and removably place a localization or marking device into a patient to demarcate a region of tissue for subsequent surgical removal ([0006]).
Regarding claim 21, Herman in view of Bellinson teaches all the limitations of claim 20.
The “slidable delivery control” configuration in view of the “branched distal segment” configuration it does not teach wherein the quarter of the circle includes a radius of between 7 and 11 mm.
However, in a separate configuration (in figs. 1 and 7), Herman further discloses a “knob handle” configuration which discloses wherein the quarter of the circle includes a radius of between 7 and 11 mm ([0203] discloses “the localization element 116 can have predetermined shape 202 of a circle or loop having a diameter of between 10.0 to 40.0 mm. The localization element 116 can have a predetermined shape 202 of a circle or loop having a diameter of approximately 25.0 mm”. A diameter of 10mm to 40mm is equivalent to radii of 5 mm to 20 mm and a diameter of 25 mm is equivalent to a radius of 12.5 mm. These stated radii overlap the recited ranges of 7 mm to 40 mm).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to the “slidable delivery control” configuration, as modified by the “branched distal segment” configuration, wherein the quarter of the circle includes a radius of between 7 and 11 mm, as taught by the “knob handle” configuration, to accurately and removably place a localization or marking device into a patient to demarcate a region of tissue for subsequent surgical removal ([0006]), while avoiding needle tract seeding, and hence improving patient outcomes ([0005]).
Furthermore, regarding the combination of the disclosed variations in Herman, [0497] states that “Each of the individual variations described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other variations. Modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the disclosure”.
Regarding claim 22, Herman in view of Bellinson teaches all the limitations of claim 20.
The “slidable delivery control” configuration in view of the “branched distal segment” configuration it does not teach wherein the free end of each hook is at a distance from a main axis of the elongate member that is comprised between 7 and 11 mm.
However, in a separate configuration (in figs. 1 and 7), Herman further discloses a “knob handle” configuration which discloses wherein the free end of each hook is at a distance from a main axis of the elongate member that is comprised between 7 and 11 mm, the distance being measured perpendicularly to the main axis between said main axis and the free end of each said hook ([0203] discloses “the localization element 116 can have predetermined shape 202 of a circle or loop having a diameter of between 10.0 to 40.0 mm. The localization element 116 can have a predetermined shape 202 of a circle or loop having a diameter of approximately 25.0 mm”. A diameter of 10mm to 40mm is equivalent to radii of 5 mm to 20 mm and a diameter of 25 mm is equivalent to a radius of 12.5 mm. These stated radii overlap the recited ranges of 7 mm to 40 mm. By way of example, for a localization element radius of 5 mm, as determined above in the rejection of claim 21, a length of the quarter of the circle is s
=
1
4
*
2
π
r
=
1
4
*
2
π
5
m
m
=
7.85mm, and a distance of a free end of each hook from a main axis of the flexible tracking wire 932 overlaps the recited range of 7 to 11 mm, depending on how the quarter circle is positioned with respect to the axis. See the 35 U.S.C. 112(b) rejection above).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to the “slidable delivery control” configuration, as modified by the “branched distal segment” configuration, wherein the free end of each hook is at a distance from a main axis of the elongate member that is comprised between 7 and 11 mm, the distance being measured perpendicularly to the main axis between said main axis and the free end of each said hook, as taught by the “knob handle” configuration, to accurately and removably place a localization or marking device into a patient to demarcate a region of tissue for subsequent surgical removal ([0006]), while avoiding needle tract seeding, and hence improving patient outcomes ([0005]).
Furthermore, regarding the combination of the disclosed variations in Herman, [0497] states that “Each of the individual variations described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other variations. Modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the disclosure”.
Regarding claim 23, Herman in view of Bellinson teaches all the limitations of claim 17.
While the “slidable delivery control” configuration relied upon above disclose in [0270] that “The localization element 930 can be a flexible length of metal or wire, a flexible length of polymer, a flexible length of shape-memory material, or combinations thereof. The localization element 930 can take on an arcuate, curvilinear, or looping shape when deployed out of the delivery needle 906”, it does not teach wherein the at least one hook includes at least two hooks, and wherein each of the at least two hooks has a free end portion extending along a perpendicular axis that is perpendicular to the main axis of the elongate member or along an inclined axis that is relative to said perpendicular axis by no more than 20⁰.
However, in a modification to the “slidable delivery control” of the localization element 930 above, Herman further discloses a “branched distal segment” configuration (see reproduced annotated fig. 17 above) which teaches teach wherein the at least one hook includes at least two hooks, and wherein each of the at least two hooks has a free end portion extending along a perpendicular axis that is perpendicular to the main axis of the elongate member or along an inclined axis that is relative to said perpendicular axis by no more than 20⁰ (see annotated reproduced fig. 17 above that shows the distal tips 1104 and 1106 negotiating a quarter of a circle turn from along the longitudinal axis to an axis perpendicular to the longitudinal axis).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure the “slidable delivery control” configuration of Herman ([0270]) wherein the at least one hook includes at least two hooks, and wherein each of the at least two hooks has a free end portion extending along a perpendicular axis that is perpendicular to the main axis of the elongate member or along an inclined axis that is relative to said perpendicular axis by no more than 20⁰, as taught by the “branched distal segment” configuration, to allow the localization element 930 to more securely anchor into the tissue of the patient, and also can more fully delineate the tissue site in three dimensions ([0311]), with a reasonable expectation of success, as the “slidable delivery control” configuration of Herman also strives to accurately and removably place a localization or marking device into a patient to demarcate a region of tissue for subsequent surgical removal ([0006]).
Furthermore, regarding the combination of the disclosed variations in Herman, [0497] states that “Each of the individual variations described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other variations. Modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the disclosure”.
Regarding claim 24, Herman in view of Bellinson teaches all the limitations of claim 17.
Herman further teaches wherein each of the at least two metal wires has a diameter comprised between 0.015 and 0.03 mm, stating in [0320] that “The filament diameter can be between approximately 0.025 mm and 0.035 mm”.
Regarding claim 28, Herman in view of Bellinson teaches all the limitations of claim 17.
Herman fails to teach wherein the indicia comprise Arabic numbers.
However, Bellinson further teaches wherein the indicia comprise Arabic numbers. Col. 3, lines 53-58 disclose that As in FIG. 3, probe 2 is depicted stretched along these marks from probe end 11 at mark 200 past mark 220. Numerals 300-320 designate the distances from probe end 11 by Arabic numbers "0-20" printed upon marks 200-220. Words 321 are also printed on the legend, describing the colors. As depicted in fig. 3, the indicia further comprise Arabic numbers distributed over the colored indicia; and the indicia comprise a first colored interval at a distal end of the sheathing, followed by a repeating pattern of an Arabic numeral over a colored hatching interval and an Arabic numeral over a colored interval, and wherein intervals beyond the repeating pattern comprise blank intervals alternating with Arabic numerals.
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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 invention to configure Herman, wherein the indicia comprise Arabic numbers, as taught by Bellinson, such modification would allow precise assessment of region of interest and its location and improve patient outcomes (col. 1, lines 30-44).
Regarding claim 29, Herman teaches a kit for localization of a tumor in a breast (Reproduced fig. 9 below shows a tissue localization device 900. [0246] provides further details of the device 900),
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comprising:
a needle (delivery needle 906 of fig. 9 and [0246]) ;
a guide element being configured to slide coaxially inside the needle ([0249] states that “The delivery needle 906 can also have a needle lumen 918 and a pusher element 920 slidably translatable within the needle lumen 918”);
a hook-wire (tracking wire flexible tracking wire 932 of fig. 9 and [0252]) comprising:
an elongate member with a proximal end and a distal end (Reproduced fig. 9 above shows the tracking wire 932 including a proximal end and a distal end);
at least one hook (localization element 930 shown in reproduced fig. 9 above) at the distal end of the elongate member (see reproduced fig. 9 above. [0252] also states that “The tissue localization device 900 can also include a localization element 930 and a flexible tracking wire 932 coupled to the localization element 930. The tracking wire 932 can have a wire distal segment 934 including a wire distal end 936 and a wire proximal segment 938 including a wire proximal end 940”), configured for insertion in a constrained state into a needle and expansion when exiting said needle ([0020] states that “The localization element can be constrained into a first configuration when within the needle lumen. The localization element can transform into a second configuration when deployed out of the delivery needle. The second configuration can be a circular shape. The second configuration can also be a half-circle shape, a crescent shape, a falciform shape, or a sickle-shape”) in order to anchor the tumor in said breast ([0312] states that “IG. 18A illustrates that the localization element 930 deployed into the tissue 1800 of a patient can encircle or radially surround at least part of a suspect tissue mass 1802. For example, the tissue 1800 can include breast tissue or lung tissue”);
wherein the elongate member and the at least one hook are formed by at least two metal wires which are twisted around each other continuously from the proximal end to the distal end and terminating each at said distal end ([0320] states that “FIG. 20A illustrates that the tracking wire 932 can be fabricated from a cable that is composed of a number of filaments 2000. For example, the cable of the tracking wire 932 can comprise or be composed of a multi-filament (e.g., 19-filament) wire, where each filament is composed of stainless steel, tungsten, or other material”) with a free curved portion forming the at least one hook (the curved localization element 930, see fig. 9 above, forms a hook at the end of the tracking wire 932); and
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a sheathing on the elongate member ([0277] states that “A polymer jacketing 1132 can cover or ensheath at least part of the tracking wire 932. The polymer jacketing 1132 can also cover or ensheath the attachment site 1130”) forming a reading surface with indicia, said reading surface extending over at least 70% of a length of the elongate member between the proximal end and the distal end ([0322] states that “The polymer jacketing 1132 can also be used to identify lengths of the tracking wire 932. For example, an additional layer of the polymer jacketing 1132 can be disposed around an approximately 3 cm long portion of the tracking wire 932 at a distal end of the wire 932. The additional layer of jacketing 1132 can change the feel of the wire 932 to a surgeon using the tracking wire 932 to locate a target tissue site, identifying to the surgeon when he/she is approaching the distal end of the tracking wire 932. Additional layers of the jacketing 1132 may be disposed at other locations along the tracking wire 932, such as every 2 cm along its length. One or more metallic ferrules (e.g. stainless steel, tantalum) may be placed at one or more locations along the length of the tracking wire 932 (e.g. beneath the polymer jacketing) to signify various levels of proximity to the localization element 930. Other depth marking methods may include printing or the use of different colored polymer segments”. That is, the polymer jacketing forms a reading surface with the change in feel of the wire 932 to signify when the surgeon’s approach to the distal end AND also as the depth markings at 2cm intervals);
wherein said hook-wire is pre-inserted inside the guide element ([0261] states that “The tracking wire 932 can be housed within a lumen of the pusher element 920 when the localization element 930 is detachably held by or detachably interlocks with the pusher element 920”); and
a ruler comprising identical indicia as of the sheathing of the hook-wire ([0256] states that “FIG. 9 also illustrates that the delivery needle 906 can have a number of needle depth markers 954. The needle depth markers 954 can be located in between the needle tip and the needle base. The needle depth markers 954 can be markings, etchings, or surface indentations on the surface of the delivery needle 906. The needle depth markers 954 can assist a user, such as a surgeon, radiologist or other imaging professional, to insert the delivery needle 906 into the tissue of a patient. The needle depth markers 954 can be separated by increments of millimeters, centimeters, inches, or combinations thereof”. The depth markers for indicia of a ruler).
wherein the indicia are distributed along the elongated member at fixed intervals ([0322] states that “Additional layers of the jacketing 1132 may be disposed at other locations along the tracking wire 932, such as every 2 cm along its length”), wherein the indicia are colored with a different color ([0322] further states that “One or more metallic ferrules (e.g. stainless steel, tantalum) may be placed at one or more locations along the length of the tracking wire 932 (e.g. beneath the polymer jacketing) to signify various levels of proximity to the localization element 930. Other depth marking methods may include printing or the use of different colored polymer segments”).
While Herman does not explicitly indicate that the coloring is after each two intervals, Herman states in [0278] that “Additional layers of the jacketing 1132 may alternatively be disposed at other locations along the tracking wire 932, such as every 2 cm along its length. Alternatively, one or more metallic ferrules (e.g. stainless steel, tantalum) may be placed at one or more locations along the length of the tracking wire 932 (e.g. beneath the polymer jacketing) to signify various levels of proximity to the localization element 930. Other depth marking methods may include printing or the use of different colored polymer segments”. That is, Herman recognizes different indicia marking methods or configurations for identifying and demarcating the location or boundary (e.g. the posterior margin) of the suspect tissue mass 1802 for further analysis or excision [0269].
Furthermore, such modification would be applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. See MPEP 2143(I)(D). That is, one of ordinary skill in the art would have recognized that providing the coloring after each two intervals would also improve the visibility of the indicia and hence improve their identification.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Herman such that the coloring is after each two intervals, as such modification would improve the identification of lengths of the tracking wire 932 to locate the target tissue site ([0278]).
Herman fails to teach wherein the indicia further comprise Arabic numbers distributed over the colored indicia; and wherein the indicia comprise a first colored interval at a distal end of the sheathing, followed by a repeating pattern of an Arabic numeral over a colored hatching interval and an Arabic numeral over a colored interval, and wherein intervals beyond the repeating pattern comprise blank intervals alternating with Arabic numerals.
However, within the same field of endeavor, Bellinson teaches a method and apparatus for monitoring the location of a fetus in a birth canal during labor using conductors of a fetal monitor probe, such as a fetal heartbeat monitor electrode, that are marked with calibration means corresponding to predetermined distances from a babyward end of the probe (see abstract and reproduced figs. 2 and 3 below). Col. 2, lines 1-13 notes that the wires could be encased in a jacket of sufficient thickness to print actual numbers on. Thus, the jacketing could be graduated in centimeters similarly to a meter stick. Alternatively, thin marks could be made on the conductor means in a coded system. Another approach would be to apply colored or distinctively sized silicone beads to the conductors. A conventional probe could be calibrated in the delivery-room by slipping a calibrated sheath over the conductors. A moveable clip could also be used to mark the starting position at the vaginal introitus. Col. 3, lines 53-58 disclose that As in FIG. 3, probe 2 is depicted stretched along these marks from probe end 11 at mark 200 past mark 220. Numerals 300-320 designate the distances from probe end 11 by Arabic numbers "0-20" printed upon marks 200-220. Words 321 are also printed on the legend, describing the colors. As depicted in fig. 3, the indicia further comprise Arabic numbers distributed over the colored indicia; and the indicia comprise a first colored interval at a distal end of the sheathing, followed by a repeating pattern of an Arabic numeral over a colored hatching interval and an Arabic numeral over a colored interval, and wherein intervals beyond the repeating pattern comprise blank intervals alternating with Arabic numerals.
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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 invention to configure Herman, wherein the indicia further comprise Arabic numbers distributed over the colored indicia; and wherein the indicia comprise a first colored interval at a distal end of the sheathing, followed by a repeating pattern of an Arabic numeral over a colored hatching interval and an Arabic numeral over a colored interval, and wherein intervals beyond the repeating pattern comprise blank intervals alternating with Arabic numerals, as taught by Bellinson, such modification would allow precise assessment of region of interest and its location and improve patient outcomes (col. 1, lines 30-44).
Regarding claim 30, Herman in view of Bellinson teaches all the limitations of claim 29 above.
Herman further teaches wherein the hook of the hook-wire is in a constrained position and inside the guide element ([0253] states that “The localization element 930 can be pressed or formed into a flat or unfurled configuration when positioned within the needle lumen 918 of the delivery needle 906”).
Regarding claim 32, Herman in view of Bellinson teaches all the limitations of claim 29 above.
Herman further teaches wherein said kit being a sterile kit ([0324] states that “FIG. 21 illustrates a method 2100 of operating the tissue localization device 900. The method 2100 can involve removing the tissue localization device 900 from a sterile package in operation 2102. The method 2100 can also involve removing a needle protector covering the delivery needle 906 in operation 2104”).
Herman does not teach that the kit is single-use.
However, Herman further teaches in [0322]-[0323], and depicted in figs. 32A and 32B, that the tissue localization device 900 is used with a securement or stabilization sling 3200 for stabilizing tissue that comprises a polymeric material, a fabric,…an iodophor-impregnated layer or coating (e.g., 3M™ Ioban™ incise drapes or coverings), for example to cover the skin and minimize the risk of surgical site infection. Hence, Herman realizes the need for implementations of the tissue localization device 900 to minimize surgical site infections, and hence providing the tissue localization device 900 a single-use kit would be within the purview of Herman.
Furthermore, such modification would be applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. See MPEP 2143(I)(D). That is, , one of ordinary skill in the art would have recognized that disposing of the tissue localization device 900 after a single use would also minimize the risks of surgical site infections.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Herman, such that the tissue localization kit is a single-use kit, to reduce surgical site infections ([0323]), and hence improving patient outcomes such as allowing the patient to return home after the procedure, in examples disclosed in [0275].
Regarding claim 33, Herman teaches a method of positioning a hook-wire in a patient's breast for targeting a sentinel lymph node or a tumor ([0324] discloses a method 2100 of operating the tissue localization device 900. [0312] discloses the intended purpose of targeting a tumor or cancerous cell), comprising the steps of:
providing a needle (delivery needle 906 of fig. 9 and [0246]);
introducing the needle inside the patient's breast (step 2108 of fig. 21 and [0324] disclose advancing the delivery needle into the tissue of a patient under ultrasonic or radiologic guidance);
inserting a guide element inside the needle([0249] states that “The delivery needle 906 can also have a needle lumen 918 and a pusher element 920 slidably translatable within the needle lumen 918”), said guide element comprising the hook-wire ([0261] states that “The tracking wire 932 can be housed within a lumen of the pusher element 920 when the localization element 930 is detachably held by or detachably interlocks with the pusher element 920”) comprising:
an elongate member with a proximal end and a distal end (Reproduced fig. 9 above shows the tracking wire 932 including a proximal end and a distal end);
at least one hook (localization element 930 shown in reproduced fig. 9 above) at the distal end of the elongate member (see reproduced fig. 9 above. [0252] also states that “The tissue localization device 900 can also include a localization element 930 and a flexible tracking wire 932 coupled to the localization element 930. The tracking wire 932 can have a wire distal segment 934 including a wire distal end 936 and a wire proximal segment 938 including a wire proximal end 940”), configured for insertion in a constrained state into a needle and expansion when exiting said needle ([0020] states that “The localization element can be constrained into a first configuration when within the needle lumen. The localization element can transform into a second configuration when deployed out of the delivery needle. The second configuration can be a circular shape. The second configuration can also be a half-circle shape, a crescent shape, a falciform shape, or a sickle-shape”) in order to anchor the tumor in said breast ([0312] states that “IG. 18A illustrates that the localization element 930 deployed into the tissue 1800 of a patient can encircle or radially surround at least part of a suspect tissue mass 1802. For example, the tissue 1800 can include breast tissue or lung tissue”);
wherein the elongate member and the at least one hook are formed by at least two metal wires which are twisted around each other continuously from the proximal end to the distal end and terminating each at said distal end ([0320] states that “FIG. 20A illustrates that the tracking wire 932 can be fabricated from a cable that is composed of a number of filaments 2000. For example, the cable of the tracking wire 932 can comprise or be composed of a multi-filament (e.g., 19-filament) wire, where each filament is composed of stainless steel, tungsten, or other material”) with a free curved portion forming one the at least one hook (the curved localization element 930, see fig. 9 above, forms a hook at the end of the tracking wire 932); and
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a sheathing on the elongate member ([0277] states that “A polymer jacketing 1132 can cover or ensheath at least part of the tracking wire 932. The polymer jacketing 1132 can also cover or ensheath the attachment site 1130”) forming a reading surface with indicia, said reading surface extending over at least 70% of a length of the elongate member between the proximal end and the distal end (([0322] states that “The polymer jacketing 1132 can also be used to identify lengths of the tracking wire 932. For example, an additional layer of the polymer jacketing 1132 can be disposed around an approximately 3 cm long portion of the tracking wire 932 at a distal end of the wire 932. The additional layer of jacketing 1132 can change the feel of the wire 932 to a surgeon using the tracking wire 932 to locate a target tissue site, identifying to the surgeon when he/she is approaching the distal end of the tracking wire 932. Additional layers of the jacketing 1132 may be disposed at other locations along the tracking wire 932, such as every 2 cm along its length. One or more metallic ferrules (e.g. stainless steel, tantalum) may be placed at one or more locations along the length of the tracking wire 932 (e.g. beneath the polymer jacketing) to signify various levels of proximity to the localization element 930. Other depth marking methods may include printing or the use of different colored polymer segments”. That is, the polymer jacketing forms a reading surface with the change in feel of the wire 932 to signify when the surgeon’s approach to the distal end AND also as the depth markings at 2cm intervals);
pushing the hook-wire inside the breast (steps 2108 and 2110 of the method 2100 in fig. 21 and [0324]-[0325] include translating or pushing the delivery control 904 of the tissue localization device 900 in a first longitudinal direction 1004 using at least one finger of the same hand holding the handle 902 in operation 2108 and translating the localization element 930 of the tissue localization device 900 out of the delivery needle 906 in response to the translation of the delivery control 904 in operation 2110);
positioning the hook nearby the tumor or the sentinel lymph node, the proximal end of the flexible hook-wire being outside the patient's breast ([0326] states “surrounding, encircling, or otherwise identifying the suspect tissue mass 1802 using the deployed localization element 930 in operation 2112”, wherein the suspect tissue mass 1802 comprises a tumor or cancerous cells according to [0312]); and
removing the needle and/or the guide element from the patient's breast ([0327] states “retracting the beveled distal end 1400 of the delivery needle 906 away from the suspect tissue mass 1802 and exposing the tracking wire 932 coupled to the localization element 930 in operation 2114”).
wherein the indicia are distributed along the elongated member at fixed intervals ([0322] states that “Additional layers of the jacketing 1132 may be disposed at other locations along the tracking wire 932, such as every 2 cm along its length”), wherein the indicia are colored with a different color ([0322] further states that “One or more metallic ferrules (e.g. stainless steel, tantalum) may be placed at one or more locations along the length of the tracking wire 932 (e.g. beneath the polymer jacketing) to signify various levels of proximity to the localization element 930. Other depth marking methods may include printing or the use of different colored polymer segments”).
While Herman does not explicitly indicate that the coloring is after each two intervals, Herman states in [0278] that “Additional layers of the jacketing 1132 may alternatively be disposed at other locations along the tracking wire 932, such as every 2 cm along its length. Alternatively, one or more metallic ferrules (e.g. stainless steel, tantalum) may be placed at one or more locations along the length of the tracking wire 932 (e.g. beneath the polymer jacketing) to signify various levels of proximity to the localization element 930. Other depth marking methods may include printing or the use of different colored polymer segments”. That is, Herman recognizes different indicia marking methods or configurations for identifying and demarcating the location or boundary (e.g. the posterior margin) of the suspect tissue mass 1802 for further analysis or excision [0269].
Furthermore, such modification would be applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. See MPEP 2143(I)(D). That is, one of ordinary skill in the art would have recognized that providing the coloring after each two intervals would also improve the visibility of the indicia and hence improve their identification.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Herman such that the coloring is after each two intervals, as such modification would improve the identification of lengths of the tracking wire 932 to locate the target tissue site ([0278]).
Herman fails to teach wherein the indicia further comprise Arabic numbers distributed over the colored indicia; and wherein the indicia comprise a first colored interval at a distal end of the sheathing, followed by a repeating pattern of an Arabic numeral over a colored hatching interval and an Arabic numeral over a colored interval, and wherein intervals beyond the repeating pattern comprise blank intervals alternating with Arabic numerals.
However, within the same field of endeavor, Bellinson teaches a method and apparatus for monitoring the location of a fetus in a birth canal during labor using conductors of a fetal monitor probe, such as a fetal heartbeat monitor electrode, that are marked with calibration means corresponding to predetermined distances from a babyward end of the probe (see abstract and reproduced figs. 2 and 3 below). Col. 2, lines 1-13 notes that the wires could be encased in a jacket of sufficient thickness to print actual numbers on. Thus, the jacketing could be graduated in centimeters similarly to a meter stick. Alternatively, thin marks could be made on the conductor means in a coded system. Another approach would be to apply colored or distinctively sized silicone beads to the conductors. A conventional probe could be calibrated in the delivery-room by slipping a calibrated sheath over the conductors. A moveable clip could also be used to mark the starting position at the vaginal introitus. Col. 3, lines 53-58 disclose that As in FIG. 3, probe 2 is depicted stretched along these marks from probe end 11 at mark 200 past mark 220. Numerals 300-320 designate the distances from probe end 11 by Arabic numbers "0-20" printed upon marks 200-220. Words 321 are also printed on the legend, describing the colors. As depicted in fig. 3, the indicia further comprise Arabic numbers distributed over the colored indicia; and the indicia comprise a first colored interval at a distal end of the sheathing, followed by a repeating pattern of an Arabic numeral over a colored hatching interval and an Arabic numeral over a colored interval, and wherein intervals beyond the repeating pattern comprise blank intervals alternating with Arabic numerals.
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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 invention to configure Herman, wherein the indicia further comprise Arabic numbers distributed over the colored indicia; and wherein the indicia comprise a first colored interval at a distal end of the sheathing, followed by a repeating pattern of an Arabic numeral over a colored hatching interval and an Arabic numeral over a colored interval, and wherein intervals beyond the repeating pattern comprise blank intervals alternating with Arabic numerals, as taught by Bellinson, such modification would allow precise assessment of region of interest and its location and improve patient outcomes (col. 1, lines 30-44).
Regarding claim 34, Herman in view of Bellinson teaches all the limitations of claim 33 above.
Herman further teaches wherein the hook is movable through spring action from a constrained position into an anchoring position ([0267] states that “The localization element 930 can be deployed out of the delivery needle 906 when the pusher distal end 922 pushes the shoulder portion 1112 of the localization element 930 in the first longitudinal direction 1004 out of the delivery needle 906. The interlocking framework of the localization element 930 can release from the delivery port 1118 of the pusher element 920 when the delivery port 1118 exits the lumen of the delivery needle 906. The localization element 930 can curl into a substantially circular deployed configuration 942 when deployed. The localization element 930 can curl or curve in a direction of the handle dorsal side 912 when deployed out of the delivery needle 906” and [0279] describes that the localization element 930 can automatically separate, detach, or dislodge from the pusher element 920 when the eyelet frame 1106 is pushed out of the needle lumen 918 and the localization element 930 no longer constrained by the interior surface of the needle lumen 918. Both scenarios describe deployment of the localization element 930 by spring action).
Regarding claim 35, Herman in view of Bellinson teaches all the limitations of claim 33 above.
Herman further teaches wherein the hook in its constrained position is substantially parallel with the guide element when the flexible hook-wire is fully inside the guide element ([0253] states that “The localization element 930 can be pressed or formed into a flat or unfurled configuration when positioned within the needle lumen 918 of the delivery needle 906”. The delivery needle 906 houses the pusher element 920, which in turn houses the localization element, as demonstrated above. Hence the localization element, in its flat configuration while residing in the pusher element 920, is parallel to the longitudinal axis of the delivery needle 906 AND the pusher element 920).
Claims 18 are rejected under 35 U.S.C. 103 as being unpatentable over Herman in view of Bellinson, as applied to claim 17 above, and further in view of Flatland, M.L., US 20190388070 A1.
Regarding claim 18, Herman in view of Bellinson teaches all the limitations of claim 17.
Herman teaches wherein the at least two metal wires are three of said metal wires ([0320] states that “FIG. 20A illustrates that the tracking wire 932 can be fabricated from a cable that is composed of a number of filaments 2000. For example, the cable of the tracking wire 932 can comprise or be composed of a multi-filament (e.g., 19-filament) wire, where each filament is composed of stainless steel, tungsten, or other material. In other variations, the tracking wire 932 can comprise or be composed of between seven and 31 filaments 2000”), but Herman in view of Bellinson fails to teach the at least one hook corresponds to three of said at least one hook.
However, within the same field of endeavor, Flatland teaches a needle assembly 18 comprising a localization needle 54 (see reproduced figs. 19A-19D 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 invention to Herman, as modified by Bellinson, wherein the at least one hook corresponds to three of said at least one hook, as taught by Flatland, to provide optimal holding power of the localization needle ([0010]-[0011]), with a reasonable expectation of success, as Herman also strives to comfortably and securely anchor the localization wire in the patient ([0004]).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Herman in view of Bellinson, as applied to claim 29 above, and further in view of Liu, S., CN 112063323 A.
Regarding claim 31, Herman in view of Bellinson teaches all the limitations of claim 29.
Herman in view of Bellinson fails to teach wherein the ruler is made of a sterile medical paper comprising a length of 120 mm and width of 20 mm.
However, within the same field of endeavor, Liu teaches a disposable medical locating paper adhesive tape and production technique thereof, the disposable medical locating paper adhesive tape comprising release paper, medical non-woven paper adhesive tape, a metal scale layer and an anti-sticking layer” (see abstract). Lines 10-12 on page 4 state that “A disposable medical locating paper tape, as shown in FIG. 1-2, comprising a release paper 1, medical nonwoven fabric paper tape 2; metal scale layer 3 and anti-sticking layer 4; the medical non-woven fabric paper tape 2 is covered on the upper side of the release paper 1”. On page 2, lines 28-30 state that “Preferably, the scale marked line is composed of multiple groups of scale units; the scale unit comprises a plurality of scale lines arranged in parallel at intervals and a digital mark; the length of each scale unit is 0-50mm, the distance between the adjacent scale lines is 1mm”, hence teaching wherein the ruler is made of a sterile medical paper.
Liu fails to explicitly teach that the paper comprises a length of 120 mm and width of 20 mm.
However, as noted above, Liu states that the scale unit is 0-50mm in lines 10-12 on page 4 and depicts the scale in fig. 1 on page 7, the ruler including millimeter markings and a width relative to the length of the scale, and encourages various changes and modifications in the scale and the production of the scale (lines 23-26 of page 5) meaning modifying the length of the scale to be 120 mm and the width to be 20 mm would be within the purview of Liu as such modification would aid in faster and more accurate determination of the position of the region of interest (lines 4-8 of page 2).
Furthermore, such modification would be applying optimization within prior art conditions or through routine experimentation. See MPEP 2144.05(II)(D). That is, one of ordinary skill in the art would have recognized that providing the appropriate scale with a length of 120 mm and a width of 20 mm, for the intended procedure would improve the diagnostic and treatment procedure (first paragraph of page 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Herman, as modified by Bellinson, to provide a disposable medical locating paper tape that is convenient to use, simple structure, low production cost and safe and sanitary (last three lines of page 1), with a reasonable expectation of success, as Herman also encourages accurate the localization of the region of interest ([0005]-[0007]).
Conclusion
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/FAROUK A BRUCE/ Examiner, Art Unit 3797
