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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/06/24 has been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-22) in the reply filed on February 19, 2026 is acknowledged. Therefore, Invention II (claims 23-25) has been withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Bayan (US 2019/0110780) and in further view of Burkett (US 2024/0389989) and Harris (US 2007/0232954)
Regarding claim 1, Bayan teaches a biopsy-capable dermatoscope for a practitioner to use on a patient [fig. 1A; par. 20, 21], the dermatoscope comprising:
a head [fig. 1A, 8, element 8] configured to be placed in operative contact with the patient's skin for skin visualization and biopsy procedures [par. 21, 23];
a handle [fig. 1A, 8, element 1] extending from the head for grasping by the practitioner, the handle having manually actuatable controls for the visualization and the biopsy procedures [par. 21];
a viewing opening [fig. 8, element 26, 260] disposed in the head and defining a viewing area, the viewing opening having at least one lens [par. 24, 38] disposed across the viewing opening and a light source [par. 24] located relative to the viewing opening to illuminate a selected skin area of the patient when the head is brought into a desired, operative position on the patient [par. 24, 38];
a blade assembly [fig. 8, element 15] configured to perform a biopsy excision in response to manual actuation of one of the controls, in response to manual actuation of one of the controls, when the head is in the desired operative position, the blade assembly being movable from a first, stowed position outside a majority of the viewing area defined by the viewing opening [par. 24, Examiner notes the blade is out of the viewing area], and a second, operative position in contact with the skin area to perform a biopsy excision thereof [par. 21];
However, Bayan does not teach a disposable cartridge removably inserted into the head;
an adhesive bandage-clip assembly disposed within the cartridge and positioned in operative proximity to the selected skin area when the head is brought into the desired operative position on the patient, the adhesive bandage-clip assembly having an adhesive bandage releasably secured relative to the cartridge to selectively separate the adhesive bandage from the head and onto the selected skin area when the head is in the desired operative position on the patient;
the blade assembly mounted within the cartridge and rotatable,
a crimping assembly disposed in operative proximity to the adhesive bandage-clip assembly, the crimping assembly having a bandage closure mechanism and a pair of arms, one of the manually actuatable controls connected to the closure mechanism to selectively move the arms inwardly in relation to the selected skin area, and toward and adjacent to the biopsy incision to crimp the adhesive bandage-clip assembly over the biopsy incision while the head is in the desired, operative position;
wherein the arms of the crimping assembly are selectively movable outwardly after the crimping of the adhesive bandage-clip assembly and do not impinge upon removal of the cartridge from the head;
and wherein the head, the handle, and the removably inserted cartridge comprise a portable, self-contained apparatus.
Burkett teaches a disposable cartridge [fig. 12A-D, element 1150] removably inserted into the head [par. 331, 332];
an adhesive bandage-clip assembly [par. 351 “cartridge 1150 can be filled with patch material via aperture 1370”] disposed within the cartridge and positioned in operative proximity to the selected skin area when the head is brought into the desired operative position on the patient, the adhesive bandage-clip assembly having an adhesive bandage releasably secured relative to the cartridge to selectively separate the adhesive bandage from the head and onto the selected skin area when the head is in the desired operative position on the patient [par. 83, 331, Examiner notes the disposable cartridge comprises patch material; par. 332, 357];
the blade assembly mounted within the cartridge and rotatable [par. 114, 349],
and wherein the head, the handle, and the removably inserted cartridge comprise a portable, self-contained apparatus [fig. 12B; par. 332]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, to incorporate a disposable cartridge removably inserted into the head; an adhesive bandage-clip assembly disposed within the cartridge and positioned in operative proximity to the selected skin area when the head is brought into the desired operative position on the patient, the adhesive bandage-clip assembly having an adhesive bandage releasably secured relative to the cartridge to selectively separate the adhesive bandage from the head and onto the selected skin area when the head is in the desired operative position on the patient; the blade assembly mounted within the cartridge and rotatable; and wherein the head, the handle, and the removably inserted cartridge comprise a portable, self-contained apparatus, to close the wound after the sample has been extracted, as evidence by Burkett [par. 332].
Harris teaches a crimping assembly [fig. 13A-13C] disposed in operative proximity to the adhesive bandage-clip assembly, the crimping assembly having a bandage closure mechanism and a pair of arms [fig. 13A-C, elements 42A, 42B; par. 23], one of the manually actuatable controls connected to the closure mechanism to selectively move the arms inwardly in relation to the selected skin area, and toward and adjacent to the biopsy incision to crimp the adhesive bandage-clip assembly over the biopsy incision while the head is in the desired, operative position [par. 23, 24];
wherein the arms of the crimping assembly are selectively movable outwardly after the crimping of the adhesive bandage-clip assembly and do not impinge upon removal of the cartridge from the head [par. 23, 24];
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, to incorporate a crimping assembly disposed in operative proximity to the adhesive bandage-clip assembly, the crimping assembly having a bandage closure mechanism and a pair of arms, one of the manually actuatable controls connected to the closure mechanism to selectively move the arms inwardly in relation to the selected skin area, and toward and adjacent to the biopsy incision to crimp the adhesive bandage-clip assembly over the biopsy incision while the head is in the desired, operative position; wherein the arms of the crimping assembly are selectively movable outwardly after the crimping of the adhesive bandage-clip assembly and do not impinge upon removal of the cartridge from the head, to close the wound after the sample has been extracted, as evidence by Harris [par. 20].
Regarding claim 17, Burkett further teaches the manually actuatable controls are interconnected to form at least one fail-safe mechanism inhibiting the actuation of at least one of the manually actuatable controls prior to a prerequisite actuation of another of the manually actuatable controls [par. 201, 359]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, to incorporate the manually actuatable controls are interconnected to form at least one fail-safe mechanism inhibiting the actuation of at least one of the manually actuatable controls prior to a prerequisite actuation of another of the manually actuatable controls, to prevent a biocompatible patch material to be dispensed and for the light source to remain unactuated, and, in a proximal position, the toggle switch will prevent the needles from retracting, as evidence by Burkett [par. 359].
Regarding claim 18, Burkett further teaches the fail-safe mechanism is configured to inhibit rotation of the blade assembly prior to manual actuation of the control corresponding to the release of the adhesive bandage-clip assembly [par. 201, 359]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, to incorporate the fail-safe mechanism is configured to inhibit rotation of the blade assembly prior to manual actuation of the control corresponding to the release of the adhesive bandage-clip assembly, to prevent a biocompatible patch material to be dispensed and for the light source to remain unactuated, and, in a proximal position, the toggle switch will prevent the needles from retracting, as evidence by Burkett [par. 359].
Claims 2-5, 9-12, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bayan, Burkett and Harris and in further view of and Wildhaber (US 2025/0268586)
Regarding claim 2, Bayan, Burkett and Harris teach a biopsy-capable dermatoscope for a practitioner to use on a patient, as disclosed above
Bayan teaches the blade assembly comprises a blade and a mounting subassembly for the blade [fig. 4, element 4]; wherein the blade is configured into an open-boat shape [fig. 4, element 15]
However, Bayan, Burkett and Harris do not teach the open-boat shape having a pair of convex sides extending upwardly from a bottom portion to define a corresponding pair of convex, upper edges, the bottom, sides, and edges defining an open volume to collect a sample after completing the biopsy incision; wherein the upper edges are sufficiently sharp to comprise respective, cutting edges, the upper edges meeting at a forward end, the forward end including a forward portion configured to be sufficiently sharp to form a cutting tip; wherein the mounting subassembly comprises at least one mounting strut rotatable about an associated transverse, blade mounting axis, the mounting strut connected to the blade to position the forward end of the blade at a predetermined operative distance from the mounting axis, whereby the blade rotates relative to the blade mounting axis at the predetermined operative distance; wherein the head includes a longitudinal axis and has longitudinally spaced ends comprising a viewing end and an operative end opposite the viewing end, the operative end terminating in inner and outer concentric edges to form a contact ring having an associated contact surface to make contact with the selected skin area when the head is brought into the desired, operative position on the patient; wherein the contact surface of the contact ring is spaced from the blade mounting axis by a contact distance; wherein the predetermined operative distance through which the blade rotates is greater than the contact distance between the blade mounting axis and the contact surface of the head to define a corresponding difference; and wherein the difference between the predetermined operative distance and the contact distance corresponds to an incision depth; whereby, in response to actuation of a corresponding one of the controls to move the blade from the stowed position to the operative position, the blade is rotatable to perform the biopsy incision at the incision depth
Wildhaber teaches the open-boat shape having a pair of convex sides extending upwardly from a bottom portion to define a corresponding pair of convex, upper edges, the bottom, sides, and edges defining an open volume to collect a sample after completing the biopsy incision [fig. 5E, element 502; par. 70];
wherein the upper edges are sufficiently sharp to comprise respective, cutting edges, the upper edges meeting at a forward end, the forward end including a forward portion configured to be sufficiently sharp to form a cutting tip [par. 69, 70];
wherein the mounting subassembly comprises at least one mounting strut [fig. 5E, element 566] rotatable about an associated transverse, blade mounting axis, the mounting strut connected to the blade to position the forward end of the blade at a predetermined operative distance from the mounting axis, whereby the blade rotates relative to the blade mounting axis at the predetermined operative distance [par. 68-70];
wherein the head includes a longitudinal axis and has longitudinally spaced ends comprising a viewing end and an operative end opposite the viewing end, the operative end terminating in inner and outer concentric edges to form a contact ring having an associated contact surface to make contact with the selected skin area when the head is brought into the desired, operative position on the patient [fig. 5D; par. 68];
wherein the contact surface of the contact ring is spaced from the blade mounting axis by a contact distance wherein the predetermined operative distance through which the blade rotates is greater than the contact distance between the blade mounting axis and the contact surface of the head to define a corresponding difference; and wherein the difference between the predetermined operative distance and the contact distance corresponds to an incision depth [fig. 5D, 5F; par. 68]; whereby, in response to actuation of a corresponding one of the controls to move the blade from the stowed position to the operative position, the blade is rotatable to perform the biopsy incision at the incision depth [par. 69, 70]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, Burkett, and Harris, to incorporate the open-boat shape having a pair of convex sides extending upwardly from a bottom portion to define a corresponding pair of convex, upper edges, the bottom, sides, and edges defining an open volume to collect a sample after completing the biopsy incision; wherein the upper edges are sufficiently sharp to comprise respective, cutting edges, the upper edges meeting at a forward end, the forward end including a forward portion configured to be sufficiently sharp to form a cutting tip; wherein the mounting subassembly comprises at least one mounting strut rotatable about an associated transverse, blade mounting axis, the mounting strut connected to the blade to position the forward end of the blade at a predetermined operative distance from the mounting axis, whereby the blade rotates relative to the blade mounting axis at the predetermined operative distance; wherein the head includes a longitudinal axis and has longitudinally spaced ends comprising a viewing end and an operative end opposite the viewing end, the operative end terminating in inner and outer concentric edges to form a contact ring having an associated contact surface to make contact with the selected skin area when the head is brought into the desired, operative position on the patient; wherein the contact surface of the contact ring is spaced from the blade mounting axis by a contact distance; wherein the predetermined operative distance through which the blade rotates is greater than the contact distance between the blade mounting axis and the contact surface of the head to define a corresponding difference; and wherein the difference between the predetermined operative distance and the contact distance corresponds to an incision depth; whereby, in response to actuation of a corresponding one of the controls to move the blade from the stowed position to the operative position, the blade is rotatable to perform the biopsy incision at the incision depth, for spooling the first end of the actuation connector , as evidence by Wildhaber [par. 70].
Regarding claim 3, Burkett further teaches the cartridge has a longitudinal axis defined therein and includes respective, opposite, longitudinal sides [fig. 12A, element 1150]; wherein the mounting subassembly and the cartridge are connected to each other at the longitudinal sides at a first, longitudinal location along the longitudinal axis of the cartridge [par. 349, 350]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, Burkett, Harris and Wildhaber, to incorporate the cartridge has a longitudinal axis defined therein and includes respective, opposite, longitudinal sides; wherein the mounting subassembly and the cartridge are connected to each other at the longitudinal sides at a first, longitudinal location along the longitudinal axis of the cartridge, to removably receive a needle cartridge, as evidence by Burkett [par. 349].
Regarding claim 4, Burkett further teaches the longitudinal sides of the cartridge have respective, longitudinally extending deployment channels formed therein, the deployment channels having two receiving locations, the first receiving location defined at the first longitudinal location, and the second receiving location defined at a second longitudinal location [par. 352, 356, 357]; wherein the mounting subassembly is movably mounted with respect to the channels and operatively connected to one of the manually actuatable controls to be translatable between the two different longitudinal locations [par. 352, 356, 357]; wherein the longitudinal location closer to the viewing end corresponds to the stowed position of the blade assembly and the longitudinal location closer to the operative end corresponds to the operative position of the blade assembly [par. 352, 356, 357]
Regarding claim 5, Harris further teaches the mounting subassembly further comprises a mounting frame and a pair of the mounting struts, the mounting frame having longitudinal sides, the pair of mounting struts located at respective convex sides of the blade [fig. 8A-F, elements 34A, 34B; par. 21]; and wherein the mounting struts are mounted to respective longitudinal sides of the mounting frame and rotatable relative to the mounting frame to the operative position in response to actuation of a corresponding one of the manually actuatable controls [fig. 8A-F, elements 34A, 34B; par. 21]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, Burkett and Wildhaber, to incorporate the mounting subassembly further comprises a mounting frame and a pair of the mounting struts, the mounting frame having longitudinal sides, the pair of mounting struts located at respective convex sides of the blade; and wherein the mounting struts are mounted to respective longitudinal sides of the mounting frame and rotatable relative to the mounting frame to the operative position in response to actuation of a corresponding one of the manually actuatable controls, allowing the blade to rotate and collect the sample, as evidence by Harris [par. 21].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, Burkett, Harris and Wildhaber, to incorporate the longitudinal sides of the cartridge have respective, longitudinally extending deployment channels formed therein, the deployment channels having two receiving locations, the first receiving location defined at the first longitudinal location, and the second receiving location defined at a second longitudinal location; wherein the mounting subassembly is movably mounted with respect to the channels and operatively connected to one of the manually actuatable controls to be translatable between the two different longitudinal locations; wherein the longitudinal location closer to the viewing end corresponds to the stowed position of the blade assembly and the longitudinal location closer to the operative end corresponds to the operative position of the blade assembly, to removably receive a needle cartridge, as evidence by Burkett [par. 349].
Regarding claim 9, Harris further teaches the mounting subassembly of the blade assembly comprises a pair of the mounting struts, each of the mounting struts extending outwardly from respective sides of the blade and transversely therefrom to terminate in connection ends at respective longitudinal sides of the cartridge [fig. 8A-F, elements 34A, 34B; par. 21]; wherein the connection ends of the struts are operatively connected to a corresponding one of the manually actuatable controls [fig. 8A-F, elements 34A, 34B; par. 21]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, Burkett, and Wildhaber, to incorporate the mounting subassembly of the blade assembly comprises a pair of the mounting struts, each of the mounting struts extending outwardly from respective sides of the blade and transversely therefrom to terminate in connection ends at respective longitudinal sides of the cartridge; wherein the connection ends of the struts are operatively connected to a corresponding one of the manually actuatable controls, allowing the blade to rotate and collect the sample, as evidence by Harris [par. 21]
Regarding claim 10, Wildhaber further teaches the open-boat shape of the blade comprises a blade with a blade width of 3 mm, a blade length of 9 mm, and a blade depth of 5 mm [par. 51, 61]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, Burkett, and Harris, to incorporate the open-boat shape of the blade comprises a blade with a blade width of 3 mm, a blade length of 9 mm, and a blade depth of 5 mm, for different shaped/sized biopsy tissue samples, as evidence by Wildhaber [par. 61].
Regarding claim 11, Wildhaber further teaches the blade has a rear end opposite the forward end, the forward and rear ends terminating in corresponding forward and rear tips; and wherein the convex edges extend between the rear and forward tips and define a mathematical ellipse having the blade length equal to three times the blade width [fig. 5E, 5F, element 502; par. 68-70]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, Burkett, and Harris, to incorporate the blade has a rear end opposite the forward end, the forward and rear ends terminating in corresponding forward and rear tips; and wherein the convex edges extend between the rear and forward tips and define a mathematical ellipse having the blade length equal to three times the blade, for different shaped/sized biopsy tissue samples, as evidence by Wildhaber [par. 61].
Regarding claim 12, Wildhaber further teaches the blade width has a maximum width at a corresponding, longitudinal location between the forward and rear ends of the blade; wherein the convex edges have forward edge portions extending between the longitudinal location of the maximum width and the forward tip, the convex edges having rear edge portions extending between the longitudinal location of the maximum width and the rear tip; and wherein the forward edge portions of the convex edges are longer than the rear edge portions of the convex edges to impart longitudinal tension on the selected skin area during rotation of the blade assembly during the performing of the biopsy incision [fig. 5E, 5F, element 502; par. 68-70]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, Burkett, and Harris, to incorporate the blade width has a maximum width at a corresponding, longitudinal location between the forward and rear ends of the blade; wherein the convex edges have forward edge portions extending between the longitudinal location of the maximum width and the forward tip, the convex edges having rear edge portions extending between the longitudinal location of the maximum width and the rear tip; and wherein the forward edge portions of the convex edges are longer than the rear edge portions of the convex edges to impart longitudinal tension on the selected skin area during rotation of the blade assembly during the performing of the biopsy incision, for collecting and/or temporarily storing the biopsy sample as evidence by Wildhaber [par. 70]
Regarding claim 19, Wildhaber further teaches the disposable cartridge comprises one of a set of disposable, removably insertable cartridges, each of the cartridges containing therein a corresponding blade assembly having a set of blade dimensions with associated clinical characteristics; wherein the set of blade dimensions of at least a first one of the set of cartridges differs from the set of blade dimensions of at least a second one of the set of cartridges, the first and second cartridges having respective indicia associated therewith to identify the associated, different blade dimensions; and whereby the disposable cartridge removably inserted into the head is selectable from the set of cartridges, including the cartridges having the indicated set of blade dimensions to perform the biopsy incision associated with the corresponding clinical characteristics [par. 61]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, Burkett, and Harris, to incorporate the disposable cartridge comprises one of a set of disposable, removably insertable cartridges, each of the cartridges containing therein a corresponding blade assembly having a set of blade dimensions with associated clinical characteristics; wherein the set of blade dimensions of at least a first one of the set of cartridges differs from the set of blade dimensions of at least a second one of the set of cartridges, the first and second cartridges having respective indicia associated therewith to identify the associated, different blade dimensions; and whereby the disposable cartridge removably inserted into the head is selectable from the set of cartridges, including the cartridges having the indicated set of blade dimensions to perform the biopsy incision associated with the corresponding clinical characteristics, for different shaped/sized biopsy tissue samples, as evidence by Wildhaber [par. 61].
Regarding claim 20, Wildhaber further teaches the set of cartridges may comprise cartridges containing blade assemblies having blade-width-to-blade-length values selected from the group consisting of 1 mm x 3 mm, 2 mm x 6 mm, 3 mm x 9 mm, 4 mm x 12 mm, 5 mm x 15 mm, 2.5 mm x 2.75 mm, and 3.5 mm x 10 mm [par. 61]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, Burkett, and Harris, to incorporate the set of cartridges may comprise cartridges containing blade assemblies having blade-width-to-blade-length values selected from the group consisting of 1 mm x 3 mm, 2 mm x 6 mm, 3 mm x 9 mm, 4 mm x 12 mm, 5 mm x 15 mm, 2.5 mm x 2.75 mm, and 3.5 mm x 10 mm, for different shaped/sized biopsy tissue samples, as evidence by Wildhaber [par. 61].
Regarding claim 21, Harris further teaches the head comprises guide rails on two sides thereof; wherein the guide rail has a lower portion; and wherein the mounting subassembly of the blade assembly is movable to position the blade mounting axis in the lower portion of the guide rail to define the predetermined operative distance through which the blade rotates [fig. 6A, element 30; par. 21]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Bayan, Burkett and Wildhaber, to incorporate the head comprises guide rails on two sides thereof; wherein the guide rail has a lower portion; and wherein the mounting subassembly of the blade assembly is movable to position the blade mounting axis in the lower portion of the guide rail to define the predetermined operative distance through which the blade rotates, allowing the blade to rotate and collect the sample, as evidence by Harris [par. 21].
Allowable Subject Matter
Claims 6-8,13-16 and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 6, neither Bayan nor the prior art of record teaches the biopsy-capable dermatoscope of base claim 1, including the following, in combination with all other limitations of the base claim:
wherein the cartridge has an outer wall receivable within the head of the dermatoscope and an inner wall defining central and edge zones within the inner wall, the central zone being visible through the viewing opening and the edge zone being not visible through the viewing opening; wherein the mounting subassembly further comprises a rack with a pair of rails extending from the edge zone of the cartridge to the central zone of the cartridge; wherein the mounting frame is slidably mounted to the rack; wherein the mounting frame is slidable, in response to a first actuation of a suitable one of the manually actuatable controls, to position the mounting frame and the blade mounted thereto in the edge zone, which position corresponds to the stowed position of the blade assembly; and wherein the mounting frame is slidable, in response to a second actuation of a suitable one of the manually actuatable controls, to position the mounting frame and the blade mounted thereto in the central zone, which position in the central zone corresponds to the second operative position in which the blade is rotatable to contact the skin area to perform the biopsy incision thereof.
As to Claim 7, neither Bayan nor the prior art of record teaches the biopsy-capable dermatoscope of base claim 1, including the following, in combination with all other limitations of the base claim:
wherein the cartridge has a distal side opposing the selected skin area of the patient when the head is brought into the desired operative position on the patient; wherein the adhesive bandage-clip assembly comprises planar upper and lower surfaces having edge portions defining a bandage area contained within and extending across the distal side of the cartridge, the lower surface including an adhesive contact surface having a corresponding adhesion value, the adhesive contact surface opposing the selected skin area when the head is brought into the desired operative position;wherein the adhesive bandage has an aperture formed therein and a pair of flanges extending adjacent the aperture on the upper surface of the adhesive bandage; wherein the cartridge includes opposite walls having engagement slots defined therein and located proximate to the distal side of the cartridge, engagement slots sized and located to releasably receive the edge portions of the bandage-clip assembly therein to retain the adhesive contact surface at a predetermined, operative distance from the selected skin area of the patient; wherein the adhesive bandage-clip assembly has a predetermined flexibility orthogonal to the planar surfaces thereof; wherein the flexibility, the adhesion value, and the operative distance are selected to cause release of the adhesive bandage-clip assembly from the cartridge in response to selective application of orthogonal force toward the selected skin area
As to Claim 8, neither Bayan nor the prior art of record teaches the biopsy-capable dermatoscope of base claim 1, including the following, in combination with all other limitations of the base claim:
wherein the dermatoscope has opposite proximal and distal ends, the handle extending from the proximal end toward the distal end, the head located at the distal end; wherein the pair of arms of the crimping assembly is rotatably mounted at least one pivot point and extends distally from the pivot point to terminate at distal ends adjacent to respective ones of the pair of flanges of the adhesive bandage-clip assembly; wherein the bandage closure mechanism of the crimping assembly comprises at least one manually actuatable gear connected to the pair of arms; and wherein the gear is mounted relative to the bandage closure mechanism so that actuation of the gear in a first direction corresponds to selectively moving the arms inwardly to crimp the adhesive bandage-clip assembly and actuation of the gear in a second direction corresponds to selectively moving the arms outwardly after the crimping
As to Claim 13, neither Bayan nor the prior art of record teaches the biopsy-capable dermatoscope of base claim 1, including the following, in combination with all other limitations of the base claim:
wherein the aperture is defined by a pair of spaced, opposing aperture edges extending between the upper and lower planar surfaces of the adhesive bandage, the aperture edges extending arcuately relative to each other to define an elongated opening therebetween; wherein the elongated opening is sized so that, after the separation of the adhesive bandage onto the selected skin area, while the head is in the desired, operative position, the blade assembly does not contact the aperture edges during rotation of the blade assembly between the stowed position and the operative position; wherein the bandage comprises absorptive material on the lower surface extending along the aperture edges; wherein the adhesive bandage-clip assembly further includes a bandage-clip secured to the upper surface of the adhesive bandage, the bandage-clip having greater rigidity than the adhesive contact surface, the bandage-clip located and extending proximate to the elongated opening; wherein the flanges include at least one structure selected from the group consisting of engagement portions extending radially outwardly from the aperture edges and a pair of lips extending proximate to the aperture edges and orthogonally from the upper surface of the bandage; wherein the flanges have flange portions oriented outwardly to selectively engage the arms of the crimping assembly when the crimping assembly is actuated by a corresponding one of the manually actuatable controls; wherein the flange portions are located relative to the aperture edges to move the corresponding edges of the aperture toward each other to close the elongated opening of the bandage upon a sufficient amount of advancement of the arms of the crimping assembly, and whereby the biopsy site is covered by the adhesive bandage
As to Claim 14, neither Bayan nor the prior art of record teaches the biopsy-capable dermatoscope of base claim 1, including the following, in combination with all other limitations of the base claim:
the bandage has edges with opposing, engageable, interlocking portions secured relative to each other when the elongated opening has been closed
As to Claim 15, neither Bayan nor the prior art of record teaches the biopsy-capable dermatoscope of base claim 1, including the following, in combination with all other limitations of the base claim:
the flanges comprise the engagement portions extending radially outwardly from the aperture edges and the pair of lips extending proximate to the aperture edges; wherein the flanges further comprise sliders independently slidable relative to the lips between a first, disengaged slider position and a second engaged slider position radially inwardly from the disengaged slider position; wherein the sliders have radially outwardly facing slider positions; and wherein the arms terminate in respective pairs of fingers, one of the fingers oriented and configured to selectively engage the engagement portions of the flanges and another of the fingers oriented and configured to selectively engage the outwardly facing portions of the sliders
As to Claim 16, neither Bayan nor the prior art of record teaches the biopsy-capable dermatoscope of base claim 1, including the following, in combination with all other limitations of the base claim:
wherein, in response to advancing the arms by actuation of corresponding controls, the lips are advanced to reduce the size of the elongated opening of the bandage by contact between the first finger and the opposing engagement portions of the flanges and, thereafter, the sliders are advanced to impart force upon the bandage upwardly relative to the planar surfaces of the bandage to promote eversion of the incision site
As to Claim 22, neither Bayan nor the prior art of record teaches the biopsy-capable dermatoscope of base claim 1, including the following, in combination with all other limitations of the base claim:
wherein the adhesive bandage-clip assembly comprises a pair of interlockable staples; wherein the crimping assembly comprises a rotatable crimping ring transversely mounted on the head; wherein the arms of the crimping assembly comprise cam portions extending radially inwardly from the rotatable crimping ring; and wherein the crimping ring is rotatable between a first position in which the arms are disengaged from the staples and a second position engaged with the staples to crimp the adhesive bandage-clip assembly.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of publish
ed or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights