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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the housing portion and the second housing portion arranged side-by-side” in lines 4-5. It is unclear how the housing comprises the first and second portions and the second portion is arranged side by side with the whole housing portion. The Examiner believes this is a typographical mistake and that the Applicant meant to recite “the first housing portion and the second housing portion arranged side-by-side”.
Claims 2-17 are similarly rejected by virtue of their dependency upon claim 1.
Claim 9 recites the limitation “the exterior surface” in lines 2-3. It is unclear if which of the first or second housing this external surface is referring to.
Claim 21 recites “wherein the visualization aid comprises a positioning of the instrument within the inner volume of the housing, the instrument positioned so as to be off-center relative to a center line of the inner volume extending longitudinally between the distal end and the proximal end of the housing.”. A product and its process must not be within the same claim
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 1-3, 5-10, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (U.S. Publication No. 20240066267), hereinafter Ma, in view of Graham et al. (U.S. Publication No. 20080166677), hereinafter Graham.
Regarding claim 1, Ma discloses an instrument delivery device (introducer 210; see FIGS. 1-5; the Examiner notes that all reference characters cited below refer to FIGS. 1-5 unless otherwise stated) for use with an intravenous catheter assembly (catheter 260 and secondary catheter 265; see [0069]), the instrument delivery device comprising:
a housing (housing 218) having a proximal end portion (portion 211) and a distal end portion (portion 212), the housing comprising a first housing portion (first housing member 220) and a second housing portion (second housing member 230), with the housing portion and the second housing portion arranged side-by-side and coupled together to define an inner volume (volume 213);
an instrument (catheter 260) movably received within the inner volume;
a coupling device (lock 240) positioned at the distal end portion of the housing and configured to couple the housing to an access connector of an intravenous catheter assembly (“the lock is coupled to the coupler 216 of the introducer housing 218”, [0080]; see FIG. 2); and
an advancement member (actuator 270) configured to move relative to the housing to advance a distal end of the instrument beyond the distal end portion of the housing and into the intravenous catheter assembly (“the actuator 270 can be moved relative to the introducer housing 218 to move the catheter 260 between a first position, in which the catheter 260 is entirely disposed within the second portion 215 of the inner volume 213, and a second position, in which at least a portion of the catheter 260 extends outside of the second portion 215 of the inner volume 213 and distal to the introducer housing 218”, [0080]).
However, Ma does not expressly state wherein the housing comprises a visualization aid configured to improve visibility of the instrument within the inner volume of the housing.
Graham teaches a light directing and amplifying device ([0007]) wherein the housing (body 16) comprises a visualization aid (coating 11) configured to improve visibility of the instrument within the inner volume of the housing (see [0020-0022]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the housing of Ma include a visualization aid configured to improve visibility of the instrument within the inner volume of the housing. Doing so would amplify the change in direction of the light source, affecting the visibility and reflective quality of the instrument, as taught by Graham (see [0020-0022]; see claim 6).
Regarding claim 2, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 1, and Ma further discloses wherein each of the first housing portion (first housing member 220) and the second housing portion (second housing member 230) comprises a top region, a bottom region, and a side region (the Examiner notes Ma discloses proximal end portions, distal end portions, and inner and external surfaces for both first and second housing members, see [0071-0072]).
However, Ma does not expressly state wherein each of the first housing portion and the second housing portion is formed of a transparent or semi-transparent material.
Graham teaches a light directing and amplifying device ([0007]) wherein each of the first housing portion and the second housing portion is formed of a transparent or semi-transparent material (“In one embodiment, the light directing and amplifying device is opaque… The clear may be amber colored”, [0007]; translucent tubular body 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the housing of Ma wherein each of the first housing portion and the second housing portion is formed of a transparent or semi-transparent material. Doing so would amplify the change in direction of the light source, affecting the visibility and reflective quality of the instrument, as taught by Graham (see [0020-0022]; see claim 6).
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to form each of the first housing portion and the second housing portion of a transparent or semi-transparent material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 3, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 2, and Graham further teaches wherein the visualization aid (coating 11) comprises a coating applied to the first housing portion, the coating applied to an interior surface of the first housing portion on at least the side region (“tubular body 16 with a light inlet 17 first end 12, a light outlet 18 second end 13, an exterior 14 and an interior 15 with a mirror coating 11”, [0020]).
Regarding claim 5, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 3, and Graham further teaches wherein the coating forms a one- way mirror that may be looked through from a first side, but has an opaque or reflective nature on an opposing second side (“FIG. 9, the light directing and amplifying device 10 is comprised of a translucent tubular body 22 coated with an internal one way mirror 23.”, [0022]).
Regarding claim 6, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 2, and Graham further teaches wherein the visualization aid (coating 11) comprises the side region of each of the first housing portion and the second housing portion (“tubular body 16 with a light inlet 17 first end 12, a light outlet 18 second end 13, an exterior 14 and an interior 15 with a mirror coating 11”, [0020]).
Regarding claim 7, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 6, however, Ma in view of Graham does not expressly state wherein the side region of each of the first and second housing portions has a thickness that is less than a thickness of the top region and the bottom region, to facilitate better visualization of the instrument through the side region.
It would have been an obvious matter of design choice to modify thickness the side region of each of the first and second housing portions to be less than a thickness of the top region and the bottom region, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 8, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 6, and Ma further discloses wherein the side region of each of the first and second housing portions (first housing member 220 and second housing member 230) has an interior surface (surface 223 and 233) and an exterior surface, with each of the interior surface and an exterior surface comprising a flat surface (see flat surfaces of the exterior of 220 and 230 in FIG. 6).
Regarding claim 9, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 6, and Ma further discloses wherein the side region of each of the first and second housing portions (first housing member 220 and second housing member 230) has an interior surface (surface 223 and 233) and an exterior surface, with the exterior surface comprising a curved surface (see FIG. 8) and the interior surface comprising a flat surface (first portion 224 of inner surface 223) or a convex surface having a larger radius than the curved exterior surface.
Regarding claim 10, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 6, and Ma further discloses wherein the side region of each of the first and second housing portions comprises a smoothed exterior surface free of any steps or indents (see distal end portion 232 of the second housing member 230 in FIG. 5 and smooth exterior of first housing member 220 in FIG. 6), the smooth exterior surface minimizing refraction and reflecting of light as it passes through the side region (the Examiner notes the smooth exterior surface being substantially free of indents or steps or other surface discontinuities provides a more uniform interface for light passing through the side region of the device. Therefore, this reduces angle of incidences and minimizes reflection of and scattering of light. Accordingly, the claimed smooth surface would be expected to facilitate more uniform transmission of light through the side region of the device.
Regarding claim 18, Ma discloses an instrument delivery device (introducer 210; see FIGS. 1-5; the Examiner notes that all reference characters cited below refer to FIGS. 1-5 unless otherwise stated) for use with an intravenous catheter assembly (catheter 260 and secondary catheter 265; see [0069]), the instrument delivery device comprising:
a housing (housing 218) having a proximal end portion (portion 211) and a distal end portion (portion 212), the housing comprising a first housing portion (first housing member 220) and a second housing portion (second housing member 230), with the housing portion and the second housing portion arranged side-by-side and coupled together to define an inner volume (volume 213);
an instrument (catheter 260) movably received within the inner volume;
a coupling device (lock 240) positioned at the distal end portion of the housing and configured to couple the housing to an access connector of an intravenous catheter assembly (“the lock is coupled to the coupler 216 of the introducer housing 218”, [0080]; see FIG. 2); and
an advancement member (actuator 270) configured to move relative to the housing to advance a distal end of the instrument beyond the distal end portion of the housing and into the intravenous catheter assembly (“the actuator 270 can be moved relative to the introducer housing 218 to move the catheter 260 between a first position, in which the catheter 260 is entirely disposed within the second portion 215 of the inner volume 213, and a second position, in which at least a portion of the catheter 260 extends outside of the second portion 215 of the inner volume 213 and distal to the introducer housing 218”, [0080]).
However, Ma does not expressly state wherein the instrument comprises a visualization aid configured to improve visibility of the instrument within the inner volume of the housing.
Graham teaches a light directing and amplifying device ([0007]) wherein the instrument (body 16) comprises a visualization aid (coating 11) configured to improve visibility of the instrument within the inner volume of the housing (see [0020-0022]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the instrument of Ma include a visualization aid configured to improve visibility of the instrument within the inner volume of the housing. Doing so would amplify the change in direction of the light source, affecting the visibility and reflective quality of the instrument, as taught by Graham (see [0020-0022]; see claim 6).
Claims 4, 11, 12, 14, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (U.S. Publication No. 20240066267), hereinafter Ma, in view of Graham et al. (U.S. Publication No. 20080166677), hereinafter Graham, in view of Ghareeb et al. (U.S. Publication No. 20200281820), hereinafter Ghareeb.
Regarding claim 4, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 3, and Graham further teaches wherein the coating comprises an opaque coating having a first color (see opaqueness and amber coloring of device in [0007]).
However, Ma in view of Graham does not expressly state wherein the instrument has a second color that is darker than the first color, such that the coating is contrasted from the instrument.
Ghareeb teaches a probe insertion system (Abstract) wherein the instrument has a second color that is darker than the first color, such that the coating is contrasted from the instrument (“For example, the body 14, 114, 214 may be manufactured from materials, e.g. plastics, having the desired colours, or may have the desired visual indicators printed or painted thereon, or may have adhesive stickers applied thereto, or sleeves fitted thereon. In cases where the visual indicators are embedded in the body 14, 114, 214 are provided on an internal surface, the body should otherwise be transparent so that the visual indictors can be seen by the user. In any event, the visual indicators are discernible by the user looking at the body 14, 114, 214.”, [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the instrument of Ma in view of Graham to have a second color that is darker than the first color, such that the coating is contrasted from the instrument. Doing so doesn’t change the device structurally or functionally. Further, the visual indicators and colors are merely a matter of desire and convenience, as taught by Ghareeb (see [0053]).
Regarding claim 11, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 2, however, Ma in view of Graham does not expressly state wherein the visualization aid comprises a sticker applied to the side region of the first housing portion, the sticker applied to an exterior surface of the side region and having a first color, and wherein the instrument has a second color that is darker than the first color, such that the instrument is contrasted from the sticker.
Ghareeb teaches a probe insertion system (Abstract) wherein the visualization aid comprises a sticker applied to the side region of the first housing portion, the sticker applied to an exterior surface of the side region and having a first color, and wherein the instrument has a second color that is darker than the first color, such that the instrument is contrasted from the sticker (“For example, the body 14, 114, 214 may be manufactured from materials, e.g. plastics, having the desired colours, or may have the desired visual indicators printed or painted thereon, or may have adhesive stickers applied thereto, or sleeves fitted thereon. In cases where the visual indicators are embedded in the body 14, 114, 214 are provided on an internal surface, the body should otherwise be transparent so that the visual indictors can be seen by the user. In any event, the visual indicators are discernible by the user looking at the body 14, 114, 214.”, [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the visualization aid of Ma in view of Graham to have a sticker applied to the side region of the first housing portion, the sticker applied to an exterior surface of the side region and having a first color, and wherein the instrument has a second color that is darker than the first color, such that the instrument is contrasted from the sticker. Visual indicators and colors are merely a matter of desire and convenience, as taught by Ghareeb (see [0053]).
Regarding claim 12, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 2, and Graham further teaches wherein the visualization aid (coating 11) comprises a sleeve secured to an exterior surface of the first housing portion (see plastic sleeve cover in [0024] of device 10).
However, Ma in view of Graham does not expressly state the sleeve having a first color, and wherein the instrument has a second color that is darker than the first color, such that the instrument is contrasted from the sleeve.
Ghareeb teaches a probe insertion system (Abstract) wherein the sleeve has a first color, and wherein the instrument has a second color that is darker than the first color, such that the instrument is contrasted from the sleeve (“For example, the body 14, 114, 214 may be manufactured from materials, e.g. plastics, having the desired colours, or may have the desired visual indicators printed or painted thereon, or may have adhesive stickers applied thereto, or sleeves fitted thereon. In cases where the visual indicators are embedded in the body 14, 114, 214 are provided on an internal surface, the body should otherwise be transparent so that the visual indictors can be seen by the user. In any event, the visual indicators are discernible by the user looking at the body 14, 114, 214.”, [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the visualization aid of Ma in view of Graham to have the sleeve having a first color, and wherein the instrument has a second color that is darker than the first color, such that the instrument is contrasted from the sleeve. Doing so doesn’t change the device structurally or functionally. Visual indicators and colors are merely a matter of desire and convenience, as taught by Ghareeb (see [0053]).
Regarding claim 14, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 1, and Graham further teaches wherein the visualization aid (coating 11) comprises an opaque material from which the first housing portion is formed, with the second housing portion formed of a transparent or semi-transparent material, the opaque material having a first color (see opaqueness and amber coloring of device in [0007]).
However, Ma in view of Graham does not expressly state wherein the instrument has a second color that is darker than the first color, such that the first housing portion is contrasted from the instrument.
Ghareeb teaches a probe insertion system (Abstract) wherein the instrument has a second color that is darker than the first color, such that the first housing portion is contrasted from the instrument (“For example, the body 14, 114, 214 may be manufactured from materials, e.g. plastics, having the desired colours, or may have the desired visual indicators printed or painted thereon, or may have adhesive stickers applied thereto, or sleeves fitted thereon. In cases where the visual indicators are embedded in the body 14, 114, 214 are provided on an internal surface, the body should otherwise be transparent so that the visual indictors can be seen by the user. In any event, the visual indicators are discernible by the user looking at the body 14, 114, 214.”, [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Ma in view of Graham wherein the instrument has a second color that is darker than the first color, such that the first housing portion is contrasted from the instrument. Doing so doesn’t change the device structurally or functionally. Visual indicators and colors are merely a matter of desire and convenience, as taught by Ghareeb (see [0053]).
Regarding claim 15, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 1, and Graham further teaches wherein the visualization aid (coating 11) comprises a semi-transparent material (amber color, see [0007;0022]) from which the first housing portion and the second housing portion are formed, the semi-transparent material having a tinted first color (amber color, see [0007;0022]).
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to form each of the first housing portion and the second housing portion of a semi-transparent material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
However, Ma in view of Graham does not expressly state wherein the instrument has a second color that is darker than the first color, such that the first housing portion and the second housing are contrasted from the instrument.
Ghareeb teaches a probe insertion system (Abstract) wherein the instrument has a second color that is darker than the first color, such that the first housing portion and the second housing are contrasted from the instrument (“For example, the body 14, 114, 214 may be manufactured from materials, e.g. plastics, having the desired colours, or may have the desired visual indicators printed or painted thereon, or may have adhesive stickers applied thereto, or sleeves fitted thereon. In cases where the visual indicators are embedded in the body 14, 114, 214 are provided on an internal surface, the body should otherwise be transparent so that the visual indictors can be seen by the user. In any event, the visual indicators are discernible by the user looking at the body 14, 114, 214.”, [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Ma in view of Graham wherein the instrument has a second color that is darker than the first color, such that the first housing portion and the second housing are contrasted from the instrument. Doing so doesn’t change the device structurally or functionally. Visual indicators and colors are merely a matter of desire and convenience, as taught by Ghareeb (see [0053]).
Regarding claim 20, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 18, and Graham further teaches wherein the visualization aid (coating 11) comprises a coloring of the instrument (amber color, see [0007;0022]).
However, Ma in view of Graham does not expressly state wherein the coloring of instrument is darker than a coloring of the housing, such that the instrument is contrasted from the housing.
Ghareeb teaches a probe insertion system (Abstract) wherein the coloring of instrument is darker than a coloring of the housing, such that the instrument is contrasted from the housing (“For example, the body 14, 114, 214 may be manufactured from materials, e.g. plastics, having the desired colours, or may have the desired visual indicators printed or painted thereon, or may have adhesive stickers applied thereto, or sleeves fitted thereon. In cases where the visual indicators are embedded in the body 14, 114, 214 are provided on an internal surface, the body should otherwise be transparent so that the visual indictors can be seen by the user. In any event, the visual indicators are discernible by the user looking at the body 14, 114, 214.”, [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Ma in view of Graham wherein the coloring of instrument is darker than a coloring of the housing, such that the instrument is contrasted from the housing. Doing so doesn’t change the device structurally or functionally. Visual indicators and colors are merely a matter of desire and convenience, as taught by Ghareeb (see [0053]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (U.S. Publication No. 20240066267), hereinafter Ma, in view of Graham et al. (U.S. Publication No. 20080166677), hereinafter Graham, in view of Ghareeb et al. (U.S. Publication No. 20200281820), hereinafter Ghareeb, in view of Blanchard et al. (U.S. Publication No. 20230338707), hereinafter Blanchard.
Regarding claim 13, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 2, and Graham further teaches wherein the visualization aid (coating 11 on light directing device) comprises an insert (tubular body 22 with coating 11) positioned adjacent an interior surface of the housing, within the inner volume (“inserting a light directing and amplifying device comprised of a tubular body, with a first end, second end, an exterior, and a mirrored interior, on the light emitting end of a dental curing device”, claim 22), the insert having a first color (see opaqueness and amber coloring of device in [0007]).
However, Ma in view of Graham does not expressly state wherein the instrument has a second color that is darker than the first color, such that the instrument is contrasted from the insert.
Ghareeb teaches a probe insertion system (Abstract) wherein the instrument has a second color that is darker than the first color, such that the instrument is contrasted from the insert (“For example, the body 14, 114, 214 may be manufactured from materials, e.g. plastics, having the desired colours, or may have the desired visual indicators printed or painted thereon, or may have adhesive stickers applied thereto, or sleeves fitted thereon. In cases where the visual indicators are embedded in the body 14, 114, 214 are provided on an internal surface, the body should otherwise be transparent so that the visual indictors can be seen by the user. In any event, the visual indicators are discernible by the user looking at the body 14, 114, 214.”, [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Ma in view of Graham wherein the instrument has a second color that is darker than the first color, such that the instrument is contrasted from the insert. Doing so doesn’t change the device structurally or functionally. Visual indicators and colors are merely a matter of desire and convenience, as taught by Ghareeb (see [0053]).
However, Ma in view of Graham in view of Ghareeb does not expressly state wherein the insert is movable from a first position adjacent the side region of the first housing portion to a second position adjacent the side region of the second housing portion via a twist knob located on the housing.
Blanchard teaches an instrument advancement device (Abstract) wherein the insert is movable from a first position adjacent the side region of the first housing portion to a second position adjacent the side region of the second housing (see FIG. 13) portion via a twist knob (member 80) located on the housing (see [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Ma in view of Graham wherein the insert is movable from a first position adjacent the side region of the first housing portion to a second position adjacent the side region of the second housing portion via a twist knob located on the housing. Doing so would create a visual indicator for the retracted versus unretracted position of the device, as taught by Blanchard (see [0039]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (U.S. Publication No. 20240066267), hereinafter Ma, in view of Graham et al. (U.S. Publication No. 20080166677), hereinafter Graham, in view of Powell et al. (U.S. Publication No. 20090264866), hereinafter Powell.
Regarding claim 16, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 1, and Graham further teaches wherein the visualization aid (coating 11) comprises the side region (see [0020-0021]).
However, Ma in view of Graham does not expressly state wherein at least one of the first housing portion and the second housing portion comprises a co-molded component having a top region, a bottom region, and a side region, wherein the top region and the bottom region are formed of an opaque material and the side region is formed of a transparent material.
Powell teaches wherein at least one of the first housing portion and the second housing portion comprises a co-molded component having a top region, a bottom region, and a side region, wherein the top region and the bottom region are formed of an opaque material and the side region is formed of a transparent material (see [0005;0023-0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Ma in view of Graham wherein at least one of the first housing portion and the second housing portion comprises a co-molded component having a top region, a bottom region, and a side region, wherein the top region and the bottom region are formed of an opaque material and the side region is formed of a transparent material. Doing so provides a suitable process for forming of the body structure that will work successfully in visual applications where legibility and clear visible information in significant, as taught by Powell (see [0005;0023-0024]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (U.S. Publication No. 20240066267), hereinafter Ma, in view of Graham et al. (U.S. Publication No. 20080166677), hereinafter Graham, in view of Blanchard et al. (U.S. Publication No. 20230338707), hereinafter Blanchard.
Regarding claim 17, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 1, and Ma further discloses the first housing portion (first housing member 220) and the second housing portion (second housing member 230) comprising a top region, a bottom region, and a side region (the Examiner notes Ma discloses proximal end portions, distal end portions, and inner and external surfaces for both first and second housing members, see [0071-0072]).
However, Ma does not expressly state wherein each of the first housing portion and the second housing portion is formed of an opaque material.
Graham teaches a light directing and amplifying device ([0007]) wherein each of the first housing portion and the second housing portion is formed of an opaque material (“In one embodiment, the light directing and amplifying device is opaque… The clear may be amber colored”, [0007]; translucent tubular body 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the housing of Ma wherein each of the first housing portion and the second housing portion is formed of an opaque material. Doing so would amplify the change in direction of the light source, affecting the visibility and reflective quality of the instrument, as taught by Graham (see [0020-0022]; see claim 6).
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to form each of the first housing portion and the second housing portion of an opaque material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
However, Ma in view of Graham does not expressly state wherein the visualization aid comprises a window formed in the side region of at least one of the first housing portion and the second housing portion, with a transparent member secured within the window.
Blanchard teaches an instrument advancement device (Abstract) wherein the visualization aid comprises a window formed in the side region of at least one of the first housing portion and the second housing portion, with a transparent member secured within the window (“The housing may include a viewing window, where the indicator is aligned with the viewing window when the instrument is in the advanced position. The indicator may include a first color or pattern and the housing may include a second color or pattern, where the first color or pattern is different than the second color or pattern.”, [0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the visualization aid of Ma in view of Graham to have a window formed in the side region of at least one of the first housing portion and the second housing portion, with a transparent member secured within the window. Doing so would create a visualization portion of the device strictly for viewing, as taught by Blanchard (See [0036]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (U.S. Publication No. 20240066267), hereinafter Ma, in view of Graham et al. (U.S. Publication No. 20080166677), hereinafter Graham, in view of Bierman et al. (U.S. Publication No. 20200038643), hereinafter Bierman.
Regarding claim 19, Ma in view of Graham teaches the claimed invention as discussed above concerning the rejection of claim 18, however, Ma in view of Graham does not expressly state wherein the visualization aid comprises a plurality of stripes formed on the instrument, each of the plurality of stripes extending circumferentially about the instrument.
Bierman teaches a dilator having a valve element configured to at least inhibit fluid flow (Abstract) wherein the visualization aid comprises a plurality of stripes formed on the instrument, each of the plurality of stripes extending circumferentially about the instrument (“The sheath body 40 may be made partially or completely from clear, translucent, transparent, or semi-opaque material. The sheath body 40 can also include one or more radiopaque markers, such as, for example, barium sulfate stripes. In a preferred embodiment, the sheath includes two such radiopaque stripes disposed on diametrically opposite sides of the body 40.”, [0078]; see FIG. 8A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the visualization aid of Ma in view of Graham wherein the visualization aid comprises a plurality of stripes formed on the instrument, each of the plurality of stripes extending circumferentially about the instrument. Doing so provides visual marker to be identified by the user, as taught by Bierman (see [0078]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
08/08/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights