DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the support feature of claims 31 and 34 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 10, 21, 22, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2020/0023176 to Hu et al. (“Hu”) in view of U.S. Patent Publication No. 2004/0236275 to Pruitt et al. (“Pruitt”), U.S. Patent No. 5,655,826 to Kouno et al. (“Kouno”), U.S. Patent Publication No. 2009/0204075 to Simpson, and JP 2004-249692 to Ito et al. (“Ito”).
Regarding claim 1, Hu teaches a catheter assembly (Fig. 1A) comprising a catheter hub (12), comprising a distal end (22), a proximal end (20), a lumen (50/52, Fig. 1D) extending through the distal end and the proximal end, and a side port (18) disposed between the distal end and the proximal end, wherein the catheter hub further comprises a first wing and a second wing opposite the first wing (Fig. 1A, wings on opposite sides of 12), a catheter (14) extending distally from the catheter hub, an extension set (16/24) coupled to the catheter hub, the extension set including a first luer adapter (40b) coupled to a proximal end of a first extension tube (30), a second luer adapter (40a) coupled to a proximal end of a second extension tube (16), and a clamp (17) on the second extension tube, the first luer adapter including a needleless access connector having a valve therein ([0034]), a needle hub (34) coupled to the proximal end of the catheter hub, and an introducer needle (36) coupled to the needle hub and extending through the catheter but does not explicitly teach the phosphorescent materials.
Pruitt teaches ends of port adapters and wings being formed of a phosphorescent material, at least one phosphorescent material being polycarbonate ([0024], 28 includes the wings). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the second luer adapter, the first wing, the second wing, and the valve of the needless access connector (which is another end of a port adapter) of Hu of at least a phosphorescent material ([0007]) being a polycarbonate material ([0024]), as taught by Pruitt to allow for greater visibility in dim or darkened environments ([0006]).
Although Pruitt does not explicitly disclose silicone as the second phosphorescent material, Pruitt does disclose that different types of light emitting substances can be used ([0007]). Kouno teaches the alternative use of silicone and polycarbonate as a phosphorescent material (column 4, lines 57-63). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the phosphorescent material of the first wing, the second wing, and the valve of the needleless access connector of Hu and Pruitt with silicone, as taught by Kouno, to yield the predictable result of providing a phosphorescent material. Both Pruitt and Kouno teach the use of phosphorescent materials for medical devices, Kouno merely shows an additional alternative example of phosphorescent material as are known in the art.
Simpson teaches a clamp being formed of a phosphorescent material ([0051]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the clamp of Hu out of phosphorescent material as taught by Simpson in order to provide an optical signal component for identification ([0051]).
Although Simpson and Kouno teach the use of a phosphorescent material in general, they do not explicitly disclose Strontium Oxide Aluminate loaded polycarbonate as the phosphorescent material. Ito teaches the use of a 45% ([0021]) loaded polycarbonate ([0020]) material that uses glow-in-the-dark pigments based on Strontium Oxide Aluminate chemistry ([0025]) and that is configured to provide a glow light discharge still visible 24 hours after exposure to radiant energy ([0024]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the phosphorescent material of the second luer adapter and clamp of Hu, Pruitt, and Simpson with loaded polycarbonate, as taught by Ito, to yield the predictable result of providing a phosphorescent material. Pruitt, Simpson, and Ito all teach the use of phosphorescent materials for medical devices, Ito merely shows an additional alternative example of phosphorescent material as is known in the art.
Regarding claim 2, Hu, Pruitt, Kouno, Simpson, and Ito teach the catheter assembly of claim 1 as shown above, Hu further teaching the first and second extension tubes are not phosphorescent (the extension tubes of Hu are not disclosed as being phosphorescent). Additionally or in the alternative, Pruitt further teaches tubes attached to the ports/adaptors are not phosphorescent ([0006], [0007], & [0024], Pruitt highlights the ports and adapters at the ends of the catheter shaft being light emitting in order to insert various medical devices therethrough, not the associated tubes themselves). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the extension tubes of Hu to not be phosphorescent as taught by Pruitt, since it is the ports of the extension set that need to be seen in the dark, not the tubes attached thereto as well as the conservation of unnecessary additional phosphorescent material.
Regarding claim 10, Hu, Pruitt, Kouno, Simpson, and Ito teach the catheter assembly of claim 1 as shown above, Ito further teaching the glow-in-the-dark pigments are disposed within a matrix of the polycarbonate material ([0021]).
Regarding claim 21, Hu, Pruitt, Kouno, Simpson, and Ito teach the catheter assembly of claim 1 as shown above, Hu further teaching the first and second wings are integrally formed as part of the catheter hub (Fig. 1A).
Regarding claim 37, Hu, Pruitt, Kouno, Simpson, and Ito teach the catheter assembly of claim 1 as shown above, Pruitt previously teaching the second luer adapter and Simpson previously teaching the clamp comprises a body molded from the phosphorescent material, which is the 45% loaded polycarbonate material previously taught by Ito.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hu, Pruitt, Kouno, Simpson, and Ito as applied to claim 1 above, and further in view of WO 00/12165 to Eliasen et al. (“Eliasen”).
Regarding claim 6, Hu, Pruitt, Kouno, Simpson, and Ito teach the catheter assembly of claim 1 as shown above, Hu further teaching a distal end of the catheter hub (22) being distal to the portion of the catheter hub, but Hu does not explicitly disclose the portion of the catheter hub between the first wing and the second wing is not phosphorescent the distal end of the catheter hub being phosphorescent.
Although Pruitt does not explicitly teach the absence of phosphorescent material on the portion of the catheter hub between the wings, it does teach various sections of the catheter can be phosphorescent in order to aid visibility ([0009], [0024], [0019], etc...).
The provision of phosphorescent material is considered a type of coloration for identification purposes, Eliasen has been cited as a teaching for alternatively coloring either the wings of a catheter (page 44, section ii, the wings are separately colored relative to the tube from which the wings extend since the tube is separately colored in claim 147) or the wings in addition to the hub (page 44, claim 147). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have only used a coloration (i.e., phosphorescent material) on the wings of the catheter of Hu and Pruitt instead of using a coloration on both the wings and the hub as taught by Eliasen, because such a modification is a simple alternative design, yielding the predictable result of providing a means of indication relative to uncolored portions of the device for identification purposes.
Pruitt further teaches a distal end of a catheter hub which is distal to the wings as being phosphorescent ([0024], as shown in annotated Fig. 1 below, Pruitt identifies the distal end of the proximal adapter, i.e. hub, as the portion connected to shaft 11, Pruitt also discloses that the distal end-face of the proximal adapter has the light emitting substance; therefore, Pruitt teaches the distal end face of the distal end of the proximal adapter, which is distal to the wings, as being phosphorescent). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter hub of Hu to implement the phosphorescent material into the distal end of the catheter hub as further taught by Pruitt in order to provide light emission ([0007]) for easier viewing in dim or darkened environments ([0006]).
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Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hu, Pruitt, Kouno, Simpson, and Ito as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2020/0023166 to Burkholz et al. (“Burkholz”).
Regarding claim 23, Hu, Pruitt, Kouno, Simpson, and Ito teach the catheter assembly of claim 1 as shown above, but do not teach the instrument advancement device.
Burkholz teaches an instrument advancement device (Fig. 7C) comprising a housing (88) having a slot (90), an advancement tab (92) disposed within the slot, an instrument (86) disposed within the housing and coupled to the advancement tab, and a distal connector (44) by which the instrument advancement device is coupled to the proximal end of the catheter hub. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the instrument advancement device of Burkholz with the catheter assembly of Hu, to yield the predictable result of providing a means to advance an instrument through a catheter assembly. The catheter assembly of Hu is designed to be used with instrument delivery devices such as shown in Fig. 2B of Hu. Burkholz merely shows an alternative example of an instrument delivery device in a highly analogous context as is known in the art.
Burkholz does not teach the distal connector being phosphorescent. Pruitt teaches that distal ports or ends of medical devices can formed of light emitting materials ([0018]) such as polycarbonate ([0024]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the distal connector of Hu the first phosphorescent material as taught by Pruitt in order to provide light emission ([0007]) for easier viewing in dim or darkened environments ([0006]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Hu, Pruitt, Kouno, Simpson, Ito, and Burkholz as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2003/0171721 to Enomoto et al. (“Enomoto”).
Regarding claim 24, Hu, Pruitt, Kouno, Simpson, Ito, and Burkholz teach the catheter assembly of claim 23 as shown above, but do not teach the tab being phosphorescent.
Enomoto teaches an advancement tab (button 67 which is intended to be pressed by a finger of a user [0183]) formed of a light emitting material ([0254]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the tab of Hu of a light emitting material as taught by Enomoto in order to allow for easy identification in the dark ([0024] such that such a button or tab may be pressed by a user).
Enomoto teaches a fluorescent material as the light emitting material instead of a phosphorescent material.
Pruitt teaches the alternative use of a phosphorescent material instead of a fluorescent material ([0007]), the phosphorescent material being the first phosphorescent material (polycarbonate, [0024]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the first phosphorescent material as the light emitting material in the tab of Hu, Burkholz, and Enomoto, as taught by Pruitt, since both Pruitt and Enomoto teach the use of light emitting materials in medical devices, Pruitt merely showing examples of art-recognized alternative light emitting materials as are known in the art.
Claims 25-28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Hu in view of U.S. Patent Publication No. 2020/0078565 to Scherich et al. (“Scherich”), CA 3216926 to Barnett-Vanes et al. (“Barnett”), Pruitt, and Ito.
Regarding claim 25, Hu teaches a catheter assembly (Fig. 1A) comprising a catheter hub (12), comprising a distal end (22), a proximal end (20), a lumen (50/52, Fig. 1D) extending through the distal end and the proximal end, and a side port (18) disposed between the distal end and the proximal end, a catheter (14) extending distally from the catheter hub, and an extension set (16/24) coupled to the catheter hub, but does not show the catheter hub stabilization device and the phosphorescence.
Scherich teaches a catheter hub stabilization device (10, Fig. 1C) configured to be selectively coupled to the proximal end of the catheter hub (16), wherein the catheter hub stabilization device comprises a platform (22). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented the catheter hub stabilization device of Scherich with the catheter of Hu because Scherich is inherently designed to be used with winged catheter assemblies, such as the one exemplified by Hu, for the purpose of advantageously stabilizing the catheter assembly relative to the skin at an angle equal to the insertion angle of the catheter ([0033]) to promote patient comfort as would be understood by one of ordinary skill.
Barnett teaches that various component parts of catheter hub stabilization devices (100) may be luminescent (page 32, last paragraph, luminescence is an art-recognized equivalent of phosphorescent as will be explained below). Examiner notes that the edge of the platform would be considered a "component" of the catheter hub stabilization device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the edge of the platform of the catheter hub stabilization device of Scherich luminescent as taught by Barnett to assist in locating the securement device at night or in low light conditions, as well as serve as a reminder to the user that they are still wearing the medical article securement device (page 32, last paragraph).
Although Barnett does not explicitly mention phosphorescence, Pruitt teaches that luminescent and phosphorescent materials are interchangeable in medical device contexts ([0007]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have exchanged the luminescent material of Barnett for phosphorescent material as taught by Pruitt because both materials are art-recognized alternatives materials to allow for greater visibility in dim or darkened environments ([0006]). Pruitt does not specify the claim details of the phosphorescent material.
Ito teaches the use of a 45% ([0021]) loaded polycarbonate ([0020]) material that uses glow-in-the-dark pigments based on Strontium Oxide Aluminate chemistry ([0025]) and that is configured to provide a glow light discharge still visible 24 hours after exposure to radiant energy ([0024]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the phosphorescent material of the Pruitt with loaded polycarbonate, as taught by Ito, to yield the predictable result of providing a phosphorescent material. Pruitt and Ito both teach the use of phosphorescent materials for medical devices, Ito merely shows an additional alternative example of phosphorescent material as is known in the art.
Regarding claim 26, Hu, Scherich, Barnett, Pruitt, and Ito teach the catheter assembly of claim 25 as shown above, Scherich further teaching the catheter hub stabilization device is configured to be selectively coupled to the proximal end of the catheter hub after removal of a needle hub and an introducer needle (the catheter hub stabilization device of Scherich is capable of being coupled to the catheter hub after a needle hub and needle are removed, it is noted that neither the hub nor the needle are positively recited).
Regarding claim 27, Hu, Scherich, Barnett, Pruitt, and Ito teach the catheter assembly of claim 25 as shown above, Scherich further teaching a distal end of the catheter hub stabilization device is configured to be inserted into or threaded with the proximal end of the catheter hub (38 is inserted into 16, Fig. 1C).
Regarding claim 28, Hu, Scherich, Barnett, Pruitt, and Ito teach the catheter assembly of claim 25, Scherich further teaching a luer adapter (46, [0042]) coupled to a proximal end of the catheter hub stabilization device, wherein the luer adapter comprises a fluid path therethrough in fluid communication with the lumen of the catheter hub and the extension set (once attached to the catheter, the fluid path 44 communicates with the lumen in the catheter hub 16).
Regarding claim 30, Hu, Scherich, Barnett, Pruitt, and Ito teach the catheter assembly of claim 25, Ito further teaching the glow-in-the-dark pigments are disposed within a matrix of the polycarbonate material ([0021]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Hu in view of U.S. Patent Scherich, Barnett, Pruitt, and Ito as applied to claim 28 above, and further in view of Burkholz and Kouno.
Regarding claim 29, Hu, Scherich, Barnett, Pruitt, and Ito teach the catheter assembly of claim 28 as shown above, Scherich further teaching the luer adapter comprises a needleless access connector ([0042]), but do not show the valve and the second phosphorescent material.
Burkholz teaches a needleless connector having a valve (59) therein ([0083]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needleless connector of Scherich to include a valve as taught by Burholz to yield the predictable result of providing a selective connection to infuse treatment material. As is understood in the art, the use of a valve in such connectors allows one-way flow of treatment material to prevent contamination. Burkholz does not teach the connector to be phosphorescent.
Pruitt teaches ends of adapters/connectors being formed of a phosphorescent material, at least one phosphorescent material being polycarbonate ([0024]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the valve of the needless access connector of Burkholz of a phosphorescent material ([0007]), as taught by Pruitt, to allow for greater visibility in dim or darkened environments ([0006]). Burkholz does not show the use of silicone.
Kouno teaches the alternative use of silicone and polycarbonate as a phosphorescent material (column 4, lines 57-63). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the phosphorescent material of the valve of the needleless access connector of Burkholz and Pruitt with silicone, as taught by Kouno, to yield the predictable result of providing a phosphorescent material. Both Pruitt and Kouno teach the use of phosphorescent materials for medical devices, Kouno merely shows an additional alternative example of phosphorescent material as are known in the art.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Hu in view of Burkholz, U.S. 2008/0300574 to Belson et al. (“Belson”), Pruitt, and Ito.
Regarding claim 31, Hu teaches a catheter assembly (Fig. 1A) comprising a catheter hub (12), comprising a distal end (22), a proximal end (20), a lumen (50/52, Fig. 1D) extending through the distal end and the proximal end, and a side port (18) disposed between the distal end and the proximal end, a catheter (14) extending distally from the catheter hub, an extension set (16/24) coupled to the catheter hub
Burkholz teaches an instrument advancement device (Fig. 7C) comprising a housing (88) having a slot (90), an advancement tab (92) disposed within the slot, an instrument (86) disposed within the housing and coupled to the advancement tab, and a distal connector (44 or portion between 82 and 88) by which the instrument advancement device is coupled to the proximal end of the catheter hub, but does not teach the support feature and the phosphorescent material.
Belson teaches a support feature (7, Figs. 2-3) disposed within a housing (1) and configured to reduce buckling of the instrument ([0023]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a support feature within a housing of the instrument advancement device of Burkholz as taught by Belson in order to avoid blowing or buckling of a wire as it is advanced within an instrument advancement device ([0023]).
Pruitt teaches ends of adapters/connectors being formed of a first phosphorescent material configured to exhibit a glowing light discharge to facilitate attachment, at least one phosphorescent material being polycarbonate ([0024]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the distal connector of Burkholz of at least a first phosphorescent material ([0007]), as taught by Pruitt, to allow for greater visibility in dim or darkened environments ([0006]). Once combined, the device of Hu, Burkholz, Belson, and Pruitt would facilitate attachment of the instrument advancement device to the proximal end of the catheter hub in the dark. Pruitt does not teach the particulars of the phosphorescent material.
Ito teaches the use of a 45% ([0021]) loaded polycarbonate ([0020]) material that uses glow-in-the-dark pigments based on Strontium Oxide Aluminate chemistry ([0025]) and that is configured to provide a glow light discharge still visible 24 hours after exposure to radiant energy ([0024]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the phosphorescent material of the Pruitt with loaded polycarbonate, as taught by Ito, to yield the predictable result of providing a phosphorescent material. Pruitt and Ito both teach the use of phosphorescent materials for medical devices, Ito merely shows an additional alternative example of phosphorescent material as is known in the art.
Claims 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Hu in view of U.S. 2019/0321590 to Burkholz et al. (“Burkholz2”), Belson, Pruitt, and Ito.
Regarding claim 31, Hu teaches a catheter assembly (Fig. 1A) comprising a catheter hub (12), comprising a distal end (22), a proximal end (20), a lumen (50/52, Fig. 1D) extending through the distal end and the proximal end, and a side port (18) disposed between the distal end and the proximal end, a catheter (14) extending distally from the catheter hub, an extension set (16/24) coupled to the catheter hub ([0052]).
Burkholz2 teaches an instrument advancement device (Fig. 2A) comprising a housing (14) having a slot (20), an advancement tab (46) disposed within the slot, an instrument (38) disposed within the housing and coupled to the advancement tab, a support feature (48) disposed within the housing and configured to reduce buckling of the instrument, and a distal connector (49) by which the instrument advancement device is coupled to a proximal end of a catheter hub ([0052]), but does not teach the phosphorescent material.
Pruitt teaches ends of adapters/connectors being formed of a first phosphorescent material configured to exhibit a glowing light discharge to facilitate attachment, at least one phosphorescent material being polycarbonate ([0024]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the distal connector of Burkholz2 of a first phosphorescent material ([0007]), as taught by Pruitt, to allow for greater visibility in dim or darkened environments ([0006]). Once combined, the device of Hu, Burkholz2, Belson, and Pruitt would facilitate attachment of the instrument advancement device to the proximal end of the catheter hub in the dark. Pruitt does not teach the particulars of the phosphorescent material.
Ito teaches the use of a 45% ([0021]) loaded polycarbonate ([0020]) material that uses glow-in-the-dark pigments based on Strontium Oxide Aluminate chemistry ([0025]) and that is configured to provide a glow light discharge still visible 24 hours after exposure to radiant energy ([0024]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the phosphorescent material of the Pruitt with loaded polycarbonate, as taught by Ito, to yield the predictable result of providing a phosphorescent material. Pruitt and Ito both teach the use of phosphorescent materials for medical devices, Ito merely shows an additional alternative example of phosphorescent material as is known in the art.
Regarding claim 32, Hu, Burkholz2, Belson, Pruitt, and Ito teach the catheter assembly of claim 31 as shown above, Burkholz2 further teaching the distal connector comprises two prongs (49) configured to clasp the proximal end of the catheter hub and a central portion (16) configured to be inserted into the lumen of the catheter hub.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Hu, Burkholz, Belson, Pruitt, and Ito as applied to claim 31 above, and further in view of Enomoto.
Regarding claim 33, Hu, Burkholz, Belson, Pruitt, and Ito teach the catheter assembly of claim 31 as shown above, but do not teach the tab being phosphorescent.
Enomoto teaches an advancement tab (button 67 which is intended to be pressed by a finger of a user [0183]) formed of a light emitting material ([0254]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the tab of Hu of a light emitting material as taught by Enomoto in order to allow for easy identification in the dark ([0024] such that such a button or tab may be pressed by a user).
Enomoto teaches a fluorescent material as the light emitting material instead of a phosphorescent material.
Pruitt teaches the alternative use of a phosphorescent material instead of a fluorescent material ([0007]), the phosphorescent material being the first phosphorescent material (polycarbonate, [0024]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the first phosphorescent material as the light emitting material in the tab of Hu, Burkholz, and Enomoto, as taught by Pruitt, since both Pruitt and Enomoto teach the use of light emitting materials in medical devices, Pruitt merely showing examples of art-recognized alternative light emitting materials as are known in the art. Once combined, Ito previously teaching the details of the first phosphorescent material.
Claims 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Hu, Burkholz, Belson, Pruitt, and Ito as applied to claim 31 above, and further in view of U.S. Patent No. 4,994,034 to Botich et al. (“Botich”).
Regarding claim 34, Hu, Burkholz, Belson, Pruitt, and Ito teach the catheter assembly of claim 31, but do not teach a phosphorescent support feature.
Botich has been cited to teach an element within a transparent housing that is formed of a fluorescent material. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made an element such as the support feature of Belson fluorescent and positioned within a transparent housing as taught by Botich to yield the predictable result of allowing internal portions of the device to be visible in low light conditions through a transparent housing (column 8, lines 51-56).
Although Botich does not explicitly mention phosphorescence, Pruitt teaches that fluorescent and phosphorescent materials are interchangeable in medical device contexts ([0007]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have exchanged the fluorescent material of Botich for phosphorescent material as taught by Pruitt because both materials are art-recognized alternatives materials to allow for greater visibility in dim or darkened environments ([0006]). Pruitt does not specify the claim details of the phosphorescent material
Ito teaches the use of a 45% ([0021]) loaded polycarbonate ([0020]) material that uses glow-in-the-dark pigments based on Strontium Oxide Aluminate chemistry ([0025]) and that is configured to provide a glow light discharge still visible 24 hours after exposure to radiant energy ([0024]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the phosphorescent material of the Pruitt with loaded polycarbonate, as taught by Ito, to yield the predictable result of providing a phosphorescent material. Pruitt and Ito both teach the use of phosphorescent materials for medical devices, Ito merely shows an additional alternative example of phosphorescent material as is known in the art.
Regarding claim 35, Hu, Burkholz, Belson, Pruitt, Ito, and Botich teach the catheter assembly of claim 34, Botich previously teaching the housing being translucent or transparent and not phosphorescent as shown above in the rejection of claim 34.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Hu, Pruitt, Kouno, Simpson, and Ito as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2005/0189795 to Roessler.
Regarding claim 36, Pruitt, Kouno, Simpson, and Ito teach the catheter assembly of claim 1 as shown above, but do not teach the doping materials.
Roessler teaches glow-in-the-dark pigments comprise strontium oxide aluminate doped with europium and dysprosium ([0021]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have doped the loaded phosphorescent material of Ito with doping materials as taught by Roessler as the doping with rare earth metals exhibit a long decay time a longer glow light discharge time after exposure to radiant energy ([0021]).
Response to Arguments
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The previous drawing objections have been withdrawn. However, new drawing objections are issued above in response to new claim amendments.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
Applicant’s arguments and amendments with respect to the art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hu, Pruitt, Kouno, Ito, and Simpson.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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