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 first and second wings being separable from the catheter hub in claim 22 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 22 recites the first and second wings “are separable from… the catheter hub.” Such a limitation does not have support in the original specification and is therefore considered new matter.
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, 2, 10, 21, and 22 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”), and U.S. Patent Publication No. 2009/0204075 to Simpson.
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 and the clamp of Hu of a first phosphorescent material and to have formed 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]), wherein the first phosphorescent material is 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 needless 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 additional alternative examples of phosphorescent materials 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 teaches the use of a phosphorescent material in general, Simpson does not explicitly disclose polycarbonate as the phosphorescent material. Kouno teaches the use of 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 clamp of Hu and Simpson with polycarbonate, as taught by Kouno, to yield the predictable result of providing a phosphorescent material. Both Simpson and Kouno teach the use of phosphorescent materials for medical devices, Kouno merely shows additional alternative examples of phosphorescent materials as are known in the art.
Regarding claim 2, Hu, Pruitt, Kouno, and Simpson 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, and Simpson teach the catheter assembly of claim 1 as shown, Pruitt further teaching the polycarbonate material including a phosphorescent coating or matrix ([0024]).
Regarding claim 21, Hu, Pruitt, Kouno, and Simpson 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 22, Hu, Pruitt, Kouno, and Simpson teach the catheter assembly of claim 1 as shown above, Hu further teaching the first and second wings being coupled to the catheter hub (Fig. 1A), but do not explicitly teach the wings being separable. However, 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 first and second wings of Hu to be separable from the catheter hub, since it has been held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961) (see MPEP § 2144.04).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hu, Pruitt, Kouno, and Simpson 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, and Simpson 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, and Simpson 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, and Simpson 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, 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, 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.
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, a new drawing objection has been issued in response to the new amendments as shown above.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The previous 112 rejections have been withdrawn. However, a new 112 rejection has been issued in response to the new amendments as shown above.
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, and Simpson.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783