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 Objections
Claims 26, 31, and 40-41 are objected to because of the following informalities:
In claim 26, line 2: “the first and second levers” should be “the first lever and the second lever”
In claim 31, line 2: “comprises gate” should be “comprises a gate”
In claim 40, line 12: “the two gates” should be “the first gate and the second gate”
In claim 41, line 1: “the two gates” should be “the first gate and the second gate”
Appropriate correction is required.
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.
Claim 32 is 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 32 recites the limitation "the two end cap components" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation will be interpreted as the gates of the first and second frames.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 22-23, 25-26, 29, 31, and 33-40 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Ribelin et al (WO 2016/187063, provided by applicant).
Regarding claim 22, Ribelin discloses:
An extended dwell catheter assembly (110; Figs. 11A-11D) comprising: a housing (120) comprising a first frame (172, left side) attached to a second frame (172, right side) and having an interior space, said housing (120) having a distal opening (see Image 1 below) and a proximal opening (Image 1); a catheter assembly (42) located in the interior space of the housing (120), said catheter assembly (42) comprising a catheter tube (44) attached to a catheter hub (46) and a needle (116) attached to a needle hub (114), wherein the needle (116) and the catheter tube (44) project out the distal opening of the housing (Fig. 11D) and the needle hub (114) projects out the proximal opening of the housing (11D), and wherein the catheter hub (46) is slidable within the interior space of the housing (Fig. 14D) from a proximal position to a distal position within the interior space (¶000122); an upper seam (visible seam between halves 172) located between the first frame (172) and the second frame (172) along a first side (top) of the housing and a lower seam (where the halves 172 meet at the bottom of halves 172, partially visible in Fig. 14D) located between the first frame (172) and the second frame (172) along a second side (partially inside) of the housing, the upper seam located above, elevation-wise, the lower seam (Fig. 11D – the upper seam is above the lower seam when the two halves 172 are closed together); and wherein the first frame (172) and the second frame (172) are separable from one another along the upper seam and the lower seam (Fig. 14D).
Image 1. Annotated portion of Fig. 11D
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Regarding claim 23, Ribelin discloses:
The extended dwell catheter assembly of claim 22, wherein the catheter hub (46) comprises an interior cavity (the catheter hub further comprises the interior cavity of handle 146) and wherein a needle guard (56; Fig. 10C) comprising a proximal wall (wall abutting friction element 82) and two arms (arms on either side of the needle and abutting friction element 82) is located in the interior cavity (interior cavity of handle 146) of the catheter hub (46).
Regarding claim 25, Ribelin discloses:
The extended dwell catheter assembly of claim 22, wherein the housing comprises a base end (112) comprising a plurality of side walls (112A, 112B).
Regarding claim 26, Ribelin discloses:
The extended dwell catheter assembly of claim 25, further comprising a first lever and a second lever (levers 150), the first and second levers (150) projecting from different surfaces (opposite sides) of base end (112) of the housing.
Regarding claim 29, Ribelin discloses:
The extended dwell catheter assembly of claim 22, wherein the housing comprises a body opening (opening within body 112) and wherein a push tab (projection on hub 46) on the catheter hub (46) is located in the body opening (Fig. 11D).
Regarding claim 31, Ribelin discloses:
The extended dwell catheter assembly of claim 22, wherein the first frame (172) comprises a gate having a living hinge (¶000144 – the door can be connected with a living hinge) and the second frame (172) comprises gate having a living hinge (¶000144).
Regarding claim 33, Ribelin discloses:
The extended dwell catheter assembly of claim 22, wherein the first frame (172) has an activation structure (see Image 2 below) and the second frame (172) has an activation structure (Image 2) and wherein a gap (Image 2) defined by the two activation structures are sized and shaped to be pushed by the catheter hub (46) to separate the first frame from the second frame (¶000126).
Image 2. Annotated portion of Fig. 14A
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Regarding claim 34, Ribelin discloses:
The extended dwell catheter assembly of claim 22, further comprising a tab adapter (140) fitted around the catheter hub (46) (Fig. 12A).
Regarding claim 35, Ribelin discloses:
The extended dwell catheter assembly of claim 22, further comprising a guidewire (122) extending through the needle (116).
Regarding claim 36, Ribelin discloses:
A method of manufacturing an extended dwell catheter assembly (410; Fig. 27) comprising: forming a housing (412), the housing comprising a first frame (472, left) attached to a second frame (472, right) and having an interior space, said housing (412) having a distal opening (opening defined by distal portion of slide 428) and a proximal opening (opening defined by proximal portion of slide 428), an upper seam (seam between frames 472 above needle 416) located between the first frame (472) and the second frame (472) along a first side (upper side) of the housing (412) and a lower seam (seam between frames 472 below needle 416) located between the first frame (472) and the second frame (472) along a second side (lower side) of the housing (412), the upper seam located above, elevation-wise, the lower seam (Fig. 27); placing a catheter assembly (440) in the interior space of the housing (412), said catheter assembly (440) comprising a catheter tube (44) attached to a catheter hub (46) and a needle (416) attached to a needle hub (448), wherein the needle (416) and the catheter tube (44) project out the distal opening of the housing (412) and the needle hub (448) projects out the proximal opening of the housing (412), and wherein the catheter hub (46) is slidable within the interior space of the housing (412) from a proximal position to a distal position within the interior space (¶000141-000143); and wherein the first frame (472) and the second frame (472) are separable from one another along the upper seam and the lower seam (¶000142).
Regarding claim 37, Ribelin discloses:
The method of claim 36, wherein the first frame (472) and the second frame (472) are separable by moving the first frame (472) in a first direction and the second frame (472) in a second direction (¶000142 – the two frames 472 move outward and away from one another to open).
Regarding claim 38, Ribelin discloses:
The method of claim 36, wherein the first frame (472) and the second frame (472) are separable by advancing the catheter hub (46) in a distal direction to push apart two activation structures located inside the interior space of the housing (¶000142 – a wedge abuts and opens the activation structures, which are the inside surfaces of the frames 472, as the hub 46 is advanced).
Regarding claim 39, Ribelin discloses:
The method of claim 36, wherein the catheter hub (46) is separable from the housing (412) by displacing two end cap components (472 – the frames 472 are in the form of end cap components) about two living hinges (¶000144 – the doors 472 can be connected via living hinges).
Regarding claim 40, Ribelin discloses:
An extended dwell catheter assembly (410; Fig. 27) comprising: a housing (412) comprising a first frame (420) attached to a second frame (430) and having an interior space, said housing (412) having a distal opening (opening defined by distal portion of slide 428) and a proximal opening (opening defined by proximal portion of slide 428); a catheter assembly (440) located in the interior space of the housing (412), said catheter assembly (440) comprising a catheter tube (44) attached to a catheter hub (46) and a needle (416) attached to a needle hub (448), wherein the needle (416) and the catheter tube (44) project out the distal opening of the housing (412) and the needle hub (448) projects out the proximal opening of the housing (412), and wherein the catheter hub (46) is slidable within the interior space of the housing (412) from a proximal position to a distal position within the interior space (¶000141-000143); and a gate assembly (470) attached to the housing (412), the gate assembly (470) comprising a first gate (472, left) attached to a living hinge (¶000144) and a second gate (472, right) attached to a living hinge (¶000144); wherein the two gates (472) are rotatable about the two living hinges to open the two gates (472) for separating the catheter assembly (440) from the housing (¶000142-000143).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 24 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Ribelin in view of Hulvershorn et al (US 2018/0133438).
Regarding claim 24, Ribelin discloses the extended dwell catheter assembly of claim 22 but is silent regarding “the first frame or the second frame comprises a plurality of tabs and the other one of the first frame or the second frame comprises a plurality of receiving slots engaging the plurality of tabs.” However, Hulvershorn teaches a catheter assembly (100A; Fig. 14), thus being in the same field of endeavor, with a pair of doors (152) in the form of frames that open to allow a catheter assembly (180A) to be released from the housing (101A) (¶0093). Hulvershorn further teaches that the doors can have mating structures such as protrusions and recesses on opposite doors that help hold the doors together and add structural integrity to the assembly when the doors are closed (¶0092). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the catheter assembly of Ribelin to incorporate the plurality of tabs and receiving slots in the frames as taught by Hulvershorn in order to provide structural integrity to the frames when they are closed, as recognized by Hulvershorn.
Regarding claim 32, Ribelin discloses the extended dwell catheter assembly of claim 31 but is silent regarding “a tab engages a recess to engage the two end cap components.” However, Hulvershorn teaches a catheter assembly (100A; Fig. 14), thus being in the same field of endeavor, with a pair of doors (152) in the form of frames that open to allow a catheter assembly (180A) to be released from the housing (101A) (¶0093). Hulvershorn further teaches that the doors can have mating structures such as protrusions and recesses on opposite doors that help hold the doors together and add structural integrity to the assembly when the doors are closed (¶0092). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the catheter assembly of Ribelin to incorporate the tab and recess in the frames as taught by Hulvershorn in order to provide structural integrity to the frames when they are closed, as recognized by Hulvershorn.
Allowable Subject Matter
Claims 27-28, 30, and 41-42 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nathan R Price can be reached on (571)270-5421. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783