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
Claim 28 is objected to because of the following informalities:
Claim 28, line 2: “the mating members” should read --the plurality of mating members--
Claim 28, line 3: “the mating members” should read --the plurality of mating members--
Appropriate correction is required.
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 20-23, 25-26 and 29-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jaros (WO 2021038041).
Regarding claim 20, Jaros teaches (Figs. 29-30) a catheter hub (130) comprising a hub body (102) with a width and a saddle socket (see annotated Fig. 30 below, comprising curved body of the catheter hub 130 contains a recess in which tab adapter’s gripping bars 432 are sized to snugly fit against the catheter hub; see also Paragraphs [00490]-[00491]) having wall surfaces defining a width that is wider than the width of the hub body (130) (see annotated Fig. 30 below; Paragraph [00497]); the hub body having an upper surface located, elevation-wise, above a lower surface (See Figs. 29-30); a catheter tube (110) having a length and a lumen extending distally of a nose section (184) of the catheter hub; a needle (112) attached to a needle hub (122) and having a needle tip (114) extending through the hub body and the lumen of the catheter tube in a ready to use position (See Fig. 1).
[AltContent: arrow][AltContent: textbox (pocket)]a hub extension (Figs. 44, 46, housing 102 additionally shown with extending left frame 193, right frame 194) having a body with a pocket (see annotated Fig. 30 below, the space around the curved body of the catheter hub 130 in which the first opening 420 and the second opening 422 are sized to fit snugly around) having at least part of the hub body (102) and the saddle socket located in the pocket and constrained from moving relative to the hub extension by the body (See Paragraphs [00490]-[00491]; Figs. 44-46).
and a tab adaptor (404) surrounding at least part of the upper surface of the catheter hub, the tab adaptor having two sidewalls (546c) defining a width that is wider than the width of the hub body, wherein the tab adaptor is separable from the catheter hub. (See Figs. 39-40; Paragraph [00511]).
Regarding claim 21, Jaros teaches wherein the hub extension (base 190) comprises a pair of wings (716) extending laterally of the pocket. (See Fig. 54).
Regarding claim 22, Jaros illustrates (Fig. 33) a tip (186) having a lumen and wherein at least part of the nose section (184) of the catheter hub (130) is located in the lumen.
Regarding claim 23, Jaros illustrates (Figs. 32-33) wherein the hub extension (193, 194) has a flat bottom surface.
Regarding claim 25, Jaros teaches wherein the tab adaptor (404) has a lower surface and two spaced apart anchors (gripping portions 432) extending from the lower surface. (See Fig. 30; Paragraph [00490]).
Regarding claim 26, Jaros teaches wherein the socket saddle has two spaced apart sockets (not shown) and wherein the two anchors (432) engage the two sockets. (Paragraph [00491] The gripping bars 432 can resemble ribs and can be provided with contoured surfaces to snuggly fit against the catheter hub. Relative to the upper part of the two openings 420, 422, the locations of the gripping bars 432 on the body of the tab adapter 404 should be located so that when mounted to the catheter hub, the two gripping bars 432 are below the centerline of the catheter hub body. The size and shape of the first and second openings 420, 422 and the locations of the two gripping bars 432 are such that the tab adapter 404 fits snuggly and grips the catheter hub body; See also Fig. 44).
Regarding claim 29, Jaros illustrates (Fig. 2) a needle guard (140) located in an interior cavity of the hub body (102).
Regarding claim 30, Jaros teaches a valve and a valve opener located in an interior cavity of the catheter hub. (Paragraph [00410]).
Regarding claim 31, Jaros illustrates (Figs. 15, 32-33) wherein the hub extension (193, 194) has a leading edge and a trailing edge that are not parallel. (Figs. 15, 32-33 show that right and left frames are curved and not parallel.)
Regarding claim 32, Jaros illustrates (Figs. 3, 15) wherein the hub extension (193, 194) is D-shaped (Fig. 15, slender “D” formed by curved frames) with a projection (surface ornamentations 220) extending axially of a curved section of the D-shaped.
Regarding claim 33, Jaros illustrates (Figs. 3, 15) wherein the hub extension has two side edges (188a, 322) defining a maximum width of the hub extension. (Paragraph [00448]).
Regarding claim 34, Jaros illustrates (Fig. 32) wherein the maximum width is wider than the width of the tab adaptor (404) and the width the hub body (102).
Regarding claim 35, Jaros teaches wherein the catheter hub (130) has a push tab (176) (Paragraph [00409]), and the tab adaptor (404) has a recessed section at a lower surface located around the push tab. (Paragraphs [00491]-[00492]).
Regarding claim 36, Jaros illustrates (Figs. 39-40) wherein the tab adaptor (404) has a concave surface located between the two sidewalls (546c).
Regarding claim 37, Jaros illustrates (Fig. 33) wherein the hub extension (193, 194) has a tip (186) comprising a distal opening and a proximal opening (Fig. 33), and wherein the distal opening has a ramped surface and the proximal opening having the nose section of the catheter hub located therein. (Paragraph [00411] the nose end or nose portion 184 can further include a nose base 192, which has an enlarged portion formed with the tip 186, and a tapered distal portion.).
Regarding claim 38, Jaros teaches a method of manufacturing a catheter assembly (100) (Paragraph [0078), comprising the steps: forming a catheter hub (130) comprising a hub body (102) with a width and a saddle socket having wall surfaces defining a width that is wider than the width of the hub body (See Fig. 30 curved body of the catheter hub 130 contains a recess in which tab adapter are sized to fit snugly around), the hub body having an upper surface located, elevation-wise, above a lower surface (See Figs. 29-30); attaching a catheter tube (110) having a length and a lumen to a nose section (184) of the catheter hub; extending a needle (112) attached to a needle hub (122) and having a needle tip (114) through the hub body and the lumen of the catheter tube in a ready to use position (See Fig. 1). (Paragraph [00490]); and attaching a hub extension (housing 102 additionally shown with extending left frame 193, right frame 194) having a body with a pocket to the catheter hub by placing at least part of the hub body and the saddle socket in the pocket and constraining the catheter hub from moving relative to the hub extension, (See Fig. 44, a tab adapter 404 can be positioned over the catheter hub 130 and secured thereto by fitment), and placing a tab adaptor (404) over at least part of the upper surface of the catheter hub, the tab adaptor having two sidewalls (546c) defining a width that is wider than the width of the hub body, wherein the tab adaptor is separable from the catheter hub. (See Figs. 39-40; Paragraph [00511]).
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.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Jaros in view of Bodicky (US 4445893) (cited by Applicant).
Regarding claim 24, Jaros does not teach “wherein the hub extension is made from a material that is softer and more flexible than a material used to form the hub body of the catheter hub.”
Bodicky, in a related field of endeavor, teaches wherein the hub extension (16) is made from a material that is softer and more flexible than a material used to form the hub body (18) of the catheter hub. (Col. 3, lines 44-47; Col. 3, lines 39-41).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Jaros to teach “wherein the hub extension is made from a material that is softer and more flexible than a material used to form the hub body of the catheter hub” as taught by Bodicky. Doing so provides a pliable and supple material that is conformable to patient when the catheter is taped to the skin for an extended period of time. (Col. 5, lines 47-52).
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Jaros in view of Chu (CN 111655112).
Regarding claim 27, Jaros teaches a pocket, i.e., the space around the curved body of the catheter hub 130 in which the first opening 420 and the second opening 422 are sized to fit snugly around and have a gripping force around the hub body (see annotated Fig. 30 above; Paragraph [00490]), but does not explicitly teach wherein the pocket has “a bottom wall comprising a plurality of mating members.”
Chu, in a related field of endeavor, illustrates (Fig. 2) an insertion device (12) wherein the pocket (See Fig. 2, the space upon which adapter 16 fits to the body 34 of the insertion device 12) has a bottom wall (intermediate portion 38) comprising a plurality of mating members (Page 8, lines 14-21, holes 56 located on the two sides of the insertion device 12, in which adapter pin 58 may be positioned to fit, snap, or otherwise fixedly connect to).
In Chu, the mating member (adapter pin 58) is shown to be located in the adapter 16 rather than a bottom wall, however, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Jaros to teach “a bottom wall comprising a plurality of mating members”, as shifting the placement of the adapter pin from the adapter portion to the intermediate portion is merely a rearrangement of parts of a coupling mechanism and would not have modified the operation of the device.
Regarding claim 28, Jaros teaches a saddle socket, i.e., recess on curved body of the catheter hub 130 in which tab adapter’s gripping bars 432 are sized to snugly fit against the catheter hub and which have a gripping force around the hub body (see annotated Figure 30 above; Paragraphs [00490]-[00491]), but does not further teach “a plurality of mating members and wherein the mating members at the bottom wall of the pocket engage the mating members on the saddle socket”.
Chu illustrates (Fig. 2) a plurality of mating members (adapter pins 58) and wherein the mating members (holes 56) at the bottom wall (intermediate portion 38) of the pocket engage the mating members (56) on the saddle socket (proximal portion 40). (Page 8, lines 14-21, holes 56 located on the two sides of the intermediate 38 and proximal portions 40 of the insertion device 12, in which adapter pin 58 may be positioned to fit, snap, or otherwise fixedly connect to).
As discussed above, in Chu, the mating members (adapter pins 58) are shown to be located in the adapter 16 rather than a bottom wall or saddle socket, as defined above, however, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Jaros to teach “a plurality of mating members and wherein the mating members at the bottom wall of the pocket engage the mating members on the saddle socket”, as shifting the placement of the adapter pins from the adapter portion to the intermediate and/or proximal portion is merely a rearrangement of parts of a coupling mechanism and would not have modified the operation of the device.
Conclusion
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/OM PATEL/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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