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 .
Response to Amendment
The Amendments filed 08/20/2025 have been entered.
Claims 1, 3-5, 9, 11, 12, 15, 18 and 20 have thereby been amended.
Claims 1-20 are being examined in this office action.
Claim Rejections - 35 USC § 102
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 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takeuchi (US 20190001112).
Regarding claim 1, Takeuchi discloses a medical device, comprising: a distal connector (1), comprising: a first lever arm (30; see annotated Fig. 14B below), comprising a distal end and a proximal end, wherein the distal end of the first lever arm comprises a first protrusion (32; see annotated Fig. 14B below); a second lever arm opposing the first lever arm (30; see annotated Fig. 14B below), the second lever arm comprising a distal end and a proximal end, wherein the distal end of the second lever arm comprises a second protrusion (30; see annotated Fig. 14B below); and a blunt cannula disposed between the first lever arm and the second lever arm (10; page 5, para. [0104], sentences 1-3); and a protective cover removably coupled to the distal connector (protective cover 100; removable from distal connector 1, para. [0241], sentences 2-3) and comprising an annular wall surrounding the blunt cannula (Fig. 12D: 116 & 117), wherein an outer surface of the annular wall comprises at least one catch (Fig. 14B: catch between 111 and 112), wherein the first protrusion and the second protrusion contact the at least one catch (Fig. 14B: 32 between 112 and 111), wherein the proximal end of the first lever arm and the proximal end of the second lever arm are configured to be pinched together toward a longitudinal axis of the distal connector to remove the first protrusion and the second protrusion from the at least one catch (page 12, para. [0199], sentence 3), thereby enabling removal of the protective cover from the distal connector (para. [0241], sentences 2-3), wherein the protective cover is attached to the distal connector when the medical device is in an initial configuration (initial configuration seen in Fig. 14B), with the first and second protrusions of the first and second lever arms engaged with the at least one catch to secure the protective cover to the distal connector (see annotated Fig. 14B below of lever arms engaged with catches), thereby protecting the blunt cannula (see annotated Fig. 14B below, wherein 100 covers/surrounds, and thereby protects cannula 10), and wherein the protective cover is removable from the distal connector via pinching of the proximal end of the first and second lever arms (para. [0241], sentences 2-3, force F being the pinching), to transition the medical device to a use configuration where the blunt cannula is exposed (Fig. 13: demonstration of how the cannula 10 is exposed upon the removal of 100 from 1), thereby enabling engagement of the distal connector with a catheter assembly.
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Annotated Fig. 14B, Takeuchi
Regarding claim 2, Takeuchi discloses the medical device of claim 1, as described above, wherein the at least one catch comprises an annular stepped surface (Fig. 14B: stepped surface between 111 and 112).
Regarding claim 3, Takeuchi discloses the medical device of claim 1, as described above, wherein an entirety of an outer surface of the blunt cannula is spaced apart from the protective cover (Fig. 14B: cover 4 separates cannula 10 from cap 100).
Regarding claim 4, Takeuchi discloses the medical device of claim 1, as described above, wherein the annular wall comprises a proximal end and a distal end, wherein the proximal end of the annular wall forms a proximal opening (Fig. 12D: proximal opening at 118), wherein a lumen extends from the proximal opening to the distal end of the annular wall, wherein the protective cover comprises an inner surface forming the lumen (Fig. 12D: lumen formed at 116, 117 and 118).
Regarding claim 5, Takeuchi discloses the medical device of claim 1, as described above, wherein in response to orienting the blunt cannula to be perpendicular to the ground and pinching the proximal end of the first lever arm and the proximal end of the second lever arm together toward the longitudinal axis of the distal connector such that the first protrusion and the second protrusion are removed from the at least one catch (page 12, para. [0199], sentences 1-3), the cover is configured to fall off of the distal connector under force of gravity. The recitations of the protective cover is configured to fall off of the distal connector under force of gravity is not explicitly discloses, but are intended use limitations and as such are given no patentable weight, as the disclosed structures of the Takeuchi cap, levers, and cap removal (page 12, para. [0199], sentences 1-3) would be capable of falling off due to gravity because it is disclosed that no additional mechanisms, actions, or forces are required for the removal.
Regarding claim 6, Takeuchi discloses the medical device of claim 1, as described above, wherein the outer surface of the annular wall comprises a ramp proximal to the at least one catch and extending outwardly in a distal to proximal direction (ramp between 111 and 112; see annotated Fig. 14B above).
Regarding claim 7, Takeuchi discloses the medical device of claim 1, as described above, wherein the outer surface of the annular wall comprises a ramp proximal to the at least one catch and extending outwardly in a proximal to distal direction (ramp between 111 and 112; see annotated Fig. 14B above).
Regarding claim 8, Takeuchi discloses the medical device of claim 1, as described above, wherein the outer surface of the annular wall comprises a plurality of protrusions distal to the at least one catch (Fig. 14A: protrusions around 102) and configured for gripping.
Regarding claim 9, Takeuchi discloses the medical device of claim 8, as described above, wherein the protrusions comprise a plurality of ribs generally aligned with the longitudinal axis of the distal connector (Fig. 14A: ribs 127, around 102 and extending proximally on other side of 105).
Regarding claim 10, Takeuchi discloses the medical device of claim 9, as described above, wherein each of the plurality of ribs comprises a proximal end that is stepped or tapered inwardly (see annotated Fig. 14B above).
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.
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 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi (US 20190001112) in view of Sonderegger (US 9795777) in further view of Gardner (US 10166381).
Regarding claim 11, Takeuchi discloses the medical device of claim 1, as described above, but fails to disclose the cover comprising an annular enclosure surrounding the annular wall and lever arms.
Sonderegger teaches an analogous medical connector with lever arms wherein the protective cover further comprises an enclosure extending from the distal end of the annular wall and configured to surround the first lever arm and the second lever arm (Figs. 42-44: 214, surrounding lever arms 216/218), wherein the annular enclosure is spaced apart from the annular wall by a channel (Fig. 42: channel between inner annular wall 210 and outer rim of encloser 214), wherein the first lever arm and the second lever arm are disposed within the annular channel (Fig. 42, lever arms 216/218 disposed in channel). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cover of Takeuchi by incorporating the outer enclosure taught by Sonderegger in order to provide an outer interface for the user to hold/handle to help prevent direct contact and contamination to the connector/inner cover components.
Takeuchi in view of Sonderegger, however, fails to teach the encloser and channel formed by the encloser as completely annular.
Gardner teaches an analogous medical connector and cover with an outer encloser, wherein the cover further comprises an annular enclosure extending from the distal end of the annular wall (Fig. 16: annular encloser 928 extending from distal end of annular wall 930), wherein the annular enclosure is spaced apart from the annular wall by an annular channel (Fig. 16: space depicted as white between sides of 930 and 928). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the annular configuration of the encloser relative to the annular wall of the cover taught by Gardner into the Takeuchi-Sonderegger combination in order to enclose all sides of the annular wall taught by Takeuchi, thereby providing the benefits of the protection from contamination to the entire device.
Regarding claim 12, Takeuchi in view of Sonderegger in further view of Gardner teaches the medical device of claim 11, as described above, wherein the annular enclosure comprises an inner surface (Sonderegger: Fig. 44: inner wall of semi-spherical 214; Gardner: Fig. 16: inner wall of sidewall 52 of cap holder 28), wherein the inner surface of the annular enclosure comprises a portion that is angled outwardly in a distal to proximal direction (Sonderegger: Fig. 44: bottom portion of inner wall of semi-spherical 214; Gardner: Fig. 16: 913 of sidewall 52 of cap holder 28) such that in response to pinching the proximal end of the first lever arm and the proximal end of the second lever arm together toward the longitudinal axis of the distal connector, the first protrusion and the second protrusion contact the portion and cam against the portion to facilitate removal of the protective cover from the distal connector (Sonderegger: col. 13, line 64 – col. 14, line 5; visualized in Fig. 42).
Regarding claim 13, Takeuchi in view of Sonderegger in further view of Gardner teaches the medical device of claim 12, as described above, wherein the enclosure is constructed of an elastomeric material (Gardner: col. 4, lines 54-57). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the Gardner teaching of the elastomeric material of the cover into the Takeuchi-Sonderegger-Gardner combination in order to create a compressible annular wall that is resilient to breaking (col. 8, lines 50-52).
Regarding claim 14, Takeuchi in view of Sonderegger in further view of Gardner teaches the medical device of claim 11, as described above, wherein the annular enclosure and the annular wall are monolithically formed as a single unit (Gardner: col. 4, lines 59-61). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the Gardner teaching of the annular wall and annular enclosure being formed as a single unit into the Takeuchi-Sonderegger-Gardner combination in order to create a simple and cost-effective cover that remains in one piece regardless of removal.
Regarding claim 15, Takeuchi in view of Sonderegger in further view of Gardner teaches the medical device of claim 11, as described above, wherein a proximal end of the protective cover comprises a flange (Takeuchi: 105) configured for gripping.
Regarding claim 16, Takeuchi in view of Sonderegger in further view of Gardner teaches the medical device of claim 15, as described above, wherein the flange is annular (Takeuchi: 105).
Regarding claim 17, Takeuchi in view of Sonderegger in further view of Gardner teaches the medical device of claim 15, as described above, wherein the annular enclosure, the annular wall, and the flange are monolithically formed as a single unit (upon combination of: annular encloser and annular wall being monolithically formed as a single unit, Gardner: col. 4, lines 59-61; and the annular wall and the flange being monolithically formed as a single unit, Takeuchi: page 11, para. [0191], last sentence).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi (US 20190001112) in view of Burkholz (US 20200016374).
Regarding claim 18, Takeuchi discloses the medical device of claim 1, as described above, but fails to explicitly disclose a catheter assembly coupled to the distal connector.
Burkholz teaches an analogous medical connector with lever arms wherein the medical device comprises a vascular access device (Fig. 6: 84), wherein the vascular access device comprises an instrument (34) configured to advance distally through the distal connector when the protective cover is removed from the distal connector (page 4, para. [0047]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector device of Takeuchi by incorporating its connection to the vascular access device taught by Burkholz in order to integrate the easily connectable and easily removable Takeuchi connector into a system for vascular access of a patient (Fig. 6; page 5, para. 0061]).
Regarding claim 19, Takeuchi in view of Burkholz teaches the medical device of claim 18, as described above, wherein the instrument comprises a tube or a guidewire (Burkholz: 34; page 4, para. [0047], sentence 2).
Regarding claim 20, Takeuchi discloses the medical device of claim 1, as described above, but fails to explicitly disclose a catheter assembly coupled to the distal connector.
Burkholz teaches an analogous medical connector with lever arms wherein the distal connector is configured to couple to a catheter assembly when the protective cover is removed from the distal connector (Fig. 6: 40 connected to catheter assembly 62 via connector 82). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector device of Takeuchi by incorporating its connection to the vascular access device taught by Burkholz in order to integrate the easily connectable and easily removable Takeuchi connector into a catheter assembly for vascular access of a patient (Fig. 6; page 5, para. 0062]).
Response to Arguments
Applicant's arguments filed 08/20/2025 regarding the prior art rejections of independent claim 1 and its depending claims 2-20 have been fully considered but they are not persuasive.
Regarding independent claim 1, Applicant argues that Takeuchi fails to disclose “a protective cover” that is “selectively attached/removed from the distal connector to provide protection to a blunt cannula and/or expose the lunch cannula.” The cover 100 disclosed by Takeuchi does read on “a protective cover,” as 100 surrounds, thereby protecting, cannula 10 when 100 is connected to 1 (as seen in Fig. 14B). Further, the amended limitations of the cover being removable and removed from distal connector 1 when the lever arms are pinched, are also all disclosed by Takeuchi, as described in the rejection above. Applicant argues that 100 of Takeuchi is not a cover, but rather a connector. However, Examiner reiterates that given the broadest reasonable interpretation of the word “cover” as recited in the claims currently written, 100 of Takeuchi does in fact serve as a cover, as it surrounds the top of the cannula and distal connector 1. Additionally, 100 of Takeuchi reads on the “protective cover,” as amended, as it surrounds the top of the cannula and distal connector 1, thereby covering and protecting it.
For these reasons, Examiner maintains the above rejections of independent claim 1 being anticipated by Takeuchi, and the rejections of its depending claims 2-20.
Conclusion
THIS ACTION IS MADE FINAL. 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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/K.A.W./ Examiner, Art Unit 3783
/NATHAN R PRICE/ Primary Examiner, Art Unit 3783