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 .
Election/Restrictions
Applicant’s election without traverse of Species C (claims 1-10 and 12-20) in the reply filed on 11/5/2025 is acknowledged.
Information Disclosure Statement
The information disclosure statement filed 1/30/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claim 10 is objected to because of the following informalities:
Regarding claim 10, line 3, the recitation “needle shield” appears to be amended to recite “the needle shield” in order to refer to “needle shield” recited in claim 1, line 8.
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.
Claim(s) 1, 2, 6, 8, 9, 12 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haining (US 5,176,650).
Regarding claim 1, Haining teaches an IV catheter device 1 (figure 1) comprising:
a catheter assembly (assembly formed by element 30, 31, 20) having a catheter adapter 30, 31 and a catheter 20 that extends distally from the catheter adapter 30, 31;
a needle assembly (device shown in figure 2 except for elements 30, 31, 20) having a needle hub 50, 51, 52 and a needle 40 that extends distally from the needle hub 50, 51, 52, the needle hub 50, 51, 52 being coupled to the catheter adapter 30, 31 such that the needle 40 extends through the catheter 20; and
a needle cover 10 that is coupled to the needle hub 50, 51, 52, the needle cover 10 being configured to function as a needle shield 10 after the needle is withdrawn from the catheter adapter (see figure 4).
Regarding claim 2, Haining teaches wherein the needle cover 10 is coupled to the needle hub 50, 51, 52 via one or more channels 90, 81, 82 and corresponding one or more guides 60, 64, 62, 63.
Regarding claim 6, Haining teaches wherein the one or more channels 90 includes a locking slot 82 into which the one or more guides 60, 64, 62, 63 are rotated (column 3, lines 29-34, in order to engage or disengage, elements 60, 64, 62, 63 needs to be pushed down wherein pushing downward causes rotation along an axis).
Regarding claim 8, Haining teaches wherein the needle cover 10 includes a channel (see “C” in figure 1 below) and the catheter adapter includes a push tab 110 extends through and slides within the channel (see “C” in figure 1 below).
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Regarding claim 9, Haining teaches wherein the channel (see “C” in figure 1 above) includes a deviation 70.
Regarding claim 12, Haining teaches an IV catheter device (figure 1) comprising:
a catheter assembly (assembly formed by element 30, 31, 20) having a catheter adapter 30, 31 and a catheter 20 that extends distally from the catheter adapter 30, 31;
a needle assembly (device shown in figure 2 except for elements 30, 31, 20) having a needle hub 50, 51, 52 and a needle 40 that extends distally from the needle hub 50, 51, 52, the needle hub 50, 51, 52 being coupled to the catheter adapter 30, 31 such that the needle 40 extends through the catheter 20; and
a needle cover 10 that is coupled to the needle hub 50, 51, 52 and configured to slide along the needle hub 50, 51, 52 from a distalmost position (position shown in figure 1) to a proximal position (position shown in figure 2), wherein the needle cover 10 encloses the needle 40 and the catheter 20 when the needle cover 10 is in the distalmost position (position shown in figure 1) and the catheter adapter 30, 31 is coupled to the needle hub 50, 51, 52, and wherein the needle cover 10 encloses the needle 40 when the needle cover 10 is in the distalmost position (position shown in figure 1) and the catheter assembly 30, 31 has been slid distally out from the needle cover 10 (see figure 4).
Regarding claim 13, Haining teaches wherein the needle cover 10 includes a channel (see “C” in figure 1 above) and the catheter adapter includes a push tab 110 extends through and slides within the channel (see “C” in figure 1 above), the push tab enabling a clinician to slide the catheter adapter out from the needle cover (engagement of element 110 with element “C” in figure 1 above enables clinician to slide the catheter adapter out from the needle cover, the claim do not require the clinician directly holding or pushing the push tab to slide the catheter adapter).
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.
Claims 3-5, 7, 10, 14-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Haining (US 5,176,650) in view of Firth et al. (US 5,356, 392).
Regarding claim 3, Haining discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 2. Haining is silent regarding the one or more channels extend along the needle hub and the corresponding one or more guides are formed on the needle cover. Instead, Haining is disclosing the opposite to the claimed limitations i.e. having the one or more channels extend along the needle cover and the corresponding one or more guides formed on the needle hub.
However, according to MPEP 2144.04 (VI)(A), it is obvious to one of ordinary skill in the art to reverse the parts therefore, reversing the placement of the channels and corresponding guides would be obvious to one of ordinary skill in the art for the purpose of achieving relative movement of the needle cover with respect to the needle hub.
Furthermore, Firth teaches a design of a needle shield (figure 3a) wherein the one or more channels 10 extend along the needle hub 1 and the corresponding one or more guides 35 formed on the needle cover 2 for the purpose of using a well-known alternative configuration to perform relative movement between the needle hub and the needle cover (column 4, line 61- column 5, line 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the placement of the one or more channels and the corresponding one or more guides of Haining to incorporate the one or more channels extend along the needle hub and the corresponding one or more guides are formed on the needle cover as taught by Firth for the purpose of using a well-known alternative configuration to perform relative movement between the needle hub and the needle cover (column 4, line 61- column 5, line 2).
Regarding claim 4, Haining discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 2. Haining is silent regarding wherein the one or more channels includes a distal stop and a retaining bump spaced from the distal stop.
However, Firth teaches wherein the one or more channels 10 includes a distal stop (see “DS” in figure 5a below) and a retaining bump 17a spaced from the distal stop (see “DS” in figure 5a below) for the purpose of using a well-known alternative configuration to perform relative movement between the needle hub and the needle cover and limiting the relative movement between the needle hub and the needle cover thereby avoiding separation of two components (figure 2a, column 3, line 65-column 4, line 7, column 4, lines 61-column 5, line 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the one of more channels of the Haining to incorporate wherein the one or more channels includes a distal stop and a retaining bump spaced from the distal stop as taught by Firth for the purpose of using a well-known alternative configuration to perform relative movement between the needle hub and the needle cover and limiting the relative movement between the needle hub and the needle cover thereby avoiding separation of two components (figure 2a, column 3, line 65-column 4, line 7, column 4, lines 61-column 5, line 2).
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Regarding claim 5, Haining discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 2. Haining is silent regarding wherein each of the one or more channels includes a proximal stop.
However, Firth teaches wherein each of the one or more channels 10 includes a proximal stop 11 for the purpose of limiting the movement between the needle hub and the needle cover (column 4, lines 63-67).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the one of more channels of Haining to incorporate wherein each of the one or more channels includes a proximal stop as taught by Firth for the purpose of limiting the movement between the needle hub and the needle cover (column 4, lines 63-67).
Regarding claim 7, Haining discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 2. Haining is silent regarding wherein the needle hub includes one or more entries corresponding to the one or more channels by which the one or more guides enter the one or more channels.
However, Firth teaches wherein the needle hub includes one or more entries 17 corresponding to the one or more channels 10 by which the one or more guides 35 enter the one or more channels 10 for the purpose of using a well-known alternative configuration to perform relative movement between the needle hub and the needle cover (column 4, line 61- column 5, line 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the one or more channels of Haining to incorporate wherein the needle hub includes one or more entries corresponding to the one or more channels by which the one or more guides enter the one or more channels as taught by Firth for the purpose of using a well-known alternative configuration to perform relative movement between the needle hub and the needle cover (column 4, line 61- column 5, line 2).
Regarding claim 10, Haining discloses the claimed invention substantially as claimed, as set forth above in claim 1. Haining is silent regarding wherein the needle hub includes one or more cutouts and the needle shield includes one or more support tabs that insert through the one or more cutouts to assembly the needle hub and needle shield.
However, Firth teaches wherein the needle hub 1 includes one or more cutouts 11 and the needle shield 2 includes one or more support tabs 35 that insert through the one or more cutouts 11 to assembly the needle hub 1 and needle shield 2 for the purpose of limiting the movement between the needle hub and the needle cover (column 4, lines 63-67).
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art, before the effective filing of the claimed invention to modify the needle hub of Haining to incorporate wherein the needle hub includes one or more cutouts and the needle shield includes one or more support tabs that insert through the one or more cutouts to assembly the needle hub and needle shield as taught by Firth for the purpose of limiting the movement between the needle hub and the needle cover (column 4, lines 63-67).
Regarding claim 14, Haining discloses the claimed invention substantially as claimed, as set forth above in claim 12. Haining is silent regarding wherein the needle hub includes one or more channels and the needle cover includes corresponding one or more guides that slide within the one or more channels. Instead, Haining is disclosing the opposite to the claimed limitations i.e. the needle cover having one or more channels and the needle hub includes the corresponding one or more guides that slide within the one or more channels.
However, according to MPEP 2144.04 (VI)(A), it is obvious to one of ordinary skill in the art to reverse the parts therefore, reversing the placement of the channels and corresponding guides would be obvious to one of ordinary skill in the art for the purpose of achieving relative movement of the needle cover with respect to the needle hub.
Furthermore, Firth teaches a design of a needle shield (figure 3a) wherein the needle hub 1 includes one or more channels 10 and the needle cover 2 includes corresponding one or more guides 35 that slide within the one or more channels 10 for the purpose of using a well-known alternative configuration to perform relative movement between the needle hub and the needle cover (column 4, line 61- column 5, line 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the placement of one or more channels and corresponding one or more guides of Haining to incorporate wherein the needle hub includes one or more channels and the needle cover includes corresponding one or more guides that slide within the one or more channels as taught by Firth for the purpose of using a well-known alternative configuration to perform relative movement between the needle hub and the needle cover (column 4, line 61- column 5, line 2).
Regarding claim 15, Haining discloses the claimed invention substantially as claimed, as set forth above in claim 12. Haining further discloses wherein each of the one or more channels 90, 82, 81 includes a retaining surface 82 that interfaces with the corresponding guide 62, 63, 60, 64 to retain the needle cover 10 in the distalmost position (position shown in figure 1). While Haining does not disclose a retaining surface being a retaining bump. Haining discloses the use of a retaining bump 70 in a different structure. Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to use the retaining bump as taught by different structure of Haining for the purpose of using alternative configuration to retain the corresponding guide into the position (figure 2, column 3, lines 46-48).
Regarding claim 16, Haining discloses the claimed invention substantially as claimed, as set forth above in claim 12. Haining further discloses wherein each of the one or more channels 90, 82, 81 includes a distal stop (end of element 90 that includes a surface to stop the further movement of element 60).
Regarding claim 18, Haining discloses an IV catheter device 1 (figure 1) comprising:
a catheter assembly (assembly formed by element 30, 31, 20) having a catheter adapter 30, 31 and a catheter 20 that extends distally from the catheter adapter 30, 31, the catheter adapter including a push tab 110;
a needle assembly (device shown in figure 2 except for elements 30, 31, 20) having a needle hub 50, 51, 52 and a needle 40 that extends distally from the needle hub 50, 51, 52, the needle hub 50, 51, 52 being coupled to the catheter adapter 30, 31 such that the needle 40 extends through the catheter 20; and
a needle cover 10 that is coupled to the needle hub 50, 51, 52, the needle cover 10 including a channel (see “C” in figure 1 above) within which the push tab 110 of the catheter adapter slides. Haining is silent regarding the needle hub having one or more channels that extend lengthwise along the needle hub and a needle cover having one or more guides that are positioned within the one or more channels to thereby couple the needle cover to the needle hub.
Instead, Haining is disclosing the opposite to the claimed limitations i.e. the needle cover having one or more channels and the needle hub includes one or more guides that are positioning within the one or more channels.
However, according to MPEP 2144.04 (VI)(A), it is obvious to one of ordinary skill in the art to reverse the parts therefore, reversing the placement of the channels and corresponding guides would be obvious to one of ordinary skill in the art for the purpose of achieving relative movement of the needle cover with respect to the needle hub.
Furthermore, Firth teaches a design of a needle shield (figure 3a) wherein the needle hub 1 includes one or more channels 10 that extend lengthwise along the needle 1 and a needle cover 2 having one or more guides 35 that are positioning within the one or more channels 10 to thereby couple the needle cover 2 to the needle hub 1 for the purpose of using a well-known alternative configuration to perform relative movement between the needle hub and the needle cover (column 4, line 61- column 5, line 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the placement of one or more channels and corresponding one or more guides of Haining to incorporate the needle hub having one or more channels that extend lengthwise along the needle hub and a needle cover having one or more guides that are positioned within the one or more channels to thereby couple the needle cover to the needle hub as taught by Firth for the purpose of using a well-known alternative configuration to perform relative movement between the needle hub and the needle cover (column 4, line 61- column 5, line 2).
Regarding claim 19, Haining is silent regarding wherein the one or more channels includes a distal stop and a retaining bump, the respective guide being selectively retained between the distal stop and the retaining bump.
However, Firth teaches wherein the one or more channels 10 includes a distal stop (see “DS” in figure 5a above) and a retaining bump 17a, the respective guide 35 being selectively retained between the distal stop and the retaining bump (see figure 3a) for the purpose of using a well-known alternative configuration to perform relative movement between the needle hub and the needle cover and limiting the relative movement between the needle hub and the needle cover thereby avoiding separation of two components (figure 2a, column 3, line 65-column 4, line 7, column 4, lines 61-column 5, line 2).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the one of more channels of the Haining to incorporate wherein the one or more channels includes a distal stop and a retaining bump, the respective guide being selectively retained between the distal stop and the retaining bump as taught by Firth for the purpose of using a well-known alternative configuration to perform relative movement between the needle hub and the needle cover and limiting the relative movement between the needle hub and the needle cover thereby avoiding separation of two components (figure 2a, column 3, line 65-column 4, line 7, column 4, lines 61-column 5, line 2).
Regarding claim 20, Haining discloses wherein the one or more channels 90 includes a locking slot 82 into which the respective guide 60, 64, 62, 63 is rotated (column 3, lines 29-34, in order to engage or disengage, elements 60, 64, 62, 63 needs to be pushed down wherein pushing downward causes rotation along an axis).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Haining (US 5,176,650) in view of D’ Alo et al. (US 4,326,519).
Regarding claim 17, Haining discloses the claimed invention substantially as claimed, as set forth above in claim 12. Haining is silent regarding wherein the catheter adapter includes a notch and the needle hub includes a protrusion that inserted into the notch to thereby limit rotation of the catheter adapter relative to the needle hub.
However, D’ Alo teaches a design of a catheter needle assembly (figure 2) wherein the catheter adapter 14 includes a notch (notch structure formed by element 46 within which element 50 gets inserted) and the needle hub 20 includes a protrusion 50 that inserted into the notch (notch structure formed by element 46 within which element 50 gets inserted) to thereby limit rotation of the catheter adapter relative to the needle hub for the purpose of using an alternative configuration to engage the needle hub with the catheter adapter (column 5, lines 13-18).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the connection between the catheter adapter and the needle hub of Haining to incorporate wherein the catheter adapter includes a notch and the needle hub includes a protrusion that inserted into the notch to thereby limit rotation of the catheter adapter relative to the needle hub as taught by D’ Alo for the purpose of using an alternative configuration to engage the needle hub with the catheter adapter (column 5, lines 13-18).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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