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 Amendment filed 4/2/2026 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 1/8/2026.
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.
Claims 8, 9 and 13 are 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.
Regarding claim 8, the recitation “a channel” in lines 1-2 renders the claim indefinite because the claim is unclear if “a channel” refers to one of the one or more channels recited in claim 1 or additional. For examination purposes, examiner construes “a channel” refers additional channel other than one or more channels recited in claim 1.
Claim 9 being dependent on claim 8 is also rejected.
Regarding claim 13, the recitation “a channel” in lines 1-2 renders the claim indefinite because the claim is unclear if “a channel” refers to one of the one or more channels recited in claim 12 or additional. For examination purposes, examiner construes “a channel” refers additional channel other than one or more channels recited in claim 12.
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 1, 8, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Haining (US 5,176,650) in view of Alvarez (US 4,170,993).
Regarding claim 1, 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 along a longitudinal axis of the IV catheter device;
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 along the longitudinal axis, 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 has a length that extends along the longitudinal axis, 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); wherein the needle cover 10 is coupled to the needle hub 50, 51, 52 via one or more guides 60, 64, 62, 63 and corresponding one or more channels 90 that extend along the longitudinal axis to thereby enable the needle hub 50, 51, 52 to slide longitudinally within the needle cover 10 (see figures 1-4) as the one or more guide 60, 64, 62, 63 slide within the one or more channels 90 but is silent regarding where at least one of the one or more channels includes a locking slot into which a corresponding at least one of the one or more guides is rotated when the needle cover is in a distalmost position within the needle cover and the needle cover is rotated relative to the needle hub around the longitudinal axis to thereby prevent the needle hub from sliding within the needle cover.
However, Alvarez teaches an IV needle carrier assembly comprising at least one of the one or more channels 30 includes a locking slot 32 into which a corresponding at least one of the one or more guides 24, 26 is rotated when the needle cover 14 is in a distalmost position (position shown in figure 3 where element 26 is positioned inside element 32) within the needle cover 14 and the needle cover 14 is rotated relative to the needle hub 16 around the longitudinal axis to thereby prevent the needle hub 16 from sliding within the needle cover 14 for the purpose of using a well-known alternative form for lockingly engage the needle hub with the needle cover (column 3, lines 43-50).
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 channel of Haining to incorporate at least one of the one or more channels includes a locking slot into which a corresponding at least one of the one or more guides is rotated when the needle cover is in a distalmost position within the needle cover and the needle cover is rotated relative to the needle hub around the longitudinal axis to thereby prevent the needle hub from sliding within the needle cover as taught by Alvarez for the purpose of using a well-known alternative form for lockingly engage the needle hub with the needle cover (column 3, lines 43-50).
Regarding claim 8, Haining discloses 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 12, Haining discloses 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 along a longitudinal axis of the IV catheter device (figure 1);
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, along the longitudinal axis, 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 has a length that extends along the longitudinal axis, the needle cover 10 being 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);
wherein the needle cover 10 is coupled to the needle hub 50, 51, 52 via one or more guides 60, 64, 62, 63 and corresponding one or more channels 90 that extend along the longitudinal axis to thereby enable the needle hub 50, 51, 52 to slide longitudinally within the needle cover 10 (see figures 1-4) as the one or more guide 60, 64, 62, 63 slide within the one or more channels 90 but is silent regarding where at least one of the one or more channels includes a locking slot into which a corresponding at least one of the one or more guides is rotated when the needle cover is in a distalmost position within the needle cover and the needle cover is rotated relative to the needle hub around the longitudinal axis to thereby prevent the needle hub from sliding within the needle cover.
However, Alvarez teaches an IV needle carrier assembly comprising at least one of the one or more channels 30 includes a locking slot 32 into which a corresponding at least one of the one or more guides 24, 26 is rotated when the needle cover 14 is in a distalmost position (position shown in figure 3 where element 26 is positioned inside element 32) within the needle cover 14 and the needle cover 14 is rotated relative to the needle hub 16 around the longitudinal axis to thereby prevent the needle hub 16 from sliding within the needle cover 14 for the purpose of using a well-known alternative form for lockingly engage the needle hub with the needle cover (column 3, lines 43-50).
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 channel of Haining to incorporate at least one of the one or more channels includes a locking slot into which a corresponding at least one of the one or more guides is rotated when the needle cover is in a distalmost position within the needle cover and the needle cover is rotated relative to the needle hub around the longitudinal axis to thereby prevent the needle hub from sliding within the needle cover as taught by Alvarez for the purpose of using a well-known alternative form for lockingly engage the needle hub with the needle cover (column 3, lines 43-50).
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(s) 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Haining (US 5,176,650) in view of Alvarez (US 4,170,993) and further in view of Wang (US 2004/0153039 A1).
Regarding claim 2, Haining/Alvarez (hereinafter referred as “modified Haining”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Haining is silent regarding wherein the one or more channels comprise two channels and the one or more guides comprise two guides and wherein each of the two channels includes a locking slot into which the corresponding guide is rotated.
However, Wang teaches a design of a needle with a cover (figure 1) wherein the one or more channels 12, 16 comprise two channels 12, 16 and the one or more guides 23 comprise two guides and wherein each of the two channels 12, 16 includes a locking slot 15 for the purpose of using a well-known alternative form of using plural number of channels and corresponding guides to slide the needle cover with respect to the needle (figure 1, paragraph 0022).
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 number of channels and guides of modified Haining to incorporate two channels and two guides along with two locking slot as taught by Wang for the purpose of using a well-known alternative form of using plural number of channels and corresponding guides to slide the needle cover with respect to the needle (figure 1, paragraph 0022).
Thus, modified Haining in view of Wang will result in having wherein the one or more channels comprise two channels and the one or more guides comprise two guides and wherein each of the two channels includes a locking slot into which the corresponding guide is rotated.
Additionally, according to MPEP 2144.04 (VI)(B), it is being held as an obvious to duplicate the parts unless a new and unexpected result is produced. In modified Haining, duplication of the channels and guides does not result in a new and unexpected results.
Regarding claim 14, modified Haining discloses the claimed invention substantially as claimed, as set forth above in claim 12. Modified Haining is silent regarding wherein the one or more channels comprise two channels and the one or more guides comprise two guides and wherein each of the two channels includes a locking slot into which the corresponding guide is rotated.
However, Wang teaches a design of a needle with a cover (figure 1) wherein the one or more channels 12, 16 comprise two channels 12, 16 and the one or more guides 23 comprise two guides and wherein each of the two channels 12, 16 includes a locking slot 15 for the purpose of using a well-known alternative form of using plural number of channels and corresponding guides to slide the needle cover with respect to the needle (figure 1, paragraph 0022).
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 number of channels and guides of modified Haining to incorporate two channels and two guides along with two locking slot as taught by Wang for the purpose of using a well-known alternative form of using plural number of channels and corresponding guides to slide the needle cover with respect to the needle (figure 1, paragraph 0022).
Thus, modified Haining in view of Wang will result in having wherein the one or more channels comprise two channels and the one or more guides comprise two guides and wherein each of the two channels includes a locking slot into which the corresponding guide is rotated.
Additionally, according to MPEP 2144.04 (VI)(B), it is being held as an obvious to duplicate the parts unless a new and unexpected result is produced. In modified Haining, duplication of the channels and guides does not result in a new and unexpected results.
Claims 3, 7, 10 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Haining (US 5,176,650) in view of Alvarez (US 4,170,993) and further in view of Firth et al. (US 5,356,392).
Regarding claim 3, modified Haining discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified 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 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 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 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 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 7, modified Haining discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified 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 modified 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, modified Haining discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified 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 the 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 modified 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 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 along a longitudinal axis of the IV catheter device, 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 along the longitudinal axis, 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 longitudinally 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).
Haining is silent regarding where at least one of the one or more channels includes a locking slot into which a corresponding at least one of the one or more guides is rotated when the needle cover is in a distalmost position within the needle cover and the needle cover is rotated relative to the needle hub around the longitudinal axis to thereby prevent the needle hub from sliding within the needle cover.
However, Alvarez teaches an IV needle carrier assembly comprising at least one of the one or more channels 30 includes a locking slot 32 into which a corresponding at least one of the one or more guides 24, 26 is rotated when the needle cover 14 is in a distalmost position (position shown in figure 3 where element 26 is positioned inside element 32) within the needle cover 14 and the needle cover 14 is rotated relative to the needle hub 16 around the longitudinal axis to thereby prevent the needle hub 16 from sliding within the needle cover 14 for the purpose of using a well-known alternative form for lockingly engage the needle hub with the needle cover (column 3, lines 43-50).
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 channel of Haining to incorporate at least one of the one or more channels includes a locking slot into which a corresponding at least one of the one or more guides is rotated when the needle cover is in a distalmost position within the needle cover and the needle cover is rotated relative to the needle hub around the longitudinal axis to thereby prevent the needle hub from sliding within the needle cover as taught by Alvarez for the purpose of using a well-known alternative form for lockingly engage the needle hub with the needle cover (column 3, lines 43-50).
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, D ‘Alessio teaches a design of a needle protector (figure 10) comprising each of the one or more channels 70 (figure 10) includes a distal stop (see “DS” in figure 10 below) and a retaining bump 78 (figure 10), respective guide 58 being selectively retained between the distal stop (see “DS” in figure 10 below) and the retaining bump 78 for the purpose of audibly alerting the user regarding lockingly engaged in the locking slot (column 8, lines 55-57).
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 locking slot of modified 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 D’ Alessio for the purpose of audibly alerting the user regarding lockingly engaged in the locking slot (column 8, lines 55-57).
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Regarding claim 20, Haining is silent regarding wherein each locking slot is positioned distal to the retaining bump of the respective channel.
However, D ‘Alessio teaches a design of a needle protector (figure 10) wherein each locking slot (position in element 70 where element 58 is present in figure 10) is positioned distal to the retaining bump 78 for the purpose of audibly alerting the user regarding lockingly engaged in the locking slot (column 8, lines 55-57).
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 locking slot of modified Haining ’50 to incorporate wherein each locking slot is positioned distal to the retaining bump of the respective channel as taught by D’ Alessio for the purpose of audibly alerting the user regarding lockingly engaged in the locking slot (column 8, lines 55-57).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Haining (US 5,176,650) in view of Alvarez (US 4,170,993) in view of Firth et al. (US 5,356,392) and further in view of D’ Alessio et al. (US 5,389,085).
Regarding claim 4, modified Haining/Firth (hereinafter referred as “modified Haining ‘50”) discloses the claimed invention substantially as claimed, as set forth above in claim 3. Haining is silent regarding wherein each of the one or more channels includes a distal stop.
However, Alvarez teaches wherein each of the one or more channels 30 includes a distal stop (stop formed in element 30 at element 32 thereby preventing further longitudinal movement of element 26 within element 30) for the purpose of using a well-known alternative form for lockingly engage the needle hub with the needle cover (column 3, lines 43-50).
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 a distal stop as taught by Alvarez for the purpose of using a well-known alternative form for lockingly engage the needle hub with the needle cover (column 3, lines 43-50).
Modified Haining ’50 is silent regarding each of the one or more channels includes a retaining bump spaced from the distal stop, wherein each locking slot is positioned distal to the retaining bump of the respective channel, wherein each retaining bump is positioned within the respective channel to cause a distal tip of the needle to be positioned within the needle cover when the respective guide is proximal to the retaining bump.
However, D ‘Alessio teaches a design of a needle protector (figure 10) comprising each of the one or more channels 70 (figure 10) includes a retaining bump 78 (figure 10) spaced from the distal stop (see “DS” in figure 10 above), wherein each locking slot (position in element 70 where element 58 is present in figure 10) is positioned distal to the retaining bump 78 for the purpose of audibly alerting the user regarding lockingly engaged in the locking slot (column 8, lines 55-57).
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 locking slot of modified Haining ’50 to incorporate wherein each of the one or more channels includes a retaining bump spaced from the distal stop, wherein each locking slot is positioned distal to the retaining bump of the respective channel as taught by D’ Alessio for the purpose of audibly alerting the user regarding lockingly engaged in the locking slot (column 8, lines 55-57).
Modified Haining ’50 modified in view of D ‘Alessio will result in a modified channel wherein each retaining bump is positioned within the respective channel to cause a distal tip of the needle to be positioned within the needle cover when the respective guide is proximal to the retaining bump because one of ordinary skill in the art when modifying modified Haining ’50 will modify element 32 of Alvarez to include retaining bump.
Regarding claim 5, modified Haining ’50 discloses the claimed invention substantially as claimed, as set forth above in claim 3. Haining further discloses wherein each of the one or more channels includes a proximal stop 81.
Claims 6, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Haining (US 5,176,650) in view of Alvarez (US 4,170,993) and further in view of D’ Alessio et al. (US 5,389,085).
Regarding claim 6, modified Haining is silent regarding wherein each locking slot is recessed relative to the corresponding channel such that a step is formed between the slocking slot and the corresponding channel to prevent the corresponding guide from being rotated out from the locking slot.
However, D’ Alessio teaches wherein each locking slot (figure 10, location in channel where element 58 is present) is recessed (the claim only requires recessed with respect to the channel and the locking slot is located little downward in longitudinal direction. Claim does not specify if recessed in a radial direction or with respect to anything else other than channel) relative to the corresponding channel 70 such that a step (step formed by element 78) is formed between the locking slot (location in channel where element 58 is present) and the corresponding channel 70 to prevent the corresponding guide from being rotated out from the locking slot for the purpose of audibly alerting the user regarding lockingly engaged in the locking slot (column 8, lines 55-57).
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 channel of modified Haining to incorporate wherein each locking slot is recessed relative to the corresponding channel such that a step is formed between the slocking slot and the corresponding channel to prevent the corresponding guide from being rotated out from the locking slot as taught by D’ Alessio for the purpose of audibly alerting the user regarding lockingly engaged in the locking slot (column 8, lines 55-57).
Regarding claim 15, modified Haining discloses the claimed invention substantially as claimed, as set forth above in claim 12. Modified Haining is silent regarding each of the one or more channels includes a retaining bump that interfaces with the corresponding guide to retain the needle cover in the distalmost position.
However, D ‘Alessio teaches a design of a needle protector (figure 10) comprising each of the one or more channels 70 (figure 10) includes a retaining bump 78 (figure 10) that interfaces with the corresponding guide 58 to retain the needle cover 60 in the position for the purpose of audibly alerting the user regarding lockingly engaged in the locking slot (column 8, lines 55-57).
Modified Haining modified in view of D ‘Alessio will result in a modified device wherein each of the one or more channels includes a retaining bump that interfaces with the corresponding guide to retain the needle cover in the distalmost position.
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 locking slot of modified Haining to incorporate each of the one or more channels includes a retaining bump that interfaces with the corresponding guide to retain the needle cover in the distalmost position of the respective channel as taught by D’ Alessio for the purpose of audibly alerting the user regarding lockingly engaged in the locking slot (column 8, lines 55-57).
Regarding claim 16, modified Haining discloses the claimed invention substantially as claimed, as set forth above in claim 12. Modified Haining is silent regarding wherein each locking slot is positioned distal to the retaining bump of the respective channel.
However, D ‘Alessio teaches wherein each locking slot (position in element 70 where element 58 is present in figure 10) is positioned distal to the retaining bump 78 of the respective channel 70 for the purpose of audibly alerting the user regarding lockingly engaged in the locking slot (column 8, lines 55-57).
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 channel of modified Haining to incorporate wherein each locking slot is positioned distal to the retaining bump of the respective channel as taught by D ‘Alessio for the purpose of audibly alerting the user regarding lockingly engaged in the locking slot (column 8, lines 55-57).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Haining (US 5,176,650) in view of Alvarez (US 4,170,993) and further in view of Sampson et al. (US 4,425,120).
Regarding claim 9, modified Haining discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 8. Haining is silent regarding wherein the channel includes a deviation that requires rotation of the catheter adapter around the longitudinal axis relative to the needle cover to enable the push tab to exit the channel in the needle cover.
However, Sampson teaches wherein the wherein the channel 43 (figure 3) includes a deviation 61 (figure 4) that requires rotation of the component 13 around the longitudinal axis relative to the needle cover 19 to enable the push tab 45 to exit the channel 43 in the needle cover 19 for the purpose of using a well-known alternative form of establishing releasable connection between the needle cover and the component (column 4, lines 30-43).
Modified Haining modified in view of Sampson will result in having wherein the channel includes a deviation that requires rotation of the catheter adapter around the longitudinal axis relative to the needle cover to enable the push tab to exit the channel in the needle cover.
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 of the catheter adapter with the needle cover of modified Haining to incorporate wherein the channel includes a deviation that requires rotation of the catheter adapter around the longitudinal axis relative to the needle cover to enable the push tab to exit the channel in the needle cover as taught by Sampson for the purpose of using a well-known alternative form of establishing releasable connection between the needle cover and the component (column 4, lines 30-43).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Haining (US 5,176,650) in view of Alvarez (US 4,170,993) and further in view of D’ Alo et al. (US 4,326,519).
Regarding claim 17, modified 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 modified 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).
Response to Arguments
Applicant’s arguments with respect to claims 1, 12 and 18 have been considered but are moot because the arguments do not apply in view of the present rejection.
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.
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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