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
This office action is responsive to the amendment filed 23 December 2025. As directed by the amendment: claims 1-4, 6, 8, and 11-14 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 23 December 2025 have been fully considered but they are not persuasive.
Applicant argues on pages 10-11, “In Vaillancourt, the second end of the collar tube is at a first position aligned with what appears to be a first insertion depth band in a series of bands (Figure 1, element 12's distal end is above the topmost band on shaft 11) during insertion (Column 2, lines 27-40) and during withdrawal is moved vertically down the shaft towards the distal end of the of the needle such that it is no longer aligned with the first insertion depth band used during insertion (Figure 3, element 12's distal end is no longer above the topmost band of shaft 11). Applicant notes that even though visually the needle 11 is shown in segments that may appear to be bands appearing across the needle shaft, Vaillancourt never actually establishes their nature in its disclosure. Regardless, given Orosz, Vaillancourt, Fischer, and Castelli all in hand and at the effective filing date of the claimed subject matter of amended independent claims 1 and 11, one of ordinary skill in art would not have looked to Vaillancourt to address the "...wherein the second end of the collar tube remains aligned with said one of the plurality of depth indication bands used when said collar tube is configured to limit the insertion depth of the safety needle into a body, said second end of the collar tube remaining aligned with said one of the plurality of depth indication bands while said collar tube is configured to withdraw the safety needle from the body... "limitation as recited because Vaillancourt teaches away from remaining aligned with a same one of plurality of depth indication bands during an insertion and a withdrawal of a safety needle shaft. See In re Grasselli, 713 F.2d 731, 218 USPQ 769 (Fed. Cir. 1983). The movement of Vaillancourt's second end of the collar tube is essential to the desired aim of the disclosure: to provide needle protection from needle sticks. If anything, any incorporation with Orosz would also have the collar tube teaching from Vaillancourt move from a first position during insertion to a second position during insertion in order to prevent needle sticks, and not to remain aligned with the same one of plurality of insertion depth bands during insertion and withdrawal. As such, Orosz and Vaillancourt, whether taken alone or in combination, fail to teach, suggest, imply, disclose or otherwise render obvious the currently recited limitation of "...wherein the second end of the collar tube remains aligned with said one of the plurality of depth indication bands used when said collar tube is configured to limit the insertion depth of the safety needle into a body, said second end of the collar tube remaining aligned with said one of the plurality of depth indication bands while said collar tube is configured to withdraw the safety needle from the body..." as in claims 1 and 11.”
The device of Vaillancourt does a movement feature, however, in Figure 1, the first and second end of the device are in a locked position with the adapter 14. This locked position allows for the second end 12 the be aligned with at least an indication band of the needle 11. Additionally, when combined with the device of Orosz, Jr., the locked position of the collar tube would be depth limiting feature that could stay aligned with the depth indication bands in both insertion and withdraw as the collar tube must intentionally be unlocked for any movement to occur. The device of Vaillancourt is to prevent needle sticks, but the part 12 does limit depth and it not necessary to be moved until withdraw of the needle.
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(s) 1-4, 6, and 11-14 and is/are rejected under 35 U.S.C. 103 as being unpatentable US 6,716,192 to Orosz, Jr in view of US 8,728,029 to Vaillancourt, further in view of US 2013/0190609 to Fischer, JR. As to claim 1 , Orosz, Jr. discloses a safety needle for administering medication and withdrawing biological fluids, comprising: a needle shaft (21) having a first, a second end and a lumen extending from the first end to the second end, the second end including a beveled tip (Figure 4); and a plurality of depth indication bands extending at least partially along a circumference of the needle shaft (Col. 3, Lines 26-40), each band of the plurality of depth indication bands having a width and being positioned at a different distance from the beveled tip, wherein a width of one of the plurality of depth indication bands is greater than a width of a remainder of the plurality of depth indication bands (22, 24, Figure 4), and wherein the plurality of depth indication bands is contiguous along a vertical length of the needle shaft (where the indicators 22 and 24 are considered bands as they are distinct regions on the needle saft that continue vertically on the shaft, the regions in between 22 and 24 and the body of the syringe are considered the spacing to consider 22 and 24 bands). Orosz, Jr. fails to disclose an adapter attached to the first end of the needle shaft; a collar tube mounted on the needle shaft, having a first end and a second end, configured to limit an insertion depth of the safety needle into a body, and wherein the first end of the collar tube contacts the adapter and the second end of the collar tube aligns with one of the plurality of depth indication bands or when said collar tube is configured to limit the insertion depth of the safety needle into the body.
Vaillancourt discloses an adapter (14) attached to the first end of the needle shaft; a collar tube mounted on the needle shaft (Figure 1), having a first end (13) and a second end (12), configured to limit an insertion depth of the safety needle into a body (where in Figure 1 the locked configuration would prevent the needle from moving past end 12), and wherein the first end of the collar tube (13) contacts the adapter and the second end of the collar tube aligns with one of the plurality of depth indication bands (Figure 1, where the banding on the need shows that the locked end 12 is aligned in a stationary position with at least the top portion). Vaillancourt further discloses wherein said collar tube is configured to limit the insertion depth of the safety needle into the body (Fig. 1, 12), and wherein the second end of the collar tube remains aligned with said one of the plurality of depth indication bands used when said collar tube is configured to limit the insertion depth of the safety needle into a body, said second end of the collar tube remaining aligned with said one of the plurality of depth indication bands while said collar tube is configured to withdraw the safety needle from the body (Fig. 1, where the second end 12 is in locked position such that it would not move during insertion or withdraw and is aligned with at least a section of the needle). The second end 12 does not move unless intentionally released (Col. 6, lines 23-33). The cap 12 of Vaillancourt may shield the device, but also prohibits the needle from being inserted further into the device when locked. The language does state that the collar tube will limit the depth of the safety needle into the body and when the locking of the cap occurs the needle is prohibited from going any further than where the cap end is located. Additionally, when combined with the Orosz Jr. the end 12 in a locked position can be aligned with at least a depth indication band. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the needle of Orosz with an adapter attached to the first end of the needle shaft; a collar tube mounted on the needle shaft, having a first end and a second end, configured to limit an insertion depth of the safety needle into a body, and wherein the first end of the collar tube contacts the adapter and the second end of the collar tube aligns with one of the plurality of depth indication bands, as taught by Vaillancourt to provide a protective shield for the needle and adapter (abstract). Orosz, Jr in view of Vaillancourt fails to disclose the safety needle wherein a width of the one of the plurality of depth indication bands nearest to the beveled tip is angled with respect to the first end of the collar tube thereby providing an indication of a proper angle of insertion of the needle shaft. In analogous prior art, Fischer, Jr. discloses a safety needle wherein a width of the one of the plurality of depth indication bands nearest to the beveled tip is angled with respect to the first end of the collar tube thereby providing an indication of a proper angle of insertion of the needle shaft (520, Figure 10 and [0052]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the depth indication band nearest the beveled tip of Orosz, Jr in view of Vaillancourt with a plurality of depth indication bands, wherein a width of the one of the plurality of depth indication bands nearest to the beveled tip is angled with respect to the first end of the collar tube thereby providing an indication of a proper angle of insertion of the needle shaft, as taught by Fischer, Jr., for optimal visualization of the medical device (abstract).
As to claim 2, Orosz, Jr. discloses the safety needle for administering medication and withdrawing biological fluids wherein each of the plurality of depth indication bands is a different color (the coloring of the end of the needle can be graded in different shades to provide indication of the depth of penetration of the needle: Column 3, lines 29-32). As to claim 3, Orosz, Jr. discloses the safety needle for administering medication and withdrawing biological fluids wherein each of the plurality of depth indication bands is a different shade of the same color (the coloring of the end of the needle can be graded in different shades to provide indication of the depth of penetration of the needle: Column 3, lines 29-32). As to claim 4, Orosz, Jr. fails to explicitly disclose the safety needle wherein each of the plurality of depth indication bands is a different shade of gray. Instead, Orosz, Jr. discloses that the tip can be black (Column 2, line 60). Orosz, Jr. further discloses that the coloring of the end of the needle can be graded in different shades to provide indication of the depth of penetration of the needle (Column 3, lines 29-32). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the kit of Orosz, Jr. with depth indication bands that are different shades of gray, since gray is a lighter shade of black. As to claim 6, the modified safety needle of Orosz, Jr. and Vaillancourt further comprises a small diameter end attached to the first end of the shaft; and a large diameter end attachable to a syringe or cannula, wherein the adapter is tapered from the small diameter to the larger diameter end (adapter, 14, Figure 1 from Vaillancourt). As to claim 11, Orosz, Jr. discloses a kit for administering medication and withdrawing biological fluids comprising at least one safety needle, the at least one safety needle comprising: a needle shaft having a first end, a second end, and a lumen extending from the first end to the second end, the second end including a beveled tip; a plurality of depth indication bands extending at least partially along a circumference of the needle shaft, each band having a width and being positioned at a different distance from the beveled tip; wherein a width of one or more of the bands (22) is greater than a width of at least one of the bands (24, Figure 4), and wherein the plurality of depth indication bands is contiguous along a vertical length of the needle shaft (where the indicators 22 and 24 are considered bands as they are distinct regions on the needle saft that continue vertically on the shaft, the regions in between 22 and 24 and the body of the syringe are considered the spacing to consider 22 and 24 bands). Orosz, Jr. fails to disclose a guide providing the distance from the beveled tip to each identification band. However, if Orosz, Jr. discloses a gradient graded in different shades to provide indication of the depth of penetration of the needle: Column 3, lines 29-32, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a guide indicating the depth corresponding to each graded shade. Orosz, Jr. fails to disclose an adapter attached to the first end of the needle shaft; a collar tube mounted on the needle shaft, having a first end and a second end, configured to limit an insertion depth of the safety needle into a body, and wherein the first end of the collar tube contacts the adapter and the second end of the collar tube aligns with one of the plurality of depth indication bands or when said collar tube is configured to limit the insertion depth of the safety needle into the body. Vaillancourt discloses an adapter (14) attached to the first end of the needle shaft; a collar tube mounted on the needle shaft (Figure 1), having a first end (13) and a second end (12), configured to limit an insertion depth of the safety needle into a body (where in Figure 1 the locked configuration would prevent the needle from moving past end 12), and wherein the first end of the collar tube (13) contacts the adapter and the second end of the collar tube aligns with one of the plurality of depth indication bands (Figure 1, where the banding on the need shows that the locked end 12 is aligned in a stationary position with at least the top portion). Vaillancourt further discloses wherein said collar tube is configured to limit the insertion depth of the safety needle into the body (Fig. 1, 12), and wherein the second end of the collar tube remains aligned with said one of the plurality of depth indication bands used when said collar tube is configured to limit the insertion depth of the safety needle into a body, said second end of the collar tube remaining aligned with said one of the plurality of depth indication bands while said collar tube is configured to withdraw the safety needle from the body (Fig. 1, where the second end 12 is in locked position such that it would not move during insertion or withdraw and is aligned with at least a section of the needle). The second end 12 does not move unless intentionally released (Col. 6, lines 23-33). The cap 12 of Vaillancourt may shield the device, but also prohibits the needle from being inserted further into the device when locked. The language does state that the collar tube will limit the depth of the safety needle into the body and when the locking of the cap occurs the needle is prohibited from going any further than where the cap end is located. Additionally, when combined with the Orosz Jr. the end 12 in a locked position can be aligned with at least a depth indication band.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the needle of Orosz with an adapter attached to the first end of the needle shaft; a collar tube mounted on the needle shaft, having a first end and a second end, configured to limit an insertion depth of the safety needle into a body, and wherein the first end of the collar tube contacts the adapter and the second end of the collar tube aligns with one of the plurality of depth indication bands, as taught by Vaillancourt to provide a protective shield for the needle and adapter (abstract).
Orosz, Jr in view of Vaillancourt fails to disclose the safety needle wherein a width of the one of the plurality of depth indication bands nearest to the beveled tip is angled with respect to the first end of the collar tube thereby providing an indication of a proper angle of insertion of the needle shaft. In analogous prior art, Fischer, Jr. discloses a safety needle wherein a width of the one of the plurality of depth indication bands nearest to the beveled tip is angled with respect to the first end of the collar tube thereby providing an indication of a proper angle of insertion of the needle shaft (520, Figure 10 and [0052]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the depth indication band nearest the beveled tip of Orosz, Jr in view of Vaillancourt with a plurality of depth indication bands, wherein a width of the one of the plurality of depth indication bands nearest to the beveled tip is angled with respect to the first end of the collar tube thereby providing an indication of a proper angle of insertion of the needle shaft, as taught by Fischer, Jr., for optimal visualization of the medical device (abstract).
As to claim 12, Orosz, Jr. discloses the safety needle for administering medication and withdrawing biological fluids wherein each of the plurality of depth indication bands is a different shade of the same color (the coloring of the end of the needle can be graded in different shades to provide indication of the depth of penetration of the needle: Column 3, lines 29-32). As to claim 13, Orosz, Jr. fails to explicitly disclose the kit wherein each of the plurality of depth indication bands is a different shade of gray. Instead, Orosz, Jr. discloses that the tip can be black (Column 2, line 60). Orosz, Jr. further discloses that the coloring of the end of the needle can be graded in different shades to provide indication of the depth of penetration of the needle (Column 3, lines 29-32). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the kit of Orosz, Jr. with depth indication bands that are different shades of gray, since gray is a lighter shade of black. As to claim 14, Orosz, Jr. discloses the safety needle for administering medication and withdrawing biological fluids wherein each of the plurality of depth indication bands is a different color (the coloring of the end of the needle can be graded in different shades to provide indication of the depth of penetration of the needle: Column 3, lines 29-32).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over US 6,716,192 to Orosz, Jr in view of US 8,728,029 to Vaillancourt, in view of US 2013/0190609 to Fischer, JR, further in view of US 3,149,717 to Castelli. As to claim 8, the modified safety needle of Orosz, Jr. discloses the adapter comprising a tapered section attached to the first end of the shaft and a cylindrical section attachable to a syringe (Figure 2), but fails to disclose a hexagonal section between the tapered section and the cylindrical section. Castelli discloses a hexagonal section between the tapered section and the cylindrical section (Column 2, lines 25-50). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a hexagonal section between the tapered section and the cylindrical section of the adapter to prevent rotation between the needle and the adapter (Column 2, lines 25-50).
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 HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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