DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because of the following informalities: Lines 9-12 reading “when the first and second wings when the first wing and the second wing” should read --when the first wing and the second wing--. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: Lines 1-2 reading “the outside surface of the first wing and the outside surface of the second wing” should read --an outside surface of the first wing and an outside surface of the second wing--. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: Line 3 reading “a medical needle” should read --the medical needle--. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: Lines 11-12 reading “configured to nest within the wing alignment when the first and second wings” should read --configured to nest within the wing alignment when the first wing and the second wing--. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: Line 20 reading “the needle wing protector” should read --a needle wing protector--. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Lines 1-2 reading “the outside surface of the first wing and the outside surface of the second wing” should read --an outside surface of the first wing and an outside surface of the second wing--. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: Line 5 reading “a medical needle” should read --the medical needle--. Appropriate correction is required.
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 9-10 and 19-20 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. Claim 9 and 19 recite the limitation “wherein the outside surface of the first wing and the outside surface of the second wing comprise at least one groove.” It is unclear from Claims 9 and 19 whether the outside surface of the first wing and the outside surface of the second wing have a single groove shared by both the first wing and the second wing or whether the outside surface of the first wing and the outside surface of the second wing each have a groove respectively. Examiner is interpreting the claim as the latter. Examiner recommends amending Claims 19 and 20 similar to that of Claims 9 and 10. Appropriate correction and/or clarification is required.
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, 3-5, 7-10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lambert (USPGPub 2013/0296804) in view of Smith et al. (USPGPub 20050107749) above, and further in view of Raines (USPN 4,631,058).
Re Claim 1, Lambert teaches a device (200) (as seen in Lambert Fig. 2) for protecting a user from a sharp tip of a medical needle (206) comprising a central body portion (202) (Lambert ¶ 0045); the medical needle (206) having a first end (208) in fluid connection with a delivery tube (204) (Lambert ¶ 0045); the medical needle (206) having an interior length inside of the central needle portion (202) (Lambert Fig. 2); the medical needle (206) having a second end (210) distal from and perpendicular to the central body portion (202) and including the sharp tip (212) (Lambert ¶ 0045); a pair of semi-rigid wings (216, 218) comprising a first wing (218) and a second wing (216) (Lambert ¶ 0046), the first wing (218) comprising a wing alignment (1042) having a semicircular shape (Lambert ¶ 0055 - wherein lip 1042 comprises a semi-circular shape), the second wing (216) comprising a stabilizer (1038, 1040) having a semicircular shape (Lambert ¶ 0055 - wherein perimeter 1040 with recessed portion 1038 comprises a semi-circular shape) and configured to nest within the wing alignment (1042) (Lambert ¶ 0055) when the first wing (218) and the second wing (216) are held together on a same side of the central body portion (202) as the medical needle (206) (Lambert ¶ 0055).
Lambert fails to teach the stabilizer configured to nest within the wing alignment when the first wing and the second wing are held together on an opposite side of the central body portion from the medical needle. Smith teaches a device (10) comprising a needle (12), a first wing (42A), and a second wing (42B) (Smith Annotated Fig. 1 below), the first wing (42A) comprising a wing alignment (42D) and the second wing (42B) comprising a stabilizer (42C), the stabilizer (42C) configured to nest within the wing alignment (42D) when the first wing (42A) and the second wing (42B) are held together on an opposite side of a central body portion (28) from the medical needle (12) (as seen in Smith Fig. 4), the configuration for securing the wings together such that they may be gripped when inserting or removing the needle (Smith ¶ 0054-0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the device of Lambert include an additional wing alignment and stabilizer (on opposite sides from the current wing alignment and stabilizer), the additional stabilizer configured to nest within the additional wing alignment when the first wing and the second wing are held together on an opposite side of the central body portion from the medical needle, the configuration as disclosed by Smith for securing the wings together such that they may be gripped when inserting or removing the needle (Smith ¶ 0054-0056).
Lambert in view of Smith fail to teach a removable needle wing protector, wherein the removable needle wing protector slides over the first wing, the medical needle, and the second wing. Raines teaches a removable needle wing protector (15) (Raines Fig. 1), wherein the removable needle wing protector (15) slides over a first wing (13), a second wing (13) and a medical needle (10) for safely securing the wings and needle in the protector in a ready to use state and preventing needle sticks (Raines Col. 1 Lines 5-33). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the device of Lambert in view of Smith include a removable needle wing protector, wherein the removable needle wing protector slides over the first wing, the medical needle, and the second wing as disclosed by Oshima for safely securing the wings and needle in the protector in a ready to use state and preventing needle sticks (Raines Col. 1 Lines 5-33).
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Re Claim 3, Lambert in view of Smith above, and further in view of Raines teach all of the limitations of Claim 1. Lambert further teaches wherein an inside surface of the first wing (218) and the outside surface of the second wing (216) comprise a lip (1038, 1042) present on at least part of a perimeter of the first wing (218) and the second wing (216) (Lambert ¶ 0055; Fig. 10). In the modified device of Lambert in view of Smith above, and further in view of Raines, an additional lip would be positioned on an outside surface of the first wing and the second wing.
Re Claim 4, Lambert in view of Smith above, and further in view of Raines teach all of the limitations of Claim 1. Lambert further teaches the first wing and the second wing comprise a raised portion (1040) (Lambert ¶ 0046; Fig. 13). In the modified device of Lambert in view of Smith above, and further in view of Raines, an additional raised portion would be positioned on an outside surface of the first wing and the second wing.
Re Claim 5, Lambert in view of Smith above, and further in view of Raines teach all of the limitations of Claim 1. Lambert in view of Raines fail to teach wherein an inside surface of the first wing and an inside surface of the second wing comprise a textured surface. Smith teaches wherein an inside surface of the first wing (42A) and an inside surface of the second wing (42B) comprise a textured surface which aid in being facilely gripped by a clinician's fingers (Smith ¶ 0055). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the inside surface of the first wing and an inside surface of the second wing of Lambert in view of Smith above, and further in view of Raines to comprise a textured surface as disclosed by Smith for aiding in being facilely gripped by a clinician's fingers (Smith ¶ 0055).
Re Claim 7, Lambert in view of Smith above, and further in view of Raines teach all of the limitations of Claim 1. Lambert fails to teach wherein the removable needle wing protector has four legs. Raines teaches a device (as seen in Raines Fig. 1) comprising a removable needle wing protector (15) (Raines Col. 1 Line 59 to Col. 2 Line 24), said removable needle wing protector (15) comprising four legs (17, 21, 22) that aid in securing the first wing (13), the second wing (13) and the medical needle (10) before and after use (Raines Col. 1 Line 5 to Col. 2 Line 24). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the removable needle wing protector of Lambert in view of Smith above, and further in view of Raines to comprise four legs as disclosed by Raines for aiding in securing the first wing, the second wing and the medical needle before and after use (Raines Col. 1 Line 5 to Col. 2 Line 24).
Re Claim 8, Lambert in view of Smith above, and further in view of Raines teach all of the limitations of Claim 1. Lambert fails to teach wherein the first wing, the medical needle, and the second wing have a leg of the removable needle wing protector on each side. Raines teaches wherein the first wing (13), the medical needle (10), and the second wing (13) have a leg of the removable needle wing protector (15) on each side for aiding in securing the first wing, the second wing and the medical needle before and after use (Raines Col. 1 Line 5 to Col. 2 Line 24; Figs. 1-7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the removable needle wing protector of Lambert in view of Smith above, and further in view of Raines such that the first wing, the medical needle, and the second wing have a leg of the removable needle wing protector on each side as disclosed by Raines for aiding in securing the first wing, the second wing and the medical needle before and after use (Raines Col. 1 Line 5 to Col. 2 Line 24; Figs. 1-7).
Re Claims 9 and 10, Lambert in view of Smith above, and further in view of Raines teach all of the limitations of Claim 1. Lambert fails to teach wherein the outside surface of the first wing and the outside surface of the second wing comprise at least one groove; and wherein the removable needle wing protector stays in place in the at least one groove of the outside surface of the first wing and the at least one groove of the outside surface of the second wing due to a press fit. Raines teaches wherein an outside surface of the removable needle wing protector (15) comprises at least one groove (21, 22) (Raines Fig. 1); and wherein the first wing (13) and the second wing (13) stay in place in the at least one groove (21, 22) of the removable needle wing protector (15) due to a press fit (Raines Col. 2 Lines 33-45), the configuration for securing a central needle portion in the needle wing protector before and after use (Raines Col. 2 Lines 33-45).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the at least one groove on the outside surface of the first wing and the outside surface of the second wing be on the removable needle wing protector, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the removable needle wing protector of Lambert in view of Smith above, and further in view of Raines wherein an outside surface of the removable needle wing protector comprises at least one groove; and wherein the first wing and the second wing stay in place in the at least one groove of the removable needle wing protector due to a press fit, the configuration as disclosed by Raines for securing a central needle portion in the needle wing protector before and after use (Raines Col. 2 Lines 33-45) and a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Re Claim 21, Lambert in view of Smith above, and further in view of Raines teach all of the limitations of Claim 1. Lambert further teaches wherein the wing alignment (1042) and the stabilizer (1038, 1040) are concentric (Lambert Fig. 10).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lambert (USPGPub 2013/0296804) in view of Smith et al. (USPGPub 2005/0107749) above, and further in view of Raines (USPN 4,631,058) as applied to Claim 1 above, and further in view of Rosato et al. (USPN 5,951,522).
Re Claim 6, Lambert in view of Smith above, and further in view of Raines teach all of the limitations of Claim 1. Lambert in view of Smith above, and further in view of Raines fail to teach wherein the central body portion comprises a gripping lip. Rosato teaches a device (20) comprising a first wing (38), a second wing (46), a central body portion (35) and a medical needle (22) (Rosato Fig. 6), wherein the central body portion (35) comprises a gripping lip (34) for handling the device after its placement (Rosato Col. 6 Lines 13-23). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the central body portion of Lambert in view of Smith above, and further in view of Raines to comprise a gripping lip as disclosed by Rosato for handling the device after its placement (Rosato Col. 6 Lines 13-23).
Claims 11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lambert (USPGPub 2013/0296804) in view of Smith et al. (USPGPub 2005/0107749) above, and further in view of Swenson et al. (USPGPub 2003/0163096).
Re Claim 11, Lambert teaches a method comprising withdrawing from a patient the sharp tip (212) of a medical needle (206) of a device (200) for protecting a user from a sharp tip (212) of a medical needle (206) wherein the device (200) comprises a central body portion (202) (Lambert ¶ 0045); the medical needle (206) having a first end (208) in fluid connection with a delivery tube (204) (Lambert ¶ 0045); the medical needle (206) having an interior length inside of the central body portion (202) (Lambert Fig. 2); the medical needle (206) having a second end (210) distal from and perpendicular to the central body portion (202) and including the sharp tip (212) (Lambert ¶ 0045); a pair of semi-rigid wings (216, 218) comprising a first wing (218) and a second wing (216) (Lambert ¶ 0046), the first wing (218) comprising a wing alignment (1042) having a semicircular shape (Lambert ¶ 0055 - wherein lip 1042 comprises a semi-circular shape), the second wing (216) comprising a stabilizer (1038, 1040) having a semicircular shape (Lambert ¶ 0055 - wherein perimeter 1040 with recessed portion 1038 comprises a semi-circular shape) and configured to nest within the wing alignment (1042) (Lambert ¶ 0055) when the first wing (218) and the second wing (216) are held together on a same side of the central body portion (202) as the medical needle (206) (Lambert ¶ 0055); and closing the pair of semi-rigid wings (216, 218) with the medical needle (206) positioned between the semi-rigid wings (216, 218) so as to protect the user from the sharp tip (212) of the medical needle (206) (Lambert Abstract).
Lambert fails to teach the stabilizer configured to nest within the wing alignment when the first wing and the second wing are held together on an opposite side of the central body portion from the medical needle. Smith teaches a device (10) comprising a needle (12), a first wing (42A), and a second wing (42B) (Smith Annotated Fig. 1 below), the first wing (42A) comprising a wing alignment (42D) and the second wing (42B) comprising a stabilizer (42C), the stabilizer (42C) configured to nest within the wing alignment (42D) when the first wing (42A) and the second wing (42B) are held together on an opposite side of a central body portion (28) from the medical needle (12) (as seen in Smith Fig. 4), the configuration for securing the wings together such that they may be gripped when inserting or removing the needle (Smith ¶ 0054-0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the device of Lambert include an additional wing alignment and stabilizer (on opposite sides from the current wing alignment and stabilizer), the additional stabilizer configured to nest within the additional wing alignment when the first wing and the second wing are held together on an opposite side of the central body portion from the medical needle, the configuration as disclosed by Smith for securing the wings together such that they may be gripped when inserting or removing the needle (Smith ¶ 0054-0056).
Lambert in view of Smith fail to teach sliding the needle wing protector over the first wing, the medical needle, and the second wing. Swenson teaches a device (24) comprising a first wing (38), second wing (40), and a medical needle (32), a needle wing protector (122) wherein the needle wing protector (122) is slid over the first wing (38), the medical needle (32), and the second wing (40), the needle wing protector for preventing needle sticks (Swenson ¶ 0039). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the first wing, the medical needle, and the second wing of Lambert in view of Smith to be slid into a needle wing protector as disclosed by Swenson for preventing needle sticks (Swenson ¶ 0039).
Re Claim 13, Lambert in view of Smith above, and further in view of Swenson teach all of the limitations of Claim 11. Lambert further teaches wherein the first wing (218) and the second wing (216) comprise a lip (1038, 1042) present on at least part of the perimeter of the first wing (218) and the second wing (216) (Lambert ¶ 0055; Fig. 10). In the modified device of Lambert in view of Smith above, and further in view of Swenson, the lip would be positioned on an outside surface of the first wing and the second wing.
Re Claim 14, Lambert in view of Smith above, and further in view of Swenson teach all of the limitations of Claim 11. Lambert further teaches the first wing (218) and the second wing (216) comprise a raised portion (1040) (Lambert ¶ 0046; Fig. 13). In the modified device of Lambert in view of Smith above, and further in view of Swenson, the raised portion would be positioned on an outside surface of the first wing and the second wing.
Re Claim 15, Lambert in view of Smith above, and further in view of Swenson teach all of the limitations of Claim 11. Lambert fails to teach wherein an inside surface of the first wing (218) and an inside surface of the second wing (216) comprise a textured surface. Smith teaches wherein an inside surface of the first wing (42A) and an inside surface of the second wing (42B) comprise a textured surface which aid in being facilely gripped by a clinician's fingers (Smith ¶ 0055). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the inside surface of the first wing and an inside surface of the second wing of Lambert in view of Smith above, and further in view of Swenson to comprise a textured surface as disclosed by Smith for aiding in being facilely gripped by a clinician's fingers (Smith ¶ 0055).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lambert (USPGPub 2013/0296804) in view of Smith et al. (USPGPub 2005/0107749) above, and further in view of Swenson et al. (USPGPub 2003/0163096) as applied to Claim 1 above, and further in view of Rosato et al. (USPN 5,951,522).
Re Claim 16, Lambert in view of Smith above, and further in view of Swenson teach all of the limitations of Claim 1. Lambert in view of Smith above, and further in view of Swenson fail to teach wherein the central body portion comprises a gripping lip. Rosato teaches a device (20) comprising a first wing (38), a second wing (46), a central body portion (35) and a medical needle (22) (Rosato Fig. 6), wherein the central body portion (35) comprises a gripping lip (34) for handling the device after its placement (Rosato Col. 6 Lines 13-23). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the central body portion of Lambert in view of Smith above, and further in view of Swenson to comprise a gripping lip as disclosed by Rosato for handling the device after its placement (Rosato Col. 6 Lines 13-23).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lambert (USPGPub 2013/0296804) in view of Smith et al. (USPGPub 2005/0107749) above, and further in view of Swenson et al. (USPGPub 2003/0163096) as applied to Claim 1 above, and further in view of Raines (USPN 4,631,058).
Re Claim 17, Lambert in view of Smith above, and further in view of Swenson teach all of the limitations of Claim 11. Lambert in view of Smith above, and further in view of Swenson fail to teach wherein the removable needle wing protector has four legs. Raines teaches a device (as seen in Raines Fig. 1) comprising a removable needle wing protector (15) (Raines Col. 1 Line 59 to Col. 2 Line 24), said removable needle wing protector (15) comprising four legs (17, 21, 22) that aid in securing the first wing (13), the second wing (13) and the medical needle (10) before and after use (Raines Col. 1 Line 5 to Col. 2 Line 24). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the removable needle wing protector of Lambert in view of Smith above, and further in view of Swenson to comprise four legs as disclosed by Raines for aiding in securing the first wing, the second wing and the medical needle before and after use (Raines Col. 1 Line 5 to Col. 2 Line 24).
Re Claim 18, Lambert in view of Smith above, and further in view of Swenson teach all of the limitations of Claim 11. Lambert in view of Smith above, and further in view of Swenson fail to teach wherein the first wing, the medical needle, and the second wing each have a leg of the removable needle wing protector on each side. Raines teaches wherein the first wing (13), the medical needle (10), and the second wing (13) have a leg of the removable needle wing protector (15) on each side for aiding in securing the first wing, the second wing and the medical needle before and after use (Raines Col. 1 Line 5 to Col. 2 Line 24; Figs. 1-7). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the removable needle wing protector of Lambert in view of Smith above, and further in view of Swenson such that the first wing, the medical needle, and the second wing have a leg of the removable needle wing protector on each side as disclosed by Raines for aiding in securing the first wing, the second wing and the medical needle before and after use (Raines Col. 1 Line 5 to Col. 2 Line 24; Figs. 1-7).
Re Claims 19 and 20, Lambert in view of Smith above, and further in view of Swenson teach all of the limitations of Claim 1. Lambert in view of Smith above, and further in view of Swenson fail to teach wherein the outside surface of the first wing and the outside surface of the second wing comprise at least one groove; and wherein the needle wing protector stays in place in the at least one groove due to a press fit. Raines teaches wherein the outside surface of the first wing (13) and the outside surface of the second wing (13) comprise at least one groove (corner at intersection of wing 13 and hub portion 14); and wherein the needle wing protector (15) stays in place in the at least one groove due to a press fit for securing a central needle portion (14) in the needle wing protector (15) before and after use (Raines Col. 2 Lines 33-45).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the device of Lambert in view of Smith above, and further in view of Swenson wherein the outside surface of the first wing and the outside surface of the second wing comprise at least one groove; and wherein the needle wing protector stays in place in the at least one groove due to a press fit as disclosed by Raines for securing a central needle portion in the needle wing protector before and after use (Raines Col. 2 Lines 33-45).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Lambert (USPGPub 2013/0296804) in view of Rosato et al. (USPN 5,951,522) and Smith et al. (USPGPub 20050107749) above, and further in view of Raines (USPN 4,631,058).
Re Claim 22, Lambert teaches a device (200) (as seen in Lambert Fig. 2) for protecting a user from a sharp tip of a medical needle (206) comprising: a central body portion (202) in fluid connection with a delivery tube (204) (Lambert ¶ 0045); the medical needle (206) having a first end (208) in fluid connection with the central body portion (202) and a second end extending away from the central body portion to the sharp tip (as seen in Lambert Fig. 10); a pair of semi-rigid wings (216, 218) comprising a first wing (218) and a second wing (216) (Lambert ¶ 0046), the first wing (218) comprising a wing alignment (1042) having a semicircular shape (Lambert ¶ 0055 - wherein lip 1042 comprises a semi-circular shape), the second wing (216) comprising a stabilizer (1038, 1040) having a semicircular shape (Lambert ¶ 0055 - wherein perimeter 1040 with recessed portion 1038 comprises a semi-circular shape) and configured to nest within the wing alignment (1042) (Lambert ¶ 0055) when the first wing (218) and the second wing (216) are held together on a same side of the central body portion (202) as the medical needle (206) (Lambert ¶ 0055); and the wing alignment (1042) and the stabilizer (1038, 1040) being concentric (as seen in Lambert Figs. 10-11); wherein an inside surface of the first wing and an inside surface of the second wing comprise a textured surface;
Lambert fails to teach wherein the central body portion comprises a gripping lip. Rosato teaches a device (20) comprising a first wing (38), a second wing (46), a central body portion (35) and a medical needle (22) (Rosato Fig. 6), wherein the central body portion (35) comprises a gripping lip (34) for handling the device after its placement (Rosato Col. 6 Lines 13-23). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the central body portion of Lambert to comprise a gripping lip as disclosed by Rosato for handling the device after its placement (Rosato Col. 6 Lines 13-23).
Lambert fails to teach the stabilizer configured to nest within the wing alignment when the first wing and the second wing are held together on an opposite side of the central body portion from the medical needle. Smith teaches a device (10) comprising a needle (12), a first wing (42A), and a second wing (42B) (Smith Annotated Fig. 1 below), the first wing (42A) comprising a wing alignment (42D) and the second wing (42B) comprising a stabilizer (42C), the stabilizer (42C) configured to nest within the wing alignment (42D) when the first wing (42A) and the second wing (42B) are held together on an opposite side of a central body portion (28) from the medical needle (12) (as seen in Smith Fig. 4), the configuration for securing the wings together such that they may be gripped when inserting or removing the needle (Smith ¶ 0054-0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the device of Lambert include an additional wing alignment and stabilizer (on opposite sides from the current wing alignment and stabilizer), the additional stabilizer configured to nest within the additional wing alignment when the first wing and the second wing are held together on an opposite side of the central body portion from the medical needle, the configuration as disclosed by Smith for securing the wings together such that they may be gripped when inserting or removing the needle (Smith ¶ 0054-0056).
Lambert also fails to teach wherein an inside surface of the first wing (218) and an inside surface of the second wing (216) comprise a textured surface. Smith teaches wherein an inside surface of the first wing (42A) and an inside surface of the second wing (42B) comprise a textured surface which aid in being facilely gripped by a clinician's fingers (Smith ¶ 0055). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the inside surface of the first wing and an inside surface of the second wing of Lambert in view of Smith above, and further in view of Swenson to comprise a textured surface as disclosed by Smith for aiding in being facilely gripped by a clinician's fingers (Smith ¶ 0055).
Lambert in view of Rosato and Smith fail to teach a removable needle wing protector having four legs, wherein the removable needle wing protector slides over the first wing, the medical needle, and the second wing. Raines teaches a removable needle wing protector (15) (Raines Fig. 1), said removable needle wing protector (15) comprising four legs (17, 21, 22) that aid in securing the first wing (13), the second wing (13) and the medical needle (10) before and after use (Raines Col. 1 Line 5 to Col. 2 Line 24), wherein the removable needle wing protector (15) slides over a first wing (13), a second wing (13) and a medical needle (10) for safely securing the wings and needle in the protector in a ready to use state and preventing needle sticks (Raines Col. 1 Lines 5-33).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the device of Lambert in view of Rosato and Smith include a removable needle wing protector, said removable needle wing protector comprising four legs as disclosed by Raines that aid in securing the first wing (13), the second wing (13) and the medical needle (10) before and after use (Raines Col. 1 Line 5 to Col. 2 Line 24), wherein the removable needle wing protector slides over the first wing, the medical needle, and the second wing as disclosed by Raines for safely securing the wings and needle in the protector in a ready to use state and preventing needle sticks (Raines Col. 1 Lines 5-33).
Response to Arguments
Applicant’s arguments filed 03/24/2026 with respect to drawings, claim objections, and 112 indefinite rejections have been fully considered and are persuasive. Due to claim amendments, the drawings, claim objections, and 112 indefinite rejections are hereinafter withdrawn. However, many issues remain present. Applicant is advised that new claim objections and 112 indefinite rejections have been issued.
Applicant's arguments filed 03/24/2026 have been fully considered but they are not persuasive. In the first full paragraph of Page 9 of the response, applicant argues “Smith does not teach wings having complementary semicircular features wherein one nests within the other.” Applicant goes on to state “Smith's articulating wings that fold or pivot for gripping are structurally and functionally different from the claimed nesting semicircular configuration that provides alignment and stability.” Examiner disagrees for the reasons provided in the rejection above. Lambert in view of Smith are relied upon to teach said configuration and it is examiner’s position that one of ordinary skill in the art would have been motivated to modify the nesting configuration of Lambert with the teachings of a nesting configuration of Smith to arrive at applicant’s claimed nesting configuration.
In the second full paragraph of Page 9 of the response, applicant argues the needle guard of secondary reference Raines is “not a structural feature of the wings themselves.” However, applicant does not claim the removable needle wing protector being a feature of the wings. In the third full paragraph of Page 9 of the response, applicant argues neither of Smith nor Raines teaches a semicircular wing alignment. Primary reference Lambert is relied upon to teach a semicircular wing alignment, as can be seen in Lambert Figs. 10-11. Although the wing configuration of Lambert Figs. 10-11 does not make perfect semi-circles, the configuration is most definitely one of semi-circular shape. On Page 10 of the response, applicant’s arguments turn to secondary reference Swenson and its application to independent Claim 11. However, these arguments are directed to the semicircular nesting feature, which primary reference Lambert was relied upon to teach, as described above.
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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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