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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/11/2026 has been entered.
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 1, 3-8, and 10 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 1 recites the limitation “a removable needle wing protector, wherein the removable needle wing protector slides along at least one groove on the outside surface of the first wing and at least one groove on the outside surface of the second wing over the first wing, the medical needle, and the second wing” in Lines 12-14. It is unclear what applicant is trying to recite in this limitation. It may be the case the limitation fails to include appropriate punctuation and grammar. Examiner request applicant to review the limitation and rewrite it. Claims 3-8 and 11 are rejected by virtue of their dependence on Claim 1. Appropriate correction and/or clarification is required.
Claims 11, 13-18, and 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 11 recites the limitation "the sharp tip" in Line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 11 recites the limitation "the needle wing protector" in Line 17. There is insufficient antecedent basis for this limitation in the claim. Claims 13-18 and 20 are rejected by virtue of their dependence on Claim 111. Appropriate correction and/or clarification is required.
Claims 11, 13-18, and 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 11 recites the limitation “sliding the needle wing protector along at least one groove on the outside surface of the first wing and at least one groove on the outside surface of the second wing over the first wing, the medical needle, and the second wing” in Lines 17-19. It is unclear what applicant is trying to recite in this limitation. It may be the case the limitation fails to include appropriate punctuation and grammar. Examiner request applicant to review the limitation and rewrite it. Claims 13-18 and 20 are rejected by virtue of their dependence on Claim 11. Appropriate correction and/or clarification is required.
Claims 22-24 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 22 recites the limitation “a removable needle wing protector having four legs, wherein the removable needle wing protector slides along at least one groove on the outside surface of the first wing and at least one groove on the outside surface of the second wing over the first wing, the medical needle, and the second wing” in Lines 16-19. It is unclear what applicant is trying to recite in this limitation. It may be the case the limitation fails to include appropriate punctuation and grammar. Examiner request applicant to review the limitation and rewrite it. Claims 23-24 are rejected by virtue of their dependence on Claim 22. 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, 7-8, 10-11, 13-15, 17-18 and 20-21 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 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 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 Fig. 10; ¶ 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 wing alignment on an outside surface of the first wing and the stabilizer on an outside surface of the second wing, 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 wing alignment (42D) on an outside surface of the first wing (42A) and the stabilizer (42C) on an outside surface of the second wing (42B), 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), similar to that of Lambert but the additional wing alignment on an outside surface of the first wing and the additional stabilizer on an outside surface of the second wing, 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, a similar embodiment on the outside surface of the wings of Smith for securing the wings together such that they may be gripped when inserting or removing the needle (Smith ¶ 0054-0056). Furthermore, such a modification would comprise a mere reversal of the essential working parts of Lambert similar to that of Smith, involving only routine skill in the art. In re Einstein, 8 USPQ 167.
Lambert in view of Smith fail to teach a removable needle wing protector, wherein the
removable needle wing protector slides along at least one groove on the outside surface of the first wing and at least one groove on the outside surface of the second wing 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 along at least one groove (14-1) (Raines Annotated Fig. 1 below) on the outside surface of the first wing (13) and at least one groove (14-2) on the outside surface of the second wing (13) over the first wing (13), the medical needle (10), and the second wing (13), the configuration for safely securing the wings and needle in the removable needle wing protector together in a secured state thus 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 along at least one groove on the outside surface of the first wing and at least one groove on the outside surface of the second wing over the first wing, the medical needle, and the second wing, the configuration as disclosed by Raines for safely securing the wings and needle in the removable needle wing protector together in a secured state thus 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 (22-1, 22-2, 23-1, 23-2) 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; Annotated Figs. 3 and 4 below). 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).
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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 Claim 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 removable needle wing protector stays in place in the at least one groove on 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 the removable needle wing protector (15) stays in place in the at least one groove (14-1) on the outside surface of the first wing (13) and the at least one groove of the outside surface of the second wing (13) due to a press fit (Raines Annotated Fig. 1 above; Figs. 1-7), the configuration for securing a central needle portion in the needle wing protector 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 removable needle wing protector of Lambert in view of Smith above, and further in view of Raines wherein the removable needle wing protector stays in place in the at least one groove on 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, 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). Furthermore, 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 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 the 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 wing alignment on an outside surface of the first wing and the stabilizer on an outside surface of the second wing, 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 above), the first wing (42A) comprising a wing alignment (42D) and the second wing (42B) comprising a stabilizer (42C), the wing alignment (42D) on an outside surface of the first wing (42A) and the stabilizer (42C) on an outside surface of the second wing (42B), 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), similar to that of Lambert but the additional wing alignment on an outside surface of the first wing and the additional stabilizer on an outside surface of the second wing, 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, a similar embodiment on the outside surface of the wings of Smith for securing the wings together such that they may be gripped when inserting or removing the needle (Smith ¶ 0054-0056). Furthermore, such a modification would comprise a mere reversal of the essential working parts of Lambert similar to that of Smith, involving only routine skill in the art. In re Einstein, 8 USPQ 167.
Lambert in view of Smith fail to teach sliding the needle wing protector along at least one groove on the outside surface of the first wing and at least one groove on the outside surface of the second wing 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 along at least one groove (14-1) (Raines Annotated Fig. 1 above) on the outside surface of the first wing (13) and at least one groove (14-2) on the outside surface of the second wing (13) over the first wing (13), the medical needle (10), and the second wing (13), the configuration for safely securing the wings and needle in the removable needle wing protector together in a secured state thus 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 method of Lambert in view of Smith include a removable needle wing protector sliding along at least one groove on the outside surface of the first wing and at least one groove on the outside surface of the second wing over the first wing, the medical needle, and the second wing, the configuration as disclosed by Raines for safely securing the wings and needle in the removable needle wing protector together in a secured state thus preventing needle sticks (Raines Col. 1 Lines 5-33).
Re Claim 13, Lambert in view of Smith above, and further in view of Raines 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 Raines, 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 Raines 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 Raines, 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 Raines 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 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 17, Lambert in view of Smith above, and further in view of Raines teach all of the limitations of Claim 11. Lambert in view of Smith fail to teach wherein the removable needle wing protector has four legs. Raines teaches the removable needle wing protector (15) comprising four legs (22-1, 22-2, 23-1, 23-2) 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; Annotated Figs. 3 and 4 above). 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 18, Lambert in view of Smith above, and further in view of Raines teach all of the limitations of Claim 11. Lambert in view of Smith 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 (22-1, 22-2, 23-1, 23-2) 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; Annotated Figs. 3 and 4 above). 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 Claim 20, Lambert in view of Smith above, and further in view of Raines teach all of the limitations of Claim 11. Lambert fails to teach wherein the removable needle wing protector stays in place in the at least one groove on the outside surface of the first wing and the at least one groove on the outside surface of the second wing due to a press fit. Raines teaches wherein the removable needle wing protector (15) stays in place in the at least one groove (14-1) on the outside surface of the first wing (13) and the at least one groove of the outside surface of the second wing (13) due to a press fit (Raines Annotated Fig. 1 above; Figs. 1-7), the configuration for securing a central needle portion in the needle wing protector 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 removable needle wing protector of Lambert in view of Smith above, and further in view of Raines wherein the removable needle wing protector stays in place in the at least one groove on 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, 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). Furthermore, 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).
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 Raines (USPN 4,631,058) as applied to Claim 11 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 111. 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 22-24 are 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).
Lambert fails to teach wherein the central body portion comprises a gripping lip on an outer surface of the central body portion for facilitating removal of the device from a patient. 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). The limitation “for facilitating removal of the device from a patient” is being considered a functional limitation, and is an inherent characteristic of prior art Rosato (MPEP 2114-I).
Lambert fails to teach the wing alignment on an outside surface of the first wing and the stabilizer on an outside surface of the second wing, 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 wing alignment (42D) on an outside surface of the first wing (42A) and the stabilizer (42C) on an outside surface of the second wing (42B), 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), similar to that of Lambert but the additional wing alignment on an outside surface of the first wing and the additional stabilizer on an outside surface of the second wing, 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, a similar embodiment on the outside surface of the wings of Smith for securing the wings together such that they may be gripped when inserting or removing the needle (Smith ¶ 0054-0056). Furthermore, such a modification would comprise a mere reversal of the essential working parts of Lambert similar to that of Smith, involving only routine skill in the art. In re Einstein, 8 USPQ 167.
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 along at least one groove on the outside surface of the first wing and at least one groove on the outside surface of the second wing 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 (22-1, 22-2, 23-1, 23-2), wherein the removable needle wing protector (15) slides along at least one groove (14-1) on the outside surface of the first wing (13) and at least one groove (14-2) on the outside surface of the second wing (13) (as seen in Raines Annotated Fig. 1 and Figs. 3 and 4 above) over the first wing (13), the medical needle (10), and the second wing (13), the configuration for safely securing the wings and needle in the removable needle wing protector together in a secured state thus 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 having four legs, wherein the removable needle wing protector slides along at least one groove on the outside surface of the first wing and at least one groove on the outside surface of the second wing over the first wing, the medical needle, and the second wing, the configuration 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).
Re Claim 23, Lambert in view of Rosato and Smith above, and further in view of Raines teach all of the limitations of Claim 22. Lambert in view of Rosato and Smith 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 a respective side thereof. Raines teaches wherein the first wing (13), the medical needle (10), and the second wing (13) have a leg (22-1, 22-2, 23-1, 23-2) of the removable needle wing protector (15) on a respective side thereof 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; Annotated Figs. 3 and 4 above). 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 Rosato and 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 a respective side thereof 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 Claim 24, Lambert in view of Rosato and Smith above, and further in view of Raines teach all of the limitations of Claim 22. 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 Rosato and 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.
Response to Arguments
Applicant’s arguments filed 09/11/2026 with respect to claim objections and 112 indefinite rejections have been fully considered and are persuasive. Due to clarifying amendments, all previously provided claim objections and 112 indefinite rejections are hereinafter withdrawn.
Applicant's arguments filed 09/11/2026 have been fully considered but they are not persuasive. Applicant’s arguments directed to 103 obviousness rejections begin at the top of Page 7 of the response. At the bottom of Page 7 and leading into Page 8 of the response, applicant argues:
Lambert's semicircular features - lip 1042 and recessed portion 1038 - are interior- facing mating surfaces that engage each other when the wings close on the same side of the central body portion as the medical needle. Lambert [0055]. As acknowledged in the Office Action, 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. Lambert's features are therefore not on the outside surfaces of the wings in any opposite-side configuration.
This is indeed the case, Lambert’s features are on inner sides of the wings. However, Smith teaches both a stabilizer and a wing alignment on outside portions of the wings. It would have been obvious to one of ordinary skill in the art to have similar features to that of Lambert on outer sides of the wings based on the teachings of secondary reference Smith and under In re Einstein. At the bottom of Page 8 of the response, applicant’s arguments turn to Raines. However, these arguments are not applicable to the current interpretation of secondary reference Raines.
On Page 9 of the response, applicant’s arguments turn to independent Claim 22. In particular, applicant’s arguments are directed to secondary reference Rosato, arguing “Rosato's gripping lip (34) is a pivotable handle fin that operates by being squeezed between the clinician's finger and thumb to pull the needle out-it is not a fixed lip on the outer surface of the central body portion.” Applicant goes on to argue “Rosato describes that a medical practitioner grabs and applies a squeezing action against the flared ends 44 and 52, which causes the main sections 40 and 48 to pivot on the aft end 26.” Nothing in Rosato’s handle fin would prevent it from being used to pull the needle from a patient. Furthermore, the limitation “to aid in lifting the device off a patient's skin” is a functional limitation and an inherent characteristic of Rosato’s handle fin 34. In the last paragraph of Page 9, applicant argues “the Office Action provides no specific motivation to combine all four references-Lambert, Rosato, Smith, and Raines-into a single device.” Examiner disagrees where each modification of Lambert is provided with motivation for doing so. Furthermore, modifications of Lambert based on the teachings of Rosato, Smith and Raines are well within the ordinary skill of the art.
Conclusion
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/WILLIAM R FREHE/Examiner, Art Unit 3783 /WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
09/20/2026
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