DETAILED ACTION
Response to Arguments
Applicant’s arguments, see Appeal Brief, filed March 31, 2026, with respect to the rejection(s) of claim(s) 1-15 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below. The same series of references is being relied upon; however, Brunel has been removed and replaced with Lowe to teach the ribs on the cap member which are engaged with central portion of a bulge on a needle hub. Lowe clearly teaches such annular engagement features to be used in addition to a proximal retaining flange thereby providing clear motivation to modify Prais to include such ribs to increase the frictional engagement of the cap on the central portion of a needle hub expanded portion. The current rejection is considered to teach the claimed device as currently set forth and has overcome any arguments as to reversal of parts or the propriety of the previously cited combination of references.
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) 1-3, 5-7, and 9-15 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Prais et al. (US 2001/0039402) in view of Lowe et al. (US 4,735,311), and further in view of Kawachi (US 2013/0012886).
Regarding claims 1-3 and 14, Prais et al. (henceforth Prais) discloses (Figures 1-3) a needle cover (22) for protecting a needle (30) mounted on a tip (Figure 2) of a medical injection device, wherein the tip comprises a distal bulge (26; it is noted that the medical injection device and its tip are not positively recited and for this reason the needle cover need only be capable of performing the claimed functions), the needle cover comprising an inner needle shield made of a material with elastomeric properties (¶ [0029]), the inner needle shield comprising a first portion, a second portion, and a third portion (terminal portion of cap adjacent needle tip after installation), the third portion being distal to the second portion being distal to the first portion and having an inner sealing portion (inner surface; 50, 52, and 54) within the second portion configured to sealingly contact an outer surface of the bulge (¶ [0029]), wherein the inner sealing portion comprises one or more ribs (e.g., 52 as a rounded internal surface for engaging the needle tip, Figure 2, the rib contacts the proximal surface of bulge 26) extending inwardly along a circumference of the inner sealing portion (Figure 3), at least one rib of the one or more ribs, being a continuous rib in the form of a ring configured to provide a continuous contact with the outer surface of the distal bulge (Figures 2-3; ¶ [0029]), and the first portion having a greater outer diameter than an outer diameter of the second portion, the first portion configured to include a space between the first portion and the tip (see annotated figure below, there is a gap between the hub shaft and the inner surface of the first portion) . Prais fails to explicitly disclose the inner sealing portion of the second portion as comprising one or more ribs configured to seal with a central portion of the outer most surface of the bulge as claimed as well as the third portion configured to accommodate the needle and so that the needle is pricked into a distal part of the third portion.
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Lowe et al. (henceforth Lowe) teaches (Figures 5 and 7) a cover for protecting a needle which comprises a plurality of ribs (66; Figure 7 depicts two rounded annular ribs as per claims 2, 3, and 14) formed on an inner surface thereof and engaged with the central portion of a bulge on the needle end (Figure 7; it can be seen in Figure 7 that the ribs 66 on the inner cap portion of Lowe are engaged with a central section of an expanded hub on the distal end of the throat portion 54; needle hub has an enlarged head portion 50 which is engaged by ribs 66 after connecting the cap to the hub; Col. 3, lines 54-66; this includes a central, largest diameter portion).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cap of Prais to comprise two sealing ribs along the central section engaged with the central surface of a bulge, as taught by Lowe so as to provide a number of annular sealing rib surfaces for engaging a bulge portion of the syringe tip for retaining the cap thereon as taught by Lowe (Col. 3, lines 54-66). Lowe teaches that two ribs are sufficient for retaining a cover on a needle assembly and it would therefore be obvious to utilize only two ribs as claimed to securely retain the cap on the tip portion as taught by Lowe. In such a combination, the cap of Prais would be modified to provide the sealing ribs of Lowe along a central section of the cap to engage with the bulge in the same manner disclosed by Lowe. This would provide additional frictional engagement between the cap and hub while retaining the primary function of the device of Prais which is to inhibit the removal of the cap until a sufficient force is generated to do so. It is further noted that Lowe teaches the circumferential ribs 66 as used along with proximal rib 58 with bevel 62 which abuts a proximal surface of the hub 50 during use, and which is analogous to element 52 of Prais.
Regarding the third, tapered portion for receiving the needle, Lowe further teaches the use of a portion of the cover which comprises a space for receiving the needle (element 24 of Lowe; Figure 2). However, Prais/Lowe fail to explicitly teach the portion of the cap for receiving the needle tip which tapers from the second portion to a distal end of the needle cover. However, Kawachi teaches (Figures 4-5) a needle cap (10) for a syringe (20) comprising a distal portion (12A, analogous to the third portion of Prais) for receiving the needle tip (22) in a piercing, or pricked, configuration after covering the needle tip with the cap (¶ [0011]).
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the elastomeric needle tip receiving section of Kawachi at the third, tapered portion of Prais so as to allow a user to safely cover the needle while providing a means of determining possible curvature or breakage of the syringe needle between uses via the transparent cap and elastomer means as taught by Kawachi (¶ [0011]).
Regarding claim 5, Prais/Lowe further discloses wherein each rib (52 and 66 of Lowe) extends inwardly in an orthogonal direction relative to a longitudinal axis of the needle shield (Figure 3 of Prais and Figure 7 of Lowe; the ribs are annular extensions which reduce the inner diameter of the cap for sealing against the hub).
Regarding claim 6, Prais/Lowe further discloses wherein each rib (52 of Prais and 66 of Lowe) is in the form of a continuous ring configured to provide a continuous contact with the outer surface of the bulge (Figure 3 of Prais; Figure 7 of Lowe, the ribs are continuous annular rings extending around the inner surface of the cap).
Regarding claim 7, Prais further discloses wherein the material is a thermoplastic elastomer (¶ [0030]).
Regarding claim 9, Prais/Lowe further disclose wherein the continuous rib is rotationally symmetrical with respect to an axis of the needle cover (Figure 7 of Lowe, the ribs are concentric about an inner surface of the needle cover as depicted).
Regarding claim 10, Prais further discloses an outer needle shield (outer surface of 22) surrounding, at least partially, the inner needle shield (the inner needle shield may be considered as the inner surface of 22 and therefore the outer surface may be considered the outer shield as claimed).
Regarding claim 11, Prais discloses a medical assembly (Figures 1-3) comprising: a medical injection device (Figure 1) comprising: a main body defining a container (syringe barrel) for containing a medical composition (44), a tip (26) extending distally from the main body, defining a fluid path extending through the tip and in fluid communication with the container (Figure 2), wherein said tip comprises a distal bulge (radially extending portion of 26 as depicted in Figure 2), a needle (30) attached to the tip and in fluid communication with the fluid path; a needle cover (22) for protecting a needle (30) mounted on a tip (Figure 2) of a medical injection device, wherein the tip comprises a distal bulge (26; it is noted that the medical injection device and its tip are not positively recited and for this reason the needle cover need only be capable of performing the claimed functions), the needle cover comprising an inner needle shield made of a material with elastomeric properties (¶ [0029]), the inner needle shield comprising a first portion, a second portion, and a third portion (terminal portion of cap adjacent needle tip after installation), the third portion being distal to the second portion being distal to the first portion and having an inner sealing portion (inner surface; 50, 52, and 54) within the second portion configured to sealingly contact an outer surface of the bulge (¶ [0029]), wherein the inner sealing portion comprises one or more ribs (e.g., 52 as a rounded internal surface for engaging the needle tip, Figure 2, the rib contacts the proximal surface of bulge 26) extending inwardly along a circumference of the inner sealing portion (Figure 3), at least one rib being a continuous rib in the form of a ring configured to provide a continuous contact with the outer surface of the distal bulge (Figures 2-3; ¶ [0029]), and the first portion having a greater outer diameter than an outer diameter of the second portion, the first portion configured to include a space between the first portion and the tip (see annotated figure below, there is a gap between the hub shaft and the inner surface of the first portion) . Prais fails to explicitly disclose the inner sealing portion of the second portion as comprising one or more ribs configured to seal with a central portion of the outer most surface of the bulge as claimed as well as the third portion configured to accommodate the needle and so that the needle is pricked into a distal part of the third portion.
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Lowe et al. (henceforth Lowe) teaches (Figures 5 and 7) a cover for protecting a needle which comprises a plurality of ribs (66) formed on an inner surface thereof (Figure 7; it can be seen in Figure 7 that the ribs 66 on the inner cap portion of Lowe are engaged with a central section of an expanded hub on the distal end of the throat portion 54; needle hub has an enlarged head portion 50 which is engaged by ribs 66 after connecting the cap to the hub; Col. 3, lines 54-66).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cap of Prais to comprise two sealing ribs along the central section engaged with the central surface of a bulge, as taught by Lowe so as to provide a number of annular sealing rib surfaces for engaging a bulge portion of the syringe tip for retaining the cap thereon as taught by Lowe (Col. 3, lines 54-66). Lowe teaches that two ribs are sufficient for retaining a cover on a needle assembly and it would therefore be obvious to utilize only two ribs as claimed to securely retain the cap on the tip portion as taught by Lowe. In such a combination, the cap of Prais would be modified to provide the sealing ribs of Lowe along a central section of the cap to engage with the bulge in the same manner disclosed by Lowe. This would provide additional frictional engagement between the cap and hub while retaining the primary function of the device of Prais which is to inhibit the removal of the cap until a sufficient force is generated to do so.
Regarding the third, tapered portion for receiving the needle, Lowe further teaches the use of a portion of the cover which comprises a space for receiving the needle (element 24 of Lowe; Figure 2). However, Prais/Lowe fail to explicitly teach the portion of the cap for receiving the needle tip which tapers from the second portion to a distal end of the needle cover. However, Kawachi teaches (Figures 4-5) a needle cap (10) for a syringe (20) comprising a distal portion (12A, analogous to the third portion of Prais) for receiving the needle tip (22) in a piercing, or pricked, configuration after covering the needle tip with the cap (¶ [0011]).
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the elastomeric needle tip receiving section of Kawachi at the third, tapered portion of Prais so as to allow a user to safely cover the needle while providing a means of determining possible curvature or breakage of the syringe needle between uses via the transparent cap and elastomer means as taught by Kawachi (¶ [0011]).
Regarding claim 12, Prais further discloses wherein the tip of the medical injection device is made of glass (see e.g., ¶ [0027] discloses that the barrel, the distal portion of which forms part of the tip section of the device, is formed from glass).
Regarding claim 13, Prais/Lowe further discloses wherein the sealing portion comprises one or two ribs (52; Figure 2; see also Figure 7 of Lowe which depicts two ribs engaged with hub 50).
Regarding claim 15, Prais discloses a medical assembly comprising: a medical injection device (syringe) comprising: a main body defining a container (inside of 24) for containing a medical composition (44), a tip (hub comprising 26) extending distally from the main body (Figure 2), defining a fluid path extending through the tip and in fluid communication with the container, wherein said tip comprises a distal bulge (26) distal to a cylindrical portion of the tip, the distal bulge having an outer surface, a needle (30) attached to the tip and in fluid communication with the fluid path; a needle cover (22) comprising an inner needle shield (inner surface of 22) made of a material with elastomeric properties (¶ [0029]), the inner needle shield comprising a first portion, a second portion, and a third portion, the third portion being distal to the second portion (see annotated figure below) and having an internal surface that tapers from the second portion to a distal end of the needle cover (the third portion can be seen to be conical and therefore tapers toward the distal end as claimed) the second portion being distal to the first portion (see annotated figure below) and having an inner sealing portion configured to sealingly contact the outer most surface of the distal bulge (it contacts the most proximal surface of 26 as depicted in Figure 2), wherein the inner sealing portion comprises one or more ribs (52) extending inwardly along a circumference of the inner sealing portion, at least one rib of the one or more ribs, being a continuous rib in the form of a ring (Figure 2, element 52 is a flange configured to engage the proximal surface of the bulge to retain the cap on the tip) configured to provide a continuous contact with a portion of the outer most surface of the distal bulge, mounted on the tip of the medical injection device. Prais does not explicitly disclose wherein one or more ribs of the inner sealing portion of the inner needle shield sealingly contact the central portion of the outer most surface of the distal bulge or the piercing of the needle into a distal part of the third portion.
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Lowe et al. (henceforth Lowe) teaches (Figures 5 and 7) a cover for protecting a needle which comprises a plurality of ribs (66) formed on an inner surface thereof (Figure 7; it can be seen in Figure 7 that the ribs 66 on the inner cap portion of Lowe are engaged with a central section of an expanded hub on the distal end of the throat portion 54; needle hub has an enlarged head portion 50 which is engaged by ribs 66 after connecting the cap to the hub; Col. 3, lines 54-66; this includes a central, largest diameter portion).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the cap of Prais to comprise two sealing ribs along the central section engaged with the central surface of a bulge, as taught by Lowe so as to provide a number of annular sealing rib surfaces for engaging a bulge portion of the syringe tip for retaining the cap thereon as taught by Lowe (Col. 3, lines 54-66). Lowe teaches that two ribs are sufficient for retaining a cover on a needle assembly and it would therefore be obvious to utilize only two ribs as claimed to securely retain the cap on the tip portion as taught by Lowe. In such a combination, the cap of Prais would be modified to provide the sealing ribs of Lowe along a central section of the cap to engage with the bulge in the same manner disclosed by Lowe. This would provide additional frictional engagement between the cap and hub while retaining the primary function of the device of Prais which is to inhibit the removal of the cap until a sufficient force is generated to do so. It is further noted that Lowe teaches the circumferential ribs 66 as used along with proximal rib 58 with bevel 62 which abuts a proximal surface of the hub 50 during use and which is analogous to element 52 of Prais.
Regarding the third, tapered portion for receiving the needle, Lowe further teaches the use of a portion of the cover which comprises a space for receiving the needle (element 24 of Lowe; Figure 2). However, Prais/Lowe fail to explicitly teach the portion of the cap for receiving the needle tip which tapers from the second portion to a distal end of the needle cover. However, Kawachi teaches (Figures 4-5) a needle cap (10) for a syringe (20) comprising a distal portion (12A, analogous to the third portion of Prais) for receiving the needle tip (22) in a piercing, or pricked, configuration after covering the needle tip with the cap (¶ [0011]).
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the elastomeric needle tip receiving section of Kawachi at the third, tapered portion of Prais so as to allow a user to safely cover the needle while providing a means of determining possible curvature or breakage of the syringe needle between uses via the transparent cap and elastomer means as taught by Kawachi (¶ [0011]).
Claim(s) 4 and 8 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Prais in view of Lowe, and further in view of Brunel et al. (US 2020/0121864).
Regarding claims 4 and 8, Prais/Lowe teach the claimed invention substantially as set forth above for claim 1, and Lowe further teaches that the inner sealing portion comprises two or three ribs (see Figure 7, there are two ribs 66 depicted). However, Prais/Lowe are silent regarding the height of the ribs as being within the claimed range of 0.1 mm and 0.4 mm or the spacing of the rib being within the claimed range of between 0.4 mm and 2.8 mm and preferably between 0.4 mm and 1.2 mm.
Brunel et al. (henceforth Brunel) teaches (Figure 3) a tip portion of a syringe comprising annular ribs (48) which are disclosed as having a height of between 0.1 mm and 0.4 mm (¶ [0042]) and a spacing between 0.4 mm and 1.2 mm (¶ [0041]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sealing rib of Prais/Lowe to be of the claimed height as Brunel teaches that such dimensions and spacings are known for use in sealing ribs on medical devices and would be advantageous depending on the fit required by the different elements during design of such a device.
Conclusion
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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