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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. DE 102019119011.8, filed on 7/12/2019.
Response to Amendment
The Amendments filed 10/03/2025 have been entered.
Claims 1 and 11 have thereby been amended.
Claims 17 and 18 have been added.
Claims 1-18 are being examined in this office action.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 11, 13, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Nagao (US 20090163944) in view of Bitdinger (US 5250037).
Regarding claim 1, Nagao discloses a protective cap for attachment to a needle stick protection device for a syringe, comprising: a sleeve-shaped cap body (202c; see annotated figure 15B below) adapted to enclose a needle guard (204c portion distal to 302c; see annotated figure 15B below) of the syringe, and two separate cap arms (see annotated figure 10A below), which are connected to the cap body and extend at a distance from each other as elongated sections from the cap body and are formed on opposite sides of the syringe (see annotated figure 10A below) to be secured in coordination with a respective elongated guide groove of the needle stick protection device (Fig. 15C: guide grooves 405c that the cap arms are secured into; para. [0092], last sentence), which elongated guide grooves form respective recesses of the needle stick protection device (Fig. 15C: recessed guide grooves 405c of needle stick protection device 101C, wherein the cap body comprises coupling elements (claws 303c), of which is coupled to a respective cap arm of the two cap arms (Fig. 15B: coupling claw 30c on arm) and which are adapted to couple the cap body to an outside of an outer housing of the needle stick protection device (Figs. 15A-C: 303c couples into 405c, 402c and 401c of housing 101c) and to secure the protective cap to the needle stick protection device, wherein the coupling elements are formed as engagement elements and are configured to engage in the recesses of the needle stick protection device (Figs. 15A-C: 303c engages with recess 405c and 401c and 402c), wherein the recesses of the needle stick protection device are delimited in a predetermined manner by the outer housing (Fig. 15C: recess 405c is delimited by 401c and 402c of 101c), wherein a respective outer contour of the engagement elements is formed in coordination with a respective contour delimiting the recesses of the needle stick protection device (Fig. 6B: contours of 303a coordinate with contours of grooves 405a and flange 401a; Fig. 6B shows embodiment different than that of Figs. 15A-C, but exemplifies the same coordinating coupling of contours; para. [0092], last sentence), and wherein each engagement element of the engagement elements comprises a predetermined shape with at least one of a triangular contour, a rectangular contour and an elongated contour (see annotated Fig. 15B below and Fig. 10B: 303C having a rectangular, triangular, and elongated contours around the perimeter of the shape). However, although Nagao teaches the claimed limitations of the engagement element on the cap arm and respective groove, Nagao fails to teach two of each of these elements on opposite sides of the cap and device.
Bitdinger teaches an analogous cap for connection to a syringe/needle device with analogous pair of elongated guide grooves (Fig. 2: 47 and 49) and engagement elements (Figs. 8 and 9: 78), there being two of each on opposite sides of the cap/device (Figs. 10 and 11). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Nagao device and cap by incorporating this teaching of Bitdinger of the opposing pair of engagement elements, such that the engagement element and respective groove, etc. disclosed by Nagao be incorporated onto both cap arms as disclosed by Nagao, in order to increase the security of the cap on the device and to make the securement more balanced/even, as achieved by Bitdinger.
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Annotated Fig. 15B, Nagao
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Annotated Fig. 10A, Nagao
Regarding claim 5, Nagao in view of Bitdinger teaches the protective cap according to claim 1, as described above, wherein the coupling elements are formed as clasping elements and is are configured to clasp a portion of the needle stick protection device (Fig. 15B: clasping claw 303c that clasps around 401c of needle stick protection device 101c).
Regarding claim 11, Nagao in view of Bitdinger teaches the protective cap of claim 1, as described above, further comprising a penetrating recess formed on at least one of the cap body and the cap arm (Fig. 15A: penetrating recess 401c).
Regarding claim 13, Nagao in view of Bitdinger teaches the protective cap according to claim 1, as described above, wherein an outer contour of the protective cap is formed in coordination with an outer contour of the outer housing of the needle stick protection device, so that a flush transition between the protective cap and the outer housing of the needle stick protection device can be established with respect to a state arranged on the needle stick protection device (Fig. 15A: portion of cap 202c labeled with 204c forms flush transition to 101c housing).
Regarding claim 15, Nagao in view of Bitdinger teaches a syringe safety system comprising: a needle stick protection device for a syringe, and a protective cap according to claim 1, as described above, which is attached to the needle stick protection device (101c) by means of the coupling elements (Figs. 15A-C: 303c couples into 405c, 402c and 401c of housing 101c).
Regarding claim 17, Nagao discloses a protective cap for attachment to a needle stick protection device for a syringe, comprising: a sleeve-shaped cap body (202c; see annotated figure 15B below) adapted to enclose a needle guard (204c portion distal to 302c; see annotated figure 15B below) of the syringe, and two separate cap arms (see annotated figure 10A below), which are connected to the cap body and extend at a distance from each other as elongated sections from the cap body and are formed on opposite sides of the syringe (see annotated figure 10A below) to be secured in coordination with a respective elongated guide groove of the needle stick protection device (Fig. 15C: guide grooves 405c that the cap arms are secured into; para. [0092], last sentence), which elongated guide grooves form respective recesses of the needle stick protection device (Fig. 15C: recessed guide grooves 405c of needle stick protection device 101C, wherein the cap body comprises coupling elements (claws 303c), of which is coupled to a respective cap arm of the two cap arms (Fig. 15B: coupling claw 30c on arm) and which are adapted to couple the cap body to an outside of an outer housing of the needle stick protection device (Figs. 15A-C: 303c couples into 405c, 402c and 401c of housing 101c) and to secure the protective cap to the needle stick protection device, wherein the coupling elements are formed as engagement elements and are configured to engage in the recesses of the needle stick protection device (Figs. 15A-C: 303c engages with recess 405c and 401c and 402c), wherein the recesses of the needle stick protection device are delimited in a predetermined manner by the outer housing (Fig. 15C: recess 405c is delimited by 401c and 402c of 101c), wherein a respective outer contour of the engagement elements is formed in coordination with a respective contour delimiting the recesses of the needle stick protection device (Fig. 6B: contours of 303a coordinate with contours of grooves 405a and flange 401a; Fig. 6B shows embodiment different than that of Figs. 15A-C, but exemplifies the same coordinating coupling of contours; para. [0092], last sentence), and wherein each engagement element of the engagement elements forms at least one of a clamp element, a clip element and a clamp sleeve (engagement element 303C clips into place to secure cap; para. [0085]). However, although Nagao teaches the claimed limitations of the engagement element on the cap arm and respective groove, Nagao fails to teach two of each of these elements on opposite sides of the cap and device.
Bitdinger teaches an analogous cap for connection to a syringe/needle device with analogous pair of elongated guide grooves (Fig. 2: 47 and 49) and engagement elements (Figs. 8 and 9: 78), there being two of each on opposite sides of the cap/device (Figs. 10 and 11). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Nagao device and cap by incorporating this teaching of Bitdinger of the opposing pair of engagement elements, such that the engagement element and respective groove, etc. disclosed by Nagao be incorporated onto both cap arms as disclosed by Nagao, in order to increase the security of the cap on the device and to make the securement more balanced/even, as achieved by Bitdinger.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nagao (US 20090163944) in view of Bitdinger (US 5250037) in further view of Novacek (US 6344031).
Regarding claim 6, Nagao in view of Bitdinger teaches the protective cap according to claim 1, as described above, but fails to disclose an adhesive surface for coupling the cap to the needle stick protection device.
Novacek teaches an analogous needle stick protection device cap wherein the coupling elements are formed as an adhesive surface and is configured to form an adhesive coupling with the outer housing of the needle stick protection device (col. 30, lines 36-46). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Nagao cap assembly by incorporating the adhesive between the cap and needle stick protection device junction, as taught by Novacek, in order to increase the retention of the cap compared to no use of adhesive (Novacek: col. 30, line 60 – col. 31, line 4), as well as to provide the additional, inherent benefits of being low-cost and conducive to single-use products as most adhesives quickly lose their tacky quality.
Claims 7-9, 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Nagao (US 20090163944) in view of Bitdinger (US 5250037) in further view of Igarashi (US 20160001012).
Regarding claim 7, Nagao in view of Bitdinger teaches the protective cap according to claim 1, as described above, but fails to disclose labels for coupling the cap to the needle stick protection device.
Igarashi teaches analogous needle stick protection device cap wherein the coupling elements are formed as labels (1, Z1 + Z2) and are configured to connect the cap body to the needle stick protection device (Figs. 1A-B: label 1 comprising Z1 + Z2 couples cap 103 to 102; para. [0029]). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Nagao cap assembly by incorporating the coupling heat-shrink label taught by Igarashi in order to provide an additional means of securely coupling the cap to the needle stick protection device, that provides indication of unsealing the cap to prevent reuse of the device (Igarashi: para. [0007], last sentence).
Regarding claim 8, Nagao in view of Bitdinger in view of Igarashi teaches the protective cap according to claim 7, as described above, wherein the label comprises a perforation (Igarashi: Fig. 2: 2, 2L1 + 2L2) along which the label is predeterminedly severable and a label portion is removable together with the cap body from the needle stick protection device (Igarashi: para. [0040], sentences 1-2).
Regarding claim 9, Nagao in view of Bitdinger teaches the protective cap according to claim 1, as described above, but fails to disclose a predetermined breaking point between the cap arm and cap body.
Igarashi teaches analogous needle stick protection device cap (1 + 103) comprising: a predetermined breaking point (rupture line 2, 2L1 + 2L2) formed between the cap body (Fig. 7A: cap body at Z2) and the at least one cap arm (Fig. 7A: cap arm Z1) such that the protective cap is predeterminedly severable and the cap body is removable from the cap arm (Fig. 7A: arm Z1 remains behind, broken off from Z2 + 103 when the cap is removed; para. [0043], sentences 2-4). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Nagao cap by incorporating the rupture line separating cap Z2 + 103 from arm Z1, such that a perforated rupture line is added between the cap body and cap arms of Nagao (see annotated figure 10A below), in order to that provides indication of unsealing the cap (Igarashi: para. [0007], last sentence) and prevent the Nagao cap from being able to be reattached to the device to prevent reuse of the needle.
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Annotated Fig. 10A, Nagao
Regarding claim 12, Nagao in view of Bitdinger teaches the protective cap according to claim 1, as described above, but fails to disclose a predetermined weakening structure.
Igarashi teaches analogous needle stick protection device cap (1 + 103) comprising: a predetermined weakening structure (rupture line 2, 2L1 + 2L2) arranged such that, with respect to a condition arranged on the needle stick protection device, an irreversible geometrical change of the protective cap is formed during a removal operation (Fig. 7A: arm Z1 remains behind, broken off from Z2 + 103 when the cap is removed; para. [0043], sentences 2-4). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Nagao cap by incorporating the rupture line separating cap Z2 + 103 from arm Z1, such that a perforated rupture line is added between the cap body and cap arms of Nagao (see annotated figure 10A above), in order to that provides indication of unsealing the cap (Igarashi: para. [0007], last sentence) and prevent the Nagao cap from being able to be reattached to the device to prevent reuse of the needle.
Regarding claim 18, Nagao discloses a protective cap for attachment to a needle stick protection device for a syringe, comprising: a sleeve-shaped cap body (202c; see annotated figure 15B below) adapted to enclose a needle guard (204c portion distal to 302c; see annotated figure 15B below) of the syringe, and two separate cap arms (see annotated figure 10A below), which are connected to the cap body and extend at a distance from each other from the cap body and are formed on opposite sides of the syringe (see annotated figure 10A below), wherein the cap body comprises coupling elements (claws 303c), of which is coupled to a respective cap arm of the two cap arms (Fig. 15B: coupling claw 30c on arm) and which are adapted to couple the cap body to an outside of an outer housing of the needle stick protection device (Figs. 15A-C: 303c couples into 405c, 402c and 401c of housing 101c) and to secure the protective cap to the needle stick protection device, wherein the coupling elements are formed as engagement elements (Figs. 15A-C: 303c engages with recess 405c and 401c and 402c), wherein a respective outer contour of the engagement elements is formed in coordination with a respective contour of the needle stick protection device (Fig. 6B: contours of 303a coordinate with contours of grooves 405a and flange 401a; Fig. 6B shows embodiment different than that of Figs. 15A-C, but exemplifies the same coordinating coupling of contours; para. [0092], last sentence). However, although Nagao teaches the claimed limitations of the engagement element on the cap arm and respective groove, Nagao fails to teach two of each of these elements on opposite sides of the cap and device, and that the coupling elements are formed as labels.
Bitdinger teaches an analogous cap for connection to a syringe/needle device with analogous pair of elongated guide grooves (Fig. 2: 47 and 49) and engagement elements (Figs. 8 and 9: 78), there being two of each on opposite sides of the cap/device (Figs. 10 and 11). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Nagao device and cap by incorporating this teaching of Bitdinger of the opposing pair of engagement elements, such that the engagement element and respective groove, etc. disclosed by Nagao be incorporated onto both cap arms as disclosed by Nagao, in order to increase the security of the cap on the device and to make the securement more balanced/even, as achieved by Bitdinger. However, Nagao in view of Bitdinger fails to teach that the coupling elements are formed as labels.
Igarashi teaches analogous needle stick protection device cap (1 + 103) in which the coupling elements is formed as a respective portion of a common label connecting the protective cap to the needle stick protection device (Fig. 7A: arm Z1 remains behind, broken off from Z2 + 103 when the cap is removed; para. [0043], sentences 2-4). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Nagao cap assembly by incorporating the coupling label taught by Igarashi in order to provide an additional means of securely coupling the cap to the needle stick protection device, that provides indication of unsealing the cap to prevent reuse of the device (Igarashi: para. [0007], last sentence).
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Nagao (US 20090163944) in view of Bitdinger (US 5250037) in further view of McLoughlin (US 20100016795).
Regarding claim 10, Nagao in view of Bitdinger teaches the protective cap according to claim 1, as described above, but fails to disclose an interlocking structure for interlocking the needle guard to the cap, instead disclosing the needle guard and cap integrally formed.
McLoughlin teaches an analogous needle stick protection device cap comprising: an interlocking structure formed on an inner surface of the cap body (Fig. 13B: interlocking structure 604 on inner surface of cap body 102) and configured to interlock with an outer surface of the needle guard of a syringe when the protective cap is attached to the syringe (Fig. 15: 604 interlocks with needle guard 602 + 601; para. [0058], last 6 sentences). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Nagao cap/needle guard assembly by incorporating the interlocking structure taught by McLoughlin, in order to preserve the Nagao cap and needle guard being removed as a unit (McLoughlin: para. [0061], sentence 1), but also such that the needle guard can protect the needle prior to the cap being engaged during assembly of the needle stick protection assembly.
Regarding claim 16, Nagao in view of Bitdinger teaches a syringe safety system according to claim 15, as described above, which is coupled to the housing by means of a coupling of the needle stick protection device (Figs. 15A-C: 303c of cap 202c couples into 405c, 402c and 401c of housing 101c), such that the protective cap encloses the needle guard (Fig. 16B: 202d encloses 204d portion distal to 302d), but fails to explicitly disclose the insert being a syringe rather than a lancet with a plunger (lancet 203d and plunger 103d).
McLoughlin teaches an analogous needle stick protection cap and system specifically used with a prefilled syringe, comprising: a syringe having a syringe housing (103), a syringe needle (105). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Nagao needle stick protection device by incorporating the insert of the prefilled syringe taught by McLoughlin in order to be able to use the needle stick protection device for administering fluids in addition to collecting blood as Nagao discloses.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Nagao (US 20090163944) in view of Bitdinger (US 5250037) in further view of Bauss (WO 2018010931).
Regarding claim 14, Nagao in view of Bitdinger teaches the protective cap according to claim 1, as described above, but fails to disclose an RFID chip and antenna.
Bauss teaches analogous needle stick protection device cap comprising: an RFID chip (Fig. 12: 202) and an antenna structure (Fig. 12: 208) coupled to each other and arranged on or in the cap body of the protective cap (Fig. 11: RFID chip and antenna arranged on cap body 13). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Nagao cap by incorporating the RFID chip and antenna taught by Bauss to the needle cap in order to digitally store important information including but not limited to tracking and contents of the syringe assembly (Bauss: page 3, lines 24-30) with the additional benefit of information storage.
Response to Arguments
Applicant’s arguments, filed 10/03/2025, with respect to the rejections of independent claim 1 with the added limitations, have been fully considered and are persuasive in view of the newly amended claims. However, upon further consideration, a new ground of rejection in light of the change in scope of independent claim 1 is made by Nagao in view of Bitdinger, as described above, which teaches all limitations of the amended claims, including the newly amended limitation of the engagement elements and grooves being in pairs on opposing sides of the device and cap.
As described in the rejections above, Bitdinger teaches analogous cap engagement elements, which are located on opposite sides of the cap/device. As a standard configuration for secure closure well-known in the art, this would have been obvious for one of ordinary skill in the art to have incorporated into the Nagao cap, such that both Nagao cap arms possess the same engagement elements for more even and more secure closure.
For these reasons, claims 1-18 stand rejected as recited in the rejections above.
Conclusion
THIS ACTION IS MADE FINAL. 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 KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783