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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/20/2026 has been entered.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 03/25/2024 and 12/30/2021 have been considered by the Examiner.
Status of the Claims
Claims 1-12 are currently pending. Claims 9-10 are withdrawn. Claim 11 is currently amended. Claim 12 is newly added. Claims 1-8 and 11-12 are currently rejected.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference interpretation applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 05/20/2026 with respect to claim 11 have been fully considered but they are not persuasive.
Applicant states that “the antenna 204 of Vitello does not extending around the longitudinal axis of the tip cap, such that the antenna extends around the tip of the medical injection device”. The Examiner does not agree with this characterization of the reference Vitello, and points to Vitello fig. 16 which shows an annularly formed antenna 204 centered on the longitudinal axis and formed as part of the tip cap which engages the tip of the medical injection device. Since the cap covers the tip of the injection device, the antenna extends around the tip of the medical injection device since these two structures are centered on the same longitudinal axis. See 103 rejection of claim 11 below.
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.
Claim 12 is 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 12 recites the limitation “the distal end portion of the tip connector” on line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether claim 12 is meant to introduce this limitation (in which case this should read “a distal end portion of the tip connector”), refer back to the distal portion of the closure cap earlier introduced in claim 11 (which would require restructuring of the claim limitation), or depend from claim 1 instead of claim 11 (since claim 1 does introduce “the tip connector having a distal end potion” on line 3. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-8 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imbert (US 20010003150 A1; hereafter Imbert) in view of Vetter et al (US 5135496 A; hereafter Vetter), Atterbury et al (US 20170354790 A1; hereafter Atterbury), and Vitello et al (US 9311592 B1; hereafter Vitello); or alternatively over Imbert in view of Vetter, Atterbury, Vitello, and further in view of Hart (US 20070008121 A1; hereafter Hart).
Regarding claim 1, Imbert discloses a tip cap (cap assembly 54, fig. 1 and luer collar 44, fig. 1, [0036]) for a medical injection device (hypodermic syringe 10, fig. 1, [0024]), comprising:
- a tip connector (luer collar 44, fig. 4, [0036]) configured to engage a tip (tip 22, fig. 2, [0036]) of the medical injection device (10, fig. 1) (see engagement in fig. 3 and fig. 4), the tip connector (44) having a distal end portion (see indicated grey-highlighted distal end portion in modified Fig. 4 below);
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- a closure cap (assembly 54 of inner and outer caps 56 and 58, figs. 1 and 4, [0036]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to sealingly close a distal opening of the tip (22) (see fig. 4 which shows that closure cap 56/58 seals a distal opening of tip 22), the closure cap (56/58) being releasably connected to the distal end portion of the tip connector (44) (see fig. 4, note that the indicated distal end portion comprises the threaded engagement portion as noted in [0036]);
the relative movement applied to the closure cap and the tip connector releases the closure cap from the tip connector ([0028] closure cap portion 56 removed from tip connector 44; see fig. 4, note reversible threaded engagement of closure cap portion 58 and tip connector 44 as noted in [0036]).
Imbert is silent to a bridge configured to break under a relative movement applied to the closure cap and the tip connector.
Vetter, directed to a tamper-proof hypodermic syringe assembly, teaches the tip connector (ring 9, col. 3 ln. 16-22; see fig. 1 which shows engagement of tip connector 9 and tip of medical injection device) and the closure cap (cap 7, col. 3 ln. 16-22, fig. 1) being made as a single piece (col. 3 ln. 16-22, “destructible connection 10 here is a thin web 8 that is unitarily formed with the cap 7 and ring 9”), and a bridge (web 8, fig. 1, col. 3 ln. 16-22) configured to break (see fig. 1, see col. 3 ln. 16-22, “destructible connection 10 here is a thin web 8”) under a relative movement applied to the closure cap (cap 7, col. 3 ln. 16-22, fig. 1) and the tip connector (ring 9, col. 3 ln. 16-22; fig. 1), the relative movement applied to the closure cap and the tip connector releases the closure cap from the tip connector (see fig. 2 which shows release of closure cap 9 from tip connector 7 due to relative movement, see col. 3 ln. 16-22, “destructible connection 10 here is a thin web 8 that is unitarily formed with the cap 7 and ring 9”… “cap 7 can only be removed by breaking this web 8”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the closure cap and tip connector of Imbert to include a tamper proof bridge integrally formed with the tip connector and closure cap and configured to break under a relative movement, as taught by Vetter, since both references deal with syringe caps. Additionally, this modification would have been obvious because Imbert includes an embodiment similar to that of fig. 4, shown in fig. 8 and discussed in [0040]. This second embodiment of Imbert teaches a tamper evident frangible label 86 which overlaps both the tip connector and closure cap to and breaks to clearly indicate when they have been separated. Imbert [0013] further notes “a frangible spot weld may connect the outer cap to the luer collar or other such needle mounting means” and describes both outer cap 58 [0031] and luer collar 44 [0039] as being made of a thermoplastic, while the inner cap 44 [0028] is made of an elastomer, while also describing that the inner and outer caps can be simultaneously molded using injection technology [0041]. One would have been motivated to make the modification because, as noted by Vetter (col. 3 ln. 27-30) the frangible connection is clearly able to indicate whether or not the device has been tampered with, and the tip connector and closure cap would not be separate prior to use of the device, therefore ensuring that the tamper evident seal cannot be circumvented. This modification would beneficially prevent a user of the device from re-using an old syringe, a defective syringe, or a compromised syringe, thus better protecting the patient.
As described above in regards to the combination of Imbert and Vetter, Imbert discloses the tip connector (luer connector 44, fig. 4) being made of a thermoplastic ([0039]), the closure cap (inner cap 56 and outer cap 58, fig. 4) being made respectively from an elastomer and a rigid thermoplastic (see [0028] and [0031]), and simultaneous injection molding of two materials ([0041] the inner and outer caps may be simultaneously molded using injection technology or sequential injection technology). Vetter teaches the tip connector (ring 9, fig. 1) and closure cap (cap 7, fig. 1) being made as a single piece (col. 3 ln. 16-18, “The destructible connection 10 here is a thin web 8 that is unitarily formed with the cap 7 and ring 9”).
Imbert as modified by Vetter is silent to the precise materials selected as the thermoplastic and elastomer.
Atterbury, directed to a device for engaging the tip of a medical syringe, teaches a device for engaging the tip of a medical syringe manufactured by a multi-component injection molding ([0045] cap 30 is formed of a two shot molding having a central body portion 125 and a gripping periphery 130) wherein a tip connector (gripping periphery 130, fig. 14) and a closure cap (central body portion 125, fig. 14) being made as a single piece ([0045] Body portion 125 is formed of a rigid material such as polycarbonate. Periphery 130 is molded onto body portion 125 out of a softer material, such as a thermoplastic elastomer) from chemically not bonding materials (Examiner notes that the instant application PGPUB recites “[0090] According to an embodiment, the tip connector may be made of polycarbonate (PC) and the closure cap may be made of a thermoplastic elastomer (TPE). However, other pairs of chemically not bonding materials suitable for the application may be used.” Since Atterbury teaches the use of polycarbonate and a thermoplastic elastomer, which are noted by the instant application as a pair of chemically not bonding materials, then Atterbury teaches injection molding of a single part from two chemically not bonding materials.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to choose the injection molded materials for Imbert modified by Vetter and Vitello to be polycarbonate and a thermoplastic elastomer, as taught by Atterbury, since Atterbury also deals with a cap-like device for engaging the tip of a medical syringe/injection device. One would have been motivated to make the modification because Atterbury, in the medical field, teaches using polycarbonate with a thermoplastic elastomer for a cap device, indicating the suitability of the materials for use with medical syringes. Imbert similarly describes an elastomer and a thermoplastic being used, further supporting the obviousness of the modification. Examiner additionally notes MPEP 2144.07, indicating that it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Imbert modified by Vetter and Atterbury is silent to an RFID tag overmolded into the tip connector and the closure cap.
Vitello, in the field of tamper evident closures for syringes, teaches an RFID tag (col. 14 ln. 63 - col. 15 ln. 6 code segment 202’ is in the form of an RFID structure) comprising a chip (col. 14 ln. 63 - col. 15 ln. 6 portion of RFID tag embedded in the end portion/indicator member 32, shown in fig. 16) and an antenna (antenna 204, shown embedded in tip connector 22), wherein the chip is overmolded in one of the tip connector (end cap 22, fig. 16, col. 9 ln. 57-63) and the closure cap (indicator 32 and syringe cap 30, col. 15 ln. 31-52, see indicator in fig. 16 and syringe cap 30 in fig. 3B; note col. 11 ln. 13-23 which explains that indicator 32 and syringe cap 30 remain linked after assembly and even after removal of tip connector 22) and the antenna is overmolded in the other one of the tip connector and the closure cap (col. 14 ln. 63 - col. 15 ln. 6 portion of RFID tag embedded in the closure cap portion 32, shown in fig. 16),
the chip and the antenna being electrically connected by a bridge (col. 14 ln. 63 - col. 15 ln. 6 antenna 204 connected to portion of RFID tag embedded in closure cap 32 via frangible members 34) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to break under a relative movement applied to the closure cap (32/30) and the tip connector (22) (col. 15 ln. 7-19 relative movement of closure cap 32/30 and tip connector 22 causes frangible portions/frangible members 34 to break, deactivating RFID tag; closure cap 32/30 remains attached to medical device when tip connector separates), the relative movement applied to the closure cap and the tip connector releases the closure cap from the tip connector (col. 15 ln. 7-19 describes separation of closure cap 32/30 from tip connector 22), and
the antenna is located at an interface between the tip connector and the closure cap (see figs. 16 and 16a which show that the antenna 204 is located through the bridge 34 which connects the tip connector 22 and the closure cap 32/30, and is thus an interface between the tip connector and the closure cap).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the tip connector and closure cap of Imbert modified by Vetter and Atterbury to include the antenna and chip overmolded into either part and connected by the bridge as taught by Vitello since all references deal with tamper detection for syringe caps. One would have been motivated to make the modification because using RFID instead of just visual indications of tampering allows for a scanner to be quickly, reliably used to check for tampering which may provide more reliable tamper recognition than mere visual assessment, in case the person who tampered with the device attempts to make it seem that the device is still whole.
Alternatively, Imbert as modified by Vetter, Atterbury, and Vitello is silent to the chip and the antenna being electrically connected by a bridge.
Hart, in the field of RFID for tamper detection, teaches the chip (etched integrated circuit 102) and the antenna (antenna 103) being electrically connected by a bridge (connectors) which is configured to break ([0022] the connectors are designed to break in response to a trigger event).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Imbert modified by Vetter and Vitello to have a bridge between the antenna and chip break as taught by Hart instead of having a portion of the antenna break, since both systems allow for signal failure after separation of two portions of an RFID tag. In this arrangement, the connector would be located in the frangible member 34 of Vitello/web 8 of Vetter, and the antenna and chip would separate due to the bridge between them breaking. It would make sense to locate the connector of Hart in the frangible portion of Vitello so that it could break and separate the antenna and chip. Furthermore, Vitello col. 14 ln. 58-62 notes that “mechanical incapacitation” is an acceptable method of inactivating the RFID tag. Essentially, Hart teaches an alternative arrangement which facilitates a similar mechanical incapacitation to that taught by Vitello. One may have been motivated to make this modification because having the antenna located solely within one cylindrical structure could simplify the construction process and reduce likelihood of errors while assembling the device. The device would still function to indicate that it had been tampered with if separation were to occur.
Regarding claim 2, Imbert as modified discloses the tip cap according to claim 1, as described above. Imbert further discloses wherein the tip connector (44, fig. 4) and the closure cap (56/58, fig. 4) comprise mutually engaging threaded portions ([0036] Assembly 54 of inner and outer caps 56 and 58 can be threadedly engaged with luer collar 44 as shown in FIG. 2; see fig. 4 which shows engagements of threaded portions).
Regarding claim 3, Imbert as modified discloses the tip cap according to claim 1, as described above. Imbert further discloses wherein the closure cap (assembly 54 of inner and outer caps 56 and 58, figs. 1 and 4, [0036]) comprises a sealing septum (inner cap 56, fig. 4, [0028]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to abut the tip (tip 22, fig. 4) of the medical injection device (10, fig. 1) ([0028] Portions of inner cap 56 extending proximally from distal end 62 define a tip-engaging portion 64 having a cavity 66 dimensioned to tightly resilient engage tip 22 of syringe barrel 12.).
Regarding claim 4, Imbert as modified discloses the tip cap according to claim 1, as described above, including wherein the antenna (Vitello: antenna 204, shown embedded in main body/end cap 22) presents a ring shape extending about a longitudinal axis of the tip cap (Vitello: fig. 16 shows antenna 204 to be annular and embedded in the main body 22 of the tip connector 200 centered around the longitudinal axis).
Regarding claim 5, Imbert as modified discloses the tip cap according to claim 4, as described above, including wherein the bridge (note that Imbert as modified in claim 1 includes the frangible member 34 of Vitello/web 8 of Vetter which are the claimed bridge) is parallel to the longitudinal axis of the tip cap (see Vetter fig. 1 which shows that web 8 is formed between two pieces aligned with the longitudinal axis of the tip cap).
Regarding claim 6, Imbert as modified discloses the tip cap according to claim 4, as described above, including all claim limitations except wherein the bridge is orthogonal to the longitudinal axis of the tip cap (instead of being parallel to the longitudinal axis a shown in fig. 1 of Vetter).
Vitello further teaches wherein the bridge (RFID antenna 204 connected to corresponding RFID structure in indicator member 32 via the frangible members 34) is orthogonal to the longitudinal axis of the tip cap (fig. 16 and 16A show that the frangible member 34 is orthogonal to the longitudinal axis of the cap).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the arrangement of Imbert as previously modified to further include the orthogonally oriented bridge taught by Vitello since this arrangement would better protect the bridge from inadvertently being broken prior to separation of the tip connector. It would further have been obvious to make this modification since this change would amount to a rearrangement of parts, and since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of indicating that the tip cap had been tampered with, as evidenced by the tamper proof cap of Vitello.
Regarding claim 7, Imbert as modified discloses the tip cap according to claim 1, as described above.
Imbert as modified is silent to the antenna comprising at least one protrusion extending radially into the material of the closure cap.
Vitello further teaches wherein the antenna (RFID antenna 204 connected to corresponding RFID structure in end portion/indicator member 32 via the frangible members 34) comprises at least one protrusion extending radially into the material of the closure cap (fig. 16 and 16A show that the frangible member 34 is orthogonal to the longitudinal axis of the cap and that the antenna 204 extends radially into closure cap portion 32).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the arrangement of Imbert as previously modified to further include the radially extending antenna protrusion taught by Vitello since this change would amount to a rearrangement of parts, and since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of indicating that the tip cap had been tampered with, as evidenced by the tamper proof cap of Vitello.
Alternatively, regarding claim 7, Imbert as modified discloses the tip cap according to claim 1, as described above.
Imbert as modified is silent to the antenna comprising at least one protrusion extending radially into the material of the closure cap.
However, Imbert teaches wherein an injection molded part (inner cap noted in [0041] the inner and outer caps may be simultaneously molded using injection technology or sequential injection technology) comprises at least one protrusion (anti rotation ribs 6 shown in fig. 1 and annular rib 80 shown in fig. 4, both described in [0038] Engagement of anti-rotation ribs 68 and 78 ensures that inner cap 56 will rotate with outer cap 58. Additionally, engagement of annular rib 80 of outer cap 58 with undercut 70 in inner cap 56 ensures that inner cap 56 will move axially in response to the threaded disengagement of outer cap 58 from luer collar 44.) extending radially into the material of another injection molded part (outer cap noted in [0041]; see fig. 1 and fig. 4 which shows protrusions 68 and 80 extending into the material which forms the outer cap 58).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the antenna, around which the closure cap and the tip connector are injection molded, to include protrusions engaging radially with the closure cap into which the antenna is embedded, because the antenna is embedded during an injection molding process, and Imbert [0038] describes the benefits of protrusions in stabilizing the connections between parts which Imbert [0041] notes can be injection molded. One would have been motivated to make the modification because the connection between the antenna and the closure cap must be strong enough that the bridge between the antenna and the chip breaks at a lower force threshold than the connection between the antenna and the closure cap, otherwise the RFID tag would fail to work appropriately. As noted by Imbert [0038], fig. 1, and fig. 4, protrusions extending radially between parts helps to ensure that the two parts will move together, both axially and rotationally.
Regarding claim 8, Imbert as modified discloses the tip cap according to claim 1, as described above, including wherein the chemically not bonding materials of the tip connector and the closure cap are polycarbonate and thermoplastic elastomer (Atterbury: [0045] cap 30 is formed of a two shot molding having a central body portion 125 and a gripping periphery 130; [0045] Body portion 125 is formed of a rigid material such as polycarbonate. Periphery 130 is molded onto body portion 125 out of a softer material, such as a thermoplastic elastomer).
Regarding claim 11, Imbert discloses a tip cap (cap assembly 54, fig. 1 and luer collar 44, fig. 1, [0036]) for a medical injection device (hypodermic syringe 10, fig. 1, [0024]), comprising:
- a tip connector (luer collar 44, fig. 4, [0036]) configured to engage a tip (tip 22, fig. 2, [0036]) of the medical injection device (10, fig. 1) (see engagement in fig. 3 and fig. 4);
- a closure cap (assembly 54 of inner and outer caps 56 and 58, figs. 1 and 4, [0036]) having a distal end (see distal end , the closure cap configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to sealingly close a distal opening of the tip (22) (see fig. 4 which shows that closure cap 56/58 seals a distal opening of tip 22), the closure cap (56/58) being releasably connected to the tip connector (44) (see fig. 4, note the releasably threaded engagement noted in [0036]), the distal end of the closure cap external to the tip connector (see modified Imbert Fig. 4.1 below, note that the distal end of the closure cap 56/58 is external to tip connector 44 since the distal end does not lie within the tip connector);
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the relative movement applied to the closure cap and the tip connector releases the closure cap from the tip connector ([0028] closure cap portion 56 removed from tip connector 44; see fig. 4, note reversible threaded engagement of closure cap portion 58 and tip connector 44 as noted in [0036]).
Imbert is silent to a bridge configured to break under a relative movement applied to the closure cap and the tip connector.
Vetter, directed to a tamper-proof hypodermic syringe assembly, teaches the tip connector (ring 9, col. 3 ln. 16-22; see fig. 1 which shows engagement of tip connector 9 and tip of medical injection device) and the closure cap (cap 7, col. 3 ln. 16-22, fig. 1) being made as a single piece (col. 3 ln. 16-22, “destructible connection 10 here is a thin web 8 that is unitarily formed with the cap 7 and ring 9”), and a bridge (web 8, fig. 1, col. 3 ln. 16-22) configured to break (see fig. 1, see col. 3 ln. 16-22, “destructible connection 10 here is a thin web 8”) under a relative movement applied to the closure cap (cap 7, col. 3 ln. 16-22, fig. 1) and the tip connector (ring 9, col. 3 ln. 16-22; fig. 1), the relative movement applied to the closure cap and the tip connector releases the closure cap from the tip connector (see fig. 2 which shows release of closure cap 9 from tip connector 7 due to relative movement, see col. 3 ln. 16-22, “destructible connection 10 here is a thin web 8 that is unitarily formed with the cap 7 and ring 9”… “cap 7 can only be removed by breaking this web 8”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the closure cap and tip connector of Imbert to include a tamper proof bridge integrally formed with the tip connector and closure cap and configured to break under a relative movement, as taught by Vetter, since both references deal with syringe caps. Additionally, this modification would have been obvious because Imbert includes an embodiment similar to that of fig. 4, shown in fig. 8 and discussed in [0040]. This second embodiment of Imbert teaches a tamper evident frangible label 86 which overlaps both the tip connector and closure cap to and breaks to clearly indicate when they have been separated. Imbert [0013] further notes “a frangible spot weld may connect the outer cap to the luer collar or other such needle mounting means” and describes both outer cap 58 [0031] and luer collar 44 [0039] as being made of a thermoplastic, while the inner cap 44 [0028] is made of an elastomer, while also describing that the inner and outer caps can be simultaneously molded using injection technology [0041]. One would have been motivated to make the modification because, as noted by Vetter (col. 3 ln. 27-30) the frangible connection is clearly able to indicate whether or not the device has been tampered with, and the tip connector and closure cap would not be separate prior to use of the device, therefore ensuring that the tamper evident seal cannot be circumvented. This modification would beneficially prevent a user of the device from re-using an old syringe, a defective syringe, or a compromised syringe, thus better protecting the patient.
As described above in regards to the combination of Imbert and Vetter, Imbert discloses the tip connector (luer connector 44, fig. 4) being made of a thermoplastic ([0039]), the closure cap (inner cap 56 and outer cap 58, fig. 4) being made respectively from an elastomer and a rigid thermoplastic (see [0028] and [0031]), and simultaneous injection molding of two materials ([0041] the inner and outer caps may be simultaneously molded using injection technology or sequential injection technology). Vetter teaches the tip connector (ring 9, fig. 1) and closure cap (cap 7, fig. 1) being made as a single piece (col. 3 ln. 16-18, “The destructible connection 10 here is a thin web 8 that is unitarily formed with the cap 7 and ring 9”).
Imbert as modified by Vetter is silent to the precise materials selected as the thermoplastic and elastomer.
Atterbury, directed to a device for engaging the tip of a medical syringe, teaches a device for engaging the tip of a medical syringe manufactured by a multi-component injection molding ([0045] cap 30 is formed of a two shot molding having a central body portion 125 and a gripping periphery 130) wherein a tip connector (gripping periphery 130, fig. 14) and a closure cap (central body portion 125, fig. 14) being made as a single piece ([0045] Body portion 125 is formed of a rigid material such as polycarbonate. Periphery 130 is molded onto body portion 125 out of a softer material, such as a thermoplastic elastomer) from chemically not bonding materials (Examiner notes that the instant application PGPUB recites “[0090] According to an embodiment, the tip connector may be made of polycarbonate (PC) and the closure cap may be made of a thermoplastic elastomer (TPE). However, other pairs of chemically not bonding materials suitable for the application may be used.” Since Atterbury teaches the use of polycarbonate and a thermoplastic elastomer, which are noted by the instant application as a pair of chemically not bonding materials, then Atterbury teaches injection molding of a single part from two chemically not bonding materials.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to choose the injection molded materials for Imbert modified by Vetter and Vitello to be polycarbonate and a thermoplastic elastomer, as taught by Atterbury, since Atterbury also deals with a cap-like device for engaging the tip of a medical syringe/injection device. One would have been motivated to make the modification because Atterbury, in the medical field, teaches using polycarbonate with a thermoplastic elastomer for a cap device, indicating the suitability of the materials for use with medical syringes. Imbert similarly describes an elastomer and a thermoplastic being used, further supporting the obviousness of the modification. Examiner additionally notes MPEP 2144.07, indicating that it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Imbert modified by Vetter and Atterbury is silent to an RFID tag overmolded into the tip connector and the closure cap.
Vitello, in the field of tamper evident closures for syringes, teaches an RFID tag (col. 14 ln. 63 - col. 15 ln. 6 code segment 202’ is in the form of an RFID structure) comprising a chip (col. 14 ln. 63 - col. 15 ln. 6 portion of RFID tag embedded in the end portion/indicator member 32, shown in fig. 16) and an antenna (antenna 204, shown embedded in tip connector 22), wherein the chip is overmolded in one of the tip connector (end cap 22, fig. 16, col. 9 ln. 57-63) and the closure cap (indicator 32 and syringe cap 30, col. 15 ln. 31-52, see indicator in fig. 16 and syringe cap 30 in fig. 3B; note col. 11 ln. 13-23 which explains that indicator 32 and syringe cap 30 remain linked after assembly and even after removal of tip connector 22) and the antenna is overmolded in the other one of the tip connector and the closure cap (col. 14 ln. 63 - col. 15 ln. 6 portion of RFID tag embedded in the closure cap portion 32, shown in fig. 16),
the chip and the antenna being electrically connected by a bridge (col. 14 ln. 63 - col. 15 ln. 6 antenna 204 connected to portion of RFID tag embedded in closure cap 32 via frangible members 34) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to break under a relative movement applied to the closure cap (32/30) and the tip connector (22) (col. 15 ln. 7-19 relative movement of closure cap 32/30 and tip connector 22 causes frangible portions/frangible members 34 to break, deactivating RFID tag; closure cap 32/30 remains attached to medical device when tip connector separates), the relative movement applied to the closure cap and the tip connector releases the closure cap from the tip connector (col. 15 ln. 7-19 describes separation of closure cap 32/30 from tip connector 22), and
the antenna is located at an interface between the tip connector and the closure cap (see figs. 16 and 16a which show that the antenna 204 is located through the bridge 34 which connects the tip connector 22 and the closure cap 32/30, and is thus an interface between the tip connector and the closure cap).
wherein the antenna presents an annular shape extending around the longitudinal axis of the tip cap (Vitello: antenna 204 shown embedded in tip connector 22, fig. 16), such that the antenna extends around the tip of the medical injection device (Vitello: fig. 16 shows antenna 204 to be annular and embedded in the tip connector 22 of the tip cap and centered around the longitudinal axis, thus extending around the tip of the medical injection device).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the tip connector and closure cap of Imbert modified by Vetter and Atterbury to include the antenna and chip overmolded into either part and connected by the bridge as taught by Vitello since all references deal with tamper detection for syringe caps. One would have been motivated to make the modification because using RFID instead of just visual indications of tampering allows for a scanner to be quickly, reliably used to check for tampering which may provide more reliable tamper recognition than mere visual assessment, in case the person who tampered with the device attempts to make it seem that the device is still whole.
Regarding claim 12, Imbert as modified discloses the tip cap according to claim 11, as applied above, including wherein the closure cap (Imbert: 56/58, fig. 4) is releasably connected to the distal end portion (see 112b interpretation above) of the tip connector (Imbert: 44, fig. 4) (see fig. 4, note that the distal end portion of the tip connector comprises the threaded engagement portion as noted in [0036]).
Conclusion
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 07/14/2026
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