DETAILED ACTION
Claims 1, 6, 7, 9, 11, 12, 15-26 are examined in this office action
Claims 1, 6, 7, 9, 11-12, and 15 are currently amended.
Claims 16-26 are new.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
Claim(s) 1, 6-7, 9, 11, 15-17, 19-22, and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirschmann et al. (EP 3244942 B1) in view of Sheffler et al. (US Patent No. 6488187 B2).
Regarding claim 1, Hirschmann discloses a tamper-evident closure (closure container 10, Fig. 1) for a medical access device (syringe 50, Fig. 2) comprising:
an enclosure (closure container 10, Fig. 1) including a first part (first casing member 100, Fig. 1) and a second part (second casing member 200, Fig. 1) rotatable relative to the first part ("… a first casing member 100 hingedly attached to a second casing member 200 …" – Para [0016]) between an open position (Fig. 2) and a closed position (Fig. 1) wherein, in the closed position, the first part and the second part co-operatively define a holding cavity (See annotated Fig. 2) sized to hold the medical access device (syringe 50, Fig. 2), and wherein the enclosure defines an access point (See annotated Fig. 3) into the holding cavity;
an actuatable door (fastener 118, Fig. 2) rotatably coupled to the first part ("the fastener 118 is flexibly connected at … the first casing member 100 …" – Para [0020]) and rotatable between:
a first rotation position in which the actuatable door covers the access point (as shown in Fig. 1); and
a second rotation position in which the actuatable door is rotated away from the access point (as shown in Fig. 2); and
a door support wall (barb 128, Fig. 2) extending from the second part (second casing member 200 and fastener 118, Fig. 2) and into the holding cavity (slot 268, Fig. 10), wherein the door support wall is configured to prevent the actuatable door from rotating to the second rotation position when the second part is in the closed position ("… when the container 10 is in a closed position, the fastener 118 preferably resides substantially within the recess 262, with the barb received within the slot 268." – Para [0030]).
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Hirschmann does not expressly disclose that the actuatable door is rotated … into the holding cavity.
Sheffler relates to a tamper evident closure for a container and while it is not configured to hold a drug delivery device such as a syringe it is still a type of tamper evident closure for medication that can be translated for use with a drug delivery device. Sheffler teaches a tamper-evident lid with two parts that are hingedly connected and an additional door between the two parts that folds inside of the cavity of the container. The additional door provides an extra layer of tamper evident security and thus improves the safety of the device. More specifically, Brozell describes that the tamper evident closure includes:
Sheffler teaches that the actuatable door (flap 70, Fig. 4) is rotated … into the holding cavity (as shown in Fig. 4).
The fastener of Hirschmann can be modified by the flap of Sheffler to fold inwards into the cavity instead of being folded out of the cavity when the enclosure is in the second or opened position as shown in Fig. 2.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tamper-evident closure of Hirschmann to include that the actuatable door is rotated … into the holding cavity as taught by Sheffler so the flap does not interfere with the operation of the rotatable cap and fixed base.
Regarding claim 6, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, wherein
Hirschmann does not expressly disclose that the first part comprises a door stop to pressure fit with the actuatable door when the actuatable door is in the second rotation position.
Sheffler teaches that wherein the first part comprises a door stop (door stop 80, Fig. 4) to pressure fit with the actuatable door (flap 70, Fig. 4) when the actuatable door is in the second rotation position ("… the door stops prevent flap 70 from passing thereby so as to protrude substantially into opening 140 …" – Col. 4 Lines 7-8, as shown Fig. 4).
The fastener of Hirschmann can be modified by the flap and door stop of Sheffler to fold inwards into the cavity and be fitted with the door stop to prevent movement when the enclosure is in the second or opened position as shown in Fig. 2.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tamper-evident closure of Hirschmann to include that that the first part comprises a door stop to pressure fit with the actuatable door when the actuatable door is in the second rotation position as taught by Sheffler so the flap does not interfere with the operation of the rotatable cap and fixed base.
Regarding claim 7, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, wherein
Hirschmann does not expressly disclose wherein the door stop is a protrusion within the holding cavity.
Sheffler teaches that the door stop (door stop 80, Fig. 4) is a protrusion (as shown in Fig. 4) within the holding cavity (the cavity depicted in Fig. 4).
The fastener of Hirschmann can be modified by the flap and door stop of Sheffler to fold inwards into the cavity and be fitted with the door stop to prevent movement when the enclosure is in the second or opened position as shown in Fig. 2. Additionally, the door stop can be pointed inwards towards the cavity that holds the syringe of Hirschmann.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tamper-evident closure of Hirschmann to include that the door stop is a protrusion within the holding cavity as taught by Sheffler so the flap does not interfere with the operation of the rotatable cap and fixed base.
Regarding claim 9, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, further comprising
a reinforcing rib (Hirschmann, ribs 152, Fig. 2) coupled to the enclosure and arranged within the holding cavity (Hirschmann, as shown in Fig. 16).
Regarding claim 11, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, further comprising
a securing strap (Hirschmann, fastener 118 and tamper-evident pull tab, Fig. 1) coupled to the enclosure (Hirschmann, closure container 10, Fig. 1).
Regarding claim 15, Hirschmann in view of Sheffler teaches a method of using the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, comprising
preventing, with the door support wall (Hirschmann, barb 128, Fig. 2) , the actuatable door (Hirschmann, fastener 118, Fig. 1) from rotating toward the second rotation position (Hirschmann, "… when the container 10 is in a closed position, the fastener 118 preferably resides substantially within the recess 262, with the barb received within the slot 268." – Para [0030]).
Regarding claim 16, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, wherein
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the reinforcing rib (Hirschmann, ribs 152, Fig. 2) defines a notch sized to receive the medical access device (Hirschmann, See annotated Fig. 16).
Regarding claim 17, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, wherein
the reinforcing rib (Hirschmann, ribs 152, Fig. 2) is a first reinforcing rib (Hirschmann, See annotated Fig. 16 above) arranged on a first side of the actuatable door (Hirschmann, first casing member 100, Fig. 1); and
the tamper-evident closure further comprises a second reinforcing rib (Hirschmann, See annotated Fig. 16 above) arranged on a second side of the actuatable door opposite the first side (Hirschmann, second casing member 200, Fig. 1).
Regarding claim 19, Hirschmann teaches a tamper-evident closure (closure container 10, Fig. 1) for a medical access device (syringe 50, Fig. 2), comprising:
an enclosure (closure container 10, Fig. 1) including a first part (first casing member 100, Fig. 1) and a second part (second casing member 200, Fig. 1) rotatable relative to the first part ("… a first casing member 100 hingedly attached to a second casing member 200 …" – Para [0016]) between an open position (Fig. 2) and a closed position (Fig. 1) wherein, in the closed position, the first part and the second part co-operatively define a holding cavity (See annotated Fig. 2 above) sized to hold the medical access device (syringe 50, Fig. 2), and wherein the enclosure defines an access point (See annotated Fig. 3 above) into the holding cavity;
an actuatable door (fastener 118, Fig. 2) rotatably coupled to the first part ("the fastener 118 is flexibly connected at … the first casing member 100 …" – Para [0020]) and rotatable between:
a first rotation position in which the actuatable door covers the access point (as shown in Fig. 1); and
a second rotation position in which the actuatable door is rotated away from the access point (as shown in Fig. 2).
Hirschmann does not expressly disclose that the actuatable door is rotated … into the holding cavity.
Sheffler relates to a tamper evident closure for a container and while it is not configured to hold a drug delivery device such as a syringe it is still a type of tamper evident closure for medication that can be translated for use with a drug delivery device. Sheffler teaches a tamper-evident lid with two parts that are hingedly connected and an additional door between the two parts that folds inside of the cavity of the container. The additional door provides an extra layer of tamper evident security and thus improves the safety of the device. More specifically, Brozell describes that the tamper evident closure includes:
Sheffler teaches that the actuatable door (flap 70, Fig. 4) is rotated … into the holding cavity (as shown in Fig. 4).
The fastener of Hirschmann can be modified by the flap of Sheffler to fold inwards into the cavity instead of being folded out of the cavity when the enclosure is in the second or opened position as shown in Fig. 2.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tamper-evident closure of Hirschmann to include that the actuatable door is rotated … into the holding cavity as taught by Sheffler so the flap does not interfere with the operation of the rotatable cap and fixed base.
Regarding claim 20, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above,
further comprising a reinforcing rib (Hirschmann, ribs 152, Fig. 2) coupled to the enclosure and arranged within the holding cavity (Hirschmann, as shown in Fig. 16).
Regarding claim 21, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, wherein
the reinforcing rib (ribs 152, Fig. 2) defines a notch sized to receive the medical access device (See annotated Fig. 16 above)
Regarding claim 22, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, wherein
the reinforcing rib (Hirschmann, ribs 152, Fig. 2) is a first reinforcing rib (Hirschmann, See annotated Fig. 16 above) arranged on a first side of the actuatable door (Hirschmann, first casing member 100, Fig. 1); and
the tamper-evident closure further comprises a second reinforcing rib (Hirschmann, See annotated Fig. 16 above) arranged on a second side of the actuatable door opposite the first side (Hirschmann, second casing member 200, Fig. 1).
Regarding claim 24, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, wherein
Hirschmann does not expressly disclose that the first part comprises a door stop to pressure fit with the actuatable door when the actuatable door is in the second rotation position.
Sheffler teaches that wherein the first part comprises a door stop (door stop 80, Fig. 4) to pressure fit with the actuatable door (flap 70, Fig. 4) when the actuatable door is in the second rotation position ("… the door stops prevent flap 70 from passing thereby so as to protrude substantially into opening 140 …" – Col. 4 Lines 7-8, as shown Fig. 4).
The fastener of Hirschmann can be modified by the flap and door stop of Sheffler to fold inwards into the cavity and be fitted with the door stop to prevent movement when the enclosure is in the second or opened position as shown in Fig. 2.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tamper-evident closure of Hirschmann to include that that the first part comprises a door stop to pressure fit with the actuatable door when the actuatable door is in the second rotation position as taught by Sheffler so the flap does not interfere with the operation of the rotatable cap and fixed base.
Regarding claim 25, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, further comprising
a securing strap (Hirschmann, fastener 118 and tamper-evident pull tab, Fig. 1) coupled to the enclosure (Hirschmann, closure container 10, Fig. 1).
Regarding claim 26, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, wherein
Claim(s) 12, 18, 23, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirschmann et al. (EP 3244942 B1) in view of Sheffler et al. (US Patent No. 6488187 B2) and in further view of Mench et al. (US Patent No. 10722680 B1).
Regarding claim 12, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, wherein
the securing strap comprises a first securing strap portion (Hirschmann, exterior surface 124, Fig. 1) secured to the first part (Hirschmann, first casing member 100, Fig. 1) and a second securing strap portion (Hirschmann, tamper-evident pull tab, Fig. 1) extending from the first securing strap portion and including a free end (Hirschmann, as shown in Fig. 2)
Hirschmann does not expressly disclose that the strap is for irreversibly securing to the second part wherein an area of weakness is defined between the first securing strap portion and the second securing strap portion , wherein a force to break the area of weakness is less than a force to separate the securing strap from the first part or second part.
Mench relates to a method, apparatus, and system for detecting tampering with enclosures that house catheters, which is the same as, or very closely analogous to those of Applicant's claims. Mench teaches multiple embodiments, one of which depicted in Figs. 9A-9D is a sticker used to secure the enclosure which can be broken when opened to indicate tamper which a person of ordinary skill in the art would understand improves the security of the drug delivery. More specifically, Mech describes that the apparatus includes:
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Mench teaches that strap (sticker 950, Figs. 9A-9D) is for irreversibly securing to the second part (second part 908, Figs. 9A-9D) wherein an area of weakness (See annotated Fig. 9D) is defined between the first securing strap portion (sticker part 950a, Fig. 9A) and the second securing strap portion (sticker part 950b, Fig. 9B), wherein a force to break the area of weakness is less than a force to separate the securing strap from the first part or second part ("… a predetermined amount of force may correspond to enough force that is necessary to tamper with the enclosure (i.e., force needed to be exerted by a user to open the enclosure without the unlocking mechanism)." - Col. 41, Lines 64-67).
The fastener and tamper-evident pull tab of Hirschmann can be modified by the strap of Mench to be irreversibly secured to the second part of the enclosure. Additionally, when the tamper-evident pull tab is pulled to break the fastener the fastener can be modified to include an area of weakness that requires a force less than the force needed to separate the tamper-evident pull tab from the housing to be broken.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tamper-evident closure of Hirschmann to include that the strap is for irreversibly securing to the second part wherein an area of weakness is defined between the first securing strap portion and the second securing strap portion , wherein a force to break the area of weakness is less than a force to separate the securing strap from the first part or second part as taught by Mench so the strap may adhere to the surface of the box, but is capable of tearing by a predetermined amount of force (Mench, Col. 41, Lines 62-63).
Regarding claim 18, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, wherein
Hirschmann does not expressly disclose that the access point is a first access point on a lateral side of the enclosure, wherein a first tube of the medical access device extends through the first access point when the medical access device is arranged within the holding cavity; and the enclosure further defines a second access point at an end of the enclosure, wherein a second tube of the medical access device extends through the second access point when the medical access device is arranged within the holding cavity.
Mench teaches that the access point is a first access point (See annotated Fig. 9A) on a lateral side of the enclosure (See annotated Fig. 9A), wherein a first tube (blood vessel line 902A, Fig. 9A) of the medical access device extends through the first access point when the medical access device is arranged within the holding cavity (as shown in Fig. 9A); and the enclosure further defines a second access point (See annotated Fig. 9A) at an end of the enclosure, wherein a second tube (lumen 902B, Fig. 9A) of the medical access device extends through the second access point (See annotated Fig. 9A) when the medical access device is arranged within the holding cavity (as shown in Fig. 9A).
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The enclosure of Hirschmann can be modified by including the access points at the two ends of the enclosure in order to fit a drug delivery device with multiple inputs or outputs as taught by Mench.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tamper-evident closure of Hirschmann to include that the access point is a first access point on a lateral side of the enclosure, wherein a first tube of the medical access device extends through the first access point when the medical access device is arranged within the holding cavity; and the enclosure further defines a second access point at an end of the enclosure, wherein a second tube of the medical access device extends through the second access point when the medical access device is arranged within the holding cavity as taught by Mench so that a portion of the blood vessel line is positioned in clamping box (Mench, Col. 41 Lines 35-40).
Regarding claim 23, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, wherein
Hirschmann does not expressly disclose that the access point is a first access point on a lateral side of the enclosure, wherein a first tube of the medical access device extends through the first access point when the medical access device is arranged within the holding cavity; and the enclosure further defines a second access point at an end of the enclosure, wherein a second tube of the medical access device extends through the second access point when the medical access device is arranged within the holding cavity.
Mench teaches that the access point is a first access point (See annotated Fig. 9A) on a lateral side of the enclosure (See annotated Fig. 9A), wherein a first tube (blood vessel line 902A, Fig. 9A) of the medical access device extends through the first access point when the medical access device is arranged within the holding cavity (as shown in Fig. 9A); and the enclosure further defines a second access point (See annotated Fig. 9A) at an end of the enclosure, wherein a second tube (lumen 902B, Fig. 9A) of the medical access device extends through the second access point (See annotated Fig. 9A) when the medical access device is arranged within the holding cavity (as shown in Fig. 9A).
The enclosure of Hirschmann can be modified by including the access points at the two ends of the enclosure in order to fit a drug delivery device with multiple inputs or outputs as taught by Mench.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tamper-evident closure of Hirschmann to include that the access point is a first access point on a lateral side of the enclosure, wherein a first tube of the medical access device extends through the first access point when the medical access device is arranged within the holding cavity; and the enclosure further defines a second access point at an end of the enclosure, wherein a second tube of the medical access device extends through the second access point when the medical access device is arranged within the holding cavity as taught by Mench so that a portion of the blood vessel line is positioned in clamping box (Mench, Col. 41 Lines 35-40).
Regarding claim 26, Hirschmann in view of Sheffler teaches the tamper-evident closure (Hirschmann, closure container 10, Fig. 1) as recited above, wherein
the securing strap comprises a first securing strap portion (Hirschmann, exterior surface 124, Fig. 1) secured to the first part (Hirschmann, first casing member 100, Fig. 1) and a second securing strap portion (Hirschmann, tamper-evident pull tab, Fig. 1) extending from the first securing strap portion and including a free end (Hirschmann, as shown in Fig. 2)
Hirschmann does not expressly disclose that the strap is for irreversibly securing to the second part wherein an area of weakness is defined between the first securing strap portion and the second securing strap portion , wherein a force to break the area of weakness is less than a force to separate the securing strap from the first part or second part.
Mench relates to a method, apparatus, and system for detecting tampering with enclosures that house catheters, which is the same as, or very closely analogous to those of Applicant's claims. Mench teaches multiple embodiments, one of which depicted in Figs. 9A-9D is a sticker used to secure the enclosure which can be broken when opened to indicate tamper which a person of ordinary skill in the art would understand improves the security of the drug delivery. More specifically, Mech describes that the apparatus includes:
Mench teaches that strap (sticker 950, Figs. 9A-9D) is for irreversibly securing to the second part (second part 908, Figs. 9A-9D) wherein an area of weakness (See annotated Fig. 9D above) is defined between the first securing strap portion (sticker part 950a, Fig. 9A) and the second securing strap portion (sticker part 950b, Fig. 9B), wherein a force to break the area of weakness is less than a force to separate the securing strap from the first part or second part ("… a predetermined amount of force may correspond to enough force that is necessary to tamper with the enclosure (i.e., force needed to be exerted by a user to open the enclosure without the unlocking mechanism)." - Co. 41, Lines 64-67).
The fastener and tamper-evident pull tab of Hirschmann can be modified by the strap of Mench to be irreversibly secured to the second part of the enclosure. Additionally, when the tamper-evident pull tab is pulled to break the fastener the fastener can be modified to include an area of weakness that requires a force less than the force needed to separate the tamper-evident pull tab from the housing to be broken.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the tamper-evident closure of Hirschmann to include that the strap is for irreversibly securing to the second part wherein an area of weakness is defined between the first securing strap portion and the second securing strap portion , wherein a force to break the area of weakness is less than a force to separate the securing strap from the first part or second part as taught by Mench so the strap may adhere to the surface of the box, but is capable of tearing by a predetermined amount of force (Mench, Col. 41, Lines 62-63).
Response to Arguments
Applicant’s arguments, see page 10, filed 8/27/2026, with respect to the rejection(s) of claim(s) 1, 6, 7, 9, 11, 12, 15-26 under 35 USC 102 and 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 made in view of Hirschmann in view of Sheffler and Mench.
Examiner interprets the Hirschmann in view of Sheffler and Mench teach the limitations of the amended and new claims as recited in the rejection above.
With respect to applicant’s arguments the rejection above teaches the claimed limitations. The rejection above is maintained.
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 ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
