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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/30/2026 has been entered.
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.
Claims 11, 14-17, 21-24, and 26-28 rejected under 35 U.S.C. 103 as being unpatentable over Pu (CN 205339743 U) in view of McKinnis et al. (US 20140121643 A1) in further view of Cohen et al. (US 5785694 A).
Regarding claim 11, Pu discloses a medicament delivery device add-on (Fig 1) comprising a first portion (first clamping part 10, Fig 1) and a second portion (second clamping part 11, Fig 1), the first portion (10) comprising at least one electronic component (first circuit board 14, Fig 6), wherein the first portion (10) is releasably attached to the second portion (11) by a magnetic lock ([0002]); a transversal rotation of the first portion (10) relative to the second portion (11) (First portion 11 rotates transversally relative to the second portion 12 while opening or closing, please see Fig 1-2).
Pu is silent wherein the magnetic lock comprises a flexible magnetic shim having a first end attached to the first portion, wherein the flexible magnetic shim stops the transversal rotation of the first portion relative to the second portion, wherein a second end of the flexible magnetic shim bends relative to a longitudinal axis of the magnetic shim to allow the second portion to move relative to the first portion when a magnetic field is applied to the flexible magnetic shim.
McKinnis teaches a teaches a lock (Fig 9) comprises a flexible shim (catch member 100, Fig 9) having a first end (1000, Annotated Fig 1) attached to the first portion (first portion 62, Fig 9), wherein the flexible shim stops (100) the transversal rotation of the first portion (62) relative to the second portion (72) (First portion 11 rotates transversally relative to the second portion 12 while opening or closing, please see Fig 9-10, Fig 19 shows the closed configuration in used), wherein a second end (1001, Annotated Fig 1) of the flexible shim (100) bends relative to a longitudinal axis (1002, Annotated Fig 1) of the shim (100) to allow the second portion (72) to move relative to the first portion (62) (Fig 10)([0047]; [0049]).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu with similar flexible shim and orientation of the magnets as taught by McKinnis for the purpose of having a portion that is accessible to an operator after the first and second portions have been coupled to one another so that the operator may manipulate the catch member to decouple first and second portions while having a magnet biasing the first and second portion into an open configuration ([0047]; [0049]).
Pu/Mckinnis is silent wherein the flexible shim is magnetic and a magnetic field is applied to the flexible magnetic shim.
Cohen teaches a flexible magnetic shim (Arm 94 + magnetic compression member 92, Fig 9A-B) wherein the flexible shim is magnetic (shim has a magnetic portion 92) and when a magnetic field (magnetic field of magnetic releasing member 96, Fig 10) is applied to the flexible magnetic shim (94+92) (Fig 9B; Col 6, lines 35-53).
Note: Pu/Mckinnis/Cohen disclose wherein the flexible magnetic shim (100, from Mckinnis, now magnetic with teaching of Cohen) stops a transversal rotation of the first portion (10, from Pu) relative to the second portion (11, from Pu), wherein a second end (1001, Annotated Fig 1, from Mckinnis) of the flexible magnetic shim (100, from Mckinnis, now magnetic with teaching of Cohen) bends relative to a longitudinal axis (1002, Annotated Fig 1, from Cohen) of the shim (100, from Mckinnis, now magnetic with teaching of Cohen) to allow the second portion (11, from Pu) to move relative to the first portion (10, from Pu) when a magnetic field (magnetic field from release member 96, from Cohen) is applied to the flexible magnetic shim (100, from Mckinnis, now magnetic with teaching of Cohen).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis with similar flexible and magnetic materials of shim and external magnetic releasing member as taught by Cohen to release the shim connection by magnetic means (Fig 9B; Col 6, lines 35-53).
Regarding claim 14, Pu/Mckinnis/Cohen discloses the medicament delivery device add-on of claim 11. Pu is silent wherein the end of the flexible magnetic shim that bends is in a cut-out or a recess in the other of the first portion and the second portion until a magnetic field is applied to the flexible magnetic shim.
Mckinnis teaches wherein the second end (1001, Annotated Fig 1) of the flexible shim (100) that bends is in a cut-out or a recess (locking surface 106, Fig 10) in the other of the first portion and the second portion (72).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis/Cohen with similar flexible shim and cut-out intercation for the purpose of having a portion that is accessible to an operator after the first and second portions have been coupled to one another so that the operator may manipulate the catch member to decouple first and second portions ([0047]; [0049]).
Pu/Mckinnis are silent wherein the flexible shim is magnetic and the end of the flexible magnetic shim is in the cut-out or a recess until a magnetic field is applied to the flexible magnetic shim.
Cohen teaches a flexible magnetic shim (Arm 94 + magnetic compression member 92, Fig 9A-B) wherein the flexible shim is magnetic (shim has a magnetic portion 92) and the end (92) of the flexible magnetic shim (92+94) is in the cut-out or a recess (recess produced by compression of 94+92) until a magnetic field (magnetic field of magnetic releasing member 96, Fig 10) is applied to the flexible magnetic shim (94+92, Fig 10).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis/Cohen with similar flexible and magnetic materials of shim and external magnetic releasing member as taught by Cohen to release the shim connection by magnetic means moving the shim away from recess (Fig 9B; Col 6, lines 35-53).
Regarding claim 15, Pu/Mckinnis/Cohen discloses the medicament delivery device add-on of claim 11. Pu is silent wherein the device configured such that the first portion is locked to the second portion by the second end of the flexible magnetic shim in the absence of a magnetic field applied to the flexible magnetic shim, and such that the first portion can be removed from the second portion when a magnetic field is applied to the shim.
Mckinnis teaches the first portion (62) is locked to the second portion (72) by the second end (1001, Annotated Fig 1) of the flexible shim (100) in the absence of a magnetic field applied to the flexible shim (no magnetic field is being applied to the shim 100), and such that the first portion (62) can be removed from the second portion (72).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis/Cohen with similar flexible shim and orientation of the magnets as taught by McKinnis for the purpose of having a portion that is accessible to an operator after the first and second portions have been coupled to one another so that the operator may manipulate the catch member to decouple first and second portions ([0047]; [0049]).
Pu/Mckinnis are silent wherein the flexible shim is magnetic and the first portion can be removed from the second portion when a magnetic field is applied to the shim.
Cohen teaches a flexible magnetic shim (Arm 94 + magnetic compression member 92, Fig 9A-B) wherein the flexible shim is magnetic (shim has a magnetic portion 92) and when a magnetic field (Fig 9B) is applied to the flexible magnetic shim (94+92) (Fig 9B; Col 6, lines 35-53)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis/Cohen with similar flexible and magnetic materials of shim and external magnetic releasing member as taught by Cohen to release the shim connection by magnetic means (Fig 9B; Col 6, lines 35-53).
Regarding claim 16, Pu/Mckinnis/Cohen discloses the medicament delivery device add-on of claim 11. Pu discloses wherein the electronic component (14) comprises a sensor (drip sensor; [0009]).
Regarding claim 17, Pu/Mckinnis/Cohen discloses claim the medicament delivery device add-on of claim 16. Pu discloses wherein the sensor provides information about a state of the device ([0038]; drip sensor electronics provide information of status of infusion bottle and alarm the nurse when the bottle is close to be emptied)
Regarding claim 21, Pu discloses an assembly comprising a medicament delivery device and an add-on component, where the add-on component comprises: a first portion (first clamping part 10, Fig 1); a second portion (second clamping part 11, Fig 1) releasably connected to the first portion (10); and a magnetic lock (first magnet16, second magnet 17, Fig 5) operatively associated with both the first (10) and second (11) portions such that magnetic lock has a first state (closed state); a transversal rotation of the first portion (10) relative to the second portion (11) (First portion 11 rotates transversally relative to the second portion 12 while opening or closing, please see Fig 1-2), wherein the first portion (10) comprises an electronic component (first circuit board 14, Fig 6) having a sensor (drip sensor; [0009]) that monitors and provides information about a state of the medicament deliver device ([0038]; drip sensor electronics provide information of status of infusion bottle and alarm the nurse when the bottle is close to be emptied).
Pu is silent wherein the flexible magnetic shim stops a transversal rotation of the first portion relative to the second portion, wherein the magnetic locking system comprises a flexible magnetic shim, wherein the flexible magnetic shim bends to allow the second portion to move relative to the first portion when a magnetic field is applied to the flexible magnetic shim.
McKinnis teaches a locking system (Fig 9) comprising a flexible shim (catch member 100, Fig 9) wherein ),wherein the flexible shim stops (100) the transversal rotation of the first portion (62) relative to the second portion (72) (First portion 11 rotates transversally relative to the second portion 12 while opening or closing, please see Fig 9-10, Fig 19 shows the closed configuration in used); the flexible shim (100) bends to allow the second portion (72) to move relative to the first portion (62) (Fig 10)([0047]; [0049]) .
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu with similar flexible shim and orientation of the magnets as taught by McKinnis for the purpose of having a portion that is accessible to an operator after the first and second portions have been coupled to one another so that the operator may manipulate the catch member to decouple first and second portions while having a magnet biasing the first and second portion into an open configuration ([0047]; [0049]).
Pu/Mckinnis is silent wherein the flexible shim is magnetic and a magnetic field is applied to the flexible magnetic shim to bend the shim.
Cohen teaches a flexible magnetic shim (Arm 94 + magnetic compression member 92, Fig 9A-B) wherein the flexible shim is magnetic (shim has a magnetic portion 92) and when a magnetic field (magnetic field of magnetic releasing member 96, Fig 10) is applied to the flexible magnetic shim (94+92) to bend the shim (Fig 9B; Col 6, lines 35-53).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis with similar flexible and magnetic materials of shim and external magnetic releasing member as taught by Cohen to release the shim connection by magnetic means (Fig 9B; Col 6, lines 35-53).
Regarding claim 22, Pu/Mckinnis/Cohen discloses the assembly of claim 21. Pu discloses wherein the medicament delivery device (infusion bottle, [0036]) cannot be removed from the add-on component (Fig 1) when the magnetic lock is in the first state ([0036]).
Regarding claim 23, Pu/Mckinnis/Cohen discloses the assembly of claim 21. Pu is silent wherein when a magnetic field is applied to the add-on component the magnetic lock will move from the first state to a second state.
Cohen teaches a flexible magnetic shim (94+92, shim has a magnetic portion 92) wherein when a magnetic field (magnetic field of magnetic releasing member 96, Fig 10) is applied to the add-on component (Add-on comprising 94+92, Fig 9A) the magnetic lock will move from the first state (closed, Fig 9A) to a second state (open, 9B).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis/Cohen with similar flexible and magnetic materials of shim and external magnetic releasing member as taught by Cohen to release the shim connection by magnetic means (Fig 9B; Col 6, lines 35-53).
Regarding claim 24, Pu/Mckinnis/Cohen discloses the assembly of claim 23. Pu discloses wherein when the magnetic lock is in the second state (open state) the first portion (10) can be moved relative to the second portion (11) and the medicament delivery device (infusion bottle; [0012]) can be removed from the add-on component (drip liquid level alarm device, Fig 1).
Regarding claim 26, Pu/Mckinnis/Cohen discloses the assembly of claim 21. Pu discloses an add on component (Fig 1). Pu is silent wherein the flexible magnetic shim moves from a locked position to an unlocked position when a magnetic field is applied to the add-on component.
Mckinnis teaches wherein the flexible shim (100) moves from a locked position (Fig 9) to an unlocked position (Fig 10).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis/Cohen with similar flexible shim and orientation of the magnets as taught by McKinnis for the purpose of having a portion that is accessible to an operator after the first and second portions have been coupled to one another so that the operator may manipulate the catch member to decouple first and second portions while having a magnet biasing the first and second portion into an open configuration ([0047]; [0049]).
Pu/Mckinnis are silent wherein the flexible shim is magnetic and the flexible magnetic shim moves from a locked position to an unlocked position when a magnetic field is applied to the add-on component.
Cohen teaches a flexible magnetic shim (Arm 94 + magnetic compression member 92, Fig 9A-B) wherein the flexible shim is magnetic (shim has a magnetic portion 92) and the flexible magnetic shim (94+92) moves from a locked position (Fig 9) to an unlocked position (Fig 10) when a magnetic field (magnetic field of magnetic releasing member 96, Fig 10) is applied to the add-on component (magnetic field is applied to portion 92 of add-on).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis/Cohen with similar flexible and magnetic materials of shim and external magnetic releasing member as taught by Cohen to release the shim connection by magnetic means (Fig 9B; Col 6, lines 35-53).
Regarding claim 27, Pu/Mckinnis/Cohen discloses the assembly of claim 21. Pu is silent wherein a free end of the flexible magnetic shim is positioned in a cut-out or recess and prevents the first portion from moving relative to the second portion.
Mckinnis discloses wherein a free end (1003, Annotated Fig 1) of the flexible shim (100) is positioned in a cut-out or recess (receiving area 104, Fig 10) and prevents the first portion (62) from moving relative to the second portion (72).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis/Cohen with similar flexible shim, cutout and orientation of the magnets as taught by McKinnis for the purpose of having a portion that is accessible to an operator after the first and second portions have been coupled to one another so that the operator may manipulate the catch member to decouple first and second portions while having a magnet biasing the first and second portion into an open configuration ([0047]; [0049]).
Pu/Mckinnis are silent wherein the flexible shim is magnetic.
Cohen teaches a flexible magnetic shim (Arm 94 + magnetic compression member 92, Fig 9A-B).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis/Cohen with similar flexible and magnetic materials of shim and external magnetic releasing member as taught by Cohen to release the shim connection by magnetic means (Fig 9B; Col 6, lines 35-53).
Regarding claim 28, Pu/Mckinnis/Cohen discloses the assembly of claim 27. Pu discloses an add on component (Fig 1). Pu is silent wherein the free end of the flexible magnetic shim moves out of the cut-out or recess when a magnetic field is applied to the add-on component.
Mckinnis teaches wherein the free end (1003, Annotated Fig 1) of the flexible shim (100) moves out of the cut-out or recess (104).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis/Cohen with similar flexible shim, cutout as taught by McKinnis for the purpose of having a portion that is accessible to an operator after the first and second portions have been coupled to one another so that the operator may manipulate the catch member to decouple first and second portions ([0047]; [0049]).
Pu/Mckinnis is silent wherein flexible shim is magnetic and the flexible magnetic shim moves out of the cut-out or recess when a magnetic field is applied to the add-on component.
Cohen teaches the free end (92) of the flexible magnetic shim (94+92, shim has a magnetic portion 92) moves out of the cut-out or recess (recess produced by compression of 94+92) when a magnetic field (magnetic field of magnetic releasing member 96, Fig 10) is applied to the add-on component (Add-on comprising 94+92, Fig 9A).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis/Cohen with similar flexible and magnetic materials of shim and external magnetic releasing member as taught by Cohen to release the shim connection out of recess by magnetic means (Fig 9B; Col 6, lines 35-53).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Pu (CN 205339743 U) in view of McKinnis et al. (US 20140121643 A1) in further view of Cohen et al. (US 5785694 A) in further view of Faries et al. (US 20130197437 A1).
Regarding claim 18, Pu/Mckinnis/Cohen discloses the medicament delivery device add-on of claim 1. Pu discloses wherein the information comprises one or more of a use status ([0038]; drip sensor electronics provide information of status of infusion bottle and alarm the nurse when the bottle is close to be emptied).
Pu/Mckinnis/Cohen are silent wherein the information comprises a temperature.
Faries teaches a medicament delivery device add-on (temperature sensing device 260, Fig 2B) wherein the information comprises one or more of a use status and of a temperature (temperature information is provided by temperature sensor device 260 [0053]-[0054]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Pu/Mckinnis/Cohen with a temperature sensor as taught by Faries for the purpose of measuring the temperature of the infusion, which enhances patient safety by preventing vascular damage and/or hypothermia if fluids are too hot or cold ([0053]; [0059])
Claim 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Juselius (WO 9943283 A1) in view of Pu (CN 205339743 U) in further view of McKinnis et al. (US 20140121643 A1) in view of Cohen et al. (US 5785694 A).
Regarding claim 19, Juselius discloses an assembly comprising: a medicament delivery device (injection pen 1, Fig 1); and a medicament delivery device add-on (indicating device 2, Fig 1) attached to the medicament delivery device (1).
Juselius is silent regarding the medicament delivery device add-on according to claim 11.
Pu teaches a medicament delivery device add-on (Fig 1) comprising a first portion (first clamping part 10, Fig 1) and a second portion (second clamping part 11, Fig 1), the first portion (10) comprising at least one electronic component (first circuit board 14, Fig 6), wherein the first portion (10) is releasably attached to the second portion (11) by a magnetic lock ([0002]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Juselius with similar locking structure as taught by Pu for the purpose of facilitating installation ([0002])
Juselius/Pu are silent wherein the magnetic lock comprises a flexible magnetic shim having a first end attached to the first portion, wherein a second end of the flexible magnetic shim bends relative to a longitudinal axis of the magnetic shim to allow the second portion to move relative to the first portion when a magnetic field is applied to the flexible magnetic shim.
McKinnis teaches a teaches a magnetic lock (Fig 9) comprises a flexible shim (catch member 100, Fig 9) having a first end (1000, Annotated Fig 1) attached to the first portion (first portion 62, Fig 9), wherein a second end (1001, Annotated Fig 1) of the flexible shim (100) bends relative to a longitudinal axis (1002, Annotated Fig 1) of the shim (100) to allow the second portion (72) to move relative to the first portion (62) (Fig 10)([0047]; [0049]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Juselius/Pu with similar flexible shim and orientation of the magnets as taught by McKinnis for the purpose of having a portion that is accessible to an operator after the first and second portions have been coupled to one another so that the operator may manipulate the catch member to decouple first and second portions while having a magnet biasing the first and second portion into an open configuration ([0047]; [0049]).
Juselius/Pu/Mckinnis are silent wherein the flexible shim is magnetic and a magnetic field is applied to the flexible magnetic shim.
Cohen teaches a flexible magnetic shim (Arm 94 + magnetic compression member 92, Fig 9A-B) wherein the flexible shim is magnetic (shim has a magnetic portion 92) and when a magnetic field (magnetic field of magnetic releasing member 96, Fig 10) is applied to the flexible magnetic shim (94+92) (Fig 9B; Col 6, lines 35-53).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Juselius/Pu/Mckinnis with similar flexible and magnetic materials of shim and external magnetic releasing member as taught by Cohen to release the shim connection by magnetic means (Fig 9B; Col 6, lines 35-53).
Regarding claim 20, Juselius/Pu/Mckinnis/Cohen disclose the assembly according to claim 19. Juselius discloses wherein the medicament delivery device (1) is an autoinjector or a pen injector (injection pen 1, Fig 1).
Response to Arguments
Applicant's arguments filed 03/10/2026 have been fully considered but they are not persuasive. Applicant submits that Pu (CN 205339743 U) , McKinnis et al. (US 20140121643 A1) and Cohen et al. (US 5785694 A) either alone or in combination does not disclose or teach amended claim limitation: “(…) wherein the flexible magnetic shim stops a transversal rotation of the first portion relative to the second portion, (…)”.
Examiner respectfully disagrees. Please refer to rejection of claim 11 and 21. Pu/Mckinnis/Cohen as combined disclose wherein the flexible magnetic shim (100, from Mckinnis, now magnetic with teaching of Cohen) stops a transversal rotation of the first portion (10, from Pu) relative to the second portion (11, from Pu) (First portion 11 rotates transversally relative to the second portion 12 while opening or closing, please see Fig 1-2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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