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 .
Response to Amendment
The amendment filed June 16, 2026 has been entered. Claims 1-17 and 19-21 remain pending in the application. Claim 18 has been cancelled. Applicant’s amendments to the claims have overcome the rejections under 35 USC 112 previously set forth in the Non-Final Office Action mailed March 19, 2026.
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 1, 3, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040015131) in view of Kriesel et al. (USPN 6126637).
Regarding claim 1, Flaherty discloses a device (fluid delivery device 530; Figures 20A-20B) for subcutaneous delivery of a medicament, comprising:
a base surface (bottom external surface of housing 20) configured to face toward the skin of a patient when the device is applied on the skin of the patient (Figures 20A-20B), the base surface comprising a through opening (hole through outlet plug 202 extends; Figures 20A-B);
a patch (adhesive layer 22 and removable protective layer 26) comprising an adhesive layer (adhesive layer 22) and a protective layer (protective layer 26);
an injection needle (cannula 72) configured to inject the medicament to the patient when the device is applied on the skin of the patient (“needle-connection tubing terminating in a skin penetrating cannula 72 is provided as an integral part of the exit port assembly 70. The exit port assembly 70 can further be provided with injection means, such as a spring-biased mechanism driven by a shaped memory element, to inject the skin penetrating cannula 72 into a patient when the fluid delivery device 10 is correctly positioned on the patient.” [0055]), the injection needle being movable between a rest position in which the injection needle is entirely arranged within the device (Figures 20A-B) and an injection position in which the injection needle protrudes at least partially from the device through the through opening (“The exit port assembly 70 can further be provided with injection means, such as a spring-biased mechanism driven by a shaped memory element, to inject the skin penetrating cannula 72 into a patient when the fluid delivery device 10 is correctly positioned on the patient” [0055]);
a cap (outlet plug 202) removably associated with the base surface at the through opening (Figure 20A); and
wherein the cap is integrally associated with the protective layer (“The outlet plug 202 is secured to the protective layer 26 of the fluid delivery device 530 so that the plug 202 is also removed from the cannula 72 when the protective layer 26 is removed from the adhesive layer 22 for attachment of the fluid delivery device 530 to a patient.” [0107]).
Flaherty fails to explicitly disclose the device comprising a shielding element arranged around the through opening and movable between a first operating position in which the shielding element protrudes from the device and a second operating position in which the shielding element does not protrude from the device; and the cap is configured to house the shielding element in the first operating position before the protective layer is removed.
Kriesel teaches a device for subcutaneous delivery of a medicament (fluid delivery device 20), comprising: a base surface (base 22); a patch (pad assembly 28) comprising an adhesive layer (foam pad 28a “having adhesive on both sides” [Col 6, line 14]) and a protective layer (peel-away member 28b); an injection needle (hollow cannula 44); a cap (removably protective cover assembly 44) removably associated with the base surface at the through opening (“removable protective cover assembly 52 surrounds cannula 44 and cover 50. Cover assembly 52 includes a downwardly depending sheath portion 52a, the upper end of which is closely receivable within a cavity 55 formed in base 22. At time of use the cover assembly 52 can be removed from the cavity 55 as shown in FIG. 7 to expose the crushable cover 50” [Col 7, line 64 – Col 8, line 3]); and a shielding element (cover 50) arranged around the through opening (Figure 1A) and movable between a first operating position in which the shielding element protrudes from the device (Figures 1A and 7) and a second operating position in which the shielding element does not protrude from the device (Figure 8; “A downward force exerted against cover 36 will cause crushable cover 50 to crush in the manner shown in FIG. 8 allowing the needle portion 44d of the cannula to penetrate the patient's skin and tissue in the manner shown in FIG. 8.” [Col 9, lines 33-37]; and the cap is configured to house the shielding element in the first operating position before the protective layer is removed (Figure 1A; “To protect the hollow cannula and its crushable cover 50 from damage, a removable protective cover assembly 52 surrounds cannula 44 and cover 50.” [Col 7, lines 63-65]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Flaherty to include a shielding element arranged around the through opening and movable between a first operating position in which the shielding element protrudes from the device and a second operating position in which the shielding element does not protrude from the device based on the teachings of Kriesel to prevent the user from seeing the needle while maintaining sterility of the injection needle prior to use (Kriesel [Col 9, lines 33-41]) and to further modify the device of Flaherty to include that the cap is configured to house the shielding element in the first operating position before the protective layer is removed based on the teachings of Kriesel to protect the injection needle and shielding element from damage prior to use (Kriesel [Col 7, lines 63-65]).
Regarding claim 3, Flaherty discloses the device of claim 1, wherein the cap is made of a rigid material (“The outlet plug 202 is unitarily formed of a material that allows the passage of air but prevents the passage of fluid, such as an ultrahigh molecular weight polyethylene in sinstered porous form, a porous ceramic, a hydrophobic gel, a woven or non-woven polytetrafluoroethylene (PTFE) such as Teflon.RTM., or woven fabric material having very small openings (e.g., 0.02 microns) such as Gortex.RTM..” [0078]).
Regarding claim 21, modified Flaherty discloses the device of claim 1, wherein the adhesive layer is integrally associated with the base surface and is configured to be attached to the skin of the patient upon removal of the protective layer (“The fluid delivery device 530 of FIGS. 20 and 20b includes an adhesive layer 22 on a bottom external surface of the housing 20 for securing the device 530 to a patient, and a removable protective layer 26 covering the adhesive layer 22 prior to attachment of the fluid delivery device 530 to a patient…the protective layer 26 is removed from the adhesive layer 22 for attachment of the fluid delivery device 530 to a patient.” [0107]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040015131) in view of Kriesel et al. (USPN 6126637) as applied in claim 1 above, and further in view of Clasen (US 20220313925).
Regarding claim 2, modified Flaherty discloses the device of claim 1, wherein the cap (outlet plug 202) comprises a collar (bottom extending portion of plug 202) integrally associated with a portion of the protective layer (“The outlet plug 202 is secured to the protective layer 26 of the fluid delivery device 530” [0107]).
Modified Flaherty fails to explicitly disclose the collar is integrally associated with a portion of the protective layer by interposition of a double-sided adhesive element.
Clasen discloses a device of subcutaneous delivery of a medicament (drug delivery system 10), comprising a base surface (bottom portion 24), a patch (adhesive pad element 200) comprising an adhesive layer (adhesive layer 202) and a protective layer (liner 204), and a cap (needle shield remover 208) comprising a collar (base portion 214) integrally associated with a portion of the protective layer by interposition of a double-sided adhesive element (“The base portion 214 may be coupled to the liner 204 of the adhesive pad element 200 via any suitable method such as, e.g., an adhesive, a mechanical connection, etc” [0054]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the collar of the cap of Flaherty to be integrally associated with a portion of the protective layer by interposition of a double-sided adhesive element based on the teachings of Casen to secure the cap to the protective layer in a manner that ensure the cap is removed when the protective layer is removed (Clasen [0053-0054]).
Claims 4-5 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040015131) in view of Kriesel et al. (USPN 6126637) as applied in claims 1 and 3 above, and further in view of Desbach et al. (US 20210030963).
Regarding claim 4, modified Flaherty discloses the device of claim 1.
Flaherty fails to explicitly disclose an elastic element configured to exert a force on the shielding element, the force being suitable to keep the shielding element in the first operating position before removing the protective layer.
Desbach discloses a device for subcutaneous delivery of a medicament (drug delivery device 10; Figures 39-41), comprising a base surface (distal surface 11.1) comprising a through opening (through which shroud 13 extends; Figures 39-41); further comprising a shielding element (shroud 13) arranged around the through opening and movable between a first operating position (Figure 39) in which the shielding element protrudes from the device (“FIG. 39, the shroud 13 is in its extended position” [0184]) and a second operating position (Figures 40-41) in which the shielding element does not protrude from the device (“FIG. 40 is a schematic view of the drug delivery device 10 placed against an injection site with the shroud 13 ahead. The shroud 13 has hence been moved in the proximal direction P into the retracted position” [0185]); and an elastic element (shroud spring 50) configured to exert a force on the shielding element, the force being suitable to keep the shielding element in the first operating position before removing a protective layer (“The shroud 13 is biased towards the extended position by a shroud spring 50.” [0181]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Flaherty to include an elastic element configured to exert a force suitable to keep the shielding element in the first operating position before removing the protective layer based on the teachings of Desbach to protect the user from accidently needle sticks both before and after delivery of the medicament (Desbach [0181-0187] and Figures 39-41).
Regarding claim 5, modified Flaherty discloses the device of claim 4.
Modified Flaherty fails to explicitly disclose the cap is configured to house the shielding element with clearance.
Kriesel teaches a device for subcutaneous delivery of a medicament (fluid delivery device 20), comprising: a base surface (base 22); an injection needle (hollow cannula 44); a cap (removably protective cover assembly 44); and a shielding element (cover 50); wherein the cap is configured to house the shielding element with clearance (Figure 1A; “To protect the hollow cannula and its crushable cover 50 from damage, a removable protective cover assembly 52 surrounds cannula 44 and cover 50.” [Col 7, lines 63-65]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the device of Flaherty to include the cap is configured to house the shielding element with clearance based on the teachings of Kriesel to protect the injection needle and shielding element from damage prior to use (Kriesel [Col 7, lines 63-65]).
Regarding claim 19, modified Flaherty discloses the device of claim 3.
Modified Flaherty fails to explicitly disclose an elastic element configured to exert a force on the shielding element, the force being suitable to keep the shielding element in the first operating position before removing the protective layer.
Desbach discloses a device for subcutaneous delivery of a medicament (drug delivery device 10; Figures 39-41), comprising a base surface (distal surface 11.1) comprising a through opening (through which shroud 13 extends; Figures 39-41); further comprising a shielding element (shroud 13) arranged around the through opening and movable between a first operating position (Figure 39) in which the shielding element protrudes from the device (“FIG. 39, the shroud 13 is in its extended position” [0184]) and a second operating position (Figures 40-41) in which the shielding element does not protrude from the device (“FIG. 40 is a schematic view of the drug delivery device 10 placed against an injection site with the shroud 13 ahead. The shroud 13 has hence been moved in the proximal direction P into the retracted position” [0185]); and an elastic element (shroud spring 50) configured to exert a force on the shielding element, the force being suitable to keep the shielding element in the first operating position before removing a protective layer (“The shroud 13 is biased towards the extended position by a shroud spring 50.” [0181]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Flaherty to include an elastic element configured to exert a force suitable to keep the shielding element in the first operating position before removing the protective layer based on the teachings of Desbach to protect the user from accidently needle sticks both before and after delivery of the medicament (Desbach [0181-0187] and Figures 39-41).
Claims 6-9 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040015131) in view of Kriesel et al. (USPN 6126637) further in view of Desbach et al. (US 20210030963) as applied in claims 4 and 5 above, and further in view of Helmer et al. (US 20190224424).
Regarding claim 6, modified Flaherty discloses the device of claim 4.
Modified Flaherty fails to explicitly disclose a flexible sleeve connected to the device around the through opening and the shielding element to form a water-tight seal, the flexible sleeve being integrally associated with the shielding element.
Helmer discloses a device for delivery of medicament (drug delivery device 10) comprising a base surface (body of device 10) having a through opening (Figures 1B), an injection needle (injection needle 17), a cap (outer cap 35), a shielding element (needle shield 26; Figures 7A-7B), and further comprising a flexible sleeve (sealing film 50) connected to the device around the through opening (Figure 7A; “The needle assembly 16 is configured to be releasably connected to the device 10. To this end, the injection needle holder 27 comprises a guiding element 36 configured to engage a corresponding guiding element (not shown) in the body of the device 10.” [0066]) and the shielding element to form a water-tight seal (“The flexible shielding tube 48 forming the needle shield 26 is fixed to the needle supporting portion 28 at one end and sealed by a sealing film 50 at the opposite end.” [0079]), the flexible sleeve being integrally associated with the shielding element (Figure 7A).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Flaherty to include a flexible sleeve based on the teachings of Helmer to ensure that the injection needle remains sterile prior to use of the device (Helmer [0060], [0079]).
Regarding claim 7, modified Flaherty discloses the device of claim 6, wherein the cap (outlet plug 202) have a truncated conical shape (Figures 20A-B, wherein the bottom portion of the plug 202 is a truncated conical shape).
Modified Flaherty fails to explicitly disclose wherein the flexible sleeve is defined by a bellows-type membrane, and the membrane has a truncated conical shape.
Helmer discloses a device for delivery of medicament (drug delivery device 10) comprising a base surface (body of device 10) having a through opening (Figures 1B), an injection needle (injection needle 17), a cap (outer cap 35), a shielding element (needle shield 26 formed of flexible shielding tube 48; Figures 7A-7B), and further comprising a flexible sleeve (sealing film 50) defined by a bellows-type membrane (Figure 7B showing the film 50 functioning as a bellows when in the retracted position and a “sealing film” is a membrane), and the membrane has a truncated conical shape (Figure 7A showing the proximal-most end of the film 50 conically shaped as the sides come to the proximal end).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Flaherty to include a flexible sleeve defined by a bellows-type membrane having a truncated conical shape based on the teachings of Helmer to ensure that the injection needle remains sterile prior to use of the device (Helmer [0060], [0079]) and to ensure that the shielding element and flexible sleeve fit within the cap (Helmer [0065]).
Regarding claim 8, modified Flaherty discloses the device of claim 6.
Modified Flaherty fails to explicitly disclose the shielding element comprises a base provided with a through hole configured to allow passage of the injection needle during movement of the injection needle between the rest position and the injection position, and the flexible sleeve is integrally associated with the base.
Helmer discloses a device for delivery of medicament (drug delivery device 10) comprising a base surface (body of device 10) having a through opening (Figures 1B), an injection needle (injection needle 17), a cap (outer cap 35), a shielding element (needle shield 26 formed of flexible shielding tube 48; Figures 7A-7B), and a flexible sleeve (sealing film 50), wherein the shielding element comprises a base (proximal end of flexible shielding tube 48) provided with a through hole configured to allow passage of the injection needle during movement of the injection needle between a rest position (Figure 7A) and an injection position (Figure 7B, see all of [0079]), and the flexible sleeve is integrally associated with the base (Figure 7A-B).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Flaherty to include the shielding element comprises a base provided with a through hole configured to allow passage of the injection needle during movement of the injection needle between the rest position and the injection position, and the flexible sleeve is integrally associated with the base based on the teachings of Helmer to ensure that the injection needle remains sterile and is protected prior to use of the device (Helmer [0009], [0060], [0079]).
Regarding claim 9, modified Flaherty discloses the device of claim 8.
Modified Flaherty fails to explicitly disclose the flexible sleeve comprises a second base surface integrally associated with the base of the shielding element, and the second base surface covers the through hole and is pierceable by the injection needle when the injection needle moves from the rest position to the injection position.
Helmer discloses a device for delivery of medicament (drug delivery device 10) comprising a base surface (body of device 10) having a through opening (Figures 1B), an injection needle (injection needle 17), a cap (outer cap 35), a shielding element (needle shield 26 formed of flexible shielding tube 48; Figures 7A-7B), and a flexible sleeve (sealing film 50), comprising a second base surface (proximal end surface of sealing film 50) integrally associated with the base of the shielding element (Figures 7A-7B), and the second base surface covers the through hole and is pierceable by the injection needle when the injection needle moves from the rest position to the injection position (“The shielding tube 48 is arranged relative to the needle 17 in such a way that the proximal end 18 pierces the sealing film 50 of the shielding tube 48 when the shielding tube 48 moves from the shielding position towards the retracted position.” [0079]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Flaherty to include the flexible sleeve comprises a second base surface integrally associated with the base of the shielding element, and the second base surface covers the through hole and is pierceable by the injection needle when the injection needle moves from the rest position to the injection position based on the teachings of Helmer to ensure that the injection needle remains sterile and is protected prior to use of the device (Helmer [0009], [0060], [0079]).
Regarding claim 14, modified Flaherty discloses the device of claim 7.
Modified Flaherty fails to explicitly disclose the shielding element comprises a base provided with a through hole configured to allow passage of the injection needle during movement of the injection needle between the rest position and the injection position, and the flexible sleeve is integrally associated with the base.
Helmer discloses a device for delivery of medicament (drug delivery device 10) comprising a base surface (body of device 10) having a through opening (Figures 1B), an injection needle (injection needle 17), a cap (outer cap 35), a shielding element (needle shield 26 formed of flexible shielding tube 48; Figures 7A-7B), and a flexible sleeve (sealing film 50), wherein the shielding element comprises a base (proximal end of flexible shielding tube 48) provided with a through hole configured to allow passage of the injection needle during movement of the injection needle between a rest position (Figure 7A) and an injection position (Figure 7B, see all of [0079]), and the flexible sleeve is integrally associated with the base (Figure 7A-B).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Flaherty to include the shielding element comprises a base provided with a through hole configured to allow passage of the injection needle during movement of the injection needle between the rest position and the injection position, and the flexible sleeve is integrally associated with the base based on the teachings of Helmer to ensure that the injection needle remains sterile and is protected prior to use of the device (Helmer [0009], [0060], [0079]).
Regarding claim 15, modified Flaherty discloses the device of claim 14.
Modified Flaherty fails to explicitly disclose the flexible sleeve comprises a second base surface integrally associated with the base of the shielding element, and the second base surface covers the through hole and is pierceable by the injection needle when the injection needle moves from the rest position to the injection position.
Helmer discloses a device for delivery of medicament (drug delivery device 10) comprising a base surface (body of device 10) having a through opening (Figures 1B), an injection needle (injection needle 17), a cap (outer cap 35), a shielding element (needle shield 26 formed of flexible shielding tube 48; Figures 7A-7B), and a flexible sleeve (sealing film 50), comprising a second base surface (proximal end surface of sealing film 50) integrally associated with the base of the shielding element (Figures 7A-7B), and the second base surface covers the through hole and is pierceable by the injection needle when the injection needle moves from the rest position to the injection position (“The shielding tube 48 is arranged relative to the needle 17 in such a way that the proximal end 18 pierces the sealing film 50 of the shielding tube 48 when the shielding tube 48 moves from the shielding position towards the retracted position.” [0079]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Flaherty to include the flexible sleeve comprises a second base surface integrally associated with the base of the shielding element, and the second base surface covers the through hole and is pierceable by the injection needle when the injection needle moves from the rest position to the injection position based on the teachings of Helmer to ensure that the injection needle remains sterile and is protected prior to use of the device (Helmer [0009], [0060], [0079]).
Regarding claim 16, modified Flaherty discloses the device of claim 5.
Modified Flaherty fails to explicitly disclose a flexible sleeve connected to the device around the through opening and the shielding element to form a water-tight seal, the flexible sleeve being integrally associated with the shielding element.
Helmer discloses a device for delivery of medicament (drug delivery device 10) comprising a base surface (body of device 10) having a through opening (Figures 1B), an injection needle (injection needle 17), a cap (outer cap 35), a shielding element (needle shield 26; Figures 7A-7B), and further comprising a flexible sleeve (sealing film 50) connected to the device around the through opening (Figure 7A; “The needle assembly 16 is configured to be releasably connected to the device 10. To this end, the injection needle holder 27 comprises a guiding element 36 configured to engage a corresponding guiding element (not shown) in the body of the device 10.” [0066]) and the shielding element to form a water-tight seal (“The flexible shielding tube 48 forming the needle shield 26 is fixed to the needle supporting portion 28 at one end and sealed by a sealing film 50 at the opposite end.” [0079]), the flexible sleeve being integrally associated with the shielding element (Figure 7A).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Flaherty to include a flexible sleeve based on the teachings of Helmer to ensure that the injection needle remains sterile prior to use of the device (Helmer [0060], [0079]).
Regarding claim 17, modified Flaherty discloses the device of claim 16, wherein the cap (outlet plug 202) have a truncated conical shape (Figures 20A-B, wherein the bottom portion of the plug 202 is a truncated conical shape).
Modified Flaherty fails to explicitly disclose wherein the flexible sleeve is defined by a bellows-type membrane, and the membrane has a truncated conical shape.
Helmer discloses a device for delivery of medicament (drug delivery device 10) comprising a base surface (body of device 10) having a through opening (Figures 1B), an injection needle (injection needle 17), a cap (outer cap 35), a shielding element (needle shield 26 formed of flexible shielding tube 48; Figures 7A-7B), and further comprising a flexible sleeve (sealing film 50) defined by a bellows-type membrane (Figure 7B showing the film 50 functioning as a bellows when in the retracted position and a “sealing film” is a membrane), and the membrane has a truncated conical shape (Figure 7A showing the proximal-most end of the film 50 conically shaped as the sides come to the proximal end).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Flaherty to include a flexible sleeve defined by a bellows-type membrane having a truncated conical shape based on the teachings of Helmer to ensure that the injection needle remains sterile prior to use of the device (Helmer [0060], [0079]) and to ensure that the shielding element and flexible sleeve fit within the cap (Helmer [0065]).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040015131) in view of Kriesel et al. (USPN 6126637) further in view of Desbach et al. (US 20210030963) further in view of Helmer et al. (US 20190224424) as applied in claims 8 and 9 above, and further in view of Shemesh et al. (US 20210361237).
Regarding claims 10-11, modified Flaherty discloses the device of claim 8.
Modified Flaherty fails to explicitly disclose a position sensor configured to detect a contact of the device with the skin of the patient, the position sensor comprising a magnet integrally connected to the shielding element and a Hall effect sensor arranged in the device proximate the magnet, as required by claim 10; and wherein the magnet is integrally connected to the base, as required by claim 11.
Shemesh teaches a medical device (measuring device MD) comprising a base surface (“Stationary members 1494′ and 1494″ are formed on a stationary plate 1496, e.g. a PCB of the motherboard of the measuring device MD.” [0177]), a shielding element (skin contact surface 1402 and displaceable plate 1498) having a base (displaceable plate 1498), and further comprising a position sensor configured to detect a contact of the device with the skin of the patient (“Hall-effect measurement data that is generated by each sensing pair is indicative of the displacement of the contact surface 1402 that is resulted from skin movement of the subject.” [0177]), the position sensor comprising a magnet (“the displaceable members 1492′ and 1492″ may be configured as constant magnets” [0177]) integrally connected to the base of the shielding element (“The contact surface 1402 is displaceable together with a displaceable plate 1498, which displaceable members 1492′ and 1492″ of Hall-effect sensing pairs are formed thereon” [0177]) and a Hall effect sensor arranged in the device proximate the magnet (“stationary members 1494′ and 1494″ may be configured as Hall-effect sensors.” [0177]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Flaherty to include a position sensor comprising a magnet and a Hall effect sensor, wherein the magnet is integrally connected to the base of the shielding element based on the teachings of Shemesh to indicate movement of the shielding device, such as when contacting the skin (Shemesh [0177]).
Regarding claim 12, modified Flaherty discloses the device of claim 9.
Modified Flaherty fails to explicitly disclose a position sensor configured to detect a contact of the device with the skin of the patient, the position sensor comprising a magnet integrally connected to the shielding element and a Hall effect sensor arranged in the device proximate the magnet.
Shemesh teaches a medical device (measuring device MD) comprising a base surface (“Stationary members 1494′ and 1494″ are formed on a stationary plate 1496, e.g. a PCB of the motherboard of the measuring device MD.” [0177]), a shielding element (skin contact surface 1402 and displaceable plate 1498), and further comprising a position sensor configured to detect a contact of the device with the skin of the patient (“Hall-effect measurement data that is generated by each sensing pair is indicative of the displacement of the contact surface 1402 that is resulted from skin movement of the subject.” [0177]), the position sensor comprising a magnet (“the displaceable members 1492′ and 1492″ may be configured as constant magnets” [0177]) integrally connected to the shielding element (“The contact surface 1402 is displaceable together with a displaceable plate 1498, which displaceable members 1492′ and 1492″ of Hall-effect sensing pairs are formed thereon” [0177]) and a Hall effect sensor arranged in the device proximate the magnet (“stationary members 1494′ and 1494″ may be configured as Hall-effect sensors.” [0177]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Flaherty to include a position sensor comprising a magnet integrally connected to the shielding element and a Hall effect sensor based on the teachings of Shemesh to indicate movement of the shielding device, such as when contacting the skin (Shemesh [0177]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040015131) in view of Kriesel et al. (USPN 6126637) further in view of Desbach et al. (US 20210030963) as applied in claim 4 above, and further in view of Shemesh et al. (US 20210361237).
Regarding claim 13, modified Flaherty discloses the device of claim 4.
Modified Flaherty fails to explicitly disclose a position sensor configured to detect a contact of the device with the skin of the patient, the position sensor comprising a magnet integrally connected to the shielding element and a Hall effect sensor arranged in the device proximate the magnet.
Shemesh teaches a medical device (measuring device MD) comprising a base surface (“Stationary members 1494′ and 1494″ are formed on a stationary plate 1496, e.g. a PCB of the motherboard of the measuring device MD.” [0177]), a shielding element (skin contact surface 1402 and displaceable plate 1498), and further comprising a position sensor configured to detect a contact of the device with the skin of the patient (“Hall-effect measurement data that is generated by each sensing pair is indicative of the displacement of the contact surface 1402 that is resulted from skin movement of the subject.” [0177]), the position sensor comprising a magnet (“the displaceable members 1492′ and 1492″ may be configured as constant magnets” [0177]) integrally connected to the shielding element (“The contact surface 1402 is displaceable together with a displaceable plate 1498, which displaceable members 1492′ and 1492″ of Hall-effect sensing pairs are formed thereon” [0177]) and a Hall effect sensor arranged in the device proximate the magnet (“stationary members 1494′ and 1494″ may be configured as Hall-effect sensors.” [0177]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Flaherty to include a position sensor comprising a magnet integrally connected to the shielding element and a Hall effect sensor based on the teachings of Shemesh to indicate movement of the shielding device, such as when contacting the skin (Shemesh [0177]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040015131) in view of Kriesel et al. (USPN 6126637) further in view of Clasen (US 20220313925) as applied in claim 2 above, and further in view of Desbach et al. (US 20210030963).
Regarding claim 20, Flaherty discloses the device of claim 2.
Modified Flaherty fails to explicitly disclose an elastic element configured to exert a force on the shielding element, the force being suitable to keep the shielding element in the first operating position before removing the protective layer.
Desbach discloses a device for subcutaneous delivery of a medicament (drug delivery device 10; Figures 39-41), comprising a base surface (distal surface 11.1) comprising a through opening (through which shroud 13 extends; Figures 39-41); further comprising a shielding element (shroud 13) arranged around the through opening and movable between a first operating position (Figure 39) in which the shielding element protrudes from the device (“FIG. 39, the shroud 13 is in its extended position” [0184]) and a second operating position (Figures 40-41) in which the shielding element does not protrude from the device (“FIG. 40 is a schematic view of the drug delivery device 10 placed against an injection site with the shroud 13 ahead. The shroud 13 has hence been moved in the proximal direction P into the retracted position” [0185]); and an elastic element (shroud spring 50) configured to exert a force on the shielding element, the force being suitable to keep the shielding element in the first operating position before removing a protective layer (“The shroud 13 is biased towards the extended position by a shroud spring 50.” [0181]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the device of Flaherty to include an elastic element configured to exert a force suitable to keep the shielding element in the first operating position before removing the protective layer based on the teachings of Desbach to protect the user from accidently needle sticks both before and after delivery of the medicament (Desbach [0181-0187] and Figures 39-41).
Response to Arguments
Applicant’s arguments with respect to claims 1-17 and 19-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Cowe et al. (USPN 11400215) discloses a device for subcutaneous delivery of a medicament (100), comprising a base surface (111); an injection needle (16) movable between a rest position (Figures 9a-b) and an injection position (Figure 12); and a shielding element (172) movable between a first operating position (Figure 9a) and a second operating position (Figure 9b).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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