$$ 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. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.— The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claims 9, 12, and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 9, the limitation “the base surface covers the through hole” in lines 2-3 renders the claim indefinite. It is unclear if “the base surface” in line 2 refers to the base surface of the flexible sleeve introduced in claim 9, line 1 (“the flexible sleeve comprises a base surface”) or the base surface of the device introduced in claim 1, line 2 (“A device…comprising: a base surface”). Additionally, it is unclear if “the through hole” in line 3 refers to the through hole of the base of the shielding element introduced in claim 8, lines 1-2 (“ the shielding element comprises a base provided with a through hole ”) or the through hole of the base surface of the device introduced in claim 1, line 3 (“A device…comprising: a base surface…comprising a through hole”). For examination purposes, the examiner has interpreted “the base surface covers the through hole” in lines 2-3 of claim 9 to be in reference to the base surface of the flexible sleeve and the through hole of the shielding element . It is suggested to amend the limitation to “the base surface of the flexible sleeve covers the through hole of the base of the shielding element ”, or similar. Claim 12 is rejected for being dependent on claim 9. Regarding claim 15, the limitation “the base surface covers the through hole” in lines 2-3 renders the claim indefinite. It is unclear if “the base surface” in line 2 refers to the base surface of the flexible sleeve introduced in claim 15, line 1 (“the flexible sleeve comprises a base surface”) or the base surface of the device introduced in claim 1, line 2 (“A device…comprising: a base surface”). Additionally, it is unclear if “the through hole” in line 3 refers to the through hole of the base of the shielding element introduced in claim 14, lines 1-2 (“ the shielding element comprises a base provided with a through hole ”) or the through hole of the base surface of the device introduced in claim 1, line 3 (“A device…comprising: a base surface…comprising a through hole”). For examination purposes, the examiner has interpreted “the base surface covers the through hole” in lines 2-3 of claim 15 to be in reference to the base surface of the flexible sleeve and the through hole of the shielding element. It is suggested to amend the limitation to “the base surface of the flexible sleeve covers the through hole of the base of the shielding element ”, or similar. Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claim s 1 and 3 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Flaherty et al. (US 20040015131) . 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) , 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]) ; 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]) ; and a cap (outlet plug 202) removably associated with the base surface at the through opening (Figure 20A) ; 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]) . Regarding claim 3 , Flaherty discloses t he 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]) . Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claim s 2 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040015131) in view of Clasen (US 20220313925) . Regarding claim 2 , Flaherty discloses t he 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]) . 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]). Regarding claim 18 , modified Flaherty teaches t he device of claim 2, 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]) . Claim s 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040015131) in view of Desbach et al. (US 20210030963). Regarding claim 4, Flaherty discloses t he device of claim 1 , wherein the cap is configured to house a structure before the protective layer is removed (Figure 20A showing at least cannula 72 housed in the plug 202). Flaherty fails to explicitly disclose 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 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; wherein the cap is configured to house the shielding element before the protective layer is removed. 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 a shielding element movable between a first operating position and a second operating position , an elastic element configured to exert a force suitable to keep the shielding element in the first operating position before removing the protective layer , and wherein the cap is configured to house the shielding element before the protective layer is removed based on the teachings of Desbach to protect the user from accidently needle sticks before or after delivery of the medicament ( Desbach [0181-0187] and Figures 39-41). Regarding claim 5 , modified Flaherty discloses t he device of claim 4, wherein the cap (outlet plug 202) is configured to house the shielding element with clearance (Figures 20A-B, showing clearance between the outlet plug 202 and cannula 72) . Claim s 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 Desbach et al. (US 20210030963) as applied in claim s 4 and 5 above, and further in view of Helmer et al. (US 20190224424). Regarding claim 6, modified Flaherty discloses t he 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 t he 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 t he 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 t he 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 t he device of claim 8 . Modified Flaherty fails to explicitly disclose the flexible sleeve comprises a base surface integrally associated with the base of the shielding element, and the 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), compri sing a base surface (proximal end surface of sealing film 50) integrally associated with the base of the shielding element (Figures 7A-7B) , and the 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 base surface integrally associated with the base of the shielding element, and the 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 t he 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 t he 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 t he device of claim 14. Modified Flaherty fails to explicitly disclose the flexible sleeve comprises a base surface integrally associated with the base of the shielding element, and the 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), compri sing a base surface (proximal end surface of sealing film 50) integrally associated with the base of the shielding element (Figures 7A-7B) , and the 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 base surface integrally associated with the base of the shielding element, and the 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 t he 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 1 7 , modified Flaherty discloses t he device of claim 1 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]). Claim s 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040015131) 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 t he 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 t he 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 s 13 is rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040015131) 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 t he 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 s 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty et al. (US 20040015131) in view of Clasen (US 20220313925) as applied in claims 2 and 18 above, and further in view of Desbach et al. (US 20210030963). Regarding claim 19, modified Flaherty discloses t he device of claim 1 8, wherein the cap is configured to house a structure before the protective layer is removed (Figure 20A showing at least cannula 72 housed in the plug 202). Modified Flaherty fails to explicitly disclose 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 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; wherein the cap is configured to house the shielding element before the protective layer is removed. 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 a shielding element movable between a first operating position and a second operating position , an elastic element configured to exert a force suitable to keep the shielding element in the first operating position before removing the protective layer , and wherein the cap is configured to house the shielding element before the protective layer is removed based on the teachings of Desbach to protect the user from accidently needle sticks before or after delivery of the medicament ( Desbach [0181-0187] and Figures 39-41). Regarding claim 20, Flaherty discloses t he device of claim 2, wherein the cap is configured to house a structure before the protective layer is removed (Figure 20A showing at least cannula 72 housed in the plug 202). Modified Flaherty fails to explicitly disclose 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 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; wherein the cap is configured to house the shielding element before the protective layer is removed. 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 a shielding element movable between a first operating position and a second operating position , an elastic element configured to exert a force suitable to keep the shielding element in the first operating position before removing the protective layer , and wherein the cap is configured to house the shielding element before the protective layer is removed based on the teachings of Desbach to protect the user from accidently needle sticks before or after delivery of the medicament ( Desbach [0181-0187] and Figures 39-41). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Hirsiger et al. (USPN 7147624) discloses a medical device (1) comprising a flexible sleeve formed by a bellows-type membrane (bellows 11) surrounding a shielding element (locking means 20). Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LEAH J SWANSON whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-0394 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9 AM- 5 PM ET . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Kevin Sirmons can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-4965 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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