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 § 102
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) 20-27 and 32-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hao (WO 2021046680 A1).
Regarding claim 20, Hao discloses a drug delivery arrangement (Fig. 1), comprising: a drug delivery device (Fig. 1 injection device 100) having a housing (Fig. 1 host 102), the housing being provided to receive a drug container (Fig. 1 syringe 107) and a needle (Fig. needle 106), and a tissue receiving element (Fig. 1 injection site holder 101) having a needle passage opening (see opening in Fig. 1 where needle passes through to contact the epidermis 103) and a tissue receiving portion (see ‘Modified Fig. 1’ below, tissue receiving portion), wherein: the tissue receiving element is arranged to contact a skin (see top layer of skin which is Fig. 1 epidermis 103) of a patient (p. 6, line 34, user) during use of the drug delivery arrangement, the tissue receiving portion extends in a distal direction away (see the members of 101 members extending outward in a distal direction away from the opening in Fig. 1) from the needle passage, the drug delivery arrangement is configured such that the needle passage opening and the needle are movable relative to one another (see ability to move relative to one another in p. 6, line 23, perform an injection process on the fixed injection site) from a first position (p. 6, line 25, fixing the epidermis 103 and subcutaneous tissue 104 of the injection site), in which the needle is arranged outside of the tissue receiving portion, into a second position (p. 6, line 35, puncture of the needle 106), in which the needle is arranged within the tissue receiving portion, the needle enters the tissue receiving portion during the relative movement from the first position into the second position to penetrate (p. 6, line 35, puncture) tissue ( Fig. 1 subcutaneous tissue 104) arranged in the tissue receiving portion, the tissue receiving element is configured to interact with the skin in order to fill the tissue receiving portion with tissue of the patient, and the tissue receiving element is part of or attachable (see 101 part of or attached to 100 in Fig. 1) to the drug delivery device.
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Regarding claim 21, Hao discloses the tissue receiving portion has a larger diameter in a distal end region (see larger diameter of tissue receiving portion compared to the needle passage opening in a distal end region near the injection site in ‘Modified Fig. 1’ above) than the needle passage opening.
Regarding claim 22, Hao discloses the tissue receiving element comprises a wall (see ‘Modified Fig. 1’ above, wall) extending in the distal direction (see wall extending out distally from the device in Fig. 1) as seen from the needle passage, and the tissue receiving portion is laterally delimited (see lateral delimiting in Fig. 1 with wall pressed against tissue injection site) by an inner surface (see surface of the wall where contact is made is an inner surface in Hao, Fig. 1) of the wall.
Regarding claim 23, Hao discloses the tissue receiving element comprises arms (see ‘Modified Fig. 1’ above, arms) defining the wall, and wherein the arms are diametrically opposed in a radial direction (see diametrically opposed in a radial direction in ‘Modified Fig. 1’ above with positioning and direction of arms) of the drug delivery arrangement.
Regarding claim 24, Hao discloses the wall has a U-shaped cross section (see ‘Modified Fig. 1’ above, U-shaped cross-section).
Regarding claim 25, Hao discloses the drug delivery arrangement comprises a needle shroud (see ‘Modified Fig. 1’ above, needle shroud) with a needle shroud body, and the tissue receiving element is arranged at a distal end of the needle shroud body or attachable to the distal end of the needle shroud body (see such attachment in ‘Modified Fig. 1’ above).
Regarding claim 26, Hao discloses the tissue receiving element is detachably connected (see such connection in ‘Modified Fig. 1’ above) to the needle shroud body.
Regarding claim 27, Hao discloses the tissue receiving element (101) is a distal end portion (see distal end portion of 102 close to injection site in Fig. 1) of the housing (102).
Regarding claim 32, Hao discloses the needle is movable relative (see ability to move relative p. 6, line 23, perform an injection process on the fixed injection site) to the housing.
Regarding claim 33, Hao discloses the drug delivery device is an auto-injector (see abstract section where injection device being “an auto-injector” is described in a “main unit (102, 411, 511, 811)” is “configured to automatically perform an injection procedure at the fixed injection site”) and/or wherein the drug delivery arrangement comprises a cap, and the cap comprises recesses in a radial direction which are suitable for receiving a portion of the tissue receiving element.
Regarding claim 34, Hao discloses the drug container (107) is a syringe (107), and/or wherein the drug delivery arrangement comprises a cap, and the cap comprises a needle shield remover.
Regarding claim 35, Hao discloses the tissue receiving portion tapers continuously (see continuous tapering as the tissue receiving portion tappers inward toward needle passage opening in Fig. 1) as seen from its distal end (see distal end tissue receiving portion close to injection site in Fig. 1) towards the needle passage opening.
Regarding claim 36, Hao discloses a drug delivery arrangement (Hao, Fig. 1), comprising: a drug delivery device (Hao, 100) having a housing (Hao, 102), the housing being provided to receive a drug container (Hao, 107) and a needle (Hao, 106), and a tissue receiving element (Hao, 101) having a needle passage opening (see opening in Hao, Fig. 1 where needle passes through to contact the epidermis 103) and a tissue receiving portion (see Hao, ‘Modified Fig. 1’ below, tissue receiving portion), wherein: the tissue receiving element is arranged to contact a skin (see top layer of skin which is Hao, Fig. 1 epidermis 103) of a patient (Hao, p. 6, line 34, user) during use of the drug delivery arrangement, the tissue receiving portion extends in a distal direction away (see the members of 101 members extending outward in a distal direction away from the opening in Hao, Fig. 1) from the needle passage opening the drug delivery arrangement is configured such that the needle passage opening and the needle are movable relative to one another (see ability to move relative to one another in Hao, p. 6, line 23, perform an injection process on the fixed injection site) from a first position, in which the needle is arranged outside of the tissue receiving portion, into a second position (Hao, p. 6, line 25, fixing the epidermis 103 and subcutaneous tissue 104 of the injection site), in which the needle is arranged within the tissue receiving portion, the needle enters the tissue receiving portion during the relative movement from the first position into the second position to penetrate (Hao, p. 6, line 35, puncture) tissue (Hao, Fig. 1 subcutaneous tissue 104) arranged in the tissue receiving portion, the tissue receiving element is configured to interact with the skin in order to fill the tissue receiving portion with tissue of the patient, the tissue receiving element is part of or attachable (see 101 part of or attached to 100 in Hao, Fig. 1) to the drug delivery device, the tissue receiving element comprises a wall (see Hao, ‘Modified Fig. 1’ above, wall) extending in the distal direction (see wall extending out distally from the device in Hao, Fig. 1) as seen from the needle passage opening, the tissue receiving portion is laterally delimited (see lateral delimiting in Hao, Fig. 1 with wall pressed against tissue injection site) by an inner surface (see surface of the wall where contact is made is an inner surface in Hao, Fig. 1) of the wall, the drug delivery arrangement comprises a needle shroud (see ‘Modified Fig. 1’ above, needle shroud) with a needle shroud body, and the tissue receiving element is arranged at a distal end of the needle shroud body or attachable to the distal end of the needle shroud body (see such attachment in ‘Modified Fig. 1’ above). discloses the drug delivery arrangement comprises a needle shroud (see ‘Modified Fig. 1’ above, needle shroud) with a needle shroud body, and the tissue receiving element is arranged at a distal end of the needle shroud body or attachable to the distal end of the needle shroud body (see such attachment in ‘Modified Fig. 1’ above).
Regarding claim 37, Hao discloses the drug delivery device comprises the drug container (107).
Regarding claim 38, Hao discloses the drug container comprises a medicament (see “inject a preset dose” (p. 14, line 8) in step 1010 in Fig. 10 which can be performed using “an embodiment of the present disclosure” (p. 5, line 30-31)).
Regarding claim 39, Hao discloses a method of delivering a medicament (see “inject a preset dose” (p. 14, line 8) in step 1010 in Fig. 10 which can be performed using “an embodiment of the present disclosure” (p. 5, line 30-31)) from a drug delivery device, the method comprising using the drug delivery device according to claim 38 (see according to claim 38 as described above).
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.
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Hao (WO 2021046680 A1)
Regarding claim 28, the embodiment of Fig. 1 of Hao does not explicitly mention the drug delivery arrangement further comprises: an energy storage unit having energy stored therein for driving a plunger in the distal direction relative to the housing to dispense a dose of drug from the drug container, and a plunger release mechanism configured to have a first state and a second state, wherein the stored energy of the energy storage unit is released when the plunger release mechanism is in the second state. However, the embodiment of Fig. 4 of Hao teaches the drug delivery arrangement (Fig. 4) further comprises: an energy storage unit (Fig. 4 driving mechanism 403) having energy stored therein (see driving mechanism 403 which has energy stored within to drive dose adjustment mechanism 402 to move as described in p. 9, line 4-5) for driving a plunger (p. 9, line 5, piston) in the distal direction (see piston being pushed to inject the medicine into the subcutaneous tissue which is in the distal direction as described in p. 9, lines 4-6) relative to the housing (Fig. 4 host 411) to dispense a dose of drug (p. 9, line 5, medicine) from the drug container (Fig. 4 syringe 404), and a plunger release mechanism (402) configured to have a first state (p. 9, line 4-5, drive mechanism 403 drives the dose adjustment mechanism 402 of the syringe 404) and a second state (p. 9, line 5-6, the dose adjustment mechanism 402 will push the piston in the pen core correspondingly injects the medicine in the pen core into the subcutaneous tissue), wherein the stored energy of the energy storage unit is released when the plunger release mechanism is in the second state.
It would have been obvious before the effective filing date of the claimed invention to modify the embodiment of Fig. 1 of Hao to include the drug delivery arrangement further comprises: an energy storage unit having energy stored therein for driving a plunger in the distal direction relative to the housing to dispense a dose of drug from the drug container, and a plunger release mechanism configured to have a first state and a second state, wherein the stored energy of the energy storage unit is released when the plunger release mechanism is in the second state, as taught by the embodiment of Fig. 4 of Hao, as the embodiment of Fig. 4 of Hao teaches “invalid or wrong injection site fixation, acupuncture and injection operations without a preset injection dose can be avoided, thereby saving energy consumption and improving safety” (Hao, p.8, line 52 to p. 9, line 2). Such a modification would contribute to help further avoid invalid or improper injection operations and unnecessary expenditure of stored energy, thereby saving energy consumption and improving safety.
Regarding claim 29, the embodiment of Fig. 1 of Hao does not explicitly mention the drug delivery device is configured such that the plunger release mechanism is switched from the first state to the second state after the needle is moved relative to the needle passage opening from the first position to the second position. However, the embodiment of Fig. 4 of Hao teaches the drug delivery device (p. 8, line 11, injection device) is configured such that the plunger release mechanism (402) is switched from the first state (p. 9, line 4-5, drive mechanism 403 drives the dose adjustment mechanism 402 of the syringe 404) to the second state (p. 9, line 5-6, the dose adjustment mechanism 402 will push The piston in the pen core correspondingly injects the medicine in the pen core into the subcutaneous tissue) after the needle (Fig. 4 needle 414) is moved relative to the needle passage (see opening in Fig. 4 where needle passes through to contact the injection site) opening from the first position (p. 8, lines 47-48, the injection site fixer 409 is activated to perform fixation) to the second position (p. 9, lines 6-7, when the preset injection dose is injected into the subcutaneous tissue).
It would have been obvious before the effective filing date of the claimed invention to modify the embodiment of Fig. 1 of Hao to include the drug delivery device is configured such that the plunger release mechanism is switched from the first state to the second state after the needle is moved relative to the needle passage opening from the first position to the second position, as taught by the embodiment of Fig. 4 of Hao, as the embodiment of Fig. 4 of Hao teaches “invalid or wrong injection site fixation, acupuncture and injection operations without a preset injection dose can be avoided, thereby saving energy consumption and improving safety” (Hao, p.8, line 52 to p. 9, line 2). Such a modification would contribute to help further avoid invalid or improper injection operations and unnecessary expenditure of stored energy, thereby saving energy consumption and improving safety.
Regarding claim 31, the embodiment of Fig. 1 of Hao in view of the embodiment of Fig. 4 of Hao discloses the needle is fixed relative (see such relative fixation in the way the needle is fixed to the housing in Fig. 1) to the housing.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Hao (WO 2021046680 A1) in view of Haralsted et al. (US 20180243498 A1).
Regarding claim 30, the embodiment of Fig. 1 of Hao in view of the embodiment of Fig. 4 of Hao does not explicitly mention the drug delivery arrangement comprises a needle shroud, the needle shroud is axially movable relative to the housing from a first needle shroud position to a second needle shroud position, and the plunger release mechanism is configured such that the plunger release mechanism is switched from the first state to the second state after the needle shroud is moved from the first needle shroud position to the second needle shroud position. However, Haralsted teaches the drug delivery arrangement (Haralsted, Fig. 1) comprises a needle shroud (Haralsted, Fig. 1 needle shield assembly 40), the needle shroud is axially movable relative (see Haralsted, p. 6, col 1, [0105], lines 1-2, during axial movement of the needle shield assembly 40 in the proximal direction) to the housing (Haralsted, Fig. 1 housing 20) from a first needle shroud position (see needle shield in first position in Haralsted, Fig. 1) to a second needle shroud position (see needle shield in second position in Haralsted, Fig. 2), and the plunger release mechanism ([0076], drive mechanism) is configured such that the plunger release mechanism is switched from the first state (p. 3, col 2, [0044], lines 12-13, the plunger or piston can be slidable moved inside the cartridge) to the second state (p. 3, col 2, [0044], lines 13-16, the space between the pierceable membrane and the movable plunger holds the drug which is pressed out as the plunger decreased the volume of the space holding the drug) after the needle shroud is moved from the first needle shroud position to the second needle shroud position.
It would have been obvious before the effective filing date of the claimed invention to modify Hao to include the drug delivery arrangement comprises a needle shroud, the needle shroud is axially movable relative to the housing from a first needle shroud position to a second needle shroud position, and the plunger release mechanism is configured such that the plunger release mechanism is switched from the first state to the second state after the needle shroud is moved from the first needle shroud position to the second needle shroud position, as taught by Haralsted, as Haralsted teaches that the needle shroud is movable from a first position “the distal tip of the needle cannula is located inside the cleaning chamber” (Haralsted, [0015]) to a second position “the distal tip of the needle cannula is located outside and distal to the cleaning chamber” (Haralsted, [0015]). This shows permitting the needle to remain covered when not in use and to initiate drug delivery after the needle has been exposed for injection. Such sequencing coordinates operation of the drug delivery mechanism with movement of the needle shroud so that actuation of the plunger follows placement of the needle in its exposed injection-ready position.
Conclusion
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/ISSA JAMIL GHANNOUM/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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