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
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 1-16, 18, 21-24, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No 8,430,850 to Gyrn.
Regarding Claim 1, Gyrn discloses a drug administration device (elastic element (1); Fig. 1) for subcutaneously administering a drug (therapeutic substance e.g., insulin) (abstract), comprising: a main body portion (housing part (2)) configured to be arranged on skin of a patient (column 4, lines 8-10); and a movable portion (needle hub (4)) to which at least one needle member (cannula (6)) protruding toward the skin is attached (the cannula (6) of the body (5) is attached to the needle hub (4) via friction wherein the cannula (6) protrudes towards the skin as seen in Fig. 1a-1c) (According to this embodiment the port-device is only secured to the elastic element 1 by the friction between the insertion needle 7 and the cannula 6 of the port-device ; column 3, lines 53-55), wherein the movable portion (4) is configured to be capable of being moved between a first position (before pushing the needle hub(4) downward; Fig. 1b (left)) that is spaced apart from the skin and a second position (after pushing the needle hub (4) downwards; Fig. 1b (right)) that is near the skin (the needle hub (4) moves from a first
position (before pushing the needle hub (4) downward; Fig. 1b (left)) that is spaced apart from the skin and a second position (after pushing the needle hub (4) downwards; Fig. 1b (right)) that is near the skin as seen in Figs. 1b-1c) (column 4, lines 20-31), the movable portion is configured to move from the second position to the first position when the movable is pulled up by a user (4, as better seen in Fig. 2a, is capable of being pulled out by a user), a leading end portion (end portion of the cannula (6)) of the needle member (6) is to be inserted into the skin when the movable portion (4) is located at the second position (Fig. 1b (right)) (the cannula (6) is inserted into the patient when the needle hub (4) is pushed downwards at the second position (Fig. 1b (right)) (column 4, lines 20-31) (column 3, lines 10-13 and 19-23), and the drug (insulin) is to be discharged from a hole (opening at the end portion of the cannula (6)) (abstract) provided in the needle member (6), when the leading end portion of the needle member is inserted into the skin (drug is capable of being discharged once cannula 6 is inserted).
Regarding Claim 2, Gyrn discloses the drug administration device according to claim 1, and further discloses wherein the movable portion (4) is configured to be held in at least one of the first position (Fig. 1b (left)) and the second position (Fig. 1b (right)) in a state in which an external force is not applied to the movable portion (the needle hub (4) is held in the first position (Fig. 1b (left)) wherein an external force is not applied to the needle hub (4) before pushing the needle hub (4) downwards) (column 4, lines 20-31).
Regarding Claim 3, Gyrn discloses the drug administration device according to claim 1, and further discloses comprising: at least one coupling portion (links (3)) that couples the main body portion (2) and the movable portion (4) to each other (the needle hub (4) and the housing part (2) are coupled via links (3), since the elastic element (1) (where the needle hub (4) is located) is connected to the housing part (2) via the links (3)) (column 3, lines 41-44) and is configured to be capable of holding the movable portion in at least one of the first position (Fig. 1b (left)) and the second position (Fig. 1b (right)) (the links (3) hold the needle hub (4) upward in the first position (Fig. 1b (left)) before pushing the needle hub (4) downward, and the links hold the needle hub (4) downward in the second position (Fig. 1b (right)) when the needle hub (4) is pushed downward).
Regarding Claim 4, Gyrn discloses the drug administration device according to claim 3, and further discloses wherein a plurality of the coupling portions are provided (there are plurality of links (3) as seen in Fig. 1a), and the coupling portions (3) are constituted by a plurality of parts that are radially arranged around the needle member (6) at predetermined intervals (the links (3) are arranged radially around the cannula (6) and spaced evenly apart around the cannula (6) as seen in Fig. 1a).
Regarding Claim 5, Gyrn discloses the drug administration device according to claim 4, and further discloses wherein the coupling portions (3) are formed of a material that can be elastically deformed (the links (3) are part of the housing part (2) wherein the housing part (2) is made of a continuous flexible material) (column 4, lines 10-15), and are configured to enter a first state (first equilibrium state) when located at the first position (Fig. 1a (left)) and enter a second state (second equilibrium state) when located at the second position (Fig. 1b (right)) (column 4, lines 20-31), the coupling portions (3) in the second state are bent, and the coupling portions in the first state are more stretched than those in the second state (the links (3) are bent in the second position (Figs. 1b and 1c (right)) and the links (3) are more stretched in the first position (Figs. 1b and 1c (left))), and the coupling portions are configured to make a transition between the first state and the second state while being elastically deformed (the links (3) transition from the first equilibrium state to the second equilibrium state when the links (3) flexibly bend outwards after pushing the needle hub (4) downwards) (column 4, lines 20-31).
Regarding Claim 6, Gyrn discloses the drug administration device according to claim 4, and further discloses wherein two to ten coupling portions are provided (there are three links as seen in Fig. 1a).
Regarding Claim 7, Gyrn discloses the drug administration device according to claim 3, and further discloses wherein the main body portion (2), the movable portion (4), and the coupling portion (3) are formed as a single body (the elastic element (1) (where the needle hub (4) is located) is part of the housing part (2) (column 3, lines 39-44), and the housing part (2) forms part of the links (3) wherein the housing part (2) is made of a continuous material (column 4, lines 10-15)).
Regarding Claim 8, Gyrn discloses the drug administration device according to claim 3, and further discloses wherein the main body portion (2), the movable portion (4), and the coupling portion (3) are formed of an elastically deformable elastomer, hard resin, or metal (the elastic element (1) (where the needle hub (4) is located) is part of the housing part (2) (column 3, lines 39-44), and the housing part (2) forms part of the links (3) wherein the housing part (2) is made of a continuous flexible material (column 4, lines 10-15). The elastic element of the links (3) bend and return to their initial state (column 4, lines 16-35); therefore, the main body portion, the movable portion, and the coupling portion are made of elastically deformable elastomer).
Regarding Claim 9, Gyrn discloses the drug administration device according to claim 1, and further discloses wherein the main body portion (2) is formed in a tubular shape (the housing part (2) is formed in a tubular shape as seen in Figs. 1a-1c), and the movable portion (4) is configured such that at least a portion of the movable portion is accommodated in the main body portion (2) when the movable portion (4) is located at the second position (Fig. 1b (right)) (the needle hub (4) moves within the housing part (2) when pushed downwards in the second position as seen in Fig. 1b (right)).
Regarding Claim 10, Gyrn discloses the drug administration device according to claim 1, and further discloses wherein a drug line (through going opening within the body (5)) for supplying the drug (insulin) can be attached, and the drug is supplied from the drug line to the needle member (6) (the invention relates to an inserter for an infusion set for intermittent or continuous administration of a therapeutical substance, such as e.g. insulin. The inserter comprises means for insertion and retraction of an introducer needle; column 1, lines 19-23) (The port-device shown in FIG. 1 comprises a body 5 provided with a through-going opening and a cannula 6 fastened unreleasably to the body 5 of the port-device and extending from the proximal side of the body 5, i.e. the proximal side of the port-device is the side which will be facing the patients skin when the device is mounted on the patient; column 3, lines 47-53) (Often the device to be inserted is an infusion part comprising a through-going opening and a cannula or the device to be inserted can be a sensor part comprising a sensor for sub- or transcutaneous positioning; column 3, lines 10-13).
Regarding Claim 11, Gyrn discloses the drug administration device according to claim 1, and further discloses comprising an operation portion (bottom portion of the housing part (2)) that is coupled to the movable portion and can be held by tools or fingers (the housing part (2) can be held with two fingers against the patient's skin as seen in Fig. 1b (right)) (The inserter device is then placed against the patients skin at a suitable position and held at that position with two fingers as indicated in FIG. 1b (right); column 4, lines 20-22).
Regarding Claim 12, Gyrn discloses the drug administration device according to claim 11, and further discloses wherein the operation portion (bottom portion of the housing part (2)) is formed in a plate shape whose external size is larger than that of the main body portion (the bottom portion of the housing part has a larger outside diameter of the upper part of the housing part (2) as seen in Fig. 1a).
Regarding Claim 13, Gyrn discloses the drug administration device according to claim 12, and further discloses comprising an extension portion (portion (2a); Fig. 1b (right)) connected to the operation portion (bottom portion of the housing part (2)) (the portion (2a) is connected to the bottom portion of the housing part as seen in Fig. 1b (right)), wherein the extension portion (2a) covers at least a portion of the main body portion (2) when the movable portion (4) is located at the second position (Fig. 1b (right)) (the portion (2a) bends inward when the needle hub (4) is pushed to the second position (Fig. 1b (right)) wherein the portion (2a) covers the inner surface of the housing part (2) as seen in Fig. 1b (right)).
Regarding Claim 14, Gyrn discloses the drug administration device according to claim 11, and further discloses wherein the operation portion (bottom portion of the housing part (2)) is configured to protrude outward from the outer circumference of the movable portion (4) in a radial direction (the bottom portion of the housing part (2) protrudes outward from the outer circumference of the needle hub (4) radially, since the housing part (2) flares at the bottom as seen in Figs. 1a-1b), and a stopper (activation button) is further included that is detachably arranged between the operation portion (bottom of the housing part (2)) and the main body portion (2) when the movable portion (4) is located at the first position (Fig. 1b (left)), and restricts movement of the movable portion to the second position (Fig. 1b (right)) (the activation button is a protrusion/protruding part located on the proximal surface of the elastic element 1 (between the housing part (2) and the bottom of the housing part (2)); the needle hub (4) is restricted from moving to the second position (Fig. 1b (right) if the activation
button is not pressed) (According to this embodiment the port-device is only secured to the elastic element 1 by the friction between the insertion needle 7 and the cannula 6 of the port-device but if for example the port-device was of a type provided with a hard cannula e.g. of steel which need no insertion needle to cut through the patients skin then the port-device could be secured to the inserter device e.g. by providing a protruding part on the proximal surface of the elastic element 1 which could be squeezed into a corresponding shaped hollow in the body 5 of the port-device and kept in position as a result of the friction between the sides of the body 5 of the port-device and at least part of the sides of the protruding parts of the elastic element 1; column lines 53-65) (The protrusion on the surface indicates where the needle hub 4 and the port-device are positioned and therefore the protrusion can be used as an activation button; column 4, lines 1-3) (The deformation of the clastic element 1 is like a jump from a first condition to a second condition therefore the light pressure on the activation button causes a fast deformation which results in the insertion needle 6 being "shot" into the patient. After the
pressure is removed from the activation button the elastic element jumps back into the first
equilibrium state and retracts the insertion needle 7 from the patient and the port-device; column
4, lines 27-35).
Regarding Claim 15, Gyrn discloses the drug administration device according to claim 1, and further discloses comprising a storage portion (through going opening within the body (5)) for storing the drug (insulin), wherein the drug is supplied from the storage portion to the needle member (6) (the invention relates to an inserter for an infusion set for intermittent or continuous administration of a therapeutical substance, such as e.g. insulin. The inserter comprises means for insertion and retraction of an introducer needle; column 1, lines 19-23) (The port-device shown in FIG. 1 comprises a body 5 provided with a through-going opening and a cannula 6 fastened unreleasably to the body 5 of the port-device and extending from the proximal side of the body 5, i.e. the proximal side of the port-device is the side which will be facing the patients skin when the device is mounted on the patient; column 3, lines 47-53) (Often the device to be inserted is an infusion part comprising a through-going opening and a cannula or the device to be inserted can be a sensor part comprising a sensor for sub- or transcutaneous positioning; column 3, lines 10-13).
Regarding Claim 16, Gyrn discloses the drug administration device according to claim 1, and further discloses comprising a base (body (5)) that supports the main body portion (2) and is to be arranged on the skin (the port-device shown in FIG. 1 comprises a body 5 provided with a through-going opening and a cannula 6 fastened unreleasably to the body 5 of the port-device and extending from the proximal side of the body 5, i.e. the proximal side of the port-device is the side which will be facing the patients skin when the device is mounted on the patient; column 3, lines 47-53).
Regarding Claim 18, Gyrn discloses the drug administration device according to claim 16, and further discloses wherein a recessed portion (clement (8)) is provided on a surface of a circumferential edge portion of the base that is to be opposite to the skin (the element (8) is located on the circumferential edge of the body (5) that is opposite to the patient's skin as seen in Fig. 1b) SO as to form a gap formed between the base and the skin (the element (8) forms gap/space between the body (5) and the skin as seen in Fig. 1b (right)).
Regarding Claim 21, Gyrn discloses the drug administration device according to claim 3, and further disclose comprising a base (lower portion of the housing part (2)) that supports the main body portion and is to be arranged on the skin (The inserter device is then placed against the patients skin at a suitable position and held at that position with two fingers as indicated in FIG. 1b (right); column 4, lines 20-22), wherein the base, the main body portion, the movable portion, and the coupling portion are formed of an elastomer as a single body (the elastic element (1) (where the needle hub (4) is located) is part of the housing part (2) (column 3, lines 39-44), and the housing part (2) forms part of the links (3) wherein the housing part (2) is made of a continuous material (column 4, lines 10-15)).
Regarding Claim 22, Gyrn discloses the drug administration device according to claim 1, and further discloses wherein the main body portion (2) is configured to be attached to the skin (The inserter device is then placed against the patients skin at a suitable position and held at that position with two fingers as indicated in FIG. 1b (right); column 4, lines 20-22), and the main body portion (2) is provided with a recessed portion so as to form a gap between the main body portion and the skin (there is a gap between the lower portion of the housing part (2) where the fingers hold the housing part and the skin as seen in Figs. 1b-1c).
Regarding Claim 23, Gyrn discloses the drug administration device according to claim 11, and further discloses wherein the needle member (6) is fixed to the operation portion (bottom of the housing part (2)), and the operation portion can be detached from the movable portion (4) together with the needle member (7) (the cannula (6) is attached to the housing part (2) (where the bottom of the housing is located) via the insertion needle (7) of the body (3) via friction wherein the cannula (6) is detached from the housing (2) (since the body (2) remains inserted into the patient after retraction) (column 3, lines 53-65) and (column 4, lines 27-35).
Regarding Claim 24, Gyrn discloses the drug administration device according to claim 1, and further discloses comprising a detaching means for detaching the needle member (6) from the movable portion (4) (the cannula (6) is connected to the body (5) wherein the body (5) and the needle hub (4) are detachably coupled via protruding members) (According to this embodiment the port-device can be secured to the elastic element 1 by structures provided in the needle hub 4 for example the needle hub 4 can be provided with one or more protruding members which fits into closely corresponding openings in the distal surface of the body 5 of the port-device; column 4, lines 49-54).
Regarding Claim 30, Gyrn discloses the drug administration device according to claim 1, and further discloses comprising an accommodation portion (element (2a)) configured to accommodate at least the movable portion (4) when the movable portion is located at the second position (Fig. 1b (right)) (the element (2a) is fully capable of accommodating the needle hub (14) when the needle hub (14) is in the second position (Fig. 1b (right), since elements (2a) help links (3) to bend away from the center of the housing part (2) as seen in Figs. 1-2).
Claims 1 and 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gyrn.
Regarding Claim 1, Gyrn discloses a drug administration device (Fig.3) for subcutaneously administering a drug (abstract), comprising: a main body portion (12) configured to be arranged on skin of a patient (column 5, lines 33-37); and a movable portion (11) to which at least one needle member (16) protruding toward the skin is attached, wherein the movable portion is configured to be capable of being moved between a first position (Fig. 3b) that is spaced apart from the skin and a second position (Fig. 3c) near the skin, the movable portion is configured to move from the second position to the first position when the movable is pulled up by a user (14 is capable of being moved by a user via 23), a leading end portion (end of 16) of the needle member is to be inserted into the skin when the movable portion is located at the second position (Fig. 3c), and the drug is to be discharged from a hole (opening at the end portion of the cannula (16) provided in the needle member when the leading end portion of the needle member is inserted into the skin (drug is capable of being discharged once cannula 16 is inserted).
Regarding Claim 25, Gyrn discloses the drug administration device according to claim 1, and further discloses comprising a cover member (25) that can cover at least a leading end of the needle member, wherein the leading end of the needle member is exposed from the cover member when the movable portion is located at the second position (Fig. 3c), and the cover member covers the leading end of the needle member and this covering state is maintained after the movable portion is moved from the second position (Fig. 3c) to the first position (Fig.3b).
Regarding Claim 26, Gyrn discloses the drug administration device according to claim 25, and further discloses wherein, at the first position (Fig. 3b) before use, the leading end of the needle member (end portion of 16) is covered by the cover member (25).
Regarding Claim 27, Gyrn discloses the drug administration device according to claim 25, and further discloses wherein the cover member (25) is configured to be capable of being detached from the movable portion (11) together with the needle member (16) (the guiding members (25) are fully capable of being detached from the clastic element (11) (since the elastic element is attached to the housing via recesses (13) in the housing (12) (column 4, lines 60-62) together with the insertion needle (16)(since the insertion needle (16) is embedded within the needle hub (14) (column 4 (lines 66-67) and column 5 (lines 1-3)))).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Gyrn (US 8430850), in particular the embodiments of Figs. 1a-ac; in view of embodiment of (Figs.3a-3d) of Gyrn.
Regarding Claim 17, Gyrn discloses all the limitations of claim 16 above. Gyrn does not appear to disclose an adhering material arranged on at least a portion of a surface of the base that is to be brought into contact with the skin. However, Gyrn, in embodiment of Fuigs.3a-3d, teaches it was known in the art to have a mounting pad (18) on the surface of body (15) attached to the patient's skin (The body 15 might be provided with a mounting pad 18 unreleasably fastened to the body 15 or the mounting pad 18 might be provided in a separate packing and attached to the patient’s skin before the inserter device is positioned on the insertion site; column 5, lines 29-33). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Gyrn to incorporate the teachings of embodiment of Figs.3a-3d to have an adhering material arranged on at least a portion of a surface of the base that is to be brought into contact with the skin in order to securely fasten the port-device with the inserter to the patient (column 5, lines 29-37).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gyrn in view of U.S. Patent Publication 2004/0162521 to Bengtsson.
Regarding Claim 19, Gyrn discloses all the limitations of claim 16. Gyrn does not appear to disclose a plurality of drug administration portions are arranged on the base, and each of the plurality of drug administration portions includes the main body portion, the movable portion, and the needle member.
Bengtsson teaches it was known in the art to have plurality of needle devices (200; Fig.7)
arranged on the base plate member (210) with a needle device (261) being arranged with a
corresponding opening in the base plate member (210, [0081]) wherein each of the
include upper wall portions (241), needle carriers (242), and needle devices (261). It is fully
capable of having multiple drug administration portions each having a housing part (2), a needle
hub (4), and cannula (6) of Gyrn that are activated by pushing the needle hub downward. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Gyrn to incorporate the teachings of Bengtsson to have a plurality of drug administration portions are arranged on the base, and each of the plurality of drug administration portions includes the main body portion, the movable portion, and the needle member in order to provide an extended operational life for a pump device ([0045]).
Regarding Claim 20, Gyrn discloses the drug administration device according to claim 19, and Bengtsson further teaches wherein all of the movable portions of the drug administration portions are coupled to each other (the needle carriers (242) are coupled to each other via the housing member (230) as seen in Figs.6-7).
Claims 28-29 and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over
Gyrn in view of U.S. Patent Publication No. 2013/0110053 to Yoshino.
Regarding Claim 28, Gyrn discloses all the limitations of claim 1 above. Gyrn does not appear to disclose the needle member has a thickness of a gauge of 30 to 35.
Yoshino teaches it was known in the art to have a needle tube (5, Fig. 1) having a thickness of 30-35 gauge ([0064]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Gyrn to incorporate the teachings of Yoshino to have a needle member has a thickness of a gauge of 30 to 35 in order to penetrate the upper layer of the skin ([0064]-[0065]).
Regarding Claim 29, Gyrn discloses the drug administration device according to claim 1, and Yoshino further teaches wherein a portion of the needle member protruding from a surface of the drug administration device that is to be fixed to the skin has a length of 1 to 10 mm (Therefore, the protruding length L of the needle tube 5 can be set in a range of 0.5-3.0 mm, [0076], last sentence).
Regarding Claim 32, Gyrn discloses a drug administration system comprising: at least one drug administration device according to claim 1 (Figs.1a-1c); Yoshino further teaches at least one drug container (3); and a drug line (seal member (32)) for supplying a drug from the drug container to the drug administration device ([0094]).
Regarding Claim 33, Gyrn discloses a drug administration system, comprising; at least one drug administration device according to claim 1 (Figs. 1a-1c); and a syringe (3) capable of supplying a drug to the needle member ([0094]).
Response to Arguments
Applicant's arguments and amendments with respect to art rejections have been fully considered but they are not persuasive. Applicant argues that the needle member 7 of Gyrn is not used to deliver a drug. As shown above, the needle member of claim 1 has been remapped as cannula 6 of Gyrn, which is capable of being used for drug delivery and is not solely used for creating a hole.
Conclusion
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.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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