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 .
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 11, 12 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Botich (US 5,788,677).
Regarding claim 1, Botich teaches an assembly for an injection device (310, Fig. 5A, 6A, 6B) for injecting a medicament 320, the assembly comprising: a container 304 containing the medicament and having a cap (end of container 304), the container sealed by a septum 301; a sealing element 302 in contact with an external surface of the cap of the container (Col. 11:22-44, sealing element 302 is engaged within a circumferential exterior groove 305 of the cap); a needle 316 for piercing the septum; and a needle hub attached to the needle (Figs. 5A, 6A, 6B structure around needle, such as 332), wherein the sealing element is disposed between the external surface of the cap of the container and an internal surface of the needle hub (Figs. 5A, 6A, 6B), wherein the assembly is configured to transition from a first state, in which the needle is held away from the septum and a free end of the needle sits in a cavity sealed by the sealing element (Fig. 6A), to a second state, in which the needle passes through the septum (Fig. 6B), and wherein a seal between the internal surface of the needle hub and the external surface of the cap is provided by the sealing element when the assembly is in the first state and wherein the seal is maintained throughout transition from the first state to the second state and is maintained when the assembly is in the second state (the sealing element 302 maintains a seal in the transition from the first state to the second state as shown in Figs. 6A and 6B).
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Regarding claim 11, Botich teaches the invention of claim 1 and Botich further teaches the needle hub defines a first inner surface extending perpendicular to the needle and facing the cap (Annotated Fig. A), a proximal protrusion which extends inwards, towards the needle (Annotated Fig. A), and a second inner surface extending parallel to the needle from the first inner surface to the proximal protrusion (Annotated Fig. A), wherein the second inner surface is configured to engage the sealing element in the first and second states and during transition therebetween (see Figs. 6A and 6B).
Regarding claim 12, Botich teaches the invention of claim 1 and Botich further teaches the cap comprises a first rib (Annotated Fig. A) and a second rib (Annotated Fig. A), and wherein the sealing element is disposed between the first and second ribs (Annotated Fig. A).
Regarding claim 16, Botich teaches a method of manufacturing an assembly for an injection device (310, Fig. 5A, 6A, 6B) for injecting a medicament 320, the method comprising providing: a container 304 having a cap (end of container 304), the container sealed by a septum 301; a sealing element 302 in contact with an external surface of the cap of the container (Col. 11:22-44, sealing element 302 is engaged within a circumferential exterior groove 305 of the cap); a needle 316 for piercing the septum; and a needle hub (Figs. 5A, 6A, 6B structure around needle, such as 332), wherein the sealing element is disposed between the external surface of the cap of the container and an internal surface of the needle hub (Figs. 5A, 6A, 6B), wherein the assembly is configured to transition from a first state, in which the needle is held away from the septum and a free end of the needle sits in a cavity sealed by the sealing element (Fig. 6A), to a second state, in which the needle passes through the septum (Fig. 6B), and wherein a seal between the internal surface of the needle hub and the external surface of the cap is provided by the sealing element when the assembly is in the first state and wherein the seal is maintained throughout transition from the first state to the second state and is maintained when the assembly is in the second state (the sealing element 302 maintains a seal in the transition from the first state to the second state as shown in Figs. 6A and 6B).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 3, 6, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Botich (US 5,788,677) in view of Weatherford (US 5, 290, 256).
Regarding claim 2, Botich teaches the invention as discussed above for claim 1 and Botich further teaches a housing defining a longitudinal axis and configured to receive the container containing the medicament (Annotated Fig. A), the housing having a distal end which defines an opening for receiving a portion of the needle (a portion of the needle will enter the housing when it pierces the septum as shown in Fig. 6A).
Botich doesn’t teach a safety shield surrounding at least a distal portion of the housing, the safety shield configured to advance distally relative to the housing from a retracted position, to a deployed position for shielding the needle; and an advancement spring arranged between the housing and the safety shield, the advancement spring configured to advance the safety shield from the retracted position to the deployed position.
Weatherford teaches a safety shield 32 for a needle. The sheath is moveable from a retracted position to a deployed position (Figs. 1 and 2, Col. 4:9-23). A spring 72 advances the sheath to the deployed position and is between a housing and the safety shield (Fig. 1). The sheath protects from inadvertent needle sticks.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the injection device of Botich have a safety shield surrounding at least a distal portion of the housing, the safety shield configured to advance distally relative to the housing from a retracted position, to a deployed position for shielding the needle; and an advancement spring arranged between the housing and the safety shield, the advancement spring configured to advance the safety shield from the retracted position to the deployed position, as taught by Weatherford, in order to prevent inadvertent needle sticks.
Regarding claim 3, Botich in view of Weatherford teaches the invention as discussed above for claim 2. Botich in view of Weatherford, as discussed so far, doesn’t teach a releasable locking mechanism configured, when engaged, to lock the safety shield in the retracted position.
Weatherford teaches a releasable locking mechanism 60. The locking mechanism can lock the safety shield in either the deployed or retracted position (Col. 4:37-50). The locking mechanism prevents deployment of the safety shield until it is needed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the injection device of Botich and Weatherford have a releasable locking mechanism configured, when engaged, to lock the safety shield in the retracted position as taught by Weatherford, in order to allow the safety shield to only be deployed when it is needed.
Regarding claim 6, Botich in view of Weatherford teaches the invention as discussed above for claim 2. Botich in view of Weatherford, as discussed so far, doesn’t teach the advancement spring is configured to interlock with the housing and the safety shield when the safety shield is in the deployed position, to thereby prevent return of the safety shield to the retracted position.
As discussed above for claim 2, the advancement spring extends to deploy the safety shield. Weatherford teaches locking means are provided for releasably locking the sheath means in both the open and closed positions and a spring is provided for urging the cap disposed on the inside surface of the sheath means against one of the pair of berms on the sheath means both in the open position and in a closed position (Col.3:32-36). Thus, in the deployed position the safety shield is prevented from returning which avoids the needle being exposed an inadvertent needle sticks.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the injection device of Botich and Weatherford have the advancement spring is configured to interlock with the housing and the safety shield when the safety shield is in the deployed position, to thereby prevent return of the safety shield to the retracted position as taught by Weatherford, in order to prevent inadvertent needle sticks.
Regarding claim 17, Botich teaches the invention as discussed above for claim 16 and Botich further teaches providing a housing defining a longitudinal axis (Annotated Fig. A), the housing having a distal end which defines an opening for receiving a portion of the needle (a portion of the needle will enter the housing when it pierces the septum as shown in Fig. 6A).
Botich doesn’t teach providing a safety shield surrounding at least a distal portion of the housing, the safety shield being distally advanceable relative to the housing from a retracted position, to a deployed position for shielding the needle; and arranging an advancement spring between the housing and the safety shield, the advancement spring configured to advance the safety shield.
Weatherford teaches a safety shield 32 for a needle. The sheath is moveable from a retracted position to a deployed position (Figs. 1 and 2, Col. 4:9-23). A spring 72 advances the sheath to the deployed position and is between a housing and the safety shield (Fig. 1). The sheath protects from inadvertent needle sticks.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the injection device of Botich to provide safety shield surrounding at least a distal portion of the housing, the safety shield being distally advanceable relative to the housing from a retracted position, to a deployed position for shielding the needle; and arranging an advancement spring between the housing and the safety shield, the advancement spring configured to advance the safety shield, as taught by Weatherford, in order to prevent inadvertent needle sticks.
Regarding claim 18, Botich in view of Weatherford teaches the invention as discussed above for claim 17. Botich in view of Weatherford, as discussed so far, doesn’t teach providing a releasable locking mechanism configured, when engaged, to lock the safety shield in the retracted position.
Weatherford teaches a releasable locking mechanism 60. The locking mechanism can lock the safety shield in either the deployed or retracted position (Col. 4:37-50). The locking mechanism prevents deployment of the safety shield until it is needed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the injection device of Botich and Weatherford to provide a releasable locking mechanism configured, when engaged, to lock the safety shield in the retracted position as taught by Weatherford, in order to allow the safety shield to only be deployed when it is needed.
Claims 7, 8, 10, 22, 24, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Botich (US 5,788,677) in view of Miller (US 2007/0246468).
Regarding claims 7, 8, 10, Botich teaches the invention of claim 1. Botich doesn’t teach the sealing element is chemically bonded to the external surface of the cap, the sealing element is over-moulded onto the external surface of the cap, the sealing element comprises a first material, the cap comprises a second material different to the first material, and the sealing element and the cap define a monolithic body formed via two-shot injection moulding.
Examiner notes in an apparatus claim, the method of forming the apparatus doesn’t distinguish over a prior art apparatus having all of the components of the claim. Nevertheless, Miller teaches manufacturing techniques for forming parts of stoppers and vials for containers associated with syringes (¶003) similar to Botich. Miller teaches a multi-material closures may have croyophillic elastomer and non-crypophilic elastomer present in various forms. Miller teaches it is also possible to provide a physical bonding of the layers or parts if the elastomers are distinct, noncompatible materials (¶27). Further, the closures may be manufactured in a number of different ways, depending
upon the particular structure and materials of the closure. Examples of suitable methods may include separate molding and subsequent lamination of the two or more parts, comolding of the parts after laying both materials in a mold, co-molding of the parts with a film laid on one or both materials, multi-shot injection molding, and rotary compression molding (¶28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the injection device of Botich have the sealing element is chemically bonded to the external surface of the cap, the sealing element is over-moulded onto the external surface of the cap, the sealing element comprises a first material, the cap comprises a second material different to the first material, and the sealing element and the cap define a monolithic body formed via two-shot injection moulding, as taught by Miller, in order to allow the parts to be suitably formed and manufactured.
Regarding claims 22, 24 and 25, Botich teaches the invention of claim 16. Botich doesn’t teach providing the sealing element comprises chemically bonding the sealing element to the external surface of the cap or over-moulding the sealing element onto the external surface of the cap, the sealing element comprises a first material and the cap comprises a second material that is different than the first material and performing a 2-shot injection moulding process.
Miller teaches manufacturing techniques for forming parts of stoppers and vials for containers associated with syringes (¶003) similar to Botich. Miller teaches a multi-material closures may have croyophillic elastomer and non-crypophilic elastomer present in various forms. Miller teaches it is also possible to provide a physical bonding of the layers or parts if the elastomers are distinct, noncompatible materials (¶27). Further, the closures may be manufactured in a number of different ways, depending upon the particular structure and materials of the closure. Examples of suitable methods may include separate molding and subsequent lamination of the two or more parts, comolding of the parts after laying both materials in a mold, co-molding of the parts with a film laid on one or both materials, multi-shot injection molding, and rotary compression molding (¶28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the injection device of Botich by providing the sealing element comprises chemically bonding the sealing element to the external surface of the cap or over-moulding the sealing element onto the external surface of the cap, the sealing element comprises a first material and the cap comprises a second material that is different than the first material and performing a 2-shot injection moulding process, as taught by Miller, in order to allow the parts to be suitably formed and manufactured..
Allowable Subject Matter
Claims 4, 5, 13, 14, 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID OLYNICK whose telephone number is (571)272-2355. The examiner can normally be reached M-F: 7:30 am-5 pm (ET).
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/DAVID P. OLYNICK/ Primary Examiner, Art Unit 3741