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.
Claims 1-7, 11, 13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Diaz (US 2020/0061306).
Regarding claim 1, Diaz discloses a safe injection system (figure 20A-20G), comprising:
an injection system body (34) defining a proximal opening at a proximal end thereof, an injection system body interior (area interior to the outer surface of 34), and a needle attachment interface (42, depicted and labeled in figure 6) at a distal end thereof;
a stopper member (36) disposed in the injection system body interior ([0037]);
a plunger member (74, figure 20A) configured to be manipulated to insert the stopper member relative to the injection system body (figure 20A-20B, [0037]); and
a needle hub assembly (120) coupled to the needle attachment interface (figure 20A-20D) and comprising
a needle hub (120) defining a latch space (area near 150) in a distal end thereof,
a needle latch (152, figure 20D-20E, [0037]) defined by the needle hub in the latch space, and
a needle (60, figures 20D-20I) removably coupled to the needle hub by the needle latch ([0034]).
Regarding claim 2, Diaz discloses wherein the needle latch comprising a distally extending arm (arm 152 extends distally) extending from a needle hub body (body 120) at a hinge (cantilevered latch member necessarily has a hinge to cantilever, [0037]), and
wherein the distally extending arm is configured to rotate about the hinge away from the needle ([0037]).
Regarding claim 3, Diaz discloses wherein the arm defines an inwardly and proximally facing beveled surface (surface inwardly extending as depicted in figure 20E around part 154).
Regarding claim 4, Diaz discloses wherein the needle defines an enlarged diameter (156) section configured to exert a distally directed force on the inwardly and proximally facing beveled surface to rotate the distally extending arm about the hinge away from the needle ([0037], upon full insertion of the plunger tip 136, the needle is pushed slightly forward equating to a distally directed force that will push the latch away from the needle about the cantilever).
Regarding claim 5, Diaz discloses wherein the needle defines a reduced diameter section (154, figure 20E) configured to interfere with the distally extending arm to removably couple the needle to the needle hub ([0037, figures 20A-20E).
Regarding claim 6, Diaz discloses wherein the arm defines an outwardly and distally facing beveled surface (edge of the latch that forms engagement with the needle preventing proximal movement, figure 20E).
Regarding claim 7, Diaz discloses wherein the needle defines an outwardly and proximally facing beveled surface (surface adjacent to the hub surface, approximately orthogonal to the axis of the needle) configured to interfere with the outwardly and distally facing beveled surface of the arm to resist proximal movement of the needle relative to the needle hub ([0037], engagement of the latch into recess prevents proximal movement).
Regarding claim 11, Diaz discloses further comprising a gasket (Figure 20F, end of equivalent part 52 best shown in figure 7Aand figure 10E) disposed partially in the injection system body interior and partially in the needle hub (figure 20G, the portion is inside both the hub and the interior of the syringe outlet by mating with the syringe),
wherein the gasket comprises an enlarged diameter proximal portion disposed in the injection system body interior (see annotated figure below), and a reduced diameter distal portion disposed in the needle hub (see annotated figure below).
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Regarding claim 13, Diaz further discloses wherein the enlarged diameter proximal portion defines a plurality of external ribs (figure 20G and figure 10E, two ribs at the end to mate with the syringe body).
Regarding claim 15, Diaz discloses wherein the enlarged diameter proximal portion defines a plurality of chamfered edges figure 10E, two ribs at the end with angled edges).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 8-10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Diaz.
Regarding claim 8, Diaz discloses the first embodiment teaching the limitations of claim 1 but the embodiment fails to teach wherein the needle hub defines a window configured to allow visualization of a distal end of the arm in the latch space from outside of the needle hub.
Diaz discloses another embodiment (figure 10G) of the safe injection device and teaches wherein the needle hub (32) defines a window (figure 9A, 10B, portion devoid of material surrounding latch member 54) configured to allow visualization of a distal end of the arm in the latch space from outside of the needle hub (the user can naturally see the inside of the device when devoid of material covering the latch).
Diaz provides a different embodiment and shows the device can be constructed a variety of ways and still achieve the same function, and contemplates multiple embodiments of the latch member/needle hub ([0029]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify the embodiments of Diaz to have a window that allows the user to view the latch since multiple embodiments are disclosed and the needle hub appears to be functionally equivalent.
Regarding claims 9-10, Diaz does not disclose wherein the needle latch is configured to open with less than 3 lbf of proximally directed force applied to the needle(claim 9) and wherein the needle latch is configured to resist opening with less than 0.25 lbf of proximally directed force applied to the needle (claim 10).
Diaz discloses the device is capable of supporting an injection load of 5lbs and meets the standard set by ISO ([0029], the opening force and resisting force of the opening of the latch are disclosed to be a result effective variable in that the device would be within the standard set by ISO and can support loads higher than claim. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Diaz device to have an opening and resist opening force within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Diaz by making the latch forces as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, Diaz does not disclose wherein the enlarged diameter proximal portion has a star- shaped cross-section.
However, it has been held that a simple change in shape is a matter for design choice absent persuasive evidence that the particular configuration is significant. Instant specification only states that the shape “may” be star shaped ([0015]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify the Diaz cross section to a star-shaped cross section since that would be a simple matter of design choice.
Claims 12 are rejected under 35 U.S.C. 103 as being unpatentable over Diaz in view of Wexler (US 2007/0093760).
Regarding claim 12, Diaz does not teach wherein the gasket comprises a distal end configured to seal after the needle is retracted proximally past the distal end of the gasket.
Wexler discloses a syringe for injection teaching a gasket (100) comprises a distal end (distal end of 100) configured to seal after the needle is retracted proximally past the distal end of the gasket ([0035], the seal is self-sealing).
Wexler provides a self-sealing membrane in order to control the movement of material until desired by the user ([0035]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Diaz by using the self-sealing membrane of Wexler in order to further control the movement of material until desired by the user.
Allowable Subject Matter
Claims 16-24 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.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach a compression ring configured to secure the needle hub assembly to the needle attachment interface. Dixon (US 5374250) while teaching a compression ring for the assembly fails to provide a valid motivation on adding a compression ring to the Diaz device. Thorley (US 2014/0330217) while teaching a ring that surrounds the syringe interface also fails to disclose the compression of the ring itself as the ring of Thorley does not stated as providing compression. Furthermore, the compression ring disclosed in Dixon and Thorley cannot be modified into the Diaz device to arrive at the instant invention since Diaz already surrounds and uses a different connection between the hub and attachment interface. Compressing the hub of Diaz would negatively affect the ability of the hub connecting the attachment interface. For these reasons claims 16-24 would be allowable if rewritten.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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