DETAILED ACTION
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.
(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.
Claim(s) 1-2, 7-8, 11, 15, 17-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schrul (U.S. Pat. Pub. No. 2021/0001048 A1).
Regarding claim 1, Schrul discloses a connection system (Fig. 17a-17b) for use with an injection device (see Fig. 1-21 and [0021-0028]), the connection system comprising: a first connection assembly (assembly of crimp 1, adhesive tape/seal 26, and flexible strip 18 – see Fig. 17a, 17b), a second connection assembly (assembly of fluid path compartment 36, adhesive tape/seal 50, and flexible strip 49 – see Fig. 17a, 17b), and a coupling assembly (biasing elements, see [0028] and [0119], ln 8-26) configured to secure the first and second connection assemblies together (see Fig. 17a, 17b, and 19-20, [0028] and [0119], ln 8-26, wherein the first connection assembly may be secured to the second connection assembly directly, such as by flexible arm attached to the crimp 1 and/or fluid path compartment 36 in [0028], or indirectly by way of the fact that the first connection assembly is attached to the medicament cartridge 29, which is fixed to the cartridge holder (37) by means of a mechanism, such as a spring, which causes the cartridge and thus the first connection assembly to be secured in a state of compression against the second connection assembly), the first connection assembly comprising: a first body (crimp 1) configured to connect to a medicament container (medicament cartridge 29) (see Fig. 17a-17b and [0109]), the first body defining a first opening therethrough (center hole 5) configured to be in fluid communication with the medicament container (upon piercing of septum 33, see Fig. 1, 17a-17b and [0110]); a first coupling surface (end wall 4) on the first body (see Fig. 1 and 17a-17b, and [0110]); a first seal (adhesive tape/seal 26) adjacent to the first coupling surface (see Fig. 17a-17b and [0119-0121]); and a first flexible barrier (flexible strip 18) disposed on the first coupling surface (via adhesive tape/seal 26 – see Fig. 17a-17b and [0119], ln 3-6), such that the first opening is closed by the first flexible barrier (see Fig. 17b, [0110], and [0119]); and the second connection assembly comprising: a second body (compartment 36, which includes side walls 42 and connecting wall 43) configured to receive a needle (needle/spike 40) therein, the second body defining a second opening (passage 38) therethrough (see Fig. 17a-17b and [0111]); a second coupling surface (end wall of connecting wall 43 which faces the medicament cartridge 29) on the second body, the second coupling surface being configured to be placed adjacent to the first coupling surface (see Fig. 17a-17b); a second flexible barrier (flexible strip 49) disposed on the second coupling surface, such that the second opening is closed by the second flexible barrier (see Fig. 17b, [0112], and [0119]); and a second seal (adhesive tape/seal 50) adjacent to the second coupling surface (see Fig. 17a-17b and [0119]), wherein, when the first and second connection assemblies are secured together, an insertion axis is defined parallel to the needle and extending through the first and second openings of the first and second connection assemblies (see Fig. 17a-17b and [0111]), wherein, when the first and second connection assemblies are secured together, the first and second flexible barriers are configured to be removed, such that the first and second openings fluidly communicate with each other (see Fig. 17a-17b and, [0026], [0111], and [0119]), wherein the needle is configured to be moved through the second opening and the first opening and into the medicament container, such that the needle is in fluid communication with the medicament container (see [0111]), and wherein an aseptic connection is formed between the first and second connection assemblies (see [0026], [0041], and [0119], ln 18-25).
Regarding claim 2, Schrul further discloses that the needle is configured to pierce a septum (33) of the medicament container so as to create the fluid communication between the needle and the medicament container (see Fig. 17a-17b and [0111], ln 8-20).
Regarding claim 7, Schrul further discloses that the needle is configured to be movable between a first position (retracted position of Fig. 17a-17b), a second position (an intermediate position in the midst of the needle’s movement towards the septum as described in [0111], ln 8-20), and a third position (the completed movement of the needle to pierce the septum and establish fluid communication with the medicament within the medicament cartridge, as described in [0111], ln 8-20), when the needle is in the first position, a tip of the needle is entirely within the second connection assembly and does not extend out of the second opening (see Fig. 17a-17b); when the needle is in the second position, the tip of the needle is disposed within the first opening of the first connection assembly (the intermediate position may be interpreted as the point along the needle’s movement whereupon this arrangement occurs); and when the needle is in the third position, the tip of the needle is configured to be in the medicament container (see Fig. 17a-17b and [0111], ln 8-20, whereupon it is clear that the needle tip must necessarily extend into the medicament container in order to establish fluid communication with the medicament within the medicament cartridge, as is described in [0111], ln 8-20).
Regarding claim 8, Schrul further discloses that the needle is disposed on a needle hub (spike holder 41) movable within a chamber (interior 47) defined by the second body of the second connection assembly (see Fig. 17a-17b and [0111]).
Regarding claim 11, Schrul discloses an injection device for providing a medicament to a user (patch pump/injector 61 - see Fig. 20-21, [0021], [0041-0042], and [0122]), the injection device comprising: a housing (assembly of housing cover 55 and bottom housing 56) having an injection needle configured to be moved to an injection site (see Fig. 20-21, [0037], ln 11-18, [0111], and [0129], wherein the injection needle is configured to be extended through aperture 62); a medicament container (cartridge 29) disposed in the housing (see Fig. 20-21 and [0128]), the medicament container being configured to receive the medicament therein ([0109]); a transfer needle (needle/spike 40) configured to be placed into fluid communication with the injection needle and the medicament container ([0022] and [0111]), such that the medicament can be moved from the medicament container to the injection needle through the transfer needle ([0022] and [0111]); and the connection system of claim 1 configured to form an aseptic connection between the transfer needle and the medicament container (see in re claim 1).
Regarding claim 15, Schrul further discloses that the housing defines a receptacle configured to receive the medicament container and the connection system therein (see Fig. 20-21 and [0128], wherein the cartridge 29 and connection system, including first connection assembly 46, are enclosed by the housing, therefore they are received within a receptacle defined by the housing).
Regarding claim 17, Schrul further discloses that the connection system comprises a coupling assembly configured to secure the first and second connection assemblies together (see in re claim 1).
Regarding claim 18, Schrul further discloses that the medicament container includes a septum (33) thereon that provides a liquid seal between the medicament in the medicament container and the connection system (see Fig. 17a-17b, [0017], [0021], and [0110]), wherein the septum is configured to be pierced by the transfer needle such that the fluid communication is formed between the transfer needle and the medicament container (see in re claim 2).
Regarding claim 20, Schrul further discloses that the injection device comprises an activation button assembly ([0042], ln 1-5) configured to cause movement of the injection needle from a first position, in which the injection needle is spaced from the injection site, to a second position, in which the needle contacts the injection site (see Fig. 20-21, [0037], ln 11-18, [0042], and [0111]).
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) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Schrul in view of Matkovich (U.S. Pat. Pub. No. 2008/0048436 A1).
Regarding claim 5, Schrul discloses the connection system of claim 1. While Schrul teaches that the first and/or second bodies may comprise coupling/biasing means for coupling the first connector to the second connector ([0028], ln 15-23), Schrul fails to teach that the coupling assembly includes a protrusion on one of the first and second bodies and a receptacle on the other of the first and second bodies, the receptacle being configured to receive the protrusion therein when the first and second connection assemblies are moved towards each other, and wherein, when the protrusion is in the receptacle, movement of the first and second connection assemblies away from each other is precluded.
Matkovich exhibits a connection system for aseptically connecting fluid paths (see Fig. 1-15 and [0003]) similar to that of Schrul, wherein a secure and biased connection between a first connector body (female fitting 120) and a second connector body (male fitting 220) is made via a coupling assembly that includes a protrusion (forks 146) provided on a flange (142) portion of the first connector body (see Fig. 3-5 and [0035-0036]) and a receptacle (slots 240) provided on a flange (242) portion of the second connector body (see Fig. 1-5 and [0036]), the receptacle being configured to receive the protrusion therein when the first and second connection assemblies are moved towards each other (see Fig. 1-5 and [0036]), and wherein, when the protrusion is in the receptacle, movement of the first and second connection assemblies away from each other is precluded (see Fig. 1-5 and [0036], wherein the forks comprise prongs 147 having catches 148 which prevent the forks from being retracted back through slots 240 once the first and second connection assemblies are interlocked). Here, Matkovich teaches that the connection is biased, since the sealing members (170, 270) which are provided on the coupling surfaces of the first connector body and second connector body (see Fig. 1-3, [0045], and [0051]) are compressed in order to ensure that an aseptic seal is maintained (see Fig. 1-3, [0047], and [0053]), in the same manner as the seals of Schrul. Matkovich teaches that such a connection configuration is one of many known mechanisms within the art to provide a secure and biased connection between a first connector body and a second connector body ([0035], ln 1-7).
Based on the teachings and example of Matkovich, and since Schrul does not teach a specific configuration that interlocks the first and second bodies together, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to embody the coupling means of Schrul according to the interlocking configuration taught by Matkovich, since this configuration is well known within the art to be suitable for providing a biased connection between connector bodies (Matkovich, [0035], ln 1-7), thereby maintaining an aseptic seal by maintaining compression on the seals of each connector body, and also provides the additional advantage of interlocking the first and second bodies, thereby preventing unintentional misalignment or disengagement of the connector bodies due to vibration or shock, for example. Upon such a modification, the proposed combination would exhibit (by virtue of incorporating the configuration of Matkovich) all claimed features of the coupling assembly (see above in re Matkovich).
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Schrul in view of Cowe (WO2020008202A1).
Regarding claim 9, Schrul discloses the connection system of claim 8. Schrul fails to teach that the chamber has a first segment having a first diameter and a second segment having a second diameter different from the first diameter, and wherein the friction between the needle hub and the first segment is greater than the friction between the needle hub and the second segment.
Cowe exhibits a connection system (Fig. 1-5) similar to that of Schrul, comprising a first connector (closure 110, similar to the first connection assembly of Schrul) that is attached to a medicament cartridge (100) (see Fig. 1-2 and English Translation, pg. 10, ln 22 – pg. 11, ln 1), and a second connector (coupling element 150) attachable to the first connector (see Fig. 2-6 and English Translation, pg. 11, ln 3-18) which accommodates a needle (204) disposed on a needle hub (200) and movable within a chamber (168) defined by the second body of the second connector (see Fig. 5-6) in order to engage a septum (112) provided in the first connector (see Fig. 5-6 and English Translation, pg. 12, ln 15 - 22 and pg. 17, ln 13-32). Cowe teaches that such a chamber may have a first narrow segment (top portion of chamber 168, as depicted in Fig. 1-10) having a first diameter (see Fig. 1-10) and a second wider segment (bottom portion of chamber 168, as depicted in Fig. 1-10) having a second diameter greater than the first diameter (see Fig. 1-10). Cowe also teaches that the needle hub may comprise protruding ridges (annular ribs 210) which are configured to engage with the chamber walls in the narrow segment (see Fig. 5), thereby forming a seal (S2) which encapsulates the needle as sealed within the chamber, keeping the needle tip (204b) sterile in its retracted position (see Fig. 5 and English Translation, pg. 13, ln 7-8). It is clear from Fig. 6, however, that these ridges do not engage with the chamber walls in the wider segment (see Fig. 6), wherein the needle has already pierced the septum and no seal is needed within the cavity in order to ensure that the needle tip and medicament remain uncontaminated (see Fig. 6). It follows that the friction between the needle hub and the first segment (wherein sealing contact is made) is greater than the friction between the needle hub and the second segment (wherein no contact is made, therefore no friction is experienced).
Based on the teachings of Cowe, and in order to provide a sealed cavity for the needle of Schrul in its retracted position in a similar manner, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber of Schrul such that the chamber has a first narrow segment having a first diameter and a second wider segment having a second diameter larger than the first diameter, in the manner taught by Cowe, and such that the needle hub comprises protruding ridges which are configured to engage with the chamber walls in the narrow segment, thereby forming a seal which encapsulates the needle as sealed within the chamber, keeping the needle tip sterile in its retracted position, as described by Cowe (see Fig. 5 and English Translation, pg. 13, ln 7-8). Upon such a modification, Schrul would then also exhibit that the friction between the needle hub and the first segment (wherein sealing contact is made) is greater than the friction between the needle hub and the second segment (wherein no contact is made, therefore no friction is experienced), in the same manner as Cowe.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Schrul in view of Scheurer (WO2020026049A1).
Regarding claim 10, Schrul discloses the connection system of claim 8, wherein the connection system is part of an injection device (see Fig. 20-21, [0041-0042], and [0122]). While Schrul fails to teach that the needle hub defines a keyed protrusion thereon configured to be received into a corresponding keyed receptacle on the injection device, it is clear from the teachings of Schrul that the needle hub is retained in a retracted position by some mechanism until activation, whereupon it is driven towards the medicament cartridge (see Fig. 17a-17b, [0041], and [0111]). Further, other references within the prior art, such as Scheurer, present very similar connection systems to that of Schrul, and further elaborate upon this mechanism. For example, Scheurer exhibits a connection system and injection device nearly identical to that of Schrul (see Fig. 1-11, pg. 26, ln 21 – pg. 27, ln 27), including a second connection assembly (housing 11) which accommodates a needle (70) mounted to a needle hub (80) that is moveable within a cavity defined by the walls of the second connection assembly (see Fig. 9-11). Scheurer further teaches that the needle hub may be biased towards the medicament cartridge by a helical spring (90) disposed between the back end of the needle hub and the back wall of the second connection assembly (see Fig. 9-11 and pg. 26, ln 21 – pg. 27, ln 6), and that the needle hub may define a keyed protrusion (counter surface 81) thereon configured to be received into a corresponding keyed receptacle (retaining surface 47) on an injection device (control element 40 of the injection device) in order to retain the needle hub in a retracted position until activation, whereupon the keyed protrusion is disengaged from the receptacle, and the needle is driven towards the medicament cartridge (see Fig. 9-11 and pg. 27, ln 7-19). Since Schrul does not provide any details regarding the mechanism by which the needle is retained or driven, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention, based upon the teachings and example of Scheurer, to modify the needle hub and injection device of Schrul to comprise the retaining/activation mechanism taught by Scheurer as a simple matter of selecting a means known within the prior art to be suitable for embodying the functionality described by Schrul.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Schrul in view of Bar-el (U.S. Pat. Pub. No. 2018/0154081 A1).
Regarding claim 19, Schrul exhibits the injection device of claim 11, wherein the medicament container (cartridge 29) may be inserted longitudinally into the receptacle (cartridge holder 37) prior to assembly of the housing (see Fig. 18 and [0122]). Schrul fails to teach any means of inserting a medicament container into the cartridge holder once the housing is assembled, let alone that the housing includes a movable door configured to be opened and closed, the medicament container being receivable onto the movable door.
Bar-el exhibits an injection device (422, see Fig. 4A-4D and [0167]) similar to that of Schrul. Bar-el teaches that the user may insert a medicament container (cartridge 420) into a receptable within the housing by means of the housing comprising a movable door (tilting bay 423) configured to be opened and closed, the medicament container being receivable onto the movable door (see Fig. 4a-4D and [0165], [0167-0170]). Such an arrangement represents a much simpler and quicker way to insert a medicament container into an injection device as compared to the method of Schrul, wherein the device must be assembled around the container and receptacle. As such, the arrangement of Bar-el allows for the user or an intermediate supplier to install a variety of different medicaments within the same injection device or stock of injection devices, as opposed to beach injection device being assembled a supplied pre-loaded. As such, installation configuration taught by Bar-el is advantageous in regards to its ease of use and flexibility as compared to the configuration of Schrul, and thus, one of ordinary skill in the art would have found it obvious, for these reasons, to modify the housing of Schrul to include a movable door configured to be opened and closed, the medicament container being receivable onto the movable door in the manner taught by Bar-el.
Claim(s) 32 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Quinn (WO2019033004A1) in view of Matkovich.
Regarding claim 32, Quinn discloses a connection system (connector 500, see Fig. 22-26) for creating an aseptic connection between a container (bottle 510) and a delivery conduit of an injection device (IV line – see [0095]) (see Fig. 22-26 and [0092-0101]), the connection system comprising: a first connection assembly (first portion 505) comprising: a first engagement body having a first end (rear, wider end facing the bottle) that includes a first opening (wider opening) and is configured to form a seal with a septum (septum 520) of a container (bottle 510) (see Fig. 23 and [0093], wherein the sidewalls of the first portion at the first end directly cover and form a seal with the radially outer edges of the septum 520), a second end (forward, narrowed end) having a second opening (opening comprising first membrane 540), a first cavity between the first and second openings (see Fig. 23, wherein a cavity is defined within the sidewalls of the first portion extending from the rear end of the septum 520 to the first membrane 540), and a first engagement surface at the second end of the first engagement body (see Fig. 23, wherein the flat surface facing the second portion 550 at the second end and comprising the second opening with the first membrane may be interpreted as a first engagement surface); and a first flexible barrier (first membrane 540, which may be made of a flexible and frangible material, such as thin polypropylene) configured to form a seal with the second opening (see Fig. 23 and [0093]); and a second connection assembly (second portion 550) comprising: a second engagement body (outer casing 560) having a first end (rear end which accommodates the slider casing 580) that includes a third opening (opening which accommodates the slider casing 580), a second end (forward end facing the first portion 505) that includes a fourth opening (opening comprising second membrane 610), a second cavity (cavity extending between the second membrane 610 and the first end, within which the slider casing and sliding tunnelling needle 570 may axially translate) between the third and fourth openings (see Fig. 23), and a second engagement surface at the second end of the second engagement body (see Fig. 23, wherein the flat surface facing the first portion 505 at the second end and comprising the fourth opening with the second membrane may be interpreted as a second engagement surface); and a needle (sliding tunnelling needle 570) operably connected to the second engagement body (slidably connected via slider casing 580); and a second flexible barrier (second membrane 610, which may be made of a flexible and frangible material, such as thin polypropylene) configured to form a seal with the fourth opening (see Fig. 23 and [0095]), and wherein the connection system is configured such that the needle is moveable relative to the fourth opening of the second engagement body from a first position where the needle is spaced from the third opening (see the intermediate position of Fig. 25, wherein the needle 570 has passed beyond the third opening, and is thus spaced from the third opening, but is not yet locked into its fully extended position), to a second position where the needle extends through the third opening (the fully retracted position of Fig. 24, wherein the needle extends through the third opening) (see Fig. 24-26 and [0098-0101], wherein prior to piercing the septum 520, the needle 570 is able to axially translate both towards the bottle 510 (extension direction) and away from the bottle 510 (retraction direction) relative to the outer casing 560 and its forward fourth opening and rearward third opening).
Quinn fails to teach that the first engagement surface further comprises a first sealing interface configured to form a seal with a second sealing interface on the second engagement surface.
Matkovich exhibits a connection system for aseptically connecting fluid paths (see Fig. 1-15 and [0003]) similar to that of Quinn, wherein the system comprises a first connector body (female fitting 120) having a first engagement surface (socket 145) and a second connector body (male fitting 220) having a second engagement surface (socket 245). Matkovich teaches that the first engagement surface may further comprise a first sealing interface (170) configured to form a seal with a second sealing interface (270) on the second engagement surface (see Fig. 1-3, [0045], and [0051]), wherein the sealing interfaces are compressed against each other when the first connector body and second connector body are connected, thereby ensuring that there is no leakage of medicament at the connection, nor any contamination of the medicament from infiltration of outside matter into the connection (see Fig. 1-3, [0045-0047], [0051-0053], and [0055-0056]).
Based on the teachings of Matkovich, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first engagement surface and second engagement surface of Quinn to include cooperative sealing interfaces like those of Matkovich, such that the first engagement surface further comprises a first sealing interface configured to form a seal with a second sealing interface on the second engagement surface, in order to thereby ensure that there is no leakage of medicament at the connection, nor any contamination of the medicament from infiltration of outside matter into the connection, as described by Matkovich (see Fig. 1-3, [0045-0047], [0051-0053], and [0055-0056]).
Regarding claim 34, Quinn further discloses that the needle is translatable relative to the second engagement surface (see Fig. 24-26 and [0098-0101]) to thereby enable the needle to pass into the first cavity (see Fig. 26) once the first engagement surface and second engagement surface of Quinn have been engaged (see Fig. 24-26), and therefore, a seal between the first and second sealing interfaces has been created according to the above modification (see in re claim 32).
Claim(s) 52 is rejected under 35 U.S.C. 103 as being unpatentable over Quinn as modified by Matkovich according to claim 32, and in further view of Min (U.S. Pat. Pub. No. 2012/0204990 A1).
Regarding claim 52, Quinn as modified by Matkovich according to claim 32 exhibits the connection system of claim 32 (see in re claim 32), wherein Quinn teaches that the first connection assembly may be mounted on and fluidly connected to a container (bottle 510) and the second connection assembly may be fluidly connected to tubing (IV line) (see in re claim 32). In discussion of earlier embodiments, however, Quinn suggests that a container may be fluidly connected to both the first and second connection assemblies, either via tubing or by direct connection ([0045] and [0060], ln 7-9). Further, it is well known within the art to apply aseptic connectors of the type disclosed by Quinn to fluid connections between a bulk storage container and a smaller container, such as a cartridge like that of Quinn. For example, Min exhibits a connection system (10) for aseptically connecting fluid paths ([0010]) of the same type taught by Quinn (see Fig. 1-3, [0023], and [0030-0031]), wherein a first connector body (housing 20) may be connected to a small container/bag (16) and a second connector body (housing 30) may be connected to a larger bulk storage container/bag (26) (see Fig. 1-3, [0023], and [0030-0031]).
Based on the teachings and example of Min, as well as the suggestions of Quinn, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the connector system of Quinn to a container filling system wherein a bulk storage container for filling the container with a medicament may be connected to the second connection assembly (such as via tubing in the manner depicted in Quinn Fig. 23-26 and in Min), the bulk storage container having an interior volume that is larger than that of the container, and wherein the container (bottle, vial, etc.) may be connected to the first connection assembly (such as in the manner depicted in Quinn, Fig. 23-26), thereby establishing an aseptic fluid connection between the bulk storage container and the container to allow for transfer of fluid without contamination of either the bulk supply or the withdrawn amount of medicament, as simple application of a known type of aseptic connection system (that of Quinn) in a known manner (Quinn teaching that the first connection assembly may be mounted to a container, and the second connection assembly may be connected to tubing, such as may then lead to a bulk storage container, as suggested by Quinn and taught by Min) in order to obtain predictable results (aseptic fluid connection). See MPEP 2143(I)(C).
Allowable Subject Matter
Claim(s) 16 is/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 cited in this office action and any prior office actions represents the closest art to the claimed invention as found by the examiner. Regarding the above cited claims, none of these references teach or suggest the claimed invention as a whole, and it would not have been obvious to one of ordinary skill in the art at the time of filing to combine teachings from these references to obtain the claimed invention. In support of this finding, a comparison of the present claim limitations to the closest prior art is presented below.
Regarding claim 16, the claim recites the limitation “wherein the housing includes a first keyed feature extending into the receptacle, the receptacle being configured to preclude movement of the connection system into the receptacle when the connection system is in the first rotational orientation, and to allow movement of the connection system into the receptacle when the connection system is in the second rotational orientation,” which alongside the remainder of the claim and any intervening claims renders the claim patentably distinct over the prior art. While references such as Schrul, Quinn, Booth (U.S. Pat. Pub. No. 2019/0111204 A1), and Hanson (U.S. Pat. Pub. No. 2018/0028747 A1) each teach similar aseptic connection and/or injection devices to that described in claims 1, 11, and 15, upon which claim 16 depends, none of these references teach the above cited limitation. The closest teaching is found in Quinn, Fig. 12B-21C, wherein keyed features (keying rings 360 and 375) may be provided on the first connection assembly and second connection assembly in order to ensure proper rotational and orientational alignment between these features. Quinn does not teach or suggest providing such keyed features on the housing of an injection device for this purpose (Quinn lacking any teaching of an injection device at all). Since these references represent the closest prior art to the claimed configuration, and since no other reference was found by the examiner which discloses or teaches this limitation(s), it is thus concluded that this limitation(s), in combination with the remainder of the claim and any intervening claims, is/are patentably distinct over prior art. Any claims that are dependent upon this claim are also considered to be patentably distinct over prior art by virtue at least of the subject matter of this claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783