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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 27, 33, and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 is indefinite. The claim, as amended, refers to “the first medicant” (the word “container” having been deleted) while the parallel element is recited as “the second medicant container.” The same clause later refers to “the first medicant container.”
It is unclear whether “the first medicant” is intended to identify the container or the medication itself. In addition, “the first medicant container” may lack clear antecedent basis if the only prior introduction of that element is the bare phrase “the first medicant.”
For consistency with claim 1 and with the second medicant container limitation in the same claim, the claim should recite “the first medicant container” in both places (e.g., “the first medicant container having a first size, the first medicant container containing a medication.”
For purposes of examination, the Examiner will interpret the phrase “the first medicant” to mean “the first medicant container.”
Claim 33 is indefinite. The claim recites “the internal support surface is spaced from the base of the shell so as to define a gap therebetween.”
There is no prior introduction of “a base of the shell.” The shell is introduced only as “a shell configured to receive the medicant container.” The subsequent use of the definite article “the” in “the base of the shell” therefore lacks antecedent basis.
Correction to “a base of the shell” (or an equivalent first introduction of that element) is required.
Claim 37 is indefinite for two independent reasons.
First, the claim recites, “wherein the gap is partially defined by the side wall of the shell.” Claim 33 (from which claim 37 depends) introduces a side wall only of the medicant container (“a side wall extending up from the base to a neck”). There is no prior introduction of a side wall of the shell. The definite article “the” in “the side wall of the shell” therefore lacks antecedent basis.
Second, the claim recites “a support structure that extends in the gap from the base of the shell to the base of the medicant container.” The term “support structure” does not appear in the specification or drawings, is not assigned a reference numeral, and is not described. It is unclear what structure is required to meet this limitation. See MPEP §2173.02.
Correction of the antecedent-basis issue and clarification of the meaning of “support structure” (or amendment to language that finds clear support in the specification) is required.
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.
(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 1-2, 4, 17, 21, 26-28, and 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McLoughlin (US Publication No. 2014/0336587), hereinafter, McLoughlin.
Regarding claim 1, McLoughlin discloses a system (auto-injector device using same cassette geometry for cassette unit 1 in figs. 1-3 and cassette unit 101 in figs. 4-6) comprising:
a device (cassette unit housing 20 of cassette unit 1 in figs. 1-3 and cassette unit housing 120 of cassette unit 101 in figs. 4-6) including a chamber (cavity sized for generally fixed receipt of the 2.25 mL syringe, para [0049]) configured to receive a first medicant container (syringe 10 in figs. 1-3) having a first size (large 2.25 mL size, para [0049]) configured to nest in the chamber (cassette unit is shaped and sized based on the geometry of the larger 2.25 mL syringe, para [0049]; cassette unit housing 20 of the cassette unit 1 is arranged to define a cassette unit housing cavity that is sized and shaped for generally fixed receipt of the syringe 10 in figs. 1-3, para [0282] and [0285]);
a second medicant container (syringe 110 in figs. 5A-5B and 6) having a second size (syringe 110 is of a standard `long` 1 mL type, para [0288-0290]) that is smaller than the first size, such that the second medicant container is not configured to nest in the chamber (syringe 110 having a smaller outer dimension (e.g. a 1 mL `long` syringe) may then be accommodated in this same cassette unit by use of a sleeve adapter 130 that effectively functions to adapt the outer syringe geometry (e.g. the outer diameter thereof) to closely correspond to or to be identical with that of the 2.25 mL syringe, para [0049]; because sleeve 130 brings syringe 110 up to the 2.25 mL cassette size, syringe 110 alone is not configured to nest in the chamber); and
a shell (sleeve adapter 130 in figs. 5A-5B and 6) configured to cover at least a portion of the second medicant container (sleeve form adapter 130 acts to sleeve a major portion of the syringe barrel 112 in figs. 5A-5B and 6, para [0292]) so as to define an assembled container structure (assembled structure comprising sleeve adapter 130 for the syringe 110 interacts with the inner wall 123 of the cassette unit housing 120, which thereby acts to constrain the position of the sleeve adapter 130 and syringe 110 within the cassette unit housing 120; para [0296]) that is configured to nest in the chamber (syringe 110 having a smaller outer dimension (e.g. a 1 mL `long` syringe) may then be accommodated in this same cassette unit by use of a sleeve adapter 130 that effectively functions to adapt the outer syringe geometry (e.g. the outer diameter thereof) to closely correspond to or to be identical with that of the 2.25 mL syringe, para [0049]).
Regarding claim 2, McLoughlin discloses the system of claim 1, wherein the system is an injector system that comprises: an injector including the chamber (cavity sized for generally fixed receipt of the 2.25 mL syringe, para [0049]), wherein the chamber is configured to receive the first medicant container (cassette unit is shaped and sized based on the geometry of the larger 2.25 mL syringe, para [0049]; cassette unit housing 20 of the cassette unit 1 is arranged to define a cassette unit housing cavity that is sized and shaped for generally fixed receipt of the syringe 10 in figs. 1-3, para [0282] and [0285]) such that the injector is configured to inject contents of the first medicant container, and whereby the injector is configured to inject the contents of the second medicant container when the assembled container structure (assembled structure comprising sleeve adapter 130 for the syringe 110 interacts with the inner wall 123 of the cassette unit housing 120, which thereby acts to constrain the position of the sleeve adapter 130 and syringe 110 within the cassette unit housing 120; para [0296]) is disposed within the chamber (syringe barrel 12 adapter size selected for suitable volume of liquid drug injection into patient, para[0042], [0053] and [0288]).
Regarding claim 4, McLoughlin discloses the system of claim 1, wherein when the assembled container structure (assembled structure comprising sleeve adapter 130 for the syringe 110 interacts with the inner wall 123 of the cassette unit housing 120, which thereby acts to constrain the position of the sleeve adapter 130 and syringe 110 within the cassette unit housing 120; para [0296]) is nested in the chamber, the chamber has a cross-sectional dimension, perpendicular to a longitudinal axis that the assembled container structure and the chamber extend along (sleeve adapter 130, syringe 110 and inner wall 123 of cassette unit housing 120 align along a longitudinal axis in figs. 5A-5B and 6; the cavity sized for generally fixed receipt of the 2.25 mL syringe has a cross section perpendicular to the longitudinal axis, para [0049]), that is substantially equal to a cross-sectional dimension of the assembled container structure (syringe 110 having a smaller outer dimension (e.g. a 1 mL `long` syringe) may then be accommodated in this same cassette unit by use of a sleeve adapter 130 that effectively functions to adapt the outer syringe geometry (e.g. the outer diameter thereof) to closely correspond to or to be identical with that of the 2.25 mL syringe, para [0049]).
Regarding claim 17, McLoughlin discloses the system of claim 1, wherein a side wall of the assembled container structure (assembled structure comprising sleeve adapter 130 for the syringe 110 interacts with the inner wall 123 of the cassette unit housing 120, which thereby acts to constrain the position of the sleeve adapter 130 and syringe 110 within the cassette unit housing 120; para [0296]) is defined by the shell (sleeve adapter 130 acts to sleeve a major portion of syringe barrel 12 in figs. 5A-5B and 6, para [0049], [0292] and [0296]).
Regarding claim 21, McLoughlin discloses the system of claim 1, wherein the shell (sleeve adapter 130 in figs. 5A-5B and 6) further comprises: an outer surface (outer surface of sleeve adapter 130 in figs. 5A-5B and 6) having at least one outer dimension that is substantially equal to a corresponding at least one outer dimension of a first standard size of a standard, wherein the outer surface is configured to be received in the chamber (cavity sized for generally fixed receipt of the 2.25 mL syringe, para [0049]), of the device (cassette unit housing 20 of cassette unit 1 in figs. 1-3 and cassette unit housing 120 of cassette unit 101 in figs. 4-6), which corresponds to the first standard size (cassette unit is shaped and sized based on the geometry of the larger 2.25 mL syringe, para [0049]; cassette unit housing 20 of the cassette unit 1 is arranged to define a cassette unit housing cavity that is sized and shaped for generally fixed receipt of the syringe 10 in figs. 1-3, para [0282] and [0285]); and
an internal cavity (cavity defined by inner surface of sleeve adapter 130 in figs. 5A-5B and 6) having at least one inner dimension that is substantially equal to a corresponding at least one inner dimension of a second standard size of the standard, the second standard size being less than the first standard size, and wherein the internal cavity is configured to receive a container that corresponds to the second standard size (syringe 110 having a smaller outer dimension (e.g. a 1 mL `long` syringe) may then be accommodated in this same cassette unit by use of a sleeve adapter 130 that effectively functions to adapt the outer syringe geometry (e.g. the outer diameter thereof) to closely correspond to or to be identical with that of the 2.25 mL syringe, para [0049]).
Regarding claim 26, McLoughlin discloses the system of claim 1, wherein the shell (sleeve adapter 130 in figs. 5A-5B and 6) includes a radially outer wall (radially outer wall of sleeve adapter 130 with rear end 132 in fig. 5A and 6) that extends circumferentially around a lip (flange 116 in figs. 5A and 6) of the second medicant container (end flange 116 of the syringe 110 then snaps into the rear end 132 of the sleeve adapter 130 such that the syringe 110 is locked into the adapter 130 once assembled in figs. 5A-5B and 6).
Regarding claim 27, McLoughlin discloses the system of claim 1, further comprising: a kit (kit of parts; para [0227-0231]) comprising:
the first medicant container, the first medicant container (syringe 10 in figs. 1-3) containing a medication (a kit of parts comprising a cassette unit and a syringe containing a liquid drug formulation, para [0227]);
the second medicant container (syringe 110 in figs. 5A-5B and 6), the second medicant container containing the medication (a kit of parts comprising a cassette unit and a syringe containing a liquid drug formulation, para [0227]); and
the shell (sleeve adapter 130 in figs. 5A-5B and 6) configured to receive the second medicant container so as to define the assembled container structure (assembled structure comprising sleeve adapter 130 for the syringe 110 interacts with the inner wall 123 of the cassette unit housing 120, which thereby acts to constrain the position of the sleeve adapter 130 and syringe 110 within the cassette unit housing 120; para [0296]),
wherein the assembled container structure has outer dimensions that are substantially equal to outer dimensions of the first medicant container (syringe 110 having a smaller outer dimension (e.g. a 1 mL `long` syringe) may then be accommodated in this same cassette unit by use of a sleeve adapter 130 that effectively functions to adapt the outer syringe geometry (e.g. the outer diameter thereof) to closely correspond to or to be identical with that of the 2.25 mL syringe, para [0049]).
Regarding claim 28, McLoughlin discloses the system of claim 27, wherein the assembled container structure (assembled structure comprising sleeve adapter 130 for the syringe 110 interacts with the inner wall 123 of the cassette unit housing 120, which thereby acts to constrain the position of the sleeve adapter 130 and syringe 110 within the cassette unit housing 120; para [0296]) has a cross-sectional dimension, perpendicular to a longitudinal axis that the assembled container structure extends along, that is substantially equal to a cross-sectional dimension of the first medicant container (sleeve adapter 130, syringe 110 and inner wall 123 of cassette unit housing 120 align along a longitudinal axis in figs. 5A-5B and 6; the cavity sized for generally fixed receipt of the 2.25 mL syringe has a cross section perpendicular to the longitudinal axis, para [0049]), and wherein the second medicant container (syringe 110 in figs. 5A-5B and 6) has a cross-sectional dimension perpendicular to the longitudinal axis that is less than the cross-sectional dimensions of the first medicant container and the assembled container structure (syringe 110 having a smaller outer dimension (e.g. a 1 mL `long` syringe) may then be accommodated in this same cassette unit by use of a sleeve adapter 130 that effectively functions to adapt the outer syringe geometry (e.g. the outer diameter thereof) to closely correspond to or to be identical with that of the 2.25 mL syringe, para [0049]).
Regarding claim 43, McLoughlin discloses a shell (sleeve adapter 130 in figs. 5A-5B and 6) comprising:
an outer surface (outer surface of sleeve adapter 130 in figs. 5A-5B and 6) having at least one outer dimension that is substantially equal to a corresponding at least one outer dimension of a first size of a standard (cavity sized for generally fixed receipt of the 2.25 mL syringe, para [0049]), wherein the outer surface is configured to be received in a chamber (cavity sized for generally fixed receipt of the 2.25 mL syringe, para [0049]) of a device (cassette unit housing 20 of cassette unit 1 in figs. 1-3 and cassette unit housing 120 of cassette unit 101 in figs. 4-6) that corresponds to the first size (cavity sized for generally fixed receipt of the 2.25 mL syringe, para [0049]); and
an internal cavity (cavity defined by inner surface of sleeve adapter 130 in figs. 5A-5B and 6) having at least one inner dimension that is substantially equal to a corresponding at least one inner dimension of a second size (syringe 110 is of a standard `long` 1 mL type, para [0288-0290]) of the standard, the second size being less than the first size, and wherein the internal cavity is configured to receive a container that corresponds to the second size (syringe 110 having a smaller outer dimension (e.g. a 1 mL `long` syringe) may then be accommodated in this same cassette unit by use of a sleeve adapter 130 that effectively functions to adapt the outer syringe geometry (e.g. the outer diameter thereof) to closely correspond to or to be identical with that of the 2.25 mL syringe, para [0049]).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over McLoughlin, as applied to claim 1 above, in view of Thomas (EP Patent No. 1157965), hereinafter, Thomas.
Regarding claim 3, McLoughlin discloses the system of claim 1 but fails to disclose that the system is a decapping system.
Thomas teaches a decapping system (Thomas: decapper for removing crimped caps from a vial in figs. 13-18) that comprises: a container decapper including the chamber (Thomas: decapper with jaws 170 for removing crimped caps from a vial in figs. 13-18; col. 11, lines 29-36 and col. 12, lines 28-39), wherein the chamber is configured to receive the first medicant container (Thomas: a vial having diameter matching the closed-jaw opening of jaws 170; col. 4, lines 28-31) such that the container decapper is configured to remove a first cap (Thomas: cap 4 is removed by jaws 170 in figs. 13-14,18; col. 11, lines 29-33) from the first medicant container, whereby the container decapper is not configured to remove a second cap (Thomas: jaws 170 are sized so that, when closed, the jaws will have an opening diameter of just greater than the diameter of the bottle or vial to be decapped and, therefore, is not configured to remove a second cap from a smaller diameter medicant container; col. 4, lines 28-31) from the second medicant container (syringe 110 in figs. 5A-5B and 6) when only the second medicant container is received in the chamber, and whereby the container decapper is configured to remove the second cap from the second medicant container when the assembled container structure is disposed within the chamber (Thomas: the same jaws 170 that close on larger diameter cap can also receive small diameter cap when the McLoughlin sleeve adapter 130 brings the outer diameter of the second container up to the jaw opening diameter).
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 device including the chamber of McLoughlin to a container decapper having jaws sized so that, when closed, the jaws form an opening of just greater than the diameter of a first (larger) medicant container, as taught by Thomas, in order to enable removal of a crimped cap from the first medicant container while still permitting the same chamber to receive and decap a second, smaller medicant container when that container is provided with the shell so as to define the assembled container structure.
Claims 11, 18, 33, 37 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over McLoughlin in view of Ally (US Publication No. 2023/0210721), hereinafter, Ally.
Regarding claim 11, McLoughlin discloses the system of claim 1 comprising a shell (sleeve adapter 130 in figs. 5A-5B and 6) and a second medicant container (syringe 110 in figs. 5A-5B and 6).
McLoughlin fails, however, to disclose that the shell comprises a radially inwardly extending rim and a floor that is offset from the radially inwardly extending rim along a longitudinal axis that the assembled container structure extends along, wherein the radially inwardly extending rim is configured to abut a shoulder of the second medicant container, and wherein the floor is configured to abut an end of the second medicant container opposite the shoulder along the longitudinal axis.
Ally teaches that the shell comprises a radially inwardly extending rim (Ally: shoulder 56 and second opening 58 form a radially inwardly extending rim in figs. 1-3 and 7-8) and a floor (Ally: locking member 20 at the bottom portion 50A of vial sleeve 50 that is configured to prevent the vial from exiting in figs. 2-6; para [0066], [0075]) that is offset from the radially inwardly extending rim along a longitudinal axis that the assembled container structure extends along (Ally: shoulder 56 and second opening 58 are offset from locking member 20 at bottom portion 50A and limit axial travel of the vial toward the open end in figs. 1-3; para [0059-0060]), wherein the radially inwardly extending rim is configured to abut a shoulder (Ally: shoulder 56 and second opening 58 form a radially inwardly extending rim that axially limits travel of vial 30 in figs. 7-8; para [0059]) of the second medicant container, and wherein the floor is configured to abut an end of the second medicant container opposite the shoulder along the longitudinal axis (Ally: locking member 20 at bottom portion 50A is locked into position to prevent vial 30 from being removed from vial sleeve 50, para [0064-0065]; locking member 20 at bottom portion 50A is offset from shoulder 56 with second opening 58 at opposite ends of vial sleeve 50 in figs. 1-3).
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 shell of McLoughlin to include a radially inwardly extending rim and a floor offset from the rim along a longitudinal axis, the rim configured to limit axial travel of the second medicant container and the floor configured to prevent the second medicant container from exiting the shell, as taught by Ally, in order to axially retain the second medicant container within the shell and prevent it from exiting either end of the assembled container structure.
Regarding claim 18, McLoughlin discloses the system of claim 1, wherein the shell (sleeve adapter 130 in figs. 5A-5B and 6) is configured to hold the second medicant container (syringe 110 in figs. 5A-5B and 6) relative to the shell, such that the assembled container structure is defined when the receptacle holds the second medicant container (assembled structure comprising sleeve adapter 130 for the syringe 110 interacts with the inner wall 123 of the cassette unit housing 120, which thereby acts to constrain the position of the sleeve adapter 130 and syringe 110 within the cassette unit housing 120; para [0296]).
McLoughlin fails, however, to disclose that the shell comprises a pair of interlocking bodies that when interlocked together define a receptacle that is configured to hold the second medicant container.
Ally teaches a shell that comprises a pair of interlocking bodies (Ally: locking member 20 at bottom portion 50A is locked into position with body 54 via locking lugs 24 and recess locks 66 to prevent vial 30 from being removed from vial sleeve 50 in figs. 1-3, para [0064-0065]) that when interlocked together define a receptacle that is configured to hold the second medicant container.
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 shell of McLoughlin to comprise a pair of interlocking bodies that, when interlocked, define a receptacle that holds the second medicant container relative to the shell, as taught by Ally, in order to securely retain the second medicant container within the shell and prevent it from exiting after assembly.
Regarding claim 33, McLoughlin discloses an assembled container structure (assembled structure comprising sleeve adapter 130 for the syringe 110 interacts with the inner wall 123 of the cassette unit housing 120, which thereby acts to constrain the position of the sleeve adapter 130 and syringe 110 within the cassette unit housing 120; para [0296]) comprising:
a shell (sleeve adapter 130 in figs. 5A-5B and 6) configured to receive the medicant container so as to define the assembled container structure that is sized in cross-section greater than the medicant container (sleeve 130 receives syringe 110 and forms the assembled structure that sits in cassette unit housing 120 which means the cross-section is greater than the cross-section of syringe 110, para [0049]), and
wherein the assembled container structure is configured to interface with an injector (second cassette unit 101 in cassette unit housing 120 is the injector interface in figs. 4-6, para [0289-0291]).
McLoughlin fails, however, to disclose a medicant container defining a base, a side wall extending up from the base to a neck, and a medicant container interface end extending up from the neck, wherein the medicant container contains a medication; and
wherein the shell has an internal support surface that supports the base of the medicant container, and the internal support surface is spaced from the base of the shell so as to define a gap therebetween, and
wherein the shell extends to the neck of the medicant container and terminates at the neck, such that the medicant container interface end of the medicant container extends out from the shell.
Ally teaches a medicant container defining a base (Ally: vial 30 has a base in figs. 1-3), a side wall extending up from the base to a neck (Ally: vial 30 a side wall extending from the base to the neck in figs. 1-3), and a medicant container interface (Ally: cap 32 in figs. 1-3) end extending up from the neck (Ally: cap 32 extends up from neck of vial 30 in figs. 1-3), wherein the medicant container contains a medication (Ally: sample 34 contained within vial 30; para [0059], [0064]); and
wherein the shell has an internal support surface (Ally: inner face of locking member 20 (annular ring) partially closes the first opening 57 and is configured to reduce the size of the first opening 57 to be small enough to prevent vial 30 from exiting in figs. 2-6; para [0066]) that supports the base of the medicant container (Ally: inner face of locking member 20 supports/retains the base of vial 30 against exit through opening 57 in figs. 2-5; para [0066], [0075]), and the internal support surface is spaced from the base of the shell so as to define a gap therebetween (Ally: shell base is the outer/bottom face of locking member 20 at end 12 together with bottom portion 50A of body 54; recess lock bottom wall 69 in figs. 4, 10-11, para [0066], [0069], [0071]; gap is the axial span of locking member 20 with side wall 21 and lugs 24 as seated in the recesses at 50A in figs. 2, 4-5, 10),and
wherein the shell extends to the neck of the medicant container and terminates at the neck (Ally: shoulder 56 of vial sleeve 50 extends to and terminates at neck of vial 30 in figs. 1-3, para [0059]), such that the medicant container interface end of the medicant container extends out from the shell (Ally: second opening 58 is configured to at least partially receive a cap 32 of the vial 30 and at least partially allow the cap 32 to extend therethrough in figs. 1, 3; para [0060]).
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 shell and container of McLoughlin to include an internal support surface that supports the base of the medicant container and is spaced from a base of the shell so as to define a gap therebetween, and to have the shell extend to and terminate at the neck of the medicant container so that the medicant container interface end extends out from the shell, as taught by Ally, in order to axially retain the medicant container within the shell, prevent it from exiting either end, and leave the interface end accessible for connection to an injector.
Regarding claim 37, modified McLoughlin discloses the assembled container structure of claim 33, further comprising a support structure (Ally: circumferential side wall 21 of ring 20, with locking lugs 24 and locking detents 26 in figs. 5-6; para [0066], [0070-0071]) that extends in the gap from the base of the shell to the base of the medicant container (Ally: circumferential side wall 21 of ring 20 extends axially and run from outer bottom of the locked ring up to the inner rim that stops vial 30 in figs. 5-6; para [0066], [0070-0071]), and wherein the gap is partially defined by the side wall of the shell (Ally: body 54/bottom portion 50A; recess entrance 62, channel 64, and lock 66 are formed in the inner surface of body 54 adjacent to end 12 in fig. 4; para [0069]).
Regarding claim 42, modified McLoughlin discloses the assembled container structure of claim 33 comprising a shell, but fails to disclose that the shell is colored, tinted, or opaque such that a user is unable to determine the color of medicant held by the medicant container.
Ally teaches that the shell is colored, tinted, or opaque such that a user is unable to determine the color of medicant held by the medicant container (Ally: vial sleeve 50 may also be constructed of an opaque material such as to prevent a user from viewing a label or identifying indicia included on the vial 30 while the vial 30 is housed within the vial sleeve 50, para [0061]).
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 shell of modified McLoughlin to be colored, tinted, or opaque such that a user is unable to determine the color of the medicant held by the medicant container, as taught by Ally, in order to conceal the contents or labeling of the medicant container from view while the container is housed in the shell.
Claims 24, 44-45 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over McLoughlin in view of Berg (US Publication No. 20240033182), hereinafter, Berg.
Regarding claim 24, McLoughlin discloses the system of claim 1 comprising a shell (sleeve adapter 130 in figs. 5A-5B and 6) with a second medicant container (syringe 110 in figs. 5A-5B and 6) that defines the assembled container structure (assembled structure comprising sleeve adapter 130 for the syringe 110 interacts with the inner wall 123 of the cassette unit housing 120, which thereby acts to constrain the position of the sleeve adapter 130 and syringe 110 within the cassette unit housing 120; para [0296]).
McLoughlin fails, however, to disclose the system of claim 1, wherein the shell includes a window, is transparent, and/or is translucent (Berg: clearances 115 in wall 114 in figs. 7-9) such that a main body of the second medicant container is at least partially visible through the shell (Berg: clearances 115 in wall 114 allow for visibility of vial 2 in figs. 7-9; para [0084]) when the shell covers at least the portion of the second medicant container so as to define the assembled container structure.
Berg teaches that the shell includes a window, is transparent, and/or is translucent (Berg: clearances 115 in wall 114 in figs. 7-9) such that a main body of the second medicant container is at least partially visible through the shell (Berg: clearances 115 in wall 114 allow for visibility of vial 2 in figs. 7-9; para [0084]) when the shell covers at least the portion of the second medicant container so as to define the assembled container structure.
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 shell of McLoughlin to include a window, or to be transparent or translucent, such that a main body of the second medicant container is at least partially visible through the shell, as taught by Berg, in order to permit visual inspection of the second medicant container or its contents while the container remains covered by the shell.
Regarding claim 44, McLoughlin discloses the shell of claim 43 but fails to disclose that the shell wherein the standard is ISO 8362-1.
Berg teaches that the standard is ISO 8362-1 (Berg: adapter configured to be coupled to a vial in accordance with standard ISO-8362-1, para [0016] and [0131-0132]).
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 shell of McLoughlin so that the standard is ISO 8362-1, as taught by Berg, in order to size the shell for compatibility with widely used pharmaceutical vials that conform to that standard.
Regarding claim 45, modified McLoughlin discloses the shell of claim 44, but fails to specify the recited R-sizes.
Berg teaches specific R-sizes that are one of 4R, 6R, 8R, 10R, 15R, 20R, 25R, or 30R, and wherein the second size is one of 2R, 4R, 6R, 8R, 10R, 15R, 20R, or 25R (Berg: adapter 1 with coupling device 11 adjust to both of the claimed sets of diameters at 13 mm, 20 mm, 28 mm, and 32 mm, para [0131-0132]).
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 shell of modified McLoughlin so that the first size is one of 4R, 6R, 8R, 10R, 15R, 20R, 25R, or 30R, and wherein the second size is one of 2R, 4R, 6R, 8R, 10R, 15R, 20R, or 25R, as taught by Berg, in order to size the shell for the most common ISO 8362-1 vial designations corresponding to those diameter ranges.
Regarding claim 47, modified McLoughlin discloses the shell of claim 44 but fails to disclose that the shell is part of a kit comprising:
the shell of claim 44, which is a first shell; and
a second shell, wherein the first shell and the second shell have different ones of the at least one inner dimension and the at least one outer dimension, and wherein none of the outer dimensions have a minimum corresponding dimension of the standard, and wherein none of the inner dimensions have a maximum corresponding dimension of the standard.
Berg teaches a kit (Berg: set comprises a first adapter and a second adapter for a vial for a medical liquid, para [0038-0042]) comprising:
the shell of claim 44, which is a first shell (Berg: first adapter, para [0136-0138]); and
a second shell (Berg: second adapter, para [0136-0138]), wherein the first shell and the second shell have different ones of the at least one inner dimension and the at least one outer dimension, and wherein none of the outer dimensions have a minimum corresponding dimension of the standard, and wherein none of the inner dimensions have a maximum corresponding dimension of the standard (Berg: set comprises two adapters, one for 13-20 mm and one for 28-32 mm, para [0038-0042], [0089-0090], [0104] and claim 10).
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 shell of modified McLoughlin to be part of a provided kit comprising a first shell and a second shell having different inner and outer dimensions, as taught by Berg’s set of adapters, in order to handle more than one vial size without redesigning the chamber or device for each size.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over McLoughlin in view of Ally, as applied to claim 33 above, and further in view of Berg.
Regarding claim 40, modified McLoughlin discloses that the assembled container structure defines a main body diameter, defines a structure head diameter, and defines a height, and wherein i) the main body diameter is 24 mm, the structure head diameter is 20 mm, and the height is 45 mm, ii) the main body diameter is 24 mm, the structure head diameter is 20 mm, and the height is 60 mm, iii) the main body diameter is 30 mm, the structure head diameter is 20 mm, and the height is 55 mm, or iv) the main body diameter is 30 mm, the structure head diameter is 20 mm, and the height is 60 mm (McLoughlin already has a sleeve larger than the container (sleeve adapter 130/cassette unit housing 120) around syringe 110 with inner wall 123 constraining the pair; it would be obvious to try sizing the container in accordance with standard vial sizes conforming to ISO 8362-1; MPEP 2143(I)(E)).
Modified McLoughlin fails to disclose that the assembled container structure of claim 33, wherein the medicant container defines a height, comprises a head defining a head diameter, and comprises a main body portion defining a main body diameter, and wherein i) the main body diameter is 22 mm, the head diameter is 20 mm, and the height is 45 mm, ii) the main body diameter is 22 mm, the head diameter is 20 mm, and the height is 40 mm, or iii) the main body diameter is 16 mm, the head diameter is 13 mm, and the height is 45 mm.
Berg teaches that the assembled container structure of claim 33, wherein the medicant container defines a height, comprises a head defining a head diameter, and comprises a main body portion defining a main body diameter, and wherein i) the main body diameter is 22 mm, the head diameter is 20 mm, and the height is 45 mm, ii) the main body diameter is 22 mm, the head diameter is 20 mm, and the height is 40 mm, or iii) the main body diameter is 16 mm, the head diameter is 13 mm, and the height is 45 mm; (Berg: vial sizes conform to ISO 8362-1 in figs. 1-2; para [0016], [0066-0067] and claims 9-10).
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 medicant container of McLoughlin, as modified by Ally, to have a main body diameter, head diameter, and height values conforming to standard vial sizes under ISO 8362-1, as taught by Berg, in order to use industry-standard vial geometries with existing filling and handling equipment.
It would further have been obvious to size the assembled container structure (shell + container) with a main body diameter, structure head diameter, and height selected from the recited ranges, because McLoughlin already teaches a sleeve larger than the container to fit a fixed chamber, and selecting standard outer dimensions that fit common chamber sizes is an obvious design choice within the art (MPEP 2143(I)(E).
Conclusion
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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