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 .
Status of Claims
This office action is responsive to the application filed 24 April 2024.
Claims 1-19 are presently pending in this application.
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.
Claims 1-4 and 6-19 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer (Foreign Patent Publication No. WO 2015185664 A1), in view of Giambattista (US Patent Publication No. 20190328968 A1), in further view of Hirschel et al. (Foreign Patent Publication No. WO 2018130944 A1), hereinafter Hirschel.
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Regarding claim 1, Helmer discloses an autoinjector needle-housing assembly (Helmer: Fig. 1, comprising cartridge holder 4 and inner needle sleeve 5) extending along an axis in a longitudinal direction (Fig. 1, axis L) from a proximal end (Fig. 1, end of sleeve 5 towards distal direction D) to a distal end (Fig. 1, end of holder 4 towards proximal direction P), the autoinjector needle-housing assembly (Fig. 1, comprising cartridge holder 4 and inner needle sleeve 5) comprising: a housing (Fig. 1, sleeve 5) comprising a proximal part (Fig. 1, area of sleeve 5 distal of second recess 5.2) and a distal part (Fig. 1, area of sleeve 5 proximal of recess 5.2); a needle (Fig. 1, needle 6) positioned at least partially within the housing (Fig. 1, sleeve 5); and a sterility barrier (Fig. 1, cartridge holder 4) attached to the distal part (Fig. 1, cartridge holder 4 is attached to the area of sleeve 5 proximal of recess 5.2 via rib 5.1) of the housing (Fig. 1, sleeve 5), wherein the housing (Fig. 1, sleeve 5) and the sterility barrier (Fig. 1, cartridge holder 4) form a first sealed cavity (Fig. 1 above, sealed cavity A), wherein a distal end of the needle (Fig. 1, inner needle section 6.2. Examiner notes that there is a typo in the prior art, and that the needle section 6.2 is meant to be an inner needle section, supported by the specification at pg. 7, ln 9-26) is in the first sealed cavity (Fig. 1 above, needle section 6.2 is inside cavity A), wherein the autoinjector needle-housing assembly (Fig. 1, comprising cartridge holder 4 and inner needle sleeve 5) comprises a recess (Fig. 1 above, recess D) formed by the distal end (Fig. 1, end of holder 4 towards proximal direction P) of the autoinjector needle-housing assembly (Fig. 1, comprising cartridge holder 4 and inner needle sleeve 5), wherein the recess (Fig. 1 above, recess D) is shaped to receive a cartridge (Fig. 1 above, recess D is shaped to receive cartridge 2) and to form a second cavity (Fig. 1 above, cavity B) between the autoinjector needle-housing assembly (Fig. 1, comprising cartridge holder 4 and inner needle sleeve 5) and the cartridge (Fig. 1, cartridge 2).
Helmer does not expressly disclose that the second cavity is sealed.
Giambattista teaches a second cavity (Giambattista: Fig. 5 and 7, the space defined by cartridge holder 330, seal 332, and the cartridge assembly 340) that is sealed (seal 332 maintains sterility of the needle assembly 310 prior to use; para. 0061).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the second cavity of Helmer such that it was sealed as taught by Giambattista in order to maintain sterility of the needle assembly 310 prior to use (Giambattista: para. 0061).
Helmer in view of Giambattista does not expressly disclose a seal, wherein the cartridge is configured to contact a seal when the cartridge is positioned in the recess.
Hirschel teaches a seal (Hirschel: Fig. 59a, elastomeric component 131), wherein a cartridge (Fig. 59a, cartridge 26) is configured to contact the seal (Fig. 59a, elastomeric component 131) when the cartridge (Fig. 59a, cartridge 26) is positioned in a recess (Fig. 59a, component 131 contacts cartridge 26 when 26 is positioned within the shown cavity).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assembly of Helmer in view of Giambattista such that it comprised a seal, wherein the cartridge is configured to contact a seal when the cartridge is positioned in the recess as taught by Hirschel in order to provide a fluid tight sealing between the first and second cavities (Hirschel: pg. 41).
Regarding claim 2, Helmer in view of Giambattista and Hirschel disclose the assembly above, wherein the recess (Fig. 1 above, recess D) is formed between the sterility barrier (Fig. 1, holder 4) of the autoinjector needle-housing assembly (Fig. 1, comprising cartridge holder 4 and inner needle sleeve 5) and the cartridge (Fig. 1, cartridge 2).
Regarding claim 3, Helmer in view of Giambattista and Hirschel disclose the assembly above, wherein the sterility barrier (Fig. 1, holder 4) comprises a wall (Fig. 1 above, wall F) positioned between the proximal part of the housing (Fig. 1, area of sleeve 5 distal of second recess 5.2) and the distal part of the housing (Fig. 1, area of sleeve 5 proximal of recess 5.2), wherein the wall (Fig. 1 above, wall F) extends in a radial direction (Fig. 1 above, holder 4 is cylindrical. Therefore, wall F would extend radially, as it covers the top of the holder 4; pg. 6, ln 15-24) relative to the axis (Fig. 1, axis L).
Regarding claim 4, Helmer in view of Giambattista and Hirschel disclose the assembly above.
Helmer in view of Giambattista does not expressly disclose the seal comprises a deformable material.
Hirschel teaches a seal comprises a deformable material (elastomeric component 131 is deformed upon cartridge insertion; pg. 41).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assembly of Helmer in view of Giambattista such that the seal comprises a deformable material as taught by Hirschel in order to provide a fluid tight sealing between the first and second cavities (Hirschel: pg. 41).
Regarding claim 6, Helmer in view of Giambattista and Hirschel disclose the assembly above.
Helmer in view of Giambattista does not expressly disclose the seal is positioned on a distal end surface of the distal part of the housing.
Hirschel teaches a seal (Hirschel: Fig. 59a, elastomeric component 131) is positioned on a distal end surface (Fig. 59a, component 131 is positioned on a proximal end portion of end wall 136) of a distal part of the housing (Fig. 59a, end wall 136).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sterility barrier of Helmer in view of Giambattista such that the seal is positioned on a distal end surface of the distal part of the housing as taught by Hirschel in order to provide sealing between a first cavity and a second cavity (Hirschel: pg. 41).
Regarding claim 7, Helmer in view of Giambattista and Hirschel discloses the assembly above.
Helmer in view of Giambattista does not expressly disclose that the seal is configured to be compressed in an axial direction relative to the axis when the cartridge is positioned in the recess.
Hirschel teaches a seal (Hirschel: Fig. 59a, component 131) is configured to be compressed in an axial direction relative to the axis (Fig. 59a, component 131 is compressed axially upon insertion of the cartridge 26; pg. 41) when the cartridge (Fig. 58, cartridge 26) is positioned in a recess (pg. 41).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assembly of Helmer in view of Giambattista such that the seal is configured to be compressed in an axial direction relative to the axis when the cartridge is positioned in the recess as taught by Hirschel in order to provide sealing between a first cavity and a second cavity (Hirschel: pg. 41).
Regarding claim 8, Helmer in view of Giambattista and Hirschel discloses the assembly above.
Helmer in view of Giambattista does not expressly disclose the seal is configured to contact a shoulder of the cartridge when the cartridge is positioned in the recess.
Hirschel teaches a seal (Fig. 59a, component 131) is configured to contact a shoulder (Fig. 59a, component 131 contacts a shouldered edge of the cartridge 26; pg. 41) of a cartridge (Fig. 58, cartridge 26) when the cartridge (Fig. 58, cartridge 26) is positioned in a recess (pg. 41).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assembly of Helmer in view of Giambattista such that the seal is configured to contact a shoulder of the cartridge when the cartridge is positioned in the recess as taught by Hirschel in order to provide sealing between a first cavity and a second cavity (Hirschel: pg. 41). Furthermore, it would have been an obvious matter of design choice to have the seal contact any portion of the cartridge, as the applicant has not disclosed any critical aspect to the contacting of the shoulder of the cartridge, and it appears that the device would perform equally well with any contact of the seal to a portion of the cartridge. Absent a teaching as to criticality that seal contacts specifically a shoulder of the cartridge, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 9, Helmer in view of Giambattista and Hirschel discloses the assembly above.
Helmer in view of Giambattista does not expressly disclose the seal is an O-ring.
Hirschel teaches a seal (Hirschel: Fig. 59a, elastomeric component 131) that is an O-ring (the elastomeric component 131 may be an O-ring; pg. 41).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sterility barrier of Helmer such that the seal is an O-ring as taught by Hirschel in order to provide sealing between a first cavity and a second cavity (Hirschel: pg. 41).
Regarding claim 10, Helmer in view of Giambattista and Hirschel discloses the assembly above.
Helmer in view of Giambattista does not expressly disclose the seal is a ring.
Hirschel teaches a seal (Hirschel: Fig. 59a, elastomeric component 131) that is a ring (the elastomeric component 131 may be an O-ring; pg. 41).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sterility barrier of Helmer such that the seal is a ring as taught by Hirschel in order to provide sealing between a first cavity and a second cavity (Hirschel: pg. 41).
Regarding claim 11, Helmer in view of Giambattista and Hirschel discloses the assembly above, wherein the distal part (Helmer: Fig. 1, area of sleeve 5 proximal of recess 5.2) of the housing (Fig. 1, comprising area of sleeve 5 distal of second recess 5.2 and area of sleeve 5 proximal of recess 5.2) comprises a tubular section (Fig. 1, holder 4 is cylindrical. Examiner interprets that sleeve 5 is cylindrical to accommodate holder 4; pg. 6, ln 15-24) and the proximal part (Fig. 1, area of sleeve 5 distal of second recess 5.2) of the housing (Fig. 1, comprising area of sleeve 5 distal of second recess 5.2 and area of sleeve 5 proximal of recess 5.2) comprises a wall (Fig. 1 above, wall G) extending in a radial direction relative to the axis (Fig. 1 above, Examiner interprets that sleeve 5 is cylindrical to accommodate holder 4. Wall G extends across sleeve 5, therefore, extends radially from axis L), the wall (Fig. 1 above, wall G) extending across a proximal end of the tubular section (Fig. 1, wall G extends cross distal end of sleeve 5 towards distal direction D).
Regarding claim 12, Helmer in view of Giambattista and Hirschel discloses the assembly above, wherein the first sealed cavity (Fig. 1 above, first cavity A) is tubular (Fig. 1 above, holder 4 is cylindrical. Examiner interprets that sleeve 5 is cylindrical to accommodate holder 4. Cavity A is, therefore, tubular; pg. 6, ln 15-24), and is formed by the tubular section of the housing (Fig. 1, holder 4 is cylindrical. Examiner interprets that sleeve 5 is cylindrical to accommodate holder 4; pg. 6, ln 15-24), the wall (Fig. 1 above, wall G) of the housing (Fig. 1, comprising area of sleeve 5 distal of second recess 5.2 and area of sleeve 5 proximal of recess 5.2) and the wall of the sterility barrier (Fig. 1 above, cavity A is formed by sleeve 5, wall G, and wall F).
Regarding claim 13, Helmer in view of Giambattista and Hirschel discloses the assembly above, wherein the distal part of the housing (Helmer: Fig. 1, area of sleeve 5 proximal of recess 5.2) includes a pair of arms (Fig. 3, two resilient arms 7.2) extending in the distal direction (Fig. 3, arms 7.2 extend from their distal ends proximally towards the promimal end of the sleeve 5) from a distal end of the distal part of the housing (Fig. 1, area of sleeve 5 proximal of recess 5.2).
It would have been an obvious matter of design choice to have the arms extend in the distal direction, since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with arms that extend in the proximal direction. Absent a teaching as to criticality that the arms extend in the distal direction, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 14, Helmer in view of Giambattista and Hirschel discloses the assembly above, wherein each of the pair of arms (Fig. 3, arms 7.2) include a protrusion (Fig. 3, second sections 7.2.2) extending radially outwards (Fig. 3, sections 7.2.2 protrude radially outwards) at an end of each of the pair of arms (Fig. 3, sections 7.2.2 protrude from the distal ends of each arm 7.2).
It would have been an obvious matter of design choice to have the protrusion extend at a distal end of each of the pair of arms, since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with protrusions that extend at a proximal end of each of the pair of arms. Absent a teaching as to criticality that the protrusion extend at a distal end of each of the pair of arms, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 15, Helmer in view of Giambattista and Hirschel discloses the assembly above, wherein each of the pair of arms (Fig. 3, arms 7.2) include a protrusion (Fig. 3, first section 7.2.1) extending radially inwards (Fig. 3, sections 7.2.1 extend radially inward).
Regarding claim 16, Helmer in view of Giambattista and Hirschel discloses an autoinjector sub-assembly (Fig. 1, comprising sleeve 7, sleeve 5, and holder 4) comprising the autoinjector needle- housing assembly of above and a needle shield (Fig. 1, outer needle sleeve 7) attached to the autoinjector needle-housing assembly (Fig. 1, sleeve 7 is attached to sleeve 5).
Regarding claim 17, Helmer in view of Giambattista and Hirschel discloses the autoinjector sub-assembly above, wherein the needle shield (Fig. 1, outer needle sleeve 7) and the autoinjector needle-housing assembly (Fig. 1, comprising sleeve 5 and holder 4) define a third sealed cavity (Fig. 1 above, third sealed cavity C, defined by sleeve 5 and sleeve 7), and wherein a proximal end of the needle (Fig. 1, outer needle section 6.1) is in the third sealed cavity (Fig. 1 above, outer needle section 6.1 is disposed in third sealed cavity C).
Regarding claim 18, Helmer disclose a method of assembling an autoinjector sub-assembly (Fig. 1, comprising sleeve 7, sleeve 5, and holder 4), the method comprising the steps of: providing an autoinjector needle-housing assembly (Fig. 1, comprising cartridge holder 4 and inner needle sleeve 5) extending along an axis in a longitudinal direction (Fig. 1, axis L) from a proximal end (Fig. 1, end of sleeve 5 towards distal direction D) to a distal end (Fig. 1, end of holder 4 towards proximal direction P), the autoinjector needle-housing assembly (Fig. 1, comprising cartridge holder 4 and inner needle sleeve 5) comprising: a housing (Fig. 1, sleeve 5) comprising a proximal part (Fig. 1, area of sleeve 5 distal of second recess 5.2) and a distal part (Fig. 1, area of sleeve 5 proximal of recess 5.2) attached to the proximal part (Fig. 1, area of sleeve 5 proximal of recess 5.2 is attached to area of sleeve 5 distal of second recess 5.2); a needle (Fig. 1, needle 6) positioned at least partially within the housing (Fig. 1, sleeve 5); a cartridge holder (Fig. 1, inner surface of cartridge holder 4 holds the cartridge 2 in place); and a sterility barrier (Fig. 1, cartridge holder 4) attached to the distal part (Fig. 1, holder 4 is attached to the area of sleeve 5 proximal of recess 5.2 via rib 5.1) of the housing (Fig. 1, sleeve 5), wherein the housing (Fig. 1, sleeve 5) and the sterility barrier (Fig. 1, holder 4) form a first sealed cavity (Fig. 1 above, sealed cavity A), wherein a distal end of the needle (Fig. 1, inner needle section 6.2. Examiner notes that there is a typo in the prior art, and that the needle section 6.2 is meant to be an inner needle section, supported by the specifications; pg. 7, ln 9-26) is in the first sealed cavity (Fig. 1 above, needle section 6.2 is inside cavity A), wherein the autoinjector needle-housing assembly (Fig. 1, comprising cartridge holder 4 and inner needle sleeve 5) comprises a recess (Fig. 1 above, recess D) formed by the distal end (Fig. 1, end of holder 4 towards P direction) of the autoinjector needle-housing assembly (Fig. 1, comprising cartridge holder 4 and inner needle sleeve 5), wherein the recess (Fig. 1 above, recess D) is shaped to receive a cartridge (Fig. 1 above, recess D is shaped to receive cartridge 2) and to form a second cavity (Fig. 1 above, cavity B) between the autoinjector needle-housing assembly (Fig. 1, comprising cartridge holder 4 and inner needle sleeve 5) and said cartridge (Fig. 1, cartridge 2); and inserting the cartridge (Fig. 1, cartridge 2) into the recess (Fig. 1 above, recess D) to create a second cavity (Fig. 1 above, cavity B) formed between the cartridge (Fig. 1 above, recess D) and the sterility barrier (Fig. 1, holder 4). When the prior art device is the same as a device described in the specification for carrying out or being made by the claimed method, it can be assumed the device will obviously perform or be made by the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). MPEP 2112.02.
Helmer does not expressly disclose that the second cavity is sealed.
Giambattista teaches a second cavity (Giambattista: Fig. 5 and 7, the space defined by cartridge holder 330, seal 332, and the cartridge assembly 340) that is sealed (seal 332 maintains sterility of the needle assembly 310 prior to use; para. 0061).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the second cavity of Helmer such that it was sealed as taught by Giambattista in order to maintain sterility of the needle assembly 310 prior to use (Giambattista: para. 0061).
Helmer in view of Giambattista does not expressly disclose a seal, wherein the cartridge is configured to contact a seal when the cartridge is positioned in the recess.
Hirschel teaches a seal (Hirschel: Fig. 59a, elastomeric component 131), wherein a cartridge (Fig. 59a, cartridge 26) is configured to contact the seal (Fig. 59a, elastomeric component 131) when the cartridge (Fig. 59a, cartridge 26) is positioned in a recess (Fig. 59a, component 131 contacts cartridge 26 when 26 is positioned within the shown cavity).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assembly of Helmer in view of Giambattista such that it comprised a seal, wherein the cartridge is configured to contact a seal when the cartridge is positioned in the recess as taught by Hirschel in order to provide a fluid tight sealing between the first and second cavities (Hirschel: pg. 41).
Regarding claim 19, Helmer in view of Giambattista and Hirschel discloses the method above,
Helmer in view of Giambattista does not expressly disclose the step of inserting a cartridge into the recess is carried out in a sterile environment.
Hirschel teaches a step of inserting a cartridge into the recess is carried out in a sterile environment (cartridge is inserted in step C, which can be carried out in an aseptic environment; pg. 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Helmer such that the step of inserting a cartridge into the recess is carried out in a sterile environment as taught by Hirschel in order to maintain sterility during insertion (Hirschel: pg. 21).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Helmer in view of Giambattista and Hirschel, in further view of Hoenninger (US Patent Publication No. 20140121601 A1).
Regarding claim 5, Helmer in view of Giambattista and Hirschel discloses the assembly above.
Helmer in view of Giambattista and Hirschel does not expressly disclose that the deformable material comprises a thermoplastic elastomer (TPE).
Hoenninger teaches a deformable material (Hoenninger: gaskets are made of a thermoplastic elastomer; para. 0047) comprises a thermoplastic elastomer (para. 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the deformable material of Helmer in view of Giambattista and Hirschel such that it comprises a thermoplastic elastomer as taught by Hoenninger in order to create a seal that is slip resistant and flexible (Hoenninger: para. 0047).
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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