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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4 May 2026 has been entered.
Status of Claims
This office action is responsive to the amendment filed 4 May 2026.
Claims 1-13 are canceled.
Claims 14, 25, and 27 are amended.
Claims 14-28 are presently pending in this application.
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 14-28 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 14 and 25 recite the limitation “first the sterility barrier and then the septum of the cartridge are pierced by the distal end of the needle”. The metes and bounds of the claim are unclear, as it is not apparent whether the apparatus requires the septum of the cartridge to be pierced by the needle, or if the septum of the cartridge is functionally capable of being pierced as a result of piercing the sterility barrier. For the purposes of examination, the language of the recited limitation is interpreted as the following: --wherein the sterility barrier and the septum are capable of being pierced by the distal end of the needle.--.
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 14-28 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).
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Regarding claim 14, 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) 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) fixedly attached to the proximal part (Fig. 1, area of sleeve 5 distal of second recess 5.2) of 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, 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), and 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 wherein the cartridge (Fig. 1, cartridge 2) is movable in the proximal direction (Fig. 1 to Fig. 2, cartridge 2 moves proximal relative to the outer body 8), resulting in the sterility barrier (Fig. 1, cartridge holder 4) also moving in the proximal direction (Fig. 1 to Fig. 2, cartridge 2 moves proximal relative to outer body 8, wherein holder 4 also moves proximally).
Helmer does not expressly disclose that the second cavity is sealed, wherein, first, the sterility barrier, and then the septum of the cartridge are pierced by the distal end of the needle.
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), wherein, first, a sterility barrier (Fig. 3, seal 332), and then a septum of the cartridge (Fig. 3, septum 344) are pierced by a distal end of a needle (Fig. 3, needle 312 pierces first seal 332 then septum 344; para. 0068).
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, wherein, first, the sterility barrier, and then the septum of the cartridge are pierced by the distal end of the needle as taught by Giambattista in order to maintain sterility of the needle assembly 310 prior to use (Giambattista: para. 0061).
Regarding claim 15, Helmer teaches 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 said cartridge (Fig. 1, cartridge 2).
Regarding claim 16, Helmer teaches the assembly above, wherein the sterility barrier (Fig. 1, holder 4) comprises a tubular portion (Fig. 1, holder 4 is cylindrical; pg. 6, ln 15-24) and a wall (Fig. 1 above, wall F) extending across the tubular portion (Fig. 1 above, wall F extends across holder 4), wherein the tubular portion (Fig. 1, holder 4 is cylindrical; pg. 6, ln 15-24) of the sterility barrier (Fig. 1, holder 4) extends in the longitudinal direction (Fig. 1, holder 4 extends longitudinally across axis L) and 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 19, Helmer teaches the assembly above, wherein the distal part (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 20, Helmer teaches 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 a wall of the sterility barrier (Fig. 1 above, cavity A is formed by sleeve 5, wall G, and wall F).
Regarding claim 21, Helmer teaches the assembly above, wherein a tubular portion of the sterility barrier (Fig. 1, holder 4 is cylindrical; pg. 6, ln 15-24) is in the tubular section of the housing (Fig. 1, holder 4 is disposed within sleeve 5).
Regarding claim 22, Helmer teaches the assembly above, wherein the sterility barrier (Fig. 1, holder 4) is movable in the longitudinal direction relative to the housing (Fig. 1 and 2, sleeve 5 is allowed to move proximally with respect to holder 4).
Regarding claim 23, Helmer teaches 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), 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 24, Helmer teaches an autoinjector comprising a cartridge (Fig. 1, cartridge 2) and the autoinjector needle-housing assembly above, wherein a proximal end of the cartridge (Fig. 1, distal end of cartridge 2 towards distal direction D) is in the recess (Fig. 1 above, recess D) of the autoinjector needle-housing assembly (Fig. 1, comprising sleeve 5 and holder 4).
Regarding claim 25, Helmer teaches 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) attached to the proximal part (Fig. 1, area of sleeve 5 distal of second recess 5.2) of 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), wherein the cartridge (Fig. 1, cartridge 2) is movable in the proximal direction (Fig. 1 to Fig. 2, cartridge 2 moves proximal relative to the outer body 8), resulting in the sterility barrier (Fig. 1, cartridge holder 4) also moving in the proximal direction (Fig. 1 to Fig. 2, cartridge 2 moves proximal relative to outer body 8, wherein holder 4 also moves proximal). 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, wherein, first, the sterility barrier, and then the septum of the cartridge are pierced by the distal end of the needle.
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), wherein, first, a sterility barrier (Fig. 3, seal 332), and then a septum of the cartridge (Fig. 3, septum 344) are pierced by a distal end of a needle (Fig. 3, needle 312 pierces first seal 332 then septum 344; para. 0068).
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, wherein, first, the sterility barrier, and then the septum of the cartridge are pierced by the distal end of the needle. as taught by Giambattista in order to maintain sterility of the needle assembly 310 prior to use (Giambattista: para. 0061).
Regarding claim 27, Helmer teaches an autoinjector sub-assembly (Fig. 1, comprising sleeve 7, sleeve 5, and holder 4) comprising: a housing (Fig. 1, sleeve 5); a needle (Fig. 1, needle 6) fixedly attached to the housing (Fig. 1, sleeve 5); a cartridge holder (Fig. 1, inner surface of cartridge holder 4 holds the cartridge 2 in place); a first sealed cavity (Fig. 1 above, first sealed cavity A) defined by an inside distal end of the housing (Fig. 1, lumen of area of sleeve 5 proximal of recess 5.2) and a proximal end (Fig. 1, proximal end E of holder 4) of an axially movable sterility barrier (Fig. 1 and 2, sleeve 5 is allowed to move proximally with respect to holder 4), where 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 positioned in the first sealed cavity (Fig. 1 above, first sealed cavity A) and the sterility barrier (Fig. 1, holder 4) comprises a distal end (Fig. 1 above, area of holder 4 that defines recess D) that defines a recess (Fig. 1 above, recess D); a second cavity (Fig. 1 above, second cavity B) defined by the recess (Fig. 1 above, recess D) and a proximal end of a proximally movable cartridge (Fig. 1 to Fig. 2, end of cartridge at 2.1 of cartridge 2, which is moved proximally) positioned in the recess (Fig. 1 above, end of cartridge 2.1 is positioned within recess D); and a third sealed cavity (Fig. 1, third sealed cavity C) defined by an inside surface (Fig. 1, inner lumen of outer needle sleeve 7) of a needle shield (Fig. 1, outer needle sleeve 7) and a proximal end of the housing (Fig. 1, comprising area of sleeve 5 distal of second recess 5.2) such that a proximal end of the needle (Fig. 1, outer needle section 6.1. Examiner notes that there is a typo in the prior art, and that the needle section 6.1 is meant to be an outer needle section, supported by the specifications; pg. 7, ln 9-26) is positioned within the third sealed cavity (Fig. 1 above, outer needle section 6.1 is positioned within third sealed cavity C).
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).
Regarding claim 28, Helmer teaches an autoinjector (Fig. 1, delivery device 1) comprising a cartridge (Fig. 1, cartridge 2) and the autoinjector sub-assembly above, wherein the proximal end of the cartridge (Fig. 1, distal end of cartridge 2 towards distal direction D) is in the recess (Fig. 1 above, recess D).
Claims 17, 18, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer, in view of Hirschel et al. (WO 2018130944 A1), hereinafter Hirschel.
Regarding claim 17, Helmer discloses the assembly above.
Helmer does not expressly disclose the sterility barrier comprises a seal on the tubular portion of the sterility barrier.
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Hirschel teaches the sterility barrier (Hirschel: Fig. 59a above, sterility barrier A) comprises a seal (Fig. 59a, elastomeric component 131) on the tubular portion of the sterility barrier (Hirschel: Fig. 59a above, sterility barrier A is cylindrical in order to fit a cylindrical cartridge; pg. 9).
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 sterility barrier comprises a seal on the tubular portion of the sterility barrier as taught by Hirschel in order to provide sealing between a first cavity and a second cavity (Hirschel: pg. 41).
Regarding claim 18, Helmer discloses the assembly above.
Helmer 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 26, Helmer teaches the method above,
Helmer 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).
Response to Arguments
Applicant's arguments filed 4 May 2026 have been fully considered but they are not persuasive.
Applicant argues that Helmer in view of Giambattista does not disclose the amended claim language of claims 14 and 25, wherein “the cartridge is movable in the proximal direction, resulting in the sterility barrier also moving in the proximal direction, first the sterility barrier and then the septum of the cartridge are pierced by the distal end of the needle” and the amended claim language of claim 27, wherein the cartridge is “proximally movable”.
Helmer discloses a proximally movable cartridge (Fig. 1, cartridge 2), resulting in the sterility barrier (Fig. 1, holder 4) moving proximally (Fig. 1 to Fig. 2, holder 4 moves proximally with cartridge 2). Giambattista teaches a sterility barrier that is first pierced by the needle, followed by the septum of the cartridge. Therefore, the rejection is maintained based on the obviousness rationale set forth above.
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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