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 .
Response to Amendment
The amendment filed 04/22/2026 has been entered. Claims 1, 4-7, 9-17, 27-32 are pending in the application. Applicant' s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 01/23/2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-7, 9, 17, 32 are rejected under 35 U.S.C. 103 as being unpatentable over Loof (US 2016/0213850) in view of Fourt (US 2015/0246181).
Regarding Claim 1, Loof discloses an injector (10, Fig 1) comprising: a housing (12 and 14, Fig 1) having a proximal end and a distal end extending along a longitudinal axis; a medicament container (18, Fig 2) containing a volume of a medicament; a button (68, Fig 8b) having a button body, a button aperture (aperture adjacent protrusion 72, Fig 8b) extending through the button body, and a fin (72, Fig 8b) extending distally from a proximal end of the button body coupled to the housing (the button body is at least indirectly coupled to the housing through the activator 74, Para 0033), the button rotatable about the longitudinal axis between a locked position (position of button relative to the activator 74 seen in Fig 9) and an unlocked position (position of button relative to the activator 74 seen in Fig 10) and movable along the longitudinal axis between a pre-firing position (longitudinal position of button seen in Figs 9 and 10) and a firing position (longitudinal position of button seen in Fig 11); a latch (40, 66, Fig 6) having a latch body (40, Fig 6), a crown (66, Fig 7) defined on a proximal end of the latch body configured to engage the fin of the button (Para 0038, See Figs 10-11), and an engagement feature (38, Fig 6) extending from the latch body, the engagement feature movable between an engaged position and a disengaged position at least partially disposed within the button (Para 0038; Examiner notes that since the fins 72 contact crown 66, the portion of the latch above crown 66 is disposed within the button); a ram (28, Fig 4) movable relative to the latch (Para 0038); and an energy source (32, Fig 2) configured to urge the ram distally along the longitudinal axis, wherein the ram is prevented from moving relative to the latch by the button in the pre-firing positions wherein rotation of the button into the unlocked position aligns the button aperture with the engagement feature (Para 0030), and wherein rotation of the button to the unlocked position and movement of the button distally along the longitudinal axis relative to the housing into the firing position allows the ram to move relative to the latch (Para 0038; the button and housing rotate relative to the activator 74).
Loof is silent regarding the fin extending distally from an interior surface of a proximal end of the button body.
Fourt teaches an analogous locking injector (20, Fig 1) comprising: a housing; a button (25, Fig 3a) having a button body and a fin (48, Fig 3c) extending distally from an interior surface of a proximal end of the button body coupled to the housing, the button rotatable about the longitudinal axis between a locked position and an unlocked position and movable along the longitudinal axis between a pre-firing position and a firing position (Para 0078-0079).
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 button with the fin on an outer surface that engages with the grooves 76 of Loof to have the fin on an inner surface that engages with grooves 264 and 266 (See Para 0066) in order to have a smaller device that is less costly (Para 0007).
Regarding Claim 4, the modified invention of Loof and Fourt discloses at least a portion of the fin (72, Fig 8b -Loof as modified by Fourt to be on an inner surface) engages the crown (66, Fig 7 -Loof) when the button is in the locked position and in the unlocked position (Para 0033, 0037-0038 -Loof; the fin and crown are in engaging one another, however cannot be actuated until the device is unlocked as described).
Regarding Claim 5, the modified invention of Loof and Fourt discloses the ram (28, Fig 4 -Loof) includes a ram body, and a ram aperture (36, Fig 4 -Loof) extending through the ram body, the ram aperture configured to receive at least a portion of the engagement feature when the button is in the pre-firing position (Para 0030 -Loof).
Regarding Claim 6, the modified invention of Loof and Fourt discloses the engagement feature (38, Fig 6 -Loof) comprises: a flexible arm (arm of holding element comprising hooks 42, Fig 5 -Loof) extending along the longitudinal axis; and a protrusion (42, Fig 5 -Loof) extending radially therefrom (Para 0038 -Loof).
Regarding Claim 7, the modified invention of Loof and Fourt discloses the protrusion (42, Fig 5 -Loof) extends radially inward from an end of the flexible arm (Para 0030 -Loof).
Regarding Claim 9, the modified invention of Loof and Fourt discloses distal movement of the button into the firing position allows the engagement feature to flex radially outward and extend at least partially through the button aperture (Para 0038 -Loof).
Regarding Claim 17, the modified invention of Loof and Fourt discloses the latch is rotationally fixed relative to the housing, and wherein the medicament container is fixed relative to the housing (Para 0037-0038 -Loof; the activator 74 moves relative to the housing, while the latch and medicament container remain fixed to the housing).
Regarding Claim 32, Loof discloses an injector (10, Fig 1) comprising: a housing (12, 14, 74, Fig 1) having a proximal end and a distal end extending along a longitudinal axis; a medicament container (18, Fig 2) containing a volume of a medicament, the medicament container fixed relative to the housing (Para 0037-0038); a button (68, Fig 8b) directly coupled to the housing, the button rotatable about the longitudinal axis between a locked position (position of button relative to the activator 74 seen in Fig 9) and an unlocked position (position of button relative to the activator 74 seen in Fig 10) and movable along the longitudinal axis between a pre-firing position (longitudinal position of button seen in Figs 9 and 10) and a firing position (longitudinal position of button seen in Fig 11); a latch (40, 66, Fig 6) at least partially disposed within the button (Para 0038; Examiner notes that since the fins 72 contact crown 66, the portion of the latch above crown 66 is disposed within the button), the latch rotationally fixed relative to the housing (Para 0037-0038; the latch and medicament container remain fixed to the housing portions 12 and 14); a ram (28, Fig 4) movable relative to the latch (Para 0038); and an energy source (32, Fig 2) configured to urge the ram distally along the longitudinal axis, wherein the ram is prevented from moving relative to the latch by the button in the pre- firing position (Para 0030), and wherein rotation of the button to the unlocked position and movement of the button distally along the longitudinal axis relative to the housing into the firing position allows the ram to move relative to the latch (Para 0038; the button and remainder of the housing rotate relative to the activator 74 and the button moves axially relative to the entire housing.
Claims 10-13, 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Loof (US 2016/0213850) in view of Fourt (US 2015/0246181) and further in view of Chou (US 2022/0160972).
Regarding Claim 10, the modified invention of Loof and Fourt discloses the injector further comprising: a plunger (17, Fig 2) disposed within the container (Para 0012, 0029), however is silent regarding the medicament container includes a luer lock extending from a distal end
Chou teaches a medicament container (12, Fig 2) including a luer lock (40, Fig 2) extending from a distal end and a luer cap (52, Fig 2).
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 medicament container to have luer lock to receive the luer cap and BI member 102 as taught by Chou in order to provide a sterilization verification system that aids in ensuring the sterilization of the container and connector (Para 0005).
Regarding Claim 11, the modified invention of Loof, Fourt, and Chou discloses the ram (28, Fig 2 -Loof) engages the plunger (17, Fig 2 -Loof) thereby moving the plunger relative to the medicament container when the button is moved into the firing position (Para 0038 -Loof).
Regarding Claim 12, the modified invention of Loof, Fourt, and Chou discloses movement of the plunger relative to the medicament container ejects the volume of the medicament from the medicament container through the luer lock (Para 0038 -Loof as modified by Chou to have a Luer Lock at the distal ends of the medicament container).
Regarding Claim 13, the modified invention of Loof, Fourt, and Chou discloses a needle (24, Fig 2 -Loof) coupled to the luer lock, the needle in fluid communication with the medicament container (Para 0029, 0038 -Loof; Examiner notes that he modified invention would have the needle coupled to the Luer Lock on the medicament container).
Regarding Claim 27, Loof discloses an injector (10, Fig 1) comprising: a housing (12, 14, 74, Fig 1) having a proximal end and a distal end extending along a longitudinal axis; a medicament container (18, Fig 2) containing a volume of a medicament; a button (68, Fig 8b) coupled to the housing, the button rotatable about the longitudinal axis between a locked position (position of button relative to the activator 74 seen in Fig 9) and an unlocked position (position of button relative to the activator 74 seen in Fig 10) and movable along the longitudinal axis between a pre-firing position (longitudinal position of button seen in Figs 9 and 10) and a firing position (longitudinal position of button seen in Fig 11); a latch (40, 66, Fig 6) at least partially disposed within the button (Para 0038; Examiner notes that since the fins 72 contact crown 66, the portion of the latch above crown 66 is disposed within the button); a ram (28, Fig 4) movable relative to the latch (Para 0038); a plunger disposed within the medicament container; and an energy source (32, Fig 2) configured to urge the ram distally along the longitudinal axis, wherein the ram is prevented from moving relative to the latch by the button in the pre- firing position (Para 0030), and wherein rotation of the button to the unlocked position and movement of the button distally along the longitudinal axis relative to the housing into the firing position allows the ram to move relative to the latch (Para 0038; the button and remainder of the housing rotate relative to the activator 74 and the button moves axially relative to the entire housing).
Loof is silent regarding the medicament container having a luer lock extending from a distal end thereof.
Chou teaches a medicament container (12, Fig 2) including a luer lock (40, Fig 2) extending from a distal end and a luer cap (52, Fig 2).
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 medicament container to have luer lock to receive the luer cap and BI member 102 as taught by Chou in order to provide a sterilization verification system that aids in ensuring the sterilization of the container and connector (Para 0005).
Regarding Claim 28, the modified invention of Loof and Chou discloses the ram (28, Fig 2 -Loof) engages the plunger (17, Fig 2 -Loof) thereby moving the plunger relative to the medicament container when the button is moved into the firing position (Para 0038 -Loof).
Regarding Claim 29, the modified invention of Loof and Chou discloses movement of the plunger relative to the medicament container ejects the volume of the medicament from the medicament container through the luer lock (Para 0038 -Loof as modified by Chou to have a Luer Lock at the distal ends of the medicament container).
Regarding Claim 30, the modified invention of Loof and Chou discloses a needle (24, Fig 2 -Loof) coupled to the luer lock, the needle in fluid communication with the medicament container (Para 0029, 0038 -Loof; Examiner notes that he modified invention would have the needle coupled to the Luer Lock on the medicament container).
Claims 14 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Loof (US 2016/0213850) in view of Fourt (US 2015/0246181) and further in view of Chou (US 2022/0160972) and further in view of Hommann (US 2006/0270984).
Regarding Claim 14, the modified invention of Loof, Fourt, and Chou discloses a luer cap (52, Fig 2 -Chou) removably coupled to the luer lock in a storage configuration, however, is silent regarding the luer cap is fully recessed within the housing.
Hommann teaches an analogous injector (10, Fig 1A) comprising a luer cap (8, Fig 1A) removably coupled to the luer lock (11a, Fig 1C) of the medical container (11, Fig 1C), wherein the luer cap is fully recessed within the housing (See Fig 1 wherein only the tool 12 extends from the housing).
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 injector to have a needle guard and a priming tool in order to have an injector that can protect from accidental sticks after the injection is administered while still allowing removal of the cap and attachment of the needle (Para 0007, 0038).
Regarding Claim 31, the modified invention of Loof and Chou discloses a luer cap (52, Fig 2 -Chou) removably coupled to the luer lock in a storage configuration, however, is silent regarding the luer cap is fully recessed within the housing.
Hommann teaches an analogous injector (10, Fig 1A) comprising a luer cap (8, Fig 1A) removably coupled to the luer lock (11a, Fig 1C) of the medical container (11, Fig 1C), wherein the luer cap is fully recessed within the housing (See Fig 1 wherein only the tool 12 extends from the housing).
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 injector to have a needle guard and a priming tool in order to have an injector that can protect from accidental sticks after the injection is administered while still allowing removal of the cap and attachment of the needle (Para 0007, 0038).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Loof (US 2016/0213850) in view of Fourt (US 2015/0246181) and further in view of Holmqvist (US 20147/0371670).
Regarding Claim 15, the modified invention of Loof and Fourt discloses all of the elements of the invention as discussed above, however, is silent regarding the button is prevented from moving proximally relative to the housing after the button is moved from the pre-firing position to the firing position.
Holmqvist teaches an analogous injector (Device of Fig 15) having a button (74’’’) and activator (201) wherein the button is prevented from moving proximally relative to the housing after the button is moved from the pre-firing position to the firing position (Para 0045; As seen in Fig 20, the button can’t be moved proximally as the protrusion 202 and the protrusion 208 prevents such movement).
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 activator and button disclosed by Loof to have the protrusions 202 and 208, respectively, as taught by Holmqvist in order to provide further support in preventing premature activation of the device and prevent additional actuations for safe discarding (Para 0045).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Loof (US 2016/0213850) in view of Fourt (US 2015/0246181) and further in view of Jenson (US 2024/0165338).
Regarding Claim 16, the modified invention of Loof and Fourt discloses all of the elements of the invention as discussed above, however, is silent regarding the volume of the medicament is at least 10 mL.
Jenson teaches an analogous injector comprising a medicament container wherein the volume of the medicament is at least 10 mL (Para 0037).
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 medicament container to have a volume that is 10mL as taught by Jenson as the volume of the drug container can be modified to accommodate the required dosage of drug (Para 0026, 0037).
Response to Arguments
Applicant’s arguments filed 04/22/2026, on pages 7-8, regarding Loof failing to teach the button having a fin extending from an interior surface of the button body have been full considered but are moot in view of the current rejection that relied on Fourt to teach the limitation.
Applicant’s arguments filed 04/22/2026, on page 8, regarding Loof failing to the button directly coupled to the housing have been fully considered but are not persuasive. As detailed in the rejections of claims 27 and 32, the housing is now being interpreted to encompass activator 74 as it houses elements of the device. Therefore, since the button 68 is directly coupled to activator 74, it is directly coupled to the housing.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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