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 09/11/2024 has been entered. Claims 1, 4-7, 9-17, 27-32 are pending in the 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 17 and 32 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.
Claims 17 and 32 recite “the latch is fixed relative to the housing”. It is unclear how this is to be interpreted in light of the specification, as the specification (in paragraphs 0074 and 0083) requires the latch 106 to have an engagement feature 174 with a flexible arm 176 that flexes outwardly, i.e., moves relative to the housing. This seems to contradict the claim language. For the sake of examination, the limitation will be interpreted as reciting “the latch is rotationally fixed relative to the housing”.
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-7, 9, 17, 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Loof (US 2016/0213850).
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).
Regarding Claim 4, Loof discloses at least a portion of the fin (72, Fig 8b) engages the crown (66, Fig 7) when the button is in the locked position and in the unlocked position (Para 0033, 0037-0038; the fin and crown are in engaging one another, however cannot be actuated until the device is unlocked as described).
Regarding Claim 5, Loof discloses the ram (28, Fig 4) includes a ram body, and a ram aperture (36, Fig 4) 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).
Regarding Claim 6, Loof discloses the engagement feature (38, Fig 6) comprises: a flexible arm (arm of holding element comprising hooks 42, Fig 5) extending along the longitudinal axis; and a protrusion (42, Fig 5) extending radially therefrom (Para 0038).
Regarding Claim 7, Loof discloses the protrusion (42, Fig 5) extends radially inward from an end of the flexible arm (Para 0030).
Regarding Claim 9, Loof 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).
Regarding Claim 17, Loof discloses the latch is rotationally fixed relative to the housing, and wherein the medicament container is fixed relative to the housing (Para 0037-0038; 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 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, the medicament container fixed relative to the housing (Para 0037-0038); 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), the latch rotationally fixed relative to the housing (Para 0037-0038; the activator 74 moves relative to the housing, while the latch and medicament container remain fixed to the housing); 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 housing rotate relative to the activator 74).
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 10-13, 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Loof (US 2016/0213850) in view of Chou (US 2022/0160972).
Regarding Claim 10, Loof 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 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 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 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 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) 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 housing rotate relative to the activator 74).
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 Chou (US 2022/0160972) and further in view of Hommann (US 2006/0270984).
Regarding Claim 14, 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).
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 Holmqvist (US 20147/0371670).
Regarding Claim 15, Loof 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 Jenson (US 2024/0165338).
Regarding Claim 16, 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).
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783