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 Objections
Claims 5 and 12 are objected to because of the following informalities:
Regarding claim 5, line 4, the recitation “an end of dose state” appears to be amended to recite “the end of dose state” in order to refer to “an end of dose state” recited in claim 4, line 3.
Regarding claim 12, line 4, the recitation “a recess, edge and step” appears to be amended to recite “the recess, edge and step” in order to refer to “a recess, edge and step” recited in claim 2.
Appropriate correction 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.
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 1-8 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirschel et al. (US 10,376,641 B2).
Regarding claim 1, Hirschel teaches an autoinjector (figure 1) comprising:
a housing 1;
a prefilled syringe 7 mounted in the housing 1; and
a drive chassis 3 mounted in the housing 1, the drive chassis 3 being biased with respect to the housing 1, the drive chassis 3 (column 6, lines 13-18) further being fixed with respect to the housing 1 and configured to move relative to the housing 1 in a storage state (state shown in figure 1) of the autoinjector, the drive chassis 3 moving relative to the housing 1 on dispensing a medicament from the pre-filled syringe 7,
the autoinjector configured to generate an audible (column 6, lines 42-53) end of dose feedback between the drive chassis 3 and the housing 1 as the autoinjector approaches an end of dispensing, and
one of the drive chassis 3 and the housing 1 comprises a click arm 3a that engages the other one of the housing 1 and the drive chassis to generate the audible end of dose feedback on moving the drive chassis 3 relative to the housing 1 (figure 4B, column 6, lines 42-53).
Regarding claim 2, Hirschel teaches wherein the housing 1 comprises one of recess, edge and step (see “R” in figure 4A below) and the drive chassis 3 comprises click arm 3a that is configured to engage the one of the recess, edge and step to generate the audible end of dose feedback (column 6, lines 42-53).
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Regarding claim 3, Hirschel teaches wherein at least one of the housing 1 and the click arm 3a comprises a chamfered part (column 6, lines 29-33, “chamfer on the ribs 1a”).
Regarding claim 4, Hirschel teaches wherein the chamfered part (column 6, lines 29-38, figures 4A, 4B) is configured to deflect a part of the drive chassis as the drive chassis 3 moves from the storage state to an end of dose state (state shown in figure 4B).
Regarding claim 5, Hirschel teaches wherein the chamfered part (column 6, lines 29-33, “chamfer on the ribs 1a”) is configured to deflect the click arm 3a as the drive chassis 3 moves from the storage state to an end of dose state (state shown in figure 4B).
Regarding claim 6, Hirschel teaches wherein the housing 1 comprises one of a recess, edge and step (see “R” in figure 4A above) and the drive chassis 3 comprises the click arm 3a that is configured to engage the one of the recess, edge and step (see “R” in figure 4A above) to generate the audible end of dose feedback (column 6, lines 42-53), and the chamfered part (column 6, lines 29-38, figure 4A) is configured to deflect the click arm 3a before the click arm 3a engages the one of the recess, edge and step (see “R” in figure 4A above).
Regarding claim 7, Hirschel teaches wherein the drive chassis 3 further comprises a dispensing limb (see “DL” in figure 4A above) to engage a plunger 7a of the pre-filled syringe 7.
Regarding claim 8, Hirschel teaches wherein the click arm 3a extends from the drive chassis 3 at a part (see “TL” in figure 4A above) of the drive chassis 3 different from the dispensing limb (see “DL” in figure 4A above).
Regarding claim 14, Hirschel teaches wherein the drive chassis 3 is of generally U-shaped design (cross-section shape of 3 near element 3a is U-shaped design).
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, 2, 7-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Carrel et al. (US 2015/0202368 A1) in view of Hirschel et al. (US 10,376,641 B2).
Regarding claim 1, Carrel discloses an autoinjector 1 (figure 1A) comprising:
a housing (housing formed by integrated structure of elements 40 and 60);
a prefilled syringe 2 mounted in the housing 40, 60; and
a drive chassis 20 mounted in the housing 40, 60 the drive chassis 20 being biased with respect to the housing 40, 60 (biased due to element 8), the drive chassis 20 further being fixed with respect to the housing 40, 60 (paragraph 0147) and configured to move relative to the housing 40, 60 in a storage state (state shown in figure 1A) of the autoinjector, the drive chassis 20 moving relative to the housing 40, 60 on dispensing a medicament 7 from the pre-filled syringe 2,
one of the drive chassis 20 and the housing 40, 60 comprises a click arm 27 that engage the other of the housing 40, 60 and the drive chassis 20 but is silent regarding the autoinjector configured to generate an audible end of dose feedback between the drive chassis and the housing as the autoinjector approaches an end of dispensing and a click arm engage to generate the audible end of dose feedback on moving the drive chassis relative to the housing.
However, Hirschel teaches a design of an autoinjector (figure 1) wherein the autoinjector (figure 1, column 6, lines 42-53) configured to generate an audible end of dose feedback between the drive chassis 3 and the housing 1 as the autoinjector approaches an end of dispensing and a click arm 3a engage to generate the audible end of dose feedback on moving the drive chassis relative to the housing (column 6, lines 42-53) for the purpose of indicating the end of delivery (column 6, lines 42-53).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the autoinjector of Carrel to incorporate the autoinjector configured to generate an audible end of dose feedback between the drive chassis and the housing as the autoinjector approaches an end of dispensing and a click arm engage to generate the audible end of dose feedback on moving the drive chassis relative to the housing as taught by Hirschel for the purpose of indicating the end of delivery (column 6, lines 42-53).
Examiner construes that one of ordinary skill in the art when modifying Carrel in view of Hirschel will result in generating the sound by modifying the device of Carrel to have element 27 (or 27a) of Carrel hit the element 45 of Carrel.
Regarding claim 2, Carrel discloses wherein the housing 40, 60 comprises one of a recess, edge and step 45 (element 45 is forming an edge or step) and the drive chassis 20 comprises the click arm 27 but is silent regarding the click arm is configured to engage the one of the recess, edge and step to generate the audible end of dose feedback.
However, Hirschell teaches the click arm 3a that is configured to engage the one of the recess, edge and step to generate the audible end of dose feedback (column 6, lines 42-53) for the purpose of indicating the end of delivery (column 6, lines 42-53).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the autoinjector of Carrel to incorporate the click arm is configured to engage the one of the recess, edge and step to generate the audible end of dose feedback as taught by Hirschell for the purpose of indicating the end of delivery (column 6, lines 42-53).
Regarding claim 7, Carrel discloses wherein the drive chassis 20 further comprises a dispensing limb 21 to engage a plunger 6 of the pre-filled syringe 2.
Regarding claim 8, Carrel discloses wherein the click arm 27 extends from the drive chassis 20 at a part 23 of the drive chassis 20 different from the dispensing limb 21.
Regarding claim 9, Carrel discloses wherein the drive chassis 20 further comprises a trigger limb 23 axially offset from the pre-filled syringe 2.
Regarding claim 10, Carrel discloses wherein the click arm 27 extends from the trigger limb 23 of the drive chassis 20.
Regarding claim 11, Carrel discloses further comprising a drive spring 8 arranged axially offset from the dispensing limb 21 and the drive spring 8 is arranged within a part 23 of the drive chassis 20 comprising the click arm 27.
Regarding claim 12, Carrel discloses wherein the housing 40, 60 is a two-part housing comprising an inner body 40 and an outer body 60 and the inner body 40 comprises one of a recess, edge and step 45.
Regarding claim 13, Carrel discloses wherein the click arm 27 is formed by a nose 27a.
Regarding claim 14, Carrel discloses wherein the drive chassis 20 is of generally U-shaped design (see figures 3A, 3B, 3C).
Regarding claim 16, Carrel discloses wherein the nose 27a has a generally outer shape (outer shape of element 27a), formed at an end of a tongue (entire structure formed by elements 26, 27) projecting from the trigger limb 23. While Carrel does not appear to be showing nose having a generally triangular outer shape in component, Carrel does show a shape of element 13 as being having a generally triangular outer shape as shown in figure 2B. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the outer shape of element 27a to be a generally triangular shape as taught by different component of Carrel for the purpose of using a well-known alternative shape of the nose of Carrel (figure 2B).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Carrel et al. (US 2015/0202368 A1) in view of Hirschel et al. (US 10,376,641 B2) and further in view of Rowe et al. (US 2017/0296753 A1).
Regarding claim 15, Carrel/Hirschel (hereinafter referred as “modified Carrel”) discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 7. Carrel further discloses wherein the drive chassis 20 further comprises a trigger limb 23 axially offset from the pre-filled syringe 2 and the drive chassis 20, the click arm 27, the trigger limb 23 and the dispensing limb 21 are formed in one piece (see figures 3A-3C). While Carrel does not explicitly recite that the drive chassis, the click arm, the trigger limb and the dispensing limb are formed from the same material, one of ordinary skill in the art can infer that the claimed components are formed from the same material because Carrel is showing these components as one piece.
Additionally, Rowe teaches a design of an autoinjector device (figure 1) wherein the different components 300, 320 can be made as a single piece of same material (paragraph 0073, lines 5-7) for the purpose of using a well-known alternative manufacturing approach (paragraph 0073, lines 5-7).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the material of the drive chassis, the click arm, the trigger limb and the dispensing limb of modified Carrel to incorporate a same material as taught by Rowe for the purpose of using a well-known alternative manufacturing approach (paragraph 0073, lines 5-7).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Marshall et al. (US 5,643,214): discloses a design of an injection device comprising sound generation using an arm engaging a recess or step.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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