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
This office action is responsive to the amendment filed on 10/30/2025. As directed by the amendment: no claims have been amended; claims 1-19 have been canceled; and no new claims have been added. Thus, claims 20-38 are presently pending in this application.
Response to Arguments
Applicant’s argument pages 6-7 of the remarks filed 10/30/2025 that Gabriel and/or Daniel fails to provide support for the design choice rejection in the Office Action, therefore the Action’s conclusions are unsupported conclusions. Applicant’s argument has been fully considered and are not persuasive. Gabriel discloses 52 clicking over teeth 49 and at each tooth providing a snap movement so that a visually impaired or blink person can count the clicks and thus set the proper dosage (col. 10 lines 46-49) and the noise is loud and easy to hear (col. 12 lines 60-64). Therefore, Gabriel supports the conclusion of making the audible signal with a volume loud enough and easy for the visually impaired or blink person to hear. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the audible signal with a volume of at least 100 dB for the visually impaired or blink person to hear. Daniel discloses in the released state, the distal end of 110 is in contact with the inner distal surface of the tubular extension part 22 to generate the audible confirmation signal. Therefore, Daniel supports the conclusion of making the audible signal with a volume loud enough and easy to hear for the user to confirm the state of the device. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the audible signal with a volume of at least 100 dB for the user to hear the confirmation signal.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 20-25, 28-32, 34-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gabriel et al. (US 5,114,406).
Regarding claim 20, Gabriel discloses
A drug delivery device (10, fig. 1) comprising a mechanical audible indicator (52, col. 12 lines 60-64) configured to produce an audible signal with a volume (see col. 12 lines 60-64 for 52 being relatively stiff and strong to produce the noise loud enough easy to hear).
Gabriel is silent about the audible signal having a volume of at least 100dB. Gabriel only discloses 52 clicking over teeth 49 and at each tooth providing a snap movement so that a visually impaired or blink person can count the clicks and thus set the proper dosage (col. 10 lines 46-49) and the noise is loud and easy to hear (col. 12 lines 60-64).
There is no evidence of record that establishes changing the volume of the audible signal would result in a difference in function of Gabriel device. Further, a person having ordinary skill in the art, being faced with modifying the mechanical audible indicator of Gabriel would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed audible signal, and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the mechanical audible indicator to have a volume of at least 100dB as an obvious matter of design choice within the skill of the art.
Regarding claim 21, Gabriel discloses
The drug delivery device of claim 20, wherein the mechanical audible indicator (52, fig. 6) comprises one or more mechanical components (52/49, col. 10 lines 46-49) configured to produce the audible signal (col. 10 lines 46-49 and col. 12 lines 60-64),
wherein one mechanical component of the one or more mechanical components (52/49) is a resilient force member (52) supported in a biased state by an element (49) of the drug delivery device to prevent transition of the resilient force member into a relaxed state (Examiner notes: when 52 clicks over 49 and engages with 49, 52 is in a biased state and 49 prevents 52 to relax. When the use rotates 56 further, 52 is passed over 49, 52 returns to its relaxed state).
Gabriel is silent about the volume of the audible signal is at least 100dB(A) at a distance of 150 mm away from the drug delivery device. Gabriel only discloses 52 clicking over teeth 49 and at each tooth providing a snap movement so that a visually impaired or blink person can count the clicks and thus set the proper dosage (col. 10 lines 46-49) and the noise is loud and easy to hear (col. 12 lines 60-64).
There is no evidence of record that establishes changing the volume of the audible signal would result in a difference in function of Gabriel device. Further, a person having ordinary skill in the art, being faced with modifying the mechanical audible indicator of Gabriel would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed audible signal, and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the mechanical audible indicator to have a volume of at least 100dB at a distance of 150 mm away from the drug delivery device as an obvious matter of design choice within the skill of the art.
Regarding claim 22, Gabriel discloses
The drug delivery device of claim 21, wherein the resilient force member (52) is configured to be inserted into a rear housing of the drug delivery device (Examiner notes: see col. 7 lines 1-13 for one end of 52 being inserted into recess 55 of 56 and 56 is rotatably mounted on the distal end of distal housing part 32).
Regarding claim 23, Gabriel discloses
The drug delivery device of claim 21, wherein the resilient force member (52) is arranged such that a longitudinal axis of the resilient force member (longitudinal axis of 52 at the center point of 52) is parallel with a longitudinal axis of the drug delivery device (see fig. 4 for the position of 52 in the device).
Regarding claim 24, Gabriel discloses
The drug delivery device of claim 21, wherein the resilient force member (52, fig. 4) comprises one or more tabs (54, fig. 4) configured to be engaged to a number of corresponding openings (55) in a housing of the drug delivery device (see col. 7 lines 1-13).
Regarding claim 25, Gabriel discloses
The drug delivery device of claim 20, wherein the mechanical audible indicator (52) comprises a resilient force member (53) configured to be supported in a biased state by a flexible arm (arm of 52 that connects to 53) of the drug delivery device to prevent a transition of the resilient force member from the biased state into a relaxed state (Examiner notes: when 52 clicks over 49 and engages with 49, 53 is in a biased state and the flexible arm holds 53 on 49 to prevent 53 to return to its relaxed state).
Regarding claim 28, Gabriel discloses
The drug delivery device of claim 20, wherein the mechanical audible indicator (52, fig. 4) comprises a resilient force member (53) configured to reside in two or more states (engage with 49 and not engage with 49), each state of the two or more states having a respective conformation, wherein, in a relaxed state (53 not engage with 49), the resilient force member is relaxed in a first conformation (relaxed conformation of 53), wherein, in a biased state (53 engages with 49), the resilient force member (53) is biased to store energy in a second conformation different than the first conformation (stored energy to produce loud noise after 53 passes over 49), and wherein the resilient force member (53) is configured to release stored energy that is stored by deflecting the resilient force member (53) to generate the audible signal (col. 12 lines 50-64) when the resilient force member (53) transitions from the biased state (engage with 49) into the relaxed state (not engage with 49) due to a transition from the second conformation to the first conformation (col. 12 lines 50-64).
Regarding claim 29, Gabriel discloses
The drug delivery device of claim 28, wherein the resilient force member (53) comprises a leaf spring (53) having a longitudinal axis (longitudinal axis of 53, along the length of 53), and the resilient force member is bent by a predetermined angle (see fig. 4 for the bent shape of 53 on 52) about the longitudinal axis to form two angled wing-shaped sections (see fig. 4) that are angled relative to each other by the predetermined angle (see fig. 4).
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Regarding claim 30, Gabriel discloses
The drug delivery device of claim 29, as set forth above, except for wherein the leaf spring has at least one of a rectangular shape, a square shape, or an oval shape.
Gabriel only discloses the resilient force member configured to engage with other element to produce a loud and easy-to-hear noise (col. 12 lines 60-64).
There is no evidence of record that establishes changing the shape of the resilient force member would result in a difference in function of Gabriel device. Further, a person having ordinary skill in the art, being faced with modifying the shape would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed shape of the resilient force member, and therefore there appears to be no criticality placed on the shape as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the resilient force member to have at least one of a rectangular shape, a square shape, or an oval shape as an obvious matter of design choice within the skill of the art.
Regarding claim 31, Gabriel discloses
The drug delivery device of claim 29, wherein the resilient force member (53) is a bi- stable resilient force member (when 53 engages with 49 and when 53 doesn’t engage with 49)
Gabriel is silent about the predetermined angle being between 130 degrees and 160 degrees.
Gabriel only discloses in fig. 4 the predetermined angle being an obtuse angle.
There is no evidence of record that establishes changing the predetermined angle of the resilient force member would result in a difference in function of Gabriel device. Further, a person having ordinary skill in the art, being faced with modifying the angle would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angle of the resilient force member, and therefore there appears to be no criticality placed on the shape as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the predetermined angle being between 130 degrees and 160 degrees as an obvious matter of design choice within the skill of the art.
Regarding claim 32, Gabriel discloses
The drug delivery device of claim 28, wherein the resilient force member (53) comprises one or more tabs (54) configured to engage with one or more openings (55) of a case (56) of the drug delivery device (see fig. 4 and col. 7 lines 7-9).
Regarding claim 34, Gabriel discloses
The drug delivery device of claim 20, wherein a free end (53) of the mechanical audible indicator is in a plastically deformed state (see fig. 4 for the plastically deformed state of 53 with an angle with respect to the rest of 52) while the drug delivery device is in a pre-use state (see fig. 4).
Regarding claim 35, Gabriel discloses
The drug delivery device of claim 20, wherein the drug delivery device (10) is an auto- injector (see fig. 1) comprising a control subassembly (45’), wherein the control subassembly (45’) comprises a slidable needle shroud (45’) configured to cover a needle (see fig. 1) that is used to deliver a drug by using the drug delivery device (see fig. 1).
Regarding claim 36, Gabriel discloses
The drug delivery device of claim 20, wherein the mechanical audible indicator (52) comprises a resilient force member (53) with a proximal spring section (53) that is configured to be supported by a supporting protrusion (49) arranged on a rear housing of the drug delivery device (see fig. 4 and 6).
Claim(s) 20, 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel (US 2016/0067407).
Regarding claim 20, Daniel discloses
A drug delivery device (1, figs. 1-6c, pars. 0037-0054) comprising a mechanical audible indicator (110, figs. 3, 4A-4C, and 6A-6C) configured to produce an audible signal with a volume (see par. 0049 for the released state, the distal end of 110 is in contact with the inner distal surface of the tubular extension part 22 to generate the audible and/or tactile and/or visible confirmation signal).
Daniel is silent about the audible signal having a volume of at least 100dB.
There is no evidence of record that establishes changing the volume of the audible signal would result in a difference in function of Daniel device. Further, a person having ordinary skill in the art, being faced with modifying the mechanical audible indicator of Daniel would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed audible signal, and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the mechanical audible indicator to have a volume of at least 100dB as an obvious matter of design choice within the skill of the art.
Regarding claim 26, Daniel discloses
The drug delivery device of claim 20, wherein the mechanical audible indicator (110) is configured to be activated by a movement of a plunger (90, see par. 0049).
Regarding claim 27, Daniel discloses
The drug delivery device of claim 26, wherein the mechanical audible indicator (110) is configured to be activated by the movement of the plunger (90) towards a distal position (position toward the injection site) at an end of a medicament delivery process (see par. 0049).
Allowable Subject Matter
Claim(s) 33, 37-38 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/DUNG T ULSH/Examiner, Art Unit 3783