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 in response to the Applicant’s amendment filed 4 February 2026 wherein Claim 1 is amended, no claims are newly cancelled, and no claims are newly added. Therefore Claims 1 – 14 are currently pending within the Application.
Response to Arguments
Applicant's arguments filed 4 February 2026 have been fully considered but they are not persuasive. The 35 U.S.C. § 103 rejection of Claims 1 – 13 over Daniel (US 2013/0035642), Maxfield (US 2018/0078703) and Atterbury (US 2017/0354779) is maintained.
The Applicant alleges that none of Daniel, Maxfield, or Atterbury teaches “wherein a recess is aligned with and axially spaced from the longitudinal feedback track to engage with the flexible finger to releasably hold the plunger rod before activation.” See page 6 of the Remarks dated 4 February 2026. The Examiner respectfully disagrees.
Atterbury teaches a recess (see Examiner annotated Fig. 6 below) being aligned with and axially spaced from the longitudinal feedback track to engage with the flexible finger (92) to releasably hold the plunger rod (62) before activation (see [0050], [0051], and Fig. 6).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plunger rod and flexible finger of the feedback assembly of Daniel and Maxfield in view of a teaching of Atterbury such that the outer surface of the plunger rod comprises a longitudinal feedback track, wherein a recess is aligned with and axially spaced from the longitudinal feedback track to engage with the flexible finger to releasably hold the plunger rod before activation; and when the plunger rod is in an activated state the flexible finger will engage the longitudinal feedback track to provide audible or tactile notification of medicament being expelled from a medicament container positioned with the medicament delivery device.
One of ordinary skill in the art would have been motivated to make this modification because Atterbury teaches that the clicker features provide an audible clicking sound during dose injecting for each medication being injected. The clicking sound that is produced during dose injecting is useful for the user to understand how the injection is progressing (i.e., the amount of medication that has been injected so far) (see [0002] and [0039] of Atterbury). Further incorporating the longitudinal feedback track provides an audible indicator that could have a changing cadence to indicate the approaching of an end of dose or the progression of the dosage (see [0010] of Atterbury).
Additionally or alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to incorporate the longitudinal feedback track of Atterbury such that it is aligned and axially spaced from the recess 94 of Daniel, since it has been held that a mere rearrangement of parts that does not affect the operation of the device is within the level of ordinary skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); MPEP 2144.04(C). Here incorporating the longitudinal feedback track such that it is aligned and axially spaced from the recess 94 of Daniel is beneficial because this location does not conflict with the elongated arms 111 of Daniel. See Fig. 3 of Daniel. Furthermore, this location would allow for the flexible tongue 121 of the tubular extension part 22 to run along the longitudinal feedback track to generate sound while dose injection is occurring. See Fig. 5 of Daniel. Therefore, a person having ordinary skill in the art would recognize the advantages to placing the longitudinal feedback track at this location because doing so would allow for the generation of clicking sounds to alert a user about ongoing dosing while retaining the functionality of the other parts of the plunger rod 90 of Daniel.
In view of the aforementioned rationales, the Applicant’s argument is unpersuasive because Atterbury teaches “wherein a recess is aligned with and axially spaced from the longitudinal feedback track to engage with the flexible finger to releasably hold the plunger rod before activation.” The 35 U.S.C. § 103 rejection of Claims 1 – 13 over Daniel (US 2013/0035642), Maxfield (US 2018/0078703) and Atterbury (US 2017/0354779) is maintained.
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 1 – 14 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 1 recites (italicized for emphasis):
A feedback assembly for a medicament delivery device comprising:
a tubular sleeve having a longitudinal axis and comprising a flexible finger biased radially inward towards the longitudinal axis;
a plunger rod positioned within the tubular sleeve and having an outer surface comprising a longitudinal feedback track and two protruding wings located at a distal end, wherein a recess is aligned with and axially spaced from the longitudinal feedback track to engage with the flexible finger to releasably hold the plunger rod before activation, and wherein rotation of the plunger rod with respect to the tubular sleeve is prevented by an engagement mechanism therebetween; and
a resilient member engaged with the plunger rod that biases the plunger rod in a proximal direction,
wherein, when the plunger rod is in a non-activated state, the flexible finger is not engaged with the longitudinal feedback track and the flexible finger is positioned within a recess of the plunger rod such that the plunger rod is axially fixed relative to the tubular sleeve, and
wherein, when the plunger rod is in an activated state, the resilient member pushes the plunger rod axially to a final position such that the plunger rod will move axially relative to the tubular sleeve such that the flexible finger will engage the longitudinal feedback track to provide audible or tactile notification of medicament being expelled from a medicament container positioned with the medicament delivery device.
Claim 1 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because the Examiner cannot determine if the recited recess aligned with and axially spaced from the longitudinal feedback track to engage with the flexible finger to releasably hold the plunger rod before activation is the same recess later recited that the flexible finger is positioned within such that the plunger rod is axially fixed relative to the tubular sleeve. In other words, Claim 1 recites “a recess” twice and it cannot be determined if there is two recesses or if both of these recitations of “a recess” are referring to the same recess.
Claims 2 – 14 are dependent upon Claim 1 and are therefore rejected under 35 U.S.C. § 112(b) for the same rationale as Claim 1.
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.
Claim(s) 1 – 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel (US 2013/0035642 A1) modified in view of Maxfield (US 2018/0078703 A1) and Atterbury et al. (US 2017/0354779 A1 hereinafter referred to as “Atterbury”).
Atterbury is cited within the Notice of References Cited form dated 23 December 2024.
With regards to claim 1, Daniel discloses a feedback assembly (see [0002]) for a medicament delivery device (1) (see [0038]) comprising:
a tubular sleeve (22) (see [0038]) having a longitudinal axis (see Fig. 5) and comprising a flexible finger (121) (see Fig. 5) biased radially inward towards the longitudinal axis (see [0048] “the opening 94 of the plunger rod 90 is engage with a radial inward projected protrusion 35 of a flexible tongue 121 of the tubular extension part 22.”);
a plunger rod (90) (see [0040]) positioned within the tubular sleeve (see Fig. 5, [0048], and [0049]) and having an outer surface (see at 90 in Fig. 4C); and
a resilient member (91) (see [0040]) engaged with the plunger rod that biases the plunger rod in a proximal direction (see [0056] “the first resilient member 91 which is adapted to apply a force to the plunger rod 90 in the proximal direction.”),
wherein, when the plunger rod is in a non-activated state, the flexible finger is not engaged with the longitudinal feedback track (see [0040], [0048], [0050], and Fig. 5 where the flexible finger is not engaged with any feedback track because the flexible finger is within the recess 94) and the flexible finger is positioned within a recess (94) of the plunger rod such that the plunger rod is axially fixed relative to the tubular sleeve (see [0040], [0048] “when the drive means are in a pre-tensioned state, i.e. the opening 94 of the plunger rod 90 is engage with a radial inward projected protrusion 35 of a flexible tongue 121 of the tubular extension part 22,” [0050], and Fig. 5), and
wherein, when the plunger rod is in an activated state, the resilient member pushes the plunger rod axially to a final position (Fig. 6c) such that the plunger rod will move axially relative to the tubular sleeve (see [0050], [0052], and see Figs. 6a – 6c).
Daniel is silent with regards to the following:
the outer surface of the plunger rod comprising a longitudinal feedback track and two protruding wings located at a distal end, wherein a recess is aligned with and axially spaced from the longitudinal feedback track to engage with the flexible finger to releasably hold the plunger rod before activation, and wherein the rotation of the plunger rod with respect to the tubular sleeve is prevented by an engagement mechanism therebetween; and
when the plunger rod is in an activated state the flexible finger will engage the longitudinal feedback track to provide audible or tactile notification of medicament being expelled from a medicament container positioned with the medicament delivery device.
Nonetheless Maxfield, which is within the analogous art of drive mechanisms for medicament delivery devices (see abstract and title), teaches (Fig. 5) the outer surface of the plunger rod comprising two protruding wings (70) (see [0024]) located at a distal end (see the location of the wings 70 in Fig. 5 and [0024]), wherein the rotation of the plunger rod (54) with respect to the tubular sleeve (62) is prevented by an engagement mechanism therebetween (see [0027] “The end cap 90 has a dome-shaped end wall 92 where its proximally directed inner surface is arranged with two arc-shaped proximally extending protrusions 94 arranged such that the distal end of the plunger rod 54 with its wings 70 will engage, whereby the plunger rod 54 is rotationally locked” and [0031] “The turning of the rotator 62 will cause the cut-out sectors 66 of the passage 64 at the end wall 60 to move in relation to the wings 70 of the plunger rod 54, wherein the plunger rod 54 is prevented from turning due to the engagement with the arc-shaped protrusions 94 of the end cap 90.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plunger rod of the feedback assembly of Daniel in view of a teaching of Maxfield such that the outer surface of the plunger rod comprises two protruding wings located at a distal end, wherein the rotation of the plunger rod with respect to the tubular sleeve is prevented by an engagement mechanism therebetween. One of ordinary skill in the art would have been motivated to make this modification because Maxfield teaches that incorporating these wings and the corresponding engagement mechanism prevents the rotation or turning of the plunger rod within the medicament delivery device (see [0027] and [0031] of Maxfield). Wherein preventing the plunger rod from rotating eliminates any potential malfunction during the medicament delivery process because of a misaligned plunger rod or from components of the plunger rod snagging or catching other components of the tubular extension part of the medicament delivery device of Daniel as the plunger rod is moved.
The feedback assembly of Daniel modified in view of a teaching of Maxfield will hereinafter be referred to as the feedback assembly of Daniel and Maxfield.
Neither Daniel or Maxfield teaches the following:
the outer surface of the plunger rod comprises a longitudinal feedback track; wherein a recess is aligned with and axially spaced from the longitudinal feedback track to engage with the flexible finger to releasably hold the plunger rod before activation; and
when the plunger rod is in an activated state the flexible finger will engage the longitudinal feedback track to provide audible or tactile notification of medicament being expelled from a medicament container positioned with the medicament delivery device.
Nonetheless Atterbury, which is within the analogous art of automatic medication injection devices with audible indications of injecting progress (see abstract and title), teaches (Figs. 1 – 5) the outer surface of the plunger rod (62; see [0037] “an axially extending plunger element 62”) comprises a longitudinal feedback track (see Examiner annotated Fig. 4 below hereinafter referred to as “Fig. A”); wherein a recess (see Fig. A below) is aligned with and axially spaced from the longitudinal feedback track to engage with the flexible finger to releasably hold the plunger rod before activation (see [0050], [0051], and Fig. 6), and
when the plunger rod is in an activated state (see Fig. 3 and [0015] “FIG. 3 is a cross-sectional side view of the device of FIG. 2 after triggering”) the flexible finger (92; see [0043] “The actuating elements 92 are positioned within the housing 23…the actuating elements 92 could be attached to, or integrally formed with, the housing to be axially fixed relative thereto” and see [0044] “a ramp that cams the actuating elements 92 radially outward such that when the actuating elements 92 pass over the sound elements 90a-j, the actuating elements 92 snap back radially inward”) will engage the longitudinal feedback track to provide audible or tactile notification (see [0040] – [0045]) of medicament being expelled from a medicament container (50; see [0034] “device 20 includes a medication-filled container provided in the form of a syringe, generally designated 50”) positioned with the medicament delivery device (see Figs. 2 – 3).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plunger rod and flexible finger of the feedback assembly of Daniel and Maxfield in view of a teaching of Atterbury such that the outer surface of the plunger rod comprises a longitudinal feedback track, wherein a recess is aligned with and axially spaced from the longitudinal feedback track to engage with the flexible finger to releasably hold the plunger rod before activation; and when the plunger rod is in an activated state the flexible finger will engage the longitudinal feedback track to provide audible or tactile notification of medicament being expelled from a medicament container positioned with the medicament delivery device.
One of ordinary skill in the art would have been motivated to make this modification because Atterbury teaches that the clicker features provide an audible clicking sound during dose injecting for each medication being injected. The clicking sound that is produced during dose injecting is useful for the user to understand how the injection is progressing (i.e., the amount of medication that has been injected so far) (see [0002] and [0039] of Atterbury). Further incorporating the longitudinal feedback track provides an audible indicator that could have a changing cadence to indicate the approaching of an end of dose or the progression of the dosage (see [0010] of Atterbury).
Additionally or alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to incorporate the longitudinal feedback track of Atterbury such that it is aligned and axially spaced from the recess 94 of Daniel, since it has been held that a mere rearrangement of parts that does not affect the operation of the device is within the level of ordinary skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); MPEP 2144.04(C). Here incorporating the longitudinal feedback track such that it is aligned and axially spaced from the recess 94 of Daniel is beneficial because this location does not conflict with the elongated arms 111 of Daniel. See Fig. 3 of Daniel. Furthermore, this location would allow for the flexible tongue 121 of the tubular extension part 22 to run along the longitudinal feedback track to generate sound while dose injection is occurring. See Fig. 5 of Daniel. Therefore, a person having ordinary skill in the art would recognize the advantages to placing the longitudinal feedback track at this location because doing so would allow for the generation of clicking sounds to alert a user about ongoing dosing while not getting in the way of other parts of the plunger rod 90 of Daniel.
The feedback assembly of Daniel and Maxfield modified in view of a teaching of Atterbury will hereinafter be referred to as the feedback assembly of Daniel, Maxfield, and Atterbury.
With regards to claim 2, the feedback assembly of Daniel, Maxfield, and Atterbury teaches the claimed invention of claim 1, however, Daniel is silent with regards to wherein the longitudinal feedback track includes a plurality of signal initiating elements.
Nonetheless Atterbury, which is within the analogous art of automatic medication injection devices with audible indications of injecting progress (see abstract and title), further teaches (Figs. 1 – 5) the longitudinal feedback track (see Fig. A above) includes a plurality of signal initiating elements (90a – 90j; see Fig. 4 and [0040] “Sound elements 90 are shown in FIGS. 2 and 3 as being a series of ten ramp-shaped protrusions or sound elements 90a, 90b, 90c, 90d, 90e, 90f, 90g, 90h, 90i and 90j that are integrally formed with drive portion 76 of plunger element 62”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the longitudinal feedback track of the feedback assembly of Daniel, Maxfield, and Atterbury in view of a further teaching of Atterbury such that the longitudinal feedback track includes a plurality of signal initiating elements. One of ordinary skill in the art would have been motivated to make this modification because Atterbury teaches that the clicker features provide an audible clicking sound during dose injecting for each medication being injected. The clicking sound that is produced during dose injecting is useful for the user to understand how the injection is progressing (i.e., the amount of medication that has been injected so far) (see [0002] and [0039] of Atterbury). Further incorporating the longitudinal feedback track with a plurality of signal initiating elements provides an audible indicator that could have a changing cadence to indicate the approaching of an end of dose or the progression of the dosage (see [0010] of Atterbury).
With regards to claim 3, the feedback assembly of Daniel, Maxfield, and Atterbury teaches the claimed invention of claim 2, however, Daniel is silent with regards to wherein the plurality of signal initiating elements comprise a number of protrusions arranged along the longitudinal axis.
Nonetheless Atterbury which is within the analogous art of automatic medication injection devices with audible indications of injecting progress (see abstract and title), further teaches (Figs. 1 – 4) wherein the plurality of signal initiating elements (90a – 90j; see Fig. 4 [0040] “Sound elements 90 are shown in FIGS. 2 and 3 as being a series of ten ramp-shaped protrusions or sound elements 90a, 90b, 90c, 90d, 90e, 90f, 90g, 90h, 90i and 90j that are integrally formed with drive portion 76 of plunger element 62”) comprise a number of protrusions (90a – 90j; see [0040]) arranged along the longitudinal axis (see Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of signal initiating elements of the feedback assembly of Daniel, Maxfield, and Atterbury in view of a further teaching of Atterbury such that the plurality of signal initiating elements comprise a number of protrusions arranged along the longitudinal axis. One of ordinary skill in the art would have been motivated to make this modification because Atterbury teaches that the clicker features provide an audible clicking sound during dose injecting for each medication being injected. The clicking sound that is produced during dose injecting is useful for the user to understand how the injection is progressing (i.e., the amount of medication that has been injected so far) (see [0002] and [0039] of Atterbury). Further incorporating plurality of signal initiating elements as a number of protrusions arranged along the longitudinal axis provides an audible indicator that could have a changing cadence to indicate the approaching of an end of dose or the progression of the dosage (see [0010] of Atterbury).
With regards to claim 4, the feedback assembly of Daniel, Maxfield, and Atterbury teaches the claimed invention of claim 3, however, Daniel is silent with regards to wherein the protrusions are wedge-shaped.
Nonetheless Atterbury, which is within the analogous art of automatic medication injection devices with audible indications of injecting progress (see abstract and title), further teaches (Figs. 1 – 4) wherein the protrusions are wedge-shaped (90a – 90j; see Fig. 4 and [0040] “Sound elements 90 are shown in FIGS. 2 and 3 as being a series of ten ramp-shaped protrusions or sound elements 90a, 90b, 90c, 90d, 90e, 90f, 90g, 90h, 90i and 90j that are integrally formed with drive portion 76 of plunger element 62”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the protrusions of the feedback assembly of Daniel, Maxfield, and Atterbury in view of a further teaching of Atterbury such that the protrusions are wedge-shaped. One of ordinary skill in the art would have been motivated to make this modification because Atterbury teaches that the clicker features provide an audible clicking sound during dose injecting for each medication being injected. The clicking sound that is produced during dose injecting is useful for the user to understand how the injection is progressing (i.e., the amount of medication that has been injected so far) (see [0002] and [0039] of Atterbury). Therefore incorporating the protrusions as wedge-shaped provides for an audible indicator that could have a changing cadence to indicate the approaching of an end of dose or the progression of the dosage (see [0010] of Atterbury).
With regards to claim 5, the feedback assembly of Daniel, Maxfield, and Atterbury teaches the claimed invention of claim 2, however, Daniel is silent with regards to wherein the plurality of signal initiating elements comprise a plurality of alternating recesses and protrusions.
Nonetheless Atterbury which is within the analogous art of automatic medication injection devices with audible indications of injecting progress (see abstract and title), further teaches (Figs. 1 – 4) wherein the plurality of signal initiating elements comprise a plurality of alternating recesses and protrusions (see Fig. 4 wherein the protrusions are shown as the ramp-shaped protrusions 90a – 90j and the recesses are the cavities between each protrusion 90a – 90j).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of signal initiating elements of the feedback assembly of Daniel, Maxfield, and Atterbury in view of a further teaching of Atterbury such that the plurality of signal initiating elements comprise a plurality of alternating recesses and protrusions. One of ordinary skill in the art would have been motivated to make this modification because Atterbury teaches that the clicker features provide an audible clicking sound during dose injecting for each medication being injected. The clicking sound that is produced during dose injecting is useful for the user to understand how the injection is progressing (i.e., the amount of medication that has been injected so far) (see [0002] and [0039] of Atterbury). Therefore modifying the plurality of signal initiating elements as a plurality of alternating recesses and protrusions provides for an audible indicator that could have a changing cadence to indicate the approaching of an end of dose or the progression of the dosage (see [0010] of Atterbury).
With regards to claim 6, the feedback assembly of Daniel, Maxfield, and Atterbury teaches the claimed invention of claim 2, however, Daniel is silent with regards to wherein the plurality of signal initiating elements are equally spaced in the longitudinal feedback track to provide a constant notification frequency of the audible or tactile notification.
Nonetheless Atterbury which is within the analogous art of automatic medication injection devices with audible indications of injecting progress (see abstract and title), further teaches (Figs. 1 – 4) wherein the plurality of signal initiating elements (90a – 90j; see Fig. 4 and [0040] “Sound elements 90 are shown in FIGS. 2 and 3 as being a series of ten ramp-shaped protrusions or sound elements 90a, 90b, 90c, 90d, 90e, 90f, 90g, 90h, 90i and 90j that are integrally formed with drive portion 76 of plunger element 62”) are equally spaced in the longitudinal feedback track (see Fig. A above) to provide a constant notification frequency of the audible or tactile notification (see [0042] “the sound elements 90 need not have variable spacing” and [0046] “the sound elements would have a constant time interval or temporal spacing throughout their use”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of signal initiating elements of the feedback assembly of Daniel, Maxfield, and Atterbury in view of a further teaching of Atterbury such that the plurality of signal initiating elements are equally spaced in the longitudinal feedback track to provide a constant notification frequency of the audible or tactile notification. One of ordinary skill in the art would have been motivated to make this modification because Atterbury teaches that the clicker features provide an audible clicking sound during dose injecting for each medication being injected. The clicking sound that is produced during dose injecting is useful for the user to understand how the injection is progressing (i.e., the amount of medication that has been injected so far) (see [0002] and [0039] of Atterbury). Therefore modifying the plurality of signal initiating elements such that they are equally spaced provides for an audible indicator that could have a changing cadence to indicate the approaching of an end of dose or the progression of the dosage (see [0010] of Atterbury). The equal spacing could also equate to a dosing regimen or individual dosage increment that has been delivered therefore notifying a user as to how much medication has been injected.
With regards to claim 7, the feedback assembly of Daniel, Maxfield, and Atterbury teaches the claimed invention of claim 2, however, Daniel is silent with regards to wherein the plurality of signal initiating elements are unequally spaced in the longitudinal feedback track to provide a variable notification frequency of the audible or tactile notification.
Nonetheless Atterbury, which is within the analogous art of automatic medication injection devices with audible indications of injecting progress (see abstract and title), further teaches (Figs. 1 – 4) wherein the plurality of signal initiating elements (90a – 90j; see Fig. 4 and [0040] “Sound elements 90 are shown in FIGS. 2 and 3 as being a series of ten ramp-shaped protrusions or sound elements 90a, 90b, 90c, 90d, 90e, 90f, 90g, 90h, 90i and 90j that are integrally formed with drive portion 76 of plunger element 62”) are unequally spaced in the longitudinal feedback track (see Fig. A above) to provide a variable notification frequency of the audible or tactile notification (see [0042] “The sound elements 90a-j are axially spaced from each other to provide a desired pattern of time intervals between audible notices…the sound elements 90 need not have variable spacing except as necessary to provide a change in cadence in audible notices to indicate an approaching end of an injection if such is desired in that embodiment” and see Fig. 4 and the unequal spacing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the plurality of signal initiating elements of the feedback assembly of Daniel, Maxfield, and Atterbury in view of a further teaching of Atterbury such that the plurality of signal initiating elements are unequally spaced in the longitudinal feedback track to provide a variable notification frequency of the audible or tactile notification. One of ordinary skill in the art would have been motivated to make this modification because Atterbury teaches that the clicker features provide an audible clicking sound during dose injecting for each medication being injected. The clicking sound that is produced during dose injecting is useful for the user to understand how the injection is progressing (i.e., the amount of medication that has been injected so far) (see [0002] and [0039] of Atterbury). Therefore modifying the plurality of signal initiating elements such that they are unequally spaced provides for an audible indicator that could have a changing cadence to indicate the approaching of an end of dose or the progression of the dosage (see [0010] of Atterbury).
With regards to claim 8, the feedback assembly of Daniel, Maxfield, and Atterbury teaches the claimed invention of claim 7, however, Daniel is silent with regards to wherein the variable notification frequency provides notice to a user that a medicament delivery sequence is progressing.
Nonetheless Atterbury which is within the analogous art of automatic medication injection devices with audible indications of injecting progress (see abstract and title), further teaches (Figs. 1 – 4) wherein the variable notification frequency provides notice to a user that a medicament delivery sequence is progressing (see [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the variable notification frequency of the feedback assembly of Daniel, Maxfield, and Atterbury in view of a further teaching of Atterbury such that the variable notification frequency provides notice to a user that a medicament delivery sequence is progressing. One of ordinary skill in the art would have been motivated to make this modification because Atterbury teaches that the clicker features provide an audible clicking sound during dose injecting for each medication being injected. The clicking sound that is produced during dose injecting is useful for the user to understand how the injection is progressing (i.e., the amount of medication that has been injected so far) (see [0002] and [0039] of Atterbury). Therefore modifying the plurality of signal initiating elements such that they are unequally spaced provides for an audible indicator that could have a changing cadence to indicate the approaching of an end of dose or the progression of the dosage (see [0010] of Atterbury).
With regards to claim 9, the feedback assembly of Daniel, Maxfield, and Atterbury teaches the claimed invention of claim 1, however, Daniel is silent with regards to wherein the flexible finger is shaped to snap into and out of the longitudinal feedback track during a medicament delivery sequence.
Nonetheless Atterbury, which is within the analogous art of automatic medication injection devices with audible indications of injecting progress (see abstract and title), further teaches (Figs. 1 – 4) wherein the flexible finger (92; see [0043] “The actuating elements 92 are positioned within the housing 23…the actuating elements 92 could be attached to, or integrally formed with, the housing to be axially fixed relative thereto” and see [0044] “a ramp that cams the actuating elements 92 radially outward such that when the actuating elements 92 pass over the sound elements 90a-j, the actuating elements 92 snap back radially inward”) is shaped to snap into and out of the longitudinal feedback track (see Fig. A above) during a medicament delivery sequence (see [0043] and [0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the flexible finger and the longitudinal feedback track of the feedback assembly of Daniel, Maxfield, and Atterbury in view of a further teaching of Atterbury such that the flexible finger is shaped to snap into and out of the longitudinal feedback track during a medicament delivery sequence. One of ordinary skill in the art would have been motivated to make this modification because Atterbury teaches that the clicker features provide an audible clicking sound during dose injecting for each medication being injected. The clicking sound that is produced during dose injecting is useful for the user to understand how the injection is progressing (i.e., the amount of medication that has been injected so far) (see [0002] and [0039] of Atterbury). Therefore modifying the flexible finger such that the flexible finger snaps into and out of the longitudinal track during a medicament delivery sequence creates an audible indicator that could have a changing cadence to indicate the approaching of an end of dose or the progression of the dosage (see [0010] of Atterbury).
With regards to claim 10, the feedback assembly of Daniel, Maxfield, and Atterbury teaches the claimed invention of claim 1, however, Daniel is silent with regards to wherein a user is notified at an end of a medicament delivery sequence.
Nonetheless Atterbury, which is within the analogous art of automatic medication injection devices with audible indications of injecting progress (see abstract and title), further teaches (Figs. 1 – 4) wherein a user is notified at an end of a medicament delivery sequence (see [0043] “when the syringe plunger 58 starts to move within barrel 52 to force medication through needle 57, and has a final click, associated with sound element 90j, when the drive mechanism 60 has completed”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the feedback assembly of Daniel, Maxfield, and Atterbury in view of a further teaching of Atterbury such that a user is notified at an end of a medicament delivery sequence. One of ordinary skill in the art would have been motivated to make this modification because Atterbury teaches that the clicker features provide an audible clicking sound during dose injecting for each medication being injected. The clicking sound that is produced during dose injecting is useful for the user to understand how the injection is progressing (i.e., the amount of medication that has been injected so far) (see [0002] and [0039] of Atterbury). Therefore a PHOSITA would be motivated to create an audible indicator that could have a changing cadence to indicate the approaching of an end of dose or the progression of the dosage (see [0010] of Atterbury).
With regards to claim 11, the feedback assembly of Daniel, Maxfield, and Atterbury teaches the claimed invention of claim 1, however, Daniel is silent with regards to wherein the flexible finger flexes radially outward as the plunger rod moves in the proximal direction during engagement with the longitudinal feedback track.
Nonetheless Atterbury, which is within the analogous art of automatic medication injection devices with audible indications of injecting progress (see abstract and title), further teaches (Figs. 1 – 4) wherein the flexible finger (92; see [0043] “The actuating elements 92 are positioned within the housing 23…the actuating elements 92 could be attached to, or integrally formed with, the housing to be axially fixed relative thereto” and see [0044] “a ramp that cams the actuating elements 92 radially outward such that when the actuating elements 92 pass over the sound elements 90a-j, the actuating elements 92 snap back radially inward”) flexes radially outward as the plunger rod (62; see [0037] “an axially extending plunger element 62”) moves in the proximal direction (see [0037] “When the plunger element 62 is so released the driver 65, which may be a compression spring already under load, forces the plunger element 62 proximally.”) during engagement with the longitudinal feedback track (see Fig. A above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the flexible finger of the feedback assembly of Daniel, Maxfield, and Atterbury in view of a further teaching of Atterbury such that the flexible finger flexes radially outward as the plunger rod moves in the proximal direction during engagement with the longitudinal feedback track. One of ordinary skill in the art would have been motivated to make this modification because Atterbury teaches that the clicker features provide an audible clicking sound during dose injecting for each medication being injected. The clicking sound that is produced during dose injecting is useful for the user to understand how the injection is progressing (i.e., the amount of medication that has been injected so far) (see [0002] and [0039] of Atterbury). Therefore a PHOSITA would be motivated to create an audible indicator that could have a changing cadence to indicate the approaching of an end of dose or the progression of the dosage (see [0010] of Atterbury).
With regards to claim 12, the feedback assembly of Daniel, Maxfield, and Atterbury teaches the claimed invention of claim 1, and Daniel further teaches (Fig. 5) wherein the flexible finger (121) generally projects proximally along the longitudinal axis (see Fig. 5).
With regards to claim 13, the feedback assembly of Daniel, Maxfield, and Atterbury teaches the claimed invention of claim 1, and Daniel further teaches (Fig. 5) wherein the flexible finger (121) is formed as an integral part of the tubular sleeve (22) (see [0038]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel, Maxfield, and Atterbury as applied to claim 1 above, and further in view of Olson et al. (US 2017/0368259 A1 hereinafter referred to as “Olson”).
With regards to claim 14, the feedback assembly of Daniel, Maxfield, and Atterbury teaches the claimed invention of claim 1, and, Daniel teaches with regards to wherein the flexible finger (121) comprises a first flexible finger (see Fig. 5).
However, Daniel is silent with regards to the feedback assembly further comprising: a second flexible finger diametrically positioned to the first flexible finger and positioned around a central opening of the tubular sleeve such that the first flexible finger and the second flexible finger both project radially into the central opening.
Nonetheless Olson, which is within the analogous art of signal delaying assemblies for medicament delivery devices (see abstract and title), teaches the flexible finger (74) (see [0042]) comprises a first flexible finger (see Fig. 6 which shows each proximally extending arm 66 having an inwardly extending protrusion 74), the feedback assembly further comprising:
a second flexible finger (see Fig. 6 which shows each proximally extending arm 66 having an inwardly extending protrusion 74) diametrically positioned to the first flexible finger and positioned around a central opening of the tubular sleeve such that the first flexible finger and the second flexible finger both project radially into the central opening (see [0042] and Fig. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the feedback assembly of Daniel, Maxfield, and Atterbury in view of a teaching of Olson such that the feedback assembly further comprises a second flexible finger diametrically positioned to the first flexible finger and positioned around a central opening of the tubular sleeve such that the first flexible finger and the second flexible finger both project radially into the central opening. One of ordinary skill in the art would have been motivated to make this modification because Olson teaches that the second flexible finger interacts with the recess on the plunger rod to hold the plunger rod in an inactivated state in which the spring is kept in tension (see [0042], [0052], and [0056] of Olson). A person having ordinary skill in the art would realize that it would be beneficial to include a second flexible finger to provide a redundant or duplicate structure to hold the plunger rod in the pretensioned state in order to provide a backup in case the first flexible finger and recess malfunctions.
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.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
05/26/2026
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