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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11 July 2025 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 11 July 2025 wherein Claims 1, 19, 20, and 21 are amended, Claims 9, 11 – 16, and 22 – 23 are previously cancelled, and no claims are newly added. Therefore, Claims 1 – 8, 10, and 17 – 21 are currently pending within the Application.
The Applicant’s amendment to the Drawings and Specification dated 1 May 2025 have overcome each Drawing and Specification Objection set forth in the Final Rejection dated 12 March 2025 (hereinafter referred to as the “Final Rejection”). Therefore each Drawing and Specification Objection set forth in the Final Rejection is withdrawn.
The Applicant’s amendment to the Claims dated 1 May 2025 have overcome each Claim Objection set forth in the Final Rejection. Therefore each Claim Objection set forth in the Final Rejection is withdrawn.
The Applicant’s amendment to the Claims dated 1 May 2025 have overcome each Claim Rejection set forth under 35 U.S.C. § 112(b) in the Final Rejection. Therefore each Claim Rejection set forth under 35 U.S.C. § 112(b) in the Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 12 – 13, filed 1 May 2025, with respect to the rejection(s) of claim(s) 1 and 21 and their respective dependent claims under 35 U.S.C. § 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Pedersen et al. (US 2013/0211330 A1) and Bollenbach et al. (US 2008/0262438 A1).
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 – 7 and 17 – 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. (US 2013/0211330 A1 hereinafter referred to as “Pedersen”) and Bollenbach et al. (US 2008/0262438 A1 hereinafter referred to as “Bollenbach”).
Bollenbach is cited in the Notice of References Cited form dated 12 March 2025.
With regards to claim 1, Pedersen discloses (Figs. 1a – 9d) a notification mechanism (see [0090]) positioned within a medicament delivery device (100) (see [0070]), where the notification mechanism comprises:
a proximal part (370) (see [0085]) comprising a central opening (see at 374 and 375 in in Fig. 2b) and a first inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the left arm 374 is the first inwardly extending ledge) and a second inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the right arm 374 is the second inwardly extending ledge) that each project radially into the central opening (see Fig. 2b), wherein the first inwardly extending ledge and the second inwardly extending ledge are each inclined in a proximal direction into the central opening (see Fig. 2b at 374, 375 and [0090] wherein proximal refers to the part/end of the device which when under use is located closest to the delivery site of the user in accordance with [0009] of the Specification of the current Application); and
an assembly (310, 330) comprising a plunger rod (310) (see [0084]) and a drive spring (330) (see [0086]), where the assembly is movably positioned within the central opening (see Figs. 2a – 6b and the movably positioning of the piston driver 310 and compression spring 330) such that a plurality of signal initiating elements (315) (see [0090]) positioned longitudinally along the assembly slidably engage both the first inwardly extending ledge and the second inwardly extending ledge (see [0090] and Figs. 2a – 6b),
wherein the plurality of signal initiating elements slidably engage with the first inwardly extending ledge and the second inwardly extending ledge during relative axial movement between the assembly and the proximal part such that a tactile or audible signal notification is provided to a user of the medicament delivery device (see [0090], [0106], and the axial movement of between the assembly 310, 330 and the proximal part 370 shown in Figs. 2a – 6b), and
wherein the first inwardly extending ledge is axially aligned with the second inwardly extending ledge (see [0086] “The small set of arms 374 has minor protrusions 375.” see Fig. 2b which shows the axial alignment of the protrusions 375).
However Pedersen is silent with regards to
wherein the plurality of signal initiating elements are circumferentially positioned around an entire circumference of the plunger rod.
Nonetheless Bollenbach, which is within the analogous art of injection devices with a time-constant delivery signal (see abstract and title), teaches wherein the plurality of signal initiating elements (31) (see [0020] “The latching elements can be annular projections which surround the circumference of the rod-shaped element,” [0065] and Figs. 10 – 11) are circumferentially positioned around an entire circumference of the plunger rod (23) (see [0042]).
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 notification mechanism of Pedersen in view of a teaching of Bollenbach such that the plurality of signal initiating elements are circumferentially positioned around an entire circumference of the plunger rod. One of ordinary skill in the art would have been motivated to make this modification because Bollenbach teaches that annular projections can be used to create the signal unit to signal different movements of the mechanism of the injection device (see [0020] of Bollenbach). It would also have been an obvious matter of design choice to modify the shape of the plurality of signal initiating elements of the notification mechanism of Pedersen in view of a teaching of Bollenbach such that the plurality of signal initiating elements are circumferentially positioned around an entire circumference of the plunger rod, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP 2144.04(IV)(B).
The notification mechanism of Pedersen modified in view of a teaching of Bollenbach will hereinafter be referred to as the notification mechanism of Pedersen and Bollenbach.
With regards to claim 2, the notification mechanism of Pedersen and Bollenbach teaches the claimed invention of claim 1, and Pedersen further teaches (Figs. 1a – 9d) wherein the first inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the left arm 374 is the first inwardly extending ledge) is part of a first flexible arm (left 374), and wherein the second inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the right arm 374 is the second inwardly extending ledge) is part of a second flexible arm (right 374).
With regards to claim 3, the notification mechanism of Pedersen and Bollenbach teaches the claimed invention of claim 2, and Pedersen further teaches (Figs. 1a – 9d) wherein the first flexible arm (left 374) and the second flexible arm (right 374) each generally projects proximally along a longitudinal axis of the assembly (310, 330) (see Fig. 2b).
With regards to claim 4, the notification mechanism of Pedersen and Bollenbach teaches the claimed invention of claim 1, and Pedersen further teaches (Figs. 1a – 9d) wherein the first inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the left arm 374 is the first inwardly extending ledge) and the second inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the right arm 374 is the second inwardly extending ledge) are diametrically positioned around the central opening (see at 374, 375 in in Fig. 2b) such that both the first inwardly extending ledge and the second inwardly extending ledge project radially into the central opening (see Fig. 2b at 374, 375 and [0090]).
With regards to claim 5, the notification mechanism of Pedersen and Bollenbach teaches the claimed invention of claim 2, and Pedersen further teaches (Figs. 1a – 9d) wherein the first flexible arm (left 374) and the second flexible arm (right 374) each flex radially outward (see [0086] and [0090]) as the assembly (310, 330) moves in a proximal direction during engagement with the plurality of signal initiating elements (315) (see [0086], [0090], and the movement shown in Figs. 2a – 6b).
With regards to claim 6, the notification mechanism of Pedersen and Bollenbach teaches the claimed invention of claim 1, and Pedersen further teaches (Figs. 1a – 9d) wherein the first inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the left arm 374 is the first inwardly extending ledge) and the second inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the right arm 374 is the second inwardly extending ledge) are each formed as an integral part of the proximal part (370) (see [0085], [0086], and Fig. 2b).
With regards to claim 7, the notification mechanism of Pedersen and Bollenbach teaches the claimed invention of claim 1, however, Pedersen is silent with regards to wherein the plurality of signal initiating elements comprise a plurality of alternating recesses and protrusions.
Nonetheless Bollenbach, which is within the analogous art of injection devices with a time-constant delivery signal (see abstract and title), teaches (Figs. 1 – 11) the plurality of signal initiating elements (31) (see [0065]) comprise a plurality of alternating recesses and protrusions (see Figs. 10 – 11 at 31, see [0020] “The latching elements can be annular projections which surround the circumference of the rod-shaped element,” and [0055]).
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 notification mechanism of Pedersen and Bollenbach in view of a further teaching of Bollenbach 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 Bollenbach teaches that a plurality of alternating recess and protrusions can be used to create the signal unit to signal different movements of the mechanism of the injection device (see [0020] of Bollenbach). It would also have been an obvious matter of design choice to modify the shape of the plurality of signal initiating elements of the notification mechanism of Pedersen in view of a teaching of Bollenbach such that the plurality of signal initiating elements comprise a plurality of alternating recesses and protrusions, since such a modification would have involved a mere change in the form or shape of a component.. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP 2144.04(IV)(B).
With regards to claim 17, the notification mechanism of Pedersen and Bollenbach teaches the claimed invention of claim 1, and Pedersen further teaches (Figs. 1a – 9d) wherein the first inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the left arm 374 is the first inwardly extending ledge) is formed at an end of a first flexible arm (left 374) that is shaped to snap into (see [0090]) and out of the plurality of signal initiating elements (315) during a medicament delivery sequence (see Figs. 2a – 6b and [0090]), and wherein the second inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the right arm 374 is the second inwardly extending ledge) is formed at an end of a second flexible arm (right 374) that is shaped to snap into and out of the plurality of signal initiating elements (315) during the medicament delivery sequence (see Figs. 2a – 6b and [0090]).
With regards to claim 18, the notification mechanism of Pedersen and Bollenbach teaches the claimed invention of claim 1, and Pedersen further teaches (Figs. 1a – 9d) wherein the user is notified at an end of a medicament delivery sequence (see [0090] “In the embodiment shown, piston driver 310 further includes one or more protrusions 315 adapted to cooperate with click arms 374 to generate click sounds during and/or at the completion of the injection.”).
With regards to claim 19, the notification mechanism of Pedersen and Bollenbach teaches the claimed invention of claim 1, and Pedersen further teaches (Figs. 1a – 9d) wherein the proximal part (370) (see [0085] “The retainer 370 is fixedly attached relative to the main housing section 300 by means of snap arms 376.”) is axially fixed relative to the assembly (310, 330) such that the first inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the left arm 374 is the first inwardly extending ledge) and the second inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the right arm 374 is the second inwardly extending ledge) each only move radially outward and radially inwardly as the assembly moves axially in the proximal direction (see the movement shown in Figs. 2a – 6b where the proximal part 370 is axially fixed and does not move based on the snap arms fixedly attaching the proximal part 370 to the main housing section 300).
With regards to claim 20, the notification mechanism of Pedersen and Bollenbach teaches the claimed invention of claim 1, and Pedersen further teaches (Figs. 1a – 9d) drive spring (330) (see [0085] and [0086]) causes the relative axial movement between the assembly (310, 330) and the proximal part (370) (see Figs. 2a – 6b).
With regards to claim 21, Pedersen discloses (Figs. 1a – 9d) a medicament delivery device (100) (see [0070]) comprising:
an outer housing (300) (see [0070]) having a longitudinal axis; and
a notification mechanism (see [0090]) comprising:
a proximal part (370) (see [0085]) having a central opening (see at 374 and 375 in Fig. 2b) and a first inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the left arm 374 is the first inwardly extending ledge) and a second inwardly extending ledge (375) (see [0086] “The small set of arms 374 has minor protrusions 375.” Where the protrusion 375 on the right arm 374 is the second inwardly extending ledge) that each project radially into the central opening (see Fig. 2b), wherein the first inwardly extending ledge and the second inwardly extending ledge are each inclined in a proximal direction into the central opening (see Fig. 2b at 375 and [0090] wherein proximal refers to the part/end of the device which when under use is located closest to the delivery site of the user in accordance with [0009] of the Specification of the current Application); and
an assembly (310, 330) comprising:
a drive spring (330) (see [0086]) having a biased state (see Fig. 2b and [0056]) and a released state (see Fig. 5b and [0060]);
a plunger rod (310) (see [0084]) positioned within the central opening (see Fig. 2b); and
a plurality of signal initiating elements (315) (see [0090]) projecting along the longitudinal axis (see at 315 in Fig. 2b),
wherein engagement of the first inwardly extending ledge with the assembly and the second inwardly extending ledge with the assembly during relative axial movement between the assembly and the proximal part produces a tactile or audible signal notification to a user of the medicament delivery device during medicament delivery (see [0090], [0106], and the movement of between the assembly 310, 330 and the proximal part 370 shown in Figs. 2a – 6b and
wherein the first inwardly extending ledge is axially aligned with the second inwardly extending ledge (see [0086] “The small set of arms 374 has minor protrusions 375.” see Fig. 2b which shows the axial alignment of the protrusions 375).
However Pedersen is silent with regards to:
wherein the plurality of signal initiating elements are circumferentially positioned around an entire circumference of the plunger rod.
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 notification mechanism of the medicament device of Pedersen in view of a teaching of Bollenbach such that the plurality of signal initiating elements are circumferentially positioned around an entire circumference of the plunger rod. One of ordinary skill in the art would have been motivated to make this modification because Bollenbach teaches that annular projections can be used to create the signal unit to signal different movements of the mechanism of the injection device (see [0020] of Bollenbach). It would also have been an obvious matter of design choice to modify the shape of the plurality of signal initiating elements of the notification mechanism of Pedersen in view of Bollenbach such that wherein the plurality of signal initiating elements are circumferentially positioned around an entire circumference of the plunger rod, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966); MPEP 2144.04(IV)(B).
Claim(s) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen and Bollenbach as applied to claim 1 above, and further in view of Atterbury et al. (US 2017/0354779 A1 hereinafter referred to as “Atterbury”).
Atterbury is cited in the Notice of References Cited form dated November 25, 2024.
With regards to claim 8, the notification mechanism of Pedersen and Bollenbach teaches the claimed invention of claim 1, however, Pedersen is silent with regards to wherein the plurality of signal initiating elements are each equally spaced to provide a constant notification frequency of the tactile or audible signal notification.
Nonetheless Atterbury, which is within the analogous art of injection devices with notification mechanisms (see abstract), teaches (Figs. 2 - 4) the plurality of signal initiating elements (90a, 90b, 90c, 90d, 90e, 90f, 90g, 90h, 90i, and 90j; see [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 each equally spaced to provide a constant notification frequency of the tactile or audible signal notification (see [0045] – [0046] “the axial spacing between the sound elements 90 could be used solely for changing speeds of the plunger element 62 in that the clicks from 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 spacing of the plurality of signal initiating of the notification mechanism of Pedersen and Bollenbach in view of a teaching of Atterbury such that the plurality of signal initiating elements are each equally spaced to provide a constant notification frequency of the tactile or audible signal notification. One of ordinary skill in the art would have been motivated to make this modification because Atterbury teaches the audible noises or signals produced by the sound elements may be designed to produce a variety of patterns, which patterns may involve the time intervals between successive sounds and/or the intensity of the sounds and/or type of the sounds. These patterns can alert the user that the medicament delivery process is nearing an end (see [0045] of Atterbury).
With regards to claim 10, the notification mechanism of Pedersen and Bollenbach teaches the claimed invention of claim 1, however, Pedersen is silent with regards to wherein the plurality of signal initiating elements are each variably spaced to provide a variable notification frequency of the tactile or audible signal notification, and wherein the variable notification frequency provides notice to the user that a medicament delivery sequence is progressing.
Nonetheless Atterbury, which is within the analogous art of injection devices with notification mechanisms (see abstract), teaches (Figs. 2 - 4) the plurality of signal initiating elements (90a, 90b, 90c, 90d, 90e, 90f, 90g, 90h, 90i, and 90j; see [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 each variably spaced to provide a variable notification frequency of the tactile or audible signal notification, and wherein the variable notification frequency provides notice to the user that a medicament delivery sequence is progressing (see [0045] “The embodiment shown in FIGS. 2 and 3 uses sound elements 90 to provide a clicking sound throughout the forcing of medication from syringe 50 by movement of plunger element 62, which clicking sounds, after the first sound associated with sound element 90a, has a constant time interval for the next three sounds produced by sound elements 90b, 90c and 90d, followed by a steadily decreasing time interval for the remaining six sounds produced by sound elements 90e, 90f, 90g, 90h, 90i and 90j. This speeding up of clicking sounds as the end of injection approaches is readily explainable to a user as the nearing of an end of a process. Rather than time intervals for the last six clicks shortening as described above, the shortening time intervals for fewer such last clicks, such as one, two, three, four of five could be employed in alternate embodiments. In addition, more than the last six clicks, including up to all of the clicks, could have a shortening time interval. Or, instead of a steadily decreasing time interval for the last several clicks, the time interval for these last clicks, such as two or three clicks, could be the same, but shorter than the earlier clicks, to indicate to the user a change in the process.”).
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 notification mechanism of Pedersen and Bollenbach in view of a teaching of Atterbury such that the plurality of signal initiating elements are each variably spaced to provide a variable notification frequency of the tactile or audible signal notification, and wherein the variable notification frequency provides notice to the 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 the audible noises or signals produced by the sound elements may be designed to produce a variety of patterns, which patterns may involve the time intervals between successive sounds and/or the intensity of the sounds and/or type of the sounds. These patterns can alert the user that the medicament delivery process is nearing an end (see [0045] of Atterbury).
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
11/03/2025
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