DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendments filed 12/20/2025 have been entered.
Claims 1, 9, 10, 12, 13 and 20 have thereby been amended.
Claims 4-8 and 15-19 were withdrawn from consideration per the Election filed 09/09/2025.
Claims 1-3, 9-14 and 20 are being examined in this office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 9-11, 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over “the first exemplary device” of Bosshard (US 20070112326) in view of “the second exemplary device” of Bosshard (US 20070112326).
Regarding claim 1, the first exemplary device of Bosshard (drawn to Figs. 2a-c) discloses a syringe, comprising: a syringe body (1) defining a cavity (2) and a port in fluid communication with the cavity (port at cannula 14; para. [0055], port of reservoir 2 connected to cannula 14 is where medicament is expelled from); a movable plunger disposed within the cavity (plunger disk 3+5 driven by plunger piston 4), wherein the plunger and cavity define a volume and the port is in fluid communication with the volume (Fig. 2b: volume of medicament 13 defined by reservoir 2 and plunger element 3, exiting from port at cannula 14); a biasing member coupled to the plunge (biasing member 6 coupled to 4 and 5 of plunger), wherein the biasing member is configured to urge the plunger toward the port (Figs. 2a-c: spring 6 pushes 3 towards 14) to allow for continuous fluid delivery through the port (para. [0055], spring 6 drives the plunger to expel the syringe contents through the cannula; para. [0046] and Figs. 1a-b: spring 6 driving the delivery at a constant conveying rate Q). The first exemplary device of Bosshard, however, does not disclose a damping mechanism.
The second exemplary device of Bosshard (drawn to Figs. 3a-b) teaches the syringe assembly further comprising a damper coupled to the plunger (Fig. 3a: damper mechanism 15), and configured to control a rate of the fluid delivery (para. [0059], sentences 9-14: the damper mechanism slows the plunger displacement to control its speed). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the damping mechanism taught by the second exemplary device of Bosshard into the first exemplary device of Bosshard, in order to control the flow of the medicament from the syringe to counteract sudden movements of the spring, and to be able to deliver a dose over a longer period of time (Bosshard: para. [0059], last three sentences).
Regarding claim 2, the first exemplary device of Bosshard in view of the second exemplary device of Bosshard teaches the syringe of claim 1, as described above, wherein the biasing member comprises a spring (spring 6; para. [0054], sentence 5).
Regarding claim 9, the first exemplary device of Bosshard in view of the second exemplary device of Bosshard teaches the syringe of claim 1, wherein the damper is configured to control a velocity of the plunger relative to the syringe body (Bosshard 2nd exemplary device: para. [0059], sentences 9-14: the damper mechanism slows the plunger displacement to control its speed).
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Second Exemplary Embodiment of Bosshard
Regarding claim 10, the first exemplary device of Bosshard in view of the second exemplary device of Bosshard teaches the syringe of claim 9, as described above, wherein the damper comprises a damper channel (Fig. 3a: channel 20), wherein the damper channel permits flow from the damper to an environment (Fig. 3a: environment, chamber 18; flow from the damper volume through the bore to the environment described in para. [0059], sentences 8-9 and 14).
Regarding claim 11, the first exemplary device of Bosshard in view of the second exemplary device of Bosshard teaches the syringe of claim 10, as described above, wherein the damper channel permits a first damper flow rate at a first plunger position (the first plunger position being more distal, as depicted by the position of 17+4 in Fig. 3b) and a second damper flow rate at a second plunger position (the second plunger position being more proximal, as depicted by the position of 17+4 in Fig. 3a), wherein the second damper flow rate is greater than the first damper flow rate (para. [0059], third-to-last sentence: the speed of the plunger piston 4 decreases exponentially as it is advanced, meaning at the more distal position as depicted in Fig. 3a, the rate of the advancement of 17+4 is faster than the rate of advancement in the most distal position as depicted in Fig. 3b. As seen in Figs. 3a-b, the position of 17+4 is directly related to the volume of the damper fluid 16 in chamber 19. Therefore, if 17+4 is advancing faster at the more proximal position depicted in Fig. 3a, the rate of the damper fluid flowing out of chamber 19 must also be faster than the rate of its flow in Fig. 3b where the rate of 17+4 advancing is also reduced).
Regarding claim 14, the first exemplary device of Bosshard in view of the second exemplary device of Bosshard teaches the syringe of claim 1, as described above, further comprising a locking member releasably attached to the plunger and the syringe body (Figs. 2a-c: locking member 7+8 engages with/releases from notch of piston 4 of the plunger), wherein the locking member is configured to prevent movement of the plunger relative to the syringe body (Fig. 2a: locking member 7+8 engages with notch of piston 4 to prevent advancement of plunger; para. [0054], sentences 6 and 8).
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First Exemplary Embodiment of Bosshard with Locking Mechanism
Regarding claim 20, the first exemplary device of Bosshard discloses a syringe, comprising: a syringe body (1) defining a cavity (2) and a port in fluid communication with the cavity (port at cannula 14; para. [0055], port of reservoir 2 connected to cannula 14 is where medicament is expelled from); a movable plunger disposed within the cavity (plunger disk 3+5 driven by plunger piston 4), wherein the plunger and cavity define a volume and the port is in fluid communication with the volume (Fig. 2b: volume of medicament 13 defined by reservoir 2 and plunger element 3, exiting from port at cannula 14); a biasing member coupled to the plunger (biasing member 6 coupled to 4 and 5 of plunger), wherein the biasing member is configured to exert a biasing force on the plunger to advance the plunger toward the port (Figs. 2a-c: spring 6 pushes 3 towards 14; para. [0055], spring 6 drives the plunger to expel the syringe contents through the cannula). The first exemplary device of Bosshard, however, does not disclose a damping mechanism.
The second exemplary device of Bosshard (drawn to Figs. 3a-b) teaches the syringe assembly comprising a damper coupled to the plunger (Fig. 3a: damper mechanism 15), and configured to exert a damping force on the plunger (para. [0059], sentences 9-14: the damper mechanism slows the plunger displacement to control its speed), wherein the basing member and the damper cooperatively provide a constant velocity for the plunger even when the biasing force and the damping force are non-linear (para. [0020], sentence 1; claim 10). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the damping mechanism taught by the second exemplary device of Bosshard into the first exemplary device of Bosshard, in order to control the flow of the medicament from the syringe to counteract sudden movements of the spring, to make the delivery rate constant as is ideal, and to be able to deliver a dose over a longer period of time (Bosshard: para. [0059], last three sentences).
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over “the first exemplary device” of Bosshard (US 20070112326) in view of “the second exemplary device” of Bosshard (US 20070112326) in further view of Niklaus (US 20140364808).
Regarding claim 3, the first exemplary device of Bosshard in view of the second exemplary device of Bosshard teaches the syringe of claim 2, as described above, an although the spring appears to be a helical spring, Bosshard fails to explicitly disclose the biasing member as a helical spring.
Niklaus teaches an analogous syringe assembly with a biasing spring, wherein the spring comprises a helical spring (Niklaus: spring 32; para. [0037], sentence 1). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the biasing spring in the first exemplary device of Bosshard by incorporating the helical spring shape taught by Niklaus, in order to best fit and apply an even force to the cylindrically shaped elements of the syringe and plunger assembly.
Regarding claim 13, the first exemplary device of Bosshard in view of the second exemplary device of Bosshard teaches the syringe of claim 1, as described above, but fails to disclose a flow controller connected to the port of the syringe.
Niklaus teaches an analogous syringe assembly with a biasing spring, further comprising a flow controller (dosing unit 60) in fluid communication with the port (Fig. 3(a): dosing unit 60 in fluid communication with port at 13), wherein the flow controller restricts the rate of the fluid delivery (Fig. 3a: 60 restricts the rate of fluid delivery because only a certain amount from 10 may pass through it at a given time; para. [0046]; para. [0047], sentences 1-3). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the syringe assembly of the first exemplary device of Bosshard by incorporating the flow controller/dosing unit taught by Niklaus, in order to deliver a more exactly measured dose to a patient, and to be able to vary those doses (Niklaus: para. [0006], second-to-last sentence).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over “the first exemplary device” of Bosshard (US 20070112326) in view of “the second exemplary device” of Bosshard (US 20070112326) in further view of “the third exemplary device” of Bosshard (US 20070112326).
Regarding claim 12, the first exemplary device of Bosshard in view of the second exemplary device of Bosshard teaches the syringe of claim 9, as described above, but fails to teach the dampening caused by a change in diameter of the cavity walls.
The third exemplary device of Bosshard (drawn to Figs. 4a-b) teaches the syringe assembly with another damping mechanism wherein the damper comprises a cavity wall (Figs. 4a-b: walls of damper cylinder 15 around cavities 19 and 18) and the cavity wall has a first diameter (Fig. 4a: wall of 15 to the left of sloped point 21 with smaller diameter) that applies a first damping force at a first plunger position (Fig. 4a: wall with first diameter contacting and applying force to 17) and a second diameter (Fig. 4a: wall of 15 to the right of sloped point 21 with larger diameter) that applies a second damping force at a second plunger position (Fig. 4b: wall with second diameter no longer contacting and applying force to 17), wherein the first damping force is greater than the second damping force (para. [0060], third-to-last sentence, the damping force greatly reduced or even eliminated at the second, more distal position in Fig. 4b). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the damping mechanism of the first exemplary device of Bosshard in view of the second exemplary device of Bosshard by incorporating the change in diameter of the cavity walls taught by the third exemplary device of Bosshard in order to dampen and control the driving of the plunger from the syringe in a more simple manner while avoiding long periods of resetting the damping mechanism for the next delivery as required by the second exemplary device using the bore dampening (para. [0059], sentences 14-17).
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Third Exemplary Embodiment of Bosshard
Response to Arguments
Applicant's arguments filed 12/20/2025 regarding the prior art rejection of independent claims 1 and 20 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant’s argues that Bosshard fails to teach the biasing member coupled to the plunger and the referenced damper is not configured to control a rate of the fluid delivery. Examiner maintains that referenced biasing member 6 is coupled to the plunger and urges it towards the port, as is clearly seen in Figs. 2a-c, referenced in the rejection above. Additionally, Applicant argues that damper 15 “is not configured to control a rate of the fluid deliver.” However, by nature of the channel 20 of this damper mechanism in which the fluid is forced through the narrow channel, the rate at which the plunger is advanced is altered, providing the “dampening” quality disclosed and referenced in the above rejections. Such “dampening,” being the deceleration of the plunger at given distances along its path, does in fact read on the limitation of a controlled rate of the fluid delivery. This dampening mechanism via the channel 20 may be integrated into the plunger of the syringe body itself, as described.
For these reasons, Examiner maintains the rejections of independent claims 1 and 20, and their depending claims, as recited above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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