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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/04/2025 has been entered.
Response to Amendment
Applicant has amended claims 1 and 17; claims 1-38 remain pending with claims 6-14, 22-30, and 33-38 withdrawn.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) and 365(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, US provisional application PRO 62916815 and foreign priority document IL 267610, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Priority documents filed in this application, which are the US provisional application PRO 62916815 and foreign priority document IL 267610 do not disclose an element configured to undergo a corresponding element motion linked to a distal displacement of the plunger rod as claimed in claims 1 and 17 of the instant application.
Thus, claims 1-32 (which include withdrawn claims) receive an effective filing date of 06/24/2020 for their proper support in the PCT application in the instant application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the Specification must provide antecedent basis for the newly recited claim term of “at least one marker” on the rotor head. The Specification currently only provides for the sensor measuring the rotation of disc apertures, and while it does say that the sensor may be configured to detect a different property “such as a magnetic change, a capacitance change, an inductance change, an impedance change, an acoustic change, a mechanical detection of rotor head apertures 143, and the like”, these alternatives are not shown in the figures or explained with any particular markers.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5 and 21 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 5 and 21 are considered to require new matter as it appears as though the claims first require markers on the rotor head (which, as shown in the Drawings, are apertures) in the respective independent claims and then additionally require separate apertures on the rotor head. This is considered new matter because Applicant’s disclosure does not disclose the use of markers which are not apertures in addition to separate apertures where the sensor is configured to measure the sequential passage of both the markers and apertures, but rather only apertures. Examiner notes that the claim term “at least one marker” is not considered new matter as an aperture could be a marker and there is support for apertures. See also the rejection below of claims 5 and 21 under 35 U.S.C. §112(b).
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 5 and 21 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.
Claims 5 and 21 are indefinite where they currently appear to require at least one marker of the rotor head which is separate from apertures of the rotor head, and where they appear to require that the sensor is configured to detect sequential passage of multiple elements (at least on marker and apertures) between the respective independent claims and claims 5 and 21. This is indefinite because it is unclear if the at least one marker is meant to be the apertures of claim 5 or if the elements are meant to be separate, and further because it is unclear how a single sensor would be configured to detect separate markers and apertures to determine amounts of relative rotational motion.
For the purposes of compact prosecution, Examiner has understood claims 5 and 21 to be referring to the markers of their respective independent claims and only further specify that the at least one marker in the independent claim is multiple markers, and that the markers are apertures. Appropriate correction is required.
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) 1-5, 15, 17-21, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vedrine et al. (US 20160325047, henceforth Vedrine) in view of Bengtsson et al. (US 20200230325, henceforth Bengtsson), Biondi et al. (US 20190321555, henceforth Biondi) and Plumptre (US 20130211343, henceforth Plumptre).
Regarding claim 1, Vedrine discloses an injection device (medicament delivery device 100, fig. 1) the device having a distal end (the end closer to needle hub 190 along axis L, fig. 1) and a proximal end (the end closer to knob 102 along axis L, fig. 1), the device comprising: a syringe (container 150 and needle hub 190, fig. 2, which is considered to be a syringe because the structures combine to be a device used to inject fluids into or withdraw them from something) comprising: a syringe chamber (interior of container 150 defined by interior wall 252, fig. 2) containing an injectant substance (medicament component 160a, 160b, fig. 2); a plunger (rod 110 and knob 102, see fig. 2) comprising: a plunger rod (rod 110, fig. 2) arranged along a longitudinal axis (see axis L, fig. 1) and configured to be axially displaceable within the syringe chamber ([0489] and see figs. 1 and 3); at least one rotor (the combination of knob 102 and rod 110 make up the claimed rotor) configured to undergo a corresponding rotor motion linked to a distal displacement of the plunger rod in a distal direction (knob 102 rotates as rod 110 is distally displaced as a result of operational track 120 in rod 110 as shown in fig. 2); and wherein an injection is performed by depressing the plunger rod in a distal direction ([0527]), compelling a corresponding rotor motion of the rotor (see [0529], [0531], [0534], knob 102 rotates in a clockwise direction as rod 110 translates distally during the injection process); wherein the rotor is configured to rotate about said longitudinal axis ([0489]) in accordance with an advancement of said plunger rod in said distal direction (see [0489], [0502], and [0503]); wherein said rotor comprises a rotor rod (rod 110, fig. 1) and a rotor head (knob 102, fig. 1) at a proximal end of said rotor rod (see fig. 1, the proximal end is the end opposite needle hub 190); wherein an injection is configured to be performed by depressing the plunger rod in a distal direction (see [0503]) which is configured to compel a corresponding rotor motion (see [0503]) and further configured to compel the injectant substance to be injected through a distal end of the syringe chamber ([0533], delivery needle 398 is the distal end of the syringe chamber which the medicament flows through, see also fig. 3).
Vedrine does not disclose the injection device comprising an electronics unit, comprising at least one sensor, configured to obtain detection readings relating to the corresponding rotor motion of the rotor; wherein the corresponding rotor motion of the rotor is detected by the sensor; and wherein the detection readings relating to the corresponding rotor motion of the rotor is processed to determine injection information comprising at least the volume of injectant substance injected. Bengtsson discloses an injection device (exemplary drug delivery pen 100’, fig. 5; the chosen embodiment does not appear to be shown but includes the optical rotary encoder of [0030]-[0034]) comprising an electronics unit (electronic sensor unit of [0030]-[0034]; note that a similar electronics unit is referred to as plug unit 280’ in Bengtsson and the electronics unit of the chosen embodiment is understood to have the same functionality as the plug unit 280’ with a different sensing mechanism), comprising at least one sensor (optical sensor of [0031], which is part of a rotary encoder in the chosen embodiment), configured to obtain detection readings (measurements of [0031]) relating to a corresponding rotational motion of an element (see [0030] and [0031], rotation of a piston assembly which corresponds to movement of a piston rod is what is measured), wherein the rotational motion of the element is a sequential passage of a marker (see [0031], the rotational movement is sequential passage of reflective surfaces rotationally relative to the light source and sensor) during said rotational motion (see [0031]), where the marker is disposed on the element (see at least [0030] and [0031], the sensor and the reflective strips must be rotatably disposed relative to each other to allow the rotation to occur) rotatably with respect to the sensor ([0030] and [0031]); wherein the corresponding rotational motion of the element is detected by the sensors ([0031]); and wherein the detection readings relating to the corresponding element motion of the element is processed to determine injection information (see [0099]) comprising at least a volume of injectant substance injected ([0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added and used an electronics unit comprising a sensor which is configured to measure rotational motion of a rotating body as in Bengtsson to the injection device of Vedrine for keeping track of doses administered and transmitting data to an external device ([0096]-[0098]) as well as preventing unwanted reuse or counterfeiting ([0101]). Such an addition would need to be arranged as in Bengtsson where the added sensor and the rotating element that it is measuring are rotating relative to each other; neither Vedrine nor Bengtsson explicitly discloses such an arrangement.
Thus, Vedrine as modified requires that the sensor be in some way arranged rotatably with respect to the rotor element.
Vedrine as modified does not disclose that the rotor is disposed within the plunger rod, that the rotor is rotatable with respect to the plunger rod such that the corresponding motion is rotational, or wherein the plunger rod has a receptacle at a proximal end thereof containing said rotor head or containing the added electronics unit of Bengtsson. Biondi teaches an injection device (assembly of fig. 12) comprising a plunger (external rod, see fig. 11) which has another element disposed inside of it (internal rod, see fig. 11) where the other element is movable relative to it ([0085]) with the plunger comprising a receptacle (sensor housing as called out in fig. 3 is a receptacle where it is an opening configured for receiving and housing other elements) at a proximal end thereof (see fig. 3, the proximal end is called out) containing a proximal end of the other element (see fig. 11, the proximal end of the internal rod is inside of the receptacle at the proximal end of the external rod) and further containing an electronics unit (PCBA, sensor, and battery as in fig. 3) and a sensor thereof (see fig. 4). Biondi additionally teaches that its plunger rod and element disposed therein cooperate together to provide an end of dose indication with use of an additional sensor (see [0087] and [0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the external plunger rod of Biondi radially around the exterior of the rotor of Vedrine and also to have added cooperating elements and a contact switch to the rotor of Vedrine for providing an additional confirmation that an end of dose has occurred (see Biondi [0087] and [0088]). Thus, in the modified device, the plunger is considered to be the combination of the added external rod from Biondi and the rotor of Vedrine and the plunger rod is considered to be the external plunger rod added from Biondi, and thus the plunger rod has the rotor disposed within it as claimed where the rotor is rotatable relative to the plunger rod as claimed, and where distal displacement of the plunger rod causes the corresponding movement of the rotor and rotor rod where the corresponding movement is rotational as the rotor and rotor rod are still meant to be rotating in the modified device to maintain the integrity of the assembly and benefits of Vedrine. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have put the electronics assembly added from Bengtsson into the receptacle at the proximal end of the added external rod of Biondi as this arrangement is taught in Biondi as being the location for the sensor and electronics assembly and because such an arrangement would have allowed for the added sensing of Bengtsson to have measured the rotation of the rotor of Vedrine relative to the added external plunger rod of Biondi.
Vedrine as modified discloses that rotation of the rotor (the claimed corresponding rotor movement) comes from an engagement between a radially inwardly protruding boss of a guide element with an operational track which extends along a length of the rotor (see boss 242a and operational track 120 as shown in fig. 2 and see [0508], [0512], and [0529]).
Vedrine as modified does not explicitly disclose how the device would be arranged such that the plunger rod rotates relative to the rotor rod such as to allow the optical encoder system of Bengtsson to work when the added plunger of Biondi is arranged around the rotor. Plumptre teaches an arrangement of a medical device (assembly of fig. 1) where a plunger (drive member 8, fig. 1) is rotatably arranged with respect to an element therein (lead screw 5, see fig. 1 and see [0089] and [0091]), with the arrangement comprising use of a longitudinal groove on the plunger rod (axial groove in the outer surface of drive member 8, [0091]) mating with a protrusion on a device housing (protruding elements of body 1, [0091]) such as to rotationally lock the plunger with respect to the device housing ([0091]) while allowing the internal element to rotate ([0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the groove of Plumptre to the plunger of Vedrine as modified such as to arrange the plunger and rotor of Vedrine as modified to rotate similarly to the arrangement of Plumptre as Plumptre teaches this arrangement as an art effective means of ensuring that rotational movements of relative device elements occur while preventing unneeded and/or unwanted rotational elements (see at least Plumptre [0091]), and further to have used the boss 242a of Vedrine as the protrusion which works on the housing as it already functions to provide desired rotational engagement with the rotor rod (see at least Vedrine [0529]). Such a modification would then mean that, in order to maintain the design of Vedrine as modified where a radially inwardly protruding boss of a guide element engages with an operational track of the rotor rod which extends along a length of the rotor rod (see boss 242a and operational track 120 as shown in fig. 2 and see [0508], [0512], and [0529]), the added groove from Plumptre onto the plunger would have to also allow the boss of the guide element of Vedrine to still mate with the operational track 120 of Vedrine by having the added groove extend all the way through the radial thickness of the wall of the plunger rod (which is the added external rod from Biondi) such as to allow the boss 242a of the guide element 140 of Vedrine to be able to pass through the added groove and engage with the operational track 120 of the rotor rod within the plunger rod.
Vedrine as modified thus discloses that the rotor is rotatably arranged relative to the sensor (see at least the modifications made with respect to Bengtsson) and that the sensor is configured such that this relative rotational movement is measured (see at least the modifications made with respect to Bengtsson above). Vedrine as modified additionally discloses that the rotor and sensor are rotatably disposed relative to each other where the sensor does not rotate relative to the plunger rod or the needle of the device (see modifications above with respect to Biondi and Plumptre).
Vedrine as modified does not explicitly disclose the device wherein said rotor head comprises at least one marker and wherein said at least one sensor is configured to detect a sequential passage of said at least one marker during said rotational motion of said rotor. However, Bengtsson teaches that its sensor is configured to determine sequential passage of at least one marker (see at least [0031]) during rotational motion of said at least one marker relative to the sensor ([0031]). Bengtsson additionally teaches that the placement of the sensor and markers is reversible as desired so long as they are rotationally mounted relative to each other ([0031]) and that the markers can be arranged on a flat surface at a single axial position which simply moves rotationally relative to the sensor (see [0120] and the arrangement of fig. 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added markers to the rotor of Vedrine for the sensor to measure the sequential rotational passage of as Bengtsson teaches this to be an art effective arrangement of measuring relative rotation with a rotary optical sensor (see at least Bengtsson [0031] and [0120] and note that the rotor and sensor of Vedrine as modified are configured similarly to the first and second plug members of fig. 15 in the modified device, see at least the modifications made with respect to Biondi and Plumptre).
Regarding claim 2, Vedrine as modified discloses the injection device wherein the rotor rod (rod 110, fig. 2) is disposed concentrically within the plunger rod (see rejection of claim 1 above, rod 110 of Vedrine is disposed concentrically within the added external plunger rod of Biondi in the modified device); and wherein the rotor head is configured to rotate in accordance with a distal advancement of the plunger rod (see [0529], [0531], [0534], knob 102 rotates in a clockwise direction as rod 110 translates distally during the injection process), such that the corresponding rotor motion is a rotational motion of the rotor head (see [0529], [0531], [0534]), and wherein the sensor is configured to detect the rotational motion of the rotor head (see Bengtsson [0030]-[0034], rotational movement is detected via an encoder assembly to keep track of administered doses; since there is only one rotational movement in the device of Vedrine which is the rotation of knob 102 and rod 110 relative to housing 170 and the added external plunger rod of Biondi, the measured rotation is the rotational movement of knob 102).
Regarding claim 3, Vedrine as modified discloses the injection device wherein the rotor rod comprises a helical screw thread (operational track 120, fig. 2), and wherein the injection device further comprises at least one guiding pin (boss 242a, figs. 2 and 10) configured to engage the screw thread (see [0529]) so as to turn the rotor rod ([0529], [0539]), producing the rotational motion of the rotor head ([0529], [0539]).
Regarding claim 4, Vedrine as modified discloses the injection device wherein the guiding pin is disposed on a ring element (plunger rod guide 140, which is a ring element as shown in fig. 10) configured to be at least partially encircling the plunger rod (see fig. 3, plunger rod guide 140 is shown as encircling rod 110 which is a part of the plunger rod in the modified device), the guiding pin extending radially inward from the ring element (see fig. 10), and wherein the guiding pin engages the screw thread ([0529]) through a plunger rod slot extending axially along the plunger rod (see the added longitudinally extending groove from Plumptre in the rejection of claim 1 which provides for a rotational locking of the added external rod from Biondi to device housing 170 of Vedrine in the modified device) such that the guiding pin is restricted to linear axial motion with respect to the plunger rod by the plunger rod slot, preventing rotation of the ring element with respect to the plunger rod (see [0512], fig. 2, and the rejection of claim 1; boss 242a would only be able to move axially with respect to the added longitudinally extending groove on the external plunger rod when the modified device is assembled).
Regarding claim 5, Vedrine as modified discloses the injection device wherein the rotor head comprises a plurality of rotor head apertures (see modifications made in the rejection of claim 1 above, the reflective surfaces of Bengtsson which are added to the rotor head of Vedrine as modified are considered to have openings, or gaps, between them which are apertures where they are separated), and wherein the sensor is configured to detect a sequential passage of the rotor head apertures during rotational motion of the rotor head (see rejection of claim 1 above, this is the modification made where the sensor of Bengtsson is added, see at least Bengtsson [0031], and note that if the reflective surfaces are being measured, then the spaces between them are also being measured such as to provide reference points for the optical rotary sensor to know that rotational motion is occurring).
Regarding claim 15, Vedrine as modified discloses the injection device wherein the electronics unit further comprises a transmitting antenna (see [0097], the electronic sensor unit uses wireless communication to transfer data; this means that it must have some kind of transceiver which is responsible for this communication, with that transceiver being a transmitting antenna since it would be a device for radiating or receiving radio waves) which is configured to transmit the detection readings to a remote location (see [0097], the data from the electronic sensor unit is sent to a remote location which is a smartphone).
Regarding claim 17, Vedrine discloses a method for completing an injection ([0526]), the method comprising the procedures of: providing an injection device (medicament delivery device 100, fig. 1), the device having a distal end (medicament delivery device 100, fig. 1) and a proximal end (medicament delivery device 100, fig. 1), the device comprising: a syringe (container 150 and needle hub 190, fig. 2, which is considered to be a syringe because the structures combine to be a device used to inject fluids into or withdraw them from something) comprising: a syringe chamber (interior of container 150 defined by interior wall 252, fig. 2) containing an injectant substance (medicament component 160a, 160b, fig. 2); a plunger (combination of device housing 170, rod 110, and knob 102, see fig. 2) comprising: a plunger rod (rod 110 and housing 170, fig. 2) arranged along a longitudinal axis (see axis L, fig. 1) and configured to be axially displaceable within the syringe chamber ([0489] and see figs. 1 and 3); at least one rotor (the combination of knob 102 and rod 110 make up the claimed rotor), configured to undergo a corresponding rotor motion linked to a distal displacement of the plunger rod (knob 102 rotates as rod 110 is distally displaced as a result of operational track 120 in rod 110 as shown in fig. 2); performing an injection by depressing the plunger rod in said distal direction ([0527]) and thereby rotating said rotor (see [0529], [0531], [0534], knob 102 rotates in a clockwise direction as rod 110 translates distally during the injection process), and compelling the injectant substance to be injected through a distal end of the syringe chamber ([0533], delivery needle 398 is the distal end of the syringe chamber which the medicament flows through, see also fig. 3).
Vedrine does not disclose the injection device comprising an electronics unit, comprising at least one sensor, configured to obtain detection readings relating to the corresponding rotor motion of the rotor; wherein the corresponding rotor motion of the rotor is detected by the sensor; and wherein the detection readings relating to the corresponding rotor motion of the rotor is processed to determine injection information comprising at least the volume of injectant substance injected. Bengtsson discloses an injection device (exemplary drug delivery pen 100’, fig. 5; the chosen embodiment does not appear to be shown but includes the optical rotary encoder of [0030]-[0034]) comprising an electronics unit (electronic sensor unit of [0030]-[0034]; note that a similar electronics unit is referred to as plug unit 280’ in Bengtsson and the electronics unit of the chosen embodiment is understood to have the same functionality as the plug unit 280’ with a different sensing mechanism), comprising at least one sensor (optical sensor of [0031], which is part of a rotary encoder in the chosen embodiment), configured to obtain detection readings (measurements of [0031]) relating to a corresponding rotational motion of an element (see [0030] and [0031], rotation of a piston assembly which corresponds to movement of a piston rod is what is measured), wherein the rotational motion of the element is a sequential passage of a marker (see [0031], the rotational movement is sequential passage of reflective surfaces rotationally relative to the light source and sensor) during said rotational motion (see [0031]), where the marker is disposed on the element (see at least [0030] and [0031], the sensor and the reflective strips must be rotatably disposed relative to each other to allow the rotation to occur) rotatably with respect to the sensor ([0030] and [0031]); wherein the corresponding rotational motion of the element is detected by the sensors ([0031]); and wherein the detection readings relating to the corresponding element motion of the element is processed to determine injection information (see [0099]) comprising at least a volume of injectant substance injected ([0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added and used an electronics unit comprising a sensor which is configured to measure rotational motion of a rotating body as in Bengtsson to the injection device of Vedrine for keeping track of doses administered and transmitting data to an external device ([0096]-[0098]) as well as preventing unwanted reuse or counterfeiting ([0101]). Such an addition would need to be arranged as in Bengtsson where the added sensor and the rotating element that it is measuring are rotating relative to each other; neither Vedrine nor Bengtsson explicitly discloses such an arrangement.
Thus, Vedrine as modified requires that the sensor be in some way arranged rotatably with respect to the rotor element.
Vedrine as modified does not disclose that the rotor is disposed within the plunger rod, that the rotor is rotatable with respect to the plunger rod such that the corresponding motion is rotational, or wherein the plunger rod has a receptacle at a proximal end thereof containing said rotor head or containing the added electronics unit of Bengtsson. Biondi teaches an injection device (assembly of fig. 12) comprising a plunger (external rod, see fig. 11) which has another element disposed inside of it (internal rod, see fig. 11) where the other element is movable relative to it ([0085]) with the plunger comprising a receptacle (sensor housing as called out in fig. 3 is a receptacle where it is an opening configured for receiving and housing other elements) at a proximal end thereof (see fig. 3, the proximal end is called out) containing a proximal end of the other element (see fig. 11, the proximal end of the internal rod is inside of the receptacle at the proximal end of the external rod) and further containing an electronics unit (PCBA, sensor, and battery as in fig. 3) and a sensor thereof (see fig. 4). Biondi additionally teaches that its plunger rod and element disposed therein cooperate together to provide an end of dose indication with use of an additional sensor (see [0087] and [0088]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the external plunger rod of Biondi radially around the exterior of the rotor of Vedrine and also to have added cooperating elements and a contact switch to the rotor of Vedrine for providing an additional confirmation that an end of dose has occurred (see Biondi [0087] and [0088]). Thus, in the modified device, the plunger is considered to be the combination of the added external rod from Biondi and the rotor of Vedrine and the plunger rod is considered to be the external plunger rod added from Biondi, and thus the plunger rod has the rotor disposed within it as claimed where the rotor is rotatable relative to the plunger rod as claimed, and where distal displacement of the plunger rod causes the corresponding movement of the rotor and rotor rod where the corresponding movement is rotational as the rotor and rotor rod are still meant to be rotating in the modified device to maintain the integrity of the assembly and benefits of Vedrine. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have put the electronics assembly added from Bengtsson into the receptacle at the proximal end of the added external rod of Biondi as this arrangement is taught in Biondi as being the location for the sensor and electronics assembly and because such an arrangement would have allowed for the added sensing of Bengtsson to have measured the rotation of the rotor of Vedrine relative to the added external plunger rod of Biondi.
Vedrine as modified discloses that rotation of the rotor (the claimed corresponding rotor movement) comes from an engagement between a radially inwardly protruding boss of a guide element with an operational track which extends along a length of the rotor (see boss 242a and operational track 120 as shown in fig. 2 and see [0508], [0512], and [0529]).
Vedrine as modified does not explicitly disclose how the device would be arranged such that the plunger rod rotates relative to the rotor rod such as to allow the optical encoder system of Bengtsson to work when the added plunger of Biondi is arranged around the rotor. Plumptre teaches an arrangement of a medical device (assembly of fig. 1) where a plunger (drive member 8, fig. 1) is rotatably arranged with respect to an element therein (lead screw 5, see fig. 1 and see [0089] and [0091]), with the arrangement comprising use of a longitudinal groove on the plunger rod (axial groove in the outer surface of drive member 8, [0091]) mating with a protrusion on a device housing (protruding elements of body 1, [0091]) such as to rotationally lock the plunger with respect to the device housing ([0091]) while allowing the internal element to rotate ([0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the groove of Plumptre to the plunger of Vedrine as modified such as to arrange the plunger and rotor of Vedrine as modified to rotate similarly to the arrangement of Plumptre as Plumptre teaches this arrangement as an art effective means of ensuring that rotational movements of relative device elements occur while preventing unneeded and/or unwanted rotational elements (see at least Plumptre [0091]), and further to have used the boss 242a of Vedrine as the protrusion which works on the housing as it already functions to provide desired rotational engagement with the rotor rod (see at least Vedrine [0529]). Such a modification would then mean that, in order to maintain the design of Vedrine as modified where a radially inwardly protruding boss of a guide element engages with an operational track of the rotor rod which extends along a length of the rotor rod (see boss 242a and operational track 120 as shown in fig. 2 and see [0508], [0512], and [0529]), the added groove from Plumptre onto the plunger would have to also allow the boss of the guide element of Vedrine to still mate with the operational track 120 of Vedrine by having the added groove extend all the way through the radial thickness of the wall of the plunger rod (which is the added external rod from Biondi) such as to allow the boss 242a of the guide element 140 of Vedrine to be able to pass through the added groove and engage with the operational track 120 of the rotor rod within the plunger rod.
Vedrine as modified thus discloses that the rotor is rotatably arranged relative to the sensor (see at least the modifications made with respect to Bengtsson) and that the sensor is configured such that this relative rotational movement is measured (see at least the modifications made with respect to Bengtsson above). Vedrine as modified additionally discloses that the rotor and sensor are rotatably disposed relative to each other where the sensor does not rotate relative to the plunger rod or the needle of the device (see modifications above with respect to Biondi and Plumptre).
Vedrine as modified does not explicitly disclose the device wherein said rotor head comprises at least one marker and wherein said at least one sensor is configured to detect a sequential passage of said at least one marker during said rotational motion of said rotor. However, Bengtsson teaches that its sensor is configured to determine sequential passage of at least one marker (see at least [0031]) during rotational motion of said at least one marker relative to the sensor ([0031]). Bengtsson additionally teaches that the placement of the sensor and markers is reversible as desired so long as they are rotationally mounted relative to each other ([0031]) and that the markers can be arranged on a flat surface at a single axial position which simply moves rotationally relative to the sensor (see [0120] and the arrangement of fig. 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added markers to the rotor of Vedrine for the sensor to measure the sequential rotational passage of as Bengtsson teaches this to be an art effective arrangement of measuring relative rotation with a rotary optical sensor (see at least Bengtsson [0031] and [0120] and note that the rotor and sensor of Vedrine as modified are configured similarly to the first and second plug members of fig. 15 in the modified device, see at least the modifications made with respect to Biondi and Plumptre).
Regarding claim 18, Vedrine as modified discloses the method wherein the rotor comprises a rotor rod (rod 110, fig. 2), concentrically disposed within the plunger rod (see rejection of claim 1 above, rod 110 of Vedrine is disposed concentrically within the added external plunger rod of Biondi in the modified device), the rotor further comprising a rotor head (knob 102, fig. 2), at a proximal end of the rotor rod (see fig. 2), wherein the rotor head is configured to rotate in accordance with a distal advancement of the plunger rod (see [0529], [0531], [0534], knob 102 rotates in a clockwise direction as rod 110 translates distally during the injection process), such that the corresponding rotor motion is a rotational motion of the rotor head (see [0529], [0531], [0534]), and wherein the sensor is configured to detect the rotational motion of the rotor head (see Bengtsson [0030]-[0034], rotational movement is detected via an encoder assembly to keep track of administered doses; since there is only one rotational movement in the device of Vedrine which is the rotation of knob 102 and rod 110 relative to housing 170 and the added external plunger rod of Biondi, the measured rotation is the rotational movement of knob 102).
Regarding claim 19, Vedrine as modified discloses the method wherein the rotor rod comprises a helical screw thread (operational track 120, fig. 2), and wherein the injection device further comprises at least one guiding pin (boss 242a, figs. 2 and 10), configured to engage the screw thread (see [0529]) so as to turn the rotor rod ([0529], [0539]), producing the rotational motion of the rotor head ([0529], [0539]).
Regarding claim 20, Vedrine as modified discloses the method wherein the guiding pin is disposed on a ring element (plunger rod guide 140, which is a ring element as shown in fig. 10) configured to be at least partially encircling the plunger rod (see fig. 3, plunger rod guide 140 is shown as encircling rod 110), the guiding pin extending radially inward from the ring element (see fig. 10), and wherein the guiding pin engages the screw thread ([0529]) through a plunger rod slot extending axially along the plunger rod (see the added longitudinally extending groove from Plumptre in the rejection of claim 1 which provides for a rotational locking of the added external rod from Biondi to device housing 170 of Vedrine in the modified device) such that the guiding pin is restricted to linear axial motion with respect to the plunger rod by the plunger rod slot, preventing rotation of the ring element with respect to the plunger rod (see [0512], fig. 2, and the rejection of claim 1; boss 242a would only be able to move axially with respect to the added longitudinally extending groove on the external plunger rod when the modified device is assembled).
Regarding claim 21, Vedrine as modified discloses the method wherein the rotor head comprises a plurality of rotor head apertures (see modifications made in the rejection of claim 17 above, the reflective surfaces of Bengtsson which are added to the rotor head of Vedrine as modified are considered to have openings, or gaps, between them which are apertures where they are separated), and wherein the sensor is configured to detect a sequential passage of the rotor head apertures during rotational motion of the rotor head (see rejection of claim 17 above, this is the modification made where the sensor of Bengtsson is added, see at least Bengtsson [0031], and note that if the reflective surfaces are being measured, then the spaces between them are also being measured such as to provide reference points for the optical rotary sensor to know that rotational motion is occurring).
Regarding claim 31, Vedrine as modified discloses the method further comprising the procedure of transmitting the detection readings to a remote location (see [0097], the data from the electronic sensor unit is sent to a remote location which is a smartphone) with a transmitting antenna of the electronics unit (see [0097], the electronic sensor unit uses wireless communication to transfer data; this means that it must have some kind of transceiver which is responsible for this communication, with that transceiver being a transmitting antenna since it would be a device for radiating or receiving radio waves).
Claim(s) 16 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vedrine et al. (US 20160325047, henceforth Vedrine) in view of Bengtsson et al. (US 20200230325, henceforth Bengtsson), Biondi et al. (US 20190321555, henceforth Biondi), and Plumptre (US 20130211343, henceforth Plumptre) as applied to claims 1 and 17 above, respectively, and further in view of Gilmore et al. (US 20140142511, henceforth Gilmore).
Regarding claims 16 and 32, Vedrine as modified discloses the injection device comprising an electronics unit (see rejection of claims 1 and 17 above regarding the electronics unit of Bengtsson) which detects injection information comprising at least the volume of injectant substance injected (see Bengtsson [0099] and rejection of claims 1 and 17 above).
Vedrine as modified does not disclose the injection device wherein the electronics unit further comprises an indicator which is configured to provide an indication of at least one injection state relating to the injection. Gilmore teaches an injection device (drug delivery deice 100, fig. 1) comprising an electronics unit (electrical circuitry 200, fig. 2) comprising an indicator (display 112, fig. 1, see [0041], [0051], and [0053]) configured to provide an indication of at least one injection state relating to the injection (see [0053], the injection state is a drug dose delivered).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the indicator of Gilmore to the modified device of Vedrine and to have used the indicator to provide the drug dose delivered for the benefit of directly providing the user with information and for being able to provide warning signs as needed (Gilmore [0053]).
Response to Arguments
Applicant's arguments filed 12/04/2025 have been fully considered but they are not persuasive.
Applicant has argued that Vedrine as modified does not disclose the newly claimed arrangement of the at least one marker and sensor. Examiner respectfully disagrees. As called out in the rejection above, in the modified device, the sensor and reflective surface arrangement of Bengtsson is relied upon where the markers are disposed at a single axial position rotating relative to the sensor; this arrangement is provided in Vedrine as modified where the sensor and rotor head rotate relative to each other and where the rotor head has a single flat surface at its interior which faces the sensor similar to the arrangement shown in Bengtsson fig. 15. It would have been obvious to a skilled artisan relying on the sensor of Bengtsson in the modified device to have arranged the sensor and reflective markings in the same manner as was disclosed in Bengtsson.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783