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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the finger stop must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim16-18 are objected to because of the following informalities: “ore” should read as “ore,” and “from from” should read as “from”. Additionally, claims 17 and 18 should be included in the objection because any claims that depend on an objected claim inherit the problems of their parent claims.
Appropriate correction is required.
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 8-19 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 8 recites the limitations "the first face of the disk-shaped circuit board.” There is insufficient antecedent basis for this limitation in the claim as the disk-shaped circuit board and its first face are only previously recited in claim 7, but not in claim 3 from which claim 8 depends upon.
Claim 12 recites the limitation "the disk-shaped base.” There is insufficient antecedent basis for this limitation in the claim as the disk-shaped base is only previously recited in claim 8 but not in claim 3 from which claim 12 depends upon.
Claim 16 recites the limitation "curled lip.” There is insufficient antecedent basis for this limitation in the claim as the curled lip is only previously recited in claim 15, from which claim 16 does not depend upon.
Claim 19 recites the limitation "the central longitudinal axis.” There is insufficient antecedent basis for this limitation in the claim as a central longitudinal axis is not recited or defined in claim 1, from which claim 19 depends upon.
Additionally, claims 9-11, 13-15 and 17-18 should be included in the rejection because any claims that depend on a rejected claim inherit the problems of their parent claims.
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 1-4, 6, 12-16 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Despa (US 20200289751) in view of Yu (20190038840).
Regarding claim 1, Despa discloses injection endpoint signalling device (Fig. 3A: 101A), adapted and configured to be mounted onto a pre-filled syringe (Fig. 3A: 101A mounted on syringe; para. [0006], sentence 1; para. [0039]), the pre- filled syringe comprising a post-injection needle shroud (Fig. 3A: 120), the needle shroud being configured to translate from a first position in which the shroud is retracted and the needle of the pre-filled syringe is exposed (Fig. 3B depicting this first position), to a second position in which the shroud is extended and the needle of the pre-filled syringe is completely surrounded by the shroud (para. [0050], sentences 2-3 and 6, deployment of shield 120 past the needle), wherein: the injection endpoint signalling device (101A) comprises a wireless injection endpoint signalling system (para. [0061]) comprising a communications circuit (para. [0061], short-distance RF) and an activation switch (Fig. 5: 148); and when mounted on the pre-filled syringe: in the first, shroud-retracted position, the activation switch maintains the circuit in an inactive state in which said circuit is off (Fig. 5: 148 is in the off position when 120 is in retracted position), and in which an injection endpoint information is inaccessible to the circuit (para. [0068], the information is supplied by the switch when it is activated); and in the second, shroud-extended position, the activation switch maintains the NFC circuit in an active state in which said circuit is on (Fig. 6: 148 is in the on position when 120 is in extended position), and in which the injection endpoint information is accessible to the circuit (para. [0068], the information is supplied by the switch when it is activated); wherein the activation switch is moved from the inactive state to the active state via mutually cooperating surface engagement between a part of the shroud and the activation switch (Figs. 5 and 6: arched portion of 120 which contacts and moves switch 148; para. [0050], third-to-last sentence; para. [0068], sentence 1). Although Despa discloses a wireless injection endpoint signaling system using short-distance RF communications (para. [0061]), of which NFC is a type of short-distance RF, it fails to explicitly disclose the NFC.
Yu teaches an analogous injection endpoint signalling device comprising a near field communications (NFC) circuit (para. [0041]). 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 Despa device by incorporating the NFC teaching of Yu to make the Despa short-distance RF circuit specifically an NFC circuit, in order to increase the security of the transmitted signals, associated with NFC.
Regarding claim 2, Despa in view of Yu teaches injection endpoint signalling device according to claim 1, as described above, wherein the mutually cooperating surface engagement between the activation switch and the needle shroud is provided when the shroud is positioned in a fully extended position (Despa: Fig. 6: arched portion of 120 which contacts and moves switch 148; para. [0050], third-to-last sentence).
Regarding claim 3, Despa in view of Yu teaches injection endpoint signalling device according to claim 1, as described above, comprising a near field communications circuit (Yu: para. [0041]) holder body (Despa: Figs. 3A-B: 109 and 111; para. [0037], sentence 2), wherein the circuit holder body is mounted on an outward facing surface of a longitudinal body of the pre-filled syringe (Despa: Figs. 3A-B: 109 and 111 of 101A is mounted around the syringe barrel 110, mounted around its outward-facing cylindrical surface).
Regarding claim 4, Despa in view of Yu teaches injection endpoint signalling device according to claim 3, as described above, wherein the circuit holder body is mounted on an outward facing surface of the needle safety shroud (Despa: Figs. 3A-B: 109 and 111 of 101A is mounted to 120 around the syringe, mounted around the outward-facing surfaces of 125 of 120).
Regarding claim 6, Despa in view of Yu teaches injection endpoint signalling device according to claim 3, as described above, wherein the circuit holder body comprises a socket configured and dimensioned to receive and locate a microcontroller (Despa: Fig. 5: printed circuit board 144 containing microcontroller, fits into socket between 109 and 111) of the near field communications circuit (Yu: para. [0041]).
Regarding claim 12, Despa in view of Yu teaches injection endpoint signalling device according to claim 3, as described above, wherein the circuit holder body comprises at least one or more walls located on a periphery of, and extending in the same direction away from, the disk-shaped base (Despa: Fig. 3A: walls 107A-B as well as inner walls around 103).
Regarding claim 13, Despa in view of Yu teaches injection endpoint signalling device according to claim 12, as described above, wherein the at least one or more extending walls are arc shaped (Despa: Fig. 3A: walls 107A-B having arched shaped “corners” and edges) and, when the device is mounted on the pre-filled syringe and/or the needle safety shroud, said walls engage in elastically deformable abutment with at least one side wall of the pre-filled syringe and/or the needle safety shroud (Despa: Figs. 3A-B: inner walls around 103 abut 125/120).
Regarding claim 14, Despa in view of Yu teaches injection endpoint signalling device according to claim 12, as described above, wherein the at least one or more extending walls each comprise a prehensile shoulder, extending substantially orthogonal to the central longitudinal axis from a proximal end of each of the respective extending walls (Despa: Fig. 3B: prehensile shoulders extending from the right and left, located at the labels 140A and 140B).
Regarding claim 15, Despa in view of Yu teaches injection endpoint signalling device according to claim 14, as described above, wherein the prehensile shoulder extends, from a radially distant end of the shoulder, in a proximal direction to form a curled lip (Despa: Fig. 3A: shoulders form a downwardly curled lip for grasping), configured to engage in elastically deformable clasping engagement with a corresponding finger stop which extends orthogonally outwardly from the body of the pre-filled syringe (Despa: Fig. 3B: distal end of 125 forming a shoulder/stop, abutting the inner shoulder of 101A seen in Fig. 1).
Regarding claim 16, Despa in view of Yu teaches injection endpoint signalling device according to claim 12, as described above, wherein one ore more of the extending walls, prehensile shoulder and curled lip are closed by a rear covering extending from from a rear edge of at least one extending wall to a rear edge of the other extending wall (Despa: Fig. 3B: rear covering shown on front face covering side between 107A and 107B).
Regarding claim 19, Despa in view of Yu teaches injection endpoint signalling device according to claim 1, as described above, wherein the circuit board activation switch, when the circuit holder body is mounted on the pre-filled syringe body and/or the needle safety shroud, is located in parallel to, and along, the central longitudinal axis (Despa: Fig. 5: switch 148 located on/along the central longitudinal axis of the device).
Regarding claim 20, Despa in view of Yu teaches injection endpoint signalling device according to claim 1, as described above, wherein the activation switch is moved from the inactive state to the active by cooperating surface engagement between a proximal part of the shroud and the activation switch (Despa: Figs. 5 and 6: arched, proximal portion of 120 which contacts and moves switch 148; para. [0050], third-to-last sentence; para. [0068], sentence 1).
Regarding claim 21, Despa in view of Yu teaches injection endpoint signalling device according to claim 1, as described above, wherein the activation switch is a displaceable, or movable, electrical contact (Despa: para. [0050], sentence 1, 148 displaced for activation; para. [0073], the activation of the electrical contact of 148 causes data transmission).
Regarding claim 22, Despa in view of Yu teaches injection endpoint signalling device according to claim 21, as described above, wherein the displaceable, or movable, electrical contact is selected from the group consisting of a microswitch, a biased, or constrained, electrically conducting metal strip, and a movable electrically conducting surface (Despa: para. [0050], sentence 1, 148 is a microswitch).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Despa (US 20200289751) in view of Yu (20190038840) in further view of Marcoz (US 20180200452).
Regarding claim 5, Despa in view of Yu teaches injection endpoint signalling device according to claim 3, as described above, but fails to teach the orientation of the circuit holder as being in a plane that lies parallel to the longitudinal axis of the syringe.
Marcoz teaches an analogous injection endpoint signalling device wherein the circuit holder body (Fig. 3: circuit holder body 56 of circuit in 31; para. [0100], sentences 1-3) is mounted on the pre-filled syringe in a plane that lies parallel to the central longitudinal axis (Fig. 3: 56 and all contained structures mounted on a plane that lies along the longitudinal axis of 21). 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 Despa-Yu device by changing the orientation of the mounted circuit and circuit body holder to be paralleled to the syringe, as taught by Marcoz, in order to create a slimmer device with easier access to the circuit and circuit holder.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Despa (US 20200289751) in view of Yu (20190038840) in further view of Larsson (US 20210099027) in further view of Steck (US 20210085880).
Regarding claim 7, Despa in view of Yu teaches injection endpoint signalling device according to claim 3, as described above, but fails to disclose the circuit board for the the near field communications circuit as disk-shaped having the switch and microcontroller on opposite sides.
Larsson teaches an analogous NFC circuit board system comprising a disk-shaped circuit board (Fig. 57: 5602; para. 0317], sentence 4). 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 shape of the Despa-Yu circuit board to make it a more circular disk-shape, as taught by Larsson, in order to design the circuit board to better fit around the perimeter of the syringe body or to provide more desirable aesthetics (see MPEP 2144.04 IV B). However, the circuit board of Despa-Yu-Larsson fails to teach the switch and microcontroller being on opposite sides.
Steck teaches an analogous injection signalling device wherein the microcontroller is located on a first face of the circuit board (Fig. 3A: 22; para. [0059], sentence 2), and the activation switch is located on an opposite, second face of the circuit board (para. [0059], sentence 4). 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 circuit board of the Despa-Yu-Larsson device by incorporating the teaching of the Steck circuit board having the microcontroller and switch on opposite faces, in order to provide more space for each of the components, and to allow for easier access to the microcontroller without compromising the positioning of the switch.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Despa (US 20200289751) in view of Yu (20190038840) in further view of Jung (20200188601).
Regarding claim 8, Despa in view of Yu teaches injection endpoint signalling device according to claim 3, as described above, but fails to explicitly teach the circuit board held to the circuit holder body with lugs.
Jung teaches an analogous injection singnalling device, wherein the first face of the disk-shaped circuit board is held against an inward facing surface of a disk-shaped base of the circuit holder body by at least one or more retaining lugs (Figs. 2A-B: circuit board 255 held against inner face of 261 via lugs of 292). 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 Despa-Yu device by incorporating the retaining lugs taught by Jung to better secure the circuit board to the inner face of the circuit holder body which it sits in.
Regarding claim 9, Despa in view of Yu in further view of Jung teaches injection endpoint signalling device according to claim 8, as described above, wherein the retaining lugs are radially distributed about an axis of rotation of the disk-shaped base of the circuit holder body (Jung: Figs. 2A-B: lugs of 292 radially distributed about 255).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Despa (US 20200289751) in view of Yu (20190038840) in further view of Jung (20200188601) in further view of Marcoz (US 20180200452).
Regarding claim 10, Despa in view of Yu in further view of Jung teaches injection endpoint signalling device according to claim 9, as described above, but fails to teach the orientation of the disk wherein its axis of rotation lies perpendicular to the central longitudinal axis of the syringe.
Marcoz teaches an analogous injection endpoint signalling device wherein the axis of rotation of the circuit board lies perpendicular to the central longitudinal axis of the pre-filled syringe (Fig. 3: 56 and contained circuit board and base mounted on a plane that lies along the longitudinal axis of 21). 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 Despa-Yu-Jung device by changing the orientation of the mounted circuit and circuit body holder to be paralleled to the syringe, as taught by Marcoz, in order to create a slimmer device with easier access to the circuit and circuit holder.
Regarding claim 11, Despa in view of Yu in further view of Jung teaches injection endpoint signalling device according to claim 9, as described above, but fails to teach the orientation of the disk wherein its axis of rotation lies perpendicular to the central longitudinal axis of the syringe.
wherein the axis of rotation of the circuit board lies perpendicular to the horizontal plane which is parallel to the central longitudinal axis (Fig. 3: 56 and contained circuit board and base mounted on a plane that lies along the longitudinal axis of 21). 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 Despa-Yu-Jung device by changing the orientation of the mounted circuit and circuit body holder to be paralleled to the syringe, as taught by Marcoz, in order to create a slimmer device with easier access to the circuit and circuit holder.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Despa (US 20200289751) in view of Yu (20190038840) in further view of Morlok (US 20190015591).
Regarding claim 17, Despa in view of Yu teaches injection endpoint signalling device according to claim 16, as described above, but fails to disclose a hinge on the rear covering.
Morlok teaches an analogous injection device and housing, wherein the rear covering (Fig. 9A: one side of the 4 and its connected finger flanges) comprises a rotatable hinge (as shown in Fig. 8A; para. [0065], sentences 3-4). 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 circuit holder body and its rear covering of Despa by incorporating a hinge, as taught by Morlok, in order to allow opening of the circuit holder body to access the circuit board and switch components inside.
Regarding claim 18, Despa in view of Yu in further view of Morlok teaches injection endpoint signalling device according to claim 17, as described above, wherein the rotatable hinge is provided along an edge of one of the extending walls (Morlok: Figs. 3A and 8A).
Conclusion
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