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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 10/15/2025, 06/02/2025, and 02/03/2023 has/have been considered by the Examiner.
Status of the Claims
Claims 1-19 are currently pending. Claims 1-19 are currently rejected.
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, “a second plurality of conductive pads” (claim 6); the simultaneous use of “a plurality of first conductive pads” with “at least one connector” and “a plurality of first electrical connectors” (claim 2); and the simultaneous use of “a plurality of spring contacts” with “at least one port” and “a plurality of second electrical connectors” (claim 2) 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
Claims 10 and 18 are objected to because of the following informalities:
Claim 10 lines 2-3 read “a first portion the further electrically conductive trace”. This should read “a first portion of the further electrically conductive trace”.
Claim 18 lines 3-4 read “a first portion the further electrically conductive trace”. This should read “a first portion of the further electrically conductive trace”.
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 2-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the following limitation:
“wherein the disposable label includes at least one connector extending from the disposable label, wherein the reusable housing includes at least one port in which the at least one connector is received, and wherein the at least one connector includes a plurality of first electrical connectors electrically coupled to the electrically conductive trace and removably electrically coupled to a plurality of second electrical connectors of the at least one port, wherein the plurality of second electrical connectors is electrically coupled to the at least one processor.”
This limitation is similar to the following limitation which is recited in the last paragraph of claim 1, except the disposable label includes a connector including a plurality of first electrical contacts (instead of the disposable label including a plurality of first conductive pads), and the reusable housing includes a port including a plurality of second electrical connectors (instead of the reusable housing including a plurality of spring contacts).
“wherein the disposable label includes a plurality of first conductive pads electrically coupled to the electrically conductive trace, wherein the reusable housing includes a plurality of spring contacts electrically coupled to the processor and removably electrically coupled to the plurality of first conductive pads,”
Due to the similarities in the limitations applied to the plurality of first electrical connectors/plurality of first conductive pads and the plurality of second electrical contacts/plurality of spring contacts, and claim 2 being dependent on claim 1, it is unclear whether the limitation “a plurality of first electrical connectors” and “a plurality of second electrical connectors” in claim 2 are meant to refer back respectively to “a plurality of first conductive pads” and “a plurality of spring contacts” as introduced in claim 1, further specify some configuration of the conductive pads/spring contacts, introduce an alternative limitation (substituting the “at least one connector includes a plurality of first electrical connectors” for the “plurality of first conductive pads” and likewise substituting “a plurality of second electrical connectors of the at least one port” for the “plurality of spring contacts), or introduce a new limitation (in which case the claim language should be altered to clarify the difference between the conductive pads/spring contacts and the connector with first electrical contacts/port with second electrical contacts). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 6 recites the limitations “a plurality of first conductive pads” on line 2. Claim 1, from which claim 6 depends, already introduced “a plurality of first conductive pads” in the last paragraph of claim 1. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to the same structure earlier introduced (in which case the article should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 6 recites the following limitation:
“a plurality of first conductive pads electrically coupled to the electrically conductive trace, wherein the reusable housing includes a plurality of second conductive pads coupled to the processor and removably electrically coupled to the plurality of first conductive pads”
This limitation is very similar to the following limitation which is recited in the last paragraph of claim 1:
“a plurality of first conductive pads electrically coupled to the electrically conductive trace, wherein the reusable housing includes a plurality of spring contacts electrically coupled to the processor and removably electrically coupled to the plurality of first conductive pads”
Due to the similarities in phrasing, claim 6 being dependent on claim 1, and the already present 112b issue regarding “a plurality of first conductive pads”, it is unclear whether the limitation “a plurality of second conductive pads” in claim 6 is meant to refer back to “a plurality of spring contacts” (in which case this limitation should read “the plurality of spring contacts”), further specify a feature of the plurality of spring contacts (in which case the claim should read something such as “wherein each spring contact of the plurality of spring contacts is/comprises a second conductive pad”, or introduce a new limitation (in which case the claim language should be altered to clarify the difference between the second conductive pads from the spring contacts). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 3-5 are rejected for being dependent upon a claim rejected under 112b, since dependent claims inherit the deficiencies of the claims on which they depend.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-4, 7-9, 12, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauss et al (US 20170235919 A1 hereafter Bauss) in view of Helmer (WO 2019129620 A1; hereafter Helmer), Bock et al (US 20140354998 A1; hereafter Bock), and Holbrook et al (US 3704724 A; hereafter Holbrook).
Regarding claim 1, Bauss discloses a sensor assembly (NFC-chip 50, fig. 2a, [0047]) for an injection device ([0023] FIG. 2 displays the use of a label comprising an NFC-tag capable of providing status information of several features and functions of a medicament delivery device) comprising:
a disposable label (see label comprising NFC-tag shown in fig. 2a, [0023]) configured to be attached to the injection device (see attachment of label to medicament delivery device in fig. 2b), the disposable label including:
an electrically conductive trace (circuit 52 and circuit 58, fig. 2a/b, [0048-0049]), wherein a first portion (circuit 52) of the electrically conductive trace (52/58) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to be altered in response to a first operation (removal of the cap noted in [0048]) of the injection device ([0048] circuit 52 may be connected to a protective cap 54 of the device. When a user removes the cap 54 the circuit is broken and thus closed, which may be detected by the NFC 50 and this information may be transmitted to the smart device as seen in FIG. 3);
a reusable housing (attachment 70, fig. 5, [0055] an attachment 70 could be provided to the smart device, FIG. 5. The attachment could for example comprise a shell enclosing at least part of the smart device) removably connected to the disposable label ([0056] “the fixed connection between the medicament delivery device and the smart device enables correct reading position of the NFC-tag”), the reusable housing including:
a processor ([0032] In this context, smart devices may include electronic devices that are provided with processors that are capable of running computer programs as well as storage space to store programs as well as data retrieved from different external sources.) coupled to the electrically conductive trace ([0032] the smart devices may be arranged with receiving and transmitting mechanisms capable of communicating with NFC tags as well as programs capable of establishing and handling the communication with the NFC tags.), wherein the processor is configured to respond to an alteration of the first portion of the electrically conductive trace ([0048] When a user removes the cap 54 the circuit is broken and thus closed, which may be detected by the NFC 50 and this information may be transmitted to the smart device as seen in FIG. 3.); and
a wireless communication device configured to wirelessly communicate, to a computing device, information associated with the alteration of the first portion of the electrically conductive trace ([0048] The smart device can store this information and/or transmit it to external databases, adding to the device history, which may be monitored by e.g. the physician of the user.).
Bauss is silent to (i) the processor removably electrically coupled to the electrically conductive trace, (ii) wherein the processor is configured to be activated in response to an alteration of the first portion of the electrically conductive trace, and (iii) wherein the disposable label includes a plurality of first conductive pads electrically coupled to the electrically conductive trace, wherein the reusable housing includes a plurality of spring contacts electrically coupled to the processor and removably electrically coupled to the plurality of first conductive pads.
Helmer, in the art of reusable devices for monitoring drug delivery devices, teaches a reusable housing (add-on device 200, fig. 5 and fig. 6, pg. 25/46 ln. 32-37; pg. 15/46 ln. 21-24 “one and the same add-on device can be used with a series of different mounting adapters”) removably connected to the disposable label (mounting adapter 100, fig. 4 and fig. 11, pg. 22/46 ln. 31-pg. 23/46 ln. 5), the reusable housing including:
a processor (processor 232, fig. 14, pg. 27/46 ln. 16-24 “the add-on device 200 comprises at least a processor 232 and a memory 234”) removably electrically coupled (pg. 25/46 ln. 31-37, add-on device 200 is electrically connected to mounting adaptor 100) to the electrically conductive trace (electric conductor 120, fig. 4 and fig. 10, pg. 22/46 ln. 36-37 “electrical conductor 120 may comprise a conductor loop and may be printed as an electrically conductive structure on the upper side 102a of the carrier 102”), wherein the processor is configured to be activated in response to cap removal (pg. 29/46 ln. 34-36 “when the low power processor 232 determines that the received signals are indicative of a typical cap removal movement of the user's hand, it may automatically switch into an activation mode”); and
a wireless communication device (communication unit 238, fig. 14) configured to wirelessly communicate, to a computing device (external electronic device 400, fig. 14) (pg. 27/46 ln. 35-36, “The add-on device may comprise a communication unit 238 configured to establish a wireless communication link to the external electronic device 400.”), information associated with cap removal (pg. 28/46 ln. 7-8 add-on device 200 establishes data transferring wireless link to external electronic device 400; see also pg. 14/46 ln. 28-30; see also pg. 29/46 ln. 34-36 which describes processor 232 recognizing and activating based on cap removal),
wherein the disposable label (mounting adapter 100) includes a plurality of first conductive pads (electrical contacts 121 and 122 of the mounting adapter 100, see figs. 9 and 10, pg. 25/46 ln. 31-37) electrically coupled to the electrically conductive trace (120) (pg. 25/46 ln. 19-20 “The electrical contacts 121, 122 are electrically or conductively connected to respective electric conductors 120 as illustrated in Fig. 10.”), wherein the reusable housing includes a plurality of contacts (electrical device contacts 221 and 222, fig. 6, pg. 25/46 ln. 31-37) electrically coupled to the processor (238, see fig. 14) and removably electrically coupled (see pg. 26/46 ln. 1-10) to the plurality of first conductive pads (121/122).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bauss to include elements of Helmer since both references deal with injection pens, labels, and auxiliary devices which read the labels. One would have been motivated to modify the device of Bauss to include, as taught by Helmer, the physical electrical connection between the reusable housing (which includes the processor) and the disposable label (which includes the conductive trace), since the physical connection would ensure consistent reading of the conductive trace without relying on potentially less robust non-physical connections which may more easily be interfered with by other nearby signals which may be potentially malicious. One would further would have been motivated to modify Bauss to include the processor being activated by the cap removal, as taught by Helmer and motivated by Helmer pg. 29/46 ln. 34-36 which notes that the processor may remain in a low power mode prior to cap removal. Thus, by having the breaking of the disposable label of Bauss when the cap is removed (see Bauss [0048]) cause the processor to activate (see Helmer pg. 29/46 ln. 34-36) the device does not unnecessarily consume energy prior to the removal of the cap.
Bauss modified by Helmer is silent to wherein the reusable housing includes a rigid deformable clip configured to clip onto an exterior surface of the injection device.
Bock, in the art of add-on monitoring modules for use with injection pens, teaches wherein a reusable housing (supplementary device 2, fig. 2b, [0066]) includes a rigid deformable clip (closure 68, fig. 13, [0195] the resilience of the closure 68 results in the latching edge 64 and the latch engaging face 66 becoming engaged with one another) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to clip onto an exterior surface of the injection device (injection pen 1, fig. 2b, fig. 14 shows injection pen held by clip 68, [0195] “closure 68 ensures that the injection pen 1 is tightly contained within the injection device receiving channel 58 and is held in place by the closure 68”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bauss modified by Helmer to include the rigid deformable clip taught by Bock since Bock is also in the field of add-on modules for use with injection devices. One would have been motivated to make the modification because the rigid deformable clip securely holds the reusable housing to the injection pen, better ensuring proper placement over time of the relative components. As noted by Bock [0063], “the mating unit allows the supplementary device 2 to sit tightly on the housing 10 of injection device 1, but is nonetheless removable from injection device 1”.
Bauss modified by Helmer and Bock is silent to the electrical contacts of the reusable housing being spring contacts.
Holbrook, in the art of fluid systems, teaches wherein an electrical contact is a spring contact (leaf spring contacts 76, 77 forming electrical contacts; fig. 10, col. 5 ln. 38-44).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the electrical contacts of the reusable housing to be spring contacts, as taught by Holbrook, since Holbrook also deals with electrically connection to a monitoring module. One would have been motivated to make the modification because the spring contacts would resiliently press against the contact pads, ensuring a solid reliable electrical connection. This modification amounts to a simple substitution of one known form of electrical connection for another to produce results predictable to one of ordinary skill in the art.
Regarding claim 2, Bauss modified by Helmer, Bock, and Holbrook discloses the sensor assembly of claim 1, as described above, including wherein the disposable label includes at least one connector (Helmer: second mount 110, fig. 9, pg. 23/46 ln. 7-15) (see 112b interpretation above) extending from the disposable label (Helmer: mounting adapter 100, figs. 7 and 8), wherein the reusable housing (Helmer: add-on device 200, fig. 5) includes at least one port (Helmer: third mount 210, figs. 5 and 6, pg. 26/46 ln. 1-10) (see 112b interpretation above) in which the at least one connector is received (Helmer: pg. 26/46 ln. 1-10 connector/second mount 110 slides into port/third mount 210), and wherein the at least one connector (110) includes a plurality of first electrical connectors (see 112b interpretation above) (Helmer: electrical contacts 121 and 122 of the mounting adapter 100, see figs. 9 and 10, pg. 25/46 ln. 31-37) electrically coupled to the electrically conductive trace (120) (Helmer: pg. 25/46 ln. 19-20 “The electrical contacts 121, 122 are electrically or conductively connected to respective electric conductors 120 as illustrated in Fig. 10.”) and removably electrically coupled (Helmer: see pg. 26/46 ln. 1-10) to a plurality of second electrical connectors (see 112b interpretation above) (Helmer: electrical device contacts 221 and 222, fig. 6, pg. 25/46 ln. 31-37) of the at least one port (210, see fig. 6), wherein the plurality of second electrical connectors (221 and 222) is electrically coupled to the at least one processor (Helmer: 238, see fig. 14).
Regarding claim 3, Bauss modified by Helmer, Bock, and Holbrook discloses the sensor assembly of claim 2, as described above.
Bauss as modified discloses the claimed invention except for wherein the at least one connector includes a plurality of connectors, and wherein the at least one port includes a plurality of ports corresponding to the plurality of connectors. It would have been obvious to one having ordinary skill in the art at the time the invention was made to add an additional pair of corresponding connector and port, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP 2144.04 (VI-B). Including the additional corresponding connector and port would provide a more robust physical connection between the disposable label and reusable housing of Bauss as modified.
Regarding claim 4, Bauss modified by Helmer, Bock, and Holbrook discloses the sensor assembly of claim 3, as described above.
Bauss as modified discloses the claimed invention except for wherein each connector of the plurality of connectors includes a single first electrical connector, and wherein each port of the plurality of ports includes a single second electrical connector.
It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to arrange each one of the two connectors to include of the two first electrical connectors of Bauss as modified and applied to claim 3 above, and likewise to arrange each one of the two ports to include one of the two second electrical connectors, thereby yielding predictable results without change to inventive function. Furthermore, having each connector/port arranged with one electrical connector each would be obvious to try by beneficially requiring both sets of connectors/ports to be properly seated for both sets of electrical contacts to correctly meet each other and thus complete the circuit, thus ensuring that the physical connection between the disposable label and the reusable housing is secure prior to the device functioning, minimizing the risk of detachment during use. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the device of Bauss as modified would still perform the intended functions.
Regarding claim 7, Bauss modified by Helmer, Bock, and Holbrook discloses the sensor assembly of claim 1, as described above.
Bauss is silent to wherein the disposable label includes an adhesive layer.
Helmer further teaches wherein the disposable label (mounting adapter 100, fig. 13) includes an adhesive layer (adhesive layer noted in pg. 24/46 ln. 25-31 “the adhesive layer may form or constitute the first mount 101”, fig. 7).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the disposable label of Bauss to include the adhesive layer taught by Helmer in light of Bauss [0070] which states “The NFC-tag 114 could for example be arranged on a label having an adhesive on one side.”, thus providing support for a label including adhesive. One would have been motivated to make the modification because the adhesive layer of Helmer facilitates the non-reversible attachment of a disposable label to an injection device which may be easily achieved at a specific time, such as in right before the device is used. Thus, this modification would help to ensure that the label is intact and undamaged prior to adhesion to the medicament delivery device, and ensures that removal of the disposable label is prevented due to the adhesion.
Regarding claim 8, Bauss modified by Helmer, Bock, and Holbrook discloses the sensor assembly of claim 1, as described above. Bauss further discloses wherein the disposable label includes a battery ([0062] The functionality of the NFC-tags may be further enhanced by adding a battery in that a timestamp of activation is achievable. For instance, when a switch as described above is affected, such as closing a circuit, a power circuit from the battery is activated.).
Regarding claim 9, Bauss modified by Helmer, Bock, and Holbrook discloses the sensor assembly of claim 1, as described above.
Bauss is silent to wherein the reusable housing includes a battery.
Helmer further teaches wherein the reusable housing (Helmer: add-on device 200) includes a battery (Helmer: pg. 27/46 ln. 36-37 “the add-on device 200 further comprises an electric power source 240, e.g. in form of a battery.”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the reusable housing of Bauss to explicitly include a battery as taught by Helmer since both references deal with reusable devices coupled to labels. One would have been motivated to make the modification because, since the reusable housing provides its own power, the processor may be kept in a low-power mode and activate automatically when the cap is removed (as described in the 103 rejection of claim 1 above). The battery thus ensures that the processor does not miss any activity related to the injection device use and facilitates good record keeping.
Regarding claim 12, Bauss modified by Helmer, Bock, and Holbrook discloses the sensor assembly of claim 1, as described above. Bauss further discloses wherein a second portion of the electrically conductive trace (circuit 58, fig. 2a/b, [0049]) is configured to be altered in response to a second operation of the injection device ([0049] circuit 58 is affected by moving components at the end of dose delivery) different than the first operation of the injection device ([0048] circuit 52 is altered when the cap 54 is removed).
Regarding claim 14, Bauss modified by Helmer, Bock, and Holbrook discloses the sensor assembly of claim 1, as described above. Bauss further discloses wherein the disposable label (NFC chip 50, fig. 2a/b) includes at least one sensor ([0065] temperature sensor is built into the NFC-chip), wherein the at least one sensor includes at least one of the following: an optical sensor, a temperature sensor (temperature sensor noted in [0065]), a force sensor, or any combination thereof, and wherein the at least one sensor is electrically coupled to the electrically conductive trace (circuit 52 and circuit 58, fig. 2a/b, [0048-0049], note that disposable label/NFC chip 50 includes both the electrically conductive trace and the temperature sensor).
Regarding claim 15, Bauss modified by Helmer, Bock, and Holbrook discloses the sensor assembly of claim 1, as described above. Bauss further discloses wherein the reusable housing includes at least one sensor ([0058] smart devices are arranged with motion sensors in three dimensions).
Bauss is silent to wherein the at least one sensor includes at least one of the following: a vibration sensor, an accelerometer, an optical sensor, a magnetic sensor, or any combination thereof.
Helmer further teaches wherein the reusable housing (add-on device 200, fig. 14) includes at least one sensor (pg. 27/46 ln. 16-24, add-on device 200 includes a sensor arrangement 236), and wherein the at least one sensor includes at least one of the following: a vibration sensor, an accelerometer, an optical sensor, a magnetic sensor, or any combination thereof (pg. 27/46 ln. 16-24 sensor arrangement 236 may comprise at least one of an acceleration sensor 251, a position sensor 252, a capacitive sensor 253, an optical sensor 254 and a magnetic sensor 255).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include the sensor arrangement taught by Helmer with the device of Bauss as currently modified since Bauss [0058] provides support for the inclusion of sensor devices, in particular motion sensors, with the reusable housing. One would have been motivated to make the modification by Helmer pg. 28/46 ln. 22-29 which notes various potential benefits/uses of the sensor assembly such as determining and recording handling steps including setting and injection of a dose. Thus, the sensor assembly can be used to provide detailed records of device use and warn users of potential dangers/errors (see Helmer pg. 28/46 ln. 36-pg. 29/46 ln. 4).
Regarding claim 16, Bauss modified by Helmer, Bock, and Holbrook discloses the sensor assembly of claim 1, as described above. Bauss further discloses wherein the alteration of the first portion of the electrically conductive trace includes a break in the first portion of the electrically conductive trace ([0048] When a user removes the cap 54 the circuit is broken and thus closed, which may be detected by the NFC 50 and this information may be transmitted to the smart device as seen in FIG. 3).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauss as modified and applied to claim 2 above and further in view of Sakamaki (US 20060035534 A1; hereafter Sakamaki).
Regarding claim 5, Bauss modified by Helmer, Bock, Holbrook, and Sakamaki discloses the sensor assembly of claim 2, as described above.
Bauss as modified discloses all the claim elements except wherein the at least one connector is press fit in the at least one port.
Sakamaki, in the art of electrical connections, teaches wherein at least one connector (first contact 12a, fig. 2, [0012]) is press fit in at least one port (first housing section 111, fig. 2, [0012] “First and second contacts 12a, 12b are press-fit into the housing 11”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bauss as modified to have the connector and port be press fit as taught by Sakamaki instead of sliding together as taught by Helmer since Sakamaki also deals with electrical connections. One would have been motivated to make the modification because the interference fit taught by Sakamaki provides resistance to separation, since the pieces re press fit together, while the sliding fit of Bauss modified by Helmer may allow for accidental separation due to sliding.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauss as modified and applied to claim 1 above and further in view of Shen (US 6368894 B1; hereafter Shen).
Regarding claim 6, Bauss modified by Helmer, Bock, and Holbrook discloses the sensor assembly of claim 1, as described above, including wherein the disposable label (Helmer: mounting adapter 100) includes a plurality of first conductive pads (see 112b interpretation above) (Helmer: electrical contacts 121 and 122 of the mounting adapter 100, see figs. 9 and 10, pg. 25/46 ln. 31-37) electrically coupled to the electrically conductive trace (120) (Helmer: pg. 25/46 ln. 19-20 “The electrical contacts 121, 122 are electrically or conductively connected to respective electric conductors 120 as illustrated in Fig. 10.”), wherein the reusable housing includes a plurality of second conductive pads (see 112b interpretation above) (Helmer: electrical device contacts 221 and 222, fig. 6, pg. 25/46 ln. 31-37) electrically coupled to the processor (238, see fig. 14) and removably electrically coupled (see pg. 26/46 ln. 1-10) to the plurality of first conductive pads (121/122).
Bauss as modified is silent to the conductive pads being coupled via a conductive adhesive applied to at least one of the plurality of first conductive pads and the plurality of second conductive pads.
Shen, in the art of semiconductors and electrical connections, teaches wherein a first plurality of conductive pads (first set of contact pads 25 of the first semiconductor chip 2, fig. 7, col. 5 ln. 11-23) and a second plurality of conductive pads (plurality of contact pads 31 of second semiconductor chip 3 contact pad surface 30, fig. 7, col. 5 ln. 11-23) are coupled via a conductive adhesive (conductive bodies 5, figs. 5 and 7, col. 4 ln. 40-46, “Each of the conductive bodies 5, in the present embodiment, may be a conductive adhesive”) applied to at least one of the plurality of first conductive pads and the plurality of second conductive pads (col. 5 ln. 11-13 “Each of the conductive bodies 5 is connected electrically to the corresponding contact pad 21 of the first semiconductor chip 2 and the corresponding contact pad 31 of the second semiconductor chip 3 so as to establish electrical connection therebetween.”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bauss as modified to further include the conductive adhesive connecting two pluralities of conductive pads as taught by Shen, since both references deal with conductive pads forming electrical connections. One would have been motivated to make the modification because the inclusion of the adhesive would better provide a reliable electrical connection between the two sets of conductive pads. This modification amounts to a simple substitution of one known form of electrical connection for another to produce results predictable to one of ordinary skill in the art.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauss modified by Helmer, Bock, and Holbrook.
Alternatively, regarding claim 1, Bauss modified by Helmer, Bock, and Holbrook disclose all claim limitations as described in the primary rejection of claim 1 above, except that the electrically conductive trace includes only circuit 52, part of which is broken and thus altered (circuit 52 and circuit 58, fig. 2a/b, [0048-0049])
Alternatively, regarding claim 1, Bauss discloses a sensor assembly (NFC-chip 50, fig. 2a, [0047]) for an injection device ([0023] FIG. 2 displays the use of a label comprising an NFC-tag capable of providing status information of several features and functions of a medicament delivery device) comprising:
a disposable label (see label comprising NFC-tag shown in fig. 2a, [0023]) configured to be attached to the injection device (see attachment of label to medicament delivery device in fig. 2b), the disposable label including:
an electrically conductive trace (circuit 52, fig. 2a/b, [0048-0049]), wherein a first portion (portion of circuit 52 which is breaks noted in [0048]) of the electrically conductive trace (52/58) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to be altered in response to a first operation (removal of the cap noted in [0048]) of the injection device ([0048] circuit 52 may be connected to a protective cap 54 of the device. When a user removes the cap 54 the circuit is broken and thus closed, which may be detected by the NFC 50 and this information may be transmitted to the smart device as seen in FIG. 3).
The remainder of alternative rejection is identical to the primary rejection of claim 1 presented above. Please see above.
Regarding claim 10, Bauss modified by Helmer, Bock, and Holbrook discloses the sensor assembly of claim 1, as described in the alternative rejection above. Bauss further discloses wherein the disposable label includes a further electrically conductive trace (circuit 58, fig. 2a/b, [0048-0049]), wherein a first portion the further electrically conductive trace (portion of circuit 58 which is breaks noted in [0049]) is configured to be altered in response to a second operation of the injection device ([0049] circuit 58 is affected by moving components at the end of dose delivery) different than the first operation of the injection device ([0048] circuit 52 is altered when the cap 54 is removed).
Examiner notes that the circuitry of Bauss modified by Helmer, as seen in the primary 103 rejection of claim 1 above, is removably electrically coupled to the processor, thus meeting the limitation of “wherein the processor is removably electrically coupled to the further electrically conductive trace”.
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauss as modified and applied to claim 10 or 12 above and further in view of Bauss et al (US 20200030535 A1; hereafter Bauss2).
Regarding claim 11, Bauss as modified discloses the sensor assembly of claim 10, as described above. Bauss further discloses wherein the first operation of the injection device includes removal of a cap or a cover of the injection device ([0048] When a user removes the cap 54 the circuit is broken and thus closed, which may be detected by the NFC 50 and this information may be transmitted to the smart device as seen in FIG. 3.).
Bauss as modified is silent to wherein the second operation of the injection device includes actuation of a button of the injection device or a deployment of a needle shield of the injection device.
Bauss2, in the art of autoinjectors and directed to a similar device, teaches wherein the second operation of the injection device includes actuation of a button (actuator 94, fig. 4, [0062] actuator 94 , FIGS. 4 and 6, is further arranged operably to the rotator 84) of the injection device or a deployment of a needle shield of the injection device ([0070] rotator 84 is provided with two NFC tags 170 , 172 , as shown in FIG. 7A and FIG. 7B. Before dose delivery the rotator 84 has one rotational position, FIG. 7A, and after completed dose delivery, the rotator 84 has a second rotational position, FIG. 7B, as described above).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bauss as modified to include recognition of button actuation, as taught by Bauss2, since Bauss2 also deals with labels indicating use cases of an injection device. One would have been motivated to make the modification because monitoring the button actuation falls in line with the teachings of Bauss [0049] wherein the second circuit 48 indicates the delivery of a dose. Additionally, this modification would better allow the device of Bauss as modified to meet the goal of Bauss [0048] of tracking device use.
Regarding claim 13, Bauss modified by Helmer, Bock, and Holbrook discloses the sensor assembly of claim 12, as described above. Bauss further discloses wherein the first operation of the injection device includes removal of a cap or a cover of the injection device ([0048] When a user removes the cap 54 the circuit is broken and thus closed, which may be detected by the NFC 50 and this information may be transmitted to the smart device as seen in FIG. 3.).
Bauss as modified is silent to wherein the second operation of the injection device includes actuation of a button of the injection device or a deployment of a needle shield of the injection device.
Bauss2, in the art of autoinjectors and directed to a similar device, teaches wherein the second operation of the injection device includes actuation of a button (actuator 94, fig. 4, [0062] actuator 94 , FIGS. 4 and 6, is further arranged operably to the rotator 84) of the injection device or a deployment of a needle shield of the injection device ([0070] rotator 84 is provided with two NFC tags 170 , 172 , as shown in FIG. 7A and FIG. 7B. Before dose delivery the rotator 84 has one rotational position, FIG. 7A, and after completed dose delivery, the rotator 84 has a second rotational position, FIG. 7B, as described above).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bauss as modified to include recognition of button actuation, as taught by Bauss2, since Bauss2 also deals with labels indicating use cases of an injection device. One would have been motivated to make the modification because monitoring the button actuation falls in line with the teachings of Bauss [0049] wherein the second circuit 48 indicates the delivery of a dose. Additionally, this modification would better allow the device of Bauss as modified to meet the goal of Bauss [0048] of tracking device use.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauss as modified and applied to claim 1 above and further in view of Kuhno (US 20070057050 A1; hereafter Kuhno).
Regarding claim 17, Bauss modified by Helmer, Bock, and Holbrook discloses a system comprising: the sensor assembly of claim 1 (see 103 rejection of claim 1 above).
Bauss as modified is silent to a container housing the sensor assembly.
Kuhno, in the art of labels, teaches a container (wheeled cart 24 and RFID printer 20, fig. 1a, [0078]) housing a sensor assembly which includes a plurality of disposable labels (RFID tags which printer 20 dispenses, fig. 1a, [0078] and [0079]) and a reusable housing (handheld barcode scanner 22, fig. 1a, [0078]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to incorporate the container of Kuhno with the system of Bauss modified by Helmer, Bock, and Holbrook since Kuhno deals with RFID labels. One would have been motivated to make the modification because having a container, such as the cart of Kuhno, on which both the disposable labels and the reusable housing can be kept facilitates ease of transportation and use of the sensor assembly.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauss as modified and applied to claim 17 above and further in view of Khoche (US 20190272458 A1; hereafter Khoche).
Regarding claim 18, Bauss as modified discloses the system of claim 17, as described above.
Bauss as modified is silent to the disposable label including a further electrically conductive trace.
Khoche, in the art of labels, teaches wherein the disposable label (segments 270, fig. 8b, [0075]) includes a further electrically conductive trace (circuitry 282, fig. 8b, [0077]), wherein a portion of the label including the further electrically conductive trace is attached to the container (tracking adhesive product 294, fig. 8b shows that cutting along line 280 separates segment 270 from the remainder of the tracking adhesive product 294, [0077]; see also roll 16, fig. 1a, [0037]), wherein a first portion the further electrically conductive trace is configured to be altered in response to removal of the sensor assembly from the container ([0077] “After the user cuts across the tracking adhesive product 294 along the designated cut-line 280, the user creates an open circuit in the loop 282, which pulls up the voltage on the switch node above the threshold level to close the switch 296 and turn on the tracking circuit 278”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the disposable label of Bauss as modified to include a further electrically conductive trace which is modified when removed from storage, as taught by Khoche. One would have been motivated to make the modification because, as noted by Khoche [0077], such a configuration prevents the label from premature transmission or activation of circuits which may unnecessarily deplete battery power if the circuit is active prior to removal from storage.
Examiner notes that Bauss as modified by Khoche would include the further electrically conductive trace in connection with the existing conductive trace of Bauss as modified by Helmer, and thus also satisfies the limitation of “wherein the processor is removably electrically coupled to the further electrically conductive trace”, because the processor of the reusable housing of Bauss modified by Helmer can be connected and disconnected to the electrically conductive trace of the disposable label. See 103 rejection of claim 1 above.
Regarding claim 19, Bauss as modified discloses the system of claim 17, as described above.
Bauss as modified is silent to the disposable label including a second portion of the electrically conductive trace configured to be altered by removal of the sensor assembly from the container.
Khoche, in the art of labels, teaches wherein a portion of the electrically conductive trace (circuitry 282, fig. 8b, [0077]) is configured to be altered ([0077] “After the user cuts across the tracking adhesive product 294 along the designated cut-line 280, the user creates an open circuit in the loop 282, which pulls up the voltage on the switch node above the threshold level to close the switch 296 and turn on the tracking circuit 278”) in response to removal of the sensor assembly from the container (tracking adhesive product 294, fig. 8b), and wherein a portion of the disposable label is attached to the container (tracking adhesive product 294, fig. 8b shows that cutting along line 280 separates segment 270 from the remainder of the tracking adhesive product 294, [0077]; see also roll 16, fig. 1a, [0037]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the disposable label of Bauss as modified to include a second portion of the electrically conductive trace which is modified when removed from storage, as taught by Khoche. One would have been motivated to make the modification because, as noted by Khoche [0077], such a configuration prevents the label from premature transmission or activation of circuits which may unnecessarily deplete battery power if the circuit is active prior to removal from storage.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Krejcarek (US 20200111343 A1) - low-power electronic tape
Koltchine (US 20160232820 A1) - rigid deformable clip
Conner (US 20090114729 A1) - label container
Ballam (US 10108898 B1) - label with frangible sections which activate/deactivate the label
Bright (US 20190050707 A1) - NFC/RFID tag with multiple frangible portions
Wilson (US 20150164741 A1) - disposable content tracker with reusable PCB
Johnson (US 20190115691 A1) - male/female port/connector electrical connection with multiple electrical contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 04/03/2026
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