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 .
Status of the Claims
Claims 18-48 are currently pending. Claims 18 and 38 are currently amended. Claims 47-48 are newly added. Claims 24-28 and 32-37 are currently withdrawn. Claims 18-23, 29-31, and 38-48 are currently rejected.
Response to Arguments
Applicant's arguments filed 05/18/2026 have been fully considered but they are not persuasive. Note that the rejections of claims 18 and 38 have been updated to address the newly added claim limitations.
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).
Applicant argues that Edwards does not disclose the limitation “the cap body including a proximal body portion and a distal body portion configured to be inserted into the medicament delivery device and surround a medicament delivery member of the medicament delivery device”.
Examiner notes that Edwards is not relied on for teaching this newly added limitation. Please see the updated 103 rejection of claims 18 and 38 below which address this new limitation with mapping to the primary reference Chang, not the secondary reference Edwards.
Applicant argues that Chang and Edwards do not teach, disclose, or suggest, “the movable member being a flexible arm fixed to the medicament delivery device such that when the cap body is removed from the medicament delivery device, the movable member stays with the medicament delivery device”.
Examiner disagrees with the characterization of Chang modified by Edwards presented by the Applicant. Applicant argues that due to the arrangement of the battery isolation tab 4860 as attached to the needle guard 4810 instead of the auto-injector 4002, that Edwards fails to teach, disclose, or suggest the noted limitation. However, Edwards is not relied upon for solely teaching the noted limitation. The teachings of Edwards are applied to modify Chang such that Chang modified by Edwards meets the noted limitation.
As previously described in the prior 103 rejection of claims 18 and 38:
Chang discloses the electronics (electronic component 320, power source 322) associated with the cap body (tubular member 311)
Chang discloses the electrical connection prevented when the cap body is attached to the medicament delivery device ([0086])
Chang is silent to a moveable member
Edwards teaches a moveable member (battery isolation tab 4860) arranged such that the separation of two structures (a cap body and a medicament delivery) pulls the flexible arm away from the structure containing the electrical components (in the case of Edwards, the device 4002) and thus allows for activation of electrical components ([1274], [1279])
As previously described, since the flexible arm, as taught by Edwards, is associated with the structure (of the two structures the cap body and the medicament delivery device) that does not contain the electronic components, then the modification of the medicament delivery device of Chang to include the movable member, such that the movable member is removed from engagement with the electronic components of the cap body during separation of the two structures (the cap body and the medicament delivery device), would have been obvious to a PHOSITA prior to the filing date of the invention.
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 18-23, 29-31, and 38-48 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 18 recites the limitation “the cap body including a proximal body portion and a distal body portion configured to be inserted into the medicament delivery device and surround a medicament delivery member” on lines 4-6. It is unclear from this phrasing whether both the proximal body portion and the distal body portion are configured to be both inserted into the medicament delivery device and surround a medicament delivery member, only the distal body portion is configured to be both inserted into the medicament delivery device and surround a medicament delivery member, or whether the proximal body portion is meant to be inserted into the medicament delivery device and the distal body portion is meant to surround a medicament delivery member. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 38 recites the limitation “the cap body including a proximal body portion and a distal body portion configured to be inserted into the medicament delivery device and surround a medicament delivery member” on lines 5-7. It is unclear from this phrasing whether both the proximal body portion and the distal body portion are configured to be both inserted into the medicament delivery device and surround a medicament delivery member, only the distal body portion is configured to be both inserted into the medicament delivery device and surround a medicament delivery member, or whether the proximal body portion is meant to be inserted into the medicament delivery device and the distal body portion is meant to surround a medicament delivery member. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 19-23, 29-31, and 39-48 are rejected for depending, either directly or indirectly, on a claim rejected under 112(b), since claims inherit the deficiencies of those claims from 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) 18-20, 38-40, and 47-48 is/are rejected under 35 U.S.C. 103 as over Chang et al (WO-2018237225-A1; hereafter Chang; submitted as part of Applicant’s IDS) view of Edwards et al (WO 2007126851 A2; hereafter Edwards). Text reference is made to the pdf of Edwards included with the Non-Final Rejection of 07/02/2025.
Regarding claim 18, Chang discloses a cap assembly (cap 310, fig. 20, [0084]; [0083] drug delivery device 300 includes similar features and elements of drug delivery device 100/200 and thus reference numerals with identical two-digit suffixes represent similar components) adapted to removably attach to a medicament delivery device (drug delivery device 300, [0083], figs. 20-23), the cap assembly ([0029] figs. 20-23 show removable cap 310) comprises:
a longitudinally extending cap body ([0065] caps 110/310 may be formed by a tubular member 111/311, shown to extend longitudinally in fig. 20) configured to be removably attached to the medicament delivery device ([0029] figs. 20-23 show a removable cap), the cap body including a proximal body portion and a distal body portion configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to be inserted into the medicament delivery device (300; note [0083] “drug delivery device 300 includes similar features and elements as the drug delivery devices 100 and 200 of Figs. 1-19”; [0079-0080] describes housing 202 and needle guard 205 of drug delivery device 200; see modified figs. 16 and 22 below which show that a body portion is inserted into the needle guard 205 of the medicament delivery device 200/300) and surround a medicament delivery member (needle noted in modified figs. 16 and 22 below) of the medicament delivery device (see fig. 22, a body portion of tubular member 311 of cap 310 surrounds medicament delivery member shown as a needle, noted in [0035]);
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an electronic component (electronic component 320) associated with the cap body (fig. 20 shows electronic component 320 with cap body; [0084] describes electronic component);
a power source (power source 322) associated with the cap body (322 shown in figs. 22 and 23 as part of cap body) and configured for powering the electronic component ([0064] power source 122 selectively powers electronic component 120; note [0083] stating essentially that 122=322 and 120=320);
a resilient member (activation mechanism 340, fig. 21, [0084] activation mechanism 340 may be constructed of a resilient material such as steel or other suitable metals) associated with the cap body (310) and configured to establish an electrical connection between the power source (322) and the electronic component (320, fig. 20) ([0086] when cap is removed facing surface 350 of activation mechanism 340 contacts rotating switch 334 and causes power to be supplied to electronic component);
and an arrangement such that when the cap body is attached to the medicament delivery device, the resilient member (340) is prevented to establish the electrical connection between the power source (322) and the electronic component (320) ([0086] needle guard contacts activation lever 344 in such a way as to bias the facing surface 350 away from rotating switch 334 thereby preventing power when cap is attached, see fig. 22).
Chang is silent to a movable member.
Edwards, in the art of drug delivery devices, teaches wherein the cap body (auto-injector 4002, fig. 57, [1277]; Examiner notes that the components associated with the cap body and medicament delivery devices are reversed due to rearrangement of parts, see below.) comprises a movable member (battery isolation tab 4860, fig. 54, [1279]), the moveable member (battery isolation tab 4860) being a flexible arm ([1274] The battery isolation tab 4860 can be constructed from any electrically isolative material, such as, for example, Mylar®.; see [1417] which notes that Mylar is a flexible material) fixed to the medicament delivery device (needle guard 4810, fig. 57; Examiner notes that the components associated with the cap body and medicament delivery devices are reversed due to rearrangement of parts, see below; [1346] the needle guard 4810 and the battery isolation tab 4860 are…coupled together. In other embodiments, a needle guard and a battery isolation tab can be constructed monolithically.) such that when the cap body (auto-injector 4002) is removed (see fig. 57) from the medicament delivery device (needle guard 4810), the movable member (battery isolation tab 4860) stays with the medicament delivery device (needle guard 4810) (see fig. 57 which shows movable member 4860 staying with medicament delivery device 4810, separating from the electronics which remain associated with cap body 4002), and
wherein the movable member (4860) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to interact with the resilient member (first electrical contact portion 4936, fig. 54, [1279]) and with a component (actuator 4864, fig. 57, [1279]) of the medicament delivery device (needle guard 4810, fig. 57, [1279]) such that when the cap body (4002) is attached to the medicament delivery device (4810), the resilient member (4936, fig. 54) is prevented to establish the electrical connection between the power source and the electronic component ([1274] battery isolation tab 4860 is movably disposed between the first electrical contact portion 4936 of the printed circuit board 4922 and the first surface 4964 of one of the batteries 4962; [1279] only after the needle guard 4810 is removed from the base 4520 of the device 4002, are the batteries activated).
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 Chang to have a movable member as taught by Edwards since both references teach alternative ways to activate a circuit of a medicament delivery device when the cap and main body are separated. The insulator of Edwards used to physical separate the electrical components could be added to the deformation requirement for activation of Chang to further ensure that activation of the circuit not happen prematurely. Examiner notes that since Edwards is modifying Chang, and Edwards has the electrical components associated with the medicament delivery device instead of with the cap body as disclosed by Chang, one of ordinary skill in the art would have been motivated to modify the cap body of Chang with the elements associated with the medicament delivery device of Edwards, and vice versa, in the manner described with reference to Edwards above. It further would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the cap body of Chang with the elements associated with the medicament delivery device of Edwards, and vice versa, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of allowing a circuit to close and indicating separation of the cap body and medicament delivery device. One would have been motivated to make the modification since the battery isolation tab 4860 of Edwards provides a visible, physical indication that the battery has been activated.
Regarding claim 19, Chang modified by Edwards discloses cap assembly according to claim 18, as described above. Chang further discloses wherein the resilient member (facing surface 350, fig. 21) is a spring arm ([0084] activation mechanism 340 is in the form of a spring lever, facing surface 50 is a part of activation mechanism 340; thus, facing surface 350 is a spring arm), a compression spring and/or a torsion spring or a combination thereof.
Regarding claim 20, Chang modified by Edwards discloses the cap assembly according to claim 18, as described above, including wherein the resilient member (Chang: 340, fig. 21; Edwards: first electrical contact portion 4936, fig. 54) comprises a fixed end (Chang: body portion 341, fig. 21; Edwards: portion of contact 4936 connected directly to cap body/auto-injector 4002) which is fixedly connected to the cap body (Chang: 310, fig. 20; fig. 22/23 show assembled state of device; Edwards: auto-injector 4002, fig. 57), and a free end (Chang: facing surface 350, fig. 22, [0086] facing surface 350 is displaced away from the rotating switch 334; Edwards: portion of contact 4936 which contacts the movable member/battery isolation tab 4860) which is releasably connected to the movable member (Edwards: note [1274] which notes connection of movable member 4860 and resilient member 4936; see Edwards fig. 57 which shows aftermath of disconnection of these elements).
Regarding claim 38, Chang discloses a cap assembly (cap 310, fig. 20, [0084]; [0083] drug delivery device 300 includes similar features and elements of drug delivery device 100/200 and thus reference numerals with identical two-digit suffixes represent similar components) adapted to removably attach to a medicament delivery device (drug delivery device 300, [0083], figs. 20-23), the cap assembly ([0029] figs. 20-23 show removable cap 310) comprises:
a longitudinally extending cap body [0065] caps 110/310 may be formed by a tubular member 111/311, shown to extend longitudinally in fig. 20) configured to be removably attached to the medicament delivery device ([0029] figs. 20-23 show a removable cap), ), the cap body including a proximal body portion and a distal body portion configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to be inserted into the medicament delivery device (300; note [0083] “drug delivery device 300 includes similar features and elements as the drug delivery devices 100 and 200 of Figs. 1-19”; [0079-0080] describes housing 202 and needle guard 205 of drug delivery device 200; see modified figs. 16 and 22 below which show that a body portion is inserted into the needle guard 205 of the medicament delivery device 200/300) and surround a medicament delivery member (needle noted in modified figs. 16 and 22 below) of the medicament delivery device (see fig. 22, a body portion of tubular member 311 of cap 310 surrounds medicament delivery member shown as a needle, noted in [0035]);
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an electronic component (electronic component 320) associated with the cap body (fig. 20 shows electronic component 320 with cap body; [0084] describes electronic component);
a power source (power source 322) associated with the cap body (322 shown in figs. 22 and 23 as part of cap body) and configured for powering the electronic component ([0064] power source 122 selectively powers electronic component 120; note [0083] stating essentially that 122=322 and 120=320);
a resilient member (activation mechanism 340, fig. 21, [0084] activation mechanism 340 may be constructed of a resilient material such as steel or other suitable metals) associated with the cap body (310) and configured to establish an electrical connection between the power source (322) and the electronic component (320, fig. 20) ([0086] when cap is removed facing surface 350 of activation mechanism 340 contacts rotating switch 334 and causes power to be supplied to electronic component);
and an arrangement such that when the cap body is attached to the medicament delivery device, the resilient member (340) is prevented to establish the electrical connection between the power source (322) and the electronic component (320) ([0086] needle guard contacts activation lever 344 in such a way as to bias the facing surface 350 away from rotating switch 334 thereby preventing power when cap is attached, see fig. 22).
Chang is silent to a movable member.
Edwards, in the art of drug delivery devices, teaches
a movable member (4860) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to interact with the resilient member (first electrical contact portion 4936, fig. 54, [1279]) and with a component (actuator 4864, fig. 57, [1279]) of the medicament delivery device (needle guard 4810, fig. 57; Examiner notes that the components associated with the cap body and medicament delivery devices are reversed due to rearrangement of parts, see below; [1346] the needle guard 4810 and the battery isolation tab 4860 are…coupled together. In other embodiments, a needle guard and a battery isolation tab can be constructed monolithically.) such that when the cap body (auto-injector 4002) such that when the cap body (auto-injector 4002, fig. 57, [1277]; Examiner notes that the components associated with the cap body and medicament delivery devices are reversed due to rearrangement of parts, see below.) is attached to the medicament delivery device (4810), the resilient member (4936, fig. 54) is prevented to establish the electrical connection between the power source and the electronic component ([1274] battery isolation tab 4860 is movably disposed between the first electrical contact portion 4936 of the printed circuit board 4922 and the first surface 4964 of one of the batteries 4962; [1279] only after the needle guard 4810 is removed from the base 4520 of the device 4002, are the batteries activated),
wherein the moveable member (battery isolation tab 4860, fig. 54, [1279]) is a flexible arm ([1274] The battery isolation tab 4860 can be constructed from any electrically isolative material, such as, for example, Mylar®.; see [1417] which notes that Mylar is a flexible material) fixed to the medicament delivery device (needle guard 4810, fig. 57; [1346] the needle guard 4810 and the battery isolation tab 4860 are…coupled together. In other embodiments, a needle guard and a battery isolation tab can be constructed monolithically.) such that when the cap body (auto-injector 4002) is removed (see fig. 57) from the medicament delivery device (needle guard 4810), the movable member (battery isolation tab 4860) stays with the medicament delivery device (needle guard 4810) (see fig. 57 which shows movable member 4860 staying with medicament delivery device 4810, separating from the electronics which remain associated with cap body 4002).
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 Chang to have a movable member as taught by Edwards since both references teach alternative ways to activate a circuit of a medicament delivery device when the cap and main body are separated. The insulator of Edwards used to physical separate the electrical components could be added to the deformation requirement for activation of Chang to further ensure that activation of the circuit not happen prematurely. Examiner notes that since Edwards is modifying Chang, and Edwards has the electrical components associated with the medicament delivery device instead of with the cap body as disclosed by Chang, one of ordinary skill in the art would have been motivated to modify the cap body of Chang with the elements associated with the medicament delivery device of Edwards, and vice versa, in the manner described with reference to Edwards above. It further would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the cap body of Chang with the elements associated with the medicament delivery device of Edwards, and vice versa, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of allowing a circuit to close and indicating separation of the cap body and medicament delivery device. One would have been motivated to make the modification since the battery isolation tab 4860 of Edwards provides a visible, physical indication that the battery has been activated.
Regarding claim 39, Chang modified by Edwards discloses cap assembly according to claim 38, as described above. Chang further discloses wherein the resilient member (facing surface 350, fig. 21) is a spring arm ([0084] activation mechanism 340 is in the form of a spring lever, facing surface 50 is a part of activation mechanism 340; thus, facing surface 350 is a spring arm), a compression spring and/or a torsion spring or a combination thereof.
Regarding claim 40, Chang modified by Edwards discloses the cap assembly according to claim 38, as described above, including wherein the resilient member (Chang: 340, fig. 21; Edwards: first electrical contact portion 4936, fig. 54) comprises a fixed end (Chang: body portion 341, fig. 21; Edwards: portion of contact 4936 connected directly to cap body/auto-injector 4002) which is fixedly connected to the cap body (Chang: 310, fig. 20; fig. 22/23 show assembled state of device; Edwards: auto-injector 4002, fig. 57), and a free end (Chang: facing surface 350, fig. 22, [0086] facing surface 350 is displaced away from the rotating switch 334; Edwards: portion of contact 4936 which contacts the movable member/battery isolation tab 4860) which is releasably connected to the movable member (Edwards: note [1274] which notes connection of movable member 4860 and resilient member 4936; see Edwards fig. 57 which shows aftermath of disconnection of these elements).
Regarding claim 47, Chang modified by Edwards discloses the cap assembly according to claim 18, as described above, including wherein the medicament delivery member is either a needle (see Chang modified figs. 16 and 22 above, note that the needle is mapped to the “medicament delivery member”) or a spray nozzle.
Regarding claim 48, Chang modified by Edwards discloses the cap assembly according to claim 38, as described above, including wherein the medicament delivery member is either a needle (see Chang modified figs. 16 and 22 above, note that the needle is mapped to the “medicament delivery member”) or a spray nozzle.
Claim(s) 21-23 and 41-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang modified by Edwards and further in view of Keen et al (US-20180160742-A1; hereafter Keen).
Regarding claim 21, Chang modified by Edwards discloses the cap assembly according to claim 18, as described above.
Chang and Edwards are silent to the flexible arm comprising a radial inwardly protruding holding member.
Keen further teaches wherein a movable member (insulator 8, fig. 3, [0054]) is a flexible arm (see fig. 3, note [0054] insulator 8 may be a paper, polymer, fabric, plastic, or combination thereof) comprising a radial inwardly protruding holding member (see fig. 3 which shows that insulator 8 can bend to have a radial inwardly protruding holding member) configured to prevent the resilient member (wire 10, [0053] wire 10 may be made of a resilient material) from establishing the electrical connection between the power source and the electronic component ([0053] removal of insulator 8 allows wire 10 to establish electrical contact with the housing and complete the circuit), and wherein the flexible arm is radially movable in relation to the cap body ([0053] note that the flexible arm that is the movable member/insulator 8 can be deflected/bent relative to the cap 45 and thus is radially movable).
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 movable member of Chang and Edwards to be a flexible arm as taught by Keen because the flexibility allowing for a radial inward protrusion of the flexible arm would allow for the movable member to effectively interrupt the circuit even if the arrangement of the resilient member and the movable member differ due to slight differences in cap body/medicament delivery device assembly.
Regarding claim 22, Chang modified by Edwards and Keen discloses the cap assembly according to claim 21, as described above, including wherein the flexible arm extends longitudinally in relation to the cap body (see Keen fig. 3, insulator 8 extends longitudinally in relation to the cap body; see also Edwards fig. 57) and the holding member is arranged on a free end of the flexible arm (see Keen fig. 3).
Regarding claim 23, Chang modified by Edwards and Keen discloses the cap assembly according to claim 21, as described above, including wherein the flexible arm extends laterally in relation the cap body (see Keen fig. 3, insulator 8 extends laterally in relation to the cap body) and the holding member is arranged on a free end of the flexible arm (see fig. 3).
Regarding claim 41, Chang modified by Edwards discloses the cap assembly according to claim 38, as described above.
Chang and Edwards are silent to the flexible arm comprising a radial inwardly protruding holding member.
Keen further teaches wherein a movable member (insulator 8, fig. 3, [0054]) is a flexible arm (see fig. 3, note [0054] insulator 8 may be a paper, polymer, fabric, plastic, or combination thereof) comprising a radial inwardly protruding holding member (see fig. 3 which shows that insulator 8 can bend to have a radial inwardly protruding holding member) configured to prevent the resilient member (wire 10, [0053] wire 10 may be made of a resilient material) from establishing the electrical connection between the power source and the electronic component ([0053] removal of insulator 8 allows wire 10 to establish electrical contact with the housing and complete the circuit), and wherein the flexible arm is radially movable in relation to the cap body ([0053] note that the flexible arm that is the movable member/insulator 8 can be deflected/bent relative to the cap 45 and thus is radially movable).
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 movable member of Chang and Edwards to be a flexible arm as taught by Keen because the flexibility allowing for a radial inward protrusion of the flexible arm would allow for the movable member to effectively interrupt the circuit even if the arrangement of the resilient member and the movable member differ due to slight differences in cap body/medicament delivery device assembly.
Regarding claim 42, Chang modified by Edwards and Keen discloses the cap assembly according to claim 41, as described above, including wherein the flexible arm extends longitudinally in relation to the cap body (see Keen fig. 3, insulator 8 extends longitudinally in relation to the cap body; see also Edwards fig. 57) and the holding member is arranged on a free end of the flexible arm (see Keen fig. 3).
Regarding claim 43, Chang modified by Edwards and Keen discloses the cap assembly according to claim 41, as described above, including wherein the flexible arm extends laterally in relation the cap body (see Keen fig. 3, insulator 8 extends laterally in relation to the cap body) and the holding member is arranged on a free end of the flexible arm (see fig. 3).
Claim(s) 29 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang modified by Edwards as applied to claim 18 above, and further in view of a second embodiment of Edwards (hereafter Edwards-2).
Regarding claim 29, Chang modified by Edwards discloses the cap assembly according to claim 18, as described above, including the resilient member (Chang: activation mechanism 340, fig. 21) is configured to decouple from the movable member (Edwards: battery isolation tab 4860, fig. 57) once the cap assembly is removed from the medicament delivery device (see rejection of claim 18 above).
Chang and Edwards are silent to the resilient member irreversibly decoupling from the movable member.
Edwards-2 teaches wherein the transition from one electronic state to another is irreversible due to a frangible “tear-through” switch ([1385] in some embodiments, a switch can be a "tear- through" switch configured to move irreversibly from a first state to a second state).
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 removal of the movable member of Chang and Edwards to incorporate the frangible, irreversible nature of the electrical transition of Edwards-2 since all references deal with electrical state transitions. One would have been motivated to make the modification because the irreversibility of the change would allow a user to know if a device had already been used, thus ensuring that a user would not mistakenly use a device which had been tampered with.
Regarding claim 44, Chang modified by Edwards discloses the cap assembly according to claim 38, as described above, including the resilient member (Chang: activation mechanism 340, fig. 21) is configured to decouple from the movable member (Edwards: battery isolation tab 4860, fig. 57) once the cap assembly is removed from the medicament delivery device (see rejection of claim 18 above).
Chang and Edwards are silent to the resilient member irreversibly decoupling from the movable member.
Edwards-2 teaches wherein the transition from one electronic state to another is irreversible due to a frangible “tear-through” switch ([1385] in some embodiments, a switch can be a "tear- through" switch configured to move irreversibly from a first state to a second state).
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 removal of the movable member of Chang and Edwards to incorporate the frangible, irreversible nature of the electrical transition of Edwards-2 since all references deal with electrical state transitions. One would have been motivated to make the modification because the irreversibility of the change would allow a user to know if a device had already been used, thus ensuring that a user would not mistakenly use a device which had been tampered with.
Claim(s) 30-31 and 45-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang modified by Edwards as applied to claim 18 above, and further in view of Felber et al (WO-2019121613-A1; hereafter Felber). Text reference is made to the pdf of Felber included with the Non-Final Rejection of 07/02/2025.
Regarding claim 30, Chang modified by Edwards discloses the cap assembly according to claim 18, as described above.
Chang and Edwards are silent to an energy harvester.
Felber, in the field of injection devices, teaches wherein the power source (RF module 212, fig. 2, pg. 9 ln. 33- pg. 10 ln. 2, RF module 212 includes an RF harvester 232) comprises an energy harvester (RF harvester 232, fig. 2) configured to harvest energy from at least one of an interrogation signal (radio frequency (RF) signal; pg. 11 ln. 19-22, RF harvester 232 can harvest energy from RF signals generated by an external device) and a removal operation of the cap assembly from the medicament delivery device.
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 Chang modified by Edwards to include the RF harvester of Felber since all references deal with drug delivery devices. One would have been motivated to make the modification because the RF harvester would allow the device to not be wholly dependent on the battery.
Regarding claim 31, Chang modified by Edwards and Felber discloses the cap assembly according to claim 30, as described above, including wherein the energy harvester (Felber: 232) is configured to harvest energy from a collateral device (Felber: pg. 11 ln. 19-22, RF harvester 232 can harvest energy from RF signals generated by an external device).
Regarding claim 45, Chang modified by Edwards discloses the cap assembly according to claim 38, as described above.
Chang and Edwards are silent to an energy harvester.
Felber, in the field of injection devices, teaches wherein the power source (RF module 212, fig. 2, pg. 9 ln. 33- pg. 10 ln. 2, RF module 212 includes an RF harvester 232) comprises an energy harvester (RF harvester 232, fig. 2) configured to harvest energy from at least one of an interrogation signal (radio frequency (RF) signal; pg. 11 ln. 19-22, RF harvester 232 can harvest energy from RF signals generated by an external device) and a removal operation of the cap assembly from the medicament delivery device.
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 Chang modified by Edwards to include the RF harvester of Felber since all references deal with drug delivery devices. One would have been motivated to make the modification because the RF harvester would allow the device to not be wholly dependent on the battery.
Regarding claim 46, Chang modified by Edwards and Felber discloses the cap assembly according to claim 45, as described above, including wherein the energy harvester (Felber: 232) is configured to harvest energy from a collateral device (Felber: pg. 11 ln. 19-22, RF harvester 232 can harvest energy from RF signals generated by an external device).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 07/23/2026
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