DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 3/19/26 have been fully considered but they are not persuasive. Applicant argues that Eichler does not teach wherein the cartridge carrier has a keyed connector protruding within the interior and facing the central axis and an activator mechanism to cause the cartridge carrier to actuate and rotate about the central axis as now claimed. The examiner disagrees and has rejected the new limitations over Eichler as described below. Eichler teaches that the locking features may have a reverse configuration from what is shown in the figures such that the inhaler 1 has the recesses and the device 23 has the projections or protrusions. (paragraph 166)
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.
Claim 5 is 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.
Regarding claim 5, the limitation “wherein the keyed connector includes one or more alignment features that protrude into the cartridge carrier” appears to conflict with the limitation of claim 1 which states the keyed connector protrudes into the interior of the cartridge carrier.
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.
Claims 1, 3-6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Eicher et al (US 2020/0384316), hereinafter Eicher.
Regarding claim 1, Eicher teaches a handheld medication dispensing device (Fig. 6) comprising:
a housing having a cartridge carrier therein (Fig. 6, Fig. 7, housing 23 has an interior to hold cartridge 1), the cartridge carrier having an interior with a central axis passing along a length of the interior, (Fig. 6: housing 23 has a central axis passing through as shown in Fig. 6 and labeled “D”, housing has interior, see fig. 6),
the cartridge carrier having a keyed connector, the keyed connector being keyed to a medication cartridge to allow for insertion and alignment of the medication cartridge within the cartridge carrier (housing 23 has coupling sections 30b,see figs. 5, 7 to hold medication cartridge 1, paragraph 122, a groove guide can be provided on the inhaler 1 and the device 23 so that the inhaler 1 can be coupled to and/ or decoupled from the device 23 by an axial movement. In particular the inhaler 1 and the device comprise mutually corresponding interlocking elements for examples grooves and chamfers); and
an activator mechanism positioned within the housing (fig. 5, paragraph 126, drive 26), the activator mechanism operably connected with the cartridge carrier to cause the cartridge carrier to actuate (paragraph 142, the transmission of torque from the drive 26 to the inhaler or a housing part of the inhaler takes place by means of the coupling device 30b ), and rotate about the central axis, (Paragraph 149, paragraph 15 3, device 23 can move, rotate, the housing parts relative to one another so that the spring is tensioned, the examiner notes that the inhaler 1 rotates about axis D)
whereby upon activation, the cartridge carrier moves an inserted medication cartridge between a stored position and a dispensing position.(Paragraph 70, during the axial tension of the energy store 7, the holder t with the container 3 is moved downwards. This positions the cartridge in an actuation ready position, paragraph 143, the device 23 and/or the drive 26 are preferably designed to put the inhaler 1 into the triggering ready state)
Eichler teaches the keyed connector is a groove and so does not teach the keyed connector protruding within the interior towards the central axis.
However, in another embodiment, Eichler teaches that the keyed connector is protruding within the interior and facing the central axis (Paragraph 166, the cartridge carrier 23 may have the protruding potions, the protrusions and grooves may be reversed)
it would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified Eichler so the keyed connector protrudes into the interior as taught by the alternative embodiment of Eichler since the courts have held that a mere reversal of parts is an obvious modification. Further, the examiner notes that the reversal of the groove and the protrusion would still result in a keyed connector.
Regarding claim 3, Eicher teaches the handheld dispensing device as set forth in claim 2, wherein the cartridge carrier includes a proximal end and a distal end, the proximal end being open for receiving the medication cartridge therein, while the distal end includes a gear wheel operably connected to the activator mechanism. (See Fig. 5, the proximal end of 30b is the insertion end for inhaler 1 and the distal end has gear wheels 29a, Fig. 6)
Regarding claim 4, Eicher teaches the handheld medication dispensing device as set forth in claim 3, wherein the activator mechanism includes at least a battery (paragraph 134, device has an integrated batter), a motor (Fig. 6, paragraph 140, motor 27), and one or more gears that are operably connected to the gear wheel (Fig. 6: 29b ), such that the activation of the activator mechanism causes the motor to turn the one or more gears and, in doing so, turn the gear wheel and rotate the cartridge carrier .(paragraph 130, paragraph 138, the gear mechanism comprises a gearwheel 29a, 29b to transmit movement from the motor to the inhaler)
Regarding claim 5, Eicher teaches the handheld medication dispensing device as set forth in claim 4, wherein the keyed connector includes one or more alignment features that protrude into the cartridge carrier. (Fig. 3: sections 31, paragraph 156, paragraph 157, fits into 32b shown in Fig. 7)
Regarding claim 6, Eicher teaches the handheld medication dispensing device as set forth in claim 5, wherein activation of the activator mechanism causes a rotation of the cartridge carrier (Paragraphs 149, 153, 30b which holds the inhaler 1 is rotated by the gears)
Regarding claim 8, Eicher teaches the handheld medication dispensing device as set forth in claim 1, wherein the keyed connector includes one or more alignment features that protrude into the cartridge carrier. (Fig. 3: sections 31, paragraph 156, paragraph 157, fits into 32b shown in Fig. 7)
Regarding claim 9, Eicher teaches the handheld medication device as set forth in claim 1, wherein activation of the activator mechanism causes a rotation of the cartridge carrier. (Paragraphs 149, 153, 30b which holds the inhaler 1 is rotated by the gears)
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Eichler et al (US 2020/0384316), hereinafter Eicher in view of Decock et al (US 2022/0379046), hereinafter Decock.
Regarding claim 7, Eicher teaches the handheld medication dispensing device as set forth in claim 6, but does not teach an authentication mechanism operably connected with the activator mechanism.
However, Decock teaches a product dispensing device (abstract) comprising an authentication mechanism operably connected with the activator mechanism (paragraph 60, when the user's fingerprint has been authenticated electronic control means, control the production of a circuit to activate the device), the authentication mechanism operable for authenticating a user and, when authenticated activation the activator mechanism to cause the cartridge carrier to actuate and move an inserted medication cartridge from the stored position to the dispensing position. (Paragraph 60 moves the actuator into a ready position to be activated)
It would have been obvious to modify the device of Eicher which the authentication mechanism of Decock in order to assure that the user is authorized to use the device. (Paragraph74)
Regarding claim 10, Eicher teaches the handheld medication dispensing device as set forth in claim 1, but does not teach an authentication mechanism operably connected with the activator mechanism.
However, Decock teaches a product dispensing device (abstract) comprising an authentication mechanism operably connected with the activator mechanism (paragraph 60, when the user's fingerprint has been authenticated electronic control means, control the production of a circuit to activate the device), the authentication mechanism operable for authenticating a user and, when authenticated activation the activator mechanism to cause the cartridge carrier to actuate and move an inserted medication cartridge from the stored position to the dispensing position. (Paragraph 60 moves the actuator into a ready position to be activated)
It would have been obvious to modify the device of Eicher which the authentication mechanism of Decock in order to assure that the user is authorized to use the device. (Paragraph 74)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, and 3-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,409,279, hereinafter Patent ‘289, in view of Eicher.
Regarding claim 1, Patent ‘279 teaches a handheld medication dispensing device (Claim 1, a handheld medication dispensing device), comprising:
a housing having a cartridge carrier therein, the cartridge carrier having a keyed connector that is keyed to a medication cartridge to allow for insertion and alignment of the medication cartridge within the cartridge carrier (Claim 1: a housing having a cartridge carrier therein, the cartridge carrier having a keyed connector that is keyed to a medication cartridge to allow for insertion and alignment of the medication cartridge within the cartridge carrier) ; and
an activator mechanism positioned within the housing, the activator mechanism operably connected with the cartridge carrier to cause the cartridge carrier to actuate and rotate about a central axis, whereby upon actuation, the cartridge carrier moves an inserted medication cartridge between a stored position and a dispensing position. (Claim 1: wherein the cartridge carrier rotatable within the housing, an activator mechanism positioned within the housing, the activator mechanism operably connected with the cartridge carrier to cause the cartridge carrier to actuate, whereby upon actuation, the cartridge carrier moves an inserted medication cartridge between a stored position and a dispensing position)
Patent ‘279 does not teach that the keyed connector protruding within the interior.
However, Eicher teaches an inhaler device wherein the cartridge carrier (23) has keyed connectors protruding towards the central axis. (Paragraph 166, features may protrude towards the inserted inhaler)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified patent ‘279 so that the keyed connector protrudes into the interior as taught by the alternative embodiment of Eichler since the courts have held that a mere reversal of parts is an obvious modification. Further, the examiner notes that the reversal of the groove and the protrusion would still result in a keyed connector.
Regarding claim 3, Patent ‘279 teaches the handheld medication dispensing device as set forth in Claim 2, wherein the cartridge carrier includes a proximal end and a distal end, the proximal end being open for receiving the medication cartridge therein, while the distal end includes a gear wheel operably connected to the activator mechanism. (Claim 2)
Regarding claim 4, Patent ‘279 teaches the handheld medication dispensing device as set forth in Claim 3, wherein the activator mechanism includes at least a battery, a motor, and one or more gears that are operably connected to the gear wheel, such that activation of the activator mechanism causes the motor to turn the one or more gears and, in doing so, turn the gear wheel and rotate the cartridge carrier. (Claim 3)
Regarding claim 5, Patent ‘279 teaches the handheld medication dispensing device as set forth in Claim 4, wherein the keyed connector includes one or more alignment features that protrude into the cartridge carrier. (Claim 4)
Regarding claim 6, Patent ‘279 teaches the handheld medication dispensing device as set forth in Claim 5, wherein activation of the activator mechanism causes a rotation of the cartridge carrier. (Claim 3, activation of the activator mechanism causes the motor to turn the one or more gears and in doing so turn the gear wheel and rotate the cartridge carrier)
Regarding claim 7, Patent ‘279 teaches the handheld medication dispensing device as set forth in Claim 6, further comprising an authentication mechanism operably connected with the activator mechanism, the authentication mechanism operable for authenticating a user and, when authenticated, activating the activator mechanism to cause the cartridge carrier to actuate and move an inserted medication cartridge from the stored position to the dispensing position. (Claim 5)
Regarding claim 8, Patent ‘279 teaches the handheld medication dispensing device as set forth in Claim 1, wherein the keyed connector includes one or more alignment features that protrude into the cartridge carrier. (Claim 4)
Regarding claim 9, Patent ‘279 teaches the handheld medication dispensing device as set forth in Claim 1, wherein activation of the activator mechanism causes a rotation of the cartridge carrier.(Claim 1)
Regarding claim 10, Patent ‘279 teaches the handheld medication dispensing device as set forth in Claim 1, further comprising an authentication mechanism operably connected with the activator mechanism, the authentication mechanism operable for authenticating a user and, when authenticated, activating the activator mechanism to cause the cartridge carrier to actuate and move an inserted medication cartridge from the stored position to the dispensing position. (Claim 5)
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:30 pm MT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARGARET M LUARCA/ Primary Examiner, Art Unit 3785
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