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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16492790, filed on 10 September 2019.
Claim Objections
Claims 11 and 12 are objected to because of the following informalities: “one of the first and the second engaging sections” should be “one of the first engaging section and the second engaging section”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10, 12-16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moller et al (US 2009/0012479).
Regarding claim 1, Moller discloses:
An injection device (Fig. 1) for injecting of a dose of a medicament (¶0054), the device comprising: an acoustic feedback arrangement (Figs. 11/12) comprising: a first feedback element (18) having a first engaging section (see Image 1 below) and having a free end section (Image 1) located at a predetermined distance from the first engaging section (Fig. 12); a second feedback element (17) having a second engaging section configured to engage with the first engaging section (¶0066); wherein the first feedback element (18) is movable, pivotable or resiliently deformable along a first direction from an initial state towards a biased state (¶0066); and a sound generator (26) audibly engageable with the free end section (Image 1) of the first feedback element (18) when the first feedback element returns from the biased state into the initial state (¶0066).
Image 1. Annotated portion of Fig. 12
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Regarding claim 2, Moller discloses:
The injection device according to claim 1, wherein the free end section (Image 1) of the first feedback element (18) is configured to strike the sound generator (26) to produce an audible feedback signal or feedback sound (¶0066 – “ a release mechanism 26 on the wedge structure 17 releases the locking mechanism, thereby releasing the tension which was previously built up in the spring arm 18. Thereby an audible signal is generated”).
Regarding claim 3, Moller discloses:
The injection device according to claim 1, further comprising a restoring element (27; Fig. 12) engaged with the first feedback element (18) and configured to provide a restoring force to displace or to pivot the first feedback element (18) from the biased state to the initial state (¶0067).
Regarding claim 4, Moller discloses:
The injection device according to claim 3, wherein the first feedback element (18) is pivotable or displaceable against the restoring force of the restoring element (27) from the initial state to the biased state (¶0067).
Regarding claim 5, Moller discloses:
The injection device according to claim 1, wherein the first feedback element (18) comprises a body having at least one hollow portion (see Image 2 below) at the free end section (Image 1).
Image 2. Annotated portion of Fig. 12
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Regarding claim 6, Moller discloses:
The injection device according to claim 1, wherein the free end section (Image 1) comprises a contact surface (end face) configured to audibly engage with the sound generator (26) when the first feedback element (18) returns from the biased state to the initial state (¶0066).
Regarding claim 7, Moller discloses:
The injection device according to claim 1, wherein the second feedback element (17) is configured to transfer the first feedback element (18) from the initial state towards the biased state (¶0066).
Regarding claim 8, Moller discloses:
The injection device according to claim 1, wherein the first feedback element (18) is transferable from the initial state towards and into the biased state through a movement of the second feedback element (17) (¶0066).
Regarding claim 9, Moller discloses:
The injection device according to claim 8, wherein a further movement of the second feedback element (17) relative to the first feedback element (18) causes a returning of the first feedback element (18) from the biased state into the initial state (¶0066 – rotation of the second feedback element 17 with respect to the first feedback element 18 causes the release mechanism 26 to activate and allow the first feedback element 18 to return to an initial state).
Regarding claim 10, Moller discloses:
The injection device according to claim 1, wherein the first feedback element (18) is translationally movable relative to the second feedback element (17) (¶0066 – because the element 18 can slide by the element 17, the movement can be considered translational).
Regarding claim 12, Moller discloses:
The injection device according to claim 1, further comprising a housing (4; Fig. 2) accommodating the acoustic feedback arrangement (Fig. 11) and a dose tracking member (10) (¶0066 – “scale drum”) movably arranged inside the housing (4) or movable attached to the housing during dispensing of the dose of the medicament, wherein one of the first and the second feedback elements (17) is connected to or integrated into the dose tracking member (10) and wherein the other one of the first and the second feedback elements (18) is connected to or integrated into the housing (4).
Regarding claim 13, Moller discloses:
The injection device according to claim 12, wherein the dose tracking member (10) comprises one of a number sleeve (¶0066 – “scale drum”), a clutch member and a drive sleeve rotationally and/or translationally movable relative to the housing (4) during dispensing of the dose of the medicament (¶0066).
Regarding claim 14, Moller discloses:
The injection device according to claim 12, further comprising: a medicament container (¶0016) filled with the medicament, arranged inside the housing (4) and sealed by a bung movably arranged inside a barrel of the medicament container (¶0016 – a piston seals the container); a piston rod (¶0016) movably arranged inside and relative to the housing (4) and operably engageable with the bung for expelling of the dose of the medicament from a cartridge (¶0016).
Regarding claim 15, Moller discloses:
An injection device (Fig. 1) for injecting of a dose of a medicament (¶0054), the device comprising: an acoustic feedback arrangement (Figs. 11/12) comprising: a first feedback element (18) having a first engaging section (Image 1) and having a free end section (Image 1) located at a predetermined distance from the first engaging section (Fig. 12); a second feedback element (17) having a second engaging section configured to engage with the first engaging section (¶0066); wherein the first feedback element (18) is movable from an initial state towards a biased state through an engagement with the second feedback element (17; ¶0066); and a sound generator (26) audibly engageable with the free end section (Image 1) of the first feedback element (18) when the first feedback element (18) returns from the biased state into the initial state (¶0066).
Regarding claim 16, Moller discloses:
The injection device according to claim 15, wherein the first feedback element (18) is one of movable, pivotable or resiliently deformable along a first direction (radially inward/outward direction) by a movement of the second feedback element (17) along a second direction (circumferential direction).
Regarding claim 18, Moller discloses:
The injection device according to claim 16, wherein the first direction is one of a circumferential or radial direction (radial direction).
Regarding claim 19, Moller discloses:
The injection device according to claim 18, wherein the first engaging section is resiliently deformable in one of the radial direction (radial direction) or circumferential direction through: a mechanical engagement with the second engaging section (17); and a longitudinal or axial movement of the second engaging section relative to the first engaging section.
Regarding claim 20, Moller discloses:
The injection device according to claim 15, wherein the first feedback element (18) is transferable from the initial state towards and into the biased state through at least one of a translational and a rotational movement (along the circumference, which is a translational movement) of the second feedback element (17).
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, 5-7, and 11-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, and 12-15 of U.S. Patent No. 11,517,680. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims anticipate the instant claims as detailed herein:
Instant
Patent No. 11517680
1. An injection device for injecting of a dose of a medicament, the device comprising:
an acoustic feedback arrangement comprising:
a first feedback element having a first engaging section and having a free end section located at a predetermined distance from the first engaging section;
a second feedback element having a second engaging section configured to engage with the first engaging section;
wherein the first feedback element is movable, pivotable or resiliently deformable along a first direction from an initial state towards a biased state; and
a sound generator
audibly engageable with the free end section of the first feedback element when the first feedback element returns from the biased state into the initial state.
1. An injection device for setting and injecting of a dose of a medicament, the injection device comprising:
an acoustic feedback arrangement comprising:
a first feedback element having a first engaging section and having a free end section located at a predetermined distance from the first engaging section;
a second feedback element having a second engaging section configured to engage with the first engaging section;
wherein the first feedback element is movable, pivotable or resiliently deformable along a first direction relative to the second feedback element from an initial state towards a biased state; and
a sound generator
formed by the first engaging section, wherein the first engaging section is configured to mechanically and audibly engage with the second engaging section when the first feedback element returns from the biased state to the initial state; or a sound generator mechanically and audibly engageable with the free end section of the first feedback element,
wherein the free end section comprises a contact surface configured to mechanically and audibly engage with the sound generator when the first feedback element returns from the biased state to the initial state.
15. An injection device for injecting of a dose of a medicament, the device comprising:
an acoustic feedback arrangement comprising:
a first feedback element having a first engaging section and having a free end section located at a predetermined distance from the first engaging section;
a second feedback element having a second engaging section configured to engage with the first engaging section;
wherein the first feedback element is movable from an initial state towards a biased state through an engagement with the second feedback element; and
a sound generator
audibly engageable with the free end section of the first feedback element when the first feedback element returns from the biased state into the initial state.
1. An injection device for setting and injecting of a dose of a medicament, the injection device comprising:
an acoustic feedback arrangement comprising:
a first feedback element having a first engaging section and having a free end section located at a predetermined distance from the first engaging section;
a second feedback element having a second engaging section configured to engage with the first engaging section;
wherein the first feedback element is movable, pivotable or resiliently deformable along a first direction relative to the second feedback element from an initial state towards a biased state; and
a sound generator
formed by the first engaging section, wherein the first engaging section is configured to mechanically and audibly engage with the second engaging section when the first feedback element returns from the biased state to the initial state; or a sound generator mechanically and audibly engageable with the free end section of the first feedback element,
wherein the free end section comprises a contact surface configured to mechanically and audibly engage with the sound generator when the first feedback element returns from the biased state to the initial state.
Instant
5
6
7
11
12
13
14
Patent
6
1
9
12
13
14
15
Claims 1, 5, 6, 12, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 15, 17, 19, and 20 of U.S. Patent No. 12,076,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims anticipate the instant claims as detailed herein:
Instant
Patent No. 12076538
1. An injection device for injecting of a dose of a medicament, the device comprising:
an acoustic feedback arrangement comprising:
a first feedback element having a first engaging section and having a free end section located at a predetermined distance from the first engaging section;
a second feedback element having a second engaging section configured to engage with the first engaging section;
wherein the first feedback element is movable, pivotable or resiliently deformable along a first direction from an initial state towards a biased state; and
a sound generator audibly engageable with the free end section of the first feedback element
when the first feedback element returns from the biased state into the initial state.
12. An injection device for injecting a dose of a medicament, the injection device comprising:
an acoustic feedback arrangement comprising:
a first feedback element having a first engaging section and having a free end section located at a predetermined distance from the first engaging section;
a second feedback element having a second engaging section configured to engage with the first engaging section of the first feedback element;
wherein the first feedback element is movable, pivotable, or resiliently deformable along a first direction relative to the second feedback element from an initial state towards a biased state; and
a sound generator audibly engageable with the free end section of the first feedback element,
wherein the free end section is configured to mechanically and audibly engage with the sound generator
when the first feedback element returns from the biased state to the initial state.
Instant
5
6
12
14
Patent
15
17
19
20
Allowable Subject Matter
Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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