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 .
Claim Objections
Claims 22 and 35 are objected to because of the following grammatical informalities:
Claim 22 is numbered as “22d.”, should read, “22.”.
Claim 35, line 1, reads “wherein the device housing…”, should read, “wherein the housing…”
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 20-31, 34-35, and 38-39 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Keller et al. (US Pub No. 20190240411 A1, herein, Keller).
Regarding claim 20, Keller discloses an injection device for setting and injecting a dose of a medicament, the injection device (10 – Fig.1) comprising:
a housing (20 – Fig.1) configured to accommodate a medicament container containing the medicament, the housing comprising a sidewall with a recess (See annotated Fig.2A below);
a drive mechanism (“plunger rod” – Para [0020]) operably engageable with the medicament container for injecting the dose of the medicament; and
a fastener (30 – Fig.2C) arranged inside the recess (See annotated Fig.2A below) and protruding outwardly from an outside surface of the housing (Fig.2A), wherein the fastener comprises a fastening structure complementary shaped to a counter fastening structure of a counter fastener of a supplementary device (40 – Fig.1) for fastening and/or fixing the supplementary device in a predefined position to the housing (Para [0051]).
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Regarding claim 21, Keller discloses the injection device as set forth above, wherein the fastener comprises a base portion and an upper portion, wherein the base portion is engaged with the recess and wherein the upper portion protrudes outwardly from the outside surface of the housing (See annotated Fig.2A.1 below).
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Regarding claim 22, Keller discloses the injection device as set forth above, wherein the recess is a through recess extending entirely through the sidewall of the housing (See annotated Fig.2A above).
Regarding claim 23, Keller discloses the injection device as set forth above, wherein the fastener closes and/or seals the recess (“integrated with the housing element of the medicament delivery device” – Para [0058], See annotated Fig.2A above).
Regarding claim 24, Keller discloses the injection device as set forth above, wherein the base portion is located inside the housing and is in abutment with an inside surface of a side edge of the recess of the sidewall (See annotated Fig.2A.1 above).
Regarding claim 25, Keller discloses the injection device as set forth above, wherein the base portion comprises a foot and a neck portion, wherein the neck portion is located between the upper portion and the base portion (See annotated Fig.2A.2 below).
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Regarding claim 26, Keller discloses the injection device as set forth above, wherein the fastener comprises a fastening structure with at least a first side edge portion to engage with a first counter fastening portion of a counter fastening structure of the counter fastener (Para [0051], See annotated Figs. 2C and 3A below).
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Regarding claim 27, Keller discloses the injection device as set forth above, wherein the fastening structure comprises at least a second side edge portion opposite to the first side edge portion to engage with a second counter fastening portion of the counter fastening structure (Para [0051], See annotated Figs. 2C and 3A below).
Regarding claim 28, Keller discloses the injection device as set forth above, wherein the fastening structure comprises one of a front edge portion and a rear edge portion to engage with a third counter fastening portion of the counter fastening structure (Para [0051], See annotated Figs. 2C and 3A below).
Regarding claim 29, Keller discloses the injection device as set forth above, wherein one of the fastening structure and the counter fastening structure comprises a groove (42 – Fig.3A) and wherein the other one of the fastening structure and the counter fastening structure comprises a protrusion or ledge portion to engage with the groove (Fig.2A, Para [0051]).
Regarding claim 30, Keller discloses the injection device as set forth above, wherein the groove is provided in or extends along at least one of the first side edge portion, the second side edge portion the front edge portion and the rear edge portion (Para [0051], See annotated Figs. 2C and 3A below).
Regarding claim 31, Keller discloses the injection device as set forth above, wherein the groove aligns with an outside surface of the housing (Fig.1, Fig.3A).
Regarding claim 34, Keller discloses a supplementary device for attachment to an injection device, the supplementary device (40 – Fig.1) comprising:
a device housing (Shown at 40 – Fig.1); and
a counter fastener (42 – Fig.1) attached and/or fixed to the device housing and comprising a counter fastening structure complementary shaped to a fastening structure of the injection device (Para [0051]), wherein the injection device comprises:
a housing (20 – Fig.1) configured to accommodate a medicament container containing the medicament, the housing comprising a sidewall with a recess (See annotated Fig.2A above);
a drive mechanism (“plunger rod” – Para [0020]) operably engageable with the medicament container for injecting the dose of the medicament; and
a fastener (30 – Fig.2C) arranged inside the recess (See annotated Fig.2A above) and protruding outwardly from an outside surface of the housing (Fig.2A), wherein the fastener comprises a fastening structure complementary shaped to a counter fastening structure of a counter fastener of the supplementary device for fastening and/or fixing the supplementary device in a predefined position to the housing (Para [0051]).
Regarding claim 35, Keller discloses the supplementary device as set forth above, wherein the device housing comprises an upper side (Shown at 10 – Fig.1) and a bottom side (Shown at 20 – Fig.1) opposite to the upper side and wherein the counter fastening structure protrudes from the bottom side or is integrated in the bottom side (“integrated with the housing element of the medicament delivery device” – Para [0058], Fig.1).
Regarding claim 38, Keller discloses a drug delivery system comprising:
injection device (10 – Fig.1) comprising:
a housing (20 – Fig.1) configured to accommodate a medicament container containing the medicament, the housing comprising a sidewall with a recess (See annotated Fig.2A above);
a drive mechanism (“plunger rod” – Para [0020]) operably engageable with the medicament container for injecting the dose of the medicament; and
a fastener (30 – Fig.2C) arranged inside the recess (See annotated Fig.2A below) and protruding outwardly from an outside surface of the housing (Fig.2A), wherein the fastener comprises a fastening structure complementary shaped to a counter fastening structure of a counter fastener of a supplementary device (40 – Fig.1) for fastening and/or fixing the supplementary device in a predefined position to the housing (Para [0051]); and
a supplementary device (40 – Fig.1) comprising:
a device housing (Shown at 40 – Fig.1); and
a counter fastener (42 – Fig.3A) attached and/or fixed to the device housing and comprising the counter fastening structure complementary shaped to the fastening structure of the injection device (Para [0051]).
Regarding claim 39, Keller discloses the injection device as set forth above, wherein the housing comprises an upper side (Shown at 10 – Fig.1) and a bottom side (Shown at 20 – Fig.1) opposite to the upper side and wherein the counter fastening structure protrudes from the bottom side or is integrated in the bottom side (Fig.1).
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.
Claims 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Keller in view of Krulevitch at al. (US Pub No. 20120004637 A1, herein, Krulevitch).
Regarding claim 32, Keller discloses the injection device as set forth above, however, Keller does not expressly disclose wherein fastener comprises a body with a transparent window.
Krulevitch teaches a fastener (202 – Fig.3) comprising a body with a transparent window (218 – Fig.3).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the fastener of Keller to comprise a body with a transparent window as taught by Krulevitch since Krulevitch teaches that the window allows the user to view the dosage amount, allowing the user to verify the intended dose before administration (Krulevitch, Para [0063]).
Regarding claim 33, Keller discloses the injection device as set forth above, however, Keller does not expressly disclose wherein the drive mechanism comprises a number sleeve at least partially arranged inside the housing and wherein a portion of the number sleeve is visible through the transparent window of the fastener.
Krulevitch teaches a drive mechanism (216 – Fig.2) comprising a number sleeve (220 – Fig.1) at least partially arranged inside a housing and wherein a portion of the number sleeve is visible through the transparent window of the fastener (“The dosage display can output the amount of fluid dispensed on a display screen such as a printed display” - Para [0032]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the drive mechanism of Keller to comprise a number sleeve that is visible through the transparent window of the fastener as taught by Krulevitch since Krulevitch teaches that window and number sleeve allows the user to view the dosage amount, allowing the user to verify the intended dose before administration (Krulevitch, Para [0063]).
Claims 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Keller in view of Cirillo et al. (US Patent No. 10773032 B2).
Regarding claim 36, Keller discloses the supplementary device as set forth above, however, Keller does not expressly disclose wherein the supplementary device comprises a secondary fastener configured to clasp at least partially around an outside surface of the housing of the injection device.
Cirillo teaches a supplementary device (1 – Fig.1) comprises a secondary fastener (15 – Fig.5) configured to clasp at least partially around an outside surface of a housing (Shown at 2 – Fig.5) of an injection device (2 – Fig.5, Fig.5).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the supplementary device of Keller to comprise a secondary fastener as taught by Cirillo so that the monitoring device of the invention is automatically correctly located and positioned on the injection pen (Cirillo, Col.6, lines 17-18).
Regarding claim 37, Keller discloses the supplementary device as set forth above, however, Keller does not expressly disclose the device further comprising:
a logic circuit;
a signal generator connected to the logic circuit; and
at least one of a switch and a detector connected to the logic circuit and operable to detect a correct assembly of the supplementary device to the housing of the injection device wherein the logic circuit is operable to generate at least one of an audible, visual or tactile signal via the signal generator in response to a detection of a correct assembly of the supplementary device to the housing of the injection device.
Cirillo teaches a logic circuit (41 - Fig.14);
a signal generator (13 – Fig.22) connected to the logic circuit; and
at least one of a switch (40 – Fig.22) and a detector (44 – Fig.22) connected to the logic circuit and operable to detect a correct assembly of the supplementary device to the housing of the injection device (“signify to the user that the monitoring device is correctly mounted and positioned on the injection pen” – Col.7, lines 33-35) wherein the logic circuit is operable to generate at least one of an audible, visual or tactile signal via the signal generator in response to a detection of a correct assembly of the supplementary device to the housing of the injection device (“ensure that the monitoring device is correctly mounted on the injection pen “ – Col.9, lines 22-33, “are in communication with the processor which is in turn communicable with an external device interface” – Col.9, lines 31-32).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the supplementary device of Keller to comprise a logic circuit, a signal generator, at least one switch, a detector, and wherein the logic circuit generates a signal in response to a detection of a correct assembly of the supplementary device as taught by Cirillo since these features provide confirmation of proper attachment, reduce user assembly errors, and ensure the device is in an operational state before use.
Conclusion
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/MARISSA TAYLOR/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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