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 Rejections - 35 USC § 102
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.
Claim(s) 16-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Butler et al. (US 2015/0343152 A1).
With regard to claim 16, Butler discloses A drug delivery device (Fig. 1-3), comprising: a dose setting and driving assembly ([0051], [0081] while specific structures of a drive assembly are not described, a drive assembly would be necessary for dispensing the medication after dose dialing. The claims do not require any specific structure for the drive assembly, therefore the teaching of dispensing a drug from the injector implies the use of some type of drive assembly) for dialing and dispensing a dose of a medicament from a cartridge (part of 106) of the drug delivery device, the dose setting and driving assembly comprising an outer housing (formed by 104 and 116 as shown in Fig. 3) having an aperture (112 and 114) or window and at least two contacts (212, 214, [0059] an array of contacts protrude from the underside of the housing) arranged within the outer housing; a number sleeve (300, Fig. 5a) (i) disposed such that a portion of the number sleeve is visible through the aperture or window (part of 300 is visible through aperture 114) in the outer housing to display a dialed dose ([0067], [0076], numbers may be printed on 300 and shown through ha separate window in the housing) and (ii) configured to rotate relative to the outer housing during dose dispensing ([0062]); and a dose dial grip (108) comprising an outer skirt partially protruding out of the outer housing (500 is considered a skirt that is connected to dose dial grip 108 and is considered to protrude from the outer housing as it is designed to be visible through window 112), the dose dial grip configured to (i) rotate relative to the outer housing during dose dialing ([0044]), (ii) be axially displaceable relative to the outer housing during dose dispensing ([0044]), and (iii) be rotationally constrained to the outer housing during dose dispensing ([0044], the dose dial only rotates within the outer housing during dose dispensing and therefore is considered to be rotationally constrained to the outer housing), at least one of the number sleeve or the outer skirt of the dose dial grip comprising at least two circumferentially spaced conductive strips distributed around an outer circumference of the number sleeve (304, 306) or the outer skirt (508) to provide at least two different pattern portions (304 and 306 are different pattern portions as can be seen in Fig. 5a, [0064], [0065]) which are electrically separate (as can be seen in Fig. 5a, the two strips 304 and 306 shown as the darkened portion is spaced apart from each other with a gap in between them), wherein the at least two contacts are biased to abut the at least two conductive strips ([0059]), wherein the at least two contacts (212, 214) are part of at least one bridge contact in the drug delivery device (see Fig. 4, the first and second sensors are considered to be bridging as they are electrically connected via circuitry to the microprocessor as shown in the schematic of Fig. 4 to determine dosing information) configured and operable to selectively establish an electric connection between the at least two different pattern portions as the number sleeve or the skirt are subject to a helical or rotational movement relative to the outer housing ([0052] an electrical connections is made via the circuitry such that the two pattern portions form dosing instructions during rotation of the outer housing), and at least one of the at least two conductive strips or the at least two contacts are accessible from outside the outer housing (they are considered accessible from outside the outer housing as they are visible through the aperture of 114 in housing 104).
With regard to claim 17, Butler discloses wherein the at least two contacts form at least one reference element (the array of contacts which form sensor element 214 are considered a reference element as they are used to sense the conductive strip and provide feedback on the rotation of the dose dialing structure to provide dosage information) and the at least two conductive strips form a pattern (306 and 304, [0069]), the at least two contacts and the at least two conductive strips together forming a detector arrangement (the contacts and the conductive strips form an arrangement since they are designed to be worked together ([0067]). The term arrangement would need to be further defined in order to overcome the rejection) comprising at least one electric sensor (214) being operable to detect a positional variation of the pattern relative to the at least one reference element ([0069]).
With regard to claim 18, Butler discloses wherein the at least one electric sensor (214) is operable to generate at least one electric signal in response to the positional variation of the pattern during a movement of at least one of the number sleeve or the outer skirt relative to the outer housing during dose dialing and dose dispensing ([0069]).
With regard to claim 19, Butler discloses wherein the pattern comprises a first pattern portion that is electrically conductive and a second pattern portion that is electrically insulating ([0064], conductive and non-conductive segments).
With regard to claim 20, Butler discloses wherein the at least two contacts of the detector arrangement are operable to alternately connect to the first pattern portion and the second pattern portion of the pattern during the movement of at least one of the number sleeve or the outer skirt relative to the outer housing during dose dialing and dose dispensing ([0064], [0067], [0068]).
With regard to claim 21, Butler discloses wherein the pattern comprises a third pattern portion that is electrically conductive, the first pattern portion and the third pattern portion being electrically separated from each other ([0066], up to seven tracks can be used each having conducting and non-conducting portions).
With regard to claim 22, Butler discloses wherein the detector arrangement and the at least one electric sensor are arranged on the outer circumference of the number sleeve or the outer skirt (116 is arranged on the outer circumference of 300, [0067]).
With regard to claim 23, Butler discloses wherein the at least one electric sensor (214) is electrically connected to the first pattern portion (304 or 306), the at least one reference element (the plurality of electrical contacts that engaged with the conductive strips ([0067]) is arranged on the outer housing, and the at least one reference element comprises an electrical bridging contact configured to alternately establish and interrupt an electric contact between the first pattern portion and the third pattern portion during the movement of at least one of the number sleeve or the outer skirt relative to the outer housing during dose dialing and dose dispensing (because a wide array of contacts are used in different ratios, any one of the contacts could be considered to “bridge” between the first pattern portion 304 and the third pattern portion, one of another of the conductive strips on 300).
With regard to claim 24, Butler discloses wherein the electrical bridging contact comprises a first electrical contact tap (the conductive strips of 304 and 306 are contacted by an array of electrical contacts that protrude the window of 114 to contact the conductive strip, suggested number of contacts could be five or four, [0067], thus any one of these contacts can be considered the electrical bridging contact and it comprises an electrical contact tap because they can be made as sprung contacts biased away from the underside of the housing of the supplementary device [0059]) of the at least two contacts and a second electrical contact tap (see description above of having multiple contacts and each can be considered an electrical contact tap [0059]) of the at least two contacts, the first electrical contact tap and the second electrical contact tap being electrically connected to each other ([0059], [0067]).
With regard to claim 25, Butler discloses wherein the first electrical contact tap and the second electrical contact tap are spatially separated from each other along a first separation direction parallel to a distance between the first pattern portion and the third pattern portion (the contacts are formed as an array and thus spatially separated from one another ([0059]).
With regard to claim 26, Butler discloses wherein the electrical bridging contact comprises a third electrical contact tap (see description above in rejection of claim 24 indicating that there can be up to seven contacts) of the at least two contacts spatially separated from at least one of the first electrical contact tap and the second electrical contact tap along a second separation direction non-parallel to the first separation direction (contacts are formed in an array and thus would have spacing both in a longitudinal and latitudinal direction).
With regard to claim 27, Butler discloses wherein the electrical bridging contact comprises a body made of sheet-metal and at least one flexible arm (sprung arm ([0059]), wherein at least one of the first electrical contact tap or the second electrical contact tap are arranged at a free end of the at least one flexible arm ([0059]).
With regard to claim 28, Butler discloses wherein the at least two conductive strips are printed on the outer skirt of the dose dial grip (500 can also have conductive strips located thereon).
With regard to claim 29, Butler discloses wherein the at least two conductive strips are provided on an encoder wheel (500) fixed to the number sleeve (300).
With regard to claim 30, Butler discloses wherein the dose dial grip (108) comprises at least one of a clip or a rotational alignment feature for attaching a separate module (116) on the dose dial grip (the dose dial grip has lines or ridges that run parallel to the longitudinal axis of the injection device as seen in Fig. 1 and can be considered an “alignment feature”. Further description of the alignment feature would be needed to overcome the rejection).
With regard to claim 31, Butler discloses A module (Fig. 2) for detecting movement of at least one component of a drug delivery device (Fig. 1), the module comprising: a microprocessor (circuitry 200 which includes microprocessor 202 can be included on 116, [0061]) for at least one of processing or storing data (memory 205) from a detector arrangement of the drug delivery device (detector arrangement formed by conductive strips on 300 and the contacts formed on the inside of 116); electrical connectors to releasably establish contact with conductive strips or contacts of the drug delivery device ([0067]); wherein the electrical connectors (112, 114) comprise metal clips having a free end biased radially inwards for abutting the conductive strips or contacts of the drug delivery device ([0059], sprung contacts, considered clips, biased away from the underside of the housing and pass through the apertures to contact the conductive strips, they would necessarily be made of a metal material as they are designed to contact the explicitly taught metal conductive strips [0065] further they are described as electrically conductive contacts [0053]); and at least one of a clip ([0045]) or a rotational alignment feature for attaching the module on the dose dial grip of the drug delivery device.
With regard to claim 32, Butler discloses wherein the clip or the rotational alignment feature is configured to attach the module to a dose dial grip of the drug delivery device ([0045]).
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.
Claim(s) 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (US 2015/0343152 A1) in view of Antonelli (EP 4,335,474 A2).
With regard to claim 34, Butler discloses the claimed invention except for a cap.
Antonelli teaches a similar drug delivery device (Fig. 4) having a body (12) and a dose dial grip (30) and further a cap (42) shaped and sized to fit over a dose dial grip (Fig. 3) of the drug delivery device, the cap comprising an outer profiled gripping surface (48) and encloses the microprocessor and the electrical connectors (surrounds the dose dial grip that has the electrical components as taught in Butler above).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Butler with a cap as taught by Antonelli for the purpose of assisting a user in rotating the dose dial grip ([0016]).
With regard to claim 35, Bulter discloses the claimed invention except for the cap.
Antonelli discloses wherein the cap is releasably attached to the dose dial grip of the drug delivery device ([0016], can be removed).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Butler with a cap as taught by Antonelli for the purpose of assisting a user in rotating the dose dial grip ([0016]).
Response to Arguments
Applicant’s arguments with respect to claim(s) s 16-32, 34-35 have been considered but are moot because the new ground of rejection does not rely on the same grounds of rejection in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Butler appears to still teach the amended claims however it is recognized that differences exist between the present invention and the prior art. If the pattern portions were to be further described to recite what information they are meant to convey or how they are placed on the injection device. Alternatively or additionally, the concept of the bridging concept could be further defined to provide some structure or specific location relative to the first and second contact.
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 LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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