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 § 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 1-19 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.
In claim 1, Applicant recites: “wherein the indicator comprises one or more magnets, the one or more magnets being coupled to move with the indicator”. The second part is unclear as the one or more magnets comprise the indicator (and are the only structure recited as part of the indicator) thus it is unclear how the one or more magnets can be coupled to move with themselves. Especially in the minimum embodiment of only one magnet, how is the magnet coupled to move with itself? It is also unclear how to interpret “the indicator and the one or more magnets rotate relative to the housing” on the last line in the minimum embodiment of one magnet being the indicator. The examiner suggest adding an indicator housing.
In claim 7, Applicant starts the claim with “further comprising an injection device and a data collection device”, but then defines the two structures as already existing structures. It is unclear how the device can further comprise two structures that are already part of the defined structure.
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) 1, 3-7 and 9-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groeschke et al (US 2015/0018775) in view of Larsen et al (US 2002/0143288).
Regarding claim 1, Groeschke discloses a medicament administration apparatus 10 comprising a housing 12; a drug container 22; a dose setting member 18 allowing a user to set a medicament dose to be delivered (¶84); an indicator 46 adapted to rotate relative to the housing during a dose delivery (¶18, ¶24, ¶92), wherein an amount of rotation of the indicator indicates a delivered medicament dose (¶18, ¶92); and a sensor arrangement comprising: at least one sensor 36 adapted to measure the amount of rotation of the indicator (¶91, ¶95, ¶96), wherein the at least one sensor is permitted to move axially together with the indicator (¶92, figs 2 and 3); and a processor 34 configured to determine an amount of medicament expelled by the medication administration apparatus based on the amount of rotation that the at least one sensor measured (¶95, ¶96), wherein the at least one sensor is at least one magnetic sensor (¶91).
While Groeschke substantially discloses the invention as claimed, it does not explicitly disclose the indicator comprises one or more magnets, the one or more magnets being coupled to move together with the indicator, and wherein the magnetic sensor varies its output due to variations in a magnetic field as the indicator and the one or more magnets rotate relative to the housing.
Larson teaches a medicament administration apparatus (fig 1) comprising a sensor arrangement (magnetic ring 7 and magnetic sensor 17) comprising: a sensor (magnetic sensor 17; ¶32) adapted to measure the amount of rotation of the indicator (magnetic ring 7; ¶32) wherein the sensor is a magnetic sensor, wherein the indicator comprises at least one or more magnets (hall elements 21-24; ¶9), the one or more magnets being coupled to move together with the indicator (fig 2), and wherein the at lest one magnetic sensor varies its output due to variations in a magnetic field as the indicator and the one or more magnets rotate relative to the housing (¶s 19-25, 41 and 42).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Groeschke such that the indicator comprises one or more magnets, the one or more magnets being coupled to move together with the indicator, and wherein the magnetic sensor varies its output due to variations in a magnetic field as the indicator and the one or more magnets rotate relative to the housing as taught by Larson as it is a known indicator/sensor configuration to detect an amount of drug injected by a device and allows one to obtain an accurate calculation of how much drug has been injected.
Regarding claim 3, wherein the sensor arrangement is a transducer that varies its output due to variations in the magnetic field based on the Hall effect (see combination in claim 1, Larsen discloses hall elements, which one would appreciate are used as part of the hall effect, ¶s 21-25).
Regarding claim 4, further comprising a wireless communications interface for communicating with another device (¶40).
Regarding claim 5, further comprising a Bluetooth interface for communicating with another device (¶40).
Regarding claim 6, wherein the indicator is configured to rotate as the medicament is expelled from the medication administration apparatus (¶18 and 92 of Groeschke and ¶19-25, 32, 41 and 42 of Larsen).
Regarding claim 7, further comprising an injection device and a data collection device, wherein the injection device comprises the drug container, and the dose setting member, and wherein the data collection device comprises the sensor arrangement (see claim 1; this claim doesn’t really add anything, merely redefines existing structures).
Regarding claim 9, wherein the data collection device includes a cavity that receives the injection device (¶87 – arcuate-structure; figs 2 and 4).
Regarding claim 10, wherein the data collection device has features 32 that mate closely with external features of the injection device (¶87).
Regarding claim 11, wherein the data collection device can be removed from the injection device through application of a removal force between the data collection device and the injection device in an axial direction (see fig 2, device may be slid off in an upward direction once any fastening members have been detached; especially if the fastening member is only frictionally engaged with housing as per ¶87).
Regarding claim 12, wherein the data collection device is configured for attachment to the injection device (¶87).
Regarding claim 13, wherein the data collection device has one or more features configured for attaching the data collection device to the injection device (¶87).
Regarding claim 14, wherein the data collection device is configured to be rotated by the user causing a dosage knob of the injection device to turn, thereby causing a dosage amount to be programmed (portion of sensing arrangement that includes scale 46 programs dosage amount - ¶s 12, 13, 17, 84 and 90-92).
Regarding claim 15, wherein the drug container is an insulin container (¶55).
Regarding claim 16, wherein the processor is configured to cause transmission of information to a device (¶40).
Regarding claim 17, wherein the information comprises determined medicament dosages (¶15 discloses medicament doses as one type of recorded data and ¶40 discloses transmitting recorded data).
Regarding claim 18, wherein the information comprises time stamp information (¶15 discloses time stamp information as one type of recorded data and ¶40 discloses transmitting recorded data).
Regarding claim 19, wherein the information comprises both determined medicament dosages and time stamp information (see claims 17 and 18 above).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groeschke et al (US 2015/0018775) in view of Larsen et al (US 2002/0143288) and Larsen et al (US 2011/0208125; Larsen ‘288 below).
Regarding claim 8, while Groeschke substantially discloses the invention as claimed, it does not disclose wherein the data collection device comprises a first portion and a second portion, and wherein the data collection device is configured to detect an axial movement of the first portion relative to the second portion using a switch, and wherein the switch is used to increase power supplied to the data collection device.
Larsen ‘288 discloses a switch associated with a dosing member to start-up the device from a sleep mode which uses less power (¶63).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Groeschke such that the data collection device comprises a first portion and a second portion, and wherein the data collection device is configured to detect an axial movement of the first portion relative to the second portion using a switch, and wherein the switch is used to increase power supplied to the data collection device as taught by Larsen ‘288 to save power/energy from the battery when the device is not being used.
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,944,796. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations are either broader or obvious in view of Groeschke et al (US 2015/0018775) in view of Larsen et al (US 2002/0143288) and Larsen et al (US 2011/0208125), see various rejections above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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