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 .
Election/Restrictions
Claims 22-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species III-VII, there being no allowable generic or linking claim. Claims 16-20 and 29-35 are generic to all species. Election was made without traverse in the reply filed on 20 January 2026.
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 21 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.
Claim 21 recites the limitation "the processor arrangement" in line 8 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, examiner interprets “the processor arrangement” to mean –the processor--.
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.
(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 16, 18-20, 29, 30, and 32-34 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Blei et al. (US Patent Publication No. 20170219486 A1), hereinafter Blei.
Regarding claim 16, Blei teaches a supplemental device (Blei: Fig. 2a, supplemental device 2) configured to be coupled to an injection device (Fig. 1a, drug delivery device 1), the supplemental device (Fig. 2a, supplemental device 2) comprising: a sensor arrangement (Fig. 3, comprising acoustical sensor 27, photometer 26, optical sensor/OCR 25, and OLED 29); and a processor (Fig. 3, processor 24) configured to cause the supplemental device (Fig. 2a, supplemental device 2) to: use the sensor arrangement (Fig. 3, comprising acoustical sensor 27, photometer 26, optical sensor/OCR 25, and OLED 29) to sense an identification feature (device 1 comprises an optical property to be sensed by the photometer 26; para. 0051) of the injection device (Fig. 1a, drug delivery device 1), and determine a type of the injection device (Fig. 1a, drug delivery device 1) based on the sensed identification feature (type of drug delivery device is determined by the optical property of the device 1, detected by photometer 26; para. 0051).
Regarding claim 18, Blei teaches the supplemental device above, further comprising: an alignment arrangement (mating unit of device 2; para. 0039), wherein the alignment arrangement (mating unit of device 2; para. 0039) is configured to interact with a corresponding alignment feature (Fig. 1b, protrusions 70 and/or indentations 52) of the injection device (Fig. 1a, drug delivery device 1) to couple the supplemental device (Fig. 2a, supplemental device 2) to the injection device (Fig. 1a, drug delivery device 1) in one of a predetermined number of orientations relative to the injection device (protrusions 70 and/or indentations 52 allow the sensor device 2 to be releasably attached to the drug delivery device 1 in a predetermined position; para. 0036).
Regarding claim 19, Blei teaches the supplemental device above, further comprising: a communication interface (Fig. 3, wireless unit 28), wherein the processor (Fig. 3, processor 24) is configured to transmit data indicating the determined type of the injection device (information includes but is not limited to the determined type of drug delivery device; para. 0051) to an external computing device via the communication interface (information is transmitted from the wireless unit 28 to another external device; para. 0054).
Regarding claim 20, Blei teaches the supplemental device above, wherein the sensor arrangement (Fig. 3, comprising acoustical sensor 27, photometer 26, optical sensor/OCR 25, and OLED 29) comprises a light source (one or more light sources may be provided in tandem with photometer 26; para. 0051) and a color sensor (Fig. 3, photometer 26), wherein the light source (one or more light sources may be provided in tandem with photometer 26; para. 0051) is arranged to illuminate a portion of the injection device (Fig. 1a, drug delivery device 1) when the supplemental device (Fig. 2a, supplemental device 2) is coupled to the injection device (light source provides light to improve color detection by photometer 26; para. 0051), wherein the color sensor (Fig. 3, photometer 26) is arranged to determine a color of the illuminated portion (photometer 26 determines color of injection device, which determines the type of injection device; para. 0051), and wherein the processor (Fig. 3, processor 24) is configured to determine the type of the injection device (Fig. 1a, drug delivery device 1) based on the determined color (processor 24 via photometer 26 determines color of injection device, which determines the type of injection device; para. 0051).
Regarding claim 29, Blei teaches a system (Fig. 3, comprising device 1 and 2) comprising: an injection device (Fig. 1a, drug delivery device 1) comprising an identification feature (device 1 comprises an optical property to be sensed by the photometer 26; para. 0051); and a supplemental device (Fig. 2a, supplemental device 2) comprising a sensor arrangement (Fig. 3, comprising acoustical sensor 27, photometer 26, optical sensor/OCR 25, and OLED 29) and a processor (Fig. 3, processor 24), wherein the processor (Fig. 3, processor 24) is configured to cause the supplemental device (Fig. 2a, supplemental device 2) to: use the sensor arrangement (Fig. 3, comprising acoustical sensor 27, photometer 26, optical sensor/OCR 25, and OLED 29) to sense the identification feature of the injection device (device 1 comprises an optical property to be sensed by the photometer 26; para. 0051), and determine a type of the injection device (Fig. 1a, drug delivery device 1) based on the sensed identification feature (type of drug delivery device is determined by the optical property of the device 1, detected by photometer 26; para. 0051).
Regarding claim 30, Blei teaches the system above, wherein the injection device (Fig. 1a, device 1) contains medicament (Fig. 1a, device 1 comprises a pre-filled insulin container 14; para. 0034).
Regarding claim 32, Blei teaches the system above, wherein the supplemental device (Fig. 2a, device 2) further comprises an alignment arrangement (mating unit of device 2; para. 0039), wherein the alignment arrangement (mating unit of device 2; para. 0039) is configured to interact with a corresponding alignment feature (Fig. 1b, protrusions 70 and/or indentations 52) of the injection device (Fig. 1a, drug delivery device 1) to couple the supplemental device (Fig. 2a, supplemental device 2) to the injection device (Fig. 1a, drug delivery device 1) in one of a predetermined number of orientations relative to the injection device (protrusions 70 and/or indentations 52 allow the sensor device 2 to be releasably attached to the drug delivery device 1 in a predetermined position; para. 0036).
Regarding claim 33, Blei teaches the system above, wherein the supplemental device (Fig. 2a, device 2) further comprises a communication interface (Fig. 3, wireless unit 28), wherein the processor (Fig. 3, processor 24) is configured to transmit data indicating the determined type of the injection device (information includes but is not limited to the determined type of drug delivery device; para. 0051) to an external computing device via the communication interface (information is transmitted from the wireless unit 28 to another external device; para. 0054).
Regarding claim 34, Blei teaches a method executed by a supplemental device (Fig. 2a, device 2), the method comprising: sensing, by a sensor arrangement (Fig. 3, comprising acoustical sensor 27, photometer 26, optical sensor/OCR 25, and OLED 29) of the supplemental device (Fig. 2a, device 2), an identification feature (device 1 comprises an optical property to be sensed by the photometer 26; para. 0051) of the injection device (Fig. 1a, device 1); and determining, by a processor (Fig. 3, processor 24) of the supplemental device (Fig. 2a, device 2), a type of the injection device (Fig. 1a, device 1) based on the sensed identification feature (type of drug delivery device is determined by the optical property of the device 1, detected by photometer 26; para. 0051). When the prior art device is the same as a device described in the specification for carrying out or being made by the claimed method, it can be assumed the device will obviously perform or be made by the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). MPEP 2112.02.
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.
Claims 17, 31, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Blei in view of Chen et al. (US Patent Publication No. 20140276583 A1), hereinafter Chen.
Regarding claim 17, Blei discloses the supplemental device above, further comprising: a dose determination unit (Blei: processor 24 may constitute a dose delivery determiner; para. 0057), wherein the processor (Fig. 3, processor 24) is further configured to cause the supplemental device (Fig. 2a, supplemental device 2) to determine a dose of medicament contained in the injection device (Fig. 1a, drug delivery device 1) by using the dose determination unit (dose delivery determiner determines dose of medicament quantity; para. 0057).
Blei does not expressly disclose that the dose is determined based on the determined type of the injection device.
Chen teaches a device (Chen: Fig. 7, injection device 700), wherein a dose is determined based on the determined type of the injection device (Fig. 9, medicament information, which includes medicament type, is received at process block 906, which is then used to determine dose at process block 908; para. 0047-0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the dose determination unit of Blei such that the dose is determined based on the determined type of the injection device as taught by Chen in order to deliver an appropriate dose based on collected information while relieving a user from manually recording injection and medicament information (Chen: para. 0019 and 0047-0048).
Regarding claim 31, Blei teaches the system above, wherein the supplemental device (Blei: Fig. 2a, device 2) further comprises a dose determination unit (processor 24 may constitute a dose delivery determiner; para. 0057) wherein the processor (Fig. 3, processor 24) is further configured to cause the supplemental device (Fig. 2a, supplemental device 2) to determine a dose of medicament contained in the injection device (Fig. 1a, drug delivery device 1) by using the dose determination unit (dose delivery determiner determines dose of medicament quantity; para. 0057).
Blei does not expressly disclose that the dose is determined based on the determined type of the injection device.
Chen teaches a device (Chen: Fig. 7, injection device 700), wherein a dose is determined based on the determined type of the injection device (Fig. 9, medicament information, which includes medicament type, is received at process block 906, which is then used to determine dose at process block 908; para. 0047-0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the dose determination unit of Blei such that the dose is determined based on the determined type of the injection device as taught by Chen in order to deliver an appropriate dose based on collected information while relieving a user from manually recording injection and medicament information (Chen: para. 0019 and 0047-0048).
Regarding claim 35, Blei teaches the method above.
Blei does not expressly disclose that the dose is determined based on the determined type of the injection device.
Chen teaches a device (Chen: Fig. 7, injection device 700), wherein a dose is determined based on the determined type of the injection device (Fig. 9, medicament information, which includes medicament type, is received at process block 906, which is then used to determine dose at process block 908; para. 0047-0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the dose determination unit of Blei such that the dose is determined based on the determined type of the injection device as taught by Chen in order to deliver an appropriate dose based on collected information while relieving a user from manually recording injection and medicament information (Chen: para. 0019 and 0047-0048).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Blei in view of Okamura et al. (US Patent Publication No. 20190091406 A1), hereinafter Okamura.
Regarding claim 21, Blei discloses the supplemental device above.
Blei does not expressly disclose that the sensor arrangement comprises a navigation switch movable between a plurality of positions, wherein the navigation switch is arranged to be biased into a position of the plurality of positions by a biasing feature of the injection device when the supplemental device is coupled to the injection device, wherein each position in the plurality of positions corresponds to a respective type of injection device, and wherein the processor is configured to determine the type of the injection device based on the position of the navigation switch.
Okamura teaches a sensor arrangement (Okamura: Fig. 10, first identification information detector 28) comprises a navigation switch (Fig. 10, minute button 28a is a switch; para. 0275) movable between a plurality of positions (button 28a can be moved from either pressed or not pressed, or a multitude of positions based on the number of identifying information; para. 0275-0277), wherein the navigation switch (Fig. 10, button 28a) is arranged to be biased into a position of the plurality of positions (para. 0275-0277) by a biasing feature (Fig. 3C-D, first identification information 104g) of an injection device (Fig. 2B, 3A-D, cartridge adapter 101) when a supplemental device (Fig. 2B, drug injection device 11) is coupled to the injection device (information 104g biases the button 28a when the adapter 101 is inserted; para. 0275), wherein each position in the plurality of positions (para. 0275-0277) corresponds to a respective type of injection device (button 28a can be moved from either pressed or not pressed, or a multitude of positions based on the number of identifying information, which sends an output signal that determines the type of cartridge adapter; para. 0275-0277), and wherein a processor (Fig. 1, arithmetic circuit 41) is configured to determine the type of the injection device (Fig. 2B, adapter 101) based on the position of the navigation switch (circuit 41 receives output signals from the detector 28, determining which type of cartridge was inserted; para. 0270 and 0275-0277).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Blei such that the sensor arrangement comprises a navigation switch movable between a plurality of positions, wherein the navigation switch is arranged to be biased into a position of the plurality of positions by a biasing feature of the injection device when the supplemental device is coupled to the injection device, wherein each position in the plurality of positions corresponds to a respective type of injection device, and wherein the processor is configured to determine the type of the injection device based on the position of the navigation switch as taught by Okamura in order to allow for a multitude of different types of drug injectors and for easy switching between injectors through mechanical detection (para. 0069-0070 and 0275-0277).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783