DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed before March 16, 2013 is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment and Request for Continued Examination (RCE) filed on 04/20/26 have been entered in the case. Claims 21, 24-38 & 40 are pending for examination and claims 1-20, 22-23 & 39 are cancelled.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
I) 1st set of rejection:
Claims 21, 24-26, 28, 33-35, 37-38 & 40 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Larsen (US 2009/0069742).
Regarding claim 21, 37-38, Larsen discloses an apparatus 1 comprising:
a housing 1 with a mating unit (at external surface of an electric module 1, see Fig. 1), wherein the mating unit is for releasably attaching to a medical device for ejecting a medicament;
at least one sensor (acoustical sensor, i.e., microphone) for capturing information related to at least one of a condition or a use of the medical device, wherein the information comprises a selected dose, para [035-0036]; and
a wireless interface (wireless means such as DECT or Bluetooth) configured for transmitting the information captured by the at least one sensor comprising the selected dose to a device, i.e., computer, cell phone, PDA, paras [0034, 0042],
wherein the at least one sensor is arranged to detect that the selected dose has been ejected (e.g., one clicked corresponded to a certain amount of expelled medicament, para [0036 & 0038, 0042], and
wherein the apparatus is arranged to transmit the information captured by the at least one sensor comprising the selected dose to the device responsive to the at least one sensor detecting that the selected dose has been ejected, paras [0036-0038, 0042].
Regarding claims 24-26, having said in the rejection in claim 21 above, wherein the information comprises information on a dose of the medicament that is ejected; wherein the information comprises information on whether an ejection of the medicament has taken place; wherein the information comprises information on a dose of the medicament that has been ejected.
Regarding claim 28, wherein the apparatus is configured to at least partially monitor a timing of an application sequence of the medical device, para [0036-0038].
Regarding claim 33, wherein the wireless interface is configured to provide the captured information to the device (computer, cell phone, PDA) via radio transmission (i.e., DECT or Bluetooth, para [0035]).
Regarding claims 34-35, as mentioned in the claim 21 above, wherein the wireless interface is configured to receive information indicative of at least a dose of the medicament to be ejected; a processor for determining a proposal of dose of the medicament (set a dose or a dose of medicament is being set) to be ejected by the medical device.
Regarding claim 40, it encompasses the same scope of the invention as to that of claim 21 except it is dratted in method format instead of apparatus format. Therefore, the claim 40 is rejected for the same reason as set forth above.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 27 & 36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Larsen (US 2009/0069742) in view of Hartmann (US 6,482,185).
Larsen discloses the invention substantially as claimed except for the limitation that at least one optical sensor configured to capture an image of an information-bearing part of the medical device,
Hartman discloses an apparatus 30a, in Figs. 1-4, comprising: a mating unit 33/34 for attaching the apparatus 30/31; wherein the mating unit for releasably attaching to a medical device 10/10a for ejecting a medicament;
at least one optical sensor 40 is configured to capture an image of an information-bearing part of the medical device 10 (e.g., dose setting displays on the display 32, col. 4, line 1-5 & lines 41-45) via a dose set display 18 of the medical device.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device system of Larsen with obtaining a dose setting display; and including an optical sensor configured to capture an image of an information-bearing part of the device, as taught by Hartman, in order to allow user to view the reading of drug administration information. For example: if a user who is having hearing problem is able to view via the display in the medical device and the mating unit.
Regarding claim 36, Larsen discloses the invention substantially as claimed except for the limitation that a measurement unit for measuring at least one parameter that is representative of a condition of a creature that is to receive the medicament ejectable by the medical device.
Hartmann discloses that an apparatus comprising a measurement unit (test strip via slot 35) for measuring at least one parameter (blood sugar value) that is representative of a condition of a creature that is to receive the medicament ejectable by the medical device.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device system of Larsen with providing a measurement unit, as taught by Hartmann, in order to allow a user to monitor blood sugar parameter.
Claims 29-32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Larsen (US 2009/0069742) in view of Hjertman et al. (US 7,164,133).
Regarding claims 27, 29-32, Larsen discloses the invention substantially as claimed except for the limitations that: at least one sensor comprises at least one optical sensor configured to capture information representative of or to determine an optical property of at least part of the medical device; the at least one optical sensor configured to capture information representative to determine a color or color coding of at least part of the medical device; wherein the apparatus is configured to recognize the color or the color coding of at least part of the medical device from the captured information; wherein the at least one sensor comprises at least one optical sensor configured to detect a code related to at least one of the medical device or the medicament contained therein.
Hjertman discloses in Figs. 5-6 that a label with markings is provided on a cartridge; wherein at least one optical sensor 57 is configured to capture/detect an image of information-bearing part of the medical device, i.e., determine a color or color coding of the marking color on the outer surface of the cartridge to inform user about the cartridge type, content or concentration of the drug;
wherein at least one optical sensor 57 is configured to capture/detect information representative of or to determine an optical property of at least part of the medical device, i.e., determine a color or color coding of the marking color on the outer surface of the cartridge to inform user about the cartridge type, content or concentration of the drug, col. 23, lines 5-30.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Larsen with adding an optical sensor configured to recognize the color or color coding of the part of the medical device from the captured information; configured to detect a code related to at least one of the medical device, as taught by Hjertman, in order to allow the user to determine a color or color coding of the marking color on the outer surface of the cartridge to inform user about the cartridge type.
Claim 32 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Larsen (US 2009/0069742) in view of Evans (US 2001/0056258).
Larsen discloses the invention substantially as claimed except for the limitations as required in the claim 32.
Evans discloses an apparatus system in Figs. 8, 11-12 comprising: a syringe 120 with barcode 142; wherein at least one sensor 160 comprises at least one optical sensor (CCD) to detect a code, i.e., bar code related to at least one of the medical devices or the medicament contained therein (e.g., drug administration information, and determining the amount of drug being administered, e.g., drug administration data, paras [0064, 0066, 0069].
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Larsen with including at least one optical sensor being detect a code related to the medical device, as taught by Evans, in order to allow user to view the reading of drug administration information such as patient's identification, type of drugs and/or amounts of drug etc....
II) 2nd set of rejection:
Claims 21, 22-26, 33-36, 38 & 40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brown (US 5,628,309) in view of Tubb et al. (US 8,660,802).
Regarding claims 21, 34 & 38, Brown discloses an apparatus 10 comprising:
A housing 18 with a mating unit 17, wherein the mating unit 17 is for releasably attaching to a medical device 32 for ejecting a medication;
At least one sensor for capturing information related to at least one of a condition or a use of the medical device, wherein the information comprises a selected dose 34 (e.g., a measuring means for measuring an electrical response from a syringe, the electrical response resulting from the voltage and indicting a size of the dose, part d) in claim 1 in Brown). Note: based on the statement in part d) in claim 1 in Brown, a measuring means is fair enough to call as a sensor.
a wiring interface 86 configured for transmitting the information captured by the sensor comprising the selected dose to a device 85 (e.g., the information captured by the sensor to detect a selected dose has been ejected being transferred to the device 85, col. 6, lines 55-63).
Note: although Brown discloses that the captured information of the selected dose being detected by the sensor and being transmitted to the device via wiring interface, meanwhile, the claimed invention requires the said information of selected dose being transmitted to the device via wireless interface; however, the marketplace reflects the reality that applying modern electronics to older devices is commonplace. Therefore, a person skilled in the art would recognize that nowadays the information being transmitted to another device via wireless in order to gain the commonly understood benefits of such adaption, such as decreased size, increased reliably, simplified operation, i.e., can carry everywhere with a patient.
Wherein the at least one sensor is arranged to detect that the selected dose has been ejected, and wherein the apparatus is arranged to transmit information captured by the at least one sensor comprising the selected dose to the device 85 responsive to that at lest one sensor detecting that the selected dose has been ejected, col. 6, lines 56-63 & claim 2 in Brown).
Tubb discloses an apparatus in Fig. 19 and/or Fig. 20 comprising: a medical device, i.e., insulin pen or insulin pump 1940 (including a dose delivering unit 140, a dose setting unit 1930 & transceiver unit 1920 are formed an insulin pen or insulin pump); a wireless interface 1920 configured for transmitted the selected dose (from the dose setting unit 1930) to a device 1920 (via transceiver unit 1920); wherein the apparatus is arranged to detect that the selected dose has been ejected (e.g., transceiver unit 1902 transmits the respective signal of the successful delivery of the dose set to the transceiver unit 1910. Thus, the successful delivery of the set dose can be protocolled by the determining unit 140 and stored in the storage unit 130, col. 27, lines 7-12);
Wherein the apparatus is arranged to transmit the captured/detected information comprising the selected dose (from the dose setting unit 1930 to the device (via transceiver unit 1910/1920 in Figs. 19-20 and/or 2010 in Fig. 20) responsive to detecting that the selected dose has been ejected, col. 27, lines 7-12, see Figs. 19-20.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Brown with obtaining a wireless interface for transmitting captured information of selected dose and/or selected dose has been ejected, as taught by Tubb, in order to inform the user or the physician the dose set being ejected in successfully via remotely location with respect to the medical device.
Regarding claim 24, Brown in view of Tubb discloses that wherein the information comprises information on a dose of the medicament that is ejected.
Regarding claim 25, Brown in view of Tubb discloses that wherein the information comprises information on whether an ejection of the medicament has taken place.
Regarding claim 26, Brown in view of Tubb discloses that wherein the information comprises information on a dose of the medicament that has been ejected.
Regarding claim 33, as discussed in the claim 21 above, Brown in view of Tubb discloses that the wireless interface is configured to provide the captured information to the device and therefore, it is well-known in the art that the wireless (or Wi-Fi) uses radio waves to transmit information between the two devices.
Regarding claim 35, Brown in view of Tubb discloses the invention. Brown further discloses that a processor for determining a proposal of at least one dose of the medicament to be ejected by the medical device (e.g., once microprocessor 30 has produced the digital value representative of the size of dose 34, it passes the value to memory 31 and display 14. Memory 31 records the digital value and display 14 displays it as a “dose selected” measurements. This alerts the patient that the injection of dose 34 is now be performed, col. 6, lines 55-60. In other words, the processor is determining a proposal/suggestion by alerting the patient to inject the selected dose).
Regarding claim 36, Brown in view of Tubb discloses the invention. Brown discloses that a measurement unit 12 (blood glucose meter) for measuring at least one parameter (blood sugar value) that is representative of a condition of a creature that is to receive the medicament ejectable by the medical device.
Regarding claim 40, it encompasses the same scope of the invention as to that of claim 21 except it is dratted in method format instead of apparatus format. Therefore, the claim 40 is rejected for the same reason as set forth above.
Claim 28 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brown (US 5,628,309) in view of Tubb et al. (US 8,660,802) and further in view of Follmann et al. (US 2009/0200185).
Regarding claim 28, Brown in view of Tubb discloses the invention substantially as claimed except for the limitation that the apparatus is configured to at least partially monitor a timing of an application sequence of the medical device.
Follmann discloses an injection medical device is configured to monitor at least a portion of timing of an application sequence (e.g., time of priming events and time of injection events, para [0068-0069]) by the injection medical device.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Brown in view of Tubb with including a function such as monitoring at least a portion of a timing of an application sequence (a priming time, an injection time), as taught by Follmann, in order to allow user to review and analysis of the data history of the injection medical device.
Claims 27, 29-32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brown (US 5,628,309) in view of Tubb et al. (US 8,660,802)and further in view of Hjertman et al. (US 7,164,133).
Regarding claims 27, 29-32, Brown in view of Tubb discloses the invention substantially as claimed except for the limitations that: at least one sensor comprises at least one optical sensor configured to capture information representative of or to determine an optical property of at least part of the medical device; the at least one optical sensor configured to capture information representative to determine a color or color coding of at least part of the medical device; wherein the apparatus is configured to recognize the color or the color coding of at least part of the medical device from the captured information; wherein the at least one sensor comprises at least one optical sensor configured to detect a code related to at least one of the medical device or the medicament contained therein.
Hjertman discloses in Figs. 5-6 that a label with markings is provided on a cartridge; wherein at least one optical sensor 57 is configured to capture/detect an image of information-bearing part of the medical device, i.e., determine a color or color coding of the marking color on the outer surface of the cartridge to inform user about the cartridge type, content or concentration of the drug;
wherein at least one optical sensor 57 is configured to capture/detect information representative of or to determine an optical property of at least part of the medical device, i.e., determine a color or color coding of the marking color on the outer surface of the cartridge to inform user about the cartridge type, content or concentration of the drug, col. 23, lines 5-30.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Brown in view of Tubb with adding an optical sensor configured to recognize the color or color coding of the part of the medical device from the captured information; configured to detect a code related to at least one of the medical device, as taught by Hjertman, in order to allow the user to determine a color or color coding of the marking color on the outer surface of the cartridge to inform user about the cartridge type.
Claim 32 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brown (US 5,628,309) in view of Tubb et al. (US 8,660,802) in view of Tubb et al. (US 8,660,802) and further in view of Evans (US 2001/0056258).
Brown in view of Tubb discloses the invention substantially as claimed except for the limitations as required in the claim 32.
Evans discloses an apparatus system in Figs. 8, 11-12 comprising: a syringe 120 with barcode 142; wherein at least one sensor 160 comprises at least one optical sensor (CCD) to detect a code, i.e., bar code related to at least one of the medical devices or the medicament contained therein (e.g., drug administration information, and determining the amount of drug being administered, e.g., drug administration data, paras [0064, 0066, 0069].
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Brown in view of Tubb with including at least one optical sensor being detect a code related to the medical device, as taught by Evans, in order to allow user to view the reading of drug administration information in order to allow user to view the reading of drug administration information such as patient's identification, type of drugs and/or amounts of drug etc....
Claim 37 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brown (US 5,628,309) in view of Tubb et al. (US 8,660,802) and further in view of Hartmann (US 6,482,185)
Brown in view of Tubb discloses the invention substantially as claimed except for the limitation that at least one sensor comprises an acoustical sensor, as required in the claim 37.
Hartmann discloses an apparatus comprising: a housing 30 with a mating unit to a medical device 10; wherein at least one sensor comprises an acoustical sensor (speaker 36) for a voice processor that coverts the dose indication into spoken acoustic information so that the dose indication also becomes audible, col. 4, lines 7-11.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Brown in view of Tubb with including an acoustical sensor, i.e. speaker, as taught by Hartmann in order to convert a dose indication into spoken acoustic information so that the dose indication also becomes audible.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21, 24-38 & 40 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights