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 .
Specification
The disclosure is objected to because of the following informalities:
Please correct the chain of continuity to include that US case No. 16549124 is now US Patent No. 11, 969,531B2 issued on Apr. 30, 2024.
Appropriate correction is required.
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.
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Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11, 969,531B2. Although the claims at issue are not identical, they are not patentably distinct from each other because
The limitation of claim 1 of the current application discloses a control component for detecting control commands for securely controlling a medical device (see claim 1 of the patent, Col. 12, line 31 up to Col. 13, line 6) comprising: at least one operating element (see claim 1 of the patent, Col. 12, line 31 up to Col. 13, line 6); a user interface configured to: detect at least one control command for the medical device (see claim 1 of the patent, Col. 12, line 31 up to Col. 13, line 6); and based on detecting the at least one control command, output a message including a request to activate the at least one operating element, wherein the control component is a tablet, smartphone or mobile terminal, and wherein the user interface comprises a graphical user interface (GUI) of the tablet, smartphone or mobile terminal (see claim 1 of the patent, Col. 12, line 31 up to Col. 13, line 6); and a processor (see claim 1 of the patent, Col. 12, line 31 up to Col. 13, line 6) configured to: assign the at least one operating element with an additional function relating to confirming execution of the at least one control command; and control the at least one operating element; wherein, for confirming execution of the at least one control command, the at least one operating element is configured to detect activation of the at least one operating element (see claim 1 of the patent, Col. 12, line 31 up to Col. 13, line 6); and send a signal to the processor indicating activation of the at least one operating element (see claim 1 of the patent, Col. 12, line 31 up to Col. 13, line 6). wherein the claim 1 of the current case is broader than claim 1 of the patent as it is silent with regard to the limitation that the request to activate the at least one operating element comprises a request for simultaneous activation of a plurality of operating elements. Also, the limitation of claim 2 of the current application (claim 2 of the patent Col. 13, lines 7-9), claim 3 (claim 3 of the patent Col. 13, lines 10-15), claim 4 (claim 4 of the patent Col. 13, lines 16-19), claim 5 (claim 5 of the patent Col. 13, lines 20-22), claim 6 (claim 6 of the patent Col. 13, lines 23-24).
Claims 12-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-12 of U.S. Patent No. 11, 969,531B2. Although the claims at issue are not identical, they are not patentably distinct from each other because
The limitation of claim 12 of the current application discloses a method of operating a control component for detecting control commands for securely controlling a medical device (see claim 7 of the patent, Col. 13, lines 26-60) the method comprises: detecting, by the control component, at least one control command via a user interface of the control component, wherein the control component is a tablet, smartphone or mobile terminal (see claim 7 of the patent, Col. 13, lines 26-60); generating, by the control component, a message including a request to activate at least one operating element (see claim 7 of the patent, Col. 13, lines 26-60); and outputting, by the control component, the message; checking, by the control component, whether activation of the at least one operating element in accordance with the request has been detected on the at least one operating element (see claim 7 of the patent, Col. 13, lines 26-60); and wherein the method further comprises: performing monitoring to determine whether activation of the at least one operating element has already been detected via the at least one operating element before outputting of the message; and in response to determining that activation of the at least one operating element has already been detected via the at least one operating element before outputting of the message, outputting a warning (see claim 7 of the patent, Col. 13, lines 26-60). wherein the claim 11 of the current case is broader as it is silent with regard to the limitation that the request to activate the at least one operating element comprises a request for simultaneous activation of a plurality of operating elements. Also, the limitation of claim 13 of the current application (claim 8 of the patent Col. 13, lines 61-62), claim 14 (claim 9 of the patent Col. 13, lines 63-65), claim 15 (claim 10 of the patent Col. 13, line 66- to col. 14, line 3), claim 16 (claim 11 of the patent Col. 14, lines 3-5), claim 17 (claim 12 of the patent Col. 14, lines 6-9).
Claims 18-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-14 of U.S. Patent No. 11, 969,531B2. Although the claims at issue are not identical, they are not patentably distinct from each other because
The limitation of claim 18 of the current application discloses a non-transitory computer-readable medium having processor-executable instructions stored thereon for operating a control component for detecting control commands for securely controlling a medical device (see claim 13 of the patent, Col. 14, lines 11-48), comprises: detecting, by the control component, at least one control command via a user interface of the control component, wherein the control component is a tablet, smartphone or mobile termina (see claim 13 of the patent, Col. 14, lines 11-48); generating, by the control component, a message including a request to activate at least one operating element (see claim 13 of the patent, Col. 14, lines 11-48); and outputting, by the control component, the message; checking, by the control component, whether activation of the at least one operating element in accordance with the request has been detected on the at least one operating element (see claim 13 of the patent, Col. 14, lines 11-48); and wherein the processor-executable instructions, when executed, further facilitate: performing monitoring to determine whether activation of the at least one operating element has already been detected via the at least one operating element before outputting of the message; and in response to determining that activation of the at least one operating element has already been detected via the at least one operating element before outputting of the message, outputting a warning (see claim 13, Col. 14, lines 11-48). wherein the claim 18 of the current case is broader than claim 13 of the patent as it is silent with regard to the limitation that the request to activate the at least one operating element comprises a request for simultaneous activation of a plurality of operating elements. Also, the limitation of claim 19 of the current application (claim 14 of the patent, Col. 14, lines 49-52), claim 20 (claim 13 of the patent Col. 14, lines 11-48), claim 21 (claim 13 of the patent Col. 14, lines 11-48), claim 22 (claim 13 of the patent Col. 14, lines 11-48), claim 23 (claim 13 of the patent Col. 14, lines 11-48). claim 24 (claim 13 of the patent Col. 14, lines 11-48).
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) 1-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamen et al. (US 20150011970 A1) (“Kamen”).
Re Claim 1, Kamen discloses a control component (3604, 3610, Fig. 37-39) for detecting control commands for securely controlling a medical device (medical device 3602, ¶0444-¶0445), the control component comprising: at least one operating element (buttons ¶0446 and/or icon on the smart phone interface ¶0450); a user interface (the interface on 3604 and 3610, Fig. 39, ¶0438-¶0439) configured to: detect at least one control command for the medical device (Fig, 41, ¶0450, step 4100); and based on detecting the at least one control command, output a message including a request to activate the at least one operating element (step 4102, ¶0050, the operating element can be START icon on the smart phone interface ¶0450 or a button ¶0462), wherein the control component is a tablet, smartphone or mobile terminal (smart phone devices, ¶0442), and wherein the user interface comprises a graphical user interface (GUI) of the tablet, smartphone or mobile terminal (application in the phone ¶0442); and a processor (processors of smart devices 3604, 3610) configured to: assign the at least one operating element with an additional function relating to confirming execution of the at least one control command (Fig. 41, steps 4106-4108, ¶0450); and control the at least one operating element (¶0450, ¶0451); wherein, for confirming execution of the at least one control command, the at least one operating element is configured to detect activation of the at least one operating element (¶0450, ¶0451); and send a signal to the processor indicating activation of the at least one operating element (¶0451-¶0452); wherein the processor is further configured to cause execution of the at least one control command on the medical device in response to receiving the signal from the at least one operating element (¶052) indicating activation of the at least one operating element in accordance with the request (¶0453); wherein the processor is further capable to: perform monitoring to determine whether activation of the at least one operating element has already been detected via the at least one operating element before outputting of the message (¶441, ¶0451); and in response to determining that activation of the at least one operating element has already been detected via the at least one operating element before outputting of the message, output a warning (alerting , ¶0441, ¶0453 and wherein an alert to change the setting can be shown after setting delivering that outside the preferences).
Re Claim 2, Kamen discloses wherein the user interface and the at least one operating element are separate components (icon on the smart phone interface ¶0450 or a separate button ¶0462).
Re Claim 3, Kamen discloses wherein the at least one operating element comprises a switch, a key, a button, or a knob (¶0442) and wherein the request to activate the at least one operating element comprises a request for performing an action with respect to the switch, the key, the button or the knob (¶0442, ¶0449 such as performing critical step).
Re Claim 4, Kamen discloses wherein the control component is arranged separately from the medical device (Fig. 39) and is configured to communicate with the medical device via a secure communications connection (¶0456).
Re Claim 5, Kamen discloses wherein the message includes a summary element which reproduces the at least one control command (¶0114, history, logbook, ¶0439 that include described commands).
Re Claim 6, Kamen discloses wherein the at least one operating element is part of the user interface ( icon on the smart phone interface ¶0450 or a button ¶0462).
Re Claim 7, Kamen discloses a control system for secure control (Fig. 37-39), wherein the control system comprises: a control component (3604 Fig. 37-39), wherein the control component is a tablet, smartphone or mobile terminal and is configured to be operated by a first user (smart phone devices, ¶0442 which can be operated by a doctor, ¶0078); and a medical device (medical device 3602 ¶0444-¶0445), wherein the medical device includes at least one operating element (3610) and is configured to be operated by a second user ( by the patient to link the pump to the with BTLE and remote controller ¶0439); and wherein the control component is arranged separately from the medical device (Fig. 39) and is configured to communicate with the medical device via a secure communications connection (¶0452 with secure password); wherein the control component is configured to: detect a control command from the first user via a graphical user interface (GUI) of the control component (interface on 3604. Step 4100, ¶0450); generate a message which includes a request for the second user to activate the at least one operating element of the medical device (step 4102, ¶0450); and send the message to the medical device (¶0450); wherein the medical device is capable to: output the message on an output interface of the medical device (3610, ¶0450); confirm execution of the at least operating element based on detecting activation of the at least one operating element by the second user in accordance with the request (¶0450); and execute the at least one control command in response to confirming execution of the at least operating element (¶0450).
Re Claim 8, Kamen discloses wherein the medical device is further capable to: perform monitoring to determine whether activation of the at least one operating element has already been detected via the at least one operating element before outputting of the message (¶451); and output a warning in response to determining that activation of the at least one operating element has already been detected via the at least one operating element before outputting of the message (alerting , ¶0441, ¶0453 and wherein an alert to change the setting can be shown after setting delivering that outside the preferences).
Re Claim 9, Kamen discloses wherein the request to activate the at least one operating element comprises a request to activate a plurality of operating elements in a defined sequence (¶0462, the order is by the specific setting such as a particular command by first scrolling to select that particular command, which may be done using any of the user inputs) and then touching the screen at another particular location and swiping the screen either left to right or right to left).
Re Claim 10, Kamen discloses wherein the at least one operating element comprises a dedicated confirmation switch (¶462, wheel).
Re Claim 11, Kamen discloses wherein executing the at least one control command in response to confirming execution of the at least one control command further comprises: sending a confirmation signal to the control component in response to confirming execution of the at least one control command; receiving the control command from the control component in response to the confirmation signal (¶0453, ¶0458); and executing the at least one control command in response to receiving the control command (¶0450, delivery command).
Re Claim 12, Kamen discloses a method (Fig..37-41) for operating a control component (Fig. 39, 3610 BS 3604) for detecting control commands for securely controlling a medical device (medical device 3602, ¶0444-¶0445), wherein the control component is arranged separately from the medical device (Fig. 39) and communicates with the medical device via a secure communications connection (¶0456), wherein the method comprises: detecting, by the control component, at least one control command via a user interface of the control component (interface on tablet 3604m step 4100), wherein the control component is a tablet, smartphone or mobile terminal (¶0442, Fig. 39), and wherein the user interface comprises a graphical user interface (GUI) of the tablet, smartphone or mobile terminal (¶0442); generating, by the control component, a message including a request to activate at least one operating element (step 4102, ¶0465- ¶0466, icon for accepting by the user or button for confirming ); outputting, by the control component, the message (steps 4102, 4104, Fig. 41, ¶0450); checking, by the control component, whether activation of the at least one operating element in accordance with the request has been detected on the at least one operating element (step 4106, ¶0453); and in response to detecting activation of the at least one operating element in accordance with the request, preparing the at least one control command for execution on the medical device (¶0453, final confirmation); wherein the method further comprises: performing monitoring to determine whether activation of the at least one operating element has already been detected via the at least one operating element before outputting of the message (alerting , ¶0441, ¶0453 and wherein an alert to change the setting can be shown after setting delivering that outside the preferences); and in response to determining that activation of the at least one operating element has already been detected via the at least one operating element before outputting of the message, outputting a warning (alerting , ¶0441, ¶0453 and wherein an alert to change the setting can be shown after setting delivering that outside the preferences).
Re Claim 13, Kamen discloses wherein the at least one control command is detected as an acoustic input (¶0109-¶0110, ¶0533, audio input).
Re Claim 14, Kamen discloses wherein the checking comprises detecting whether a confirmation signal has been received (¶0453, checking that final confirmation or the command will not reach to the pump).
Re Claim 15, Kamen discloses wherein the at least one control command is detected on an input interface (interface in 3604, ¶0445), and wherein the activation of the at least one operating element is not detected on the input interface (button activation on device 3604, ¶0453).
Re Claim 16, Kamen discloses wherein the at least one control command and/or the message comprises a time stamp (Fig. 48a-b which adjusting the time stamp).
Re Claim 17, Kamen discloses wherein the request to activate the at least one operating element is generated dynamically in accordance with a preconfigured plan stored in a memory (¶0451, the save history and logbook on memory, ¶0495).
Re Claim 18, Kamen discloses a non-transitory computer-readable medium ( f\Fig. 39, ¶0442, 3604 smart phone) having processor-executable instructions stored thereon for operating a control component for detecting control commands for securely controlling a medical device, (a process of the smart phone, Fig. 39, pump 3602), wherein the control component is arranged separately from the medical device (Fig. 39, ¶0444-¶0445) and communicates with the medical device via a secure communications connection (¶0456), wherein the processor-executable instructions, when executed, facilitate: detecting, by the control component, at least one control command via a user interface of the control component (interface on 3604, step 4100, Fig. 41, ¶0450), wherein the control component is a tablet, smartphone or mobile terminal, and wherein the user interface comprises a graphical user interface (GUI) of the tablet, smartphone or mobile terminal (Fig. 39, ¶0450); generating, by the control component, a message including a request to activate at least one operating element; outputting (step 4102), by the control component, the message (¶0450); checking, by the control component, whether activation of the at least one operating element in accordance with the request has been detected on the at least one operating element (¶0450, ¶0466); and in response to detecting activation of the at least one operating element in accordance with the request, preparing the at least one control command for execution on the medical device (¶0453); wherein the processor-executable instructions, when executed, further facilitate: performing monitoring to determine whether activation of the at least one operating element has already been detected via the at least one operating element before outputting of the message (alerting , ¶0441, ¶0453 and wherein an alert to change the setting can be shown after setting delivering that outside the preferences); and in response to determining that activation of the at least one operating element has already been detected via the at least one operating element before outputting of the message, outputting a warning * alerting , ¶0441, ¶0453 and wherein an alert to change the setting can be shown after setting delivering that outside the preferences).
Re Claim 19, Kamen discloses wherein the non-transitory computer-readable medium comprises a protected memory region of the control component (¶0495 the nonvolatile memory, ¶0593).
Re Claim 20, Kamen discloses wherein the at least one control command is detected as an acoustic input (¶0109-¶0110, ¶0533, audio input).
Re Claim 21, Kamen discloses wherein the checking comprises detecting whether a confirmation signal has been received (step 4104, 4106, Fig. 41).
Re Claim 22, Kamen discloses the at least one control command is detected on an input interface (interface in 3604, ¶0445), and wherein the activation of the at least one operating element is not detected on the input interface (button activation on device 3604, ¶0453).
Re Claim 23, Kamen discloses wherein the at least one control command and/or the message comprises a time stamp (Fig. 48a-b which adjusting the time stamp).
Re Claim 24, Kamen discloses wherein the request to activate the at least one operating element is generated dynamically in accordance with a preconfigured plan (¶0451, the save history and logbook on memory, ¶0495).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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