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 .
Status of the Claims
Claims 1 and 7 are currently modified. Claims 1-12 are currently pending. Claims 1-12 are currently rejected.
Response to Arguments
Applicant's arguments filed 06/02/2026 have been fully considered but they are somewhat persuasive, requiring a modified rejection and further interpretation of the prior art.
Applicant argues that the modification of Kamen’s safety verification module (mini-remote interface 3610) to be installed in the functional device (infusion pump 3602) as taught by Rosinko ([0023]) is impossible since claim 1 of Kamen recites the limitation “a second remote interface, located separate from the first medical device and the first remote interface” and claim 7 of Kamen recites “safety critical information to the first medical device requires confirmation using the second remote interface”. Examiner does not depend upon the indicated claim language of Kamen, but rather on the disclosure of Kamen as a whole. Furthermore, even if the disclosure of Kamen as a whole were to support the Applicant’s argument of the installation of the mini-remote interface 3610 in the infusion pump 3620 because the second remote interface must be separate from the first medical device and the first remote interface, the modification of Kamen with Rosinko installs only one of the claimed remote interfaces of Kamen (see first and second remote interfaces in claim 1 of Kamen) in the functional device/infusion pump 3602, therefore there would still be a remote interface satisfying the limitation of being “separate from” the first medical device and first remote interface. Be that as it may, Examiner reiterates that the claims indicated by Applicant are not depended upon or referenced in regard to the prior rejection of claim 1 of the instant application. Applicant is improperly reading additional limitations from unreferenced sections of Kamen into the Examiner’s interpretation of Kamen.
Applicant argues that since Rosinko requires tracing of an icon as a verification instruction, Rosinko fails to teach or disclose the instant claim limitation “the verification instruction includes a user’s body movements configured to match the received functional instruction”. This argument is unpersuasive, since Rosinko does requiring the tracing of particular icons to match particular functional instructions, as previously outlined in the rejection of claim 1 see Rosinko [0030] “In addition, in one embodiment the tracing pattern of each icon would be different from the tracing pattern of each other icon to further help avoid possible accidental confirmation.”
Applicant further specifies that Rosinko fails to meet the newly amended claim limitation “wherein the verification instruction is completed without carrying parts of devices or without directly touching the functional devices”. Examiner notes that the claim limitation recited at the top of page 12 (see Remarks filed 06/02/2026) by the Applicant differs in language slightly from the claims as actually amended. Nonetheless, the new amendment to the independent claims 1 and 7 introduces additional 112 issues (see Claim Rejections - 35 USC § 112 section below) which render the claims indefinite. Furthermore, as currently written, this limitation is an alternative. That is to say, in order to meet the limitation, the verification instruction should be completed “without carrying parts or without directly touching the functional devices” (emphasis added). Rosinko, as noted in the updated rejections below, does not require the user to carry “parts” (see 112b interpretation below). Additionally, Examiner asks Applicant to consider Rosinko [0037] “In one embodiment, a video or graphic can be displayed on the device instructing the user as to the specific, e.g., gesture, required to confirm a specific parameter.” when considering further amendments.
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 1-12 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.
Claim 1 recites the limitation "the functional devices" in the last line. There is insufficient antecedent basis for this limitation in the claim. This limitation refers to multiple functional devices, when only one has been introduced on line 3. It is thus unclear whether this limitation is meant to refer to only that one previously introduced functional device, introduce multiple new functional devices, or both refer back to the previously introduced functional device and introduce an additional functional device. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 1 recites the limitation "without carrying parts" in the second to last line. It is unclear what exactly the term “parts” encompasses. Is “parts” meant to refer back to several elements mentioned earlier in the claim? Is “parts” meant to introduce an additional separate limitation referring to some specific mechanical part such as a screw? Does “parts” encompass any other object or device carried on a person’s body, such as earbuds, a phone, a bag, or clothing? For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 1 recites the limitation "without directly touching the functional devices" in the last line. It is unclear how such a limitation could be accomplished given that the functional device must touch the user’s body in order to accomplish drug infusion as claimed. Furthermore, it is unclear what exactly is not “directly touching” the functional device. Is this limitation in reference to a patient not directly touching the functional device, a clinician not directly touching the functional device, or some other claim feature (such as a safety verification, a remote device, a verification instruction, a user’s body movements) not directly touching the functional device? For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Similarly, claim 7 recites the limitation "the functional devices" in the last line. There is insufficient antecedent basis for this limitation in the claim. This limitation refers to multiple functional devices, when only one has been introduced on line 3. It is thus unclear whether this limitation is meant to refer to only that one previously introduced functional device, introduce multiple new functional devices, or both refer back to the previously introduced functional device and introduce an additional functional device. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Similarly, claim 7 recites the limitation "without carrying parts" in the second to last line. It is unclear what exactly the term “parts” encompasses. Is “parts” meant to refer back to several elements mentioned earlier in the claim? Is “parts” meant to introduce an additional separate limitation referring to some specific mechanical part such as a screw? Does “parts” encompass any other object or device carried on a person’s body, such as earbuds, a phone, a bag, or clothing? For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Similarly, claim 7 recites the limitation "without directly touching the functional devices" in the second to last line and last line. It is unclear how such a limitation could be accomplished given that the functional device must touch the user’s body in order to accomplish drug infusion as claimed. Furthermore, it is unclear what exactly is not “directly touching” the functional device. Is this limitation in reference to a patient not directly touching the functional device, a clinician not directly touching the functional device, or some other claim feature (such as a safety verification, a remote device, a verification instruction, a user’s body movements) not directly touching the functional device? For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 2-6 and 8-12 are rejected for being dependent upon a claim rejected under 112b, since dependent claims inherit the deficiencies of the claims on which they depend
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4-8, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamen et al (US 20190167902 A1; hereafter Kamen) in view of Rosinko (US 20180021514 A1; hereafter Rosinko).
Regarding claim 1, Kamen discloses a medical device with a safety verification, comprising:
a remote device (remote interface 3604, [0454], fig. 39);
a functional device (infusion pump 3602, [0454], fig. 39), wherein the remote device establishes a communication with the functional device so that the functional device receives functional instructions from the remote device ([0453] the remote interface 3604 may be used for non safety critical inputs and viewing, for example, initiate commands (but not confirming them), entering information for the bolus calculator/wizard and viewing the calculations and recommended volume of infusible fluid to be delivered using the remote interface 3604, but not confirming the information/volume or instructing the infusion pump 3602 to deliver…changes to the time of day may be done through the remote interface 3604), the functional instructions include drug infusion instructions or non-infusion instructions ([0453] mentions initiating commands and entering information as examples of functional instructions); and
a safety verification module (mini-remote interface 3610, [0454]), after the safety verification module receives a verification instruction (step 4106, fig. 41, “user confirms on mini-remote interface”) that matches one of the functional instructions (step 4100, fig. 41, “user enters/changes safety critical settings and/or commands into remote interface), the functional device executes the functional instructions (step 4108 fig. 41, “setting/command communicated to the infusion pump and/or implemented into the system”).
Kamen is silent to the safety verification module installed in the functional device and the verification instruction includes a user's body movements configured to match the received functional instruction, wherein different functional instructions are matched by different verification instructions having different body movements.
Rosinko, in the art of insulin delivery devices, teaches a safety verification module (graphic user interface 60 having a touch sensitive screen 46, fig. 2, [0023]) installed in a functional device (pump 12, fig. 1, [0023] pump 12 includes a user interface) and the verification instruction includes a user's body movements configured to match the received functional instruction ([0035] the described confirmation procedures requiring a user to trace an icon related to the programmed parameter or providing another associative confirmation as described herein can be applied to any programming aspect of such a pump, including, for example, programming a basal rate, programming operation limits, such as, e.g., a maximum bolus amount, programming alerts and reminders, etc.), wherein different functional instructions are matched by different verification instructions having different body movements ([0030] In addition, in one embodiment the tracing pattern of each icon would be different from the tracing pattern of each other icon to further help avoid possible accidental confirmation.) ([0036] icons may be tapped in multiple spots instead of being traced) ([0037] rather than or in addition to tracing a pattern of an icon, a user can be required to make a gesture, movement, reorientation, etc. of the device to provide the confirmation as measured by, e.g., a gyroscope or accelerometer within the device. In one embodiment, a video or graphic can be displayed on the device instructing the user as to the specific, e.g., gesture, required to confirm a specific parameter.), wherein the verification instruction is completed without carrying parts (see 112b interpretation above) (Examiner notes that Rosinko does not require the user to carry an additional physical part such as a stylus to complete the verification instruction, since the user may trace the icon directly on the screen.) or without directly touching the functional devices (see 112b interpretation above) ([0037] notes that the user may be required to make a specific gesture / movement / reorientation of the device in order to confirm a specific parameter.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the functional device/infusion pump 3602 to include the safety verification module/mini-remote interface 3610 of Kamen as taught by Rosinko’s pump 12 incorporating user interface 60 which is used to verify commands, and to modify the verification instruction of Kamen to be specific to the functional instruction, as taught by Rosinko [0030] and [0037], since both references deal with insulin delivery devices. One would have been motivated to make the modification because having the safety verification module included in the functional device ensures that the user of the functional device has access to and control of the safety verification module for improved security and, as noted by Rosinko [0030], having a different confirmation movement (tracing pattern) for each type of entry/instruction (each icon matches a type of entry) helps avoid possible accidental confirmation of an improper entry, which Rosinko [0029] notes “can lead to serious medical consequences”.
Regarding claim 2, Kamen modified by Rosinko discloses the medical device with the safety verification of claim 1, as described above, including wherein: the safety verification module includes a linear acceleration sensor or a gyroscope sensor (Rosinko: [0037] a user can be required to make a gesture, movement, reorientation, etc. of the device to provide the confirmation as measured by, e.g., a gyroscope or accelerometer within the device).
Regarding claim 4, Kamen modified by Rosinko discloses the medical device with the safety verification of claim 1, as described above. Kamen further discloses wherein: a drug includes insulin ([0453] the amount of infusible fluid (e.g., insulin) to deliver to the user), and one of the drug infusion instructions includes a basal insulin infusion instruction or a bolus insulin infusion instruction ([0453] commands may include the amount of infusible fluid (e.g. insulin) to be delivered to the user, the timing of delivery, and/or the command to deliver the infusible fluid to the user).
Regarding claim 5, Kamen modified by Rosinko discloses the medical device with the safety verification of claim 4, as described above. Kamen further discloses wherein: the non-infusion instructions include one of a start/stop instruction of the functional device ([0453] commands the command to deliver the infusible fluid to the user or to cancel delivery of infusible fluid), a function switching instruction, a function selection instruction, a data recording/display instruction, a failure detection instruction, a reconnection/disconnection instruction or a pairing instruction between the remote device and the functional device, or a combination of these said instructions.
Regarding claim 6, Kamen modified by Rosinko discloses the medical device with the safety verification of claim 5, as described above, including wherein: the body movements include one of jumping, squatting, leg movements, arm movements, taps on the functional device (Rosinko: [0036] the user may be required to touch the icon in a designated number of discrete locations without specific icons dictating the locations of those touches), bending over, torso twist, walking, or a combination of these said movements, and the verification instructions that match different functional instructions are not exactly the same (Rosinko: [0036] FIGS. 11A-11C therefore depict alternative icons for carbohydrate confirmation 144, BG level confirmation 152 and insulin bolus confirmation 160 according to embodiments of the present invention; [0037] In one embodiment, a video or graphic can be displayed on the device instructing the user as to the specific, e.g., gesture, required to confirm a specific parameter.).
Examiner further notes that another embodiment of Kamen teaches wherein a body movement may be taps ([0519] tapping on the device in specific codes may convey information) on the functional device ([0519] the infusion pump 1802, 19002 may include at least one accelerometer), further supporting the previously established modification of Kamen by Rosinko.
Regarding claim 7, Kamen discloses a method for a safety verification of a medical device, comprising:
providing a remote device (remote interface 3604, [0454], fig. 39), a functional device (infusion pump 3602, [0454], fig. 39), and a safety verification module (mini-remote interface 3610, [0454]), wherein the remote device establish a communication with the functional device ([0458] . For example, in some embodiments, the remote interface 3604 may communicate using a low power protocol radio with the infusion pump 3602),
a user operates the remote device to wirelessly send functional instructions (step 4100, fig. 41, “user enters/changes safety critical settings and/or commands into remote interface) to the functional device ([0453] the remote interface 3604 may be used for non safety critical inputs and viewing, for example, initiate commands (but not confirming them), entering information for the bolus calculator/wizard and viewing the calculations and recommended volume of infusible fluid to be delivered using the remote interface 3604, but not confirming the information/volume or instructing the infusion pump 3602 to deliver…changes to the time of day may be done through the remote interface 3604), the functional instructions include drug infusion instructions or non-infusion instructions ([0453] mentions initiating commands and entering information as examples of functional instructions);
the user sends a verification instruction (user input at step 4106, fig. 41, “user confirms on mini-remote interface”) that matches one of the functional instructions (step 4100, fig. 41, “user enters/changes safety critical settings and/or commands into remote interface) to the safety verification module (mini-remote interface 3610);
the safety verification module receives the verification instruction (mini-remote interface recognizes user input at step 4106, fig. 41, “user confirms on mini-remote interface”); and
the functional device executes the functional instructions (step 4108 fig. 41, “setting/command communicated to the infusion pump and/or implemented into the system”).
Kamen is silent to the safety verification module set in the functional device and the verification instruction includes a user's body movements configured to match the received functional instruction, wherein different functional instructions are matched by different verification instructions having different body movements.
Rosinko, in the art of insulin delivery devices, teaches wherein a safety verification module (graphic user interface 60 having a touch sensitive screen 46, fig. 2, [0023]) is set in the functional device (pump 12, fig. 1, [0023] pump 12 includes a user interface),
and the verification instruction includes a user's body movements configured to match the received functional instruction ([0035] the described confirmation procedures requiring a user to trace an icon related to the programmed parameter or providing another associative confirmation as described herein can be applied to any programming aspect of such a pump, including, for example, programming a basal rate, programming operation limits, such as, e.g., a maximum bolus amount, programming alerts and reminders, etc.), wherein different functional instructions are matched by different verification instructions having different body movements ([0030] In addition, in one embodiment the tracing pattern of each icon would be different from the tracing pattern of each other icon to further help avoid possible accidental confirmation.) ([0036] icons may be tapped in multiple spots instead of being traced) ([0037] rather than or in addition to tracing a pattern of an icon, a user can be required to make a gesture, movement, reorientation, etc. of the device to provide the confirmation as measured by, e.g., a gyroscope or accelerometer within the device. In one embodiment, a video or graphic can be displayed on the device instructing the user as to the specific, e.g., gesture, required to confirm a specific parameter.), wherein the verification instruction is completed without carrying parts (see 112b interpretation above) (Examiner notes that Rosinko does not require the user to carry an additional physical part such as a stylus to complete the verification instruction, since the user may trace the icon directly on the screen.) or without directly touching the functional devices (see 112b interpretation above) ([0037] notes that the user may be required to make a specific gesture / movement / reorientation of the device in order to confirm a specific parameter.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the functional device/infusion pump 3602 to include the safety verification module/mini-remote interface 3610 of Kamen as taught by Rosinko’s pump 12 incorporating user interface 60 which is used to verify commands, and to modify the verification instruction of Kamen to be specific to the functional instruction, as taught by Rosinko [0030] and [0037], since both references deal with insulin delivery devices. One would have been motivated to make the modification because having the safety verification module included in the functional device ensures that the user of the functional device has access to and control of the safety verification module for improved security and, as noted by Rosinko [0030], having a different confirmation movement (tracing pattern) for each type of entry/instruction (each icon matches a type of entry) helps avoid possible accidental confirmation of an improper entry, which Rosinko [0029] notes “can lead to serious medical consequences”.
Regarding claim 8, Kamen modified by Rosinko discloses the method for the safety verification of the medical device of claim 7, as described above, including wherein: the safety verification module includes a linear acceleration sensor or a gyroscope sensor (Rosinko: [0037] a user can be required to make a gesture, movement, reorientation, etc. of the device to provide the confirmation as measured by, e.g., a gyroscope or accelerometer within the device).
Regarding claim 10, Kamen modified by Rosinko discloses the method for the safety verification of the medical device of claim 7, as described above. Kamen further discloses wherein: a drug includes insulin ([0453] the amount of infusible fluid (e.g., insulin) to deliver to the user), and the drug infusion instructions include a basal insulin infusion instruction or a bolus insulin infusion instruction ([0453] commands may include the amount of infusible fluid (e.g. insulin) to be delivered to the user, the timing of delivery, and/or the command to deliver the infusible fluid to the user).
Regarding claim 11, Kamen modified by Rosinko discloses the method for the safety verification of the medical device of claim 10, as described above. Kamen further discloses wherein: the non-infusion instructions include one of a start/stop instruction of the functional device ([0453] commands the command to deliver the infusible fluid to the user or to cancel delivery of infusible fluid), a function switching instruction, a function selection instruction, a data recording/display instruction, a failure detection instruction, a reconnection/disconnection instruction or a pairing instruction between the remote device and the functional device, or a combination of these said instructions.
Regarding claim 12, Kamen modified by Rosinko discloses the method for the safety verification of the medical device of claim 11, as described above, including wherein: the body movements include one of jumping, squatting, leg movements, arm movements, taps on the functional device (Rosinko: [0036] the user may be required to touch the icon in a designated number of discrete locations without specific icons dictating the locations of those touches), bending over, torso twist, walking, or a combination of these said movements, and the verification instructions that match different functional instructions are not exactly the same (Rosinko: [0036] FIGS. 11A-11C therefore depict alternative icons for carbohydrate confirmation 144, BG level confirmation 152 and insulin bolus confirmation 160 according to embodiments of the present invention; [0037] In one embodiment, a video or graphic can be displayed on the device instructing the user as to the specific, e.g., gesture, required to confirm a specific parameter.).
Examiner further notes that another embodiment of Kamen teaches wherein a body movement may be taps ([0519] tapping on the device in specific codes may convey information) on the functional device ([0519] the infusion pump 1802, 19002 may include at least one accelerometer), further supporting the previously established modification of Kamen by Rosinko.
Claim(s) 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen modified by Rosinko and further in view of Pulliam et al (US 9782122 B1; hereafter Pulliam).
Regarding claim 3, Kamen modified by Rosinko discloses the medical device with the safety verification of claim 2, as described above.
Kamen and Rosinko are silent to the acceleration sensor being a three-axis linear acceleration sensor.
Pulliam, in the art of insulin infusion and measurement devices, teaches wherein: the linear acceleration sensor is a three-axis linear acceleration sensor (col. 21 ln. 35-36, preferably, the accelerometers are 3-axis accelerometers capable of measuring acceleration in all 3 axes).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the linear acceleration sensor of Kamen modified by Rosinko to be a three-axis linear acceleration sensor as taught by Pulliam, since both deal with drug delivery and sensing patient movement. Using a three-axis acceleration sensor would be a simple substitution that would not detract from the device’s functionality. One would have been motivated to make the modification because, as noted by Pulliam col. 21 ln. 35-36, the 3-axis accelerometer can measure acceleration in all three axes. This would allow the device of Yang to better monitor the position of the patient and determine the patient’s type of movement.
Regarding claim 9, Kamen modified by Rosinko discloses the method for the safety verification of the medical device of claim 8, as described above.
Kamen and Rosinko are silent to the acceleration sensor being a three-axis linear acceleration sensor.
Pulliam, in the art of insulin infusion and measurement devices, teaches wherein: the linear acceleration sensor is a three-axis linear acceleration sensor (col. 21 ln. 35-36, preferably, the accelerometers are 3-axis accelerometers capable of measuring acceleration in all 3 axes).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the linear acceleration sensor of Kamen modified by Rosinko to be a three-axis linear acceleration sensor as taught by Pulliam, since both deal with drug delivery and sensing patient movement. Using a three-axis acceleration sensor would be a simple substitution that would not detract from the device’s functionality. One would have been motivated to make the modification because, as noted by Pulliam col. 21 ln. 35-36, the 3-axis accelerometer can measure acceleration in all three axes. This would allow the device of Yang to better monitor the position of the patient and determine the patient’s type of movement.
Claim(s) 6 and 12 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Kamen modified by Rosinko and further in view of Yang et al (WO 2018058287 A1; hereafter Yang).
Alternatively, regarding claim 6, Kamen modified by Rosinko discloses the medical device with the safety verification of claim 5, as described above, including wherein: the verification instructions that match different functional instructions are not exactly the same (Rosinko: [0036] FIGS. 11A-11C therefore depict alternative icons for carbohydrate confirmation 144, BG level confirmation 152 and insulin bolus confirmation 160 according to embodiments of the present invention; [0037] In one embodiment, a video or graphic can be displayed on the device instructing the user as to the specific, e.g., gesture, required to confirm a specific parameter.).
Kamen and Rosinko are silent to the body movement being jumping, squatting, leg movements, arm movements, taps on the functional device, bending over, torso twist, walking, or a combination of these said movements.
Yang, in the art of drug delivery devices, teaches wherein the body movements include one of jumping, squatting (pg. 6 para. 3, authentication is a jumping or squatting linear movement made by the user, see fig. 7), leg movements, arm movements, taps on the functional device, bending over, torso twist (pg. 6 para. 3, authentication is a twisting movement like twisting her or his body clockwise, see fig. 8), walking, or a combination of these said movements.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the specific body movement verification instructions of Kamen and Rosinko (which match specific functional instructions) to include jumping, squatting, and/or twisting as taught by Yang since Yang also deals with a drug delivery device. One would have been motivated to make the modification because, as noted by Rosinko [0041] “complex confirmation procedures requiring more than a simple tap or press of the screen described herein provide the additional advantage of substantially reducing the possibility of an inadvertent confirmation occurring while the device is stored by the user” and Rosinko [0037] “In one embodiment, a video or graphic can be displayed on the device instructing the user as to the specific, e.g., gesture, required to confirm a specific parameter.” Thus, Rosinko motivates the inclusion of more complex specific gestures to confirm specific parameters. Incorporating a full body movement requires more muscles and would further differentiate different gestures.
Alternatively, regarding claim 12, Kamen modified by Rosinko discloses the method for the safety verification of the medical device of claim 11, as described above, including wherein: the verification instructions that match different functional instructions are not exactly the same (Rosinko: [0036] FIGS. 11A-11C therefore depict alternative icons for carbohydrate confirmation 144, BG level confirmation 152 and insulin bolus confirmation 160 according to embodiments of the present invention; [0037] In one embodiment, a video or graphic can be displayed on the device instructing the user as to the specific, e.g., gesture, required to confirm a specific parameter.).
Kamen and Rosinko are silent to the body movement being jumping, squatting, leg movements, arm movements, taps on the functional device, bending over, torso twist, walking, or a combination of these said movements.
Yang, in the art of drug delivery devices, teaches wherein the body movements include one of jumping, squatting (pg. 6 para. 3, authentication is a jumping or squatting linear movement made by the user, see fig. 7), leg movements, arm movements, taps on the functional device, bending over, torso twist (pg. 6 para. 3, authentication is a twisting movement like twisting her or his body clockwise, see fig. 8), walking, or a combination of these said movements.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the specific body movement verification instructions of Kamen and Rosinko (which match specific functional instructions) to include jumping, squatting, and/or twisting as taught by Yang since Yang also deals with a drug delivery device. One would have been motivated to make the modification because, as noted by Rosinko [0041] “complex confirmation procedures requiring more than a simple tap or press of the screen described herein provide the additional advantage of substantially reducing the possibility of an inadvertent confirmation occurring while the device is stored by the user” and Rosinko [0037] “In one embodiment, a video or graphic can be displayed on the device instructing the user as to the specific, e.g., gesture, required to confirm a specific parameter.” Thus, Rosinko motivates the inclusion of more complex specific gestures to confirm specific parameters. Incorporating a full body movement requires more muscles and would further differentiate different gestures.
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.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 06/25/2026
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