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 .
Notice of Amendment
In response to the amendment filed on 1/6/2026, amended claims 16, 22, 24-25, 28, and 32 are acknowledged. Claims 16-35 remain pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 16-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martin et al. (US Publication No. 2017/0332969 A1) (cited by Applicant), further in view of Kahl et al. (US Patent No. 10,687,753 B2) (previously cited).
Regarding claim 16, Martin et al. discloses a sensor assembly comprising:
a sensor element (130A, 130B) configured to be arranged external to a drug delivery device (100) that is configured to be held by a user of the drug delivery device through gripping of the sensor element (see Figures 1-3B and [0035] – “the force sensors 130A,B can be configured to detect one or more forces exerted on the exterior of the diagnostic measurement device 100”),
wherein the sensor element is configured to detect a contact area (110A, 110B) of a hand of the user when the user grips the sensor element (see [0030] – “the sensors may include any sensors capable of detecting force, pressure, or load”; see also [0042] and [0048]); and
an electronic module coupled to the sensor element and comprising a clock device (145) configured to provide the detection results of the contact area of the hand of the user with a time index indicating the point of time and date of the detection of the sensor element (see [0040] – “The timer 145 can allow for time measurements to be correlated with measurements of one or more of the force sensors 130A,B and location sensors 170” and [0049] – “For example, force sensors may be used to monitor a gripping or squeezing action to provide data relevant to grip strength. Motion sensors can be used to monitor bending, rotation, or movement of the wrist, hand, and/or arm to provide data relevant to range of motion. A timer can be used in conjunction with one of the other sensors to determine an amount of time taken to perform a particular action or a duration of time between two actions”).
It is noted Martin et al. does not specifically teach the sensor element defines a sensor area comprising a plurality of adjacent pixels and is configured to detect an absolute size of a contact area of a hand of the user when the user grips the sensor element. However, Kahl et al. teaches the sensor element defines a sensor area (2) comprising a plurality of adjacent pixels (22) and is configured to detect an absolute size of a contact area of a hand of the user when the user grips the sensor element (see Figures 1A-2B and [0068] – “FIGS. 1A-B and 2A-B illustrate how to measure a hand pressure map at hand-object contact interfaces. A pressure pad 2 is fixed about a cylinder 4. The pressure pad 2 includes an array of pressure sensors 22 (see FIG. 2A). When a hand 6 is in physical contact with the pressure pad 2, e.g., gripping the cylinder 4, a distribution 8 of contact pressure values at the contact interface can be measured by the array of pressure sensors 22 of the pressure pad 2, as shown in FIG. 2A. The distribution 8 of contact pressure values as measured by the pressure pad 2 can be converted to a 2D representation 12 of palmar view of the hand 6, as shown in FIG. 2B. Such conversion can be performed by, for example, assigning each of the pressure sensors 22 of FIG. 2A to the respective locations on the palmar view of the hand 6. In the depicted embodiment, the 2D representation 12 can serve as a 2D hand pressure map, which may display varying contact pressure values at different locations of the palm side of the hand”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor assembly of Martin et al. to include the sensor element defines a sensor area comprising a plurality of adjacent pixels and is configured to detect an absolute size of a contact area of a hand of the user when the user grips the sensor element, as disclosed in Kahl et al., so as to measure a hand pressure map at hand-object contact interfaces (see Kahl et al.: [0068]).
Regarding claim 17, Martin et al. discloses the sensor assembly is configured to be mounted to an outer surface of a body of the drug delivery device (see [0014] – “The force sensors may also be adapted to couple with the exterior surface of an injection device” and [0046] – “the module may be cylindrical in shape, and configured to reversibly mount to the exterior cover or cap of an autoinjector”).
Regarding claim 18, Martin et al. discloses the contact area corresponds to a size of an area on the user's hand, wherein the area on the user's hand touches the sensor element when the user grips the sensor element and/or wherein the contact area corresponds to a position of the contact of the hand of the user of the drug delivery device and/or wherein the contact area corresponds to a number of contacts of the hand of the user of the drug delivery device (see [0024] – “The overmolds 110A,B can include textured surfaces 198 configured to provide ergonomic comfort and to provide an indication of where a user should grip the diagnostic measurement device”; see also [0028]-[0029]).
Regarding claim 19, Martin et al. discloses the sensor element is configured to be wrapped around the outer surface of the body of the drug delivery device, or
the sensor element is configured to be slipped or clipped over the outer surface of the body of the drug delivery device (see [0046] – “the module may be cylindrical in shape, and configured to reversibly mount to the exterior cover or cap of an autoinjector”), or
the sensor assembly further comprises a sleeve configured to be disposed at the outer surface of the body of the drug delivery device, wherein the sensor element is mounted to the sleeve or is integrated into the sleeve (see [0046] – “the module may be cylindrical in shape, and configured to reversibly mount to the exterior cover or cap of an autoinjector”), or
the sensor element is configured to be integrated into the outer surface of the body (108) of the drug delivery device.
Regarding claim 20, Martin et al. discloses the sensor element is sized so as to be at least partially contactable by a palm, phalanx, and finger joints areas of the user's hand (see Figures 1-3B and [0024] – “The overmolds 110A,B can include textured surfaces 198 configured to provide ergonomic comfort and to provide an indication of where a user should grip the diagnostic measurement device”; see also [0028]-[0029]).
Regarding claim 21, Martin et al. discloses the sensor element is smaller than a total area of the palm, phalanx and finger joints areas of the user's hand (see Figures 1-3B and [0024] – “The overmolds 110A,B can include textured surfaces 198 configured to provide ergonomic comfort and to provide an indication of where a user should grip the diagnostic measurement device”; see also [0028]-[0029]).
Regarding claim 22, Martin et al. discloses the electronic module (160) is configured to communicate with an external electronic device (185) (see Figure 4 and [0037] – “The communication module 160 can communicate with an external device 185 such as a mobile device, home health monitor, computer, server, or any other electronic external device that is known in the art”).
Regarding claim 23, Martin et al. discloses the electronic module is configured to transmit data representing a detection result of the sensor element to the external electronic device (see [0035] – “The processor 150 can also be programmed to initiate the transmission of the force measurements and/or force data to an external device, such as external device 185, via the communication module 160”).
Regarding claim 24, Martin et al. discloses the electronic module comprises a memory (140) configured to store a plurality of detection results of the sensor element (see [0039] – “the memory can be configured to store one or more of force measurements, force data, motion measurements, and motion data”).
Regarding claim 25, Martin et al. discloses the electronic module is configured to carry out a comparison of the detection results of the sensor element consecutively, to carry out an analysis of the comparison and to derive a result of a therapy for the treatment of rheumatoid arthritis from the analysis (see [0040] – “The timer 145 can allow for time measurements to be correlated with measurements of one or more of the force sensors 130A,B and location sensors 170”; see also [0003] – “rheumatoid arthritis”, [0018], and [0049]).
Regarding claim 26, Martin et al. discloses the sensor element is configured to detect an orientation of the user's hand relative to the sensor element or the drug delivery device (see [0036] – “the motion sensors can be configured to detect one or more movements and/or orientations of the diagnostic measurement device 100”; see also [0042] and [0048]).
Regarding claim 27, Martin et al. discloses the sensor assembly comprises an ergonomic shape (see [0024] – “The overmolds 110A,B can include textured surfaces 198 configured to provide ergonomic comfort and to provide an indication of where a user should grip the diagnostic measurement device”).
Regarding claim 28, Martin et al. discloses a drug delivery system, comprising:
a drug delivery device (100) (see [0018]), and
a sensor assembly comprising a sensor element (130A, 130B) (see Figures 1-3B and [0035] – “the force sensors 130A,B can be configured to detect one or more forces exerted on the exterior of the diagnostic measurement device 100”), wherein the sensor element is configured to detect a contact area of a hand of a user and is configured to be arranged external to the drug delivery device (see [0014] – “The force sensors may also be adapted to couple with the exterior surface of an injection device” and [0046] – “the module may be cylindrical in shape, and configured to reversibly mount to the exterior cover or cap of an autoinjector”), and wherein the drug delivery device is configured to be held by the user of the drug delivery device through gripping of the sensor element (see [0030] – “the sensors may include any sensors capable of detecting force, pressure, or load”; see also [0042] and [0048]) and wherein the sensor assembly comprises an electronic module coupled to the sensor element and comprising a clock device (145) configured to provide the detection results of the contact area of the hand of the user with a time index indicating the point of time and date of the detection of the sensor element (see [0040] – “The timer 145 can allow for time measurements to be correlated with measurements of one or more of the force sensors 130A,B and location sensors 170” and [0049] – “For example, force sensors may be used to monitor a gripping or squeezing action to provide data relevant to grip strength. Motion sensors can be used to monitor bending, rotation, or movement of the wrist, hand, and/or arm to provide data relevant to range of motion. A timer can be used in conjunction with one of the other sensors to determine an amount of time taken to perform a particular action or a duration of time between two actions”).
It is noted Martin et al. does not specifically teach the sensor element defines a sensor area comprising a plurality of adjacent pixels to detect an absolute size of a contact area of a hand of a user. However, Kahl et al. teaches the sensor element defines a sensor area (2) comprising a plurality of adjacent pixels (22) to detect an absolute size of a contact area of a hand of a user (see Figures 1A-2B and [0068] – “FIGS. 1A-B and 2A-B illustrate how to measure a hand pressure map at hand-object contact interfaces. A pressure pad 2 is fixed about a cylinder 4. The pressure pad 2 includes an array of pressure sensors 22 (see FIG. 2A). When a hand 6 is in physical contact with the pressure pad 2, e.g., gripping the cylinder 4, a distribution 8 of contact pressure values at the contact interface can be measured by the array of pressure sensors 22 of the pressure pad 2, as shown in FIG. 2A. The distribution 8 of contact pressure values as measured by the pressure pad 2 can be converted to a 2D representation 12 of palmar view of the hand 6, as shown in FIG. 2B. Such conversion can be performed by, for example, assigning each of the pressure sensors 22 of FIG. 2A to the respective locations on the palmar view of the hand 6. In the depicted embodiment, the 2D representation 12 can serve as a 2D hand pressure map, which may display varying contact pressure values at different locations of the palm side of the hand”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery system of Martin et al. to include the sensor element defines a sensor area comprising a plurality of adjacent pixels to detect an absolute size of a contact area of a hand of the user, as disclosed in Kahl et al., so as to measure a hand pressure map at hand-object contact interfaces (see Kahl et al.: [0068]).
Regarding claim 29, Martin et al. discloses the drug delivery device is an injection device configured to inject a medicine for the treatment of a chronic disease (see [0018] – “ORENCIA® and HUMIRA®”).
Regarding claim 30, Martin et al. discloses the chronic disease comprises rheumatoid arthritis (see [0003] – “rheumatoid arthritis”; see also [0018]).
Regarding claim 31, Martin et al. discloses the sensor assembly is configured to be mounted to an outer surface of a body of the drug delivery device (see [0014] – “The force sensors may also be adapted to couple with the exterior surface of an injection device” and [0046] – “the module may be cylindrical in shape, and configured to reversibly mount to the exterior cover or cap of an autoinjector”).
Regarding claim 32, Martin et al. discloses a system comprising:
an electronic device (150, 185);
a drug delivery device (100) (see [0018]);
a sensor assembly comprising a sensor element (130A, 130B) configured to be arranged external to the drug delivery device (see [0014] – “The force sensors may also be adapted to couple with the exterior surface of an injection device” and [0046] – “the module may be cylindrical in shape, and configured to reversibly mount to the exterior cover or cap of an autoinjector”), wherein the drug delivery device is configured to be held by a user of the drug delivery device through gripping of the sensor element, wherein the sensor element is configured to detect a contact area of a hand of the user when the user grips the sensor element (see [0030] – “the sensors may include any sensors capable of detecting force, pressure, or load”; see also [0042] and [0048]) and comprises an electronic module coupled to the sensor element and comprising a clock device (145) configured to provide the detection results of the contact area of the hand of the user with a time index indicating the point of time and date of the detection of the sensor element (see [0040] – “The timer 145 can allow for time measurements to be correlated with measurements of one or more of the force sensors 130A,B and location sensors 170” and [0049] – “For example, force sensors may be used to monitor a gripping or squeezing action to provide data relevant to grip strength. Motion sensors can be used to monitor bending, rotation, or movement of the wrist, hand, and/or arm to provide data relevant to range of motion. A timer can be used in conjunction with one of the other sensors to determine an amount of time taken to perform a particular action or a duration of time between two actions”); and
a communication link (160, 186) between the electronic device and the drug delivery device, wherein the electronic device is configured to receive the detected contact area via the communication link (see Figure 4 and [0037] – “The communication module 160 can communicate with an external device 185 such as a mobile device, home health monitor, computer, server, or any other electronic external device that is known in the art”),
wherein the electronic device is configured to provide the detected contact area to an output unit (187) (see Figure 4 and [0037] – “In one embodiment, the external device includes a display 187 to allow a user to read data on the external device”; see also [0017] and [0042]).
It is noted Martin et al. does not specifically teach the sensor element defines a sensor area comprising a plurality of adjacent pixels and is configured to detect an absolute size of a contact area of a hand of the user when the user grips the sensor element. However, Kahl et al. teaches the sensor element defines a sensor area (2) comprising a plurality of adjacent pixels (22) and is configured to detect an absolute size of a contact area of a hand of the user when the user grips the sensor element (see Figures 1A-2B and [0068] – “FIGS. 1A-B and 2A-B illustrate how to measure a hand pressure map at hand-object contact interfaces. A pressure pad 2 is fixed about a cylinder 4. The pressure pad 2 includes an array of pressure sensors 22 (see FIG. 2A). When a hand 6 is in physical contact with the pressure pad 2, e.g., gripping the cylinder 4, a distribution 8 of contact pressure values at the contact interface can be measured by the array of pressure sensors 22 of the pressure pad 2, as shown in FIG. 2A. The distribution 8 of contact pressure values as measured by the pressure pad 2 can be converted to a 2D representation 12 of palmar view of the hand 6, as shown in FIG. 2B. Such conversion can be performed by, for example, assigning each of the pressure sensors 22 of FIG. 2A to the respective locations on the palmar view of the hand 6. In the depicted embodiment, the 2D representation 12 can serve as a 2D hand pressure map, which may display varying contact pressure values at different locations of the palm side of the hand”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Martin et al. to include the sensor element defines a sensor area comprising a plurality of adjacent pixels and is configured to detect an absolute size of a contact area of a hand of the user when the user grips the sensor element, as disclosed in Kahl et al., so as to measure a hand pressure map at hand-object contact interfaces (see Kahl et al.: [0068]).
Regarding claim 33, Martin et al. discloses the drug delivery device is an injection device configured to inject a medicine for the treatment of a chronic disease (see [0018] – “ORENCIA® and HUMIRA®”).
Regarding claim 34, Martin et al. discloses the sensor assembly is configured to be mounted to an outer surface of a body of the drug delivery device (see [0014] – “The force sensors may also be adapted to couple with the exterior surface of an injection device” and [0046] – “the module may be cylindrical in shape, and configured to reversibly mount to the exterior cover or cap of an autoinjector”).
Regarding claim 35, Martin et al. discloses the communication link comprises an electronic module configured to transmit data representing a detection result of the sensor element to the electronic device (see [0035] – “The processor 150 can also be programmed to initiate the transmission of the force measurements and/or force data to an external device, such as external device 185, via the communication module 160”).
Response to Arguments
Applicant's arguments filed 1/6/2026 have been fully considered but they are not persuasive.
Applicant argues that one of ordinary skill in the art would not be motivated to combine the Martin and Kahl references because the proposed combination would not allow for the detection of an absolute size area of a hand. However, Applicant fails to provide any evidence or argument in support of this claim and instead mischaracterizes the proposed modification set forth in the rejection. The rejection does not modify the exterior surface of Martin with the pressure sensors of Kahl, because Martin already discloses that the sensor element can be arranged external to the drug delivery device (see [0014] – “The force sensors may also be adapted to couple with the exterior surface of an injection device” and [0046] – “the module may be cylindrical in shape, and configured to reversibly mount to the exterior cover or cap of an autoinjector”). Instead, Kahl is relied upon to teach the sensor element defining a sensor area (i.e. sensor pad 2 comprising an array of pressure sensors 22) comprising a plurality of adjacent pixels and configured to detect an absolute size of a contact area of a hand of the user when the user grips the sensor element. In particular, Kahl describes a hand pressure map at hand-object contact interfaces (see [0068]), and Figures 2A-2B show a representation of the hand pressure map indicating an absolute size of a contact area of a hand of the user when the user grips the sensor element.
In response to Applicant’s argument that modifying Martin would render the reference inoperable and unsatisfactory for its intended purpose, the Examiner respectfully disagrees and again notes this argument appears to rely on a mischaracterization of the proposed combination. Martin is not limited to only a sensor assembly having force sensors designed to fit within an interior space of an injection device. Instead, Martin explicitly describes the force sensors being adapted to couple with the exterior surface of an injection device. The additional component such as transparent viewing windows 192A/B would not impede the overall hand measurement, as Applicant argues, because they are not located where the device is supposed to be gripped. This is quite clear because the purpose of the windows is to view internal components of the device, such as the syringe (see [0024]). There is nothing in the claim language or the proposed rejection that suggests the entire outer surface of Martin needs to be covered with pressure sensors. Thus, Applicant’s argument that leaving some areas without sensors would render Martin inoperable for its intended purpose is not persuasive.
In response to Applicant’s argument that Martin fails to teach or suggest analysis and monitoring over time that is conducted by the diagnostic measurement device itself, the Examiner respectfully disagrees and notes the whole point of the sensors in Martin is to provide relevant diagnostic assessment of health or disease progression (see [0042] and [0048]). In particular, Martin describes measuring grip strength, and/or when force is applied and not applied, and/or particular locations where force is applied and the time taken to touch the particular locations, and previous measurements may be recalled by the memory and delayed on the diagnostic measurement device to allow for a comparison of measurements at different times throughout the progression of a disease (see [0042]).
In response to Applicant’s argument that neither Martin nor Kahl appear to teach or disclose an electronic module configured to provide the detected absolute size of the contact area of the hand of the user with a time index because Kahl allegedly only describes a static comparison and does not involve tracking how the contact area changes over time, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The rejection relies upon Martin to teach most of this limitation (with the exception of the detection result being an absolute size of a contact area of a hand as taught by Kahl). In particular, Martin describes an electronic modules comprising a timer (145) to correlate a time index with measurements from the force and location sensors to determine an amount of time taken to perform a particular action or a duration of time between two actions (see [0040] and [0049]). Martin further describes allowing the patient to track their grip strength and range of motion of time to monitor disease progression (see [0018]) and recalling previous measurements from memory to compare measurements at different times throughout the progression of a disease (see [0042]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791