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 .
Response to Amendment
Applicant amended claims 1-6, 8, 10-12, and 15. Claims 1-15 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 1-11 of Applicant’s Remarks, filed 12/04/25, with respect to the rejections of claims 1-2, 6, and 9-11 under 35 U.S.C. 102(a)(1) as being anticipated by Lorentz, of claims 3 and 8 under 35 U.S.C. 103 as unpatentable over Lorentz in view of Feghali, of claims 4-5 and 7 as unpatentable over Lorentz in view of Reiner, of claims 12-14 as unpatentable over Lorentz in view of Hanuka, and of the claim 15 as unpatentable over Lorentz in view of Windeballe have been fully considered and are persuasive in light of the amendments to the claims. Accordingly, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection have been made as indicated below.
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.
Claims 1-2, 4-7, and 9-11 is rejected under 35 U.S.C. 103 as being unpatentable over Lorentz (US 2017/0290744 A1) in view of Reiner (US 2017/0367579 A1) and in further view of Erramilli et al. (US 2022/0175263 A1).
Regarding claim 1, Lorentz discloses an ostomy device for digestive tracts (Fig. 1 and Annotated Fig. 1, feat. 100; ¶0033), comprising: an ostomy body (Annotated Fig. 1, feat. 110; ¶0033-0034), including a first end (A) and a second end (B), the ostomy body further including an outer surface (C), an inner surface (D), and an ostomy hole passing through the ostomy body (¶0034: ostomy body 110 is a tube, and therefore has a hole passing through it); an outer retaining plate (130; ¶0034) disposed in proximity to the first end of said ostomy body (Annotated Fig. 1, feats. A and 130), said outer retaining plate including an outer contact surface (E); an inner retaining member (120; ¶0034) disposed in proximity to the second end of said ostomy body (Annotated Fig. 1, feats. B and 120), said inner retaining member including an inner contact surface (F); wherein said outer surface (Annotated Fig. 1, feat. C) of the ostomy body extends between said outer retaining plate (130) and said inner retaining member (120); a sensor unit system composed of a third plurality of sensor units (Fig. 2, feats. 144a-d and 148a-d; ¶0039-0043), wherein each sensor unit of said third plurality of sensor units includes a sensing surface (Fig 2; ¶0040 and 0043: pressure sensors 144a-d and moisture sensors 148a-d each have a portion exposed on the skin facing surface, or outer contact surface, of outer retaining plate 130 housing 140, and therefore each have a sensing surface); at least one sensor unit of said third plurality thereof being disposed on at least one of the outer contact surface (Fig. 2: ¶0040 and 0043: sensors 144a-d and 148a-d are on the skin facing surface, or outer contact surface, of outer retaining plate 130 housing 140) and the inner contact surface, wherein the sensing surface of each sensor unit of said third plurality thereof is exposed on a respective one of the inner surface, the outer contact surface (Fig. 2: ¶0040 and 0043: sensors 144a-d and 148a-d each have a portion exposed on the skin facing surface, or outer contact surface, of outer retaining plate 130 housing 140) or the inner contact surface; a processing unit, the processing unit being in signal communication with the sensor unit system for receiving sensor information of the sensor unit system (¶0038 and 0050-0053); a power supply unit, electrically connected to the sensor unit system and the processing unit (¶0008, 0038, and 0050-0053).
Lorentz does not disclose that the sensor unit system includes a first plurality of sensor units and a second plurality of sensor units, wherein each sensor unit of the said first and second pluralities includes a sensing surface, wherein said sensing surface of said each sensor unit of said first plurality of sensor units is disposed at said outer surface of said ostomy body between said outer retaining plate and said inner retaining member and flush with said outer surface, and wherein said sensing surface of said each sensor unit of said second plurality of sensor units is recessed in said outer surface of said ostomy body.
Reiner teaches biosensors (Fig. 1, feats. 101 and 102; ¶0038) which are embedded into the inner walls (103; ¶0039) or outer walls (104; ¶0039) of a tubular medical device such as a gastrostomy device (¶0063 and Table 1). Reiner teaches that such sensors allow for pH, carbon dioxide, and internal flow rates to be monitored such that changes in the position and functionality of the device can be determined and localized (¶0036, 0042-0043, 0055, and 0062). A first set of sensors (Fig. 1, feat. 101) are embedded into the outer wall (Fig. 1, feat. 104), and a second set of sensors (Fig. 1, feat. 102), are embedded into the inner wall (Fig. 1, feat. 103). Furthermore, because the second set of sensors are embedded into the inner wall, they are recessed from the outer wall. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device disclosed by Lorentz so that the sensor unit system includes a first plurality of sensor units and a second plurality of sensor units, wherein each sensor unit of the said first and second pluralities includes a sensing surface, wherein said sensing surface of said each sensor unit of said first plurality of sensor units is disposed at said outer surface of said ostomy body between said outer retaining plate and said inner retaining member and wherein said sensing surface of said each sensor unit of said second plurality of sensor units is recessed in said outer surface of said ostomy body in order to enable changes in the position and functionality of the device to be determined and localized as taught by Reiner.
Lorentz in view of Reiner does not disclose that each sensor unit of said first plurality of sensor units is flush with said outer surface.
Erramilli teaches a gastric tube (Fig. 8, feat. 810; ¶0119-0124) comprising sensors positioned on or within the outer wall of the tube (820; ¶0120-0122 and 0145). Erramilli teaches that the sensors may be flush with or have a minimal protrusion from the outer surface of the tube in order to minimize the overall profile of the device (¶0014 and 0071). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Lorentz in view of Reiner so that each sensor unit of said first plurality of sensor units is flush with said outer surface in order to minimize the overall profile of the device as taught by Erramilli.
Regarding claim 2, Lorentz in view of Reiner and in further view of Erramilli suggests the device of claim 1, and Lorentz further discloses that said third plurality of sensor units are annularly arranged on the outer contact surface (Fig. 2, feats. 144a-d: sensors 144a-d are positioned in a ring around the through-hole 142 on the skin-facing, outer contact surface, of the outer retaining plate 130).
Regarding claims 4-5, Lorentz in view of Reiner and in further view of Erramilli suggests the device of claim 1. As discussed above, Reiner teaches biosensors (Fig. 1, feats. 101 and 102; ¶0038) which are embedded into the inner walls (103; ¶0039) or outer walls (104; ¶0039) of a tubular medical device such as a gastrostomy device (¶0063 and Table 1). Reiner teaches that the sensors embedded in the outer wall or inner wall may comprise multiple types of sensors (¶0058, 0065, and 0068). Therefore, Lorentz in view of Reiner and in further view of Erramilli further suggests that said first and second plurality of sensor units are annularly arranged on the outer surface, with respect to claim 4, and that said third plurality of sensor units are annularly arranged on the inner surface, with respect to claim 5.
Regarding claim 6, Lorentz in view of Reiner and in further view of Erramilli suggests the device of claim 1, and Lorentz further discloses that the sensor unit system contains at least one of a blood glucose sensor, a pH sensor, a tension sensor (Fig. 2, feats. 144a-d; ¶0039-0040; The present specification indicates that tension sensors monitor the balance of pressure in ¶0045, and therefore pressure sensors 144a-d of Lorentz are tension sensors), a blood oxygen sensor, a temperature sensor and a flow rate sensor.
Regarding claim 7, Lorentz in view of Reiner and in further view of Erramilli suggests the device of claim 1. Reiner further teaches that the biosensors may be ultrasonic sensors which may advantageously be used to continuously monitor the flow, volume, pressure, motion, location, and/or patency of the medical device (¶0079-0083). Reiner further teaches that such sensors are in electrical and signal communication with a processing system for real-time and continuous monitoring (Fig. 1, feats. 105 and 106; ¶0039). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Lorentz in view of Reiner and in further view of Erramilli to include an ultrasonic unit on the ostomy body, wherein the ultrasonic unit is electrically connected to the power supply unit and is in signal communication with the processing unit in order to provide real-time and continuous monitoring of the flow, volume, pressure, motion, location, and/or patency of the device as taught by Reiner.
Regarding claim 9, Lorentz in view of Reiner and in further view of Erramilli suggests the device of claim 1, and Lorentz further discloses a warning unit (Fig. 3, feats. 150a-d; ¶0047-0048), wherein the warning unit is in signal communication with the processing unit (¶0050-0054), and the warning unit is electrically connected to the power supply unit (¶0008, 0038, and 0050-0054).
Regarding claim 10 Lorentz in view of Reiner and in further view of Erramilli suggests the device of claim 1, and Lorentz further discloses that the processing unit and the power supply unit are disposed on an outside of the ostomy body (¶0008, 0036-0038, and 0050-0051: processor, control circuitry, and battery are disposed in the housing 140 of the outer retaining plate 130, and are therefore disposed on an outside of the ostomy body 110), the power supply is connected to the sensor unit system with a wire (Fig. 5; ¶0053: pressure sensor 144 is powered by a 5V wire), and the processing unit is connected to the sensor unit system through a signal wire (Fig. 5: pressure sensor 144 is connected to the controller/processor via a wire).
Regarding claim 11, Lorentz in view of Reiner and in further view of Erramilli suggests the device of claim 1. Lorentz further discloses that the outer retaining plate (Figs. 1-3, feat. 130) may have a silicone layer (160; ¶0044-0045) with protrusions (166a-d) from the skin facing surface, or outer contact surface, that provide a means of force propagation from the skin surface to the pressure sensors (144a-d). Therefore, Lorentz further discloses that said sensing surface of said each sensor unit of said third plurality thereof is flush with or recessed in a respective one of the outer contact surface, the inner surface, or the inner contact surface; or said sensing surface of said each sensor unit of said third plurality thereof protrudes from the outer contact surface (Fig. 2, feat. 166a-d).
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Lorentz in view of Reiner, in further view of Erramilli, and in view of Feghali (US 2018/0280248 A1).
Regarding claim 3, Lorentz in view of Reiner and in further view of Erramilli suggests the device of claim 1, but does not disclose that said third plurality of sensor units are annularly arranged on the inner contact surface.
Feghali teaches an ostomy device (Figs. 1-6, feat. 100; ¶0030-0036) comprising an ostomy body (4), an outer retaining plate (Figs. 5-6, feat. 5; ¶0076), and an inner retaining plate (Figs. 1-6, feat. 1). The inner retaining plate comprises a force sensor annularly arranged around the plate (Figs. 1 and 3, feat. 2; ¶0031-0038) which advantageously enables medical personnel to assess the pressure being applied by the inner retaining plate to the gastric wall and take corrective action before such pressure results in a medical issue (¶0031). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Lorentz in view of Reiner and in further view of Erramilli so that said third plurality of sensor units are annularly arranged on the inner contact surface in order to enable medical personnel to assess the pressure being applied by the inner retaining plate to the gastric wall and take corrective action before such pressure results in a medical issue as taught by Feghali.
Regarding claim 8, Lorentz in view of Reiner and in further view of Erramilli suggests the device of claim 1. Lorentz further discloses a wireless unit (¶0049), wherein the wireless unit is in signal communication with the processing unit (¶0031 and 0049-0051), wherein the processing unit receives a sensor signal from the sensor unit system (¶0050-0054) and transmits the sensor signal through the wireless unit (¶0031 and 0049: pressure measurements from the pressure sensors 144a-d are transmitted to external computing platforms using the wireless unit). Lorentz in view of Reiner and in further view of Erramilli does not disclose that the wireless unit is electrically connected to the power supply unit or that the wireless unit and the processing unit are disposed on the ostomy body.
As discussed above, Feghali teaches an ostomy device (Figs. 1-6, feat. 100; ¶0030-0036) comprising an ostomy body (4), an outer retaining plate (Figs. 5-6, feat. 5; ¶0076), and an inner retaining plate (Figs. 1-6, feat. 1) with a force sensor (Figs. 1 and 3, feat. 2; ¶0031-0038). Feghali further teaches that the force sensor is in communication with a processing device for analyzing the force data (¶0055) and that the ostomy body may incorporate a wireless transmitter for wirelessly communicating readings from the force sensor to wirelessly communicate force information to a receiving unit (Figs. 4-6, feat. 14) and alert indicator (9; ¶0062-0065) incorporated into the ostomy body outside of the patient. Feghali further teaches that the ostomy body may include a power source (Figs. 4-6, feat. 12) for electrically powering the components of the device (¶0071-0072). As discussed above, Feghali teaches that wirelessly communicating the force data to the receiving unit and alert indicator advantageously enables medical personnel to assess the pressure being applied by the inner retaining plate to the gastric wall and take corrective action before such pressure results in a medical issue (¶0031). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Lorentz in view of Reiner and in further view of Erramilli so that the wireless unit is electrically connected to the power supply unit and so that the wireless unit and the processing unit are disposed on the ostomy body in order to enable medical personnel to assess the pressure being applied by the inner retaining plate to the gastric wall and take corrective action before such pressure results in a medical issue as taught by Feghali.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lorentz in view of Reiner, in further view of Erramilli, and in further view of Hanuka et al. (US 2012/0136324 A1).
Regarding claim 12, Lorentz in view of Reiner and in further view of Erramilli suggests the device of claim 1, but does not disclose that said each sensor unit of said second plurality of sensor units is disposed in a respective inner groove.
Hanuka teaches an ostomy device (Figs. 1-4, feat. 100; ¶0146) comprising an ostomy body (Figs. 1 and 4, feats. 2 and 27; ¶0147 and 0163), an outer retaining plate (28), and an inner retaining member (Figs. 1-2C, feat. 1; ¶0150). The inner retaining member comprises an inner annular cavity or groove (Fig. 2B, feat. 5; ¶0150) which extends perpendicular to the central axis (Fig. 2B, feat. CL) of the inner surface of the ostomy device. The inner annular cavity may include a pressure sensor (Fig. 2B, feat. 88) which advantageously indicates when there is a high pressure in the cavity, which indicates a need for evacuation (¶0158). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Lorentz in view of Reiner and in further view of Erramilli so that said each sensor unit of said second plurality of sensor units is disposed in a respective inner groove so that a high pressure indicating a need for evacuation can be detected as taught by Hanuka.
Regarding claim 13, Lorentz in view of Reiner, in further view of Erramilli, and in further view of Hanuka suggests the device of claim 1. As discussed above, Hanuka further teaches that the inner annular cavity or groove (Fig. 2B, feat. 5) extends perpendicularly to the central axis (Fig. 2B, feat. CL) of the inner surface of the ostomy device. Therefore, Lorentz in view of Reiner, in further view of Erramilli, and in further view of Hanuka further suggests that an extension axis of the inner groove is perpendicular or inclined to the outer contact surface, the inner surface, the outer surface, or the inner contact surface.
Regarding claim 14, Lorentz in view of Reiner, in further view of Erramilli, and in further view of Hanuka suggests the device of claim 12. As discussed above, Hanuka further teaches that the inner cavity or groove is annular (Figs. 1-2B, feat. 5). Therefore, Lorentz in view of Reiner, in further view of Erramilli, and in further view of Hanuka further suggests that the inner groove is annular.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lorentz in view of Reiner, in further view of Erramilli, and in further view of Windeballe et al. (US 2022/0079803 A1).
Regarding claim 15, Lorentz in view of Reiner in further view of Erramilli suggests the ostomy device of claim 1. As discussed above with respect to claim 2, Lorentz discloses pressure (Fig. 2, feat. 144a-d) and moisture (Fig. 2, feat. 148a-d) sensors which are arranged annularly on the outer contact surface. The sensors of Lorentz are multiple individual sensors which are arranged annularly, and therefore Lorentz does not disclose that the sensor unit is annular.
Windeballe teaches a sensor patch (Figs. 1A-D, feat. 100; ¶0091) for attaching to the skin facing surface an ostomy base plate (¶0034), such as the outer contact surface of the outer retaining plate of Lorentz. Windeballe teaches the sensor patch comprises substantially ring-shaped or annular electrodes (Fig. 1A, feats. 102a-b; ¶0091) on a ring-shaped or annular adhesive layer (110). Windeballe teaches that a ring-shaped or annular sensor advantageously facilitates monitoring in a full circle around the stoma (¶0040). This has an advantage over the sensor configuration of multiple individual sensors being arranged annularly disclosed by Lorentz, which can only monitor the locations in which the individual sensors are located. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device suggested by Lorentz in view of Reiner and in further view of Erramilli so that at least one of the sensor units of the sensor unit system is annular in order to facilitate monitoring in a full circle around the stoma as taught by Windeballe.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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