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
The amendments of claims 19, 21-22, 25-26, 28-29, 31-32, 34-35, and 38 are acknowledged.
Response to Arguments
Applicant’s arguments regarding amendments overcoming previous 35 USC 112(b) rejections are persuasive and as such, those previous rejections are withdrawn.
Applicant’s arguments that double patenting rejections be held in abeyance are not persuasive, as double patenting rejections must be addressed if they apply. As such, double patenting rejections are updated below to apply to the most recent amendments.
Applicant’s arguments with respect to claim(s) 19, 26, and 32 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Prior art rejections have been updated below to address the most recent amendments.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 19-23, 25-29, 31-36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Millot et al. (US 6,171,289) in view of Locke et al. (US 2008/0071214), both disclosed in the IDS dated February 19, 2024.
Regarding claim 19, Millot discloses a computing device configured to receive notifications from an ostomy apparatus (see Figs. 2-4), the computing device comprising: at least one processor (see Fig. 4, col. 5, lines 30-33; cl. 3) and memory comprising instructions that (see col. 2, lines 37-46; col. 4, lines 45-59, comparing to a predetermined threshold value would require a memory with instructions about the comparison/calculation), when executed by the at least one processor, cause the computing device to: receive a signal from the ostomy apparatus (see Fig. 2; col. 4, lines 25-33), the signal corresponding to a change in impedance of at least one electrode pair 17, 18 (see Figs. 2-3; col. 3, lines 39-60) incorporated into the ostomy apparatus (see Figs. 2-3). Millot further discloses the signal corresponds to a degree of ostomy leakage of the ostomy appliance (see col. 2, lines 37-46) and discloses the degree of ostomy leakage is in a range from no leakage to full saturation around a sensor of the ostomy appliance (see Figs. 2-3, col. 2, lines 37-46; col. 4, lines 20-25).
Millot does not disclose determining, based on the signal, a degree of ostomy leakage from a plurality of non-zero leakage degrees associated with the ostomy apparatus.
Locke discloses multiple threshold levels, and therefore degrees, used, each representing a different leakage level (e.g. low, medium, or high), interpreted as non-zero leakage degrees, and may cause a different alarm, audible and/or visual, to be initiated (see par. 51). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have, instead of the one threshold disclosed by Millot (see col. 2, lines 37-46), to include multiple thresholds each representing a different leakage level and causing a different alarm as disclosed by Locke, therefore providing more notice to the user of the different stages of leakage levels. This would predictably result in the indication of fluid leakage during use (see Locke, par. 51) of the ostomy apparatus.
Millot does not disclose a display; and the computing device displaying, on the display, information indicating the determined degree of ostomy leakage.
Locke further discloses a display 500 (see par. 44), and the computing device displaying, on the display 500, information 604 indicating the determined degree of leakage (see Fig. 6A, par. 44, 46, shows the degree of fluid leak in being low, medium, or high). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a known technique to improve similar devices in the same way, and therefore have the device of Millot and Locke further include the improvement of including a display and the computing device displaying, on the display, information indicating the determined degree of leakage, as disclosed by Locke, with the results of such communication of information via the display being predictable to one of ordinary skill in the art. Additionally, the added display provides the benefit of clear communication to the user.
Regarding claim 20, Millot and Locke disclose the limitations of claim 19 and Millot further discloses the signal corresponds to a moisture propagation absorbed by the ostomy apparatus (see Figs. 2, 3, positions of electrode pairs allow for detection from a radial direction).
Regarding claim 21, Millot and Locke disclose the limitations of claim 19 and further disclose the plurality of non-zero leakage degrees associated with the ostomy apparatus comprises at least a first non-zero leakage degree and a second non-zero leakage degree greater than the first non-zero leakage degree (see rejection of claim 19, low, medium, and high would require multiple non-zero leakage degrees with some being greater than others).
Regarding claim 22, Millot and Locke disclose the limitations of claim 21 and further disclose the plurality of non-zero leakage degrees comprises leakage degrees within a range greater than no leakage and up to full saturation (see rejection of claim 19, low, medium, and high would be non-zero in such a range) around a sensor of the ostomy apparatus (see Millot, Figs. 2-3, col. 2, lines 37-46; col. 4, lines 20-25).
Regarding claim 23, Millot and Locke disclose the limitations of claim 19 and Millot further discloses the computing device comprising at least one of: generating an auditory indication; or generating a vibratory indication (see col. 3, lines 60-65).
Regarding claim 25, Millot and Locke disclose the limitations of claim 19 and Millot further discloses the signal further comprises at least one of a usage statistic or a status for the ostomy appliance (see col. 1, lines 63-66; col. 2, lines 37-46; col. 2, lines 65-67, status showing that patient needs to take action).
Regarding claim 26, Millot discloses a method for processing a signal from an ostomy apparatus (see Fig. 4, col. 5, lines 30-33; cl. 3), the method comprising: receiving, from the ostomy apparatus the signal corresponding to a change in impedance of at least one electrode pair 17, 18 (see Figs. 2-3; col. 3, lines 39-60) incorporated into an ostomy apparatus (see Figs. 2-3); and at least one of: displaying information about the ostomy apparatus based upon the received signal; generating an auditory indication based upon the received signal; or generating a vibratory indication based upon the received signal (see col. 3, lines 60-65). Millot further discloses the signal corresponds to a degree of ostomy leakage of the ostomy appliance (see col. 2, lines 37-46) and discloses the degree of ostomy leakage is in a range from no leakage to full saturation around a sensor of the ostomy appliance (see Figs. 2-3, col. 2, lines 37-46; col. 4, lines 20-25).
Millot does not disclose determining, based on the signal, a degree of ostomy leakage from a plurality of non-zero leakage degrees associated with the ostomy apparatus.
Locke discloses multiple threshold levels, and therefore degrees, used, each representing a different leakage level (e.g. low, medium, or high), interpreted as non-zero leakage degrees, and may cause a different alarm, audible and/or visual, to be initiated (see par. 51). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have, instead of the one threshold disclosed by Millot (see col. 2, lines 37-46), to include multiple thresholds each representing a different leakage level and causing a different alarm as disclosed by Locke, therefore providing more notice to the user of the different stages of leakage levels. This would predictably result in the indication of fluid leakage during use (see Locke, par. 51) of the ostomy apparatus. Consequently, the alarm would be based upon the determined degree of ostomy leakage.
Millot does not disclose a display; and the computing device displaying, on the display, information indicating the determined degree of ostomy leakage.
Locke further discloses a display 500 (see par. 44), and the computing device displaying, on the display 500, information 604 indicating the determined degree of leakage (see Fig. 6A, par. 44, 46, shows the degree of fluid leak in being low, medium, or high). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a known technique to improve similar devices in the same way, and therefore have the device of Millot and Locke further include the improvement of including a display and the computing device displaying, on the display, information indicating the determined degree of leakage, as disclosed by Locke, with the results of such communication of information via the display being predictable to one of ordinary skill in the art. Additionally, the added display provides the benefit of clear communication to the user.
Regarding claim 27, Millot and Locke disclose the limitations of claim 26, and Millot further discloses the signal corresponds to a moisture propagation absorbed by the ostomy apparatus (see Figs. 2, 3, positions of electrode pairs allow for detection from a radial direction).
Regarding claim 28, Millot and Locke disclose the limitations of claim 26 and further disclose the plurality of non-zero leakage degrees associated with the ostomy apparatus comprises at least a first non-zero leakage degree and a second non-zero leakage degree greater than the first non-zero leakage degree (see rejection of claim 26, low, medium, and high would require multiple non-zero leakage degrees with some being greater than others).
Regarding claim 29, Millot and Locke disclose the limitations of claim 28 and further disclose the plurality of non-zero leakage degrees comprises leakage degrees within a range greater than no leakage and up to full saturation (see rejection of claim 26, low, medium, and high would be non-zero in such a range) around a sensor of the ostomy apparatus (see Millot, Figs. 2-3, col. 2, lines 37-46; col. 4, lines 20-25).
Regarding claim 31, Millot and Locke disclose the limitations of claim 26 and Millot further discloses the signal further comprises at least one of a usage statistic or a status for the ostomy apparatus (see col. 1, lines 63-66; col. 2, lines 37-46; col. 2, lines 65-67, status showing that patient needs to take action).
Regarding claim 32, Millot discloses a method, comprising: receiving a signal from an ostomy apparatus (see Fig. 2; col. 4, lines 25-33), the signal corresponding to a change in impedance of at least one electrode pair incorporated into the ostomy apparatus (see Figs. 2-3; col. 3, lines 39-60). Millot further discloses the signal corresponds to a degree of ostomy leakage of the ostomy appliance (see col. 2, lines 37-46) and discloses the degree of ostomy leakage is in a range from no leakage to full saturation around a sensor of the ostomy appliance (see Figs. 2-3, col. 2, lines 37-46; col. 4, lines 20-25).
Millot does not disclose determining, based on the signal, a degree of ostomy leakage from a plurality of non-zero leakage degrees associated with the ostomy apparatus.
Locke discloses multiple threshold levels, and therefore degrees, used, each representing a different leakage level (e.g. low, medium, or high), interpreted as non-zero leakage degrees, and may cause a different alarm, audible and/or visual, to be initiated (see par. 51). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have, instead of the one threshold disclosed by Millot (see col. 2, lines 37-46), to include multiple thresholds each representing a different leakage level and causing a different alarm as disclosed by Locke, therefore providing more notice to the user of the different stages of leakage levels. This would predictably result in the indication of fluid leakage during use (see Locke, par. 51) of the ostomy apparatus. Consequently, the alarm would be based upon the determined degree of ostomy leakage.
Millot does not disclose a display; and the computing device displaying, on the display, information indicating the determined degree of ostomy leakage.
Locke further discloses a display 500 (see par. 44), and the computing device displaying, on the display 500, information 604 indicating the determined degree of leakage (see Fig. 6A, par. 44, 46, shows the degree of fluid leak in being low, medium, or high). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a known technique to improve similar devices in the same way, and therefore have the device of Millot and Locke further include the improvement of including a display and the computing device displaying, on the display, information indicating the determined degree of leakage, as disclosed by Locke, with the results of such communication of information via the display being predictable to one of ordinary skill in the art. Additionally, the added display provides the benefit of clear communication to the user.
Regarding claim 33, Millot and Locke disclose the limitations of claim 32 and Millot further discloses the signal corresponds to a moisture propagation absorbed by the ostomy apparatus (see Figs. 2, 3, positions of electrode pairs allow for detection from a radial direction).
Regarding claim 34, Millot and Locke disclose the limitations of claim 32 and further disclose the plurality of non-zero leakage degrees associated with the ostomy apparatus comprises at least a first non-zero leakage degree and a second non-zero leakage degree greater than the first non-zero leakage degree (see rejection of claim 32, low, medium, and high would require multiple non-zero leakage degrees with some being greater than others).
Regarding claim 35, Millot and Locke disclose the limitations of claim 34 and further disclose the plurality of non-zero leakage degrees comprises leakage degrees within a range greater than no leakage and up to full saturation (see rejection of claim 32, low, medium, and high would be non-zero in such a range) around a sensor of the ostomy apparatus (see Millot, Figs. 2-3, col. 2, lines 37-46; col. 4, lines 20-25).
Regarding claim 36, Millot and Locke disclose the limitations of claim 32 and Millot further discloses the method comprising at least one of: generating an auditory indication; or generating a vibratory indication (see col. 3, lines 60-65).
Regarding claim 38, Millot and Lock disclose the limitations of claim 32 and Millot further discloses the signal further comprises at least one of a usage statistic or a status for the ostomy apparatus (see col. 1, lines 63-66; col. 2, lines 37-46; col. 2, lines 65-67, status showing that patient needs to take action).
Claim(s) 24, 30, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Millot and Locke as applied to claim 19, 26, or 32 above, and further in view of Marsiquet et al. (WO 2013/114273). The Marsiquet citations below are to the English translation provided with the non-final office action of March 30, 2026.
Regarding claim 24, Millot and Locke disclose the limitations of claim 19 and while Millot discloses the at least one electrode pair comprises a first electrode pair and a second electrode pair (see Figs. 2-3), Millot and Locke as described above do not disclose the signal corresponds to a moisture propagation direction associated with a change in impedance between the first electrode pair and the second electrode pair.
Marsiquet discloses the signal corresponds to a moisture propagation direction associated with a change in impedance between two consecutive electrodes, for at least a plurality of the consecutive pairs of electrodes that covers an area of the absorbent, allowing for the level of saturation to be measured at each location, and showing a map of saturated zones (see page 3, par. 5- page 4, par. 3; page 5, par. 4-5; page 8, par. 11-page 9, par. 1). Consequently, the signal created that allows for the level of saturation would correspond to a moisture propagation direction due to that saturation associated with a change in impedance between the first electrode pair and the second electrode pair. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the signal as disclosed by Marsiquet in order to determine more information about the degree of hydration/saturation of the ostomy apparatus, therefore helping in determining whether the adhesive of the ostomy apparatus is insufficient for satisfactory securing and sealing of the apparatus (see Millot; col. 2, lines 44-46 connecting adhesive for securing with degree of hydration/saturation).
Regarding claim 30, Millot and Locke disclose the limitations of claim 26 and Millot further discloses the at least one electrode pair comprises a first electrode pair and a second electrode pair (see Figs. 2-3), but as described above does not disclose the signal corresponds to a moisture propagation direction associated with a change in impedance between the first electrode pair and the second electrode pair.
Marsiquet discloses the signal corresponds to a moisture propagation direction associated with a change in impedance between two consecutive electrodes, for at least a plurality of the consecutive pairs of electrodes that covers an area of the absorbent, allowing for the level of saturation to be measured at each location, and showing a map of saturated zones (see page 3, par. 5- page 4, par. 3; page 5, par. 4-5; page 8, par. 11-page 9, par. 1). Consequently, the signal created that allows for the level of saturation would correspond to a moisture propagation direction due to that saturation associated with a change in impedance between the first electrode pair and the second electrode pair. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the signal as disclosed by Marsiquet in order to determine more information about the degree of hydration/saturation of the ostomy apparatus, therefore helping in determining whether the adhesive of the ostomy apparatus is insufficient for satisfactory securing and sealing of the apparatus (see Millot; col. 2, lines 44-46 connecting adhesive for securing with degree of hydration/saturation).
Regarding claim 37, Millot and Locke disclose the limitations of claim 32 and while Millot discloses the at least one electrode pair comprises a first electrode pair and a second electrode pair (see Figs. 2-3), Millot and Locke as described above do not disclose the signal corresponds to a moisture propagation direction associated with a change in impedance between the first electrode pair and the second electrode pair.
Marsiquet discloses the signal corresponds to a moisture propagation direction associated with a change in impedance between two consecutive electrodes, for at least a plurality of the consecutive pairs of electrodes that covers an area of the absorbent, allowing for the level of saturation to be measured at each location, and showing a map of saturated zones (see page 3, par. 5- page 4, par. 3; page 5, par. 4-5; page 8, par. 11-page 9, par. 1). Consequently, the signal created that allows for the level of saturation would correspond to a moisture propagation direction due to that saturation associated with a change in impedance between the first electrode pair and the second electrode pair. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the signal as disclosed by Marsiquet in order to determine more information about the degree of hydration/saturation of the ostomy apparatus, therefore helping in determining whether the adhesive of the ostomy apparatus is insufficient for satisfactory securing and sealing of the apparatus (see Millot; col. 2, lines 44-46 connecting adhesive for securing with degree of hydration/saturation).
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 19-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, or 17 of U.S. Patent No. 11, 890, 219, hereinafter ‘219, in view of Locke.
Regarding claim 19, claim 1 of ‘219 disclose substantially all limitations required by claim 19 of the current application except determining, based on the signal, a degree of ostomy leakage from a plurality of non-zero leakage degrees associated with the ostomy apparatus and a display; and the computing device displaying, on the display, information indicating the determined degree of ostomy leakage.
Locke discloses multiple threshold levels, and therefore degrees, used, each representing a different leakage level (e.g. low, medium, or high), interpreted as non-zero leakage degrees, and may cause a different alarm, audible and/or visual, to be initiated (see par. 51). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include multiple thresholds each representing a different leakage level and causing a different alarm as disclosed by Locke, therefore providing more notice to the user of the different stages of leakage levels. This would predictably result in the indication of fluid leakage during use (see Locke, par. 51) of the ostomy apparatus. Consequently, the alarm would be based upon the determined degree of ostomy leakage.
Locke further discloses a display 500 (see par. 44), and the computing device displaying, on the display 500, information 604 indicating the determined degree of leakage (see Fig. 6A, par. 44, 46, shows the degree of fluid leak in being low, medium, or high). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a known technique to improve similar devices in the same way, and therefore have the device further include the improvement of including a display and the computing device displaying, on the display, information indicating the determined degree of leakage, as disclosed by Locke, with the results of such communication of information via the display being predictable to one of ordinary skill in the art. Additionally, the added display provides the benefit of clear communication to the user.
Regarding claims 20 and 23-25, the following claims of ‘219 disclose the additional limitations required by claims 20 and 23-25 of the current application:
Current application
20
23
24
25
Claims of ‘219
1
7
17
6
Regarding claim 21, claim 1 of ‘219 and Locke disclose the limitations of claim 19 and further disclose the plurality of non-zero leakage degrees associated with the ostomy apparatus comprises at least a first non-zero leakage degree and a second non-zero leakage degree greater than the first non-zero leakage degree (see rejection of claim 19, low, medium, and high would require multiple non-zero leakage degrees with some being greater than others).
Regarding claim 22, claim 1 of ‘219 and Locke disclose the limitations of claim 21 and further disclose the plurality of non-zero leakage degrees comprises leakage degrees within a range greater than no leakage and up to full saturation (see rejection of claim 19, low, medium, and high would be non-zero in such a range) around a sensor of the ostomy apparatus.
Regarding claim 26, claim 7 of ‘219 disclose substantially all limitations required by claim 26 of the current application except determining, based on the signal, a degree of ostomy leakage from a plurality of non-zero leakage degrees associated with the ostomy apparatus and a display; and the computing device displaying, on the display, information indicating the determined degree of ostomy leakage.
Locke discloses multiple threshold levels, and therefore degrees, used, each representing a different leakage level (e.g. low, medium, or high), interpreted as non-zero leakage degrees, and may cause a different alarm, audible and/or visual, to be initiated (see par. 51). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include multiple thresholds each representing a different leakage level and causing a different alarm as disclosed by Locke, therefore providing more notice to the user of the different stages of leakage levels. This would predictably result in the indication of fluid leakage during use (see Locke, par. 51) of the ostomy apparatus. Consequently, the alarm would be based upon the determined degree of ostomy leakage.
Locke further discloses a display 500 (see par. 44), and the computing device displaying, on the display 500, information 604 indicating the determined degree of leakage (see Fig. 6A, par. 44, 46, shows the degree of fluid leak in being low, medium, or high). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a known technique to improve similar devices in the same way, and therefore have the device further include the improvement of including a display and the computing device displaying, on the display, information indicating the determined degree of leakage, as disclosed by Locke, with the results of such communication of information via the display being predictable to one of ordinary skill in the art. Additionally, the added display provides the benefit of clear communication to the user.
Regarding claims 27 and 31, the following claims of ‘219 disclose the additional limitations required by claims 27 and 31 of the current application:
Current application
27
31
Claims of ‘219
7
7
Regarding claim 28, claim 7 of ‘219 and Locke disclose the limitations of claim 26 and further disclose the plurality of non-zero leakage degrees associated with the ostomy apparatus comprises at least a first non-zero leakage degree and a second non-zero leakage degree greater than the first non-zero leakage degree (see rejection of claim 26, low, medium, and high would require multiple non-zero leakage degrees with some being greater than others).
Regarding claim 29, claim 7 of ‘219 and Locke disclose the limitations of claim 28 and further disclose the plurality of non-zero leakage degrees comprises leakage degrees within a range greater than no leakage and up to full saturation (see rejection of claim 26, low, medium, and high would be non-zero in such a range) around a sensor of the ostomy apparatus.
Regarding claim 30, claim 17 of ‘219 disclose substantially all limitations required by claim 30 of the current application except, determining, based on the signal, a degree of ostomy leakage from a plurality of non-zero leakage degrees associated with the ostomy apparatus and a display; and at least one of: displaying information indicating the determined degree of ostomy leakage; generating an auditory indication based upon the determined degree of ostomy leakage; or generating a vibratory indication based upon the determined degree of ostomy leakage.
Locke discloses multiple threshold levels, and therefore degrees, used, each representing a different leakage level (e.g. low, medium, or high), interpreted as non-zero leakage degrees, and may cause a different alarm, audible and/or visual, to be initiated (see par. 51). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include multiple thresholds each representing a different leakage level and causing a different alarm as disclosed by Locke, therefore providing more notice to the user of the different stages of leakage levels. This would predictably result in the indication of fluid leakage during use (see Locke, par. 51) of the ostomy apparatus. Consequently, the alarm would be based upon the determined degree of ostomy leakage.
Locke further discloses a display 500 (see par. 44), and the computing device displaying, on the display 500, information 604 indicating the determined degree of leakage (see Fig. 6A, par. 44, 46, shows the degree of fluid leak in being low, medium, or high). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a known technique to improve similar devices in the same way, and therefore have the device further include the improvement of including a display and the computing device displaying, on the display, information indicating the determined degree of leakage, as disclosed by Locke, with the results of such communication of information via the display being predictable to one of ordinary skill in the art. Additionally, the added display provides the benefit of clear communication to the user.
Regarding claim 32, claim 1 of ‘219 disclose substantially all limitations required by claim 32 of the current application except determining, based on the signal, a degree of ostomy leakage from a plurality of non-zero leakage degrees associated with the ostomy apparatus and a display; and the computing device displaying, on the display, information indicating the determined degree of ostomy leakage.
Locke discloses multiple threshold levels, and therefore degrees, used, each representing a different leakage level (e.g. low, medium, or high), interpreted as non-zero leakage degrees, and may cause a different alarm, audible and/or visual, to be initiated (see par. 51). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include multiple thresholds each representing a different leakage level and causing a different alarm as disclosed by Locke, therefore providing more notice to the user of the different stages of leakage levels. This would predictably result in the indication of fluid leakage during use (see Locke, par. 51) of the ostomy apparatus. Consequently, the alarm would be based upon the determined degree of ostomy leakage.
Locke further discloses a display 500 (see par. 44), and the computing device displaying, on the display 500, information 604 indicating the determined degree of leakage (see Fig. 6A, par. 44, 46, shows the degree of fluid leak in being low, medium, or high). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a known technique to improve similar devices in the same way, and therefore have the device further include the improvement of including a display and the computing device displaying, on the display, information indicating the determined degree of leakage, as disclosed by Locke, with the results of such communication of information via the display being predictable to one of ordinary skill in the art. Additionally, the added display provides the benefit of clear communication to the user.
Regarding claims 33 and 36-38, the following claims of ‘219 disclose the additional limitations required by claims 33 and 36-38 of the current application:
Current application
33
36
37
38
Claims of ‘219
1
7
17
6
Regarding claim 34, claim 1 of ‘219 and Locke disclose the limitations of claim 32 and further disclose the plurality of non-zero leakage degrees associated with the ostomy apparatus comprises at least a first non-zero leakage degree and a second non-zero leakage degree greater than the first non-zero leakage degree (see rejection of claim 32, low, medium, and high would require multiple non-zero leakage degrees with some being greater than others).
Regarding claim 35, claim 1 of ‘219 and Locke disclose the limitations of claim 34 and further disclose the plurality of non-zero leakage degrees comprises leakage degrees within a range greater than no leakage and up to full saturation (see rejection of claim 32, low, medium, and high would be non-zero in such a range) around a sensor of the ostomy apparatus.
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 ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA E EISENBERG can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARIANA ZIMBOUSKI/ Primary Examiner, Art Unit 3781
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