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 .
Claim Objections
Claims 7 and 16 are objected to because of the following informalities:
Regarding claim 7, ”the sensor component” should be corrected to “the sensor base component” for claim language consistency.
Regarding claim 16, “the first period of time” should be corrected to “the first wear period” for claim language consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-11 and 18-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 8, the combination of the new limitations of claim 7 and the limitations of claim 8 are not supported by the original disclosure. The original disclosure does not support the “…the drug delivery device base component including and an adhesive for direct attachment to a user's body…” (from claim 7) and “an adhesive pad for the drug delivery device… wherein a bottom surface of the adhesive pad is operable to be coupled via the adhesive to the user's body” (from claim 8).
In the embodiment of the invention in which adhesive pad 802 is included, the drug delivery device 902 is coupled to the adhesive pad 802, not directly attached to a user’s body, as the new limitations of claim 7 suggest. The original disclosure does not provide detail supporting a drug delivery system in which the adhesive pad is used and the drug delivery device is directly attached to a user’s body. The original disclose does not provide support for a drug delivery system in which the adhesive pad 802 and the drug delivery device base component are both directly attached to a user’s body. The adhesive pad 802 is coupled via an adhesive to the user’s body, with the drug delivery device 902 coupled to the adhesive pad 802.
Regarding claim 10, the combination of the new limitations of claim 7 and the limitations of claim 10 are not supported by the original disclosure. The original disclosure does not support the “a sensor having a sensor base component and operable to couple directly to a user's body via an adhesive on the sensor base component” (from claim 7) and “wherein the sensor… is positioned on top of the adhesive pad” (from claim 10).
The sensor 804 is disclosed as either positioned on top of adhesive pad 802 or incorporated into an opening of adhesive pad 802. However, as claimed in claim 7, the sensor is limited to be coupled directly to a user’s body. In this configuration, the disclosure provides support for the sensor 804 being incorporated into an opening of the adhesive pad 802, not positioned on top of adhesive pad 802. If sensor 804 is positioned on top of adhesive pad 802, it cannot be directly coupled to a user’s body.
Claims 9 and 11 are rejected due to their dependency on claim 8.
Similarly, regarding claim 18, the new limitations are not supported by the original disclosure. The original disclosure does not support “…attaching an adhesive pad and a sensor to a body of a user wherein the adhesive pad is coupled to a sensor base component, the sensor base component coupled directly to the body of the user via an adhesive on the sensor base component…” and “the drug delivery device base component coupled directly to the body of the user via a separate adhesive on the drug delivery device base component...” (emphasis added).
In the embodiment of the invention in which adhesive pad 802 is included, the drug delivery device 902 is coupled to the adhesive pad 802, not directly attached to a user’s body, as the new limitations suggest. The original disclosure does not provide detail supporting a drug delivery system including a drug delivery device configured to directly couple to a user’s body and to an adhesive pad. The original disclose does not provide support for a drug delivery system in which the adhesive pad 802 and the drug delivery device base component are both directly coupled to a user’s body. The adhesive pad 802 is coupled via an adhesive to the user’s body, with the drug delivery device 902 coupled to the adhesive pad 802.
Additionally, the original disclosure does not provide detail supporting the sensor base component coupled to the body of the user via an adhesive and coupled to an adhesive pad. The disclosure provides support for the sensor 804 being incorporated into an opening in the adhesive pad, with the adhesive pad 802 positioned over an entirety of the underside of the CGM sensor 804 other than at the opening to accommodate the site 810 (see [0060]), or positioned on top of the adhesive pad. Claims 19-26 are rejected due to their dependency on claim 18.
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 8-11 and 18-26 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.
Regarding claim 8, the limitation of “an adhesive pad for the drug delivery device… a bottom surface of the adhesive pad is operable to be coupled via the adhesive to the user's body” renders the claim unclear. The Examiner is uncertain if the adhesive pad, in light of the new amendments to claim 7, is intended to be a separate adhesive element from the adhesive on the sensor base component and/or the adhesive on the base component or intended to be in reference to one of the adhesives, either on the sensor base component or the base component. The claim introduces “an adhesive pad” but “a bottom surface of the adhesive pad is operable to be coupled via the adhesive” (emphasis added). The Examiner is unsure if the adhesive referenced in the last line of the claim is in reference to the adhesive of the sensor base component and/or the adhesive of the base component, or a separate adhesive. For purposes of examination, “an adhesive pad” is being interpreted as in reference to the sensor base component and the adhesive on the sensor base component. This consideration is in line with what is shown in the embodiment of Fig. 8-13.
Regarding claim 18, the limitations of “attaching an adhesive pad and a sensor to a body of a user wherein the adhesive pad is coupled to a sensor base component, the sensor base component coupled directly to the body of the user via an adhesive on the sensor base component” and “coupling a first drug delivery device including a drug delivery device base component that contacts the adhesive pad… the drug delivery device base component coupled directly to the body of the user via a separate adhesive on the drug delivery device base component…” renders the claim unclear. First, the Examiner is unsure how the sensor base component can be coupled directly to the body of the user and to an adhesive pad, which is also attached to the body. For purposes of examination, “an adhesive pad” is being interpreted as in reference to the sensor base component and the adhesive on the sensor base component. This consideration is in line with what is shown in the embodiment of Fig. 8-13.
Second, the Examiner is unsure how the drug delivery device can contact the adhesive pad and be coupled directly to the body of the user. If the drug delivery device is in contact with the adhesive pad, which is attached to the body of the user, the drug delivery device cannot also directly couple to the body of the user. For purposes of examination, the limitation of “coupled directly to the body of the user” is being interpreted as simply limiting the drug delivery device to be coupled to the body.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 7 and 12-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoss (US 20100274112 A1).
Regarding claim 7, Hoss discloses a drug delivery system (“modular combination of medication delivery and physiological condition monitoring system”, [0101]-[0115] & Fig. 14-17), comprising: a sensor having a sensor base component and operable to couple directly to a user's body via an adhesive on the sensor base component (analyte sensor having an anchor portion 1407/1507 with an adhesive to couple directly to a skin surface 1404/1504, [0101]-[0102] and [0107]-[0108] & Fig. 14A-15C; “the analyte sensor may be provided with an adhesive layer on the bottom surface to secure positioning on the patient's skin surface during usage.”, [0111]), wherein the sensor includes one or more sensing cannulas extending from a bottom surface of the sensor into the user's body (”a tip portion 1508 which is configured for transcutaneous placement for fluid contact with the patient's analyte.”, [0108] and [0102] & Fig. 14C and 15C); and
a drug delivery device having a base component that is separate from the sensor component and configured for placement on the user's body adjacent the sensor, the drug delivery device base component including an adhesive for direct attachment to a user's body and an infusion cannula configured to deliver a liquid drug to the user (“a patch pump housing 1501 which is configured for positioning on the skin surface 1504 of the patient, and which is operatively coupled to a transcutaneously positioned cannula 1502 for medication delivery to the patient.”, [0106] and [0101] & Fig. 14A-15C; “the patch pump housing… may be provided with an adhesive layer on the bottom surface to secure positioning on the patient's skin surface during usage”, [0111]; pump 1401/1501 placed adjacent to the analyte sensor, see Fig. 14C, 15C, and 17), wherein
the drug delivery device is removably attachable to the user (”the integrated system may be used as a stand along infusion device, the patch pump and the analyte sensor may be replaced or changed independent of each other, and without substantially increasing the profile or the on-body size of the overall system, the sensor may be inserted or positioned in the patient independent of the patch pump, and also removed independent of the pump housing.”, [0105] and [0115]; pump 1401/1501 may be removably attachable to the user) such that the drug delivery device can be detached after a first wear period that is shorter than a wear period of the sensor, while the sensor remains positioned and operational on the user's body (“the various components of the integrated system, for example, of the infusion device and analyte monitoring system 100 (FIG. 1) may need periodic replacement, where the components may require replacement at different times during the usage of the integrated system. For example, the infusion device cannula may require replacement after about each 3-days of usage, while the analyte sensor for use in the analyte monitoring system may not require replacement until at least about five or seven days of usage. Accordingly, in one embodiment, the components of the integrated system may be provided as replaceable modular components such that one or more components may be replaced at different times during the usage of the integrated system without substantially impacting the remaining portion of the integrated system.”, [0100]),
wherein the drug delivery device is operable to: deliver a liquid drug to the user's body via the infusion cannula (“a patch pump housing 1501 which… is operatively coupled to a transcutaneously positioned cannula 1502 for medication delivery to the patient.”, [0106] & Fig. 15C), and to be detached from the user's body without disrupting a positioning or operation of the one or more sensing cannulas (“the components of the integrated system may be provided as replaceable modular components such that one or more components may be replaced at different times during the usage of the integrated system without substantially impacting the remaining portion of the integrated system”, [0100]; “, the patch pump and the analyte sensor may be replaced or changed independent of each other”, [0105] and [0115]; pump 1401/1501 can be detached without disrupting tip portion 1408/1508 positioning or operation as the analyte sensor can be coupled to subsequent pumps for further use).
Regarding claim 12, Hoss discloses all the limitations of claim 7. Hoss further discloses the drug delivery system wherein the bottom surface of the sensor is coplanar with a bottom surface of the drug delivery device when the sensor is positioned within an opening or recess of the drug delivery device (the bottom of pump 1401/1501 and anchor portions 1407/1507 of the analyte sensors are coplanar when the analyte sensors are coupled to, or positioned within, connection port 1403/1503, which is being interpreted as an opening or recess of pump 1401/1501, [0101]-[0102] and [0107]-[0109] see Fig. 14C and 15C; “connection port of the patch pump housing provided on an end surface or a top surface of the pump housing, within the scope of the present disclosure, the connection port of the patch pump may be provided on any location of the patch pump housing. For example, within the scope of the present disclosure, the connection port providing a water tight seal when connected with an end cap (to establish closure), or with an analyte sensor (to use the patch pump in an integrated system with analyte monitoring), may be provided on the bottom, side, or any other surface of the patch pump housing.”, [0109]).
Regarding claim 13, Hoss discloses all the limitations of claim 7. Hoss further discloses the drug delivery system wherein the drug delivery device is operable to be positioned over the sensor (pump 1401/1501 is capable of being positioned over the analyte sensor considering the pump 1401/1501 may be positioned anywhere on the skin, [0101] and [0106] & Fig. 14A-15C; pump 1401/1501 may be positioned at a site on the skin above a site chosen for the analyte sensor).
Regarding claim 14, Hoss discloses all the limitations of claim 7. Hoss further discloses the drug delivery system wherein the drug delivery device and the sensor are communicatively coupled together when the drug delivery device is positioned over the sensor (pump 1401/1501 and the analyte sensor are configured to electrically communicate with each other when connected through connector portion 1405/1506, [0104] and [0107] & Fig. 14C and 15C; pump 1401/1501 is capable of being positioned over the analyte sensor considering the pump 1401/1501 may be positioned anywhere on the skin, [0101] and [0106] & Fig. 14A-15C; pump 1401/1501 may be positioned at a site on the skin above a site chosen for the analyte sensor).
Regarding claim 15, Hoss discloses all the limitations of claim 7. Hoss further discloses the drug delivery system wherein the sensor is a continuous glucose monitor and the liquid drug is insulin ([0029]-[0030], [0045], [0091], and [0182]).
Regarding claim 16, Hoss discloses all the limitations of claim 7. Hoss further discloses the drug delivery system wherein the drug delivery device is operable to be removed after the first period of time and be replaced with a subsequent drug delivery device that is operable to be positioned over the sensor (“the patch pump and the analyte sensor may be replaced or changed independent of each other, and without substantially increasing the profile or the on-body size of the overall system, the sensor may be inserted or positioned in the patient independent of the patch pump, and also removed independent of the pump housing “, [0105]; “each component may be independently replaced”, [0115]; “the various components of the integrated system, for example, of the infusion device and analyte monitoring system 100 (FIG. 1) may need periodic replacement, where the components may require replacement at different times during the usage of the integrated system. For example, the infusion device cannula may require replacement after about each 3-days of usage, while the analyte sensor for use in the analyte monitoring system may not require replacement until at least about five or seven days of usage. Accordingly, in one embodiment, the components of the integrated system may be provided as replaceable modular components such that one or more components may be replaced at different times during the usage of the integrated system without substantially impacting the remaining portion of the integrated system.”, [0100]; pump 1401/1501 can be removed and replaced after a period of, for example, 3 days with a subsequent pump 1401/1501; pump 1401/1501 is capable of being positioned over the analyte sensor considering the pump 1401/1501 may be positioned anywhere on the skin, [0101] and [0106] & Fig. 14A-15C; pump 1401/1501 may be positioned at a site on the skin above a site chosen for the analyte sensor).
Regarding claim 17, Hoss discloses all the limitations of claim 7. Hoss further discloses the drug delivery system wherein the sensor has a central axis that is coaxial with a central axis of the drug delivery device (the longitudinal central axis of the analyte sensor and the longitudinal central axis of pump 1401 are coaxial, see Fig. 14C).
Claim Rejections - 35 USC § 103
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 1-3, 18-20, and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Gyrn (US 20120184909 A1), in view of Mounce (US 20080051709 A1), and further in view of Flaherty (US 20020040208 A1).
Regarding claim 1, Gyrn discloses a method, comprising: removing a first drug delivery device including a base component of the first drug delivery device having adhesive from a drug delivery system from a first infusion site of the drug delivery system (delivery part 8, which is being interpreted as the first drug delivery device, is detachable and configured to attach to two separate positions for cannulas, see abstract, [0088] and [0101]-[0103] & Fig 14 and 15; the first infusion site being the site of cannula part 7 and cannula 22b and the second infusion site being the site of second cannula part 7 and cannula 22a, see [0103] & Fig. 14 and 15; the bottom of delivery part 8 is being interpreted as the drug delivery device base component; see Fig. 14-15); and
leaving a sensor having a sensor base component coupled directly to a body of a user via an adhesive on the sensor base component that is separate from the base component of the first drug delivery device (the sensor part 70, [0102] & Fig. 14A; base part 1, which is being interpreted as the sensor base component, is coupled directly to a patient/user and is separate from the bottom of delivery part 8, [0102] & Fig. 14-15; base part 1 includes a pressure adhesive layer, [0057] and [0102] & Fig. 14) attached to the body of the user at a position of an opening of the first drug delivery device during removal of the first drug delivery device (sensor part 70 and base part 1 are positioned with respect to contact 71a, which is being interpreted as an opening of delivery part 8, [0103] & Fig. 14-15; the sensor is attached at a position of contact 71a; alternatively, the entire open bottom side of delivery part 8 can be interpreted as an opening of delivery part 8, see Fig. 1B; sensor part 70 and base part 1 remain attached to the body of the user during removal of delivery part 8, [0088] and [0102]-[0103] & Fig. 14-15), wherein: the drug delivery system includes the first drug delivery device and the sensor (sensor part 70 and base part 1 and delivery part 8 are being interpreted as the drug delivery system, abstract, [0102] & Fig. 14-15),
the sensor is coupled to a sensing site on the user (the subcutaneous unit 72 of sensor 70 is designed for insertion into the subcutaneous layer of a user, [0102] & Fig. 14), and the first drug delivery device including a reservoir (reservoir 6, [0102] & Fig. 14) operable to store a liquid drug (via “...permit a fluid to flow from the reservoir 6,” [0102] & Fig. 14; the fluid may be medication, [0064]) and having a drug delivery component (connector needle 19, [0102] & Fig. 14) operable to extract a portion of the liquid drug from the reservoir and deliver a dose of the liquid drug to the user (via “when the delivery part 8 is pushed against the base part 1a first fluid path will be formed as the connector needle 19 of the delivery part will penetrate the top opening of the cannula part 7 and permit a fluid to flow from the reservoir 6 to the base part 1,” [0102] & Fig. 14) via a first infusion cannula (subcutaneous unit 22b, [0102] & Fig. 14).
However, Gyrn does not explicitly disclose a method comprising: removing a first drug delivery device (delivery part 8, [0102] & Fig. 14) having adhesive after a first period of time from a first infusion site of the drug delivery system.
However, Mounce teaches a method comprising: removing a first drug delivery device (disposable housing portion, [0082] & Fig. 2 and 3) after a first period of time from a drug delivery system (via “the disposable housing portion may be disengaged... after it has been in use for a period of time, or after one or a prescribed number of uses,” [0082] & Fig. 2 and 3).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method as disclosed by Gyrn with Mounce to include the removal of the first drug delivery device after a first period of time since such a modification would allow for the connection of a potentially new, refurbished, or re-filled subsequent drug delivery device capable of being positioned at a different infusion site, thereby providing the predictable results pertaining to attaching a subsequent drug delivery device capable of continuing operation of the drug delivery system as a whole. Mounce teaches that “after disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion (such as a new, refurbished, refilled or re-manufactured disposable housing portion) for further operation,” [0082]. The modification with Mounce provides for the replaceability of delivery part 8 which allows for the removal and replacement of the reservoir while allowing for the retraction of used cannulas and insertion of new cannulas into different infusion sites via the base which remains attached to the patient as disclosed in Gyrn, see [0088].
Further, Flaherty teaches a first drug delivery device (disposable assembly 94, [0097] & Fig. 10) having adhesive (disposable assembly 94 utilizing adhesive bonds as a means of attachment to reusable assembly 93, [0097] & Fig. 10) and configured to be removable from a reusable component ([0095]-[0097] & Fig 10). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first drug delivery device of Gyrn, as modified, with Flaherty to include adhesive since Flaherty teaches adhesive to be an art effective equivalent to snaps, mating threads, and other known attachment means between a reusable and disposable assembly (see [0097] and [0093] of Flaherty).
Regarding claim 2, Gyrn, as modified, discloses all of the limitations of claim 1. Gyrn further discloses the method of claim 1, further comprising: removal of the first drug delivery device from the drug delivery system (via “the delivery part is detachable which means it can be fastened to the base part 1 and released again as often as the user wishes,” [0102] & Fig. 14 and 15). However, Gyrn does not explicitly disclose the method further comprising: positioning a second drug delivery device over the sensor, the sensor positioned within an opening of the second drug delivery device.
However, Mounce teaches the method further comprising: positioning a second drug delivery device over the sensor (via “after disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion,” [0082] & Fig. 2 and 3), the sensor positioned within an opening of the second drug delivery device (the second drug delivery device, in the instant application and in Mounce, is the same in structure and function as the first drug delivery device; therefore, the opening of the second drug delivery device can be contact 71a, [0102] & Fig. 14 of Gyrn, of the second, structurally identical, drug delivery part 8).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method as disclosed by Gyrn with Mounce to include a second drug delivery device positioned over the sensor, the sensor positioned within an opening of the second drug delivery device, since such a modification would allow for the connection of a new, refurbished, or re-filled drug delivery device capable of being positioned at a different infusion site, thereby providing the predictable results pertaining to attaching a second drug delivery device capable of continuing operation of the drug delivery system as a whole. Mounce teaches that “after disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion (such as a new, refurbished, refilled or re-manufactured disposable housing portion) for further operation,” [0082].
Regarding claim 3, Gyrn, as modified, discloses all the limitations of claim 2. Gyrn further discloses the method of claim 2, further comprising: extending a second infusion cannula (via cannula 22a, [0103] & Fig. 14B) from a periphery of a bottom surface of a drug delivery device (extension of cannula 22a occurring from the bottom of connector needle 19 and delivery part 8, [0102] & Fig. 14 and 15), wherein the second infusion cannula is positioned at a second infusion site (the site of second cannula part 7 and cannula 22a is being interpreted as the second infusion site, [0103] & Fig. 14-15) and away from a former position of the first infusion cannula (via “FIG. 14B shows a base part 1 in a second state where a second cannula part 7 with a cannula 22a has been inserted through an opening 12A in the base part 1 at a second position,” [0103]).
However, Gyrn does not explicitly disclose the second drug delivery device. However, Mounce teaches the second drug delivery device (the disposable housing portion; via “after disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion,” [0082] & Fig. 2 and 3).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method as disclosed by Gyrn with Mounce to include a second drug delivery device, since such a modification would allow for the connection of a new, refurbished, or re-filled drug delivery device capable of being positioned at a different infusion site, thereby providing the predictable results pertaining to attaching a second drug delivery device capable of continuing operation of the drug delivery system as a whole. Mounce teaches that “after disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion (such as a new, refurbished, refilled or re-manufactured disposable housing portion) for further operation,” [0082].
Regarding claim 18, Gyrn, as best understood in light of the 112(b) rejection set forth above, discloses a method, comprising: attaching an adhesive pad (base part 1, [0102] & Fig. 14; “the base part 1… is provided with a mounting surface; normally the mounting surface will consist of a pressure adhesive layer either welded to the lower side of the base part 1 or adhered directly to the lower side of the base part 1”, [0057]) and a sensor (sensor part 70, [0102] & Fig. 14) to a body of a user (base part 1 being “attached to the patient’s skin” and sensor part 70 being coupled to the base part 1, [0102] & Fig. 14) wherein the adhesive pad is coupled to a sensor base component (base part 1 and its adhesive layer is being interpreted as the sensor base component; sensor 70 configured to be coupled to base part 1, see abstract, [0059], and [0102] & Fig. 14-15), the sensor base component coupled directly to the body of the user via an adhesive on the sensor base component (sensor part 70, [0057] and [0102] & Fig. 14-15; base part 1, which is being interpreted as the sensor base component, is coupled directly to a patient/user; base part 1 includes a pressure adhesive layer, [0057] and [0102] & Fig. 14);
extending one or more sensing cannulas from a bottom surface of the sensor (via subcutaneous unit 72 extending from the bottom of sensor part 70, [0102] & Fig. 14); coupling a first drug delivery device (delivery part 8, [0102] & Fig. 14) including a drug delivery base component that contacts the adhesive pad separate from the sensor base component when positioned over the sensor in a first position (the bottom of delivery part 8 is being interpreted as the drug delivery base component, see Fig. 14-15; the bottom of delivery part 8 contacts base part 1 separately from the bottom of sensor 70 when positioned in a first position illustrated in Fig. 15A), the drug delivery device base component coupled directly to the body of the user via release handles on the drug delivery device base component, independently of the sensor base component (the bottom of delivery part 8 coupled to the body via release handles 9, [0061] & Fig. 1A-1B; the release handles 9 are independent structures that are not structurally part of base part 1, [0061]-[0062] & Fig. 1A-1B),
wherein the first position being at one of a plurality of possible orientations relative to a positioning of the sensor (via “the delivery part 8 is pushed against the base part 1 a first fluid path will be formed as the connector needle 19 of the delivery part will penetrate the top opening of the cannula part 7 and permit a fluid to flow from the reservoir 6 to the base part 1,” [0102] & Fig. 14; the delivery part 8 can be turned 180 degrees to provide a second fluid path in a second position relative to a positioning of the sensor 70, Figure 14A and 15); extending a first infusion cannula from the first drug delivery device (the extension of subcutaneous unit 22b, [0102] & Fig. 14); and infusing a liquid drug into the body of the user from the first drug delivery device (via “when the delivery part 8 is pushed against the base part 1 a first fluid path will be formed as the connector needle 19 of the delivery part will penetrate the top opening of the cannula part 7 and permit a fluid to flow from the reservoir 6 to the base part 1,” [0102] & Fig. 14; Fluid flow from reservoir 6 to base part 1 is done in order for the liquid drug to be subcutaneously injected through unit 22b).
However, Gyrn does not explicitly disclose the infusion of a liquid drug into the body of the user over a first duration and the drug delivery device base component coupled directly to the body of the user via a separata adhesive on the drug delivery device base component
However, Mounce teaches the infusion of a liquid drug into the body of the user from the first drug delivery device (disposable housing portion, [0082] & Fig. 2 and 3) over a first duration (via “the disposable housing portion may be disengaged... after it has been in use for a period of time, or after one or a prescribed number of uses,” [0082] & Fig. 2 and 3). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the drug delivery system as disclosed by Gyrn with Mounce to include the infusion of a liquid drug into the body of the user over a first duration, since such a modification would designate a time frame for use of the first drug delivery device, thereby providing the predictable results pertaining to informing the user of first drug delivery device expiration, potentially prompting the user to attach a subsequent drug delivery device capable of continuing operation of the drug delivery system as a whole. Mounce teaches that “after disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion (such as a new, refurbished, refilled or re-manufactured disposable housing portion) for further operation,” [0082].
Further, Flaherty teaches a drug delivery device base component (disposable assembly 94, [0097] & Fig. 10) having adhesive (disposable assembly 94 utilizing adhesive bonds as a means of attachment to reusable assembly 93, [0097] & Fig. 10) and configured to be removable from a reusable component ([0095]-[0097] & Fig 10). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the drug delivery device base component of Gyrn, as modified, with Flaherty to include adhesive since Flaherty teaches adhesive to be an art effective equivalent to snaps, mating threads, and other known attachment means between a reusable and disposable assembly (see [0097] and [0093] of Flaherty).
Regarding claim 19, Gyrn, as modified, discloses all the limitations of claim 18. Gyrn further discloses the method wherein the first drug delivery device is coupled to the adhesive pad (the delivery part 8 being coupled to the base part 1, [0102] & Fig. 14; delivery part 8 is being interpreted as the first drug delivery device and the base part is being interpreted as the pad). Gyrn explicitly discloses that “the delivery part is detachable which means it can be fastened to the base part 1 and released again as often as the user wishes,” [0102].
Regarding claim 20, Gyrn, as modified, discloses all the limitations of claim 18. Gyrn further discloses the method of claim 18, wherein the first infusion cannula (subcutaneous unit 22b, [0102] & Fig. 14) extends from the first drug delivery device (delivery part 8, [0102] & Fig. 14) through a first opening in the adhesive pad to reach the body of the user (via the cannula part 7 having an opening allowing the subcutaneous unit 22b to extend from it, Fig. 14 and 15), the first opening associated with the first position of the first drug delivery device (via “the base part also comprises... one or more openings through which two or more subcutaneous units in the form of at least one cannula and at least one sensor part or at least two cannulas extend,” [0008]; and “FIG. 14 shows a base part 1 in a first state where a first cannula part 7 with a cannula 22b has been inserted,” [0102]).
Regarding claim 23, Gyrn, as modified, discloses all the limitations of claim 18. Gyrn further discloses the method further comprising: removing the first drug delivery device while maintaining positioning of the adhesive pad and the sensor (via “the delivery part 8 also comprises two contacts 71a which... create a signal path for the sensor part 70 regardless of the position of the delivery part 8 relative to the base part 1,” [0102] & Fig. 14 and 15; the delivery part 8 can be removed and positioned in a second state without disturbing the positioning of the base part 1 or sensor 70, [0103] & Fig. 14 and 15). However, Gyrn fails to expressly disclose the method further comprising: coupling a second drug delivery device to the body of the user.
However, Mounce teaches the method further comprising coupling a second drug delivery device (disposable housing portion, [0094] & Fig. 2 and 3; “the disposable housing portion may be readily disposed of after it has been in use for a period of time, or after one or a prescribed number of uses. After disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion,” [0082] & Fig. 3) to the body of the user (via “the base 21 of the disposable housing portion 20 has a bottom surface that is configured to secure to a patient-user's skin at a desired location on the patient-user,” [0093] & Fig. 2 and 3).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method as disclosed by Gyrn with Mounce to include coupling a second drug delivery device to the body of the user, since such a modification would allow for the connection of a new, refurbished, or re-filled drug delivery device capable of being positioned at a different infusion site, thereby providing the predictable results pertaining to attaching a second drug delivery device capable of continuing operation of the drug delivery system as a whole. Mounce teaches that “after disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion (such as a new, refurbished, refilled or re-manufactured disposable housing portion) for further operation,” [0082].
Regarding claim 24, Gyrn, as modified, discloses all the limitations of claim 23. Gyrn further discloses the method of claim 23, wherein when the second drug delivery device is coupled to the body of the user, the second drug delivery device is coupled to the adhesive pad and over the sensor in a second position different from the first position (via the delivery part 8 having two contacts 71a, which are being interpreted as openings for the sensor to be positioned in, and the delivery part 8 configured to attach to the base part 1 and the sensor part 70 using either contact, [0102] & Fig. 14 and 15; the second state and second position being different than the first state and first position of delivery part 8).
Regarding claim 25, Gyrn, as modified, discloses all the limitations of claim 23. Gyrn further discloses the method of claim 23, further comprising: extending a second infusion cannula (cannula 22A, [0103] & Fig. 14) from the second drug delivery device through a second opening in the adhesive pad (opening 12a, [0103] & Fig. 14) to reach the body of the user, the second opening associated with the second position of the second drug delivery device; and infusing the liquid drug into the body of the user from the second drug delivery device (“FIG. 14[B] shows a base part 1 in a second state where a second cannula part 7 with a cannula 22a has been inserted through an opening 12A in the base part 1 at a second position. A fluid path to the cannula 22a at the second position can be obtained by turning the delivery part 8 180 degree[s],” [0103]; the fluid path intended for drug delivery into the body of a user). However, Gyrn does not explicitly disclose infusing the liquid drug into the body of the user from the second drug delivery device over a second duration. However, Mounce teaches infusing the liquid drug into the body of the user from the second drug delivery device over a second duration (via “the disposable housing portion may be disengaged... after it has been in use for a period of time, or after one or a prescribed number of uses,” [0082] & Fig. 2 and 3).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the drug delivery system as disclosed by Gyrn with Mounce to include the infusion of a liquid drug into the body of the user over a second duration, since such a modification would designate a time frame for use of the second drug delivery device, thereby providing the predictable results pertaining to informing the user of second drug delivery device expiration, potentially prompting the user to attach a subsequent drug delivery device capable of continuing operation of the drug delivery system as a whole. Mounce teaches that “after disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion (such as a new, refurbished, refilled or re-manufactured disposable housing portion) for further operation,” [0082].
Regarding claim 26, Gyrn, as modified, discloses all the limitations of claim 25. Gyrn further discloses the method wherein the second opening is up to 180 degrees away from a first opening relative to a central axis of the sensor (via the second opening on the base part 1 can be seen in Figure 14A and 14B to be between 0 and 180 degrees away from the first opening relative to a central axis of sensor part 70).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Gyrn (US 20120184909 A1), in view of Mounce (US 20080051709 A1), in view of Flaherty (US 20020040208 A1), and further in view of Bengtsson (US 20040162521 A1).
Regarding claim 4, Gyrn, as modified, discloses all the limitations of claim 3. Gyrn further discloses the method further comprising: removing the second drug delivery device while maintaining attachment of the sensor to the body of the user (via “regardless of the position of the active cannula part 7, signals are obtained and sent via the same sensor part 70; the sensor part 70 is though connected to the delivery part 8 via another contact 71a,” [0103] & Fig. 14; the sensor part 70 and base part 1 remain in contact with the body of the patient/user while delivery part 8 is detached/reattached, [0102]-[0103]).
However, Gyrn does not explicitly disclose the method further comprising: removing the second drug delivery device after a second period of time; and positioning a third drug delivery device on the body of the user at a third infusion site, wherein the third infusion site is away from the former position of the first infusion cannula and a former position of the second infusion cannula.
However, Mounce teaches the method further comprising: removing the second drug delivery device after a second period of time (via “the disposable housing portion may be disengaged... after it has been in use for a period of time, or after one or a prescribed number of uses,” [0082] & Fig. 2 and 3); and positioning a third drug delivery device on the body of the user (via “after disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion,” [0082] & Fig. 2 and 3; like the second drug delivery device, the third drug delivery device would be a third, structurally identical, delivery part 8).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method as disclosed by Gyrn with Mounce to include removing the second drug delivery device after a second period of time; and positioning a third drug delivery device on the body of the user, since such a modification would allow for the connection of a new, refurbished, or re-filled drug delivery device capable of being positioned at a different infusion site, thereby providing the predictable results pertaining to attaching a third drug delivery device capable of continuing operation of the drug delivery system as a whole. Mounce teaches that “after disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion (such as a new, refurbished, refilled or re-manufactured disposable housing portion) for further operation,” [0082].
Further, the Examiner notes that Gyrn discloses the possibility of modifying the delivery part 8 and base part 1 to include more than two cannula parts 7 while still maintaining signal contact with a single sensor, see [0088] and [0104] of Gyrn, but fails, as stated above, to explicitly disclose positioning a third drug delivery device at a third infusion site, wherein the third infusion site is away from the former position of the first infusion cannula and a former position of the second infusion cannula.
However, Bengtsson teaches a third infusion site, wherein the third infusion site is away from the former position of the first infusion cannula and a former position of the second infusion cannula (three infusion needles 422 and corresponding insertion means 432 each being at different infusion sites, see [0045] and [0092] & Fig. 9A-9B).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Gyrn, as modified by Mounce, with Bengtsson to include a third infusion site, wherein the third infusion site is away from the former position of the first infusion cannula and a former position of the second infusion cannula, since such a modification would further extend operational life of the drug delivery system, since an infusion needle can only remain at a given site for a limited period of time, and yield predictable results pertaining to improved quality of treatment (see [0024]-[0026] and [0045] of Bengtsson).
As modified, the reservoir of delivery part 8 could be operable for connection to an additional, third, infusion site on base part 1 comprised of an inserted third cannula part 7, as is already contemplated by Gyrn, and a third cannula, as explicitly taught by Bengtsson and inherently included in the contemplated modifications of Gyrn. Additionally, as inherently disclosed in Gyrn and explicitly taught in Bengtsson, the third infusion site would be spaced away from the first and second infusion sites.
The Examiner notes that in Gyrn, “the object of having two cannulas is to be able to retract one cannula while inserting another cannula and still be using the same patch and e.g. also the same sensor. This feature will increase the service life of a patch including both cannula and sensor as the cannula normally will have to be retracted after 3 days while the sensor normally can stay inserted in 6-10 days”, see [0088] of Gyrn.
The addition of a third infusion site provides the user with an additional option for subcutaneous infusion needle entry while maintaining positioning of the base pad and sensor considering, as is well known in the art, that an infusion needle can only remain at a given site for a limited period of time (see [0025] of Bengtsson and [0088] of Gyrn). The modification allows for the continued use of the sensor and base pad while changing infusion sites, and delivery parts, an additional time (see [0008]-[0009], [0018], and [0104] of Gyrn).
Regarding claim 5, Gyrn, as modified, discloses all the limitations of claim 4. Gyrn further discloses the method wherein positioning of the third drug delivery device on the body further comprises: placing the third drug delivery device over the sensor, the sensor is positioned within an opening of the third drug delivery device (the third drug delivery device being identical in structure to the first and second drug delivery devices, contact 71a, [0102] & Fig. 14 of Gyrn, can be interpreted as the opening; the third drug delivery device being placed over the sensor part 70 and base part 1).
Regarding claim 6, Gyrn, as modified, discloses all the limitations of claim 5. Gyrn, as modified, further discloses the method further comprising: extending a third infusion cannula from a periphery of a bottom surface of the third drug delivery device (needle 422 of Bengtsson, which is being interpreted as the third cannula, would extend from the bottom of the third drug delivery device (see [0092] & Fig. 9A-9B of Bengtsson); identical to cannulas 22a and 22b of Gyrn extending from delivery part 8), wherein the third infusion cannula is positioned away from a former position of the second infusion cannula and the former position of the second infusion cannula (as modified above, all three infusion sites, which each include their respective cannulas/needles, are positioned away from each other).
Claims 7-10 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gyrn (US 20120184909 A1), in view of Flaherty (US 20020040208 A1).
Regarding claims 7-8, Gyrn, as best understood in light of the 112(b) rejection above, discloses a drug delivery system, comprising: a sensor having a sensor base component and operable to couple directly to a user's body via an adhesive on the sensor base component (sensor part 70, [0057] and [0102] & Fig. 14-15; base part 1, which is being interpreted as the sensor base component, is coupled directly to a patient/user; base part 1 includes a pressure adhesive layer, [0057] and [0102] & Fig. 14), wherein the sensor includes one or more sensing cannulas extending from (the subcutaneous unit 72, [0102] & Fig. 14) a bottom surface of the sensor into the user's body (the subcutaneous unit 72 extends from the bottom of sensor part 70, Fig. 14); and
a drug delivery device having a base component that is separate from the sensor component and configured for placement on the user's body adjacent the sensor (delivery part 8, [0102]-[0103] & Fig. 14-15; the bottom of delivery part 8 is being interpreted as the drug delivery device base; see Fig. 14-15; delivery part 8 is configured for placement adjacent sensor 70 and base part 1, [0102] & Fig. 14-15), the drug delivery device base component including an infusion cannula configured to deliver a liquid drug to the user (subcutaneous unit 22b, [0102] & Fig. 14; subcutaneous unit 22b is designed for subcutaneous entry and is connected to the base part 1, [0102] & Fig. 14), wherein the drug delivery device is removably attachable to the user such that the drug delivery device can be detached after a first wear period that is shorter than a wear period of the sensor (“The delivery part is detachable which means it can be fastened to the base part 1 and released again as often as the user wishes.”, [0102]; delivery part 8 is capable of being detached after a first period of time that is shorter than a wear time of sensor 70 and base part 1, see [0103]-[0104] & Fig. 14-15), while the sensor remains positioned and operational on the user's body (“the delivery part 8 also comprises two contacts 71a which contacts 71a create a signal path for the sensor part 70 regardless of the position of the delivery part 8 relative to the base part 1,” [0102] & Fig. 14; the delivery part 8 can be removed without disturbing the positioning or use of subcutaneous unit 72, [0103] and [0102]),
wherein the drug delivery device is operable to: deliver a liquid drug (reservoir 6 containing a “fluid” [0102] & Fig. 14; this fluid can be medication, [0018]) to the user's body via the infusion cannula (via “when the delivery part 8 is pushed against the base part 1 a first fluid path will be formed... and permit a fluid to flow from the reservoir 6 to the base part 1,” [0102] & Fig. 14; from the base part 1 the fluid is injected subcutaneously through subcutaneous unit 22b), and to be detached from the user's body (via “the delivery part is detachable which means it can be fastened to the base part 1 and released again as often as the user wishes,” [0102]) without disrupting positioning or operation of the one or more sensing cannulas (via “the delivery part 8 also comprises two contacts 71a which contacts 71a create a signal path for the sensor part 70 regardless of the position of the delivery part 8 relative to the base part 1,” [0102] & Fig. 14; the delivery part 8 can be removed without disturbing the positioning or use of subcutaneous unit 72, [0103] and [0102]),
an adhesive pad for the drug delivery device (base part 1, including the pressure adhesive layer, [0057] and [0102] & Fig. 14), the adhesive pad having at least one opening that is operable to allow the infusion cannula to access the user's body, wherein a bottom surface of the adhesive pad is operable to be coupled via the adhesive to the user's body (via “the base part 1 also comprises a lower mounting surface 2 and one or more openings (12A, 12C) through which two or more subcutaneous units (7,70) in the form of at least one cannula and at least one sensor part or at least two cannulas extend,” [Abstract]; “the base part 1… is provided with a mounting surface; normally the mounting surface will consist of a pressure adhesive layer either welded to the lower side of the base part 1 or adhered directly to the lower side of the base part 1”, [0057] & Fig. 1A and 14-15; the pressure adhesive layer coupling base part 1 to the user’s body).
However, Gyrn fails to explicitly disclose the drug delivery device base component including an adhesive for direct attachment to a user's body. However, Flaherty teaches a first drug delivery device (disposable assembly 94, [0097] & Fig. 10) having adhesive (disposable assembly 94 utilizing adhesive bonds as a means of attachment to reusable assembly 93, [0097] & Fig. 10) and configured to be removable from a reusable component ([0095]-[0097] & Fig 10). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first drug delivery device of Gyrn, as modified, with Flaherty to include adhesive since Flaherty teaches adhesive to be an art effective equivalent to snaps, mating threads, and other known attachment means between a reusable and disposable assembly (see [0097] and [0093] of Flaherty).
Regarding claim 9, Gyrn, as modified, discloses all the limitations of claim 8. Gyrn further discloses the drug delivery system wherein the drug delivery device is operable to be releasably attachable to the adhesive pad (via “the delivery part is detachable which means it can be fastened to the base part 1 and released again as often as the user wishes,” [0102] & Fig. 14A) in one of a plurality of positions relative to a fixed position of the adhesive pad on the user’s body (the delivery part 8 can be positioned in a first and second position with base part 1 remaining on the user’s body, [0103] & Fig. 14A/B and 15A/B).
Regarding claim 10, Gyrn, as modified, discloses all the limitations of claim 8. Gyrn further discloses the drug delivery system wherein the sensor is incorporated into an opening in the adhesive pad or is positioned on top of the adhesive pad (via sensor part 70 being inserted onto base part 1 through opening 12C, [0102] & Fig. 1A and 14-15).
Regarding claim 13, Gyrn, as modified, discloses all the limitations of claim 7. Gyrn further discloses the drug delivery system wherein the drug delivery device is operable to be positioned over the sensor (via the sensor part 70 being positioned under delivery part 8 and in contact with contact 71a [0102] & Fig. 14).
Regarding claim 14, Gyrn, as modified, discloses all the limitations of claim 7. Gyrn further discloses the drug delivery device wherein the drug delivery device and the sensor are communicatively coupled together when the drug delivery device is positioned over the sensor (via “the delivery part 8 also comprises two contacts 71a which contacts 71a create a signal path for the sensor part 70,” [0102] & Fig. 14).
Regarding claim 15, Gyrn, as modified, discloses all the limitations of claim 7. Gyrn further discloses the drug delivery device wherein the sensor is a continuous glucose monitor and the liquid drug is insulin (via “the sensor part measures glucose or an analyte corresponding to glucose and the medication delivered through the at least one cannula is insulin,” [0026]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gyrn (US 20120184909 A1), in view of Flaherty (US 20020040208 A1), and further in view of Mounce (US 20080051709 A1).
Regarding claim 16, Gyrn, as modified, discloses all the limitations of claim 7. However, Gyrn fails to expressly disclose the drug delivery device wherein the drug delivery device is operable to be removed after the first period of time and be replaced with a subsequent drug delivery device that is operable to be positioned over the sensor. However, Mounce teaches the drug delivery device (disposable housing portion, [0082] & Fig. 2 and 3) wherein the drug delivery device is operable to be removed after the first period of time (via “the disposable housing portion may be disengaged... after it has been in use for a period of time, or after one or a prescribed number of uses,” [0082] & Fig. 2 and 3) and be replaced with a subsequent drug delivery device that is operable to be positioned over the sensor (via “after disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion,” [0082] & Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the drug delivery system as disclosed by Gyrn with Mounce to include the drug delivery device wherein the drug delivery device is operable to be removed after the first period of time and be replaced with a subsequent drug delivery device that is operable to be positioned over the sensor, since such a modification would allow for the connection of a new, refurbished, or re-filled drug delivery device capable of being positioned at a different infusion site, thereby providing the predictable results pertaining to attaching a subsequent drug delivery device capable of continuing operation of the drug delivery system as a whole. Mounce teaches that “after disengagement and separation from a disposable housing portion, the durable housing portion may be engaged and operatively connected to another disposable housing portion (such as a new, refurbished, refilled or re-manufactured disposable housing portion) for further operation,” [0082].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gyrn (US 20120184909 A1), in view of Flaherty (US 20020040208 A1), and further in view of O’Connor (US 20170173261 A1).
Regarding claim 11, Gyrn, as modified, discloses all the limitations of claim 8. However, Gyrn fails to expressly disclose the drug delivery system, further comprising: a sensor configuration module operable to be positioned over the sensor, wherein the sensor configuration module includes a user interface component for configuring operation of the sensor when the sensor configuration module is coupled to the adhesive pad and positioned over the sensor, and the sensor configuration module is operable to be removed from the adhesive pad after the configuring operation of the sensor.
However, O’Connor teaches the drug delivery system (system 100, [0013] & Fig. 1A) further comprising: a sensor configuration module (electronics module 302, [0042] & Fig. 3A/B; the Examiner notes that module 302 can include all the features described with reference to electronic device 106, [0043]) operable to be positioned over the sensor (sensor 108 and medical device 102 may be incorporated into the same unit, [0023]; module 302 positioned over sensor 108 in this configuration, see Fig. 3A/B), wherein the sensor configuration module includes a user interface component (“the module 302 can include a transceiver to enable the medical device 102 to wirelessly communicate with any other device or component depicted in FIG. 1A, 1B, or 2”, [0043]; the transceiver is being interpreted as the user interface component considering it allows for communication to local electronic device 116 which allows for monitoring and command delivery, [0028]-[0029],) for configuring operation of the sensor (module 302 configured for communication to sensor 108 allowing for operation of sensor 108, [0020]-[0025] and [0043] & Fig. 1 and 3A/B) when the sensor configuration module is coupled to the adhesive pad and positioned over the sensor (module 302 coupled to pad 304, which includes an adhesive, through device 102 and positioned over sensor 108, [0042] & Fig. 3A/B), and the sensor configuration module is operable to be removed from the adhesive pad after the configuring operation of the sensor (module 302 being removably attached to medical device 102, subsequently rendering module 302 removably attachable to pad 304, [0044] & Fig. 3A/B; module 302 is operable to be removed after configuring operation of sensor 108).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the drug delivery system of Gyrn, as modified, with O’Connor to include a sensor configuration module operable to be positioned over the sensor, wherein the sensor configuration module includes a user interface component for configuring operation of the sensor when the sensor configuration module is coupled to the adhesive pad and positioned over the sensor, and the sensor configuration module is operable to be removed from the adhesive pad after the configuring operation of the sensor since such a modification would provide structure to transmit commands or receive information to/from the drug delivery device and sensor wirelessly and yield predictable results pertaining to system operation (see [0020]-[0021] and [0043] of O’Connor).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Gyrn (US 20120184909 A1), in view of Mounce (US 20080051709 A1), in view of Flaherty (US 20020040208 A1), and further in view of Amirouche (US 20130274576 A1).
Regarding claim 21, Gyrn, as modified, discloses all the limitations of claim 18. However, Gyrn fails to expressly disclose the method further comprising: coupling a sensor configuration module to the adhesive pad and over the sensor. However, Amirouche teaches the method further comprising: coupling a sensor configuration module (screen 300, [0056] & Fig. 1C) to the adhesive pad (adhesive patch platform 240 and lower housing 210, [0052] & Fig. 1C) and over the sensor (sensor 400, [0052] & Fig. 1C). Attaching housing 200, which contains screen 300, to the lower housing 210, which has an adhesive patch platform 240 and sensor 400, results in the screen 300 being coupled to the platform 240 and over the sensor 400.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method as disclosed by Gyrn, and as modified by Mounce, with Amirouche to include coupling a sensor configuration module to the pad and over the sensor, since such a modification would allow the sensor configuration module to communicate with the sensor, thereby providing the predictable results pertaining to allowing communication between the sensor and the sensor configuration module. Amirouche teaches that “screen 300 may be configured as a "touch-screen," permitting a user to control one or more functions of system 100 by touching various portions of the screen. In this manner, the user may operate or program system 100 by accessing one or more menus through direct interaction with screen 300,” [0056].
Regarding claim 22, Gyrn, as modified, discloses all the limitations of claim 21. However, Gyrn fails to expressly disclose the method further comprising: engaging a user interface component positioned on the sensor configuration module to configure operation of the sensor. However, Amirouche further teaches the method further comprising: engaging a user interface component (via screen 300 being a “touch screen” which “may operate or program system 100,” [0056] & Fig. 1C) positioned on the sensor configuration module to configure operation of the sensor (system 100 includes the sensor 400 and subsequent control electronics, [0066]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method as disclosed by Gyrn, and as modified by Mounce, with Amirouche to include the method further comprising: engaging a user interface component positioned on the sensor configuration module to configure operation of the sensor, since such a modification would provide a structure for the user to interact directly with the sensor, thereby providing the predictable results pertaining to allowing the user to configure the operation of the sensor. Amirouche teaches that “screen 300 may be configured as a "touch-screen," permitting a user to control one or more functions of system 100 by touching various portions of the screen. In this manner, the user may operate or program system 100 by accessing one or more menus through direct interaction with screen 300,” [0056].
Response to Arguments
Applicant's arguments filed 3/30/2026 have been fully considered but they are not persuasive. In response to Applicant’s arguments to Hoss, the Examiner finds that Hoss teaches a configuration of a dual-base-component, dual-adhesive structure wherein both components independently couple directly to the user’s body (“one or more of the patch pump housing and the analyte sensor may be provided with an adhesive layer on the bottom surface to secure positioning on the patient's skin surface during usage.”, [0111]; see [0105] and [0115] & Fig. 14A-15C).
Applicant’s arguments with respect to the claim(s) 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.
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Prosecution Insights