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 Arguments
Applicant's arguments filed 12/18/2025 have been fully considered.
Applicant argues that the combination of McConnell in view of Edman in view of Chowdhury does not disclose or suggest a microneedle device including a substrate having flexible ribs and a two-dimensional array or rigid islands between the flexible ribs, wherein the rigid islands comprise microneedles. Chowdhury was previously relied upon to teach the claimed flexible ribs and islands. Applicant argues that Chowdhury teaches a one-dimensional array or linear rigid segments, designed for flexibility in only one dimension. Applicant further argues that the instant invention is designed to have flexibility to conform to a two-dimensional surface. The examiner does not find this argument convincing. The claim does not call for flexibility in two directions, but rather a two-dimensional array of rigid islands between the flexible ribs. Chowdhury teaches an array of islands between flexible ribs as explained in the prior office action. The array of islands is a two-dimensional array because they have a length and a width making them two-dimensional.
The remainder of the arguments appear to hinge on the arguments to the independent claims discussed above, and therefore they are not convincing for similar reasons.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4-10, 12, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over McConnell et al (WO 00/35530 A1) in view of Edman et al (WO 2005/058385 A2) in view of Chowdhury et al (GB 2478363 A).
Regarding claim 1, McConnell discloses a microneedle device (fig. 3) comprising an array of microneedles 32 on a substrate 34 (fig. 3; page 13, lines 37-29). McConnell further discloses a flexible tubing 20 connecting the array of microneedles to an applicator (figs. 2, 3; page 13, lines 22-24: pump), the applicator administers the therapeutic agent from the fluid source to the treatment site via the microneedles. The limitation “when placed at a wound site”, “administers the therapeutic agent from the reservoir to the wound site” are interpreted to be intended use limitations. The device of McConnell is capable of delivering the therapeutic to whatever site the microneedle patch is place, including a wound.
McConnell fails to disclose the components of the pump. Edman teaches a delivery device including an infusion structure 134 connected to a pump via a flexible tubing 132 (fig. 1), the pump including a reservoir 114 and an applicator 112 that administer the therapeutic agent from the reservoir to the infusion structure, the reservoir and the applicator are housed in a housing 118 (fig. 1; page 5, lines 5-8). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of McConnell to include the type of pump taught by Edman including a pump and a reservoir contained in a housing to provide a portable and durable pump to deliver the desired dose to the patient in a reliable and comfortable manner. The limitation “reusable module” is interpreted to be an intended use limitation. The pump and reservoir of McConnell in view of Edman discussed above is capable of being reused and therefore forms a reusable module.
Claim 1 further calls for the substrate to have flexible ribs and a two-dimensional array of rigid islands between the flexible ribs, and wherein the rigid islands comprise the microneedles. McConnell discloses that the microneedle array includes a flexible substrate so that the array can conform to the contours of the body (page 10, lines 3-9), but fails to disclose the claimed configuration. Chowdhury teaches a flexible microneedle array formed by providing microneedles are rigid rows of substrate (forming the claimed islands), the rows being connected by flexible connections (forming the claimed ribs) thereby forming a microneedle array that can conform to a rounded surface (abstract) such at the arm or wrist as discussed by McConnell while providing the rigidity to allow the microneedle to reliably puncture the skin. The rigid islands are arranged in a two-dimensional array because the structure has a length and a width thereby forming a two-dimensional array. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microneedle array of McConnell to include flexible ribs and rigid islands carrying the microneedles as taught by Chowdhury to allow the array to conform to a rounded contour while providing rigidity of the needle to puncture the skin.
Regarding claim 4, McConnell discloses that the microneedles have a cone shape (figs. 3, 4).
Regarding claim 5, McConnell discloses that the microneedles in the array are hollow, and the distal end of each hollow microneedle comprises a hole 36 (fig. 4).
Regarding claim 6, McConnell discloses that the microneedles are solid (fig. 2; page 13, lines 15-16).
Regarding claim 7, McConnell discloses that the substrate is flexible so that it conforms to the object’s surface (page 10, lines 4, 8-9).
Regarding claim 8, Edman teaches that the applicator is a micropump in fluid communication with the reservoir (page 13, lines 15-16: MEMS pump). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a micropump as taught by Edman in the combination described above with regard to claim 1 to provide a small and compact pump to increase patient comfort during use.
Regarding claim 9, Edman teaches that the device comprises a control module configured to communication with the applicator and an external source (page 15, lines 13-19: microprocessor and transceiver). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a control module in communication with the applicator and an external source as taught by Edman in the combination described above with regard to claim 1 so that the fluid can be delivered in a controlled manner to ensure that the user receives the proper dose in the proper time.
Regarding claim 10, Edman further teaches that the control module wirelessly communicates with the external source (col. 15, lines 17-24). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of McConnel in view of Edman to further include wireless communications as taught by Edman to increase ease of use of the device as the pump can receive delivery instructions wirelessly thereby eliminating the need for a docking station or connection cord.
Regarding claim 12, McConnell discloses that the microneedles are formed form PEEK (page 11, lines 14-15) which is a thermoplastic resin.
Claim 14 calls for the microneedles to be produced by three-dimensional printing. This is interpreted to be a product-by-process limitation. The scope of such limitations is not limited to the recited steps, but rather to the structure implied by the steps. In this case, the structure implied by the recited steps is identical to the structure described by McConnell, namely the microneedles recited in claim 1, and therefore claim 14 is anticipated by McConnell.
Claim(s) 2, 3, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over McConnell in view of Edman in view of Chowdhury as applied to claim 1 above, and further in view of Black et al (US 2011/0306853).
Claim 2 differs from McConnell in calling for each of the microneedles to have a length of about 0.8 mm to about 3 mm and a base size of about 0.5 mm to about 1.5 mm. McConnell does not teach this specific size, but discloses that the size of the microneedles can be selected dependent on the type of tissue to be penetrated, the condition of the patient, the type of medication, and other factors (page 9, lines 8-13). Black teaches a microneedle array for delivering a medicament wherein the microneedles have a length of 0.5mm to 2mm (page 3, para. 0060: 500-2000 µm), and further teaches that the microneedles have a diameter at the base of 1mm to 20 µm (page 4, para. 0078; page 16, claim 27 specifies the base diameter). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microneedles of McConnell to be of the size taught by Black to achieve the appropriate depth of injection and rate of delivery.
Regarding claim 3, McConnell discloses that the microneedles are hollow and having an opening (fig. 4), but fails to disclose the opening diameter. Black further microneedles having an opening diameter of 1 µm to 1 mm (page 4, para. 0078). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the openings of the microneedles of McConnell to have an opening diameter as claimed because Black teaches that it is known in the art to provide opening diameter within the claimed range to achieve the desired flow characteristics through the microneedles.
Claim 15 calls for the device to comprise a potentiometric pH sensor. McConnell discloses that the device includes sensors, but fails to disclose a potentiometric pH sensor. Black teaches a microneedle device including a potentiometric pH sensor (page 9, para. 0161: pH glass electrode is a potentiometric pH sensor) which provides a fast and reliable blood gas measurement. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor of McConnell to include a potentiometric pH sensor as taught by Black to monitor the blood gas of the user to ensure that they are within the desired parameters so that the therapeutic has the desired effects.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over McConnell in view of Edman in view of Chowdhury as applied to claim 9 above, and further in view of Newberry (US 2017/0181678).
Claim 11 calls for the external source to be a low-energy Bluetooth module. Edman teaches a wireless communication as discussed above with regard to claim 9, but fails to disclose the specific type. Newberry teaches a drug delivery device comprising a microneedle array (page 5, para. 0075)and further that a Bluetooth Low Energy module that communicates with the user device (page 3, para. 0054). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wireless remote unit of McConnell in view of Edman to use a Bluetooth Low Energy protocol as taught by Newberry to provide a reliable means for communication between the devices that does not require excessive battery power thereby reducing the battery life of the device.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over McConnell in view of Edman in view of Chowdhury as applied to claim 1 above, and further in view of Maenozono et al (JP 2005021677 A). See machine translation provided herewith for ease of discussion.
Regarding claim 13, McConnell discloses that the microneedles are formed from a biodegradable material (page 8, lines 27-29), but fails to specifically disclose a biodegradable resin. Maenozono teaches a microneedle array for drug delivery wherein the microneedles are formed from biodegradable resin so that if the needles accidentally break off within the skin of the patient, the needles will dissolve without causing any damage to the patient (abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microneedles of McConnell to comprise a biodegradable resin as taught by Maenozono to ensure that if the needles accidentally break and remain in the user’s skin, they will biodegrade without any negative effects.
Claim(s) 16, 17, 19-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over McConnell in view of Edman in view of Chowdhury in view of McAnulty et al (US 8,709,393).
Regarding claim 16, McConnell discloses method of delivering a therapeutic to a target site comprising applying an array of microneedles 32 on a flexible substrate 34 (fig. 3; page 10, lines 8-9; page 13, lines 37-29), pressure is applied to the microneedles to puncture the target area so that the therapeutic agent can be delivered (page 20, lines 6-8). McConnell further discloses a flexible tubing 20 connecting the array of microneedles to an applicator (figs. 2, 3; page 13, lines 22-24: pump), the applicator administers the therapeutic agent from the fluid source to the treatment site via the microneedles.
McConnell fails to disclose the components of the pump. Edman teaches a delivery device including an infusion structure 134 connected to a pump via a flexible tubing 132 (fig. 1), the pump including a reservoir 114 and an applicator 112 that administer the therapeutic agent from the reservoir to the infusion structure, the reservoir and the applicator are housed in a housing 118 (fig. 1; page 5, lines 5-8). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of McConnell to include the type of pump taught by Edman including a pump and a reservoir contained in a housing to provide a portable and durable pump to deliver the desired dose to the patient in a reliable and comfortable manner. The limitation “reusable module” is interpreted to be an intended use limitation. The pump and reservoir of McConnell in view of Edman discussed above is capable of being reused and therefore forms a reusable module.
Claim 16 further calls for the substrate to have flexible ribs and a two-dimensional array of rigid islands between the flexible ribs. McConnell discloses that the microneedle array includes a flexible substrate so that the array can conform to the contours of the body (page 10, lines 3-9), but fails to disclose the claimed configuration. Chowdhury teaches a flexible microneedle array formed by providing microneedles are rigid rows of substrate (forming the claimed islands), the rows being connected by flexible connections (forming the claimed ribs) thereby forming a microneedle array that can conform to a rounded surface (abstract) such at the arm or wrist as discussed by McConnell while providing the rigidity to allow the microneedle to reliably puncture the skin. The rigid islands are arranged in a two-dimensional array because the structure has a length and a width thereby forming a two-dimensional array. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microneedle array of McConnell to include flexible ribs and rigid islands carrying the microneedles as taught by Chowdhury to allow the array to conform to a rounded contour while providing rigidity of the needle to puncture the skin.
Claim 16 differs from the McConnell in calling for a method of treating a wound, the above device being used for wound care and being applied to a wound for delivery of the therapeutic to a wound. McAnulty teaches a method of delivering a therapeutic to a wound to assist in wound healing (col. 8, lines 24-25) wherein the wound active agents are applied to the wound using a microneedle array (col. 25, line 59 – col. 26, line 1). McAnulty is silent as to the structure or method of using a microneedle array. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of McConnell to be used in a wound care method wherein the method is performed for delivery of the therapeutic to a wound because McAnulty teaches that therapeutic agents can be delivered to a wound to assist in wound healing using microneedles and McConnell discloses that the delivery using microneedles reduces pain thereby being appropriate for use in a wound which might already be painful.
Regarding claim 17, Edman further teaches that the device is programmable comprising a control module coupled to an in communication with the microneedle array and the applicator, and configured for controlling transdermal delivery of the therapeutic agent (col. 15, lines 10-20). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of McConnell in view of Edman as discussed above with regard to claim 16 to include the control module for controlling the transdermal delivery as taught by Edman to provide the desired dosage of medicament over the proper time period to achieve the desire effect of the therapy.
Regarding clam 19, McConnell discloses that the microneedle array includes solid microneedles (fig. 2; page 13, lines 15-16).
Regarding claim 20, McAnulty teaches that the wound is a chronic wound (col. 3, lines 16-17). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method described above with regard to claim 16 to treat a chronic wound as taught by McAnulty because such wounds require therapeutic treatment to assist healing that could not be achieved by other means.
Regarding claim 21, McAnulty teaches that chronic wounds can be cause by wound infection (col. 1, lines 30-32; col. 4, line 57: treatment with anti-infective agents implies bacterial infection). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the method described above with regard to claim 20 in a patient that has a chronic wound due to a bacterial infection as McAnulty recognizes that chronic wounds maybe caused by infection.
Regarding claim 22, McAnulty teaches that the therapeutic agent is an anti- inflammatory agent (col. 4, line 59), an anti-infection agent (col. 4, line 57), or a growth factor (col. 5, line 38). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use one of the listed therapeutic agents in the method described above with regard to claim 16 as taught by McAnulty to treat a wound and assist in wound healing.
Regarding claim 23, McAnulty teaches that the growth agent is vascular endothelial growth factor (col. 21, lines 3-6). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention include delivery of VEGF in the method described above as taught by McAnulty to assist in wound healing.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over McConnell in view of Edman in view of Chowdhury in view of McAnulty as applied to claim 16 above, and further in view of Black.
Regarding claim 18, McConnell discloses that the microneedles are hollow (fig. 4). Claim 18 differs from McConnell in calling for each of the microneedles to have a length of about 0.8 mm to about 3 mm and a base size of about 0.5 mm to about 1.5 mm. McConnell does not teach this specific size, but discloses that the size of the microneedles can be selected dependent on the type of tissue to be penetrated, the condition of the patient, the type of medication, and other factors (page 9, lines 8-13). Black teaches a microneedle array for delivering a medicament wherein the microneedles have a length of 0.5mm to 2mm (page 3, para. 0060: 500-2000 µm), and further teaches that the microneedles have a diameter at the base of 1mm to 20 µm (page 4, para. 0078; page 16, claim 27 specifies the base diameter). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microneedles of McConnell to be of the size taught by Black to achieve the appropriate depth of injection and rate of delivery.
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over McConnell in view of Edman in view of Chowdhury in view of McAnulty as applied to claim 16 above, and further in view of Kim et al (KR 20180002233 A). For ease of discussion please refer to machine translation of Kim provided herewith.
Claim 40 calls for the wound care product to comprise at least one of a flexible pH sensor and a temperature sensor, and the method comprises measuring at least one of the pH or the temperature using the above sensor. McConnell discloses that the device includes sensors, but fails to disclose a flexible pH sensor or temperature sensor. Kim teaches a microneedle device including a flexible pH sensor 130 and/or a flexible temperature sensor 140 (page 4: sensors are formed from wires located on a flexible substrate such as silicone and therefore are flexible), the sensors are used to measure the temperature and the pH of the treatment site. These measurements allow the device to more accurately monitor the patient’s status and correct measured glucose concentration values based on the measure parameters (page 18). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of McConnell to include a flexible pH sensor and a flexible temperature sensor as taught by Kim so that the system can monitor the pH and temperature at the treatment site to provide more accurate information for patient parameters and therefore more accurate treatment.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783