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 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.
Claim(s) 21-22, 34, and 36-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1).
In regards to claim 21 Crespo Paravano teaches a microneedle array patch the microneedle array patch including a base structure and a plurality of microneedles disposed on a flat surface of the base structure [0022] “In one embodiment, every electrode required for the electrochemical readout is implemented in individual microneedles and/or needles that are in turn implemented in a polymeric substrate”, [0063] Fig 1 shows that substrate is flat,
the base structure configured to provide support to the plurality of needles during insertion of the plurality of microneedles into skin ([0059] “This layer also facilitates skin penetration”, microneedles are attached to substrate which supports them).
Crespo Paravano fails to teach generating an identifier record for an identifier affixed to a microneedle array patch, the identifier being affixed to the microneedle array patch during manufacturing of the microneedle array patch; generating an object record for the microneedle array patch; associating, by an information system, the identifier record with the object record so that the microneedle array patch including the identifier affixed thereon is associated with the identifier; in response to receiving prescription information for a patient from a first device associated with a prescribing entity, associating a patient record of the patient with the identifier record so that the microneedle array patch including the identifier affixed thereon is associated with the patient; receiving a request to validate the identifier and the microneedle array patch determining whether the microneedle array patch is valid based on object information of the microneedle array patch, the object information including at least one of a type of the microneedle array patch, a manufacturing lot of the microneedle array patch, instructions of use of the microneedle array patch, an expiration date of the microneedle array patch, or recall data of the microneedle array patch; sending, when the identifier is valid and when the microneedle array patch is valid, a response to the second device that indicates that the administration of the microneedle array patch can proceed; and sending, when the identifier is not valid or when the microneedle array patch is not valid, an error to the second device that causes the second device to notify the patient.
Addy teaches a method, comprising:
generating an identifier record for an identifier affixed to medication,
the identifier being affixed to the medication during manufacturing of the medication (Fig. 4 Steps 404 and 410),
generating an object record for the medication ([0027] barcode is associated with medication which is the object record);
associating, by an information system, the identifier record with the object record so that the medication including the identifier affixed thereon is associated with the identifier (Fig. 4 Step 404, [0027] barcode is associated with medication which is the object record);
in response to receiving prescription information for a patient from a first device associated with a prescribing entity, associating a patient record of the patient with the identifier record so that the medication including the identifier affixed thereon is associated with the patient (Fig. 4 Step 406, [0027] first device is processor that creates barcode);
receiving a request to validate the identifier and the medication from a second device associated with the patient prior to administration of the medication ([0028] “Accordingly, the system is initially powered on at step 502, optionally by the user depressing the power button, and a verification program 125 is retrieved by the processor 116 from the data storage means 122”);
determining whether the identifier is valid based on the identifier record, and the patient record, and the associations therebetween ([0031] “Next, at step 516, the verification program compares the current medication bar code value to the previously stored medication bar code value associated with the patient to determine if there is a match 518”);
sending, when the identifier is valid, a response to the second device that indicates that the administration of the medication can proceed ([0032] “If the current medication bar code value matches a medication bar code value previously stored as associated with the patient (see step 406 described above), the verification program 125 causes a positive verification message to be communicated to the health care professional in the form of a text or graphic display output and/or an audible tone or message or any other message indicating a positive verification 520”, display is second device);
and sending, when the identifier is not valid, an error to the second device that causes the second device to notify the patient ([0036] If no matching medication bar code exists either because the medication having the current medication bar code was not for administration to the patient and/or because no patient having a matching enrollment iris code was enrolled in the medical facility, the verification program 125 causes a negative verification message to be communicated to the health care professional in the form of a text or graphic display output and/or an audible tone or message or any other message indicating a negative verification 522).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Crespo Paravano to include the barcode to patient mapping method of Addy and display system of Addy. Doing so would merely be combining prior art elements according to known methods to yield predictable result of validating a user is given the sensor that they are prescribed.
Modified Crespo Paravano fails to teach determining whether a microneedle array patch is valid based on object information of the microneedle array patch, the object information including at least one of a type of the microneedle array patch, a manufacturing lot of the microneedle array patch, instructions of use of the microneedle array patch, an expiration date of the microneedle array patch, or recall data of microneedle array patch.
Seelinger teaches determining whether a medication is valid based on object information of the medication, the object information including at least one of a type of the medication, a manufacturing lot of the medication, instructions of use of the medication, an expiration date of the medication, or recall data of medication ([0089] “Based on the affected lot number(s), the bedside scanning systems alert the clinician when the recalled product is scanned at the point of care. Additionally, inclusion of the expiration date in the scan code ensures that the patient does not receive a medication that is beyond its expiration date”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Crespo Paravano to include a step of validating that the medicine is not recalled or expired and alert the user if it is like the method of Seelinger. Doing so would merely be combining prior art elements according to known methods to yield predictable result of preventing a user from administering expired or recalled microarray patches.
In regards to claim 22 modified Crespo Paravano teaches the method of claim 21, wherein the plurality of microneedles includes first and second sets of microneedles, the first set of microneedles having a first length and the second set of microneedles having a second length greater than the first length (Crespo Paravano [0129] “In one specific example, the modified microneedles and needles are of different lengths to reach the interstitial fluid and the bloodstream simultaneously by means of the same patch”).
In regards to claim 34 modified Crespo Paravano teaches the method of claim 21, wherein the identifier is at least one of a quick-response (QR) code, a bar code, a radiofrequency identification (RFID) chip, or a serial number (Addy [0017] “The bar code can be a 1D, 2D, 1D stacked or 2D stacked bar code of any type of symbology such as PDF417, Aztec, QR Code, Vericode and the like”).
In regards to claim 36 modified Crespo Paravano teaches the method of claim 21, wherein validating the identifier and the information of the patient includes: retrieving, by the information system, the identifier record associated with the identifier and the patient record associated with the user and determining that the identifier record and the patient record are associated with one another (Addy [0031] “Subsequent to current iris code and current medication bar code conversion at steps 506 and 512, respectively, in one embodiment, the verification program 125 proceeds to query the database to retrieve the patient record associated with the current iris code 515. Next, at step 516, the verification program compares the current medication bar code value to the previously stored medication bar code value associated with the patient to determine if there is a match 518”).
In regards to claim 37 modified Crespo Paravano teaches the method of claim 21, further comprising:
measuring, via a sensor disposed on a microneedle of the plurality of microneedles, one or more physiological parameters when the microneedle array patch is inserted into the skin of the user (Crespo Paravano [0024] The wearable sensing (micro)needle patch is compatible with an electronics module that allows for the analyte sensing through fluctuations in the analytical signal (e.g., voltage, current, resistance, capacitance, impedance, etc.). The wearable sensing (micro)needle patch preferably detects parameters that are depending on the analyte concentration/activity/level in a biological fluid but also in any kind of sample);
and transmitting, via a transmitter disposed on the microneedle array patch, the measurements of the one or more physiological parameters to the information system (Crespo Paravano [0090] “It is here preferred the implementation of miniaturized PCB circuit boards for the wireless transmission of the measurements to a device for data harvesting, treatment and interpretation during on-body portability.”).
In regards to claim 38 modified Crespo Paravano teaches the method of claim 37, wherein the one or more physiological parameters include skin impedance, pH, a level of interstitial fluid, or a concentration of biomarkers (Crespo Paravano [0024] “the wearable sensing (micro)needle patch is configured for the transdermal detection of ions (e.g., potassium, sodium, pH, magnesium, calcium, ammonium, chloride, etc.) through potentiometric readout by the fabrication of a working electrode and reference electrode”).
Claim(s) 21-22, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robertson (US 20100312188 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1).
In regards to claim 21 Robertson teaches a microneedle array patch the microneedle array patch including a base structure and a plurality of microneedles disposed on a flat surface of the base structure ([0253] substrate is base structure that microneedles sit on),
the base structure configured to provide support to the plurality of needles during insertion of the plurality of microneedles into skin ([0248] microneedles are attached to substrate which inherently supports them as they insert into the skin).Robertson fails to teach generating an identifier record for an identifier affixed to a microneedle array patch, the identifier being affixed to the microneedle array patch during manufacturing of the microneedle array patch; generating an object record for the microneedle array patch; associating, by an information system, the identifier record with the object record so that the microneedle array patch including the identifier affixed thereon is associated with the identifier; in response to receiving prescription information for a patient from a first device associated with a prescribing entity, associating a patient record of the patient with the identifier record so that the microneedle array patch including the identifier affixed thereon is associated with the patient; receiving a request to validate the identifier and the microneedle array patch determining whether the microneedle array patch is valid based on object information of the microneedle array patch, the object information including at least one of a type of the microneedle array patch, a manufacturing lot of the microneedle array patch, instructions of use of the microneedle array patch, an expiration date of the microneedle array patch, or recall data of the microneedle array patch; sending, when the identifier is valid and when the microneedle array patch is valid, a response to the second device that indicates that the administration of the microneedle array patch can proceed; and sending, when the identifier is not valid or when the microneedle array patch is not valid, an error to the second device that causes the second device to notify the patient.
Addy teaches a method, comprising:
generating an identifier record for an identifier affixed to medication,
the identifier being affixed to the medication during manufacturing of the medication (Fig. 4 Steps 404 and 410),
generating an object record for the medication ([0027] barcode is associated with medication which is the object record);
associating, by an information system, the identifier record with the object record so that the medication including the identifier affixed thereon is associated with the identifier (Fig. 4 Step 404, [0027] barcode is associated with medication which is the object record);
in response to receiving prescription information for a patient from a first device associated with a prescribing entity, associating a patient record of the patient with the identifier record so that the medication including the identifier affixed thereon is associated with the patient (Fig. 4 Step 406, [0027] first device is processor that creates barcode);
receiving a request to validate the identifier and the medication from a second device associated with the patient prior to administration of the medication ([0028] “Accordingly, the system is initially powered on at step 502, optionally by the user depressing the power button, and a verification program 125 is retrieved by the processor 116 from the data storage means 122”);
determining whether the identifier is valid based on the identifier record, and the patient record, and the associations therebetween ([0031] “Next, at step 516, the verification program compares the current medication bar code value to the previously stored medication bar code value associated with the patient to determine if there is a match 518”);
sending, when the identifier is valid, a response to the second device that indicates that the administration of the medication can proceed ([0032] “If the current medication bar code value matches a medication bar code value previously stored as associated with the patient (see step 406 described above), the verification program 125 causes a positive verification message to be communicated to the health care professional in the form of a text or graphic display output and/or an audible tone or message or any other message indicating a positive verification 520”, display is second device);
and sending, when the identifier is not valid, an error to the second device that causes the second device to notify the patient ([0036] If no matching medication bar code exists either because the medication having the current medication bar code was not for administration to the patient and/or because no patient having a matching enrollment iris code was enrolled in the medical facility, the verification program 125 causes a negative verification message to be communicated to the health care professional in the form of a text or graphic display output and/or an audible tone or message or any other message indicating a negative verification 522).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Robertson to include the barcode to patient mapping method of Addy. Doing so would merely be combining prior art elements according to known methods to yield predictable result of validating a user is given the sensor that they are prescribed.
Modified Robertson fails to teach determining whether a microneedle array patch is valid based on object information of the microneedle array patch, the object information including at least one of a type of the microneedle array patch, a manufacturing lot of the microneedle array patch, instructions of use of the microneedle array patch, an expiration date of the microneedle array patch, or recall data of microneedle array patch.
Seelinger teaches determining whether a medication is valid based on object information of the medication, the object information including at least one of a type of the medication, a manufacturing lot of the medication, instructions of use of the medication, an expiration date of the medication, or recall data of medication ([0089] “Based on the affected lot number(s), the bedside scanning systems alert the clinician when the recalled product is scanned at the point of care. Additionally, inclusion of the expiration date in the scan code ensures that the patient does not receive a medication that is beyond its expiration date”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Robertson to include a step of validating that the medicine is not recalled or expired and alert the user if it is like the method of Seelinger. Doing so would merely be combining prior art elements according to known methods to yield predictable result of preventing a user from administering expired or recalled microarray patches.
In regards to claim 22 modified Robertson teaches the method of claim 21, wherein the plurality of microneedles includes first and second sets of microneedles, the first set of microneedles having a first length and the second set of microneedles having a second length greater than the first length (Robertson [0252] “The length of the microneedles may also vary, ranging in some instances between 10 μm and 1 mm, such as between 100 μm and 500 μm, and including between 150 μm and 350”).
In regards to claim 31 modified Robertson teaches the method of claim 22, wherein the first length is in a range of between about 500 and about 800 pm and the second length is in a range of between about 50 μm and 250 μm (Robertson [0252] “The length of the microneedles may also vary, ranging in some instances between 10 μm and 1 mm, such as between 100 μm and 500 μm, and including between 150 μm and 350”).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) as applied to claim 21, further in view of Pierart (US 20220287638 A1 - previously cited).
In regards to claim 23 modified Crespo Paravano teaches the method of claim 21. Modified Crespo Paravano fails to teach each microneedle of the plurality of microneedles including a square obelisk structure. Pierart teaches microneedles in the shape of a square obelisk structure ([0043][0047] “The microneedle 20 as a whole can preferably be of obelisk shape”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the microneedles of modified Crespo Paravano to be obelisk shaped like the microneedles of Pierart in order to “minimize the penetration diameter into the skin whilst maximizing the surface area of the active portion” (Pierart [0047]).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) as applied to claim 21, Mathur (US 20090280850 A1 - previously cited).
In regards to claim 24 modified Crespo Paravano teaches the method of claim 21, wherein receiving the request to validate the identifier and the information of the patient includes:
processing the request to managing validation of the identifier and the microneedle array patch, (Addy Fig.5 Steps 502-516);
wherein determining whether the identifier is valid and determining whether the microneedle array patch is valid is executed by retrieving information from a database of the information system (Addy Fig.5 step 516).
Modified Crespo Paravano fails to teach an application programming interface (API) with two layers. Mathur teaches an application programming interface (AP with multiple layers to handle data ([0011] “with the operating system including a plurality of layers including an application programming interface that handles media and more than one layer of the plurality of layers configured to handle media transmitted from the application programming interface to the wireless communication interface”). It would have been prima facie obvious to a person of ordinary skill in the art to make the software of modified Crespo Paravano to be a multiple layer API like Mathur in order to carry out the actions of receiving the patient information from the mobile app and searching the database.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) in view of Mathur (US 20090280850 A1 - previously cited) as applied to claim 24, in view of Hayter (US 20250235100 A1 - previously cited).
In regards to claim 25 modified Crespo Paravano teaches the method of claim 24, further comprising: receiving, at the first layer of the information system, the treatment data including the identifier, the prescription, (Addy [0027] barcode is identifier and associated with prescription filled by pharmacist)
and processing and routing the treatment data to one or more modules of a second layer such that the treatment data is stored in the database of the information system and/or sent to the third device (Addy [0027] identifier information stored in database).
Modified Crespo Paravano fails to teach the first layer receiving usage data of the microneedle array patch and one or more additional microneedle array patches. Hayter teaches treatment data including an identifier, a prescription, and usage data of a sensor and one or more additional sensors ([0118] prescription data and sensor data are associated with sensor, sensor data is usage data, [0199] Identifier is matched to patient information, database would inherently receive usage data for multiple sensors/orders to create the database). It would have been prima facie obvious to a person of ordinary skill in the art to make the software of modified Crespo Paravano to include sensor usage data in the database like the method of Hayter. Doing so would merely combining prior art elements according to known methods to yield the predictable result of tracking the use of the patch with the user in order to keep track of the patient’s condition/treatment within the system.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) as applied to claim 21, further in view of Burns (US 20250064349 A1 - previously cited).
In regards to claim 32 modified Crespo Paravano teaches the method of claim 21. Modified Crespo Paravano fails to teach a method wherein the microneedle array is arranged on the flat surface of the base structure in an area having a width of between about 2 mm and about 30 mm and a length of between about 10 mm and about 30 mm. Burns teaches a microarray patch with an area having a width of between about 2 mm and about 30 mm and a length of between about 10 mm and about 30 mm ([0043] In the exemplary embodiment, patch component 112 may have a patch component length 124 of approximately 25 millimeters (mm) and a patch component height 126 of approximately 13 mm). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the substrate base of modified Crespo Paravano to have a width of 13 mm and a length of 25 mm like the patch of Burns. Doing so would be a mere change in size/shape. MPEP 2144.04.IV
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) as applied to claim 21, in view of Hyde (US 20130046235 A1 - previously cited).
In regards to claim 33 modified Crespo Paravano teaches the method of claim 21. Modified Crespo Paravano teaches a method wherein the plurality of microneedles are arranged on the flat surface of the base structure in an array that is 10 microneedles to 50 microneedles by 10 microneedles to 50 microneedles. Hyde teaches a microneedle array that is 10 microneedles by 10 microneedles ([0074][0088] “Microneedle arrays (10.times.10) containing 100 microneedles in an area of 20.times.20 mm are constructed with conical microneedles approximately 100 .mu.m to 1000 .mu.m in length and 300 .mu.M in diameter”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the array of modified Crespo Paravano to have be 10 x 10 microneedles like the array of Hyde. Doing so would be a mere duplication of parts and rearrangement of parts. MPEP 2144.04.VI
Claim(s) 35, 42 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) as applied to claim 21, in view of Frankel (US 20240130660 A1).
In regards to claim 35 modified Crespo Paravano teaches the method of claim 21 further comprising: in response to receiving, at the second device, a response from the information system indicating that the administration of the microneedle array patch can proceed (Addy [0032] “If the current medication bar code value matches a medication bar code value previously stored as associated with the patient (see step 406 described above), the verification program 125 causes a positive verification message to be communicated to the health care professional in the form of a text or graphic display output and/or an audible tone or message or any other message indicating a positive verification 520. In one embodiment, subsequent to a positive verification message, the verification program automatically removes the medication bar code value's association with the patient in the database. Accordingly, the health care professional can administer the medication and feel confident that the correct patient has been identified as the patient appropriate for administration of the specific medication”). Modified Crespo Paravano fails to teach presenting instructions to the patient to administer the microneedle array patch. Frankel teaches an application that presenting instructions to the patient to administer a sensor after sensor identification (Fig 7B shows identifying sensor, Fig 7C shows instructions to apply sensor). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of modified Crespo Paravano to include a step of displaying instructions for use of the microneedle array patch to the user when the microneedle array patch has been verified like the method of Frankel. Doing so would combining prior art elements according to known methods to yield the predictable result of ensuring the user properly applies the sensor.
In regards to claim 42 modified Crespo Paravano teaches the method of claim 21, further comprising. Modified Crespo Paravano fails to teach retrieving, after determining the identifier is valid and the microneedle array patch is valid, the type of microneedle array patch and the instructions of use of the microneedle array patch based on the type of microneedle array patch; sending a response including the instructions of use of the microneedle array patch to the second device to cause the second device to present the instructions of use of the microneedle array patch to the patient.
Frankel teaches an application that presenting instructions to the patient to administer a sensor after sensor identification (Fig 7B shows identifying sensor, Fig 7C shows instructions to apply sensor). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of modified Crespo Paravano to include a step of displaying instructions for use of the microneedle array patch to the user when the microneedle array patch has been verified like the method of Frankel. Doing so would combining prior art elements according to known methods to yield the predictable result of ensuring the user properly applies the sensor.
In regards to claim 44 modified Crespo Paravano teaches the method of claim 42, comprising sending, to a third device associated with managing electronic records of patients, treatment data associated with the administration of the microneedle array patch such that the third device can update electronic records of the patient ([0130] “It is here of interest the implementation of miniaturized PCB circuit boards for the wireless transmission of the measurements to a device for data harvesting, treatment and interpretation”, patch measurements are sent to a device where they are stored).
Claim(s) 39-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) as applied to claim 37, further in view of Abadi (US 20230065458 A1 - previously cited).
In regards to claim 39 modified Crespo Paravano teaches the method of claim 37, including sensing glucose (Crespo Paravano [0122] patch detects glucose). Modified Crespo Paravano fails to teach: processing the measurements of the one or more physiological parameters to obtain the treatment data, the treatment data including information associated with at least one of: confirmation of administration, efficacy of treatment, performance of the microneedle array patch, or side effects. Abadi teaches a device comprising microneedles for drug delivery ([0030] “Some adhesive embodiments utilize an array of needles, for example microneedles, while others utilize only a single needle”, [0174] insulin is administered when glucose is above or below a threshold) and an administration sensor that detects that a dose of a drug has been administered ([0140] “indicating that the administration of the scheduled and available dose has been detected by the device's onboard administration sensor(s)”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the microneedle array of modified Crespo Paravano to both sense glucose and deliver drugs like the device of Abadi in order to deliver drugs when a user’s glucose is too low or high. It would also be obvious to include the administration sensor Abadi which inherently detects a parameter that is processed in order to confirm that administration of the drug was carried out.
In regards to claim 40 modified Crespo Paravano teaches the method of claim 37, including sensing glucose (Crespo Paravano [0122] patch detects glucose). Modified Crespo Paravano fails to teach sending, via the transmitter, the physiological information to the information system such that the information system can monitor one or more vitals of the patient and provide feedback for adjusting usage of a subsequent microneedle array patch. Abadi teaches a device comprising microneedles for drug delivery ([0030] “Some adhesive embodiments utilize an array of needles, for example microneedles, while others utilize only a single needle”, [0174] insulin is administered when glucose is above or below a threshold) and monitoring vitals one or more vitals of the patient and provide feedback for adjusting usage of a subsequent microneedle array patch ([0229] “Vitals 1337 may indicate anomalies or trends within the dataset. Such data may for example drive decisions by a pharmaceutical company in regards to suggested dosing, side effect warnings, risks to certain demographics, and indications for use”).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the microneedle array of modified Crespo Paravano to both sense glucose and deliver drugs like the device of Abadi in order to deliver drugs when a user’s glucose is too low or high. It would have also been obvious to include a vitals sensor on the patch to detect vitals that can be used to adjust dosage in the future like the method of Abadi.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) as applied to claim 21, in view of Abadi (US 20230065458 A1 - previously cited) in view of Gan (US 20210257073 A1- previously cited).
In regards to claim 41 modified Crespo Paravano teaches the method of claim 21, including sensing glucose (Crespo Paravano [0122] patch detects glucose). Modified Crespo Paravano fails to teach: recording that the microneedle array patch and one or more additional microneedle array patches have been administered by a user based on the treatment data received from the information system; and calculating a compliance score of the user based on the prescription for the user and the recorded administration of the microneedle array patch and the one or more additional microneedle array patches.
Abadi teaches a device comprising microneedles for drug delivery ([0030] “Some adhesive embodiments utilize an array of needles, for example microneedles, while others utilize only a single needle”, [0174] insulin is administered when glucose is above or below a threshold) and an administration sensor that detects that a dose of a drug has been administered ([0140] “indicating that the administration of the scheduled and available dose has been detected by the device's onboard administration sensor(s)”) and records the administered doses ([0162] dosage inherently must to be recorded to know the completely successful administrations up to present). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the microneedle array of modified Crespo Paravano to both sense glucose and deliver drugs like the device of Abadi in order to deliver drugs when a user’s glucose is too low or high. It would also be obvious to include the administration sensor Abadi which inherently detects a parameter that is processed in order to confirm and record that administration of the drug was carried out.
Modified Crespo Paravano fails to teach calculating a compliance score of the user based on the prescription for the user and the recorded administration of the microneedle array patch and the one or more additional microneedle array patches. Gan teaches calculating a compliance score of the user based on the prescription for the user and the recorded administration of a medicine ([0055] According to a concept of the invention, there is proposed a method and system of predicting or estimating an adherence score representing a subject's adherence to a medication dosage scheme. A subject-reported adherence score is upwardly revised based on application usage information of an application used by the subject to report their adherence). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the microneedle array of modified Crespo Paravano to calculate an adherence score like the method described in Gan in order to accurately assess adherence to a medication scheme, in a way that is both cheap and relatively simple to implement (Gan [0005]).
Claim(s) 43, 45, and 52-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) in view of Frankel (US 20240130660 A1).
In regards to claim 43 Crespo Paravano teaches a microneedle array patch the microneedle array patch including a base structure and a plurality of microneedles disposed on a flat surface of the base structure [0022] “In one embodiment, every electrode required for the electrochemical readout is implemented in individual microneedles and/or needles that are in turn implemented in a polymeric substrate”, [0063] Fig 1 shows that substrate is flat,
the base structure configured to provide support to the plurality of needles during insertion of the plurality of microneedles into skin ([0059] “This layer also facilitates skin penetration”, microneedles are attached to substrate which supports them).
Crespo Paravano fails to teach generating an identifier record for an identifier affixed to a microneedle array patch, the identifier being affixed to the microneedle array patch during manufacturing of the microneedle array patch; generating an object record for the microneedle array patch; associating, by an information system, the identifier record with the object record so that the microneedle array patch including the identifier affixed thereon is associated with the identifier; in response to receiving prescription information for a patient from a first device associated with a prescribing entity, associating a patient record of the patient with the identifier record so that the microneedle array patch including the identifier affixed thereon is associated with the patient; receiving a request to validate the identifier and the microneedle array patch from a second device associated with the patient prior to administration of the microneedle array patch; determining whether the identifier is valid based on the identifier record, and the patient record, and the associations therebetween; determining whether the microneedle array patch is valid based on object information of the microneedle array patch, the object information including at least one of a type of the microneedle array patch, a manufacturing lot of the microneedle array patch, instructions of use of the microneedle array patch, an expiration date of the microneedle array patch, or recall data of the microneedle array patch; retrieving, after determining the identifier is valid and the microneedle array patch is valid, the object information including the type of microneedle array patch and the instructions of use of the microneedle array patch based on the type of microneedle array patch; sending, after retrieving the object information, a response including the instructions of use of the microneedle array patch to the second device to cause the second device to present the instructions of use of the microneedle array patch to the patient.
Addy teaches a method, comprising:
generating an identifier record for an identifier affixed to medication,
the identifier being affixed to the medication during manufacturing of the medication (Fig. 4 Steps 404 and 410),
generating an object record for the medication ([0027] barcode is associated with medication which is the object record);
associating, by an information system, the identifier record with the object record so that the medication including the identifier affixed thereon is associated with the identifier (Fig. 4 Step 404, [0027] barcode is associated with medication which is the object record);
in response to receiving prescription information for a patient from a first device associated with a prescribing entity, associating a patient record of the patient with the identifier record so that the medication including the identifier affixed thereon is associated with the patient (Fig. 4 Step 406, [0027] first device is processor that creates barcode);
receiving a request to validate the identifier and the medication from a second device associated with the patient prior to administration of the medication ([0028] “Accordingly, the system is initially powered on at step 502, optionally by the user depressing the power button, and a verification program 125 is retrieved by the processor 116 from the data storage means 122”);
determining whether the identifier is valid based on the identifier record, and the patient record, and the associations therebetween ([0031] “Next, at step 516, the verification program compares the current medication bar code value to the previously stored medication bar code value associated with the patient to determine if there is a match 518”);
sending, when the identifier is valid, a response to the second device that indicates that the administration of the medication can proceed ([0032] “If the current medication bar code value matches a medication bar code value previously stored as associated with the patient (see step 406 described above), the verification program 125 causes a positive verification message to be communicated to the health care professional in the form of a text or graphic display output and/or an audible tone or message or any other message indicating a positive verification 520”, display is second device);
and sending, when the identifier is not valid, an error to the second device that causes the second device to notify the patient ([0036] If no matching medication bar code exists either because the medication having the current medication bar code was not for administration to the patient and/or because no patient having a matching enrollment iris code was enrolled in the medical facility, the verification program 125 causes a negative verification message to be communicated to the health care professional in the form of a text or graphic display output and/or an audible tone or message or any other message indicating a negative verification 522).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Crespo Paravano to include the barcode to patient mapping method of Addy and display system of Addy. Doing so would merely be combining prior art elements according to known methods to yield predictable result of validating a user is given the sensor that they are prescribed.
Modified Crespo Paravano fails to teach determining whether a microneedle array patch is valid based on object information of the microneedle array patch, the object information including at least one of a type of the microneedle array patch, a manufacturing lot of the microneedle array patch, instructions of use of the microneedle array patch, an expiration date of the microneedle array patch, or recall data of microneedle array patch; and retrieving, after determining the identifier is valid and the microneedle array patch is valid, the object information including the type of microneedle array patch and the instructions of use of the microneedle array patch based on the type of microneedle array patch; sending, after retrieving the object information, a response including the instructions of use of the microneedle array patch to the second device to cause the second device to present the instructions of use of the microneedle array patch to the patient.
Seelinger teaches determining whether a medication is valid based on object information of the medication, the object information including at least one of a type of the medication, a manufacturing lot of the medication, instructions of use of the medication, an expiration date of the medication, or recall data of medication ([0089] “Based on the affected lot number(s), the bedside scanning systems alert the clinician when the recalled product is scanned at the point of care. Additionally, inclusion of the expiration date in the scan code ensures that the patient does not receive a medication that is beyond its expiration date”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Crespo Paravano to include a step of validating that the medicine is not recalled or expired and alert the user if it is like the method of Seelinger. Doing so would merely be combining prior art elements according to known methods to yield predictable result of preventing a user from administering expired or recalled microarray patches.
Modified Crespo Paravano fails to teach sending, after retrieving the object information, a response including the instructions of use of the microneedle array patch to the second device to cause the second device to present the instructions of use of the microneedle array patch to the patient.
Frankel teaches an application that presenting instructions to the patient to administer a sensor after sensor identification (Fig 7B shows identifying sensor, Fig 7C shows instructions to apply sensor). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of modified Crespo Paravano to include a step of displaying instructions for use of the microneedle array patch to the user when the microneedle array patch has been verified like the method of Frankel. Doing so would combining prior art elements according to known methods to yield the predictable result of ensuring the user properly applies the sensor.
In regards to claim 45 modified Crespo Paravano teaches the method of claim 43, wherein the plurality of microneedles includes first and second sets of microneedles, the first set of microneedles having a first length and the second set of microneedles having a second length greater than the first length (Crespo Paravano [0129] “In one specific example, the modified microneedles and needles are of different lengths to reach the interstitial fluid and the bloodstream simultaneously by means of the same patch”).
In regards to claim 52 modified Crespo Paravano teaches the method of claim 43, wherein the identifier is at least one of a quick-response (QR) code, a bar code, a radiofrequency identification (RFID) chip, or a serial number (Addy [0017] “The bar code can be a 1D, 2D, 1D stacked or 2D stacked bar code of any type of symbology such as PDF417, Aztec, QR Code, Vericode and the like”).
In regards to claim 53 modified Crespo Paravano teaches the method of claim 43, wherein validating the identifier and the information of the patient includes: retrieving, by the information system, the identifier record associated with the identifier and the patient record associated with the user and determining that the identifier record and the patient record are associated with one another (Addy [0031] “Subsequent to current iris code and current medication bar code conversion at steps 506 and 512, respectively, in one embodiment, the verification program 125 proceeds to query the database to retrieve the patient record associated with the current iris code 515. Next, at step 516, the verification program compares the current medication bar code value to the previously stored medication bar code value associated with the patient to determine if there is a match 518”).
In regards to claim 54 modified Crespo Paravano teaches the method of claim 43, further comprising:
measuring, via a sensor disposed on a microneedle of the plurality of microneedles, one or more physiological parameters when the microneedle array patch is inserted into the skin of the user (Crespo Paravano [0024] The wearable sensing (micro)needle patch is compatible with an electronics module that allows for the analyte sensing through fluctuations in the analytical signal (e.g., voltage, current, resistance, capacitance, impedance, etc.). The wearable sensing (micro)needle patch preferably detects parameters that are depending on the analyte concentration/activity/level in a biological fluid but also in any kind of sample);
and transmitting, via a transmitter disposed on the microneedle array patch, the measurements of the one or more physiological parameters to the information system (Crespo Paravano [0090] “It is here preferred the implementation of miniaturized PCB circuit boards for the wireless transmission of the measurements to a device for data harvesting, treatment and interpretation during on-body portability.”).
In regards to claim 55 modified Crespo Paravano teaches the method of claim 43, further comprising: sending, when the identifier is not valid or when the microneedle array patch is not valid, an error to the second device that causes the second device to notify the patient (Addy [0036] If no matching medication bar code exists either because the medication having the current medication bar code was not for administration to the patient and/or because no patient having a matching enrollment iris code was enrolled in the medical facility, the verification program 125 causes a negative verification message to be communicated to the health care professional in the form of a text or graphic display output and/or an audible tone or message or any other message indicating a negative verification 522).
Claim(s) 43, 45, and 49, is/are rejected under 35 U.S.C. 103 as being unpatentable over Robertson (US 20100312188 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) in view of Frankel (US 20240130660 A1).
In regards to claim 43 Robertson teaches a microneedle array patch the microneedle array patch including a base structure and a plurality of microneedles disposed on a flat surface of the base structure ([0253] substrate is base structure that microneedles sit on),
the base structure configured to provide support to the plurality of needles during insertion of the plurality of microneedles into skin ([0248] microneedles are attached to substrate which inherently supports them as they insert into the skin).
Robertson fails to teach generating an identifier record for an identifier affixed to a microneedle array patch, the identifier being affixed to the microneedle array patch during manufacturing of the microneedle array patch; generating an object record for the microneedle array patch; associating, by an information system, the identifier record with the object record so that the microneedle array patch including the identifier affixed thereon is associated with the identifier; in response to receiving prescription information for a patient from a first device associated with a prescribing entity, associating a patient record of the patient with the identifier record so that the microneedle array patch including the identifier affixed thereon is associated with the patient; receiving a request to validate the identifier and the microneedle array patch from a second device associated with the patient prior to administration of the microneedle array patch; determining whether the identifier is valid based on the identifier record, and the patient record, and the associations therebetween; determining whether the microneedle array patch is valid based on object information of the microneedle array patch, the object information including at least one of a type of the microneedle array patch, a manufacturing lot of the microneedle array patch, instructions of use of the microneedle array patch, an expiration date of the microneedle array patch, or recall data of the microneedle array patch; retrieving, after determining the identifier is valid and the microneedle array patch is valid, the object information including the type of microneedle array patch and the instructions of use of the microneedle array patch based on the type of microneedle array patch; sending, after retrieving the object information, a response including the instructions of use of the microneedle array patch to the second device to cause the second device to present the instructions of use of the microneedle array patch to the patient.
Addy teaches a method, comprising:
generating an identifier record for an identifier affixed to medication,
the identifier being affixed to the medication during manufacturing of the medication (Fig. 4 Steps 404 and 410),
generating an object record for the medication ([0027] barcode is associated with medication which is the object record);
associating, by an information system, the identifier record with the object record so that the medication including the identifier affixed thereon is associated with the identifier (Fig. 4 Step 404, [0027] barcode is associated with medication which is the object record);
in response to receiving prescription information for a patient from a first device associated with a prescribing entity, associating a patient record of the patient with the identifier record so that the medication including the identifier affixed thereon is associated with the patient (Fig. 4 Step 406, [0027] first device is processor that creates barcode);
receiving a request to validate the identifier and the medication from a second device associated with the patient prior to administration of the medication ([0028] “Accordingly, the system is initially powered on at step 502, optionally by the user depressing the power button, and a verification program 125 is retrieved by the processor 116 from the data storage means 122”);
determining whether the identifier is valid based on the identifier record, and the patient record, and the associations therebetween ([0031] “Next, at step 516, the verification program compares the current medication bar code value to the previously stored medication bar code value associated with the patient to determine if there is a match 518”);
sending, when the identifier is valid, a response to the second device that indicates that the administration of the medication can proceed ([0032] “If the current medication bar code value matches a medication bar code value previously stored as associated with the patient (see step 406 described above), the verification program 125 causes a positive verification message to be communicated to the health care professional in the form of a text or graphic display output and/or an audible tone or message or any other message indicating a positive verification 520”, display is second device);
and sending, when the identifier is not valid, an error to the second device that causes the second device to notify the patient ([0036] If no matching medication bar code exists either because the medication having the current medication bar code was not for administration to the patient and/or because no patient having a matching enrollment iris code was enrolled in the medical facility, the verification program 125 causes a negative verification message to be communicated to the health care professional in the form of a text or graphic display output and/or an audible tone or message or any other message indicating a negative verification 522).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Robertson to include the barcode to patient mapping method of Addy and display system of Addy. Doing so would merely be combining prior art elements according to known methods to yield predictable result of validating a user is given the sensor that they are prescribed.
Modified Robertson fails to teach determining whether a microneedle array patch is valid based on object information of the microneedle array patch, the object information including at least one of a type of the microneedle array patch, a manufacturing lot of the microneedle array patch, instructions of use of the microneedle array patch, an expiration date of the microneedle array patch, or recall data of microneedle array patch; and retrieving, after determining the identifier is valid and the microneedle array patch is valid, the object information including the type of microneedle array patch and the instructions of use of the microneedle array patch based on the type of microneedle array patch; sending, after retrieving the object information, a response including the instructions of use of the microneedle array patch to the second device to cause the second device to present the instructions of use of the microneedle array patch to the patient.
Seelinger teaches determining whether a medication is valid based on object information of the medication, the object information including at least one of a type of the medication, a manufacturing lot of the medication, instructions of use of the medication, an expiration date of the medication, or recall data of medication ([0089] “Based on the affected lot number(s), the bedside scanning systems alert the clinician when the recalled product is scanned at the point of care. Additionally, inclusion of the expiration date in the scan code ensures that the patient does not receive a medication that is beyond its expiration date”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Robertson to include a step of validating that the medicine is not recalled or expired and alert the user if it is like the method of Seelinger. Doing so would merely be combining prior art elements according to known methods to yield predictable result of preventing a user from administering expired or recalled microarray patches.
Modified Robertson fails to teach sending, after retrieving the object information, a response including the instructions of use of the microneedle array patch to the second device to cause the second device to present the instructions of use of the microneedle array patch to the patient.
Frankel teaches an application that presenting instructions to the patient to administer a sensor after sensor identification (Fig 7B shows identifying sensor, Fig 7C shows instructions to apply sensor). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the method of modified Robertson to include a step of displaying instructions for use of the microneedle array patch to the user when the microneedle array patch has been verified like the method of Frankel. Doing so would combining prior art elements according to known methods to yield the predictable result of ensuring the user properly applies the sensor.
In regards to claim 45 modified Robertson teaches the method of claim 43, wherein the plurality of microneedles includes first and second sets of microneedles, the first set of microneedles having a first length and the second set of microneedles having a second length greater than the first length (Robertson [0252] “The length of the microneedles may also vary, ranging in some instances between 10 μm and 1 mm, such as between 100 μm and 500 μm, and including between 150 μm and 350”).
In regards to claim 49 modified Robertson teaches the method of claim 45, wherein the first length is in a range of between about 500 and about 800 pm and the second length is in a range of between about 50 μm and 250 μm (Robertson [0252] “The length of the microneedles may also vary, ranging in some instances between 10 μm and 1 mm, such as between 100 μm and 500 μm, and including between 150 μm and 350”).
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) in view of Frankel (US 20240130660 A1) as applied to claim 43, further in view of Pierart (US 20220287638 A1- previously cited).
In regards to claim 46 modified Crespo Paravano teaches the method of claim 43. Modified Crespo Paravano fails to teach each microneedle of the plurality of microneedles including a square obelisk structure. Pierart teaches microneedles in the shape of a square obelisk structure ([0043][0047] “The microneedle 20 as a whole can preferably be of obelisk shape”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the microneedles of modified Crespo Paravano to be obelisk shaped like the microneedles of Pierart in order to “minimize the penetration diameter into the skin whilst maximizing the surface area of the active portion” (Pierart [0047]).
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) in view of Frankel (US 20240130660 A1) as applied to claim 43, Mathur (US 20090280850 A1 - previously cited).
In regards to claim 47 modified Crespo Paravano teaches the method of claim 43, wherein receiving the request to validate the identifier and the information of the patient includes:
processing the request to managing validation of the identifier and the microneedle array patch (Addy Fig.5 Steps 502-516);
wherein determining whether the identifier is valid and determining whether the microneedle array patch is valid is executed by retrieving information from a database of the information system (Addy Fig.5 step 516).
Modified Crespo Paravano fails to teach an application programming interface (API) with two layers. Mathur teaches an application programming interface (AP with multiple layers to handle data ([0011] “with the operating system including a plurality of layers including an application programming interface that handles media and more than one layer of the plurality of layers configured to handle media transmitted from the application programming interface to the wireless communication interface”). It would have been prima facie obvious to a person of ordinary skill in the art to make the software of modified Crespo Paravano to be a multiple layer API like Mathur in order to carry out the actions of receiving the patient information from the mobile app and searching the database.
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) in view of Mathur (US 20090280850 A1) as applied to claim 47, in view of Hayter (US 20250235100 A1- previously cited).
In regards to claim 48 modified Crespo Paravano teaches the method of claim 47, further comprising: receiving, at the first layer of the information system, the treatment data including the identifier, the prescription, (Addy [0027] barcode is identifier and associated with prescription filled by pharmacist)
and processing and routing the treatment data to one or more modules of a second layer such that the treatment data is stored in the database of the information system and/or sent to the third device (Addy [0027] identifier information stored in database).
Modified Crespo Paravano fails to teach the first layer receiving usage data of the microneedle array patch and one or more additional microneedle array patches. Hayter teaches treatment data including an identifier, a prescription, and usage data of a sensor and one or more additional sensors ([0118] prescription data and sensor data are associated with sensor, sensor data is usage data, [0199] Identifier is matched to patient information, database would inherently receive usage data for multiple sensors/orders to create the database). It would have been prima facie obvious to a person of ordinary skill in the art to make the software of modified Crespo Paravano to include sensor usage data in the database like the method of Hayter. Doing so would merely combining prior art elements according to known methods to yield the predictable result of tracking the use of the patch with the user in order to keep track of the patient’s condition/treatment within the system.
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) in view of Frankel (US 20240130660 A1) as applied to claim 43, further in view of Burns (US 20250064349 A1).
In regards to claim 50 modified Crespo Paravano teaches the method of claim 43. Modified Crespo Paravano fails to teach a method wherein the microneedle array is arranged on the flat surface of the base structure in an area having a width of between about 2 mm and about 30 mm and a length of between about 10 mm and about 30 mm. Burns teaches a microarray patch with an area having a width of between about 2 mm and about 30 mm and a length of between about 10 mm and about 30 mm ([0043] In the exemplary embodiment, patch component 112 may have a patch component length 124 of approximately 25 millimeters (mm) and a patch component height 126 of approximately 13 mm). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the substrate base of modified Crespo Paravano to have a width of 13 mm and a length of 25 mm like the patch of Burns. Doing so would be a mere change in size/shape. MPEP 2144.04.IV
Claim(s) 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1) in view of Frankel (US 20240130660 A1) as applied to claim 43, in view of Hyde (US 20130046235 A1- previously cited).
In regards to claim 51 modified Crespo Paravano teaches the method of claim 43. Modified Crespo Paravano teaches a method wherein the plurality of microneedles are arranged on the flat surface of the base structure in an array that is 10 microneedles to 50 microneedles by 10 microneedles to 50 microneedles. Hyde teaches a microneedle array that is 10 microneedles by 10 microneedles ([0074][0088] “Microneedle arrays (10.times.10) containing 100 microneedles in an area of 20.times.20 mm are constructed with conical microneedles approximately 100 .mu.m to 1000 .mu.m in length and 300 .mu.M in diameter”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the array of modified Crespo Paravano to have be 10 x 10 microneedles like the array of Hyde. Doing so would be a mere duplication of parts and rearrangement of parts. MPEP 2144.04.VI
Response to Arguments
Applicant’s arguments, see remarks, filed 07/08/2026, with respect to the 35 U.S.C 112(b) rejections of claims 21-25 and 31- 41 have been fully considered and are persuasive. The 35 U.S.C 112(b) rejections of claims 21-25 and 31- 41 have been withdrawn.
Applicant’s arguments, see remarks, filed 07/08/2026, with respect to the rejection(s) of claim(s) 21 and its dependent claims under 35 U.S.C 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Crespo Paravano (US 20230023786 A1 - previously cited) in view of Addy (US 20110015945 A1) in view of Seelinger (US 20020077857 A1).
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 LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY EPPERT/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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