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 .
Status of Claims
This office action is responsive to the amendment filed on June 3, 2025. As directed by the amendment, claims 34, 52, 59, and 60 have been amended, and claims 1-30, 33, and 51 have been canceled. Thus, claims 31-32, 34-50, and 52-60 remain pending.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 31, 32, 34, 38, 40, 41-50, 52, 56, and 58-60 are rejected under 35 U.S.C. 103 as being unpatentable in view of Quin et al. (US20210353267; hereinafter known as “Qin”; previously cited) in view of Pryor et al. (US9615779B2; hereinafter known as Pryor).
Regarding claim 31, Qin teaches an applicator device configured for insertion of a microneedle array sensor into an epidermis or a dermis of a subject (See Qin summary [0008], skin piercing), the device comprising: a body configured to be grasped by a hand of a user (See Quin Figure 5 part 1—the extraction device);
a carrier positioned within a portion of the body (See Qin Figure 7 part 112, the carrier of the needle assembly is connected to 112 and housing 102) and configured to guide the microneedle array toward a skin surface of the subject while moving from a loaded position (See Qin Figure 7 and [0083][00103], the leaf spring is released to penetrate the skin of), in which the microneedle array sensor is retained against the carrier, to an unloaded position, wherein, in the unloaded position, the microneedle array sensor is inserted into the epidermis or the dermis of the subject via the skin surface (See Qin [0081], the chamber can be released or ejected from the housing 102 the needle assembly 110 is released); and
a gating feature disposed on the body (See Qin [0009][0079][0082], the plunger engages with the piercing end and is located within the body also see Figure 5), the gating feature configured to retain the carrier in the loaded position, and in response to a minimum actuation force, allow-movement of the carrier from the loaded position to the unloaded position and release of the microneedle array (See Qin [0082], lifting of the plunger 108 disconnects the piston 132 on the needle assembly 110, resulting in the vacuum chamber 106 and the needle assembly 110 being released or ejected from the device housing 102. The vertical translation mechanism provided by the combination of the plunger 108 and coil spring 104 uses the kinetic energy stored in the coil spring 104 to move the needle assembly 110 down toward the skin to effect piercing by the microneedle array 130). Qin is silent to in which the microneedle array sensor is automatically released from the carrier. Pryor teach the microneedle array sensor is automatically released from the carrier (See Pryor Col. 6 lines 5-21, the applicator is attached to the skin and has a sensor and released from housing). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify Qin with a microneedle array sensor which can automatically be released from the carrier as taught by Pryor so as to attach a sensor to skin in order to measure analyte information (See Pryor Col. 7 lines 5-22).
Regarding claim 32, Qin teaches that the carrier (See Qin Figure5 100, the carrier of the needle assembly is connected to 112 and housing 102) comprises a tongue and a locking tab extending from the tongue (See Qin 5 [0083] [0085], rotational positioning mechanism to keep loaded), the locking tab releasably engaging with the gating feature (See Qin [0083-0085]), and wherein a user-directed application of the minimum actuation force (See Qin [0087], the plunger transfers force down) on a portion of the tongue releases the locking tab front the gating feature and allows the carrier to move from the loaded position to the unloaded position (See Qin [0083-0085]).
Regarding claim 34, Qin teaches that the gating feature comprises a cavity (See Qin Figure 5 [0083], plunge mechanism, cavity 100) configured to retain the carrier in the loaded position, and wherein the carrier is configured to automatically release the microneedle array sensor when the carrier is released from the cavity upon application of the minimum actuation force (See Qin [0083]).
Regarding claim 38, Qin teaches the insertion of the microneedle array sensor is achieved via the user-directed application (See Qin [0084],pressed down for insertion). Regarding claim 40, Qin teaches that the tongue follows a radial trajectory during the movement of the carrier from the loaded position to the unloaded position (See Qin [0084], movement is in a downward motion). Regarding claim 41 and 47, Qin teaches that the tongue comprises a raised portion defining an actuation area, and wherein the user applies the minimum actuation force to the actuation area (See Qin [0083-0084], 122 vacuum chamber is pressed). Regarding claim 42, Qin teaches that the gating feature comprises a cavity disposed in an inner wall of the body (See Qin 5 108 is within the inner wall), and wherein a portion of the locking tab is releasably retained within the cavity when the carrier is in the loaded position (See Qin Figure 5 [0083-0085]).
Regarding claim 43, Qin teaches a system for continuous glucose monitoring comprising: a microneedle array sensor, comprising: a microneedle array, the microneedle array comprising (See Qin abstract and [0008], skin piercing) a plurality of microneedles having a vertical extent between 200 microns to 2000 microns (See Qin [0062]); and a skin-facing adhesive configured to adhere the microneedle array to a skin surface of the subject (See Qin [0063], base adhered); and an applicator configured to apply the microneedle array sensor to the skin surface of the subject and insert the plurality of microneedles into an epidermis or a dermis of the subject, the applicator comprising: a body configured to be grasped by a hand of a user (See Quin Figure 5 part 1—the extraction device); a carrier positioned within a portion of the body (See Qin Figure 7 part 112, the carrier of the needle assembly is connected to 112 and housing 102) and configured to guide the microneedle array sensor toward the skin surface of the subject while moving from a loaded position (See Qin Figure 7 and [0083][00103], the leaf spring is released to penetrate the skin of), in which the microneedle array is retained against the carrier, to an unloaded position, in which the microneedle array sensor is automatically released from the carrier and the plurality of microneedles are inserted into the epidermis or the dermis of the subject via the skin surface (See Qin [0081], the chamber can be released or ejected from the housing 102 the needle assembly 110 is released); and a gating feature disposed on the body (See Qin [0009][0079][0082], the plunger engages with the piercing end and is located within the body also see Figure 5), the gating feature configured to retain the carrier in the loaded position, and, in response to a minimum actuation force, allow movement of the carrier from the loaded position to the unloaded position and release of the microneedle array (See Qin [0082], lifting of the plunger 108 disconnects the piston 132 on the needle assembly 110, resulting in the vacuum chamber 106 and the needle assembly 110 being released or ejected from the device housing 102. The vertical translation mechanism provided by the combination of the plunger 108 and coil spring 104 uses the kinetic energy stored in the coil spring 104 to move the needle assembly 110 down toward the skin to effect piercing by the microneedle array 130). Qin is silent with respect to the microneedle array sensor configured to measure at least one of an endogenous or exogenous biochemical agent, metabolite, drug, pharmacologic, biological, or medicament indicative of a particular physiological or metabolic state in a physiological fluid of a subject. Pryor teaches a microneedle array sensor configured to measure at least one of an endogenous or exogenous biochemical agent, metabolite, drug, pharmacologic, biological, or medicament indicative of a particular physiological or metabolic state in a physiological fluid of a subject. (See Pryor Col. 7 lines 5-22). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify Qin with a sensor configured to measure at least one of an endogenous or exogenous biochemical agent, metabolite, drug, pharmacologic, biological, or medicament indicative of a particular physiological or metabolic state in a physiological fluid of a subject as taught by Pryor so as to attach a sensor to skin in order to measure at least one of an endogenous or exogenous biochemical agent, metabolite, drug, pharmacologic, biological, or medicament indicative of a particular physiological or metabolic state in a physiological fluid of a subject (See Pryor Col. 7 lines 5-22).
Regarding claim 44, Qin teaches that the plurality of microneedles comprises seven microneedles (See Qin [0062], the microneedles and [0063]). Regarding claim 45, Qin teaches that each microneedle of the plurality of microneedles comprises an electrode located in a distal region of the microneedle (See Qin [0062], the microneedles and [0063]). Regarding claim 46, Qin teaches that the microneedle array sensor is configured for electrochemical quantification of glucose in the epidermis or the dermis of the subject (See Qin [0009]). Regarding claim 48, Qin teaches that the applicator further comprises an energy storage device configured to accelerate the carrier and microneedle array sensor during movement of the carrier from the loaded position to the unloaded position (See Qin [0089], thump triggers and moves the plunging seal tip down also see Figure 9b). Regarding claim 49, Qin teaches that the energy storage device comprises a spring that accelerates the carrier and the microneedle array sensor during movement of the carrier from the loaded position to the unloaded position (See Qin [0083-0085]). Regarding claim 50, Qin teaches that the carrier comprises a tongue (See Qin 5 [0083] [0085], rotational positioning mechanism to keep loaded) and a locking tab extending from the tongue to releasably engage with gating feature (See Qin [0083-0085]), and wherein a user-application of the minimum actuation force on a portion (See Qin [0087], the plunger transfers force down) of the tongue releases the locking tab from the gating feature and allows the carrier to move from the loaded position to the unloaded position (See Qin [0083-0085]). Regarding claim 52, Qin teaches that the gating feature comprises a cavity (See Qin Figure 5 [0083]), configured to retain the carrier in the loaded position, and wherein the carrier is configured to release the microneedle array sensor when the carrier is released from the cavity upon application of the minimum actuation force (See Qin [0083]). Regarding claim 56, Qin teaches that the insertion of the plurality of microneedles is achieved with the user-directed application (See Qin [0089], thumb triggers and applying force). Regarding claim 58, Qin teaches that the gating feature comprises a cavity disposed in an inner wall of the body (See Qin 5 108 is within the inner wall), and wherein a portion of the locking tab is releasably retained within the cavity when the carrier is in the loaded position (See Qin Figure 5 [0083-0085]). Regarding claim 59, Qin teaches an applicator device configured for insertion of a microneedle array sensor into an epidermis or a dermis of a subject, the device comprising (See Qin [0008]): a body configured to be grasped by a hand of a user (See Quin Figure 5 part 1—the extraction device); a carrier positioned within a portion of the body (See Qin Figure 7 part 112, the carrier of the needle assembly is connected to 112 and housing 102) and comprising a locking tab extending from the carrier (See Qin [0093], the plunger seal 322), the carrier further configured to guide the microneedle array toward a skin surface of the subject while moving from a loaded position, in which the microneedle array sensor is retained against the carrier, to an unloaded position (See Qin [0095], the plunger is expelled down and the keylock structure (locking tab) releases the plunger and the compressed), and microneedle array sensor is inserted in the epidermis or the dermis of the subject via the skin surface (See Qin [0081], the chamber can be released or ejected from the housing 102 the needle assembly 110 is released); and a gating feature comprising a cavity configured to retain the microneedle array sensor against the carrier when the carrier is in the loaded position, and wherein the gating feature is further configured to, in response to a minimum actuation force, disengage with the locking tab to automatically release the microneedle array sensor from the carrier and allow movement of the carrier from the loaded position to the unloaded position (See Qin [0082], lifting of the plunger 108 disconnects the piston 132 on the needle assembly 110, resulting in the vacuum chamber 106 and the needle assembly 110 being released or ejected from the device housing 102. The vertical translation mechanism provided by the combination of the plunger 108 and coil spring 104 uses the kinetic energy stored in the coil spring 104 to move the needle assembly 110 down toward the skin to effect piercing by the microneedle array 130). Qin is silent with respect to the microneedle array sensor being automatically released from the carrier.
Pryor teaches a microneedle array sensor automatically released from the carrier (See Pryor Col. 6 lines 5-21, the applicator is attached to the skin and has a sensor and released from housing). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify Qin with a microneedle array sensor which can automatically be released from the carrier as taught by Pryor so as to attach a sensor to skin in order to measure analyte information (See Pryor Col. 7 lines 5-22). Regarding claim 60, Qin teaches a microneedle array sensor into an epidermis or a dermis of a subject (See Qin summary [0008], skin piercing) comprising: providing an applicator comprising the microneedle array sensor (See Qin abstract and [0008], skin piercing), the applicator comprising: a body configured to be grasped by a hand of a user (See Quin Figure 5 part 1—the extraction device); a carrier a carrier positioned within a portion of the body and comprising a locking tab extending from the carrier (See Qin Figure 7 part 112, the carrier of the needle assembly is connected to 112 and housing 102), the carrier further configured to guide the microneedle array toward the skin surface of the subject while moving from a loaded position, in which the microneedle array sensor is retained against the carrier, to an unloaded position, in which the microneedle array sensor is automatically released from the carrier and the microneedle array sensor is inserted in the epidermis or the dermis of the subject via the skin surface (See Qin [0081], the chamber can be released or ejected from the housing 102 the needle assembly 110 is released); and a gating feature comprising a cavity (See Qin Figure 5 1-8), configured to releasably engage with the locking tab of the carrier to retain the carrier in the loaded position, and wherein the gating feature is further configured to, in response to a minimum actuation force, disengage with the locking tab to automatically release the microneedle array sensor and allow movement of the carrier from the loaded position to the unloaded position (See Qin [0083-0085]), positioning the applicator on the skin surface of the subject at a target location of the microneedle array (See Qin Figure 7 and [0083][00103], the leaf spring is released to penetrate the skin of); applying a minimum actuation force to a portion of the carrier, thereby releasing the locking tab from the gating feature (See Qin [0082], lifting of the plunger 108 disconnects the piston 132 on the needle assembly 110, resulting in the vacuum chamber 106 and the needle assembly 110 being released or ejected from the device housing 102. The vertical translation mechanism provided by the combination of the plunger 108 and coil spring 104 uses the kinetic energy stored in the coil spring 104 to move the needle assembly 110 down toward the skin to effect piercing by the microneedle array 130); and removing the applicator from the skin surface of the subject, wherein the microneedle array sensor and the locking tab of the carrier are releasably engaged with the gating feature when the applicator is provided (See Qin [0104], the loaded spring of the device was then released and triggered the launching of the microneedle array. The microneedle array was driven by the spring force and impacted the subject's skin with a force). Qin is silent with respect to the microneedle array sensor configured to measure at least one of an endogenous or exogenous biochemical agent, metabolite, drug, pharmacologic, biological, or medicament indicative of a particular physiological or metabolic state in a physiological fluid of a subject. Pryor teaches the microneedle array sensor to measure at least one of an endogenous or exogenous biochemical agent, metabolite, drug, pharmacologic, biological, or medicament indicative of a particular physiological or metabolic state in a physiological fluid of a subject. (See Pryor Col. 7 lines 5-22). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify Qin with a microneedle array sensor configured to measure at least one of an endogenous or exogenous biochemical agent, metabolite, drug, pharmacologic, biological, or medicament indicative of a particular physiological or metabolic state in a physiological fluid of a subject as taught by Pryor to attach a sensor to skin in order to measure the at least one of an endogenous or exogenous biochemical agent, metabolite, drug, pharmacologic, biological, or medicament indicative of a particular physiological or metabolic state in a physiological fluid (See Pryor Col. 7 lines 5-22).
Claims 35-37, and 53-55 are rejected under 35 U.S.C. 103 as being unpatentable over Qin in view of Pryor in view of Fredrickson et al (US20140330209A1; hereinafter known as “Fredrickson”; previously cited).
Regarding claim 35 and 53, Qin teaches the tongue (See Qin [0093], the plunger seal 322) comprises a spring that accelerated the carrier and the microneedle array sensor during movement of the carrier from the loaded position to the unloaded position (See Qin [0094], and Figure 11b, the spring is pushing the plunger which is connected to the plunger seal 322 to move the array) .
Qin is silent with respect to a leaf spring. Fredrickson teaches an applicator device with a gating feature (See Fredrickson [0050]) and further teaches a leaf spring (See Fredrickson [0008] [0050], drive member is a spring plunger such as a leaf spring). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Qin with a leaf spring as taught by Fredrickson so that the device can propel the patch forward (See Fredrickson [0047], leaf spring).
Regarding claim 36 and 54, Qin teaches that the microneedle array sensor is inserted with an impact force of between 0.3N and 30N (See Qin [0071], 1 and 2 N). Regarding claim 37 and 55, Qin teaches that the microneedle array sensor is inserted with an impact velocity of between 0.15m/s and 15 m/s (See Qin [0071], 1.5 and 2.5 m/s velocity).
Claims 39 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Qin.
Regarding claims 39 and 57, Qin teaches that the microneedle array sensor is inserted with an impact velocity at any suitable speed (See Qin [0071]), which suggests that the speed is subject to optimization. The impact velocity would depend upon the factors of performance and patient comfort. As such, the impact velocity is a results-effective variable that would have been optimized through routine experimentation based on the factors of performance and patient comfort. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the impact velocity so as to obtain the desired performance and patient comfort.
Response to Arguments
Applicant’s argument filed June 3, 2025 with respect to claims 34, 52, 59, and 60 rejected under 35 U.S.C. 112(a) and 112(b) have been considered and are persuasive, therefore the rejection has been withdrawn. Applicant’s argument filed June 3, 2025 with respect to claims 31-34, 38, 40-52, and 56-60 rejected under 35 U.S.C 102 specifically regarding “Qin fails to teach or suggest a microneedle array sensor, Qin needle assembly is not a sensor at all much less a microneedle, much less a microneedle array sensor. Qin needle features no elements that might enable it to “sense”. to the extend Qin describes “sensing at all. Qin superficially notes that ISF collected from the external skin surface after puncture by the needle assemble can be analyzed. But Qin’s sensing is not performed by the microneedle array of Qin needle assembly not by any other component of Qin needle assembly or device.” has been fully considered and is persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of Pryor.
Applicant’s argument filed June 3, 2025 specifically regarding with respect to claims 31-34, 38, 40-52, and 56-60 rejected under 35 U.S.C 102 “Second Qin does not teach or suggest a carrier configured to guide the microneedle array sensor toward a skin surface of the subject while moving from a loaded position in which the microneedle array sensor is retained against the carrier, to an unloaded position, in which the microneedle array sensor is automatically released from the carrier and is inserted into the epidermis or the dermis of the subject via the skin surface” has been fully considered and is not persuasive. The claims do not state the microneedle array remains within the skin surface of the subject. Qin teaches a plunger method in which the microneedle array is retained within the housing and is ejected (See Qin [00079][0082], and claim 1, [0084] plunger gear places needle on skin). Applicant’s argument filed June 3, 2025 with respect to claims 31-34, 38, 40-52, and 56-60 rejected under 35 U.S.C 102 specifically regarding “Qin fails to teach or suggest that its needle assembly is inserted into the epidermis or the dermis of the subject via the skin surface upon disconnection of the needle assembly…Applicant respectfully submits that paragraph [0082] of Qin cannot logically be interpreted as teaching re-insertion and retention of the needle assembly as appears to be suggested by the Office action” has been fully considered and is persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of Pryor.
Applicant’s argument filed June 3, 2025 with respect to claims 31-34, 38, 40-52, and 56-60 rejected under 35 U.S.C 102 specifically regarding “Applicant respectfully submits that paragraph [0082] of Qin cannot reasonably be interpreted as teaching re-puncturing of the skin of the subject subsequent to ejection of the vacuum chamber and the needle assembly such that the needle assembly resides at/within the skin, as required by the claimed invention” has been fully considered and is persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of Pryor.
Applicant’s argument filed June 3, 2025 with respect to claims 35-37, and 53-55 rejected under 35 U.S.C 103 specifically regarding “Qin fails to teach or suggest each and every limitation” has been fully considered is persuasive. However, upon further consideration, a new ground(s) of rejection is made in view of Pryor.
Conclusion
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/M.R.K./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791