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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 33, 39, 43, 45, 56, and 84 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 33, the phrase "substantially rounded rectangular cross-sectional shape" renders the claim indefinite because it is unclear what kind of shape “substantially rounded rectangular” is referring to.
Claims 39, 43, 45, 56, and 84 recite “microstructures” without “blade” in front. Thus, it is indefinite because it is unclear whether those microstructures are referring to the blade or a different component.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 5, 8, 11, 15, 18, 25, 27, 29, 33, 35, 39, 43, 45, 51, 56, 75, 84, 87, and 96 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US20190125223- Previously cited), hereinafter Wang.
Regarding claims 1 and 96, Wang teaches a system and method, for performing a biological subject (abstract), the system and method including: a) at least one substrate including one or more blade microstructures configured to breach a functional barrier of the subject (¶[0008,0064], microneedle structure array ¶[0065] has substrate ¶[0067], patch transdermally attached. Fig. 1A, element 101 is in a blade shape, thus, the term “blade” is interpreted to encompass any type of blade shape without more details in the claim), wherein the one or more blade microstructures include a molecularly imprinted polymer for binding one or more analytes (¶[0083-0084] and see claim 9 and 10, element has an imprinted polymer); b) at least one sensor operatively connected to the one or more blade microstructure (¶ [0064]), the at least one sensor being configured to measure response signals from the at least one microstructure (¶ [0065], microneedle sensing electrodes); and, c) one or more electronic processing devices that: i) determine the measured response signals (¶ [0007], probe sensing signals); and, ii) perform an analysis at least in part using the measured response signals to determine at least one indicator at least partially indicative of analyte presence, absence, level or concentration in the subject (¶ [0009][0061][0062][0067], detects signals, determines analyte levels, and thresholds). Regarding claim 2, Wang teaches a system where the molecularly imprinted polymer is formed from pyrrole (¶ [0111], using pyrrole). Regarding claim 5, Wang teaches a system where the molecularly imprinted polymer is an insulating polymer selected from the group consisting of poly-o-phenylenediamine (¶ [0084], entrapment performed by poly(o phenylenediamine). Regarding claim 8, Wang teaches the molecularly imprinted polymer is a conductive polymer selected from the group consisting of polypyrrole (¶ [0111], using polypyrrole). Regarding claim 11, Wang teaches the molecularly imprinted polymer further comprises a dopant selected from dodecylbenzene sulfonate (¶ [0112], sodium dodecybenzenesulfonate doped polypyrole). Regarding claim 15, Wang teaches wherein the one or more blade microstructures are coated with molecularly imprinted polymer or the one more blade microstructures are formed from the molecularly imprinted polymer (¶ [0111], using pyrrole). Regarding claim 18, Wang teaches the one or more analytes are a small molecule (¶ [0059,0062], glucose). Regarding claim 25, Wang teaches the system includes a signal generator operatively connected to the at least one or more blade microstructure to apply a stimulatory signal (¶ [0012][0013] [0059-0060], electrochemical stimuli applied to polymer material) and wherein the one or more processing device are configured to control the signal generator to cause measurement to be performed (¶ [0012][0013] [0059-0060]). Regarding claim 27, Wang teaches response and stimulatory signals include electrical signals, and wherein the substrate includes electrical connections to allow electrical signal to be applied and/or received from respective microstructures (¶ [0012][0013] [0059-0060],).
Regarding claim 29, Wang teaches the system includes one or more switches for selectively connecting at least one of at least one sensor and at least one signal generator to one or more of the blade microstructures (¶ [0059], the device can employ various electrochemical techniques to perform electrochemical reactions directly to a microneedle and transduce a signal, this is controlled by an integrated logic system or a processing system [0060][0067][]0070], the system has a logic gate system to allow multiple microneedles to receive distinct signals), wherein the one or more processing device are configured to control the switches to control which microstructures are used to measure response signals/ apply stimulation (¶ [0070], multiple analytes can be detected depending on the microneedle). Regarding claim 35, Wang teaches the blade microstructures are applied to skin of the subject, and wherein at least some of the blade microstructures penetrate the stratum corneum (¶ [0143]); Regarding claim 39, Wang teaches at least some of the blade microstructures include an electrode and wherein the at least one electrode (¶ [0065][0077]) at least one of: a) extends over a length of a distal portion of the microstructure; b) extends over a length of a portion of the microstructure spaced from the tip; c) is positioned proximate a distal end of the microstructure; d) is positioned proximate a tip of the microstructure; e) extends over at least 25% of a length of the microstructure; f) extends over less than 50% of a length of the microstructure; g) extends over about 60pm of the microstructure; h) is configured to be positioned in a viable epidermis of the subject in use; and, i) has a surface area of at least one of: i) less than 200,000pm2 ;ii) about 22,500pm2; and ,iii) at least 2,000pm2 (¶ Figure 2A and [0077] strip system for microneedle array). Regarding claim 43, Wang teaches at least some of the blade microstructures include an insulating layer extending over at least one of: a) part of a surface of the microstructure; b) a proximal end of the microstructure; c) at least half of a length of the microstructure; d) about 90 pm of a proximal end of the microstructure; and, e) at least part of a tip portion of the microstructure (¶ Claim 1, electrically insulating protruded needle structure). Regarding claim 45, Wang teaches at least some of the blade microstructures are arranged in groups, and wherein at least one of: a) response signals are measured between microstructures in different group; b) stimulation is applied between microstructures in different groups; and c) the group is a pair of microstructures including spaced apart plate microstructures having substantially planar electrodes in opposition (¶ [0011], sensing electrodes disposed in groups). Regarding claim 51, Wang teaches at least one of: a) the one or more blade microstructures interact with one or more analytes of interest such that a response signal is dependent on a presence, absence, level or concentration of the one or more analytes of interest; and b) the one or more analytes interact with a coating on the blade microstructures to change electrical and/or optical properties of the coating, thereby allowing the one or more analytes to be detected (¶ [0070], multiple analytes can be detected depending on the microneedle). Regarding claim 56, Wang teaches at least some of the blade microstructures are at least partially coated with a coating and wherein at least different parts of microstructures include different coatings (¶ [0070][0087], multiple analytes can be detected depending on the microneedle).
Regarding claim 75, Wang teaches analyzing measured response signals to determine at least one indicator at least partially indicative of a physiological status associated with the subject (¶ [0101], glutamate levels determined); andb) analyze measured response signals to determine at least one metric and use the at least one metric to determine at least one indicator, the at least one indicator being at least partially indicative of a physiological status associated with the subject, wherein the one or more processing device apply the at least one metric to at least one computational model to determine the indicator, the at least one computational model embodying a relationship between a health status and the at least one metric and being obtained by applying machine learning to reference metrics derived from subject data measured for one or more reference subjects (¶ [0007], the processing unit can compare the data to a threshold value to determines whether the analyte concentration reflects a healthy or disease state).
Regarding claim 84, Wang teaches the system includes a monitoring device and a patch including the substrate and microstructures (¶ [0007], adhesive patch on the skin) and wherein at least the monitoring device is at least attached to the patch (¶ [0067], array attached to adhesive patch); and, at least partially analyze measurements (¶ [0108], transdermal monitoring).
Regarding claim 87, Wang teaches the system includes at least one of: a) a wearable monitoring device that performs the measurements (¶ [0108], transdermal monitoring); and. b) a processing system that: i) receives subject data derived from the measured response signals (¶ [0061]); and ii) analyses the subject data to generate at least one indicator, the at least one indicator being at least partially indicative of a health status associated with the subject.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Wang et al. (US20170188916A1- Previously cited), hereinafter Wang16.
Regarding claim 20, Wang teaches one or more analytes (¶ [0013]). Wang is silent as to the analyte being troponin or a subunit or complex thereof, or IL-6. Wang 16 teaches a device for determining an analyte concentration, and further teaches the one or more analytes is from IL-6 (¶16 [0210][0420]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Wang with one or more analytes consisting of troponin or a subunit or complex thereof, or IL-6 because the agent reduces inflammation when an analyte sensor system is being used (¶[0210] of Wang16).
Claims 33 is rejected under 35 U.S.C. 103 as being unpatentable over Wang, as applied to claim 1, and further in view of Cormier et al. (US 20020016562), hereinafter Cormier.
Regarding claim 33, Wang fails to teach that the blade microstructures are plate microstructures that are at least partially tapered and have substantially rectangular cross sectional shape.
Cormier teaches an analyte sampling device comprising microblades to assist in retaining the sampling device in the skin (¶[0002] and abstract). The blade portion has a substantially rectangular cross sectional shape (fig. 2 and 29).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Wang, such that the blade microstructures are plate microstructures that are at least partially tapered and have substantially rectangular cross sectional shape, as taught by Cormier, to aid in retaining the sampling device in the skin. Claim 61 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al. (US20160220808A1- Previously cited), hereinafter Hyde. Regarding claim 61, Wang teaches the system includes an actuator configured to apply a force to the substrate to at least one of pierce and penetrate the stratum corneum (¶ [0143]). Wang is silent to a) the actuator is at least one of: iii) a piezoelectric actuator. Hyde teaches the actuator is at least one of: a piezoelectric actuator (¶ [0090] [00143]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Wang with a piezoelectric actuator configured to detect pressure (¶ [0070]) since (1) it is a simple substitution of one known actuator for another to obtain predictable results and/or (2) a type of actuator is required and Hyde teaches one such actuator.
Response to Arguments
Applicant's arguments filed 10/27/2025 have been fully considered but they are not fully persuasive.
Applicants amendment addressing 35 U.S.C. 112(b) rejection of claim 33 is not persuasive and still does not overcome the rejection. It is unclear to what degree the term “substantially” is intended to have, e.g. +/- 0.15, 30%, etc. Rejection can be overcome by providing more details or omitting the term, appropriately, to the limitation.
Applicant contends that Wang does not disclose a blade microstructure in claim 1, on page 19 of the Remarks. Examiner disagrees. Applicant describes Wang’s microstructure to be configured in a pyramidal shape with a triangular base, which in itself describes a type of blade. Thus, Wang does show a type of blade as required by claim 1. However, Wang does not teach the specifics as seen in claim 33. As such, the rejection of claim 33 has been amended in view of the changes and Cormier.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Abramson teaches a myoelectric sensor (e.g., electrode) may comprise a biocompatible metal wire formed into a flat blade having a sharp tip and serrations along at least one edge. US 20140352702
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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