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 .
Election/Restrictions
Applicant’s election without traverse of Group III (Claims 55-60) in the reply filed on 03/09/2026 is acknowledged.
The following office action addresses Group III (Claims 55-60). Groups I and II, directed to claims 41-48 and 49-54, respectively, are non-elected inventions and are therefore, withdrawn from consideration.
Acknowledgement of Amendment
The following office action is in response to the applicant’s amendment filed on 06/30/2026. Claims 41-60 are pending. Claims 1-40 have been cancelled. Claims 55 and 56 are amended. Claims 41-54 are withdrawn. Claims 55-60 are rejected under 35 U.S.C. 103 for the reasons stated in the Response to Arguments and 35 U.S.C. 103 sections below.
Response to Arguments
Applicant’s arguments, see Remarks page 12, filed 06/30/2026, with respect to the objections to the drawings and specification have been fully considered and are persuasive given the amendments thereto. The objections to the drawings and specification in the non-final rejection of 04/01/2026 has been withdrawn.
Applicant’s arguments, see Remarks page 12-17, filed 06/30/2026, with respect to the rejection of claims 55, 57 and 60 under 35 U.S.C. 102 and claims 56, 58 and 59 under 35 U.S.C. 103 have been fully considered and are persuasive.
Claim 55
Regarding claim 55, the Applicant respectfully submits that the cited reference do not disclose, teach, or suggest features recited in amended claim 55. For example, the amended Claim 55 recites, inter alia:
“an electrically triggerable membrane comprising electrically triggerable material that encapsulates the microneedle and defining at least one reservoir between the microneedle and the electrically triggerable membrane, wherein the electrically triggerable material disintegrates in response to electrical triggers”.
Support can be found in the present application. For example, paragraphs [0324]-[0325] of the originally filed specification.
The Office Action argued:
[r]egarding claim 55, Bennet teaches ... "an electrically triggerable membrane encapsulating the microneedle and defining at least one reservoir between the microneedle and the electrically triggerable membrane" (See [0039] and [0042] above. As shown in FIG. 3, the reservoir 314 attaches to the microneedle 320 and is located within the sensor patch 310, the sensor patch representing an electrically triggerable membrane since it contains sensors which send and receive signals. Therefore, the sensing apparatus includes an electrically triggerable membrane (i.e. sensor patch 310) encapsulating the microneedle 320 and defining at least one reservoir (i.e. 314) between the microneedle and the electrically triggerable membrane.).
See Office Action, pages 6-7 (emphasis added). Applicant respectfully disagrees with the Office Action's arguments, and respectfully submits that the "sensor patch" of Bennet does not disclose, teach, or suggest the "electrically triggerable membrane" of Claim 55. Paragraph [0032] of Bennet states:
“[s]ensor patch 110 can be made from compliant polymeric materials and can have an adhesive on a bottom surface 111. In some embodiments, sensor patch 110 can comprise a material that is well-suited for the convenient placement on the patient's skin, consistent retention thereon, and non-irritating skin contact. For example, sensor patch 110 can comprise a soft elastomer such as a thermoplastic elastomer, silicone, or the like.
The Applicant argues that Bennet does not disclose, teach, or suggest the "sensor patch" using any electrically triggerable material that disintegrates in response to electrical triggers. In addition, paragraph [0031] of Bennet states that "[a] power source such as a battery (not shown), and electrical contacts that mate with complementary contacts on control unit 120 can also be included in the sensor patch 110." As such, a person having ordinary skill in the art would not modify the "sensor patch" of Bennet using electrically triggerable material, as doing so would frustrate the purpose of Bennet. Applicant respectfully submits that Bennet does not disclose, teach, or suggest features recited in the amended Claim 55 such as, but not limited to, "an electrically triggerable membrane comprising electrically triggerable material that encapsulates the microneedle and defining at least one reservoir between the microneedle and the electrically triggerable membrane, wherein the electrically triggerable material disintegrates in response to electrical triggers."
Accordingly, for at least the various reasons set forth above, Applicant respectfully submits that the cited references fail to disclose, teach, or suggest each and every element of independent Claim 55. Applicant respectfully requests that the rejection of independent Claim 55 be withdrawn, and that Claim 55 be allowed.
The examiner acknowledges that Bennet does not disclose, teach, or suggest the "sensor patch" using any electrically triggerable material that disintegrates in response to electrical triggers. Furthermore, the examiner recognizes that a person having ordinary skill in the art would not modify the "sensor patch" of Bennet using electrically triggerable material, as doing so would frustrate the purpose of Bennet.
Therefore, the rejection of claim 55 (and dependent claims 57 and 60) under 35 U.S.C. 102 in the non-final rejection of 04/01/2026 have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of McAllister et al. JP 2021/121339 A “McAllister” as discussed in the 35 U.S.C. 103 section below.
b. Claim 56
Regarding claim 56, this claim depends from independent Claim 55 discussed above, and include all of the recitations thereof. Accordingly, for this reason and for the reasons stated above with respect to independent Claim 55, dependent Claim 56 is patentable over the references cited in the Office Action.
In addition, Applicant respectfully submits that the cited references fail to disclose, teach, or suggest features recited in Claim 56. For example, the amended Claim 56 recites, inter alia, "in response to the release control signal, transmit the electrical trigger to the microneedle to cause disintegration of the electrically triggerable material to expose the microneedle." Support for these features can be found in the present application. For example, paragraph [0331] of the originally filed specification provides, inter alia:
[a]s described above, the controller 1521 is coupled to one or more microneedles (for example, the microneedle 1523A, the microneedle 1523B, and the microneedle 1523C). In some embodiments, the controller 1521 is configured to transmit an electrical trigger to the one or more microneedles to cause a disintegration of the electrically triggerable membrane 1527 that covers the one or more microneedles and a release of content from the at least one reservoir.
Support can also be found in at least FIG. 15C to FIG. 15G. Additional support can be found in other portions of the present application.
The Office Action argued:
[r]egarding claim 56, […] Sanjiv teaches "further comprising: a controller coupled to the microneedle and configured to transmit an electrical trigger to an electrical trigger to the microneedle to cause a disintegration of the electrically triggerable membrane and a release from the at least one reservoir; wherein the controller is configured to: receive a release control signal, wherein the release control signal comprises a microneedle indication associated with the microneedle, and in response to the release control signal, transmit the electrical trigger to the microneedle" ("Referring to figure 4, there is shown an alternative patch according to an embodiment of the invention, the patch comprises a main polymeric base 10 made up of an array of microneedles 11. In this figure, solid microneedles are shown although it is equally feasible to use hollow microneedles as disclosed herein. As shown, the base 10 further comprises at least one channel 19 which is/are positioned in between the microneedle projections or their bases. Channel is/are connected to a supply or reservoir of agent as depicted in figure 2" [Page 13, Line 27-Page 14, Line 1]; "In yet a further preferred embodiment, delivery of agent is actuated by a stimulus. For example, the agents might be encapsulated in a metal layer (Au, Ag or Pt) which will corrode to release to an electrical stimulus" [Page 4, Lines 21-24].
See Office Action, pages 11-12. Applicant respectfully disagrees with the Office Action's arguments. The Office Action argued that Sanjiv allegedly describes that "the agents might be encapsulated in a reservoir coated with a metal layer (Au, Ag or Pt) which will corrode to release the entrapped drug in response to an electrical stimulus;" however, the "metal layer" of Sanjiv that coats the reservoir does not encapsulate any microneedle.
As shown in FIG. 4 of Sanjiv, the microneedles 11 are not encapsulated by the coating of the reservoir. As such, Applicant respectfully submits that Sanjiv does not cure the deficiencies of Bennet, and that Bennet and Sanjiv do not disclose, teach, or suggest at least "an electrically triggerable membrane comprising electrically triggerable material that encapsulates the microneedle ... ,wherein the electrically triggerable material disintegrates in response to electrical triggers" recited in the amended independent Claim 55 and at least "in response to the release control signal, transmit the electrical trigger to the microneedle to cause disintegration of the electrically triggerable material to expose the microneedle" recited in the amended Claim 56. Applicant respectfully requests that these claims be allowed.
The examiner respectfully acknowledges that Sanjiv does not teach "an electrically triggerable membrane comprising electrically triggerable material that encapsulates the microneedle ... ,wherein the electrically triggerable material disintegrates in response to electrical triggers". As shown in FIG. 4 of Sanjiv, the microneedles 11 are not encapsulated by the coating of the reservoir. In fact, the "metal layer" of Sanjiv that coats the reservoir does not encapsulate any microneedle. Furthermore, although Sanjiv discloses “Further, the microneedles are coated with a dissolvable or substantially dissolvable material 3, whereupon insertion into the skin and more particularly the aqueous environment of the interstitial fluid (ISF), said material dissolves” [Page 11, Lines 22-25], this material 3 is not an electrically triggerable material which disintegrates in response to electrical triggers.
Therefore, the rejection of claim 56 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of McAllister et al. JP 2021/121339 A “McAllister” as discussed in the 35 U.S.C. 103 section below.
c. Claims 57-60
Claims 57-60 are dependent from independent Claim 55 discussed above, and are patentable for at least the same reasons. Applicant, therefore, respectfully submits that the rejections herewith are overcome and requests that the rejections be withdrawn. Because each dependent claim is also deemed to define an additional aspect of the invention, however, the individual reconsideration of the patentability of each on its own merits is respectfully requested.
Because Applicant maintains that all claims are allowable for at least the reasons presented hereinabove, in the interests of brevity, this response does not comment on each and every comment made by the Examiner in the Office Action. This should not be taken as acquiescence of the substance of those comments, and Applicant reserves the right to address such comments.
Regarding claims 57-60, the examiner acknowledges that due to their dependence on claim 55, either directly or indirectly, these claims are subject to the reasoning provided therein. Thus, the rejection of claims 57-60 under 35 U.S.C. 102 and 35 U.S.C. 103, respectively, have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of McAllister et al. JP 2021/121339 A “McAllister” as discussed in the 35 U.S.C. 103 section below.
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.
Claim(s) 55-57 and 60 is/are rejected under 35 U.S.C. 103 as being anticipated by Bennet et al. US 2019/0223806 A1 “Bennet” and further in view of McAllister et al. JP 2021/121339 A “McAllister”.
Regarding claim 55, Bennet teaches “A sensing apparatus for deep tissue sensing and transdermal delivery comprising:” (“Referring to FIG. 3, a cross-sectional side view of another example modular external monitoring device 300 is depicted on the skin 210 of a patient. Monitoring device 300 includes microneedles 320 that can be employed as sensors, injection devices, sampling devices, and for other like purposes. Microneedles 320 can be barbed or otherwise include structures which facilitate adherence to skin 210” [0038]; “Microneedles 320 penetrate the skin 210 and the distal tips of the microneedles 320 reside subdermally. Therefore, microneedles 320, when used as sensors, have enhanced signal reception (e.g., for ECG, EEG, EMG, etc.). […] The portions of microneedles 320 near sensor patch 310 can be insulated portions 321 such that the only electrical recording would come from the exposed electrodes at the distal end of microneedles 320 that are positioned deeper into the tissue” [0039]; and “In some embodiments, microneedles 320 can alternatively be used for drug delivery by injecting medication from a reservoir 314 located within or coupled to sensor patch 310” [0042]. Therefore, FIG. 3 depicts a sensing apparatus (i.e. external monitoring device 300) for deep tissue sensing (i.e. via the distal ends of microneedles 320 positioned deeper into the tissue, see [0039]) and transdermal delivery (i.e. employing the microneedles 320 as injection devices, see [0038], [0042]).);
“a base layer configured to interface with a skin surface of a subject” (See [0039] above and FIG. 3. As shown in FIG. 3, the external monitoring device 300 is positioned on the skin 210 of the patient, such that the microneedles 320 penetrate the skin 210 and reside subdermally (see [0039]). Therefore, the sensing apparatus (i.e. 300) includes a base layer configured to interface with a skin surface of a subject.);
“a sensing layer positioned above the base layer and comprising one or more waveform detectors and one or more waveform generators configured to emit wave signals” (“Some embodiments of microneedles 320 can carry fiber optic elements and can transmit light for oximetry sensing. […] In one embodiment, a first microneedle 320 has a side aperture to transmit light. A neighboring microneedle 320 has a complementary side aperture to receive the light transmitted from the first microneedle 320 via the tissue. Thus, the actual technique is transmissive from two neighboring microneedles 320 placed in the tissue. In another embodiment, light is transmitted from a microneedle 320 and the light transmitted through the tissue is received at a sensor on the bottom surface of sensor patch 310. This embodiment could rely on measurement of reflective light or transmissive light, depending on geometric arrangement of the microneedle 320 relative to the base of sensor patch 310” [0041]. As shown in FIG. 3, the sensor patch 310 is located above the base layer (i.e. the connection between the external monitoring device 300 and the skin 210). In order for the sensors within the sensor patch 310 to receive light transmitted from a microneedle 320 and through the tissue, the sensing patch 310 has to include both waveform detectors and waveform generators configured to emit wave signals (i.e. light). Therefore, the sensing apparatus (i.e. 300) includes a sensing layer (i.e. 310) positioned above the base layer (i.e. the connection between the external monitoring device 300 and the skin 210) and comprising one or more waveform detectors (i.e. sensors) and one or more waveform generators configured to emit wave signals (i.e. light, such that the microneedles 320 can transmit light into tissue).);
“a microneedle attached to a skin-interfacing portion of the base layer and configured to waveguide the wave signals into a deep tissue of the subject” (See [0039] and [0041] above. Therefore, the sensing apparatus (i.e. 300) includes a microneedle (i.e. 320) attached to a skin-interfacing portion of the base layer (see FIG. 3) and configured to waveguide the wave signals (i.e. light, see [0041]) into a deep tissue of the subject (see [0039]).).
Bennet does not teach “an electrically triggerable membrane comprising electrically triggerable material that encapsulates the microneedle and defining at least one reservoir between the microneedle and the electrically triggerable membrane, wherein the electrically triggerable material disintegrates in response to electrical triggers”.
McAllister is within the same field of endeavor as the claimed invention because it involves a drug delivery device with an array of microneedles (see FIG. 1A).
McAllister teaches “an electrically triggerable membrane comprising electrically triggerable material that encapsulates the microneedle and defining at least one reservoir between the microneedle and the electrically triggerable membrane, wherein the electrically triggerable material disintegrates in response to electrical triggers” (“In one embodiment, the triggering system is in at least one direction and / or on at least a portion or portion of the microneedle to interfere with the release of the drug from the microneedle for a predetermined time. Includes barrier material to be placed. The barrier material may, for example, completely or partially enclose all or part of the microneedle agent, cover at least the microneedle portion, or a combination thereof. Triggered changes can be in the following three categories: (I) Triggered changes can be due to spontaneous changes in the tissue environment that are not the result of human intervention (e.g., analytical enrichment changes) (II) Triggered changes can be due to human intervention, such as applying an electric field or applying pressure, or (III) Triggered changes, once sufficient dissolution occurs, the pre-encapsulated drug. It can be classified as one of those that can be due to changes within the microneedles without human intervention, such as a dissolution process that acts like dissolution that can be released” [Page 4, Para. 1, Lines 6-14]; “In one embodiment, the triggering system comprises a barrier that is placed in or on at least a portion of the microneedle. The barrier provided by the barrier, in the embodiment, interferes with the release of the drug from the within at least one direction and / or for a predetermined time” [Page 11, Para. 2, Lines 1-3]; “Also, changes in the barrier and / or charge state of the drug can change the release of the drug under the influence of the electric field. Emissions can also be triggered by the application of changes in the electric field. For example, an electric field can be applied across the and targeted tissue, and optionally at different time points to affect the kinetics of the release” [Page 14, Para. 6, Lines 1-4].
Therefore, the sensing apparatus includes an electrically triggerable membrane (i.e. barrier material/barrier) comprising electrically triggerable material that encapsulates the microneedle (see [Page 4, Para. 1, Lines 6-14]) and defining at least one reservoir between the microneedle and the electrically triggerable membrane (i.e. in which the drug is located, see [Page 11, Para. 2, Lines 1-3], wherein the electrically triggerable material disintegrates in response to electrical triggers (i.e. electric field, see [Page 14, Para. 6, Lines 1-4].).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing apparatus of Bennet such that it includes an electrically triggerable membrane (i.e. barrier material) comprising electrically triggerable material that encapsulates the microneedle and defining at least one reservoir between the microneedle and the electrically triggerable membrane, wherein the electrically triggerable material disintegrates in response to electrical triggers as disclosed in McAllister in order to improve drug delivery by changing the rate of release of a drug (see McAllister: [Page 4, Para. 1, Lines 1-4]: “Improved drug delivery devices and methods that allow control of drug release are also provided. In embodiments, the drug delivery device comprises an array of microneedles containing and projecting from the base and from the microneedles and from the biological tissue after the microneedles have been inserted into the biological tissue at least partially. Includes a system for triggering changes in the rate of release of the drug”). An electrically triggerable member/material is one of a finite number of materials which can be utilized to cover a microneedle to encapsulate a drug and cause the release thereof when an electrical trigger (i.e. electrical field) is applied to a device with a reasonable expectation of success. Thus, modifying sensing apparatus of Bennet such that it includes an electrically triggerable membrane (i.e. barrier material) comprising electrically triggerable material that encapsulates the microneedle and defining at least one reservoir between the microneedle and the electrically triggerable membrane, wherein the electrically triggerable material disintegrates in response to electrical triggers as disclosed in McAllister would yield the predictable result of improving drug delivery by changing the rate of release of a drug when an electrical field (i.e. electrical trigger) is provided.
Regarding claim 56, Bennet in view of McAllister discloses all features of the claimed invention as discussed with respect to claim 55 above. Although Bennet discloses “When control unit 120 is installed in sensor patch 110, electrical connections are made such that control unit 120 is in electrical communication with the sensors that are visible on the bottom of sensor patch 110” [0030] and “In some embodiments, microneedles 320 can alternatively be used for drug delivery by injecting medication from a reservoir 314 located within or coupled to sensor patch 310.” [0042], Bennet in view of McAllister does not teach “further comprising: a controller coupled to the microneedle and configured to transmit an electrical trigger to the microneedle to cause a disintegration of the electrically triggerable membrane and a release of content from the at least one reservoir; wherein the controller is configured to: receive a release control signal, wherein the release control signal comprises a microneedle indication associated with the microneedle, in response to the release control signal, transmit the electrical trigger to the microneedle to cause disintegration of the electrically triggerable material to expose the microneedle”.
McAllister further teaches “further comprising: a controller coupled to the microneedle and configured to transmit an electrical trigger to the microneedle to cause a disintegration of the electrically triggerable membrane and a release of content from the at least one reservoir; wherein the controller is configured to: receive a release control signal, wherein the release control signal comprises a microneedle indication associated with the microneedle; in response to the release control signal, transmit the electrical trigger to the microneedle to cause disintegration of the electrically triggerable material to expose the microneedle” (“In one embodiment, the triggering system is in at least one direction and / or on at least a portion or portion of the microneedle to interfere with the release of the drug from the microneedle for a predetermined time. Includes barrier material to be placed. The barrier material may, for example, completely or partially enclose all or part of the microneedle agent, cover at least the microneedle portion, or a combination thereof. Triggered changes can be in the following three categories: (I) Triggered changes can be due to spontaneous changes in the tissue environment that are not the result of human intervention (e.g., analytical enrichment changes) (II) Triggered changes can be due to human intervention, such as applying an electric field or applying pressure, or (III) Triggered changes, once sufficient dissolution occurs, the pre-encapsulated drug. It can be classified as one of those that can be due to changes within the microneedles without human intervention, such as a dissolution process that acts like dissolution that can be released” [Page 4, Para. 1, Lines 6-14]; “In one embodiment, the triggering system comprises a barrier that is placed in or on at least a portion of the microneedle. The barrier provided by the barrier, in the embodiment, interferes with the release of the drug from the within at least one direction and / or for a predetermined time” [Page 11, Para. 2, Lines 1-3]; “Also, changes in the barrier and / or charge state of the drug can change the release of the drug under the influence of the electric field. Emissions can also be triggered by the application of changes in the electric field. For example, an electric field can be applied across the and targeted tissue, and optionally at different time points to affect the kinetics of the release” [Page 14, Para. 6, Lines 1-4].
Therefore, the sensing apparatus further comprises: a controller (i.e. triggering system) coupled to the microneedle and configured to transmit an electrical trigger (i.e. electrical field) to the microneedle to cause a disintegration of the electrically triggerable membrane (i.e. barrier material/barrier) and a release of content (i.e. drug) from the at least one reservoir, wherein the controller (i.e. triggering system) is configured to: receive a release control signal (i.e. corresponding to the electric field), wherein the release control signal comprises a microneedle indication associated with the microneedle, in response to the release control signal, transmit the electrical trigger to the microneedle to cause disintegration of the electrically triggerable material (i.e. barrier material/barrier) to expose the microneedle. ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing apparatus of Bennet such that it includes an electrically triggerable membrane (i.e. barrier material) comprising electrically triggerable material that encapsulates the microneedle and defining at least one reservoir between the microneedle and the electrically triggerable membrane, wherein the electrically triggerable material disintegrates in response to electrical triggers as disclosed in McAllister in order to improve drug delivery by changing the rate of release of a drug (see McAllister: [Page 4, Para. 1, Lines 1-4]: “Improved drug delivery devices and methods that allow control of drug release are also provided. In embodiments, the drug delivery device comprises an array of microneedles containing and projecting from the base and from the microneedles and from the biological tissue after the microneedles have been inserted into the biological tissue at least partially. Includes a system for triggering changes in the rate of release of the drug”). An electrically triggerable member/material is one of a finite number of materials which can be utilized to cover a microneedle to encapsulate a drug and cause the release thereof when an electrical trigger (i.e. electrical field) is applied to a device with a reasonable expectation of success. Thus, modifying sensing apparatus of Bennet such that it includes an electrically triggerable membrane (i.e. barrier material) comprising electrically triggerable material that encapsulates the microneedle and defining at least one reservoir between the microneedle and the electrically triggerable membrane, wherein the electrically triggerable material disintegrates in response to electrical triggers as disclosed in McAllister would yield the predictable result of improving drug delivery by changing the rate of release of a drug when an electrical field (i.e. electrical trigger) is provided.
Regarding claim 57, Bennet in view of McAllister discloses all features of the claimed invention as discussed with respect to claim 55 above, and Bennet further teaches “further comprising a microneedle array comprising a plurality of microneedles that includes the microneedle, wherein the electrically triggerable membrane encapsulates each of the plurality of microneedles” (See FIG. 3. As shown in FIG. 3, the external monitoring device 300 includes a plurality of microneedles 320 which each protrude from the sensor patch 310 (i.e. electrically triggerable membrane). Therefore, the sensing apparatus further comprises a microneedle array comprising a plurality of microneedles that includes the microneedle, wherein the electrically triggerable membrane (i.e. sensor patch 310) encapsulates each of the plurality of microneedles.).
Regarding claim 60, Bennet in view of McAllister discloses all features of the claimed invention as discussed with respect to claim 55 above, and Bennet further teaches “further comprising: a controller in electronic communication with the one or more waveform generators and the one or more waveform detectors, the controller is configured to:” (See [0041] as discussed with respect to claim 55 above and “When control unit 120 is installed in sensor patch 110, electrical connections are made such that control unit 120 is in electrical communication with the sensors that are visible on the bottom of sensor patch 110. Sensor patch 110 includes, in this example embodiment, an ECG electrode 112 and a bioimpedance sensor 114. However, a wide variety of types, configurations and numbers of sensors can be included in sensor patch 110 as described further herein, and as known in the art” [0030]; “A power source such as a battery (not shown), and electrical contacts that mate with complementary contacts on control unit 120 can also be included in the sensor patch 110” [0031]. Although the control unit 120 is described with respect to the embodiment shown within FIG. 1, it would be obvious to include a control unit within the embodiment shown in FIG. 3 to enable it to perform similar functions to that of the embodiment of FIG. 1. Furthermore, in order for the microneedles 320 to transmit light, the microneedles 320 had to receive the light from one or more waveform generators present within the sensor patch 110/310, the sensor patch being configured to also receive light transmitted through tissue, (see [0041]). Therefore, since the control unit 120 is installed in sensor patch 110 and electrical connections are made with the sensors included therein (See [0031]), the sensor patch including one or more waveform generators and the one or more waveform detectors in order to transmit/receive light, respectively, the sensing apparatus further comprises: a controller in electronic communication with the one or more waveform generators and the one or more waveform detectors.);
“operate the one or more waveform generators to define a sensing field within the deep tissue of the subject via the wave signals and the microneedle as a waveguide” (See [0041] as discussed with respect to claim 55 above. In order for the microneedles to transmit light for oximetry sensing, the microneedles had to receive light from the one or more waveform generators. Therefore, the controller (i.e. control unit 120) is configured to operate the one or more waveform generators to define a sensing field within the deep tissue of the subject via the wave signals (i.e. light) and the microneedle as a waveguide (i.e. fiber optic elements to transmit light, see [0041]).);
“generate sensing data based at least in part on reflected wave signals detected at the one or more waveform detectors” (See [0041]. Thus, since the light transmitted through the tissue is received at a sensor on the bottom surface of sensor patch 310, the controller is configured to generate sensing data based at least in part on reflected wave signals detected at the one or more waveform detectors (i.e. sensors in the sensor patch 310).); and
“transmit, via wireless communication, the sensing data to a workstation” (“While control unit 120 typically downloads the health parameter data to a base station or equivalent device, in some cases control unit 120 while installed in the sensor patch 110 can send wireless transmissions to the base station or over cellular networks based on triggering events. Such triggering events can be determined for a particular patient and programmed into control units 120 for the patient. For example, a triggering event may be a particular variability in RR over a short time period, or an ECG QRS morphology, or the like” [0036]. Therefore, since the control unit 120 can send wireless transmissions to the base station, the controller is configured to transmit, via wireless communication, the sensing data to a workstation (i.e. base station).).
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bennet et al. US 2019/0223806 A1 “Bennet” and McAllister et al. JP 2021/121339 A “McAllister” as applied to claim 55 above, and further in view of Young et al. KR 2019/0136727 A “Young”.
Regarding claim 58, Bennet in view of McAllister discloses all features of the claimed invention as discussed with respect to claim 55 above. Bennet further teaches “wherein the microneedle is configured as an optical waveguide for the light signals” (See [0041] as discussed with respect to claim 55 above. Therefore, since the microneedles 320 can carry fiber optic elements to transmit light for oximetry sensing, the microneedle is configured as an optical waveguide for the light signals.).
However, the combination does not teach “wherein the one or more waveform generators comprise one or more light-emitting diodes configured to emit light signals”, or “wherein the light signals include visible red light signals and near-infrared signals”.
Young is within a related field of endeavor to the claimed invention because it involves a microneedle plat with a plurality of LED light sources to emit LED light though a microneedle plate (see [Abstract]).
Young teaches “wherein the one or more waveform generators comprise one or more light-emitting diodes configured to emit light signals” and “wherein the light signals include visible red light signals and near-infrared signals” (“Referring to FIG. 4, the LED light source 40 is installed at the rear of the microneedle plate 20 and irradiates LED light to the skin through the microneedle plate 20. The LED light source 40 is a red LED 41 for generating red light of 650 ~ 670 nanometer wavelength, blue LED 42 for generating blue light of 400 ~ 450 nanometer wavelength, 870 ~ 890 nanometer wavelength. It may include a near infrared LED 43 for generating a near infrared” [Page 3, Lines 34-38]; “The operation mode input through the mode switching switch 60 is a vibration mode in which only the vibration motor 30 operates for a set time, a red LED 41 mode in which the red LED 41 lights up for a set time, and the blue color. The blue LED 42 mode in which the LED 42 lights up for a set time, the near infrared LED 43 mode in which the near-infrared LED 43 lights up for a set time, and the vibration motor 30 and the red LED 41.” [Page 4, Lines 6-9]. “Referring to FIG. 6, the microneedle of the microneedle plate 20 functions as a kind of optical fiber to increase the total amount of light transmitted through the skin and to increase the depth at which the light penetrates” [Page 5, Lines 1-2].
Therefore, sensing apparatus includes one or more waveform generators, wherein the one or more waveform generators comprise one or more light-emitting diodes (i.e. LED light source 40 with red LED 41 and near infrared LED 43) configured to emit light signals, wherein the light signals include visible red light signals and near-infrared signals.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing apparatus of Bennet in view of McAllister such that the one or more waveform generators comprise one or more light-emitting diodes are configured to emit light signals, wherein the light signals include visible red light signals and near-infrared signals as disclosed in Young in order to deliver light of different wavelengths to the skin of a patient. When red light is transmitted through the skin of a patient, it plays a role in promoting collagen production in the skin (See Young: [Page 4, Lines 35-36]). Alternatively, when near-infrared light is transmitted through the skin of a patient, it stimulates cell activity and provides skin healing effects (see Young: [Page 4, Lines 40-41]). Therefore, modifying the sensing apparatus of Bennet such that the one or more waveform generators comprise one or more light-emitting diodes are configured to emit light signals, wherein the light signals include visible red light signals and near-infrared signals as disclosed in Young would yield the predictable result of delivering light of different wavelengths to the skin of a patient so as to promote collagen production (i.e. red LED) and stimulate cell activity/provide skin healing effects (i.e. near-infrared LED).
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bennet et al. US 2019/0223806 A1 “Bennet” and McAllister et al. JP 2021/121339 A “McAllister” as applied to claim 55 above, and further in view of Gyu et al. KR 102367746 B1 “Gyu”.
Regarding claim 59, Bennet in view of McAllister discloses all features of the claimed invention as discussed with respect to claim 55 above. However, the combination does not teach “wherein the one or more waveform generators comprise one or more ultrasonic generators configured to emit ultrasonic signals, and wherein the microneedle is configured to act as ultrasonic waveguides for the ultrasonic signals”.
Gyu is within the same field of endeavor as the claimed invention because it involves a method for producing transdermal administration type drug patch microneedles and an ultrasonic device for injection (see [Abstract]).
Gyu teaches “wherein the one or more waveform generators comprise one or more ultrasonic generators configured to emit ultrasonic signals, and wherein the microneedle is configured to act as ultrasonic waveguides for the ultrasonic signals” (“The ultrasonic device for injection is characterized by comprising: a flexible hydrogel base layer having an average thickness of 1-1.5 millimeters; a microneedle layer in which one or more conical microneedles are disposed at regular intervals on one plane of the hydrogel base layer, wherein the microneedles are formed by mixing biodegradable polymers with a medicine solution; and a piezoelectric film layer which is closely attached to the other plane of the hydrogel base layer, is flexible, and generates an ultrasonic signal of 20-1,000 megahertz by the application of an operating power source” [Abstract]; “The transdermal injection-type drug patch microneedle ultrasonic injection device 900 is configured to include a hydrogel base layer 1000, a chemical solution microneedle 2000, a piezoelectric film layer 3000, and a power supply unit 4000” [Page 4, Lines 16-18]; “The piezoelectric film layer 3000 is closely adhered to the other side plane of the hydrogel base layer 1000, is flexible, and generates and outputs an ultrasonic signal of 20 to 1,000 megahertz by the application of operating power” [Page 5, Lines 15-16].
Since the piezoelectric film layer 3000 generates and outputs an ultrasonic signal, the piezoelectric film layer 3000 represents an ultrasonic generator. As shown in FIG. 2, the transdermal injection-type drug patch microneedle includes microneedles 2000 on the hydrogel base layer 1000, the piezoelectric film layer 3000 being on the other side of the hydrogel base layer 1000. Therefore, in order for the ultrasonic signal from the piezoelectric film layer 3000 to each the patient, the ultrasonic signal must pass through the hydrogel base layer 1000 and the microneedles 2000. Thus, the microneedles 2000 must act, at least in part as an ultrasonic waveguide. Therefore, the sensing apparatus includes one or more waveform generators in the form of one or more ultrasonic generators (i.e. piezoelectric film layer 3000) configured to emit ultrasonic signals, and wherein the microneedle (i.e. 2000) is configured to act as ultrasonic waveguides for the ultrasonic signals.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing apparatus of Bennet in view of McAllister such that the one or more waveform generators comprise one or more ultrasonic generators configured to emit ultrasonic signals, and wherein the microneedles is configured to act as ultrasonic waveguides for the ultrasonic signals as disclosed in Gyu in order to easily enable ultrasonic signals to be emitted into the patient for performing diagnosis and assessment thereof. Emitting ultrasonic signals to a patient through microneedles is one of a finite number of techniques which can be used to deliver ultrasonic signals to a patient with a reasonable expectation of success. Thus, modifying the sensing apparatus of Bennet such that the one or more waveform generators comprise one or more ultrasonic generators configured to emit ultrasonic signals, and wherein the microneedles is configured to act as ultrasonic waveguides for the ultrasonic signals as disclosed in Gyu would yield the predictable result of easily enabling ultrasonic signals to be emitted into the patient for performing diagnosis and assessment thereof.
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.
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797
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