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 1 in the reply filed on February 25, 2026 is acknowledged. Currently claims 1-20 are pending in this application with claims 19-20 withdrawn from consideration.
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.
Claim 5 is 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.
Claim 5 recites the phrase “wherein the support substrate is the electrode whereby the electrode and the transfer member are a unitary structure.” This phrase is unclear, as it is not clear how the electrode and the support substrate can be two different structures as required by claim 1 but also “the support substrate is the electrode”.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 4 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 4 recites the phrase “. . . with the end portion forming a point and having a height selected to pierce through an epidermis layer of a patient's skin, but to not pierce so far as to reach the patient's nerves.” Applicant appears to be claiming positive recitation of the epidermis layer of the patient’s skin. It is suggested to claim that the device is adapted to pierce the skin or similar claim language if supported by the specification.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rajaraman (US
2014/0303471).
Regarding claim 1, Rajaraman discloses a transducer array, comprising:
an electrode having a first skin-facing side and an opposing outwardly-facing second side, the electrode comprising a first electrode surface on the first skin-facing side, and a second electrode surface on the opposing outwardly-facing second side (e.g. conductive pad 606 which has two sides as shown in Figure 6C);
and a transfer member comprising a support substrate having a first substrate surface on a first skin-facing side, wherein the support substrate is located on the first skin-facing side of the electrode (e.g. rectangle portion of electrode array 612 as labeled A in the expanded Figure 6C)
and wherein the transfer member further comprises at least one protrusion extending in a skin-facing direction from the first substrate surface and is configured to pierce a patient at a target area, the at least one protrusion having a base portion and an end portion (e.g. protrusion portion of 612 as labeled B and C in the expanded figure 6C below).
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602
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Regarding claim 2, Rajaraman additionally discloses wherein the transfer member is constructed of a flexible material configured to contour to a shape of the target area (e.g. flexible device as disclosed in Abstract).
Regarding claim 3, Rajaraman additionally discloses wherein the transfer member is constructed of a conductive material (e.g. electrode array 612 is conductive).
Regarding claim 4, Rajaraman additionally discloses wherein the at least one protrusion includes one or more of a needle and a microneedle, wherein the needle or microneedle has an elongated cone-shape or is a slender rodlike instrument with the end portion forming a point and having a height selected to pierce through an epidermis layer of a patient's skin, but to not pierce so far as to reach the patient's nerves (e.g. electrode array 612 is capable of performing this functional use limitation as shown in Figure 2B).
Regarding claim 5, as best the claim can be understood, Rajaraman additionally discloses
wherein the support substrate is the electrode whereby the electrode and the transfer member are a unitary structure (e.g. as shown in Figure 6C).
Claims 1-5, 9, and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saigal (US 2021/0106520).
Regarding claim 1, Saigel discloses a transducer array, comprising:
an electrode having a first skin-facing side and an opposing outwardly-facing second side, the electrode comprising a first electrode surface on the first skin-facing side, and a second electrode surface on the opposing outwardly-facing second side (e.g. platform 110 as shown in Figure 1B); and
a transfer member comprising a support substrate having a first substrate surface on a first skin-facing side, wherein the support substrate is located on the first skin- facing side of the electrode (e.g. metal layer 108) and wherein the transfer member further comprises at least one protrusion extending in a skin-facing direction from the first substrate surface and is configured to pierce a patient at a target area, the at least one protrusion having a base portion and an end portion (e.g. protrusions that include microneedle scaffold structure 112 that has a base and a pointy end).
Regarding claim 2, Saigal additionally discloses the transfer member is constructed of a flexible material configured to contour to a shape of the target area. (e.g. flexible device as disclosed in [0085]).
Regarding claim 3, Saigal additionally discloses wherein the transfer member is constructed of a conductive material (e.g. protrusions that include metal layer 108 and conducive coating 104 and area a part of the transfer member).
Regarding claim 4, Saigal additionally discloses wherein the at least one protrusion includes one or more of a needle and a microneedle, wherein the needle or microneedle has an elongated cone-shape or is a slender rodlike instrument with the end portion forming a point and having a height selected to pierce through an epidermis layer of a patient's skin, but to not pierce so far as to reach the patient's nerves (e.g. cones as shown in Figure 1B that are sized and shaped such only pierce the epidermis).
Regarding claim 5, as best the claim can be understood, Saigal ‘520 additionally discloses wherein the support substrate is the electrode whereby the electrode and the transfer member are a unitary structure (e.g. as shown in Figure 1B).
Regarding claim 9, Saigal additionally discloses wherein the end portion of the at least one protrusion is constructed of, or is embedded with, a salt (e.g. therapeutic agent which can include a pharmaceutically acceptable salt as disclose din [0088]).
Regarding claim 14, Saigal additionally discloses an interface member disposed against the first substrate surface of the support substrate (e.g. conductive coating 104 as shown in Figure 1B).
Regarding claim 15, Saigal additionally discloses wherein the interface member is a conductive adhesive layer (e.g. conductive coating 102 which can be considered adhesive).
Regarding claim 16, Saigal additionally discloses wherein the interface member has a first height less than a second height of the at least one protrusion (e.g. thickness or “height” of conductive coating 102 is less than the height of microneedle scaffold structure 112).
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 7-8, 10-13 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Saigal in view of Kendall (US 2021/0402182).
Regarding claims 7 and 10-12, Saigal discloses the claimed invention except the express mention of support substrate comprises a second substrate surface opposite to the first substrate surface, and wherein the transfer member further comprises a plurality of voids extending from the second substrate surface to the first substrate surface. Kendall discloses that such voids are known in the art of microneedles (e.g. the port 513.3 as shown in Figure 7B that can be considered a void; [0525]). It would have been obvious to one having ordinary skill in the art to include the void of Kendall in the device of Saigal since such a modification would provide the system with the predictable results of a reliable means of applying a hydrogel.
Regarding claim 8, Kendall additionally discloses wherein one or more of the plurality of voids is sized such that one or more of a gel, a hydrogel, and a conductive adhesive can pass through the one or more of the plurality of voids (e.g. hydrogel coating as described in [0274]).
Regarding claim 13, Kendall additionally discloses wherein the at least one protrusion extending from the support substrate includes a first protrusion and a second protrusion, and wherein the first protrusion extends at a first angle relative to the electrode and the second protrusion extends at a second angle relative to the electrode, and wherein the first angle is different from the second angle (e.g. different angle of protrusions as seen in Figure 5K).
Regarding claim 17, Kendall additionally discloses wherein the support substrate comprises a second substrate surface opposite to the first substrate surface, and wherein the transducer array further comprises an interface member disposed between the first electrode surface of the electrode and the second substrate surface of the support substrate, wherein the interface member is one or more of a gel, a hydrogel, and a conductive adhesive layer (e.g. hydrogel layer as disclosed in [0274]).
Regarding claim 18, Kendall additionally discloses a conductive material and wherein the at least one protrusion is either a needle or microneedle having a hollow core, the hollow core having the conductive material disposed therein (e.g. hollow needles as disclosed in [0292]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Saigal or Rajaraman in view of Pushpala et al. (US 2017/0128009).
Regarding claim 6, Saigal or Rajaraman disclose the claimed invention except the express mention of a dielectric material positioned between a first skin-facing side of the electrode and the first substrate surface of the transfer member. Pushpala discloses that it was well known in the art of microneedles to use dielectric materials between a first skin-facing side and a first substrate surface (e.g. as disclosed in Figure 7b and [0064]). It would have been obvious to one having ordinary skill in the art to include the dielectric material of Pushpala in the device of Saigal or Rajaraman, since such a modification would provide the system with the predictable results of a reliable means of positioning the microneedle.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792
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