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 § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(2) as being taught by US 20190201675 A1 (Miller et al.).
Regarding Claim 1, Miller teaches a method for constructing a flexible micro-needle electrode (MNE) [1500, 1550] for biopotential monitoring comprising the steps of:
providing a negative stamp [1100] that has been structured with a plurality of micro-needle structures (see Fig. 1b);
depositing [1004] at least one layer of electrically conductive (e.g., Nickel) material onto the negative stamp (see para. 0006; see also Fig. 1B);
and peeling off [1005] the at least one layer of electrically conductive material from the negative stamp to obtain the flexible micro-needle electrode [1500, 1550] comprising the at least one layer of electrically conductive material defined with the plurality of micro-needle structures (see Fig. 1B).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2-9 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190201675 A1 (Miller et al.) in view of “Lotus Leaf Structured Fluoropolymer Foils for Superhydrophobicity and Enhanced Light Management in Photovoltaic Devices (2022)” (Yoo et al.).
Regarding Claim 2, Miller does not explicitly teach that the negative stamp comprises a stamp substrate fabricated using nanoimprinting lithography, but does teach that the stamps “can be formed from any useful process” (see para. 0033). Yoo teaches a negative stamp comprising a stamp substrate fabricated using nanoimprinting lithography (see III in Fig. 1). It would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify the teachings of Miller in view of Yoo and provide that the negative stamp comprise a stamp substrate fabricated using nanoimprinting lithography. Doing so would provide a fast, accessible, and scalable stamp replication process, as recognized by Yoo.
Regarding Claim 3, Miller teaches the negative stamp is defined with the plurality of micro-needle structures having a pyramid shape (see Fig. 1B).
Regarding Claim 4, Miller does not explicitly teach the plurality of micro-needle structures include a height in a range from 20 to 200 μm, a pitch in a range from 50 to 500 μm, and a length in a range from 20 to 300 μm. However, Miller discloses structures generally within that range (see e.g., para. “a microelectrode (e.g., having a critical dimension on the range of 1 to 1000 μm, such as a radium, width, or length from about 1 to 1000 μm)”; see also para. 0097-0098, “a four sided-pyramid measuring 550 μm in height and 250 μm in its base”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the dimensions of the micro-needle structures of Miller as claimed as applicant appears to have placed no criticality on the claimed range (see para. 0119 indicating "other geometries (e.g. cone, cylinder, etc.) and dimensions (e.g. height from 20 to 200 μm, pitch from 50 to 500 μm, length from 20 to 300 μm, etc.) can also be used) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 5, Miller teaches the step of providing the negative stamp that has been structured with a plurality of micro-needle structures comprises the steps of:
providing a molding material [1100] to replicate the plurality of micro-needle structures from a positive mold [1400] (see Fig. 1B);
curing the molding material to provide the stamp substrate (see para. 0099).
Regarding Claim 6, Miller teaches the positive mold [1400] includes a positive PDMS mold defined with the plurality of micro-needle structures (see Fig. 1B; see also para. 0034, “the masters … can be formed from any useful material . . . e.g., poly(dimethylsiloxane) (PDMS)”).
Regarding Claim 7, Miller teaches the molding material [1100] includes a polymer molding material (see para. 0034).
Regarding Claim 8, Miller teaches a molding material [1100] that is UV-curable (e.g., e-Shell 200, see para. 0034).
Regarding Claim 9, Miller teaches the negative stamp is electrically conductive, and wherein the at least one layer of electrically conductive material [1200] is deposited [1003] onto the negative stamp [1100] by electrodepositing (see Fig. 1B; see also para. 0024 and 0039).
Claim(s) 11-14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190201675 A1 (Miller et al.) in view of “Lotus Leaf Structured Fluoropolymer Foils for Superhydrophobicity and Enhanced Light Management in Photovoltaic Devices (2022)” (Yoo et al.) and further in view of US 20220176096 A1 (Aksit et al.).
Regarding Claim 11-12, the combination of Miller and Yoo described above does not explicitly teach the negative stamp includes a layer of indium tin oxide (ITO) sputtered onto the stamp substrate to provide the negative stamp. However, Miller teaches an electrically conductive seed layer [1200] and that indium tin oxide is a useful conductive material (see para. 0044). Furthemore, Aksit teaches sputtering a layer of indium titanium oxide onto an insulative substrate to provide an electrically conducting substrate (see para. 0135). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Miller in view of Yoo and Aksit to further provide that the negative stamp [1100] include a layer of ITO sputtered onto the stamp substrate as the seed layer [1200] (see Fig. 1B). Doing so would allow for the negative stamp to become suitable for the following electrodeposition steps.
Regarding Claim 13, Miller teaches an exemplary seed layer with an exemplary thickness of 110 nm (see para. 0113), and Aksit teaches an ITO layer with a thickness of 60 nm (see para. 0135). Miller also discloses that varying seed layer thicknesses were tested “for their ability to remain adherent to the mold, film electrical resistance, and removal from mold post electroplating”. As such, the thickness of the seed layer (the ITO in the combination discussed above) is disclosed to be a result effective variable in that changing the thickness of the ITO can affect the desired adherence to the stamp. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Miller in view of Yoo and Aksit by modifying the thickness of the ITO to be approximately 250 nm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 14, Miller teaches the at least one layer of electrically conductive material could include gold (Au), nickel (Ni), or other metals (see para. 0039). Miller also teaches using multilayers of these conductive metals (see para. 0039). Aksit also teaches that microneedles can be coated with a nickel film followed by a gold film (see para. 0078). As such, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to include layers of both gold and nickel for the electrically conductive material of the combined invention of Miller, Yoo, and Aksit described above. Doing so would allow the microneedles to have the desired biocompatible surface profiles, as recognized by Aksit (see para. 0078).
Regarding Claim 17, Miller teaches a flexible micro-needle electrode [1500] for biopotential monitoring (see e.g., para. 0066 and 0085), comprising at least one layer of electrically conductive material [1550] defined with the plurality of micro-needle structures [1500] (see para. 0066; see also Fig. 1B).
Claim(s) 15-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190201675 A1 (Miller et al.) in view of “Lotus Leaf Structured Fluoropolymer Foils for Superhydrophobicity and Enhanced Light Management in Photovoltaic Devices (2022)” (Yoo et al.) and US 20220176096 A1 (Aksit et al.) and further in view “High‑Performance Flexible Microneedle Array as a Low‑Impedance Surface Biopotential Dry Electrode for Wearable Electrophysiological Recording and Polysomnography (2022)” (Junshi et al.).
Regarding Claim 15, the combination of Miller, Yoo, and Aksit, does not explicitly teach a layer of gold and a layer of nickel are sequentially electrodeposited onto the negative stamp employing a step-up current source. However, Junshi teaches electrodepositing using a step-up current because excessive deposition currents can result in gold surface profiles that are rough, fluffy, and are easy to crack or chip (see p. 4, sec. 2.4 Surface Modification). It would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify the combined teachings of Miller, Yoo, and Aksit in view of Junshi to provide that the gold and nickel are sequentially electrodeposited onto the negative stamp employing a step-up current source. Doing so would be a way to achieve the desired surface profiles of the microneedles, as recognized by Junshi.
Regarding Claim 16, Miller teaches a layer of 100 nm gold and a “thicker” layer of nickel (see para 0100-0101) and further teaches that “electroplating conditions may be optimized to provide the desired layer thickness for that particular electroplated metal or metal alloy” (see para. 0096). The thickness of the gold and nickel layers is disclosed to be a result effective variable in that changing the thickness will change the resulting microneedle thickness, and the microneedles can be adapted for different purposes depending on their final structure (see e.g. para 0035). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Miller in view of Yoo, Aksit, and Junshi by modifying the gold and nickel layers to include respectively a thickness of 500 nm and 5 µm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claims 18-19, Miller teaches a flexible micro-needle electrode (MNE) [1500] for biopotential monitoring and an electrical conductor arranged to electrically connect the flexible micro-needle electrode to a biopotential monitoring device (see para. 0066). Miller does not explicitly teach that the flexible micro-needle electrode is a dry electrode adapted to be worn by a patient as a patch electrode. However, Miller does suggest placing the electrode on the skin of a subject (see para. 0066). Additionally, Junshi teaches using dry electrodes as patches for biopotential monitoring (see p. 12-14, sec. 3.3. Wearable Biopotentials Recording via Wireless Flexible Electronics). It would have been obvious for a person having ordinary skill in the art to configure the electrode of Miller as a dry electrode worn as a patch. Doing so would be an obvious way to utilize the electrode for biopotential monitoring.
Regarding Claim 20, Junshi teaches the flexible micro-needle electrode is adapted to be worn for at least twenty-four hours without loss of performance (see p. 12, para. 1) due to the fact that dry electrodes “are more suitable for long-term applications”. As such, in the combination of Miller, Yoo, Aksit, and Junshi described above, similar long-term performance would be expected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN M SARCENO ROBLES whose telephone number is (571)272-8786. The examiner can normally be reached M-F: 8:30AM - 5:00PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.S./ Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/ Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights