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 .
Response to Amendment
This office action is responsive to the amendment filed on 4/15/2026. As directed by the amendment: claims 1 and 15-16 have been amended. Thus, claims 1-10 and 13-18 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 4/15/2026 have been fully considered but they are not fully persuasive.
Regarding applicant’s argument regarding the preceding 112b rejection on page 5:
Applicant's present amendment resolves the preceding office actions stated 112b rejection of claims 1 and 15-16.
Regarding applicant’s argument regarding the independent claims on page 6-14:
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that the prior art reference of Sun “fails to disclose or teach the technical effects achieved by the parallel shunting architecture of the application” because 1) a technical effect of the relative difference between a resistance R2 of a user’s skin and a dielectric layer’s predetermined resistance R1 results in a greater proportion of an electric current translating through the dielectric layer as opposed to the user’s skin, consequently passively limiting a current flowing through the skin, 2) Applicant alleges that Sun “not assign any resistance-matching or shunt-regulating function to its carrier layer, nor does it teach or suggest that the carrier layer could be configured as an independent shunt branch connected in parallel with the skin” and 3) the invention of the application “explicitly utilizes the Joule heat generated by the current flowing through the dielectric layer to raise the skin surface temperature, thereby enhancing the permeability of the stratum corneum and facilitating drug penetration -- Sun neither mentions nor utilizes this thermal effect whatsoever”.
Examiner notes regarding the first two points in applicant’s arguments that while Sun may appear silent regarding a supposed shunting or relative differential of current which travels through a dielectric layer as compared to an amount of current which travels through a user’s skin, it is readily apparent to a person of ordinary skill in the art that Sun’s disclosed invention does explicitly disclose that some there is some diffusion of electrical current between both a dielectric layer and a user’s skin during the iontophoretic function of Sun’s invention. Paragraph 2-3 of Sun discuss that electric iontophoresis devices rely on an electric potential produced between an anode and cathode which are applied to a barrier membrane/user’s skin to enable enhance permeation of ionic species into the barrier membrane/skin. Further paragraph 27-30+74-76+89-90 of Sun explicitly states that the present invention relates to a device which is arranged in communication with a barrier membrane such that electricity and an active agent stored/electrochemically generated within a carrier/dielectric layer may be administered from the carrier/dielectric layer and into the barrier membrane/skin, and noting that electric current travels through the carrier/dielectric layer between the electrodes due to the electric potential between the electrodes. Notably paragraph 32 of Sun states that the current density used by the invention is defined in terms of current intensity per unity area of the barrier membrane, further demonstrating that current is applied to the barrier membrane.
Examines summarizes that Sun does disclose an invention where there is some parallel electrical arrangement between the carrier/dielectric layer and the barrier membrane/skin of a user, such that according to the plainly understood Ohm’s Law the relative amount current travelling between these parallel circuit paths, as driven by the electric potential between Sun’s electrodes, is determined based on the relative resistance of these circuit paths.
In response to the third point in applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the Joule heat generated by the current flowing through the dielectric layer to raise the skin surface temperature, thereby enhancing the permeability of the stratum corneum and facilitating drug penetration) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that the prior art reference of Schneider is 1) not considered analogous art and thus would have not motivation to combine the prior art in the described manner, 2) there are allegedly “Fundamental differences [which] exist between schneider's "conductive material" and the application's "dielectric material" such that analogy between the two and constitutes an unreasonable extension of the disclosure because the noted structures have supposed differences material properties, physical form, circuit position, and design purpose, 3) Schneider allegedly does not disclose or suggest a circuit architecture with a conductive material in parallel with skin, 4) Schneider allegedly does not disclose or suggest the specific resistance ratio between R1 and R2 such that less current travels through a user’s skin relative to an amount of current passing through a conductive material, and 5) applicant alleges that Schneider teaches away from the application because Schenider allegedly states that more current could travel through a user’s skin if the resistance of the conductive medium is raised relative to the resistance of the user’s skin.
Regarding applicant’s first point that Schneider is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Schneider is reasonably pertinent to the particular problem of controlling an amount of current distributed through a user’s skin relative to an amount of current distributed to an electrically conductive medium in parallel connection with the skin. Further Schneider pertains to a manner of diffusing ionic agents into a user’s skin via electromotive force, and therein also pertains to an iontophoresis administration invention.
Regarding applicant’s second and third points, Examiner’s office action is clear in that Schneider is not relied upon for incorporating the structure of Schneider’s invention, rather Schneider clearly teaches in its paragraph 60 that where iontophoretic arrangement comprises a parallel arrangement of a user’s tissue and an electrically conductive layer as driven by an electric potential between electrodes, the same arrangement disclosed by applicant and the primary reference of Sun, there may be a relative differential in the amount of current travelling through the parallel circuit paths. Accordingly, Schneider does pertain to the circuit structure pertinent to Sun and the disclosed invention such that the teachings provided by Schneider are applicable and incorporable the invention of Sun to arrive at the claimed invention.
Regarding applicant’s fourth and fifth points, Examiner’s office action is clear that Schneider teaches it is desirable for the resistance of a conductive medium to be some amount less a resistance of user’s skin, such that more current travels through the conductive medium as opposed to travelling through a user’s skin. Examiner’s office action is clear in that it is not being relied upon for an alleged teaching/motivation that a resistance of a conductive medium should be lower than a resistance of a user’s skin. It is well understood by all persons of ordinary skill in the art that any two resistance values in an electrical circuit, have a resistance ratio between them, whether they are of equivalent resistance such that the ratio is 1:1 or as represented by a percentage as 100%, or if a first resistor is significantly less than a second resistor such that the ratio is 1:1.1, 1:5, 1:10, or 1:100000. Such Schneider’s teachings provide sufficient specificity that during routine optimization of the resistance of Sun’s claimed integrated dielectric layer to be some amount less than the resistance of a barrier membrane/tissue/user’s skin, there naturally exists a ratio between these two resistances, such that the claimed ratio, or the claimed amount of a first resistance is less than a second resistance, between these two elements would be an obvious to arrive at. Examiner further notes that this ratio simply relates to an analysis of parallel resistors in a circuits based on the well understood and established Ohm’s Law.
Applicant summarizes that such a combination of references would rely upon impermissible hindsight.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant's argument that the parallel shunting architecture and specific resistance ratio, as required by the claimed device, achieve unexpected technical effects, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Accordingly, the rejection of applicant’s claims in view of the prior art of record as presented in the preceding and present office action stands.
Claim Rejections - 35 USC § 103
Claims 1-2, 4-6, 8-10, 13-14, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 20040267232 A1, henceforth written as Sun, in view of US 20210113829 A1, henceforth written as Qiu, in view of US 20150272906 A1, henceforth written as Jordan, and further in view of US 20070239212 A1, henceforth written as Schneider.
Regarding Claim 1,
Sun discloses:
An iontophoresis administration device, comprising:
(device 500; fig 1)
a power supply for generating electricity required to penetrate a medicament to be penetrated into an administered area of an organism; --
(paragraph 27-33; battery 320 provide electrical power to dispense the active agent within carrier layer 120 into a barrier membrane such as skin of a user; fig 1)
an integrated dielectric layer for covering the administered area,
(paragraph 82+88-89; carrier layer 120 is applied over a barrier membrane)
wherein the integrated dielectric layer comprises: a gel,
(paragraph 35+37+41-42+86; carrier layer 120 contains a gel or may be considered a semi-solid gel)
and the medicament to be penetrated, wherein the medicament is polarized and dispersed in the gel in a free-state;
(paragraph 34-36+54-67, the active agent is considered an electrolyte and thus is charged/polarized; paragraph 27-29+55+74+76, the active agent is dispersed from the carrier 120 via iontophoresis, and thus can be considered to be dispersed in a free state)
a plurality of electrodes for electrically connecting with the power supply and the integrated dielectric layer respectively,
(electrode 240 and electrode 140 are disposed in carrier layer 120 and connected to power supply 320 via wire 110 and wire 210; fig 1)
such that the electricity generated by the power supply flows through the administered area and at least part of the integrated dielectric layer respectively, --
(paragraph 27-30+73-76, demonstrate that such an invention as disclosed in fig 1 produces a current which travels between electrode 240 and electrode 140 through the carrier, and which travels through the barrier membrane of the user inducing a biological response)
wherein the plurality of electrodes comprises at least a first electrode, a second electrode, -- wherein the first electrode is electrically connected with a first end of the first power supply, the second electrode is electrically connected with a second end of the first power supply, --
(paragraph 81; electrode 140 and 240 are connected to opposite poles of battery 320; fig 1)
the integrated dielectric layer -- is in parallel connection with -- the administered area --
(paragraph 27-30+73-76; the electrical current induced by the electrical energy provided by battery 320 to electrodes 140 240 travels through both carrier layer 120 and the barrier membrane of a user, thus can be considered to be in parallel connection)
wherein the plurality of electrodes are -- conductive electrode films separated from each other;
(fig 1 illustrates electrodes 140 240 as relatively thin in a height direction compared to the height of the entire device 500, thus the electrodes 140 240 may be considered a film; paragraph 82, electrodes 140 240 are separated from each other by a gap "a")
the iontophoresis administration device further comprising: a back substrate layer for covering the plurality of electrodes, and the back substrate layer is an insulation material;
(paragraph 81+83; backing layer 160 formed from polyethylene, an insulative material)
and a plurality of connectors for electrically connecting the power supply and the plurality of electrodes respectively, each of the plurality of connectors is at least partially disposed in the back substrate layer.
(wires 110 210 connect power supply 320 and electrodes 140 240 together, and are disposed in backing layer 160; fig 1)
Sun discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
wherein the power supply comprises at least a first power supply and a second power supply;
wherein the plurality of electrodes comprises at least a --, a third electrode and a fourth electrode, -- the third electrode is electrically connected with a first end of the second power supply and the fourth electrode is electrically connected with a second end of the second power supply;
Sun notably provides in paragraph 78-79 that the device 500 may be fabricated into various shapes and sizes to fit the contours of various anatomical surfaces, such as taking the form of a facial mask.
However Qiu teaches a iontophoretic drug delivery system formed into a facial mask comprised of a multitude of pairs of drug delivering electrode arrays, see electrode assembly pairs 1 1’, 2 2’, 3a 3a’, 3b 3b’ in fig 8-9, where each electrode is connected to an end of at least one of a plurality of power sources, see fig 3+11, through a switch matric/multiplexer. Paragraph 121+123+144-153+158-163+240-250 demonstrate that the switch matrix/multiplexer is utilized to selectively drive the electrode assembly to deliver drug to a user’s skin in a uniform manner. Paragraph 124-125 demonstrate that this invention is advantageous in that it promotes a controlled and even distribution of drug, see fig 4+5.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Qiu’s teachings of implementing multiple electrodes connected to multiple power sources in a facial mask to the device disclosed by Sun which may be formed into a facial mask, by replacing the switch and battery disclosed by Sun with the multiplexer/switches and multitude of power sources taught by Qiu to drive a multitude of Sun’s device disposed in a manner similar to the electrode array arrangement taught by Qiu, in order to advantageously arrive at a facial mask with a multitude of selectively actuable electrode arrays for distributing a therapeutic material to a facial area in a controlled and evenly distributed manner.
Sun in view of Qiu discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
wherein the plurality of electrodes are flexible
However Jordan teaches an iontophoretic drug delivery device where the plurality of its electrodes 226 236 are flexible/stretchable to allow the device 200 to conform to a therapy site, see paragraph 44+59 and fig 2-4.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement the flexible electrode teachigns of Jordan to the electrode and device of Sun in view of Qiu, in order to advantageously arrive at an invention which can better conform to, be applied to, and adhere to a therapy site of a user, see paragraph 44 of Jordan
Sun in view of Qiu and Jordan discloses the elements of the present claim, as described above. Yet, it remains silent regarding:
wherein the at least part of the integrated dielectric layer has a predetermined resistance value, R1;
the predetermined resistance value R1 of the integrated dielectric layer is 10%-90% of the skin resistance R2 of the administered area;
However Schneider teaches an iontophoresis device having multiple electrode joined by a conductive material conveying a current through the conductive material and tissue, and specifically teaches in paragraph 60 that “When the resistance of the tissue is greater than the resistance of the conductive material, then proportionally more current may flow through the conductive material than through the tissue. Accordingly, in various embodiments, a conductive material may be selected, which has a resistance that may be greater or less than the anticipated resistance of a type of target tissue, depending on whether more or less current is desired to flow through the target tissue.”
To re-phrase this with the language provided in the claims, the dielectric layer has a resistance relative to the resistance of the skin to have medicament administered to it to elicit a desired current through the administered area.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to implement Schneider’s teachings of the criticality of the relative electrical resistance between a conductive material and skin resistance to the integrated dielectric layer disclosed by Sun by routinely optimizing the resistance of Sun’s dielectric layer relative to a user’s skin within the claimed range, in order to advantageously arrive at an invention which dispenses a desired amount of current through the administered area, see paragraph 60 of Schneider and MPEP 2144.05, therein avoiding risks associated with high currents through a biological specimen such as tissue damage and death.
Regarding claim 2, the modified device of Sun in view of Qiu, Jordan, and Schneider discloses:
The device according to Claim 1, wherein the gel comprises at least one of the following components: polyethylene glycol, polyvinyl alcohol, polyhydroxyethyl methacrylate, --, --, gelatin, alginic acid.
Sun: (paragraph 35+37+41-42+86; carrier layer gel 120 can contain polyethylene glycol, polyvinyl alcohol, polymer hydroxyethyl methacrylate, gelatin, alginic acid)
Regarding claim 4, the modified device of Sun in view of Qiu, Jordan, and Schneider discloses:
The device according to Claim 1, wherein the medicament to be penetrated comprises vitamin C and arbutin.
(paragraph 55+57-58; the carrier comprises multiple active agents such as vitamin c and arbutin)
Regarding claim 5, the modified device of Sun in view of Qiu, Jordan, and Schneider discloses:
The device according to Claim 1, wherein the medicament to be penetrated comprises vitamin C and tranexamic acid.
(paragraph 55+57-58; the carrier comprises multiple active agents such as vitamin c and tranexamic acid)
Regarding claim 6, the modified device of Sun in view of Qiu, Jordan, and Schneider discloses:
The device according to Claim 1, wherein the medicament to be penetrated has a molecular weight less than or equal to 10,000 daltons.
(paragraph 55-57; the active agent may be vitamin c, which has a molecular weight of 176 daltons)
Regarding claim 8, the modified device of Sun in view of Qiu, Jordan, and Schneider discloses:
The device according to Claim 1, wherein the electricity is an alternating current and the current intensity of the electricity is less than or equal to 5 mA.
Examiner note in light of the modification made in claim 1 above, the claimed electricity of the modified device is provided by the power source of Qiu, which provides an alternating current between 0.01 and 4 mA, see paragraph 167-168+173.
Regarding claim 9, the modified device of Sun in view of Qiu, Jordan, and Schneider discloses:
The device according to Claim 1, wherein the electricity is a direct current and the current intensity of the electricity is less than or equal to 5 mA.
Examiner note in light of the modification made in claim 1 above, the claimed electricity of the modified device is provided by the power source of Qiu, which provides a direct current between 0.01 and 4 mA, see paragraph 167-168+173.
Regarding claim 10, the modified device of Sun in view of Qiu, Jordan, and Schneider discloses:
The device according to Claim 9, wherein the current intensity of the electricity is greater than or equal to 0.01 mA.
Examiner note in light of the modification made in claim 1 above, the claimed electricity of the modified device is provided by the power source of Qiu, which provides a direct current between 0.01 and 4 mA, see paragraph 167-168+173.
Regarding Claim 13, The modified device of Sun in view of Qiu, Jordan, and Schneider discloses:
The device according to Claim 1, wherein the power supply further comprises a third power supply and a fourth power supply,
(Examiner notes that in view of the combination of Sun in view of Qiu made in claim 1 above, that the device’s of Sun are disposed in the sub-electrode assembly positions 1 1’ 2 2’ 3a 3a’ 3b 3b’ of Qiu, such that each discrete sub-electrode assembly has Sun’s two electrodes. Thus as noted in paragraph 149 of Qiu, the number of power supplies is at least double the number of electrodes and consequently the modified device comprises at least a third power supply and a fourth power supply)
and the plurality of electrodes further comprises a fifth electrode,
(Examiner notes that in view of the combination of Sun in view of Qiu made in claim 1 above, that the device’s of Sun are disposed in the sub-electrode assembly 1 1’ 2 2’ 3a 3a’ 3b 3b’ of Qiu, such that each discrete sub-electrode assembly has Sun’s two electrodes. Thus the modified device has at least a fifth electrode)
wherein a first end of the third power supply is electrically connected with the second end of the first power supply, a second end of the third power supply is electrically connected with the fifth electrode, a first end of the fourth power supply is electrically connected with the first end of the first power supply, and a second end of the fourth power supply is electrically connected with the second end of the third power supply.
(see examiner’s annotation of Qiu’s fig 11, a simplified view of Qiu’s power supply connection to various electodes, demonstrating the claimed power supply and electrode configuration was implemented in the modification made in claim 1 above)
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Regarding Claim 14, The modified device of Sun in view of Qiu, Jordan, and Schneider discloses:
The device according to Claim 1, the iontophoresis administration device comprises plurality of power supplies,
(Examiner notes that in view of the combination of Sun in view of Qiu made in claim 1 above, that the device’s of Sun are disposed in the sub-electrode assembly positions 1 1’ 2 2’ 3a 3a’ 3b 3b’ of Qiu, such that each discrete sub-electrode assembly has Sun’s two electrodes. Thus as noted in paragraph 149 of Qiu, the number of power supplies is at least double the number of electrodes and consequently the modified device comprises a plurality of power supplies)
the plurality of power supplies are connected in series and/or in parallel with each other for providing appropriate voltage and current to penetrate the medicament to be penetrated into the administered area.
Qiu: (fig 3+11 of Qiu, implemented in the modification made in claim 1 above, demonstrate that the power supplies are connected in series/parallel to provide a desired voltage/current to the administered area; paragraph 168)
Regarding claim 17, the modified device of Sun in view of Qiu, Jordan, and Schneider discloses:
The device according to Claim 1, wherein the gel comprises collagen.
(paragraph 41; carrier medium comprises gelatin, a form of collagen)
Regarding claim 18, the modified device of Sun in view of Qiu, Jordan, and Schneider discloses:
The device according to Claim 8, wherein the current intensity of the electricity is greater than or equal to 0.01 mA.
Examiner note in light of the modification made in claim 1 above, the claimed electricity of the modified device is provided by the power source of Qiu, which provides an alternating current between 0.01 and 4 mA, see paragraph 167-168+173.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sun in view of Qiu, Jordan, and Schneider as applied to claim 1 above, and further in view of US 20050228336 A1, henceforth written as Keusch.
Regarding Claim 3,
Sun in view of Qiu, Jordan, and Schneider discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, is silent regarding:
wherein the plurality of flexible conductive electrode films separated by a predetermined interval, wherein the predetermined interval is 0.1 to 10 mm.
However, Keusch teaches an iontophoresis device
wherein the plurality of flexible conductive electrode films separated by a predetermined interval, wherein the predetermined interval is 0.1 to 10 mm.
(paragraph 63; selecting the distance between electrodes 104 106 based on factors such as thickness, width, surface area, and other factors can ensure a more uniform distribution of media, Keusch arrives at 0.25 inches, 6.35 mm, as shortest appropriate distance for its invention; fig 8-9)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to implement Keusch’s teachings regarding the criticality of the distance between electrodes as a result effective variable impacting the uniformity of media delivery to the modified device Sun in view of Qiu, Jordan, and Schneider in order to arrive at an invention which advantageously routinely optimizes the distance between electrodes distributing media in order to more uniformly distribute said media, see paragraph 63 of Keusch and MPEP 2144.05.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sun in view of Qiu, Jordan, and Schneider as applied to claim 1 above, and further in view of US 20150094647 A1, henceforth written as Kalghatgi.
Regarding Claim 7,
Sun in view of Qiu, Jordan, and Schneider discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However is silent regarding:
The device according to Claim 1, wherein the thickness of the integrated dielectric layer is less than or equal to 50 mm.
However, Kalghatgi teaches an iontophoresis device
wherein the thickness of the integrated dielectric layer is less than or equal to 50 mm.
(paragraph 54; a 1mm insulating dielectric barrier 304; fig 3)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the dielectric layer thickness taught by Kalghatgi to the integrated dielectric layer of the modified device of Sun in view of Qiu, Jordan, and Schneider in order to ensure that the electrode is adequately covered and therein ensure discharging the electrode results in iontophoresis into the medium and not an air gap without medicament to be distributed.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sun in view of Qiu, Jordan, and Schneider as applied to claim 1 above, and further in view of US 20080188791 A1, henceforth written as DiFiore.
Regarding Claim 15,
Sun in view of Qiu, Jordan, and Schneider discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However is silent regarding:
The device according to Claim 1, wherein the predetermined resistance value R1 is greater than 100 ohms and less than or equal to 100K ohms.
As examiner noted in claim 1 above, Jordan teaches that the relative resistance difference between a claimed dielectric layer and a patient’s skin is a result effective variable for distributing a desirable amount of current to a patient, and accordingly it was obvious to arrive at the aspect of the claimed invention where the dielectric layer’s resistance is the claimed amount less than patient’s skin resistance.
However, DiFiore teaches an iontophoresis device in paragraph 60 that skin resistance varies amongst humans in a meaningful range of about 30 kOhm to 40 kOhm.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to consider DiFiore’s skin resistance range teachings, in light of Jordan’s teachings of a relative resistance between a conducting layer and skin driving a desired current through skin, by routinely optimizing the resistance of dielectric layer of the modified device relative to a known range of human skin resistance in order to arrive at an invention which is relatively safe for human use, see paragraph 60 of DiFiore and MPEP 2144.05.
Regarding Claim 16,
Sun in view of Qiu, Jordan, Schneider, and DiFiore discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However is silent regarding:
The device according to Claim 15, wherein the predetermined resistance value R1 is greater than 1K ohms and less than or equal to 12K ohms.
As examiner noted in claim 1 above, Jordan teaches that the relative resistance difference between a claimed dielectric layer and a patient’s skin is a result effective variable for distributing a desirable amount of current to a patient, and accordingly it was obvious to arrive at the aspect of the claimed invention where the dielectric layer’s resistance is the claimed amount less than patient’s skin resistance.
However, DiFiore teaches an iontophoresis device in paragraph 60 that skin resistance varies amongst humans in a meaningful range of about 30 kOhm to 40 kOhm.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to consider DiFiore’s skin resistance range teachings, in light of Jordan’s teachings of a relative resistance between a conducting layer and skin driving a desired current through skin, by routinely optimizing the resistance of dielectric layer of the modified device relative to a known range of human skin resistance in order to arrive at an invention which is relatively safe for human use, see paragraph 60 of DiFiore and MPEP 2144.05.
Conclusion
THIS ACTION IS MADE FINAL. 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 FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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