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 .
Drawings
The drawings are objected to because:
Fig. 2 contains a reference character, I, in between 133 and 112. It is unclear as to what this character is referring to.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0074], line 5 refers to “the electrodes 128”, however the electrodes have been previously defined as 129 and the sonicator has previously been defined as 128.
Appropriate correction is required.
Claim Objections
Claims 2, 5, 10, 14, 15, and 18 are objected to because of the following informalities:
In claim 2, line 2, “centred” should read “centered”
In claim 5, line 2, “heater” should read “the heater”
In claim 10, line 2, “prior completion” should read “prior to completion”
In claim 14, line 2, “heater” should read “the heater”
In claim 15, line 3, “prior operating” should read “prior to operating”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the sequence of operation of the elements" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 5-9 are rejected by virtue of their dependency on claim 4.
Claim 18 refers to a “unitary assembly of a sonicator and an electrode”. It is unclear whether these are the same sonicator and electrodes as referred to in claim 1 or separate sonicator and electrodes altogether.
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) 1-2, 4-12, 15, 18-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Jafarzadeh (WO 2021243403 A1) in view of Sibalis (WO 8907269).
Regarding claim 1, Jafarzadeh discloses a transdermal drug applicator (skin care device 102 in Fig. 1), comprising:
a dock for a liquid drug capsule (paragraph [0062]: “connector of the device”);
a dermal contact face (application face 300 in Fig. 3);
a delivery channel (fluid conduit 139 in Fig. 12C) configured for delivering liquid from the drug capsule (paragraph [0061]) through a delivery port (apertures or pores 142) of the dermal contact face;
a controller (control processor 146 in paragraph [0069]);
a permeation enhancing subsystem interfacing the dermal contact face, the permeation enhancing subsystem comprising permeation enhancing elements operatively surrounding the delivery port and which are operative to enhance transdermal drug delivery at the contact face, the elements comprising:
a sonicator configured to apply ultrasound to the skin contacting the dermal contact face (vibration actuator 132 in paragraph [0056]);
electrodes configured to apply electric current to the skin contacting the dermal contact face (iontophoresis module 136 in paragraph [0058]);
a heater configured to heat the skin contacting the dermal contact face (heat elements 134 in paragraph [0057]); and
red light LEDs configured to apply red light to the skin contacting the dermal contact face (LEDs 130 in paragraph [0055]) and wherein the controller is programmed with a delivery program and wherein the controller is configured for controlling the operation of the elements according to the delivery program (paragraph [0070]);
Jafarzadeh is silent as to the specifics of the transdermal drug applicator being wearable.
However, Sibalis teaches a wearable transdermal drug applicator (applicator 134 in Figs. 12-13) capable of enhancing transdermal drug delivery through the use of electrodes (positive and negative applicator patches 182A and 182B) which are controlled by a controller (programmable computer 158). Sibalis teaches that it is advantageous to have a system wherein the drug applicator is mounted to the skin in order to deliver the drug at a steady state, constant state, and over a long period of time, since drug delivery is best accomplished in this manner, and further, to address the issue of the patient forgetting to activate the drug delivery mechanism (page 2, lines 1-20). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply this known technique of mounting the device to the skin such that the transdermal drug applicator is wearable as disclosed by Sibalis to modify and improve the transdermal drug applicator of Jafarzadeh to facilitate consistent and steady drug delivery.
Regarding claim 2, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 1, and Jafarzadeh further discloses that the LEDs are configured to emit a wavelength centered at approximately 670 nm (paragraph [0055] teaches that LEDs may emit light around 633 nm).
Regarding claim 4, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 1, and Jafarzadeh further discloses that the controller is configured for controlling the sequence of operation of the elements according to the delivery program (paragraph [0070]).
Regarding claim 5, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 4, and Jafarzadeh further discloses that the delivery program comprises a heat sequence during which the heater is controlled accordingly, a current sequence during which the electrodes are controlled, an ultrasound sequence during which the sonicator is controlled and a light sequence during which the red light LEDs are controlled (paragraph [0070]).
Regarding claim 6, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 4, and Jafarzadeh further discloses that the delivery program encodes an intermittent delivery sequence and wherein the controller is configured for controlling operation and non-operation of at least one of the elements accordingly (paragraph [0070]).
Regarding claim 7, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 6, and Jafarzadeh further discloses that the controller is configured for controlling the operation of at least one of the elements according to the intermittent delivery sequence (paragraph [0070]). Even though Jafarzadeh teaches the controller controls the operation of at least one of the elements, it is silent as to the specifics of controlling vasodilatory effects. However, it is well-known in the art that vibration therapy can increase vasodilation in blood vessels. Therefore, 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 device as taught by Jafarzadeh in view of Sibalis to be capable of controlling vasodilatory effects in order to increase skin absorption of the applied fluid, as taught in paragraph [0066] of Jafarzadeh.
Regarding claim 8, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 6, and Jafarzadeh further discloses that the controller is configured for controlling the operation of at least two of the elements according to the intermittent delivery sequence (paragraph [0070]). Even though Jafarzadeh teaches the controller controls the operation of at least two of the elements, it is silent as to the specifics of controlling vasodilatory effects. However, it is well-known in the art that vibration therapy can increase vasodilation in blood vessels. Therefore, 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 device as taught by Jafarzadeh in view of Sibalis to be capable of controlling vasodilatory effects in order to increase skin absorption of the applied fluid, as taught in paragraph [0066] of Jafarzadeh.
Regarding claim 9, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 8, and Jafarzadeh further discloses that the controller is configured for controlling simultaneous operation and non-operation of the sonicator and LEDs (paragraph [0070]).
Regarding claim 10, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 1, and while Jafarzadeh in view of Sibalis is silent as to the specifics of the controller ceasing operation of the heater prior to the completion of the delivery program, Jafarzadeh teaches that during a first phase of a routine, the control processor can prompt the heat element to heat the user’s skin to a specified heat temperature (paragraph [0071], lines 1-5). It would be well known in the art that once the skin temperature reaches the specified temperature, the heater would be stopped at the end of this first period of the routine. Therefore, 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 device as taught by Jafarzadeh in view of Sibalis to have the controller configured to cease operation of the heater prior to completion of the delivery program.
Regarding claim 11, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 10, and Jafarzadeh further discloses that the device further comprises a thermometer interfacing the dermal contact face (paragraph [0053], lines 1-2) and wherein the controller is configured for controlling the operation of the heater according to a temperature setpoint (paragraph [0071], lines 1-5).
Regarding claim 12, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 11, and Jafarzadeh further discloses that the controller is configured for operating the heater at a temperature setpoint of less than a maximum temperature setpoint. Jafarzadeh defines the radiator as being capable of heating up to 50 oC (paragraph [0057], lines 2-3). Jafarzadeh further specifies that in an exemplary routine, the heat element would be configured to heat the user’s skin to a setpoint of 40 oC (paragraph [0071], lines 1-5). Based on this teaching, one skilled in the art would understand that the operation of the heater at a standard setpoint set by the controller would be less than the maximum heat capable of being radiated.
Regarding claim 15, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 1, and Jafarzadeh further discloses that the controller is configured to detect skin contact by measuring skin electrical conductivity between the electrodes (paragraph [0053]). While Jafarzadeh fails to teach the specifics that the detection of skin contact by the controller is done prior to operation of the permeation enhancing elements, one skilled in the art would understand that this would be done prior to operation of the permeation enhancing elements in order to detect proper contact with the skin. Therefore, 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 device as taught by Jafarzadeh in view of Sibalis to have a controller capable of detecting skin contact by measuring electrical conductivity between the electrodes prior to operation of the permeation enhancing subsystem.
Regarding claim 18, as best understood based on the 35 U.S.C. 112(b) issue identified above, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 1, and Jafarzadeh further discloses that the applicator comprises a unitary assembly of a sonicator and an electrode (paragraph [0075], lines 2-4).
Regarding claim 19, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 1, and Jafarzadeh further discloses that the permeation enhancer elements substantially concentrically surround the delivery port (Fig. 3).
Regarding claim 20, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 1, and Sibalis further discloses that the applicator is a wrist worn device which comprises a wrist strap connected either side thereof without obstructing the elements (Figs. 12-13).
Regarding claim 21, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 1, and Jafarzadeh further discloses that the dock comprises puncture formations (piercing tip 166 in Fig. 12D) which puncture the capsule when the capsule is inserted into the dock (paragraph [0093], lines 2-3).
Regarding claim 23, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 12, and Jafarzadeh further discloses that the dock comprises a compression spring (actuator 208 in Fig. 2) therein which compresses the drug capsule (paragraph [0063]).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Jafarzadeh in view of Sibalis as applied to claim 1 above, and further in view of Ingman (US 20180326208 A1).
Regarding claim 3, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 1, but is silent as to the specifics of the heat element being an electrical resistive heater element.
However, Ingman teaches a wearable transdermal drug applicator (device 100 in Fig. 1A) comprising a heater configured to heat the skin (heating element 314; paragraph [0279]). Ingman further teaches that the heater is an electrical resistive heater element (paragraph [0398], lines 1-5). Based on Ingman’s teaching, it would be well known to one of ordinary skill in the art to use a resistor as a heat source. Therefore, it would have been obvious to one of ordinary skill in the art to modify the device as taught by Jafarzadeh in view of Sibalis to include a heater that is an electrically resistive heat element as taught by Ingman, as Ingman teaches that it is well known to use a resistor as a heat source.
Claim(s) 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Jafarzadeh in view of Sibalis as applied to claim 1 above, and further in view of Enos (US Patent 10,144,547).
Regarding claim 13, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 1, but is silent to the applicator comprising a reader configured to read delivery program instructions encoded by the drug capsule.
However, Enos teaches a device comprising a reader (scanner 18) capable of identifying a drug capsule and determining delivery program instructions encoded by the drug capsule (Col. 18, lines 37-52). Enos further teaches that having the capsule encode delivery instructions is advantageous because it reduces the risk of human errors associated with sloppy handwriting, inconsistent interpretations, and improper documentation that may lead to improper delivery (Col. 2, lines 16-24). Therefore, it would have been obvious to one of ordinary skill in the art to modify the devices as taught by Jafarzadeh in view of Sibalis to include a reader capable of identifying a drug capsule and determining delivery program instructions encoded by the drug capsule as taught by Enos to reduce the risk of human error in identifying the drug and delivering the drug to the patient.
Regarding claim 14, Jafarzadeh in view of Sibalis and in further view of Enos discloses the applicator as claimed in claim 13, and Jafarzadeh further discloses that the delivery program instructions encode a heat sequence during which the heater is controlled accordingly, a current sequence during which the electrodes are controlled accordingly, an ultrasound sequence during which the sonicator is controlled accordingly and a light sequence during which the red light LEDs are controlled accordingly (paragraph [0070]).
Claim(s) 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jafarzadeh in view of Sibalis as applied to claim 1 above, and further in view of Sullivan (US 20120068723 A1).
Regarding claim 16, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 1, but is silent as to the controller being configured to detect delivery of the liquid via the delivery channel by measuring electrical conductivity through the liquid between the electrodes.
However, Sullivan discloses a device (detector circuit 600 in Figs. 7 and 8) capable of detecting the presence and delivery of a liquid by measuring electrical conductivity through the liquid between the electrodes. Specifically, Sullivan discloses: “A conductivity detector detects the electrical conductivity of a fluid under analysis for determining chemical or physical properties of the fluid that are related its electrical properties” (Abstract). Sullivan further discloses that when liquid is present and flowing between the electrodes, conductivity is measurable, thereby detecting delivery; and when liquid is absent, conductivity drops, thereby detecting non-delivery (paragraph [0072]). Therefore, 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 device as taught by Jafarzadeh in view of Sibalis to have a controller capable of detecting the presence and delivery of a liquid by measuring electrical conductivity through the liquid between the electrodes, as taught by Sullivan, to ensure proper delivery of the liquid to the patient.
Regarding claim 17, Jafarzadeh in view of Sibalis and in further view of Sullivan discloses the applicator as claimed in claim 16, and Sullivan further discloses the controller being configured to detect when the liquid has been depleted according to the electrical conductivity. Specifically, Sullivan discloses: “if a large volume of gas is present in the fluid chamber, the resistance and/or impedance at R.sub.Unknown 602, and possibly resistances R7 640 and R8 642, will begin to rise towards infinity. This is because the volume of gas in the fluid chamber "opens" or breaks the detector circuit 600. The meter 609 can detect this increasing resistance and, if it rises above a predetermined threshold, the detector circuit 600 can determine the fluid chamber is not properly filled” (paragraph [0072]). Sullivan further discloses that the detector circuit can provide a warning or shut down the procedure if voids in the fluid might create a safety issue (paragraph [0072]). This disclosure teaches that when liquid is depleted, the resistance rises toward infinity, thereby enabling the controller to detect when the liquid has been depleted according to the electrical conductivity. Therefore, it would have been obvious to one of ordinary skill in the art to modify the device as taught by Jafarzadeh in view of Sibalis in order to be capable of detecting depletion of the liquid according to the electrical conductivity, as taught by Sullivan, in order to prevent safety issues.
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Jafarzadeh in view of Sibalis as applied to claim 21 above, and further in view of Yoshino (US 20130110053 A1).
Regarding claim 22, Jafarzadeh in view of Sibalis discloses the applicator as claimed in claim 21, but is silent as to the capsule having compressive sidewalls configured to deform when the capsule is pressed to thereby pressurize liquid contents therein.
However, Yoshino teaches a dock having puncture formations (needle tip 9 in Fig. 30) which puncture the capsule when inserted into the dock and a capsule (container body 191 in Fig. 28) having compressive sidewalls (sheet-like first member 195 and sheet-like second member 196 in Fig. 30) configured to deform when the capsule is pressed to thereby pressurize liquid contents therein (paragraph [0370]). Yoshino further teaches that this method of drug delivery is advantageous because the time for administering the drug, as well as the burden on the user, can be reduced (paragraph [0372], lines 4-6). Therefore, 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 capsule as taught by Jafarzadeh in view of Sibalis to have compressive sidewalls configured to deform when the capsule is pressed to thereby pressurize liquid contents therein, as taught by Yoshino, to reduce delivery time and burden on the user.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AIDAN L NATHAN whose telephone number is (571)270-0798. The examiner can normally be reached Monday-Friday 8:00 AM - 5:00 PM.
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, BHISMA MEHTA can be reached at (571) 272-3383. 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.
/AIDAN L NATHAN/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights