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 Objections
Claim 6 is objected to because of the following informalities: line 5 recites “dug source” instead of “drug source”. 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 5, 6 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 5 calls for “the microfluidic chip, the drug source and the membrane” to be fixed by a PDMS having adhesive properties. Claim 3, from which claim 5 depends, calls for the microfluidic chip to comprise a drug source, a membrane, and a receptor channel. Since the drug source and the membrane are part of the microfluidic chip, as defined by claim 3, it is not clear how the microfluidic chip is fixed to the drug source and the membrane. The specification page 9, para. 0054 describes the drug source and the membrane to be fixed with PDMA, thereby forming the microfluidic chip unit. Since it is unclear how the microfluidic chip is fixed to portions of itself, the scope of claim 5 is unclear.
Claim 6 calls for the microfluidic chip, the drug source, the membrane, and the receptor channel to be fixed to a PMMA plate. As discussed above, the drug source, the membrane, and the receptor channel for the microfluidic chip itself, and therefore, it is unclear how the microfluidic chip is fixed to these elements.
Claim 6 calls for the elastomeric polymer and a curing agent to be mixed at a second ratio. It appears as though this second ration is defined with regard to a first ratio as recited in claim 5. However, claim 6 does not include claim 5, as both claims depend from claim 3, and therefore, the scope of “a second ratio” as recited in claim 6 cannot be determined.
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.
Claim(s) 1, 3, 4, 7-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sibalis et al (US 5,135,479).
Regarding claim 1, Sibalis discloses an iontophoresis transdermal drug delivery device (col. 10, line 18). The limitation “for cancer treatment” is interpreted to be an intended use limitation. The device of Sibalis is capable of delivering any ionic drug, including cancer treating drugs, and therefore is capable of being used for cancer treatment. Sibalis discloses the device comprising: a power module comprising a battery 28 (col. 4, line 62); a microcontroller module 212 configured to receive a voltage from the power module to output a constant-current electrical signal (col. 13, lines 30-33; col. 6, lines 18-20); and a microfluidic chip 10 configured to store a drug and deliver the stored drug to the skin on the basis of the electrical signal (col. 4, lines 25-35).
Regarding claim 3, Sibalis discloses that the microfluidic chip comprises a drug source 24, a membrane 22, and a receptor channel (pores; col. 4, lines 25-33).
Regarding claim 4, the membrane is disposed between the drug source and the receptor channel (fig.2).
Regarding claim 7, Sibalis discloses an iontophoresis transdermal drug delivery system (col. 10, line 18). The limitation “for cancer treatment” is interpreted to be an intended use limitation. The device of Sibalis is capable of delivering any ionic drug, including cancer treating drugs, and therefore is capable of being used for cancer treatment. Sibalis discloses the system comprising: a drug delivery device 134 configured to store a drug and generate an electrical signal according to an iontophoresis mode to deliver the stored drug to the skin (col. 11, lines 55-58); and a mobile terminal 136 configured to generate a control signal for switching the iontophoresis mode or controlling the intensity of the electrical signal and transmit the control signal to the drug delivery device to control the drug delivery to the skin (col. 11, lines 36-47).
Regarding claim 8, Sibalis discloses that the mobile terminal switches the polarity of the electrical signal according to the control signal (col. 12, lines 62-68).
Regarding claim 9, Sibalis discloses that the device provides a first mode where a negative charge is applied from the battery and a second mode where a positive charge is applied from the battery (col. 12, lines 62-68). Drug permeation is either increased or interfered with based on the ionized charge of the drug.
Regarding claim 10, Sibalis discloses that when the polarity of the drug is anionic, the mobile terminal switches the first mode to an anodic mode where the polarity of the electrical signal is anodic, and switches the second mode to a cathodic mode where the polarity of the electrical signal is cathodic (col. 12, lines 62-68).
Regarding claim 11, Sibalis discloses that when the polarity of the drug is cationic, the mobile terminal switches the first mode to a cathodic mode where the polarity of the electrical signal is cathodic, and switches the second mode to an anodic mode where the polarity of the electrical signal is anodic (col. 12, lines 62-68).
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.
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sibalis in view of Yairi (US 2009/0259176).
Claim 2 differs from Sibalis in calling for the microfluidic chip to be composed of a polymethylmethacrylate (PMMA)-based fluidic plastic. Yairi teaches a microfluidic chip for use in iontophoresis (abstract), wherein the chip is composed of a suitably material such as polymethylmethacrylate (PMMA) (page 3, para. 0033). 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 of Sibalis to form the microfluidic chip from PMMA as taught by Yairi because PMMA is a suitable material for this purpose as it is non-reactive, sterilizable, and biocompatible.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sibalis in view of Kim et al (WO 2016/122148 A1). See machine translation provided herewith.
Claim 5 differs from Sibalis in calling for the microfluidic chip, the drug source and the membrane are fixed by a polymethylsiloxane (PDMS) having adhesive properties with an elastomeric polymer and a curing agent mixed at a first ratio. Kim teaches an electronic chip for use in iontophoresis, wherein the components are fixed using PDMS having adhesive properties with an elastomeric polymer and a curing agent mixed at a first ratio (top of page 8). It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the microfluidic chip of Sibalis to include PDMS adhesive with a curing agent at a first ration for fixing the membrane and the drug reservoir as taught by Kim to provide a secure and inert flexible adhesive.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sibalis in view of Yairi in view of Kim.
Claim 6 differs from Sibalis in calling for in the microfluidic chip, the drug source, the membrane, and the receptor channel to be fixed to a PMMA plate by curing a polymethylsiloxane (PDMS) with an elastomeric polymer and a curing agent mixed at a second ratio around the drug source, the membrane, and the receptor channel, to prevent the leakage of a drug between the dug source, the membrane, and the receptor channel. Yairi teaches a microfluidic chip for use in iontophoresis (abstract), wherein the chip is composed of a suitably material such as a polymethylmethacrylate (PMMA) plate (page 3, para. 0033). 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 of Sibalis to form the microfluidic chip from PMMA as taught by Yairi because PMMA is a suitable material for this purpose as it is non-reactive, sterilizable, and biocompatible. Kim further teaches an electronic chip for use in iontophoresis, wherein the components are fixed using PDMS having adhesive properties with an elastomeric polymer and a curing agent mixed at a first ratio (top of page 8). It would have been obvious to one of the ordinary skills in the art before the effective filing date of the claimed invention to modify the microfluidic chip of Sibalis to include PDMS adhesive with a curing agent at a first ration for fixing the membrane and the drug reservoir as taught by Kim to provide a secure and inert flexible adhesive.
Conclusion
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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