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 as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
4221a in figure 12c
4221b in figure 12c
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
5231 on page 25, line 17
5231a on page 25, line 17
5231b on page 25, line 18
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract contains more than 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The reference character “120” has been used to refer to “filling module” on page 7, line 2 and “adhesive patch” on page 7, line 7.
The reference character “100” has been used to refer to “control structure” on page 7, line 23 and “control mechanism module” on page 7, line 2.
The reference character “110” has been used to refer to “infusion structure” on page 7, line 31 and “infusion mechanism module” on page 7, line 2.
The reference character “1310” has been used to refer to “power unit” on page 18, line 12 and “driving unit” on page 15, line 13.
The reference character “315” has been used to refer to “screw” on page 29, line 29 and “drive wheel” on page 29, line 3.
The reference character “136” has been used to refer to “screw” on page 29, line 35 and “elastic conductor” on page 18, line 9. Examiner has identified a single instance however; applicant is requested to check and correct all the instances in the entire specification.
Appropriate correction is required.
Claim Objections
Claims 2-17 are objected to because of the following informalities:
Regarding claims 2-17, line 1, the recitation “A skin patch drug infusion device” appears to be amended to recite “The skin patch drug infusion device” in order to refer to “A skin patch drug infusion device” recited in claim 1, line 1.
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 1-17 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.
Regarding claim 1, the recitation of “the infusion mechanism module includes an infusion module” in lines 2-3 renders the claim indefinite because the claim and the specification does not specify which components or structure of the invention are construed as “an infusion module”. Therefore, one of ordinary skill in the art would not be able to construe regarding which components or parts of infusion mechanism module be construed as a part of “an infusion module” especially when “the circuit module” claims almost all the components of the infusion mechanism module. For examination purposes, examiner construes that all the components of “the infusion mechanism module” not included in “the circuit module” are construed as a part of “an infusion module”.
Claims 2-17 being dependent on claim 1 are also rejected.
Regarding claim 12, line 3, the recitation “the control mechanism module is reusable” renders the claim indefinite because the specification describes “control mechanism module 100 is discarded after a single use” on page 7, lines 16-17 and “control mechanism module can be reused” on page 3, lines 8-9. Thus, applicant is disclosing two conflicting information in the specification. For examination purposes, examiner construes that “control mechanism module” is construed as element 100 which can include the reservoir and even though the recommendation is to discard after the use, element 100 could be reused again.
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.
Claims 1-3, 7 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hanson et al. (US 2011/0213306 A1) in view of Koizumi et al. (US 4,733,036).
Regarding claim 1, Hanson discloses a skin patch drug infusion device 12 (figure 3 or figure 19 with embodiment shown in figures 27A and 27B), comprising:
an infusion mechanism module 30 (901 in figure 27A), wherein the infusion mechanism module 30 includes an infusion module (module formed by all the components inside element 30 excluding elements 84, 82 and “other electronic circuitry” as described in paragraph 0109, lines 1-4) and a circuit module (module formed by elements 84, 82 and “other electronic circuitry” as described in paragraph 0109, lines 1-4), the circuit module includes:
a circuit board or a three-dimensional circuit (“other electronic circuitry” in paragraph 0109, lines 1-4);
a driving unit 84, for pushing a driving wheel (see element “DW” in figure 5c below) of the infusion mechanism module to implement drug infusion;
a conductive tower-spring 919 (figure 27A), for fixing (due to element 919, the driving unit are being fixed to element 20 or element 902 in figure 27A) the driving unit 80 and electrically (paragraph 0193, lines 12-18, without proper alignment, enabling signal would not be generated thereby electrically disabling the operation of the device therefore, the electronic circuit would not enable the operation of the driving unit) connecting the driving unit and a connection end on the circuit board or the three-dimensional circuit;
a control mechanism module 20 (or 24, 902 in figure 27A), electrically connected with the infusion mechanism module (electrically connected via elements 912, 914, 916 and 922, 924, 920); and
an adhesive patch (paragraph 0085, lines 4-8), for attaching the infusion mechanism module and the control mechanism module to a skin surface. Hanson is silent regarding a conductive tower-spring including a middle part with a small diameter and two end parts with large diameters in axial direction.
However, Koizumi et al. teaches a design of a key switch comprising a conductive tower-spring (figure 7) including a middle part 52 with a small diameter and two end parts with large diameters 53, 57 in axial direction for the purpose of accurate pressing of the object (column 2, lines 9-13 and manufacturing using simple and efficient method (column 2, lines 14-18).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the conductive tower-spring of Hanson to incorporate a conductive tower-spring including a middle part with a small diameter and two end parts with large diameters in axial direction as taught by Koizumi for the purpose of accurate pressing of the object (column 2, lines 9-13 and manufacturing using simple and efficient method (column 2, lines 14-18). One will be motivated to combine Hanson and Koizumi because Hanson discloses the use of the spring for moving the electrical contacts in first and second position (i.e. expanded and contract position) in the similar manner as keys of Koizumi move in up and down position. Therefore, one will be motivated to look into Koizumi for the purpose of using a spring that allows simple and efficient manufacturing process.
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Regarding claim 2, Hanson discloses wherein the infusion mechanism module 30 further includes a frame (frame formed by element 30), the frame (frame formed by element 30) is provided with a rotation shaft (see “RS” in figure 5c above, “RS” refers to a shaft extending between “DW” and element 84 in figure 5c above), the driving unit 80 is sleeved on the rotation shaft (see “RS” in figure 5c above) and rotated around the rotation shaft.
Regarding claim 3, Hanson is silent regarding wherein the diameter of the middle part of the conductive tower-spring remains the same, and the diameters of the two end parts gradually expand in a horn-like shape.
However, Koizumi teaches wherein the diameter of the middle part 52 of the conductive tower-spring remains the same, and the diameters of the two end parts 53, 57 gradually expand in a horn-like shape (see figure 7) for the purpose of accurate pressing of the object (column 2, lines 9-13 and manufacturing using simple and efficient method (column 2, lines 14-18).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the conductive tower-spring of Hanson to incorporate wherein the diameter of the middle part of the conductive tower-spring remains the same, and the diameters of the two end parts gradually expand in a horn-like shape as taught by Koizumi for the purpose of accurate pressing of the object (column 2, lines 9-13 and manufacturing using simple and efficient method (column 2, lines 14-18).
Regarding claim 7, Hanson discloses wherein the driving unit 84 includes at least one driving end (end of element 84 connected to element “RS” in figure 5c above), and a number of the at least one driving end is one or two.
Regarding claim 12, Hanson discloses wherein the infusion mechanism module 30 and the control mechanism module 20 are datable to each other and the control mechanism module 20 is reusable.
Regarding claim 13, Hanson discloses wherein the infusion mechanism module 30 and the control mechanism module 24 are disposed in one housing 21, discarded together after a single-use (elements 30 and 24 could be discarded together).
Regarding claim 14, Hanson discloses wherein the control mechanism module 902 is provided with a plurality of first electrical contacts 922, 924 exposed on a surface (surface of element 902 exposing element 924 and 922) of the control mechanism module 902 and the infusion mechanism module 901 is provided with a plurality of second electrical contacts 912, 914, 916 electrically connected with the first electrical contacts 922, 924 (see figure 27B).
Regarding claim 15, Hanson discloses wherein the first electrical contacts are rigid metal pins or elastic conductive members (paragraph 0187, lines 3-7) or the second electrical contacts are rigid metal pins or elastic conductive members (paragraph 0174, lines 5-7).
Regarding claim 16, Hanson discloses wherein the infusion mechanism module 30 further includes a case (housing of element 30), the case is provided with an outward extending portion (see “EP” in figure 19 below) and a block (see “B” in figure 19 below) is provided on an outside of the outward extending portion.
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Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hanson et al. (US 2011/0213306 A1) in view of Koizumi et al. (US 4,733,036) and further in view of Kamen et al. (US 2007/0219597 A1).
Regarding claim 8, Hanson/Koizumi (hereinafter referred as “modified Hanson”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Hanson is silent regarding wherein the circuit board is flexible.
However, Kamen teaches an adhesive patch system including a printed circuit board wherein the circuit board is flexible (paragraph 0373, lines 5-8) for the purpose of using a well-known alternative circuit design (paragraph 00373, lines 5-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the circuit board of modified Hanson to incorporate wherein the circuit board is flexible as taught by Kamen for the purpose of using a well-known alternative circuit design (paragraph 00373, lines 5-8).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hanson et al. (US 2011/0213306 A1) in view of Koizumi et al. (US 4,733,036) and further in view of Wilhelmson et al. (US 3,731,679).
Regarding claims 9 and 10, modified Hanson discloses the claimed invention substantially as claimed, as set forth above in claim 1. Hanson further discloses wherein the infusion mechanism module further includes a power supply (paragraph 0109, lines 1-4, “power source”). Modified Hanson is silent regarding an elastic conductor with protrusions, used for electrically connecting the power supply and the connection end of the circuit board or the three-dimensional circuit, wherein the elastic conductor is at least one of a conductive spring, a conductive leaf spring, a conductive rubber and a conductive silica gel.
However, Wilhelmson teaches a design of an infusion system (figure 1) comprising an elastic conductor 164 (figure 2) with protrusions (end of element 164 is protruding), used for electrically connecting the power supply and the connection end of the circuit board or the three-dimensional circuit (column 4, lines 12-28), wherein the elastic conductor is at least one of a conductive spring 164, a conductive leaf spring, a conductive rubber and a conductive silica gel for the purpose of using a well-known approach to establish the connection between the circuit and the power supply (column 4, lines 12-28).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the connection between the power supply and the circuit board or the three-dimensional circuit of modified Hanson to incorporate an elastic conductor with protrusions, used for electrically connecting the power supply and the connection end of the circuit board or the three-dimensional circuit, wherein the elastic conductor is at least one of a conductive spring, a conductive leaf spring, a conductive rubber and a conductive silica gel as taught by Wilhelmson for the purpose of using a well-known approach to establish the connection between the circuit and the power supply (column 4, lines 12-28).
Regarding claim 11, modified Hanson discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Hanson is silent regarding wherein the power supply is a double-row battery pack.
However, Wilhelmson teaches wherein the power supply is a double-row battery pack 160 (figure 2, batteries could be construed as being arranged in two rows) for the purpose of providing power to operate the circuit board and the components of the medical device (column 4, lines 12-28).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the power supply of modified Hanson to incorporate wherein the power supply is a double-row battery pack as taught by Wilhelmson for the purpose of providing power to operate the circuit board and the components of the medical device (column 4, lines 12-28).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Hanson et al. (US 2011/0213306 A1) in view of Koizumi et al. (US 4,733,036) and further in view of Heyer (US 4,534,762).
Regarding claim 17, modified Hanson discloses the claimed invention substantially as claimed, as set forth above in claim 1. Hanson further discloses wherein the adhesive patch comprises a tape 101 and a protective film (paragraph 0085, lines 8-10), a first side of the tape 101 is fixedly connected with the skin patch drug infusion device and a second side opposite the first side of the tape is coated with a paste material (paragraph 0085, lines 8-10, element 101 is formed with adhesive). However, Hanson is not clear if adhesive is provided directly or as a tape coated with adhesive and the protective film is fixed around an outer edge of the first side of the tape, an outer edge of the protective film contour corresponds to the outer edge of the first side of the tape.
However, Heyer teaches a design of a vascular puncture dressing comprising a tape 14.1 (figure 3) having a paste material 14.2 and the protective film is fixed around an outer edge of the first side of the tape, an outer edge of the protective film contour corresponds to the outer edge of the first side of the tape (see figure 2) for the purpose of using a well-known approach in protecting the adhesive layer until the use of the device (column 3, lines 32-36).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the tape and the protective film of modified Hanson to incorporate a tape coated with a paste and the protective film is fixed around an outer edge of the first side of the tape, an outer edge of the protective film contour corresponds to the outer edge of the first side of the tape as taught by Heyer for the purpose of using a well-known approach in protecting the adhesive layer until the use of the device (column 3, lines 32-36).
Hanson is further silent regarding a rockwell hardness of the protective film is higher than a rockwell hardness of the tape. The instant disclosure describes the parameter of a rockwell hardness of the protective film is higher than a rockwell hardness of the tape as being merely preferable, and does not describe a rockwell hardness of the protective film is higher than a rockwell hardness of the tape as contributing any unexpected results to the system. As such, parameters such as a rockwell hardness are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of a rockwell hardness of the protective film is higher than a rockwell hardness of the tape would be dependent on the actual application of the skin patch drug infusion device and, thus would be a design choice based on the actual application.
Allowable Subject Matter
Claims 4-6 are would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Hanson et al. (US 2011/0213306 A1) in view of Koizumi et al. (US 4,733,036), fails to disclose wherein the middle part of the conductive tower-spring is interference fit with the rotating shaft in combination with other claimed limitations of claim 4.
Claims 5 and 6 being dependent on claim 4 are also indicated allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783