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 do not include the following reference sign(s) mentioned in the description: 320 in paragraph 0049.
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. 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:
The reference character “321” in paragraph 0065, “320” in paragraph 0049 and “330” in paragraph 0051 are all referring to “second shock wave generating electrode”.
The reference character “200” in paragraph 0067, line 12 and “2000” in paragraph 0067, line 3 are both referring to “drug”.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, line 13, space needs to be removed between “a” and “n” to recite “an”.
Appropriate correction is required.
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.
Claims 1 and 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Srinivasan et al. (US 2004/0260234 A1).
Following is the rejection of claim 1, under first interpretation of Srinivasan
Regarding claim 1, Srinivasan teaches a needle-free injector 100 (figure 1 with embodiment shown in figure 13) using pulsed shock waves, the needle-free injector comprising:
a power unit 122, 106, 124 (paragraph 0096, lines 5-13, paragraph 0093, lines 1-8) configured to generate pulsed power;
a pulsed shock wave generating unit (unit formed by elements 432, 434, 436, paragraph 0090, lines 1-3) configured to receive the pulsed power and generate the pulsed shock wave;
an upper housing (see “UP” in figure 13 below) in which a liquid 436 and the pulsed shock wave generating unit 432, 434, 436 are disposed therein;
a lower housing (see “LP” in figure 13 below) connected to the upper housing (see “UP” in figure 13 below) and having a drug 108 disposed therein;
a shock wave transmitting unit 438 provided between the upper housing (see “UP” in figure 13 below) and the lower housing (see “LP” in figure 13 below) and configured (paragraph 0092) to transmit the shock waves generated in the upper housing to the lower housing; and
an injection unit 114 disposed in the lower housing (see “LP” in figure 13 below) and configured to inject the drug.
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Following is the rejection of claims 1 and 8, under second interpretation of Srinivasan
Regarding claim 1, Srinivasan teaches a needle-free injector 100 (figure 1 with embodiment shown in figure 13) using pulsed shock waves, the needle-free injector comprising:
a power unit 122, 106 (paragraph 0096, lines 5-13, paragraph 0093, lines 1-8) configured to generate pulsed power;
a pulsed shock wave generating unit (unit formed by elements 432, 434, 436, 124, paragraph 0090, lines 1-3) configured to receive the pulsed power and generate the pulsed shock wave;
an upper housing (see “UP” in figure 13 above) in which a liquid 436 and the pulsed shock wave generating unit 432, 434, 436 are disposed therein;
a lower housing (see “LP” in figure 13 above) connected to the upper housing (see “UP” in figure 13 above) and having a drug 108 disposed therein;
a shock wave transmitting unit 438 provided between the upper housing (see “UP” in figure 13 above) and the lower housing (see “LP” in figure 13 above) and configured (paragraph 0092) to transmit the shock waves generated in the upper housing to the lower housing; and
an injection unit 114 disposed in the lower housing (see “LP” in figure 13 above) and configured to inject the drug.
Regarding claim 8, Srinivasan discloses wherein the pulsed shock wave generating unit 432, 434, 436, 124 includes a cable 124 configured to connect the power unit 122, 106 and a shock wave generating electrode 432.
Claims 9-11 are rejected under both interpretation of Srinivasan.
Regarding claim 9, Srinivasan discloses wherein when bubbles generated from the pulsed shock wave generating unit 432, 434, 436 (and/or 124) increases pressure in the upper housing (paragraph 0092), the shock wave transmitting unit transmits the increased pressure to the lower housing.
Regarding claim 10, Srinivasan teaches wherein the injection unit 114 injects the drug when increased pressure in the upper housing (paragraph 0092) is transmitted to the lower housing.
Regarding claim 11, Srinivasan teaches further comprising: a drug storage unit 102 (paragraph 0080, lines 1-2) configured to store the drug 108 to be provided to the lower housing; and a check valve 112 (paragraph 0081, lines 1-5) configured to allow the drug to be delivered only in a direction from the drug storage unit to the lower housing.
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.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasan et al. (US 2004/0260234 A1), under first interpretation, in view of Hunter et al. (US 7,833,189 B2).
Regarding claim 2, Srinivasan discloses the claimed invention substantially as claimed, as set forth above in claim 1. Srinivasan further discloses wherein the power unit 122, 106, 124 includes:
a power supply unit 122 (paragraph 0127, lines 7-10) configured to supply a voltage and a current; and
a switch 106 configured to apply electrical energy as pulsed power from the power supply unit 122. Srinivasan is silent regarding an electricity storage unit configured to store electricity supplied from the power supply unit, a switch configured to apply stored electrical energy from the storage unit.
However, Hunter teaches a design of a controlled needle-free injector (figures 1, 4) comprising an electricity storage unit 412 (column 9, lines 63-67) configured to store electricity supplied from the power supply unit, a switch 108 (column 7, lines 35-39) configured to apply stored electrical energy from the storage unit for the purpose of using a well-known alternative configuration to provide voltage and/or current to operate the device (column 14, lines 33-37).
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 unit of Srinivasan to incorporate an electricity storage unit configured to store electricity supplied from the power supply unit, a switch configured to apply stored electrical energy from the storage unit as taught by Hunter for the purpose of using a well-known alternative configuration to provide voltage and/or current to operate the device (column 14, lines 33-37).
Regarding claim 3, Srinivasan discloses the claimed invention substantially as claimed, as set forth above in claim 1. Srinivasan further discloses wherein the power unit 122, 106, 124 further includes an electrical circuit 124 configured to maintain a form of a generated pulse.
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasan et al. (US 2004/0260234 A1), under both interpretations, in view of Gluckman et al. (US 2013/0053934 A1).
Regarding claim 4, Srinivasan discloses the claimed invention substantially as claimed, as set forth above in claim 1. Srinivasan discloses wherein the pulsed shock wave generating unit 432, 434, 436 includes: one or more shock wave generating electrodes 432, 434 (paragraph 0090) configured to receive the pulsed power and allow a current to flow. Srinivasan is silent regarding an insulating tube disposed in proximity to at least one of the shock wave generating electrodes in contact or non-contact with the at least one of the shock wave generating electrodes.
However, Gluckman teaches a design of an electrode (figures 1(a)-(c)) wherein an insulating tube (tube corresponding to the legend “Insulator” in figurers 1(a)-(c)) disposed in proximity to at least one of the shock wave generating electrodes (see “E” in figure 1(b) below) in contact or non-contact with the at least one of the shock wave generating electrodes for the purpose of restricting electrical axis only through the desired area of interest (paragraph 0031, lines 5-9).
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 shock wave generating electrode of Srinivasan to incorporate an insulating tube disposed in proximity to at least one of the shock wave generating electrodes in contact or non-contact with the at least one of the shock wave generating electrodes as taught by Gluckman for the purpose of restricting electrical axis only through the desired area of interest (paragraph 0031, lines 5-9).
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Regarding claim 5, Srinivasan discloses the claimed invention substantially as claimed, as set forth above in claim 1. Srinivasan is silent regarding wherein in the pulsed shock wave generating unit, one end of the electrode is not exposed outside the insulating tube.
However, Gluckman teaches wherein in the pulsed shock wave generating unit (figures 1(a)-(c)), one end of the electrode (one end of “E” in figure 1(b) above is not extending beyond the tube identified with legend “insulator”) is not exposed outside the insulating tube for the purpose of restricting electrical axis only through the desired area of interest (paragraph 0031, lines 5-9).
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 pulsed shock wave generating unit of Srinivasan to incorporate wherein in the pulsed shock wave generating unit, one end of the electrode is not exposed outside the insulating tube as taught by Gluckman for the purpose of restricting electrical axis only through the desired area of interest (paragraph 0031, lines 5-9).
Regarding claim 6, Srinivasan discloses the claimed invention substantially as claimed, as set forth above in claim 1. Srinivasan further discloses wherein the shock wave generating electrodes 432, 434 includes a first shock wave generating electrode 432 and a second shock wave generating electrode 434 but is silent regarding wherein the insulating tube includes a first insulating tube having the first shock wave generating electrode located therein and longer than the first shock wave generating electrode.
However, Gluckman teaches wherein the insulating tube (see tube with legend “insulator” in figure 1(b)) includes a first insulating tube (see tube with legend “insulator” in figure 1(b)) having the first shock wave generating electrode (see “E” in figure 1(b) above) located therein and longer than the first shock wave generating electrode (see tube labeled with legend “insulator” has length greater than length “L” in figure 1(b) above of electrode “E” in figure 1(b) above) for the purpose of restricting electrical axis only through the desired area of interest (paragraph 0031, lines 5-9).
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 shock wave generating electrodes of Srinivasan to incorporate wherein the insulating tube includes a first insulating tube having the first shock wave generating electrode located therein and longer than the first shock wave generating electrode as taught by Gluckman for the purpose of restricting electrical axis only through the desired area of interest (paragraph 0031, lines 5-9).
Regarding claim 7, Srinivasan discloses the claim3ed invention substantially as claimed, as set forth above in claim 1. Srinivasan is silent regarding wherein the insulating tube further includes a second insulating tube having the second shock wave generating electrode located therein and longer than the second shock wave generating electrode.
However, Gluckman teaches wherein the insulating tube (see tube with legend “insulator” in figure 1(b)) includes a second insulating tube (see tube with legend “insulator” in figure 1(b)) having the second shock wave generating electrode (see “E” in figure 1(b) above) located therein and longer than the second shock wave generating electrode (see tube labeled with legend “insulator” has length greater than length “L” in figure 1(b) above of electrode “E” in figure 1(b) above) for the purpose of restricting electrical axis only through the desired area of interest (paragraph 0031, lines 5-9).
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 shock wave generating electrodes of Srinivasan to incorporate wherein the insulating tube includes a second insulating tube having the second shock wave generating electrode located therein and longer than the second shock wave generating electrode as taught by Gluckman for the purpose of restricting electrical axis only through the desired area of interest (paragraph 0031, lines 5-9).
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