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 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, 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keenan et al (Pub. No.: US 2010/0228122).
Regarding claim 1, Keenan et al disclose a method comprising:
providing a syringe device having a single needle (hollow patient needle 27) [see 0131 and fig 5] by disclosing handheld device is loaded with two syringes containing a drug (13) and a sterile saline solution (29) [see 0131];
a first syringe (microbubble syringe 7) comprising saline with microbubbles [see 0109, 0131, 0139 and figs 2, 5] by disclosing a small quantity of saline solution infused with gas microbubbles a brief distance in order to clearly indicate the position of the needle tip and enable the safe guidance of the needle to the tumor [see 0139];
a second syringe comprising a therapeutic compound (drug 13) [see 0131 and fig 5] by disclosing handheld device is loaded with two syringes containing a drug (13) and a sterile saline solution (29) [see 0131];
a connector (Y-shaped conduit) coupling the single needle to the first syringe and to the second syringe [see 0131 and fig 5] by disclosing a Y-shaped conduit connects the outlet of each of the syringes and merges the two fluid paths into a single fluid path connected to a hollow patient needle (27) that may be inserted into the point of interest (28) [see 0131];
guiding the single needle to an injection site of a patient [see abstract, 0138-0139] by disclosing a small quantity of saline solution infused with gas microbubbles a brief distance in order to clearly indicate the position of the needle tip and enable the safe guidance of the needle to the tumor [see 0139];
injecting, with the first syringe, a quantity of saline with microbubbles [see 0101, 0139] by disclosing a small quantity of saline solution infused with gas microbubbles a brief distance in order to clearly indicate the position of the needle tip and enable the safe guidance of the needle to the tumor [see 0139];
confirming a desired position of the single needle, with ultrasound imaging, by identifying the microbubbles in the quantity of saline relative to a tip of the single needle and further relative to one or more anatomical landmarks visible with the ultrasound imaging [see abstract, 0138-0139, fig 5] by disclosing a small quantity of saline solution infused with gas microbubbles a brief distance in order to clearly indicate the position of the needle tip and enable the safe guidance of the needle to the tumor [see 0139];
injecting, with the second syringe, the therapeutic compound at the injection site [0037, 0129, 0131, 0138-0139] by disclosing the liquid drug may be any suitable therapeutic agent or agents that can be delivered under pressure through a needle [see 0129].
Regarding claim 5, Keenan et al disclose a method comprising:
providing a syringe device having a single needle (hollow patient needle 27) [see 0131 and fig 5] by disclosing handheld device is loaded with two syringes containing a drug (13) and a sterile saline solution (29) [see 0131];
a first syringe comprising saline with microbubbles and having a first-syringe plunger (microbubble syringe plunger, see 0122) [see 0028, 0131];
a second syringe having a second-syringe plunger (drug syringe plunger) that is independently (fig 5 shows several syringes) operable relative to the first-syringe plunger [see 0122 and fig 5] and also disclose therapeutic agent may be delivered to the point of interest prior to, simultaneously with, or after the delivery of the transient bubbles [see 0045] and since the drug and the saline are delivered through two separate syringes with a different plunger each; therefore, delivering the therapeutic agent prior or after indicates that the two plungers operated independently (emphasis added);
a connector coupling the single needle to the first syringe and to the second syringe [see 0131 and fig 5] by disclosing a Y-shaped conduit connects the outlet of each of the syringes and merges the two fluid paths into a single fluid path connected to a hollow patient needle (27) that may be inserted into the point of interest (28) [see 0131];
guiding the single needle to a treatment site of a patient [see abstract, 0138-0139] by disclosing a small quantity of saline solution infused with gas microbubbles a brief distance in order to clearly indicate the position of the needle tip and enable the safe guidance of the needle to the tumor [see 0139];
injecting, with the first syringe, a quantity of saline with microbubbles [see 0101, 0139] by disclosing a small quantity of saline solution infused with gas microbubbles a brief distance in order to clearly indicate the position of the needle tip and enable the safe guidance of the needle to the tumor [see 0139];
confirming a desired position of the single needle, with ultrasound imaging, by identifying the microbubbles in the quantity of saline relative to a tip of the single needle and further relative to one or more anatomical landmarks visible with the ultrasound imaging [see abstract, 0138-0139, fig 5] by disclosing a small quantity of saline solution infused with gas microbubbles a brief distance in order to clearly indicate the position of the needle tip and enable the safe guidance of the needle to the tumor [see 0139];
with the second syringe, injecting a therapeutic compound at the treatment site [0037, 0129, 0131, 0138-0139] by disclosing the liquid drug may be any suitable therapeutic agent or agents that can be delivered under pressure through a needle [see 0129].
Regarding claim 6, Keenan et al disclose wherein injecting with the first syringe comprises
depressing the first-syringe plunger [see 0141] by disclosing the drug (13) may be delivered to the point of interest by manual means, for example by depressing a syringe plunger [see 0141].
Regarding claim 7, Keenan et al disclose wherein the second syringe comprises the therapeutic compound, and wherein injecting the therapeutic compound comprises depressing the second-syringe plunger (drug syringe plunger) [see 0122, 0141] by disclosing the drug (13) may be delivered to the point of interest by manual means, for example by depressing a syringe plunger [see 0141].
Claim(s) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al (Pub. No.: US 2010/0228122) in view of Nayak et al (Pub. No.: US 2006/0041243).
Regarding claim 2, Keenan et al don’t disclose corticosteroid.
Nonetheless, Nayak et al disclose the therapeutic compound comprises a corticosteroid [see 0221].
Therefore, one skilled in the art at the time the invention was filed would have been motivated to combine Keenan et al and Nayak et al by injecting a corticosteroid; due to its anti-inflammatory effects.
Regarding claim 3, Keenan et al don’t disclose lidocaine.
Nonetheless, Nayak et al disclose the therapeutic compound comprises lidocaine [see 0199, 0221].
Therefore, one skilled in the art at the time the invention was filed would have been motivated to combine Keenan et al and Nayak et al by injecting lidocaine; due to its anesthetic effects.
Claim(s) 4, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al (Pub. No.: US 2010/0228122) in view of Riopelle et al (Pub. No.: US 2011/0152836).
Regarding claim 4, Keenan et al disclose a method comprising:
providing a syringe device having a single needle (hollow patient needle 27) [see 0131 and fig 5] by disclosing handheld device is loaded with two syringes containing a drug (13) and a sterile saline solution (29) [see 0131];
a first syringe comprising saline with microbubbles [see 0109, 0131, 0139 and figs 2, 5] by disclosing a small quantity of saline solution infused with gas microbubbles a brief distance in order to clearly indicate the position of the needle tip and enable the safe guidance of the needle to the tumor [see 0139];
a connector coupling the single needle to the first syringe and to the second syringe [see 0131 and fig 5] by disclosing a Y-shaped conduit connects the outlet of each of the syringes and merges the two fluid paths into a single fluid path connected to a hollow patient needle (27) that may be inserted into the point of interest (28) [see 0131];
guiding the single needle to the treatment site [see abstract, 0138-0139] by disclosing a small quantity of saline solution infused with gas microbubbles a brief distance in order to clearly indicate the position of the needle tip and enable the safe guidance of the needle to the tumor [see 0139];
injecting, with the first syringe, a quantity of saline with microbubbles [see 0101, 0139] by disclosing a small quantity of saline solution infused with gas microbubbles a brief distance in order to clearly indicate the position of the needle tip and enable the safe guidance of the needle to the tumor [see 0139];
confirming a desired position of the single needle, with ultrasound imaging, by identifying the microbubbles in the quantity of saline relative to a tip of the single needle and further relative to one or more anatomical landmarks visible with the ultrasound imaging [see abstract, 0138-0139, fig 5] by disclosing a small quantity of saline solution infused with gas microbubbles a brief distance in order to clearly indicate the position of the needle tip and enable the safe guidance of the needle to the tumor [see 0139].
Keenan et al don’t disclose a second syringe configured to aspirate fluid from a treatment site of a patient, and aspirating, with the second syringe, fluid from the treatment site.
Nonetheless, Riopelle et al disclose a second syringe configured to aspirate fluid from a treatment site of a patient, and aspirating, with the second syringe, fluid from the treatment site [see 0024] by disclosing the plunger of the syringe can be withdrawn after the needle is placed beneath the skin to create a subatmospheric pressure within the syringe barrel, facilitating withdrawal of fluid when the needle tip enters the vessel/organ lumen [see 0024].
Therefore, one skilled in the art at the time the invention was filed would have been motivated to combine Keenan et al and Riopelle et al by aspirating, with the second syringe, fluid from the treatment site; to create a subatmospheric pressure within the syringe barrel, facilitating withdrawal of fluid when the needle tip enters the vessel/organ lumen [see 0024, Riopelle et al].
Regarding claim 8, Keenan et al don’t disclose wherein the second syringe is configured to aspirate fluid from a treatment site of a patient, and wherein aspirating fluid from the treatment site comprises drawing back the second-syringe plunger.
Nonetheless, Riopelle et al disclose aspirate fluid from a treatment site of a patient, and wherein aspirating fluid from the treatment site comprises drawing back the second-syringe plunger [see 0024] by disclosing the plunger of the syringe can be withdrawn after the needle is placed beneath the skin to create a subatmospheric pressure within the syringe barrel, facilitating withdrawal of fluid when the needle tip enters the vessel/organ lumen [see 0024].
Therefore, one skilled in the art at the time the invention was filed would have been motivated to combine Keenan et al and Riopelle et al by aspirating fluid from a treatment site of a patient, and wherein aspirating fluid from the treatment site comprises drawing back the second-syringe plunger; to create a subatmospheric pressure within the syringe barrel, facilitating withdrawal of fluid when the needle tip enters the vessel/organ lumen [see 0024, Riopelle et al].
Conclusion
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3798