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, 2, 5, 8, 11, 12, 17, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spears (US 5,407,426).
Regarding claim 1, Spears discloses a system comprising: a fluid delivery device configured to deliver gas nanobubbles to a target site of a patient from a solution comprising a fluid supersaturated with a gas (col. 2, lines 45-49), wherein the fluid delivery device defines a flow channel configured to flow the solution through the flow channel such that the gas in the supersaturated fluid forms gas nanobubbles as the solution flows through the flow channel towards the target site, and wherein the gas nanobubbles remain in the fluid at least until delivery to the target site (col. 8, lines 20-32).
Regarding claim 2, Spears discloses that the fluid delivery device comprises a capillary defining a capillary flow channel extending from a capillary inlet to a capillary outlet defined by the capillary, and wherein the flow channel comprises the capillary flow channel (col. 2, lines 45-49; fig. 3).
Regarding claim 5, Spears discloses that the fluid delivery device comprises a nozzle defining a nozzle flow channel extending from a nozzle inlet and a nozzle outlet defined by the nozzle, and wherein the flow channel comprises the nozzle flow channel (fig. 2: the delivery catheter is interpreted to be a nozzle).
Regarding claim 8, Spears discloses a container 14 defining a cavity configured to contain the fluid and the gas; and a pressurization device 10 configured to pressurize the fluid and the gas within the cavity such that the fluid and the gas form the solution (fig. 1; col. 2, lines 35-40).
Regarding claim 11, Spears discloses that the target site is a vasculature of the patient (col. 7, lines 35-37).
Regarding claim 12, Spears discloses a method comprising: delivering, via a fluid delivery device, gas nanobubbles to a target site of a patient from a solution comprising a fluid supersaturated with a gas (col. 8, lines 21-33), wherein the fluid delivery device defines a flow channel configured to flow the solution through the flow channel such that the gas in the supersaturated fluid forms gas nanobubbles as the solution flows through the flow channel towards the target site, and wherein the gas nanobubbles remain in the fluid at least until delivery to the target site (col. 8, lines 23-27).
Regarding claim 17, Spears discloses that the gas nanobubbles are formed ex-vivo (fig. 1).
Regarding claim 18, Spears discloses that the target site is a vasculature of the patient (col. 7, lines 35-37).
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) 9, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spears in view of Myrick et al (US 6,555,059).
Regarding claim 9, Spears discloses that the fluid comprises water and the gas comprises oxygen (col. 2, lines 59-54). Claim 9 differs in calling for the fluid to be saline. Myrick teaches an oxygen supersaturated saline (abstract; col. 20, lines60-63) to provide oxygenation to tissues. 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 fluid of Spears to be saline as taught by Myrick as saline is a suitable fluid for delivering oxygen to tissues and provides additional benefits such as hydration.
Regarding claim 15, Spears discloses that the fluid comprises water and the gas comprises oxygen (col. 2, lines 59-54). Claim 9 differs in calling for the fluid to be saline. Myrick teaches an oxygen supersaturated saline (abstract; col. 20, lines60-63) to provide oxygenation to tissues. 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 fluid of Spears to be saline as taught by Myrick as saline is a suitable fluid for delivering oxygen to tissues and provides additional benefits such as hydration.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spears in view of Grady et al (US 8,579,880).
Claim 10 differs from Spears in calling for a bubble trap configured to prevent gas nanobubbles having a diameter greater than or equal to a threshold size from flowing toward the target site, wherein the bubble trap is in fluid communication with the flow channel. Grady teaches a system for delivering a liquid supersaturated with oxygen to a patient (abstract), and further including a bubble trap configured to prevent gas bubbles from being delivered to the patient (col. 9, lines 39-49) and thereby prevent air embolisms. A filter necessarily has a threshold size for particles that are able to pass through the filter. 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 Spears to include a bubble trap as taught by Grady to prevent bubbles that have nucleated out of the supersaturated fluid from being delivered to the patient thereby preventing air embolisms.
Claim(s) 19, 20 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Spears in view of Ladizinsky (US 2008/0262413).
Claim 19 differs from Spears in calling for the step of delivering the solution to the target site that is subcutaneous. Ladizinsky teaches delivery of oxygen enriched saline to a site that is subcutaneous to eliminate deleterious effects of tissue that is compromised by ischemia (pages 2-3, paras. 0034, 0044). 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 method of Spears to include delivery of the solution to a subcutaneous site as taught by Ladisinsky to treat ischemic tissue and prevent tissue damage in the area of a tumor that is being treated, for example.
Claim 20 differs from Spears in calling for the step of delivering the solution intraosseously. Ladizinsky teaches delivery of oxygen enriched saline intraosseously to eliminate deleterious effects of tissue that is compromised by ischemia (pages 2-3, paras. 0034, 0044). 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 method of Spears to include delivery of the solution intraosseously as taught by Ladisinsky to assist in healing of injured bones.
Allowable Subject Matter
Claims 3, 4, 6, 7, 13, 14, 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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 subject matter of the claims listed above could not be found and was not suggested by the prior art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783