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.
Claims 1-3 and 7-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rucinski US Patent Application Publication 2007/0225662.
As to claim 1, Rucinski teaches a flow control device 2 comprising:
a body with a connecting portion (Fig. 2), and connecting threads 18 (Fig. 6, para. 0056),
wherein the body comprises:
a structure defining at least one or more pre-existing fluid channels 3 (Fig. 4; para. 0039), wherein the at least one or more pre-existing fluid channels are configured to control a fluid flow rate of a fluid exiting the body (para. 0039), and
wherein controlling the fluid flow rate comprises controlling a predetermined pressure of the fluid flow rate (paras. 0018, 0038, 0042-0043, 0086); and
wherein the connecting portion is configured to attach to a container 1 (Fig. 1).
As to claim 2, Rucinski teaches the predetermined pressure ranges from about 5 psi to about 15 psi (para. 0042, 0065, claim 8).
As to claim 3, the body 2 comprises a first surface and a second surface – where Rucinski teaches the nozzle has a larger diameter on the inner face of the discharge means (2) and a smaller diameter on the outside face of the discharge means (Figs.2, 4; para. 0043).
As to claim 7, the second surface is at least partially recessed on the body defining an interior well on the body (Figs. 2, 5, 9A, 9AB, 11, and 12).
As to claim 8, the second surface of the body is substantially perpendicular to a longitudinal axis of the body (Figs. 2).
As to claim 9, the flow control device is configured to be used in a medical, sterile environment (paras. 0006, 0013, 0039, 0066).
As to claim 10, the connecting portion is threaded (Figs. 2, 6, 10, and 17).
As to claim 11, Rucinski teaches a container 1,40, 60 comprising the flow control device of claim 1 (Figs. 1, 3-5, 10).
As to claim 12, Rucinski teaches the container 1, 40, 60 is configured to contain the fluid prior to the fluid exiting the body (paras. 0039).
As to claim 13, Rucinski teaches a method comprising:
connecting a fluid control device 2,10 to a container (Figs. 1, 2, 4, and 5; paras. 0058),
wherein the fluid control device comprises:
a body with a connecting portion – threads shown in Fig. 2, and connecting threads 18 (Fig. 6, para. 0056),
wherein the body comprises: a structure defining at least one or more pre-existing fluid channels 3, 14, 26, 50, 52 (Figs. 2, 4, 6, 7A, 9A; paras. 0043, 0045, 0056-0058);
wherein the at least one or more pre-existing fluid channels are configured to control a fluid flow rate of a fluid exiting the body (paras. 0042-0045), and
wherein controlling the fluid flow rate comprises controlling a predetermined pressure of the fluid flow rate (paras. 0039, 0042, 0044-0045); and
wherein the connecting portion is configured to attach to the container (Figs. 1, 2, 4-6, 7B, 9A, 9B; paras. 0056, 0060 and
delivering the fluid to a site from the container at a controlled fluid flow rate (paras. 0042, 0045).
As to claim 14, Rucinski teaches the method of claim 13, wherein delivering the fluid to the site from the container at the controlled fluid flow rate comprises deforming the container – where Rucinski teaches the reservoir housing can be squeezed or compressed by hand to exert pressure on the contents of the reservoir (para. 0048).
As to claim 15, Rucinski teaches the method of claim 14, wherein deforming the container comprises compressing the container (para. 0039).
As to claim 16, Rucinski teaches delivering the fluid to the site from the container at the controlled fluid flow rate comprises delivering the fluid at the predetermined pressure (paras. 0042, 0065, 0080, 0086).
As to claim 17, Rucinski teaches the predetermined pressure ranges from about 5 psi to about 15 psi (paras. 0042, 0065).
As to claim 18, Rucinski teaches a kit comprising:
a flow control device 2,10 comprising:
a body with a connecting portion– threads shown in Fig. 2, and connecting threads 18 (Fig. 6, para. 0056),
wherein the body comprises:
a structure defining at least one or more pre-existing fluid channels 3, 14, 26, 50, 52 (Figs. 2, 4, 6, 7A, 9A; paras. 0043, 0045, 0056-0058);
wherein the at least one or more pre-existing fluid channels are configured to control a fluid flow rate of a fluid exiting the body (paras. 0042-0045), and
wherein controlling the fluid flow rate comprises controlling a predetermined pressure of the fluid flow rate (paras. 0039, 0042, 0044-0045); and
wherein the connecting portion is configured to attach to a container (Figs. 1, 2, 4-6, 7B, 9A, 9B; paras. 0056, 0060); and
a sealed package providing a sterile environment, wherein the flow control device is in the sterile environment of the sealed package (para. 0078).
As to claim 19, Rucinski teaches the body 2, 10 comprises a first surface and a second surface (Figs. 2, 5, 6, 7A, 9A, 9B).
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.
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.
Claims 4-6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rucinski US Patent Application 2007/0225662.
As to claims 4 and 20, Rucinski teach the present invention substantially as claimed. Rucinski does not specifically teach the at least one or more pre-existing fluid channels comprise a first plurality of pre-existing fluid channels on the first surface and a second plurality of pre-existing fluid channels on the second surface. However, Rucinski does teach additional circularly disposed row of nozzles that can increase the volume of irrigation solution used in the irrigation process. Rucinski teaches the number of nozzles can vary from as little as 2 to as many as 24 or more as desired (para. 0045). Based on the teachings of Rucinski, it would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the fluid channels as claimed to allow greater volume of irrigation solution to be directed to the wound (para. 0045).
As to claim 5, Rucinski teaches a cross-sectional area of each fluid channel of the first plurality of pre- existing fluid channels is the same – where Rucinski teaches the nozzle-forming portions can be the same size or the ports can be different sizes and shapes (para. 0042).
As to claim 6, a cross-sectional area of each fluid channel of the first plurality of pre- existing fluid channels is different than a cross-sectional area of each fluid channel of the second plurality of pre-existing fluid channels - where Rucinski teaches the nozzle-forming portions can be the same size or the ports can be different sizes and shapes (para. 0042).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Meyer USPN 9981786 and Young USPN 7328820 are cited to show fluid control caps attached to a container.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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