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 .
Acknowledgments
This office action is in response to the reply filed on 2/2/26 where applicant elected, without traverse, Group II, claims 5-12. Applicant characterized the group as consisting of claims 1, 5-17. Examiner disagrees with respect to claims 13-15. Claim 13 is not generic in that the flexible tubing (Fig.10) represents a different species of inlet and outlet that is not usable with the device of claim 1 (Fig.7). Claims 1, 5-12 and 16-17 will be examined as pertaining to Group II and claims 2-4, 13-15 and 18-20 being withdrawn. Claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/17/24 is in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDS is being considered by the Examiner.
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, 5-12, 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wigness et al. (US 4,846,806) (“Wigness”).
(claim 1) Wigness discloses: A hydraulically actuated valve device 20’, comprising: a valve body (Figs. 5,6) having an inner cavity 26’,24’, an inlet channel 48’ extending to the inner cavity, an outlet channel 7’ extending from the inner cavity, and an open end (Fig. 5) that opens to the inner cavity; a septum 42’ located in the inner cavity, the septum being arranged to seal the open end of the valve body and being configured to receive a needle 90’ through which an operating fluid may be selectively injected into the inner cavity of the valve body to increase a fluid pressure in the inner cavity of the valve body, or selectively withdrawn from the inner cavity to reduce the fluid pressure in the inner cavity C11L42-59; a valve closing member 36’,38’,65 arranged in the inner cavity of the valve body, the valve closing member having an unactuated state to enable a first fluid to flow from the inlet channel to the outlet channel when the fluid pressure of operating fluid in the inner cavity of the valve body is below a closing pressure (Fig. 5) C11L42-52, the valve closing member having an actuated state that inhibits the first fluid from flowing into the inner cavity from the inlet channel or out of the inner cavity through the outlet channel when the operating fluid in the inner cavity of the valve body is at or above the closing pressure (Fig. 6) C11L37-42.
Claim 5: the valve closing member 36’,38’,65 comprises a diaphragm 36’,38’,65 located within the cavity of the valve body.
Claim 6: the diaphragm is a deformable diaphragm configured to be in a first state when the fluid pressure of operating fluid in the inner cavity of the valve body is below the closing pressure, and to deform from the first state to a second state when the fluid pressure of the operating fluid in the inner cavity of the valve body is at or above the closing pressure, wherein the deformable diaphragm enables the first fluid to flow from the inlet channel to the outlet channel when the deformable diaphragm is in the first state, and wherein the deformable diaphragm obstructs at least one of the inlet channel and the outlet channel to inhibit flow of the first fluid from the inlet channel to the outlet channel when the deformable diaphragm is in the second state Figs. 5,6; C11L3-59.
Claim 7: the valve body has a valve seat 11’ in a flow path between the inlet channel and the outlet channel, and wherein the diaphragm 36’,38’ is configured to enable flow of the first fluid from the inlet channel, through the flow path, to the outlet channel when the fluid pressure of the operating fluid in the inner cavity of the valve body is below the closing pressure (Fig. 5), and to seal against the valve seat and inhibit flow of the first fluid to the outlet channel when the fluid pressure of the operating fluid in the inner cavity of the valve body is at or above the closing pressure (Fig. 6).
Claim 8: the diaphragm is a deformable diaphragm configured to deform from a first state to a second state as the fluid pressure of the operating fluid in the inner cavity 24’ of the valve body is raised from below to above the closing pressure.
Claim 9: further comprising a flexible tubing 4’ in the inner cavity of the valve body and extending between the inlet channel and the outlet channel, for flow of the first fluid from the inlet channel to the outlet channel when the fluid pressure of the operating fluid in the inner cavity of the valve body is below the closing pressure, wherein the diaphragm has a protruding obstruction feature 11’ configured to press against and close the flexible tubing to inhibit flow of the first fluid from the inlet channel to the outlet channel when the fluid pressure of the operating fluid in the inner cavity of the valve body is at or above the closing pressure. (Fig. 6)
Claim 10: further including a needle guard 68’ comprising a rigid body resistant to being pierced by the needle, wherein the rigid body of the needle guard is located in the inner cavity of the valve body between the septum and the diaphragm, to protect the diaphragm from needle piercing. (Figs. 5,6)
Claim 11: the rigid body of the needle guard includes at least one fluid flow passage 26’ through which the operating fluid may flow when the operating fluid is injected into the inner cavity of the valve body. (see Fig. 5, arrows in 26’)
Claim 12: the rigid body of the needle guard has an outer peripheral edge that includes a plurality of channels defining fluid flow passages through which the operating fluid may flow when the operating fluid is injected into the inner cavity of the valve body. (see Fig. 5, arrows in 26’)
Claim 16: further comprising a needle guide located on the open end of the valve body for guiding the needle toward a central portion of the septum. (see Fig. 5 at 48’)
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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Wigness in view of Burns et al. (US 2008/0021375) (“Burns”).
Wigness discloses the invention as substantially claimed, but does not directly disclose the needle guide comprises an annular body having a tapered surface extending to a central opening through which the needle may be passed. Burns, in the analogous art, teaches a tapered needle guide on the open end of a valve body for guiding a needle toward a central opening of a septum, see Figs. 7a,b, 12. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have tapered the needle guide of Wigness as taught by Burns to ensure proper placement of the needle through the septum.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEANNA K HALL/Primary Examiner, Art Unit 3783