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 6/5/26. In the reply, the applicant amended claims 1, 3-6, 9-10, 12, 16. Claims 1-20 are pending. Claims 1, 5-12 and 16-17 will be examined as pertaining to Group II and claims 2-4, 13-15 and 18-20 being withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/23/26 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 § 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 1, 5-12, 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Miethke (US 8,870,809) in view of Trine et al. (US 4,102,201) (“Trine”).
(claim 1) Miethke discloses: A hydraulically actuated valve device Fig. 2, comprising: a valve body 1 having an inner cavity 4, an inlet channel 2 extending to the inner cavity, the inlet channel located proximate a first end of the valve body, an outlet channel 3 extending from the inner cavity. Miethke does not directly disclose an open end that opens to the inner cavity, the open end located proximate a second end of the valve body opposite of the first end. Trine, in the analogous art, teaches this open end (Figs. 8,9) in the cap. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to add the open end to the cap of Miethke as taught by Trine for sampling or for addition of fluids via the cannula 20 of Miethke.
a septum (101b Miethke; 61 Trine) 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 (20 Miethke; 49 Trine) 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 (C10L63-C11L21 Miethke; claim 16 Trine);
a valve closing member 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 C10L63-C11L21, claim 1 Miethke , 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 C10L63-C11L21, claim 1 Miethke
Claim 5: the valve closing member of Miethke comprises a diaphragm (5,8,6a,6b) 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, wherein the deformable diaphragm comprises an obstruction tab 6a, 6b, and wherein at least a portion of the obstruction tab is configured to be received within the outlet channel to obstruct the outlet channel and inhibit flow of the first fluid from the inlet channel to the outlet channel when the deformable diaphragm is in the second state C10L63-C11L21 Miethke
Claim 7: the valve body has a valve seat in a flow path between the inlet channel and the outlet channel, and wherein the diaphragm 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, 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. C10L63-C11L21 Miethke, 6a, 6b, Figs.1a,2a
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 of the valve body is raised from below to above the closing pressure. Fig. 1a vs Fig. 2a
Claim 9: further comprising a flexible tubing 101a 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 6a,6b configured to press against a portion of 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, and wherein the portion of the flexible tubing is located between the inlet channel and the outlet channel. C10L63-C11L21
Claim 10: further including a needle guard (Fig. 3, outside border containing 7) 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 and wherein the diaphragm is located in the inner cavity of the valve body between the first end of the valve body and the needle guard.
Claim 11: the rigid body of the needle guard includes at least one fluid flow passage 7 through which the operating fluid may flow when the operating fluid is injected into the inner cavity of the valve body.
Claim 12: the rigid body of the needle guard has an outer peripheral edge that includes a plurality of channels defining fluid flow passages 7 through which the operating fluid may flow when the operating fluid is injected into the inner cavity of the valve body. Fig.3
Claim 16: further comprising a tapered needle guide located on the open end of the valve body for guiding the needle toward a central portion of the septum. See Figs. 8, 9 Trine
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection was necessitated by applicant’s amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
Prosecution Insights