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. Election/Restrictions Applicant's election with traverse of Group 1(a) in the reply filed on February 3, 2026 is acknowledged. The traversal is on the ground(s) that Ng does not teach or disclose the newly amended limitation drawn to a catheter so that the groups have unity of invention. This is not found persuasive because the shared technical feature of the amended claims still does not make a contribution over the prior art, as discussed in more detail below with respect to the rejection of claim 1. The requirement is still deemed proper and is therefore made FINAL. Claims 6-11 and 17-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 3, 2026. Information Disclosure Statement The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections Claims 1 and 12 are objected to because of the following informalities: the claims should be amended so there is a semicolon before the last “wherein” clause. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claims 13 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding claim 13 , the claim recites “a first/second diaphragm body having formed as a recess”. Based on the working of these limitations, it is unclear if the body is formed as a recess or if the body has a recess. For examination purposes, the second interpretation was used. Claim 14 is also rejected by virtue of being dependent on claim 13. 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(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCullough (US 20220096747 ) in view of Louis (US 3620500 ) . Regarding claim 1 , McCullough discloses a valve assembly for controlled drainage or delivery of a fluid from or to a patient, the valve assembly comprising: a first port ( primary valve inlet 136a in fig. 1); a second port ( secondary valve outlet 136c in fig. 1); a diaphragm chamber (volume 140a in fig. 2a); a diaphragm (diaphragm 142 in fig. 2a) dividing the diaphragm chamber into a first chamber cavity (cavity 14 5 in fig. 2a ) and a second chamber cavity (cavity 14 4 in fig. 2a), the diaphragm being deflectable toward a first wall of the diaphragm chamber wherein the first chamber cavity contracts and the second chamber cavity expands (fig. 2 d ), and oppositely toward a second wall of the diaphragm chamber wherein the second chamber cavity contracts and the first chamber cavity expands (fig. 2 b ); and a single valve (fluid valve 126 in fig. 1) actuatable between: a first actuation state that establishes fluid communication between the first port and the second chamber cavity, and separately between the second port and the first chamber cavity ( paragraph 44 discloses that the digital controller 122 actuates the valve to cause the inlet 136a to be in fluid communication with outlet 136c so it is in fluid communication with cavity 144 and to cause the valve outlet 138c to be in fluid communication to valve inlet 138b so it is in fluid communication with cavity 145) ; and a second actuation state that establishes fluid communication between the first port and the first chamber cavity, and separately between the second port and the second chamber cavity (paragraph 45 discloses the valve is actuated again so that valve inlet 136a is in fluid communication with inlet 136b so that it is connected to cavity 145 and outlet 138c is in fluid communication with inlet 138a so that it is connected to cavity 144) ; wherein said first chamber cavity and said second chamber cavity are fluidically isolated from one another in all actuation states of said valve (fig. 2a-d); While McCullough discloses said first port or said second port is fluidly connected to a needle configured for fluidic communication to or from a patient (needle 118 in fig.1; paragraph 34), McCullough does not teach or disclose the ports being in fluidic communication with a catheter. Louis is directed towards an infusion system (fig. 1) in which the system can be connected to either a catheter or a needle ( 2:6-9 discloses the needle can be substituted for a catheter). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have substituted the needle of McCullough to be a catheter instead, as taught by Louis, as catheters are generally understood to be more comfortable for longer term use. Regarding claim 2 , in the modified assembly of McCullough, McCullough discloses the valve is configured to be successively actuated between the first actuation state and the second actuation state (paragraphs 44 and 45) , wherein in the first actuation state fluid can be drawn from the patient or from a pressurized supply reservoir up to a maximum volume of the second chamber cavity (paragraph 44 and figs. 2b-d) and in the second actuation state fluid can be drawn from the patient or the pressurized supply reservoir up to a maximum volume of the first chamber cavity (paragraph 45 and figs. 2b-d) . Regarding claim 3 , in the modified assembly of McCullough, McCullough discloses said maximum volume of the first chamber cavity being equal to said maximum volume of the second chamber cavity, the maximum volume of said first chamber cavity being achieved by deflecting said diaphragm against said second wall of said diaphragm chamber and the maximum volume of said second chamber cavity being achieved by deflecting said diaphragm against said first wall of said diaphragm chamber (fig. 2b/d shows the diaphragm abutting against the first and second walls; paragraphs 44 and 45 discloses end of travel sensors 146 which are positioned against the walls) . Regarding claim 4 , in the modified assembly of McCullough, McCullough discloses when the valve is in the second actuation state movement of the diaphragm toward the second wall causes fluid accumulated in the second chamber cavity to exit through the second port while fluid is drawn into the first chamber cavity through the first port, and wherein when the valve is in the first actuation state movement of the diaphragm toward the first wall causes fluid in the first chamber cavity to exit through the second port while fluid is drawn into the second chamber cavity through the first port (paragraph 44s and 45) . Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCullough in view of Louis, as applied to claim 1 above, and further in view of Gill (US 20090082758) . Regarding claim 5 , modified McCullough teaches all of the claimed limitations set forth in claim 1, as discussed above . McCullough further teaches a controller for controlling actuation of the valve (digital controller 122 in fig. 1; paragraph 44). Additionally, McCullough further teaches a different embodiment of a valve (valve 926 in fig. 13a) which is disclosed to be rotatable (paragraph 64). However, McCullough does not teach or disclose a motor for actuating the valve; and a controller for controlling operation of the motor, wherein the motor is a stepper motor that is operatively coupled to a plug of said valve and adapted to rotate said plug to actuate it to successively achieve said first actuation state and said second actuation state of said valve. Gill teaches a similar valve (fig. 15A/B) comprising a plug (central portion 450 in fig. 15A) which is rotatable relative to a base (base portion 452 in fig. 15A) to successively achieve a first and second actuation states (figs. 15A and 15B). Gill further teaches a motor for actuating a valve (paragraph 105 discloses a stepper motor for rotating a rotatable valve). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the valve of McCullough to be a rotatable valve comprising a plug rotatable relative to a base and a motor coupled to the valve for rotating between the two states and to have the controller of McCullough coupled to the motor for controlling the position of the valve, as taught by Gill. The examiner notes that McCullough appears to already suggest a similar embodiment (fig. 13 ) and such modification would provide for an equivalent means of switching the valve between the first and second actuation states. Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCullough in view of Gill and in view of Louis . Regarding claim 12 , modified McCullough teaches a valve assembly for controlled drainage or delivery of a fluid from or to a patient (fig. 1) , the valve assembly comprising: a diaphragm (diaphragm 142 in fig. 2a) disposed in a diaphragm chamber (volume 140a in fig. 2a) and dividing the diaphragm chamber into a first chamber cavity (cavity 145 in fig. 2a) and a second chamber cavity (cavity 144 in fig. 2a) , the diaphragm being deflectable toward a first wall of the diaphragm chamber to contract the first chamber cavity and expand the second chamber cavity (fig. 2d) , and oppositely toward a second wall of the diaphragm chamber to contract the second chamber cavity and expand the first chamber cavity (fig. 2b) ; a valve (fluid valve 126 in fig . 1) , a first port passage (see below) fluidly connecting a first port of the valve body ( port 136a in fig. 1 ) , a second port passage (see below) fluidly connecting to a second port of the valve body (see below) , a first chamber passage fluidly connecting to the first chamber cavity (port 140c in fig. 1) , and a second chamber passage fluidly connecting to the second chamber cavity (port 140b in fig. 1) ; and the valve movable between: a first actuation state that establishes fluid communication between the first port passage and the second chamber passage, and separately between the second port passage and the first chamber passage (paragraph 44 discloses that the digital controller 122 actuates the valve to cause the inlet 136a to be in fluid communication with outlet 136c so it is in fluid communication with cavity 144 and to cause the valve outlet 138c to be in fluid communication to valve inlet 138b so it is in fluid communication with cavity 145) ; and a second actuation state that establishes fluid communication between the first port passage and the first chamber passage, and separately between the second port passage and the second chamber passage (paragraph 45 discloses the valve is actuated again so that valve inlet 136a is in fluid communication with inlet 136b so that it is connected to cavity 145 and outlet 138c is in fluid communication with inlet 138a so that it is connected to cavity 144) ; wherein said first chamber cavity and said second chamber cavity are fluidically isolated from one another in all actuation states of said valve (fig. 2a-d) . McCullough further teaches an embodiment which appears to show a valve body having a central chamber with a rotatable plug ( fig. 13A-D). However, McCullough does not explicitly teach or disclose a valve body having a central chamber , a first port passage fluidly connecting the central chamber to a first port of the valve body, a second port passage fluidly connecting the central chamber to a second port of the valve body, a first chamber passage fluidly connecting the central chamber to the first chamber cavity, and a second chamber passage fluidly connecting the central chamber to the second chamber cavity; and plug disposed in the central chamber and rotatable within the central chamber between the actuation states. Additionally, while McCullough discloses said first port or said second port is fluidly connected to a needle configured for fluidic communication to or from a patient (needle 118 in fig. 1), McCullough does not teach or disclose a catheter being in communication with the ports. Gill teaches a valve body (base portion 452 in fig. 15A) comprising a central chamber (paragraph 124 discloses that the base portion 452 comprises a central portion 450 which is rotatable; it is understood that the portion of the base in which central portion 450 rotates is the “central chamber”) and comprises a first port passage fluidly connecting the central chamber to a first port of the valve body, a second port passage fluidly connecting the central chamber to a second port of the valve body, a first chamber passage fluidly connecting the central chamber to the first chamber cavity, and a second chamber passage fluidly connecting the central chamber to the second chamber cavity (see below). Gill further discloses plug (central portion 450 in fig. 15A/B) disposed in the central chamber and rotatable within the central chamber (paragraph 124) between the first actuation state (fig. 15A) and the second actuation state (fig. 15B) . Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of McCullough to have the rotatable valve with a plug of Gill instead of the valving mechanism of McCullough. It appears that McCullough already contemplates such an arrangement (fig. 13A-D) and Gill teaches that this arrangement would provide for an equivalent valving means which serves to be actuatable between the two actuation states and since McCullough teaches that these types of valves may be preferable to solenoids since solenoids are large (paragraph 64). Louis is directed towards an infusion system (fig. 1) in which the system can be connected to either a catheter or a needle (2:6-9 discloses the needle can be substituted for a catheter). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have substituted the needle of McCullough to be a catheter instead, as taught by Louis, as catheters are generally understood to be more comfortable for longer term use. Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCullough in view of Gill in view of Louis, as applied to claim 12 above, and further in view of Burke (US 8273058). Regarding claim 13 , modified McCullough teaches all of the limitations set forth in claim 12, as discussed above. McCullough further discloses a first half of a diaphragm body having formed as a recess in an upper surface thereof said first wall of the diaphragm chamber (see below); and a second half of a diaphragm body having formed as a recess in a lower surface thereof said second wall of the diaphragm chamber (see below). However, modified McCullough does not teach or disclose the two diaphragm body halves are two separate bodies and wherein the upper surface of the first diaphragm body is disposed in registry with the lower surface of the second diaphragm body such that the first wall and the second wall define and enclose said diaphragm chamber. Burke teaches a first diaphragm body (housing 50 in fig. 4) and a second diaphragm body (faceplate 56 in fig. 4), wherein the upper surface of the first diaphragm body is disposed in registry with the lower surface of the second diaphragm body (see below) such that the first wall and the second wall define and enclose said diaphragm chamber (fig. 4) . Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the diaphragm body of modified McCullough to comprise a first diaphragm body and a second diaphragm body wherein the upper surface of the first diaphragm body is disposed in registry with the lower surface of the second diaphragm body such that the first wall and the second wall define and enclose said diaphragm chamber , as taught by Burke, as an alternative means for connecting the diaphragm to a diaphragm housing. Regarding claim 14 , in the modified assembly of McCullough, McCullough discloses the first chamber passage being partially defined by a lower conduit extending through the first diaphragm body and fluidly communicating with the first chamber cavity through the first wall (port 140c in fig. 1 ) , and the second chamber passage being partially defined by an upper conduit extending through the second diaphragm body and fluidly communicating with the second chamber cavity through the second wall (port 140b in fig. 1) . Allowable Subject Matter Claims 15 and 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: Regarding claim 15 , the closest prior art is McCullough which does not teach or disclose the plug is configured to be successively actuated between the first actuation state and the second actuation state, wherein in the first actuation state fluid can be drawn from the patient up to a maximum volume of the second chamber cavity and in the second actuation state fluid can be drawn from the patient up to a maximum volume of the first chamber cavity. In McCullough, the fluid is drawn up from a pump (pump in fig. 1) and the pressure exerted by the pump is greater than a resilience of the diaphragm (paragraph 45). As such, there is insufficient indication in McCullough to indicate that the device would operate as claimed if fluid were drawn up from the patient instead. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT COURTNEY FREDRICKSON whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-7481 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday (9 AM - 5 PM 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, FILLIN "SPE Name?" \* MERGEFORMAT BHISMA MEHTA can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-3383 . 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. /COURTNEY B FREDRICKSON/ Primary Examiner, Art Unit 3783