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 .
Response to Amendment
This office action is responsive to the amendment filed on January 2, 2026. As directed by the amendment: claims 1 and 12 have been amended, claims 13-14 have been added, no claims have been canceled. Thus claims 1-14 are presently pending in this application. Applicant's amendments to the Claims have overcome each and every objection and the 35 U.S.C. 112(b) rejections previously set forth in the Non-Final Office Action mailed October 2, 2025.
Response to Arguments
Applicant's arguments filed January 2, 2026, see Remarks, have been fully considered but they are not persuasive. On pgs. 4-8, the applicant argues that none of Kietzmann, Joyce or McEvoy disclose wherein the resilient member maintains the slider in the opening position. The examiner respectfully disagrees, as Kietzmann does disclose this limitation, Fig. 1 shows that spring 8 biases valve 4 such that the valve 4 and its plug 6 are separated from outflow opening 5, which is defined as the opening position. Therefore, the device of Kietzmann meets the limitation. On pgs. 8-9, the applicant argues that McEvoy Jr does not meet the limitation said holder including an outer ring forming part of the housing, as the valve seat 4 and shoe 6 are improperly considered a part of the housing. The examiner respectfully disagrees, as seen in Fig. 1-2 of McEvoy Jr, the plug seat 4 is in threaded connection with the pipe 1 and its connection forms the proper seating and connection between the shoe 6 and pipe 1, which together form the outer housing, as the shoe 6 interacts with the same threaded connection on the pipe 1 as the plug seat 4, until it abuts the plug seat. Therefore, the plug seat 4 may be considered as a portion of the housing. Thus, the device of McEvoy meets the limitation, and the combination of Kietzmann, Joyce, and McEvoy fully read on claim 1.
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.
Claims 1 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kietzmann (DE 202007003817), in view of Joyce (US 1275697) and McEvoy Jr (US 1630666).
Regarding claim 1, Kietzmann discloses a device (PEEP valve system of Fig. 1) comprising a housing (Fig. 1, housing 1), said housing defining an internal conduit for circulation of the fluid (Fig. 1, fluid flow within conduit space of housing 1) from a fluid inlet (Fig. 1, in flow opening 1) to a fluid outlet (Fig. 1, outflow opening 5), a slider (Fig. 1, valve 4) arranged inside the internal conduit such that the slider is movable along a central longitudinal axis (Fig. 1, valve 4 is arranged in conduit space of housing 1 and is moveable longitudinally (see Figs. 1-3 and [0025], wherein longitudinal movement of valve plate. 4.1 moves closure 6(components of valve 4)) between an opening position, wherein the medical fluid is allowed to flow through the fluid outlet (Fig. 1, valve 4 is movable from an "opening position" wherein the outflow opening 5 is open and allows fluid to move through outlet opening 5. (Examiner notes: [0026], shaft may be altered/mechanically adjusted to user's desired specifications, including adjusting shaft length, therefore valve plate need not necessarily close inflow opening 2 when in "opening position' shown in Fig. 1, and [0032], when valve is in the first position (defined as "closed position" in Kietzmann in [0020]), there can still be a small opening therefore in valve housing therefore valve plate 4.1 need not close inflow opening 2)), and a closing position, wherein the medical fluid is prevented from flowing through said fluid outlet (Figs. 1 and 3 and [0025, 0030], valve 4 is movable to a "closing position" wherein the outflow opening is closed by closure 6 , which prevents fluid from flowing through outflow opening 5), the slider including a connecting rod extending along the central longitudinal axis A (Fig. 1, valve plate 4 comprising longitudinally extending shaft 7), said connecting rod connecting an actuation member to a plug (Fig. 1 and [0025], shaft 7 connecting valve configured to close the fluid outlet when the slider is in the closing position (Fig. 3 and [0025, 0030], closure 6 configured to close outflow opening 5 when valve 4 is in "closing position"), a resilient member (Fig. 1, spring 8) disposed proximally to the plug and configured to exert a proximal force on said the slider such that the resilient member maintains the slider in the opening position (Fig. 1 and [0024], spring 8 is connected to distal face of valve plate 4.1 (is therefore at least partially proximal to the closure 6) and exerts a force Ff on the valve plate 4.1 to maintain the valve 4 in the "opening position"), and a proximally oriented pressure area provided on the actuation member of the slider (Fig. 1 and [0024], proximal face of valve plate 4.1 which receive pressure Fp from channel 3), said pressure area being configured to cause the slider to reach the closing position against the action of the resilient member when the medical fluid pressure exerted upon said pressure area is equal to or higher than a predetermined threshold, thereby causing the plug to close the fluid outlet (Fig. 1-3 and [0024-0026, 0028-0030], proximal face of valve plate 4.1 is configured to cause valve 4 to reach "closing position" against the action Ff of the spring 8 when the force Fp from channel 3 is equal to or higher than predetermined threshold of force Ff of spring 8, therefore causing closure 6 to close outflow opening 5).
Kietzmann fails to disclose the device for fluidly connecting a medical container containing a medical fluid to a connector; and a holder, said holder including a guiding element for guiding the connecting rod along the central longitudinal axis , such that the holding elements delimit openings for allowing the medical fluid to flow through the holder. However, Joyce discloses the device for fluidly connecting a medical container containing a medical fluid to a connector (Fig. 1 and ln. 8-12 and 64-68, valve housing includes threads 11 at either end for connecting the valve device within a larger system and the valve regulates liquid passing through, therefore the valve device may be configured to fluidly connect a medical container containing a medical fluid to a connector); and a holder (Fig. 1 and 3, integral spider 10), said holder including a guiding element for guiding the connecting rod along the central longitudinal axis (Fig. 1 and ln. 60-63, spider 10 has a central hole which receives the stem 13 of the valve to form guide for stem 13), such that the holding elements delimit openings for allowing the medical fluid to flow through the holder (Fig. 1 and 3 and ln.86-92, spider 10 has side openings (see Fig. 3) wherein fluid may pass through).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kietzmann to incorporate the disclosures of Joyce and modify the proximal and distal ends of the valve device to have components with internal threads for connecting the valve device between other components, and to modify the valve housing to have a holder including a guiding element for guiding the connecting rod along the central longitudinal axis, such that the holding elements delimit openings for allowing the medical fluid to flow through the holder. Doing so would allow the valve device to be installed anywhere in a system (Joyce, ln. 64-68); and would provide a guide for the valve stem thus ensuring that the valve disk is seated correctly in the valve system (Joyce, ln. 60-64, 76-78).
Kietzmann, in view of Joyce, fails to disclose an outer ring forming part of the housing , and holding elements connecting the guiding element to the outer ring. However, McEvoy Jr discloses an outer ring forming part of the housing (Fig. 1-2, system includes plug seat 4 which connects to the other components of the device housing (shoe 6 and pipe 1) to form part of the housing), and holding elements connecting the guiding element to the outer ring (Fig. 1-2 and ln. 80-84, plug seat 4 is formed similar to spider of Joyce and comprises the central bore 7 which receives and guides valve stem 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kietzmann, in view of Joyce, to incorporate the disclosures of McEvoy Jr and modify the housing to comprise an outer ring which is connected to the guiding element via the holding elements. Doing so would provide a valve system wherein the housing configuration may help to secure the valve seat in place, as the other components of the housing may act as a seat and a lock nut for the valve seat (McEvoy Jr, ln. 66-79).
Regarding claim 12 and Kietzmann, in view of Joyce and McEvoy Jr, Kietzmann further discloses a method for manufacturing the device according to claim 1, said method comprising the steps of: assembling the slider, the resilient member and the plug (Fig. 1 and [0024-0025], valve 4, spring 8, and closure 6 are assembled together to form the PEEP valve).
As noted above, Kietzmann fails to disclose the holder, and is thus silent to assembling the holder, slider, the resilient member and the plug. However, Joyce further discloses assembling the holder, slider, the resilient member and the plug (Fig. 1 and ln. 69-85, spider 10 is assembled with stem 13, disk 12 and spring 14 to from valve system).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kietzmann, in view of Joyce and McEvoy Jr, to further incorporate the disclosures of Joyce and modify the method to include assembling the holder, slider, the resilient member and the plug. Doing so would provide a guide for the valve stem thus ensuring that the valve disk is seated correctly in the valve system (Joyce, ln. 60-64, 76-78).
Kietzmann, in view of Joyce, is silent to wherein the housing comprises a top housing and a bottom housing; securing the holder to the bottom housing, preferably by ultrasonic welding; securing the holder to the top housing, preferably by ultrasonic welding. However, McEvoy Jr further discloses wherein the housing comprises a top housing (Fig. 1, housing comprises pipe 1) and a bottom housing (Fig. 1, housing comprises shoe 6); securing the holder to the bottom housing, preferably by ultrasonic welding (Fig. 1 and ln. 66-68, valve seat 4 is secured onto shoe 6); securing the holder to the top housing, preferably by ultrasonic welding (Fig. 1 and ln. 66-68, valve seat 4 is secured onto the lower end of the pipe 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kietzmann, in view of Joyce and McEvoy Jr, to further incorporate the disclosures of McEvoy Jr and modify the method to include wherein the housing comprises a top housing and a bottom housing; securing the holder to the bottom housing, preferably by ultrasonic welding; securing the holder to the top housing, preferably by ultrasonic welding. Doing so would provide a valve system wherein the housing configuration may help to secure the valve seat in place, as the other components of the housing may act as a seat and a lock nut for the valve seat (McEvoy Jr, ln. 66-79).
Claims 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kietzmann (DE 202007003817), in view of Joyce (US 1275697) and McEvoy Jr (US 1630666), as applied to claim 1 above, and further in view of Hathaway et al. (US 20170314695), hereinafter Hathaway.
Regarding claim 2, Kietzmann, in view of Joyce and McEvoy Jr, discloses the device according to claim 1.
Kietzmann, in view of Joyce and McEvoy Jr, fails to disclose wherein the actuation member includes a peripheral edge that is configured to guide the sliding movement of the slider between the opening and the closing positions, and the pressure area delimits at least two through-holes allowing the medical fluid to pass through the actuation member. However, Hathaway discloses wherein the actuation member includes a peripheral edge that is configured to guide the sliding movement of the slider between the opening and the closing positions (Figs. 1-2 and [0019], piston head 54 of valve body (equivalent to valve plate of Kietzmann) is configured in size and shape to be commensurate with the size and shape of passage 20 to guide the seal within the passage), and the pressure area delimits at least two through-holes allowing the medical fluid to pass through the actuation member (Fig. 1-2 and [0019], head 54 has openings 44 through which fluid may flow through).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kietzmann, in view of Joyce and McEvoy Jr, to incorporate the disclosures of Hathaway and modify the actuation member to include a peripheral edge that is configured to guide the sliding movement of the slider between the opening and the closing positions, and at least two through-holes allowing the medical fluid to pass through the actuation member. Doing so would prevent fluid from flowing along the circumference of the actuation member yet ensuring the slider is still movable within the housing and configures the pressure area of the actuation member to allow sufficient flow to pass through and apply pressure to the actuation member at the same time (Hathaway, [0019]).
Regarding claim 3, Kietzmann, in view of Joyce, McEvoy Jr, and Hathaway, discloses the device according to claim 2, as explained above. As noted above, Kietzmann, Joyce, and McEvoy Jr fail to disclose the at least two through-holes and are thus silent to wherein the at least two through-holes are symmetric relative to a longitudinal plane containing the central longitudinal axis. However, Hathaway further discloses wherein the at least two through-holes are symmetric relative to a longitudinal plane containing the central longitudinal axis (Fig. 1-2 and [0019], openings 44 may in any design, and are shown in figs. 1-2 as being symmetric about a longitudinal plane).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kietzmann, in view of Joyce, McEvoy Jr, and Hathaway, to incorporate the disclosures of Hathaway and modify the at least two through-holes to be symmetric relative to a longitudinal plane containing the central longitudinal axis. Doing so configures the pressure area of the actuation member to allow sufficient flow to pass through and apply pressure to the actuation member at the same time (Hathaway, [0019]).
Regarding claim 4 and Kietzmann, in view of Joyce, McEvoy Jr, and Hathaway, Kietzmann further discloses ---the device according to claim 3, wherein the actuation member is disk shaped (Fig. 1 and [0011], valve plate 4.1 is part of valve disk, and is therefore disk shaped).
Regarding claim 5 and Kietzmann, in view of Joyce, McEvoy Jr, and Hathaway, Kietzmann further discloses ---the device according to claim 4, wherein the pressure area is orthogonal to the central longitudinal axis (Fig. 1, pressure area from force Fp is orthogonal to the central longitudinal axis).
Regarding claim 6 and Kietzmann, in view of Joyce, McEvoy Jr, and Hathaway, Kietzmann further discloses ---the device according to claim 5, wherein the actuation member is integral with the connecting rod such that the actuation member and the connecting rod form a single piece (Fig. 1 and [0025-0026], valve plate 4.1 and shaft 7 are formed as integral, as the shaft 7 is an extension portion of valve plate 4.1).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kietzmann (DE 202007003817), in view of Joyce (US 1275697), McEvoy Jr (US 1630666), and Hathaway (US 20170314695), as applied to claim 6 above, and further in view of, Whitley (US 20060142735).
Regarding claim 7, Kietzmann, in view of Joyce, McEvoy Jr, and Hathaway, discloses the device according to claim 6.
Kietzmann, in view of Joyce, McEvoy Jr, and Hathaway, fails to disclose wherein the resilient member is a bellow extending around the connecting rod. However, Whitley discloses wherein the resilient member is a bellow extending around the connecting rod (Fig. 3 and 6-7 and [0040], biasing device 34 is a is an accordion (bellowed) shaped silicone spring, which extends around the moving valve components (equivalent to the shaft of Kietzmann)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kietzmann, in view of Joyce, McEvoy Jr, and Hathaway, to incorporate the disclosures of Whitley and modify the resilient member to be a bellow extending around the connecting rod. Doing so would allow the resilient member to also act as a seal to aid in containing fluid within the housing (Whitley, [0039]).
Regarding claim 8, Kietzmann, in view of Joyce, McEvoy Jr, Hathaway and Whitley, discloses the device according to claim 7, as explained above. As noted above, Kietzmann fails to disclose the holder and is thus silent to wherein the resilient member extends between the actuation member and the guiding element of the holder. However, Joyce further discloses wherein the resilient member extends between the actuation member and the guiding element of the holder (Fig. 1, resilient member 14 extends between the non-pressure area face of the valve disk 12 (equivalent to the non-pressure area face of valve plate 4.1 of Kietzmann) and the guide hole of spider 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kietzmann, in view of Joyce, McEvoy Jr, Hathaway, and Whitley to further incorporate the disclosures of Joyce and modify the biasing element connection such that the biasing element is connected to the holder within the housing such that it extends between the actuation member and the guiding element of the holder. Doing so would provide a guide for the valve stem thus ensuring that the valve disk is seated correctly in the valve system while allowing the spring to engage with the spider and urge the valve disk away from it into the valve's resting position (Joyce, ln. 60-64, 76-85).
Regarding claim 9, Kietzmann, in view of Joyce, McEvoy Jr, Hathaway and Whitley, discloses the device according to claim 8, as explained above. As noted above, Kietzmann fails to disclose the holder forming part of the housing and is thus silent to wherein the housing comprises a top housing and a bottom housing, the outer ring of the holder forming an intermediate housing portion interposed between the top and the bottom housings. However, McEvoy Jr further discloses wherein the housing comprises a top housing (Fig. 1, pipe 1) and a bottom housing (Fig. 1, shoe 6), the outer ring of the holder forming an intermediate housing portion interposed between the top and the bottom housings (Figs. 1-2, and ln. 66-68, 76-79, valve seat 4 is secured between the lower end of the pipe 1 and the upper end of the shoe 6 to form the complete housing for valve device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kietzmann, in view of Joyce, McEvoy Jr, Hathaway, and Whitley, to further incorporate the disclosures of McEvoy Jr and modify the housing to comprise a top housing and a bottom housing, the outer ring of the holder forming an intermediate housing portion interposed between the top and the bottom housings. Doing so would provide a valve system wherein the housing configuration may help to secure the valve seat in place, as the other components of the housing may act as a seat and a lock nut for the valve seat (McEvoy Jr, ln. 66-79).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kietzmann (DE 202007003817), in view of Joyce (US 1275697), McEvoy Jr (US 1630666), Hathaway (US 20170314695), and Whitley (US 20060142735) as applied to claim 9 above, and further in view of Farano (US 20060278279).
Regarding claim 10, Kietzmann, in view of Joyce, McEvoy Jr, Hathaway and Whitley, discloses the device according to claim 9.
Kietzmann, in view of Joyce, McEvoy Jr, Hathaway and Whitley, fails to disclose wherein the plug is made of a softer material than the slider. However, Farano discloses wherein the plug is made of a softer material than the slider (Fig. 1 and [0018-0020], valve movable body 13 is made of an elastically flexible material, and is therefore more structured than the rigid material of the slider 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kietzmann, in view of Joyce, McEvoy Jr, Hathaway, and Whitley, to further incorporate the disclosures of Farano and modify the plug to be made of an elastically flexible material such that it is made of a softer material than the slider. Doing so would further allow the plug to be able to rest and press against the opening in the housing to help prevent any backflow of liquid (Farano, [0025]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kietzmann (DE 202007003817), in view of Joyce (US 1275697), McEvoy Jr (US 1630666), Hathaway (US 20170314695), Whitley (US 20060142735), and Farano (US 20060278279), as applied to claim 10 above, and further in view of Teh (US 5514110).
Regarding claim 11, Kietzmann, in view of Joyce, McEvoy Jr, Hathaway, Whitley and Farano, discloses the device according to claim 10.
Kietzmann, in view of Joyce, McEvoy Jr, Hathaway, Whitley and Farano, fails to disclose a medical container comprising a reservoir for containing a medical fluid and the device according to claim 10 fluidly connected to the reservoir of said medical container. However, Teh discloses a medical container comprising a reservoir for containing a medical fluid (Fig. 2 and Col. 2:66-67, IV container 6 which holds and administers IV fluids) and the device according to claim 10 fluidly connected to the reservoir of said medical container (Fig. 2-3, IV container 6 is fluidly connected to an automatic flow control device 1 (Similar to PEEP valve of Kietzmann)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kietzmann, in view of Joyce, McEvoy Jr, Hathaway, Whitley, and Farano, to further incorporate the disclosures of Farano to modify the device to be fluidly connected to a reservoir of a medical container, wherein the reservoir contains a medical fluid. Doing so would provide an easy to operate IV fluid flow control device which can accurately control the flow of fluid into a patient (Teh, Col. 2:6-9).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kietzmann (DE 202007003817), in view of Joyce (US 1275697) and McEvoy Jr (US 1630666), as applied to claim 12 above, and further in view of Kindler (US 7291133).
Regarding claim 13, Kietzmann, in view of Joyce and McEvoy Jr discloses the method according to claim 12.
Kietzmann, in view of Joyce and McEvoy Jr, fails to disclose wherein securing the holder to the bottom housing and the top housing is by ultrasonic welding. However, Kindler discloses wherein securing the holder to the bottom housing and the top housing is by ultrasonic welding (Fig. 2 and Col. 4:41-57, housing sections 10 and 20 are welded together, with a portion of valve body 31 (similar to valve seat 4 of McEvoy Jr) included in the welding, therefore the holder is welded to both the top and bottom housing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kietzmann, in view of Joyce and McEvoy Jr, to incorporate the disclosures of Kindler and modify the method to include wherein securing the holder to the bottom housing and the top housing is by ultrasonic welding. Doing so secures the housing components and the holder in position relative to each other (Kindler, Col. 4:54-57).
Allowable Subject Matter
Claim 14 is 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 14, Kietzmann, in view of Joyce and McEvoy Jr, discloses the device according to claim 1.
Kietzmann, in view of Joyce and McEvoy Jr, is silent to wherein the outer ring forms part of an outer surface of the housing. No reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kietzmann, in view of Joyce and McEvoy Jr, to satisfy these limitations in combination with the limitations of claim 1.
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 SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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