DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed on 08/01/25 has been entered in the case. Claims 1-5, 7-8, 10-12, 14, 16-21 are pending for examination and claims 2, 6, 9, 13, 15 are cancelled.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3- 5, 7-8, 10-12, 14, 16-18, 20-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Feith et al. (US 5,730,418) in view Lopez (US 5,685,866) & Panian et al. (US 2013/0190684).
Regarding claim 1, Feith discloses a needleless valve assembly in Fig. 9 comprising:
a compressible valve body 614 having a retaining flange and a head, the retaining flange having a proximal end and a distal end, see the marked-up Fig. 9 below, and the head having a proximal end (see marked-up Fig. 9) and a distal end (at a continuous top surface 621), wherein a proximal-most surface of the proximal end of the head defines a proximal-most end of the valve body, and the head comprises a continuous top surface, and the compressible valve body 614 comprises an asymmetrical cavity 616 that extends from a bottom surface of the valve body toward the continuous top surface, wherein the asymmetrical cavity 616 is offset from a center cross-section of the body; and
a housing (outer sleeve), wherein the valve body 614 is positioned within the housing for controlling a fluid flow through the needleless valve assembly; and
the needless valve assembly comprising a closed position with the compressible valve in a relaxed position (Fig. 9).
Feith fails to disclose that wherein a proximal-most surface of the proximal end of the retaining flange and a proximal-most surface of the proximal end of the head are coplanar; an unsealed position wherein the continuous top surface is non-planar when the valve body is compressed during the fluid flow.
Note: it appears in the Fig. 3 in Feith that the proximal-most surface of the proximal end of the retaining flange is almost in coplanar with a proximal-most surface of the proximal end of the head.
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Lopez discloses a compressible valve 36, in Figs. 1-3 having a retaining flange 42 and a head 36 (Fig. 3), the retaining flange 42 (see marked-up Fig. 3 below) having a proximal end and a distal end, the head having a proximal end (see marked-up Fig. 3) and a distal end 40b; wherein a proximal-most surface of the proximal end of the retaining flange and a proximal-most surface of the proximal end of the head are coplanar and define a proximal-most end of the valve body.
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It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify a retaining flange and a proximal portion of the head of the valve body in Feith with obtaining a proximal-most surface of the proximal end of the retaining flange and a proximal-most surface of the proximal end of the head are coplanar, as taught by Lopez, in order to fit snugly within the cavity in the top and bottom housing of the valve.
Note: as mentioned the above, Feith shows in Fig. 3 that the proximal-most surface of the proximal end of the retaining flange is almost in coplanar with a proximal-most surface of the proximal end of the head. Meanwhile, Lopez clearly shows that the proximal-most surface of the proximal end of the retaining flange is in coplanar with a proximal-most surface of the proximal end of the head. Thus, Feith in view of Lopez discloses that the proximal most surface of the proximal end of the head is coplanar with the proximal-most surface of the proximal end of the retaining flange.
Feith in view of Lopez discloses the invention substantially as claimed except for the limitation that the continuous top surface is non-planar when the valve body is uncompressed during the fluid flow.
Panian discloses a compressible valve body 110, in Fig. 1-4 comprising: a slit/opening 130; a continuous top surface 120 is non-planar in a relax state, para [0015]; therefore, at some forces apply on the top surface 120, wherein the continuous top surface 120 is non-planar in V-shaped 122 during the fluid flow through the needleless valve assembly.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify a head portion of the valve body Feith (or Feith in view of Lopez device) with obtaining a non-planar in V-shaped (as shown in Figs. 1-2) with or without a slit, as taught by Panian, in order to provide more spring force on the valve body to enhance the fluid flowing around continuous top surface via V-shaped/trough to an interior space of the housing in the valve assembly.
Thus, Feith in view of Lopez and Panian discloses that the needleless valve assembly comprising a closed position with the compressible valve in relaxed position, and an unsealed position wherein the continuous top surface is non-planar when the valve body is compressed during the fluid flow (see similar Fig. 4 in Panian, for example: the continuous top surface 120 is non-planar, i.e., V-shaped when the valve body is compressed).
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Regarding claim 3, Feith discloses that wherein the continuous top surface is tilted relative to a top surface of the housing during the fluid flow through the needleless valve assembly, see similar Fig. 2.
Regarding claim 4, Feith or (Feith in view of Lopez & Panian) discloses that the continuous top surface is deformed in a V-shaped during the fluid flow through the needleless valve assembly.
Regarding claim 5, Feith discloses that wherein the continuous top surface does not require a slit, see Fig. 9.
Regarding claim 7, Feith discloses that wherein a cross-sectional profile of the asymmetrical cavity 616, along a central longitudinal axis of the valve body, (a dot line at a central longitudinal axis, in Fig. 9) comprises an amorphous shape.
Regarding claim 8, Feith discloses a compressible valve body 614 for controlling a fluid flow through a compressible needleless valvue assembly, in Fig. 9, the valve body 614 comprising: a retaining flange and a head, the retaining flange having a proximal end and a distal end, see the marked-up Fig. 9 below, and
the head having a proximal end (see marked-up Fig. 9 above) and a distal end (at a continuous top surface 621), wherein a proximal-most surface of the proximal end of the head defines a proximal-most end of the valve body, and the head comprises a continuous top surface, and the compressible valve body 614 comprises an asymmetrical cavity 616 that extends from a bottom surface of the valve body toward the continuous top surface, wherein the asymmetrical cavity 616 is offset from a center cross-section of the body; wherein the compressible valve body comprises a relaxed position for being seated in a housing (outer sleeve).
Feith fails to disclose that wherein a proximal-most surface of the proximal end of the retaining flange and a proximal-most surface of the proximal end of the head are coplanar; an unsealed position wherein the continuous top surface is non-planar when the valve body is compressed during the fluid flow.
Note: it appears in the Fig. 3 in Feith that the proximal-most surface of the proximal end of the retaining flange is almost in coplanar with a proximal-most surface of the proximal end of the head.
Lopez discloses a compressible valve 36, in Figs. 1-3 having a retaining flange 42 and a head 36 (Fig. 3), the retaining flange 42 (see marked-up Fig. 3 above in the rejection of claim 1) having a proximal end and a distal end, the head having a proximal end (see marked-up Fig. 3 above) and a distal end 40b; wherein a proximal-most surface of the proximal end of the retaining flange and a proximal-most surface of the proximal end of the head are coplanar and define a proximal-most end of the valve body.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify a retaining flange and a proximal portion of the head of the valve body in Feith with obtaining a proximal-most surface of the proximal end of the retaining flange and a proximal-most surface of the proximal end of the head are coplanar, as taught by Lopez, in order to fit snugly within the cavity in the top and bottom housing of the valve.
Note: as mentioned the above, Feith shows in Fig. 3 that the proximal-most surface of the proximal end of the retaining flange is almost in coplanar with a proximal-most surface of the proximal end of the head. Meanwhile, Lopez clearly shows that the proximal-most surface of the proximal end of the retaining flange is in coplanar with a proximal-most surface of the proximal end of the head. Thus, Feith in view of Lopez discloses that the proximal most surface of the proximal end of the head is coplanar with the proximal-most surface of the proximal end of the retaining flange.
Feith in view of Lopez discloses the invention substantially as claimed except for the limitation that the continuous top surface is non-planar when the valve body is uncompressed during the fluid flow.
Panian discloses a compressible valve body 110, in Fig. 1-4 comprising: a slit/opening 130; a continuous top surface 120 is non-planar in a relax state, para [0015]; therefore, at some forces apply on the top surface 120, wherein the continuous top surface 120 is non-planar in V-shaped 122 during the fluid flow through the needleless valve assembly.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify a head portion of the valve body Feith (or Feith in view of Lopez device) with obtaining a non-planar in V-shaped (as shown in Figs. 1-2) with or without a slit, as taught by Panian, in order to provide more spring force on the valve body to enhance the fluid flowing around continuous top surface via V-shaped/trough to an interior space of the housing in the valve assembly.
Thus, Feith in view of Lopez and Panian discloses that the needleless valve assembly comprising a closed position with the compressible valve in relaxed position, and an unsealed position wherein the continuous top surface is non-planar when the valve body is compressed during the fluid flow (see similar Fig. 4 in Panian, for example: the continuous top surface 120 is non-planar, i.e., V-shaped when the valve body is compressed). See the marked-up Fig. 9 in the rejection claim 1.
Regarding claim 10, wherein the continuous top surface is tilted relative to a plane defined by the proximal most end of the valve body when the distal end of the head is compressed toward the proximal most end of the valve body (e.g., when the force of a syringe acts on the top surface of the valve body, the continuous top surface being deformed and bent at a groove/recess 81, see similar Fig. 2).
Regarding claim 11, Panian (or Feith in view of Lopez and Panian) discloses that wherein the continuous top surface is deformed in V-shaped when the distal end of the head is compressed toward the proximal most end of the valve body, see Figs. 2 & 4 in Panian or the marked-up Fig. 9 in the rejection of claim 1 above.
Regarding claim 12, wherein the continuous top surface does not require a slit.
Regarding claim 14, wherein a cross-sectional profile of the asymmetrical cavity 616, along a central longitudinal axis (a dot line at a central longitudinal axis, in Fig. 9) of the valve body, comprises an amorphous shape.
Regarding claims 16-17, Feith in view of Lopez and Panian discloses all claimed subject matter. Feith discloses that wherein the compressible valve body comprises a rubber, col. 8, line 13. Meanwhile the claimed invention requires that the compressible valve body formed of silicone. It would have been obvious to one having ordinary skill in the art at the time the invention was made to obtain the compressible valve body formed of a silicone material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. For example: silicon material has similar characteristics as a rubber such as: compressible and sealable.
Regarding claim 18, Feith discloses a needleless valve assembly in Fig. 9 (or marked-up Fig. 9 above) comprising:
a compressible valve body 614 and a housing, the compressible valve body 614 having a head, a retaining flange, and an asymmetrical cavity 616 that extends from a bottom surface of the compressible valve body toward a continuous top surface of the head; and the compressible valve body 614 is seated in the housing by the retaining flange such that a port 621 of the housing is sealed by the head, see Fig. 9 and the compressible valve body is collapsible in the area 81 of compression feature, see similar Fig. 2. Note: the valve body 614 in Fig. 9 includes a reduced diameter portion 81, as shown in Fig. 2. When a force applies on the continuous top surface of the valve body, the portion 81 being deformed in compression feature; wherein the compressible valve body comprises a relaxed position for being seated in a housing (outer sleeve).
Feith fails to disclose that wherein a proximal-most surface of the proximal end of the retaining flange and a proximal-most surface of the proximal end of the head are coplanar; an unsealed position wherein the continuous top surface is non-planar when the valve body is compressed during the fluid flow.
Note: it appears in the Fig. 3 in Feith that the proximal-most surface of the proximal end of the retaining flange is almost in coplanar with a proximal-most surface of the proximal end of the head.
Lopez discloses a compressible valve 36, in Figs. 1-3 having a retaining flange 42 and a head 36 (Fig. 3), the retaining flange 42 (see marked-up Fig. 3 above in the rejection of claim 1) having a proximal end and a distal end, the head having a proximal end (see marked-up Fig. 3 above) and a distal end 40b; wherein a proximal-most surface of the proximal end of the retaining flange and a proximal-most surface of the proximal end of the head are coplanar and define a proximal-most end of the valve body.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify a retaining flange and a proximal portion of the head of the valve body in Feith with obtaining a proximal-most surface of the proximal end of the retaining flange and a proximal-most surface of the proximal end of the head are coplanar, as taught by Lopez, in order to fit snugly within the cavity in the top and bottom housing of the valve.
Note: as mentioned the above, Feith shows in Fig. 3 that the proximal-most surface of the proximal end of the retaining flange is almost in coplanar with a proximal-most surface of the proximal end of the head. Meanwhile, Lopez clearly shows that the proximal-most surface of the proximal end of the retaining flange is in coplanar with a proximal-most surface of the proximal end of the head. Thus, Feith in view of Lopez discloses that the proximal most surface of the proximal end of the head is coplanar with the proximal-most surface of the proximal end of the retaining flange.
Feith in view of Lopez discloses the invention substantially as claimed except for the limitation that the continuous top surface is non-planar when the valve body is uncompressed during the fluid flow.
Panian discloses a compressible valve body 110, in Fig. 1-4 comprising: a slit/opening 130; a continuous top surface 120 is non-planar in a relax state, para [0015]; therefore, at some forces apply on the top surface 120, wherein the continuous top surface 120 is non-planar in V-shaped 122 during the fluid flow through the needleless valve assembly.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify a head portion of the valve body Feith (or Feith in view of Lopez device) with obtaining a non-planar in V-shaped (as shown in Figs. 1-2) with or without a slit, as taught by Panian, in order to provide more spring force on the valve body to enhance the fluid flowing around continuous top surface via V-shaped/trough to an interior space of the housing in the valve assembly.
Thus, Feith in view of Lopez and Panian discloses that the needleless valve assembly comprising a closed position with the compressible valve in relaxed position, and an unsealed position wherein the continuous top surface is non-planar when the valve body is compressed during the fluid flow (see similar Fig. 4 in Panian, for example: the continuous top surface 120 is non-planar, i.e., V-shaped when the valve body is compressed). See the marked-up Fig. 9 in the rejection claim 1.
Regarding claim 19, Feith in view of Lopez and Panian discloses that wherein the continuous top surface is tilted relative to a top surface of the housing during a fluid flow through the needleless valve assembly, see similar Figs. 2 & 4 in Panian or the marked-up Fig.9 above.
Regarding claim 20, wherein the continuous top surface is tilted relative to a top surface of the housing during a fluid flow through the needleless valve assembly, see similar Fig. 2.
Regarding claim 21, Panian (or Feith in view of Lopez and Panian) discloses that wherein the continuous top surface is deformed in V-shaped during the fluid flow through the needleless valve assembly, see Figs. 2 & 4 in Panian or the marked-up Fig. 9 in the rejection of claim 1 above.
Response to Arguments
Applicant's arguments filed 08/01/25 have been fully considered but they are not persuasive.
Applicant argues that Panian discloses the “continuous top surface 120 is non-planar in relaxed state of head portion 1110. This is based, in part, on opening 130 being in a relaxed open position.” Applicant further states that the office action does not identify the applied references to disclose the features in which the “valve body is positioned within the housing for controlling a fluid flow through the needless valve assembly, and the needless valve assembly comprising a closed position with the compressible valve in a relaxed position, and un unsealed position wherein the continuous top surface is non-planar when the valve body is comprised during he fluid flow“, as recited in independent claim 1.
In response, Panian discloses in Fig. 1 that the valve body includes a continuous top surface 120 with an opening 130 in a relaxed position. Meanwhile, the Fig. 3 (different embodiment with Fig. 1), the valve body includes a continuous top surface 315 and a slit 130 in a relaxed position. Panian clearly discloses that valve body is positioned within the housing for controlling a fluid flow through the needless valve assembly, and the needless valve assembly comprising a closed position (Fig. 1 & 3) with the compressible valve in a relaxed position, and an unsealed position (Figs. 2 & 4) wherein the continuous top surface is non-planar when the valve body is comprised during the fluid flow. Therefore, a person skilled in the art recognize that modifying the valve assembly in Feith (or Feith in view of Lopez) by obtaining a continuous top surface being non-planar (V-shape, as shown in Fig. 1) or being a flat surface (as shown in Fig. 3) with including an opening (Fig. 1) or a slit (Fig. 3) in the valve body in Feith (or Feith in view of Lopez), as suggested by Panian, in order to allow fluid to flow around continuous top surface via V-shaped/trough to an interior space of the housing in the valve assembly with less stress from the valve body to create more spring force on the valve body to enhance the fluid flowing around continuous top surface via V-shaped/trough to an interior space of the housing in the valve assembly.
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 QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783