403DETAILED ACTION
This office action is in response to applicant’s communication of 3/26/2026. Currently claims 1-20 are pending and rejected below.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Examiner is unclear how the rotatable element” moves in a “first”, “second”, “third” and “fourth” direction. Examiner is of the Examiner is of the position that the application only show a rotatable element that moves in two directions a first clockwise direction or a second anticlockwise direction. It is unclear what the third and fourth directions are. It is unclear what the claim language of the third and fourth directions are referring to. Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “rotatable element” that is rotatable in a “first”, “second”, “third” and “fourth” direction must be shown or the feature(s) canceled from the claim(s).
Examiner is of the position that the drawings only show a rotatable element that moves in two directions a first clockwise direction or a second anticlockwise direction. It is unclear what the third and fourth directions are.
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over ZIV et al. (US 2007/0287953 A1) in view of Manska (US 5,046,528) or also Harautuneian (US 3,185,179).
Ziv disclose a valve (as in figure 1-60D) comprising a body (512 for example) and a rotatable element positioned at least partially within the body such that the rotatable element (557) is rotatable around an axis of rotation between a first configuration and a second configuration, and the rotatable element is displaceable along the axis of rotation (see element 557), the body having a first port (518) , a second port (514), and a third port (528), and the rotatable element having a channel fluidly coupling an inlet port (near 552), an outlet port (opposite side of 552), and a side port (side ports of 552 near 554) of the rotatable element, wherein, the rotatable element is engaged against the body in the first configuration (see figure 40C, 50C or 60C) such that a fluid flow path through the channel extends along the first port, the inlet port, the side port, the third port, and the outlet port, and the second port, and the rotatable element is displaced along the axis of rotations from the body in the second configuration (40A) such that the fluid flow path through the channel extends directly between the inlet port to the outlet port.
Concerning the claim language regarding the first, second, third and fourth directions that the rotatable element moves in (as in the amended claims) examiner is of the position that Ziv does disclose a rotatable element that moves in a similar clockwise/anticlockwise fashion like the applicant’s rotatable member. It is examiner position that this rotatable element may move in four directions that oppose one another as shown in Ziv figures 9A, 8B, 9C, and 9E for examples of the four directions.
In similar Harautuneian teaches a post 55/58 and interior bore (interior of 15) with the same rational as above.
Concerning the language of the channel extends directly between the inlet port to the outlet port “and fluidically isolated from the third port” see figure 40A.
Ziv discloses the claimed invention except for the body having a post and a rotatable element with a bore in the center. Manska teaches that it is known to use a body having a post and a rotatable element with a bore in the center as set forth in figures 1-4 and body 20 with post 102/16 and rotatable element 40 with bore 42 to provide a well known and alternative means to secure a rotatable element within a body portion in a valve. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Ziv with a body having a post and a rotatable element with a bore in the center as taught by Manska, since such a modification would provide the system with a body having a post and a rotatable element with a bore in the center for providing a well known and alternative means to secure a rotatable element within a body portion in a valve. It is examiner’s position that a PHOSITA would know that forming the rotatable valve member to move within and rotate in a body can be secured to each other by the way Ziv does or by way that Manska teaches by a post and interior bore of the rotating member. Examiner is of the position that these are alternative ways to secure and would perform the task of rotation within a body equally with the Ziv means of securing or the Manska means or securing with a post and interior bore.
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Concerning claim 2 and in the first configuration the fluid flows through an interior space of the third port (see figure 50C for example).
Concerning claim 3 and in the second configuration, at least a portion of the fluid entering the first port flows to the second port without passing through the side port (see figure 40A for example).
Concerning claim 4 and the rotatable element comprises a first side port and a second side port (note side ports around 552 near 554).
Concerning claim 5 and in the first configuration, the first port is fluidly coupled to the inlet port and the first side port, the second port is fluidly coupled to the outlet port and the second side port, and the first and second side ports are coupled to the third port (see figure 50C or 60C).
Concerning claim 6 and the third port comprises a needleless access port configured to be actuated by a needleless connector (see element 324).
Concerning claim 7 and the second configuration, a gap (near 327 space) is formed between the body and rotatable element (As in figure 40A for example). It is examiner position that with the taught prior art Mauska teaching a post (as shown in 102 of Mauska) the fluid gap would be between these two structures as the gap would traverse through the space of the rotatable element that has the post on one side and when in this configuration would allow for the flow directly from the inlet to the outlet.
Concerning claim 8 and further comprising a third configuration, wherein the inlet port of the rotatable element is fluidly coupled to the third port of the body, and the side port of the rotatable element is fluidly coupled to the second port of the body, such that the first port is fluidly isolated from the second and third ports (see figure 40B for example).
Concerning claim 9 and further comprising a fourth configuration, wherein the outlet port of the rotatable element is fluidly coupled to the third port of the body, and the side port of the rotatable element is fluidly coupled to the second port of the body, such that the second port is fluidly isolated from the first and third ports (see figure 40D).
Concerning claim 10 and the channel extends along an outer surface of the rotatable element (note channel on figures 35A and 35B).
Concerning claim 11 and a rotatable element positioned at least partially within the body such that the rotatable element is movable around an axis of rotation and the rotatable element is displaceable along the axis of rotation (see element 557) between a first configuration and a second configuration, the body having a first port, a second port, and a third port, and the rotatable element having a channel fluidly coupling an inlet port, an outlet port, and a side port of the rotatable element, wherein, in the first configuration, the first port is aligned with the inlet port, the side port is aligned with the third port, and the outlet port is aligned with the second port, and in the second configuration, the rotatable element is diplaced from the body along the axis of rotation such that the first port is aligned with the outlet port, the side port is misaligned with the third port, and the second port is aligned with the inlet port (note disclosure and identifying structures as discussed in claim 1 above). Concerning the language of the second port “fluidically isolated from the third port” see figure 40A.
Concerning the claim language regarding the first, second, third and fourth directions that the rotatable element moves in (as in the amended claims) examiner is of the position that Ziv does disclose a rotatable element that moves in a similar clockwise/anticlockwise fashion like the applicant’s rotatable member. It is examiner position that this rotatable element may move in four directions that oppose one another as shown in Ziv figures 9A, 8B, 9C, and 9E for examples of the four directions.
Ziv discloses the claimed invention except for the body having a post and a rotatable element with a bore in the center. Manska teaches that it is known to use a body having a post and a rotatable element with a bore in the center as set forth in figures 1-4 and body 20 with post 102/16 and rotatable element 40 with bore 42 to provide a well known and alternative means to secure a rotatable element within a body portion in a valve. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Ziv with a body having a post and a rotatable element with a bore in the center as taught by Manska, since such a modification would provide the system with a body having a post and a rotatable element with a bore in the center for providing a well known and alternative means to secure a rotatable element within a body portion in a valve. It is examiner’s position that a PHOSITA would know that forming the rotatable valve member to move within and rotate in a body can be secured to each other by the way Ziv does or by way that Manska teaches by a post and interior bore of the rotating member. Examiner is of the position that these are alternative ways to secure and would perform the task of rotation within a body equally with the Ziv means of securing or the Manska means or securing with a post and interior bore.
Concerning claim 12 and in the first configuration, the rotatable element is engaged against the body to resist a fluid flow directly from the inlet port to the outlet port (see figure 50C or 60C).
Concerning claim 13 and in the first configuration the fluid flows through an interior space of the third port (again note 50C or 60C).
Concerning claim 14 and in the second configuration a gap is formed between the body and rotatable element (see gap near 327 space).
Concerning claim 15 and in the second configuration, a gap is formed between the body and rotatable element (see figure 40A for example). It is examiner position that with the taught prior art Mauska teaching a post (as shown in 102 of Mauska) the fluid gap would be between these two structures as the gap would traverse through the space of the rotatable element that has the post on one side and when in this configuration would allow for the flow directly from the inlet to the outlet.
Concerning claim 16 and a valve comprising a body and a rotatable element positioned at least partially within the body, and the rotatable element is displaceable along the axis of rotation (see element 557) the rotatable element having a first configuration wherein a fluid flow path through the valve includes a first port of the body, an inlet port of the rotatable element, a side port of the rotatable element, a third port of the body, and an outlet port of the rotatable element, and a second port of the body, and a second configuration wherein the fluid flow path through the valve bypasses the third port, and wherein the rotatable element is displaced along the axis of rotation when rotated around an axis of rotation from the first configuration to the second configuration (again see identifying of structures and configurations as in claim 1 discussion above). Concerning the language of “fluidically isolated from the third port” see figure 40A.
Concerning the claim language regarding the first, second, third and fourth directions that the rotatable element moves in (as in the amended claims) examiner is of the position that Ziv does disclose a rotatable element that moves in a similar clockwise/anticlockwise fashion like the applicant’s rotatable member. It is examiner position that this rotatable element may move in four directions that oppose one another as shown in Ziv figures 9A, 8B, 9C, and 9E for examples of the four directions.
Ziv discloses the claimed invention except for the body having a post and a rotatable element with a bore in the center. Manska teaches that it is known to use a body having a post and a rotatable element with a bore in the center as set forth in figures 1-4 and body 20 with post 102/16 and rotatable element 40 with bore 42 to provide a well known and alternative means to secure a rotatable element within a body portion in a valve. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Ziv with a body having a post and a rotatable element with a bore in the center as taught by Manska, since such a modification would provide the system with a body having a post and a rotatable element with a bore in the center for providing a well known and alternative means to secure a rotatable element within a body portion in a valve. It is examiner’s position that a PHOSITA would know that forming the rotatable valve member to move within and rotate in a body can be secured to each other by the way Ziv does or by way that Manska teaches by a post and interior bore of the rotating member. Examiner is of the position that these are alternative ways to secure and would perform the task of rotation within a body equally with the Ziv means of securing or the Manska means or securing with a post and interior bore.
Concerning claim 17 and in the first configuration, the rotatable element is engaged against the body to resist a fluid flow directly between the inlet port to the outlet port (see figure 50C or 60C).
Concerning claim 18 and in the first configuration the fluid flows through an interior space of the third port (note space within third port interior of 324/316).
Concerning claim 19 and in the second configuration, a gap 327 is formed between the post 356 and rotatable element (see gap near 327 space). It is examiner position that with the taught prior art Mauska teaching a post (as shown in 102 of Mauska) the fluid gap would be between these two structures as the gap would traverse through the space of the rotatable element that has the post on one side and when in this configuration would allow for the flow directly from the inlet to the outlet.
Concerning claim 20 and in the second configuration, the side port is misaligned with the third port (note position of side port as in figure 40A for example).
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Response to Arguments
Applicant’s arguments, filed 11/02/2025, have been fully considered but they are not persuasive. Examiner is of the position that the prior art Ziv does disclose a rotatable element that moves in a similar clockwise/anticlockwise fashion like the applicant’s rotatable member. It is examiner position that this rotatable element may move in four directions that oppose one another as shown in Ziv figures 9A, 8B, 9C, and 9E for examples of the four directions. Examiner is of the position that the prior art rotates the same way that the applicant’s rotatable member rotates and in my be set in four different positions or directions as the applicants.
As discussed in the rejection above examiner if of the position that the teachings and the combination of the prior art would teach that a PHOSITA may form a rotatable element with an interior bore on a post on a body. This would be a known way in which a PHOSITA would secure a rotatable element on a body as taught in Manska.
The elements disclosed in Ziv in view of Manska are fully capable of satisfying all structural, functional, spatial, and operational limitations in the amended claims, as currently written, and the rejection is made.
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 PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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, Michael Tsai can be reached on (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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