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
The claims filed 08/07/2024 has been entered. Claims 1-19 are pending in the application.
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 second fluid flow path described in Claim 10 must be shown or the feature(s) canceled from the claim(s). 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 § 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.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification fails to described a second fluid flow path at all. While paragraph 0026 and paragraph 0031 describe two different embodiments of a first fluid flow path, there is no description of a second fluid flow path in either embodiment or how the second fluid flow path relates to the first fluid flow path.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 8-10, 1-12, 17, 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leeflang (US 2018/0304041).
Regarding Claim 1, Leeflang discloses a hemostasis valve device (Device of Fig 7), comprising: a body member (531, Fig 7) comprising a body bore (536, Fig 7) extending therethrough, wherein the body bore comprises a distal bore portion (536c, Fig 7) and a proximal bore portion (536b, Fig 7); a side-arm (540, Fig 7) extending radially outward from the body member and comprising a side-arm bore (546, Fig 7) extending therethrough and in fluid communication with the proximal bore portion; and a valve member (550, Fig 7) disposed within the body bore proximally of the side-arm and configured to selectively restrict fluid flow through the body bore, wherein the proximal bore portion comprises a first fluid flow path configured to flush air bubbles from the proximal bore portion (Para 005-0056).
Regarding Claim 2, Leeflang discloses the first fluid flow path is configured to flush air bubbles from a distal surface of the valve member (Para 0056).
Regarding Claim 3, Leeflang discloses a fluid flow insert (512, Fig 7) co-axially disposed within the proximal bore portion distally of the valve member (See Fig 7).
Regarding Claim 8, Leeflang discloses the side-arm (540, Fig 7) is offset from a vertical plane (plane aligned with axis 518, Fig 7) aligned with a longitudinal axis of the body member (See Fig 7 wherein the side-arm is laterally and angularly offset from the vertical plan ).
Regarding Claim 9, Leeflang discloses the side-arm bore (546, Fig 7) comprises a side-arm bore outlet (outlet of bore 546 near region 536b, Fig7) in fluid communication with the proximal bore portion and disposed offset from the vertical plane (Para 0055, See Fig 7).
Regarding Claim 10, Leeflang discloses a second fluid flow path comprising: a second side-arm bore segment extending through the side-arm bore (Para 0055, lines 9-10); a side-arm bore outlet segment extending through the side-arm bore outlet (Para 0055, lines 10-11); and a second proximal bore segment comprising a second circular or spiral or swirl shape path (Para 0055, lines 12-14).
Regarding Claim 11, Leeflang discloses a hemostasis valve device (Device of Fig 7), comprising: a body member (531, Fig 7) comprising a body bore (536, Fig 7) extending therethrough, wherein the body bore comprises a distal bore portion (536c, Fig 7) and a proximal bore portion (536b, Fig 7); a side-arm (540, Fig 7) extending radially outward from the body member and comprising a side-arm bore (546, Fig 7) extending therethrough and in fluid communication with the proximal bore portion; a valve member (550, Fig 7) disposed within the body bore proximally of the proximal bore portion and configured to selectively restrict fluid flow through the body bore; and a fluid flow insert (512, Fig 7) co-axially disposed within the body bore distally of the valve member, wherein the fluid flow insert is configured to direct a fluid flowing within the proximal bore portion in a circular flow path to flush air bubbles from the proximal bore portion (Para 0055-0056).
Regarding Claim 12, Leeflang discloses the fluid flow insert (512, Fig 7) is configured to direct the fluid flowing within the proximal bore portion in a circular or spiral or swirling shape flow path to flush air bubbles from a distal surface of the valve member (Para 0055-0056).
Regarding Claim 17, Leeflang discloses a method of removing air bubbles from a medical device, comprising: injecting fluid through a side-arm bore (546, Fig 7) of the medical device into a proximal body bore portion (536b, Fig 7) of the medical device, wherein the proximal body bore portion includes a circular, spiral, or swirling shape flow path (Para 0055).
Regarding Claim 19, Leeflang discloses injecting fluid through the side-arm bore (546, Fig 7) of the medical device into the proximal body bore portion of the medical device comprises injecting the fluid through a side-arm bore outlet disposed offset from a vertical plane (plane aligned with axis 518, Fig 7) aligned with a longitudinal axis of the proximal bore portion (See Fig 7 wherein the side-arm is laterally and angularly offset from the vertical plan).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-7, 13-16, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang (US 2018/0304041) in view of McKinnon (US 2010/0204660).
Regarding Claim 4, Leeflang discloses the fluid flow insert (512, Fig 7) comprises: a flow channel (flow channel formed between the hub passage 536 and insert 512, Fig 7), however, is silent regarding the fluid flow insert comprises a flow channel comprising: an inlet portion in fluid communication with the side-arm bore; an outlet portion in fluid communication with the proximal bore portion; and a flow channel having a spiral shape and extending between and in fluid communication with the inlet portion and the outlet portion.
McKinnon teaches an analogous hub (Device of Fig 8) comprising a body member (41, Fig 5) comprising a body bore (42, Fig 5) extending therethrough, wherein the body bore comprises a distal bore portion and a proximal bore portion; a fluid flow inserts (74, Fig 7) co-axially disposed within the proximal bore portion (See Fig 8), wherein the proximal bore portion comprises a first fluid flow path configured to flush air bubbles from the proximal bore portion (Para 0009-0010, 0048); the fluid flow insert comprises: a flow channel (80, Fig 7) comprising: an inlet portion (portion of channel near proximal end 76); an outlet portion (portion of channel near numeral 54) in fluid communication with the proximal bore portion; and a flow channel having a spiral shape and extending between and in fluid communication with the inlet portion and the outlet portion (Para 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow insert to comprise a helical flow channel as taught by McKinnon in order to cause causes a faster flow rate and a more turbulent flow to eliminate, prevent, or limit regions of stagnant flow to provide better flush properties (Para 0010, 0048).
Regarding Claim 5, the modified invention of Leeflang and McKinnon discloses the fluid flow insert further comprises a protrusion (79, Fig 7 -McKinnon) at least partially surrounding the inlet portion and configured to be at least partially disposed within a distal portion of the side-arm bore (The proximal end of insert 512 in Leeflang is partially disposed within an outlet portion of the side arm bore 546. Thus, the modified insert would have the protrusion 79 on the proximal end partially disposed within an outlet portion of the side arm bore).
Regarding Claim 6, the modified invention of Leeflang and McKinnon discloses a first fluid flow path comprising: a first side-arm bore segment extending through the side-arm bore (Para 0055, lines 9-10 -Leeflang); an inlet segment extending through the inlet portion (Flow into the helical channel 80, Para 0048 - McKinnon); a channel segment extending through the flow channel (Flow through the helical channel 80, Para 0048 - McKinnon); an outlet segment extending through the outlet portion (Flow out of the helical channel 80, Para 0048 - McKinnon); and a first proximal bore segment comprising a first circular or spiral or swirl shape path (Para 0055, lines 13-14 -Leeflang).
Regarding Claim 7, the modified invention of Leeflang and McKinnon discloses the fluid flow insert comprises an insert bore (516, Fig 7 -Leeflang) extending through the fluid flow insert and in communication with the proximal bore portion and the distal bore portion (Para 0055 -Leeflang).
Regarding Claim 13, Leeflang discloses the fluid flow insert (512, Fig 7) comprises: a flow channel (flow channel formed between the hub passage 536 and insert 512, Fig 7), however, is silent regarding the fluid flow insert comprises a flow channel comprising: an inlet portion in fluid communication with the side-arm bore; an outlet portion in fluid communication with the proximal bore portion; and a flow channel having a spiral shape and extending between and in fluid communication with the inlet portion and the outlet portion.
McKinnon teaches an analogous hub (Device of Fig 8) comprising a body member (41, Fig 5) comprising a body bore (42, Fig 5) extending therethrough, wherein the body bore comprises a distal bore portion and a proximal bore portion; a fluid flow inserts (74, Fig 7) co-axially disposed within the proximal bore portion (See Fig 8), wherein the proximal bore portion comprises a first fluid flow path configured to flush air bubbles from the proximal bore portion (Para 0009-0010, 0048); the fluid flow insert comprises: a flow channel (80, Fig 7) comprising: an inlet portion (portion of channel near proximal end 76); an outlet portion (portion of channel near numeral 54) in fluid communication with the proximal bore portion; and a flow channel having a spiral shape and extending between and in fluid communication with the inlet portion and the outlet portion (Para 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow insert to comprise a helical flow channel as taught by McKinnon in order to cause causes a faster flow rate and a more turbulent flow to eliminate, prevent, or limit regions of stagnant flow to provide better flush properties (Para 0010, 0048).
Regarding Claim 14, the modified invention of Leeflang and McKinnon discloses the fluid flow insert further comprises a protrusion (79, Fig 7 -McKinnon) at least partially surrounding the inlet portion and configured to be at least partially disposed within a distal portion of the side-arm bore (The proximal end of insert 512 in Leeflang is partially disposed within an outlet portion of the side arm bore 546. Thus, the modified insert would have the protrusion 79 on the proximal end partially disposed within an outlet portion of the side arm bore).
Regarding Claim 15, the modified invention of Leeflang and McKinnon discloses a first fluid flow path comprising: a first side-arm bore segment extending through the side-arm bore (Para 0055, lines 9-10 -Leeflang); an inlet segment extending through the inlet portion (Flow into the helical channel 80, Para 0048 - McKinnon); a channel segment extending through the flow channel (Flow through the helical channel 80, Para 0048 - McKinnon); an outlet segment extending through the outlet portion (Flow out of the helical channel 80, Para 0048 - McKinnon); and a first proximal bore segment comprising a first circular or spiral or swirl shape path (Para 0055, lines 13-14 -Leeflang).
Regarding Claim 16, the modified invention of Leeflang and McKinnon discloses the fluid flow insert comprises an insert bore (516, Fig 7 -Leeflang) extending through the fluid flow insert and in communication with the proximal bore portion and the distal bore portion (Para 0055 -Leeflang).
Regarding Claim 18, Leeflang discloses injecting fluid the through the side-arm bore of the medical device into the proximal body bore portion of the medical device comprises injecting the fluid through a fluid flow channel of a fluid flow insert (512, Fig 7) (Para 0055-0056), however, is silent regarding the fluid flow channel comprises a spiral shape.
McKinnon teaches an analogous hub (Device of Fig 8) comprising a body member (41, Fig 5) comprising a body bore (42, Fig 5) extending therethrough, wherein the body bore comprises a distal bore portion and a proximal bore portion; a fluid flow inserts (74, Fig 7) co-axially disposed within the proximal bore portion (See Fig 8), wherein the proximal bore portion comprises a first fluid flow path configured to flush air bubbles from the proximal bore portion (Para 0009-0010, 0048); the fluid flow insert comprises: a flow channel (80, Fig 7) comprising: an inlet portion (portion of channel near proximal end 76); an outlet portion (portion of channel near numeral 54) in fluid communication with the proximal bore portion; and a flow channel having a spiral shape and extending between and in fluid communication with the inlet portion and the outlet portion (Para 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid flow insert to comprise a helical flow channel as taught by McKinnon in order to cause causes a faster flow rate and a more turbulent flow to eliminate, prevent, or limit regions of stagnant flow to provide better flush properties (Para 0010, 0048).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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