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 .
Acknowledgment
Claims 1, 7-8, 13-15 are amended and field on 8/27/2026 and claim 19-34 are canceled.
The 101 rejection in the action mailed on 5/27/2026 is withdrawn due to the amendment to claim 1.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5, 9-13, 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ensminger et al. (US. 5520643) (“Ensminger”).
Re claim 1, Ensminger discloses a vascular access device (Fig. 1-3b, Col. 2, lines 1-28, abstract) configured to be disposed subcutaneously (Col. 2, lines 1-28, abstract), comprising: a catheter (17) defining a catheter lumen (lumen of the catheter, Fig. 3) and configured to provide fluid communication with a vasculature of a patient (Col. 2, lines 1-28); and a port including a body (16, 28) defining a port lumen extending along a longitudinal axis from an inlet (annotated Fig, 3 of Ensminger) to an outlet ( close to 4b, Fig. 3), the port lumen defining a uniform cross-sectional diameter between the inlet and the outlet ( lumen for 46, annotated Fig. 3 of Ensminger).
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Annotated Fig. 3 of Ensminger
Re claim 2, Ensminger discloses wherein the port lumen defines a uniform cross-sectional area (circular cross area, see Fig. 3).
Re claim 3, Ensminger discloses wherein the port lumen defines a uniform cross-sectional shape (circular cross shape, see Fig. 3).
Re claim 4, Ensminger discloses wherein the port lumen includes a valve or a needle penetrable septum configured to control a fluid flow therethrough (valve assembly 34, Fig. 3, 4).
Re claim 5, Ensminger discloses wherein the outlet of the port is defined by a stem (50) configured to be inserted into the lumen of the catheter (Fig. 3).
Re claim 9, Ensminger discloses further including a nub ( side wall and lower wall of 25 of the entrance 24, Fig. 3) extending proximally from a lower edge of the inlet ( annotated Fig. 3 of Ensminger) and configured to receive an access needle, impinging thereon, and direct the needle towards the inlet (Col. 7, lines 4-13).
Re claim 10, Ensminger discloses wherein the nub includes a side wall extending perpendicular from an edge of the nub and extending longitudinally ( side wall of 24), the side wall configured to direct a needle impinging thereon towards the inlet (Col. 7, lines 4-13).
Re claim 11, Ensminger discloses wherein an axis of a portion of the port lumen aligns with an axis of the catheter lumen (a portion close to 50/ 16, Fig. 3).
Re claim 12, Ensminger discloses wherein the portion of the port lumen extends between a septum (34) and the outlet (16, Fig. 3).
Re claim 13, Ensminger discloses wherein an axis of a second portion of the port lumen ( the sloped portion close to inlet , Fig. 3). extends at an angle relative to axis of the portion of the port lumen, the second portion disposed proximal of the septum ( the sloped portion close to inlet , Fig. 3).
Re claim 16, Ensminger discloses wherein the port body includes an echogenic or radiopaque material ( the material of the body can be made of metal which is an echogenic or radiopaque material see Col. 2, lines 1-28).
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.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ensminger in view of Saab (US 8979806 B2).
Re claim 6, Ensminger is silent with regards to the limitation that the diameter of the port lumen is equal to a diameter of the lumen of the catheter in a relaxed state.
However, Saab discloses a venous access port (Fig. 1, abstract) and wherein the diameter of the port lumen (lumen of 16, 136, Fig. 1) is equal to a diameter of the lumen of the catheter in a relaxed state (lumen of 150, Fig. 1).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the port of Ensminger so that the diameter of the port lumen is equal to a diameter of the lumen of the catheter in a relaxed state as taught by Saab for the purpose of having desired size of conduit for enhance the performance (Saab, Fig. 1, Col. 8, lines 55-65 and Col. 18, lines 10).
Re claim 7, Ensminger is silent with regards to the limitation that wherein a cross-sectional area of the port lumen is equal to a cross-sectional area of the lumen of the catheter in a relaxed state.
However, Saab discloses a venous access port (Fig. 1, abstract) and wherein the cross-sectional area of the port lumen (lumen of 16, 136, Fig. 1) is equal to a cross-sectional area of the lumen of the catheter in the relaxed state (lumen of 150, Fig. 1).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the port of Ensminger so that the cross-sectional area of the port lumen is equal to a cross-sectional area of the lumen of the catheter in the relaxed state as taught by Saab for the purpose of having desired size of conduit for enhance the performance (Saab, Fig. 1, Col. 8, lines 55-65 and Col. 18, lines 10).
Re claim 8, Ensminger is silent with regards to the limitation that a cross-sectional shape of the port lumen is equal to a cross-sectional shape of the lumen of the catheter in a relaxed state.
However, Saab discloses a venous access port (Fig. 1, abstract) and wherein the cross-sectional shape of the port lumen (lumen of 16, 136, Fig. 1) is equal to a cross-sectional shape of the lumen of the catheter in the relaxed state (lumen of 150, Fig. 1).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the port of Ensminger so that the cross-sectional shape of the port lumen is equal to a cross-sectional shape of the lumen of the catheter in the relaxed state as taught by Saab for the purpose of having desired size of conduit for enhance the performance (Saab, Fig. 1, Col. 8, lines 55-65 and Col. 18, lines 10).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ensminger
Re claim 14, Ensminger is silent with regards to the limitation that wherein an outermost diameter of the port body is less than double an outer diameter of the catheter.
The instant disclosure describes the parameter of the an outermost diameter of the port body as being merely preferable (see ¶0039 of the current application), and does not describe the an outermost diameter of the port body as contributing any unexpected results to the system. As such, parameters such as an outermost diameter of the port body are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the an outermost diameter of the port body would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Re claim 15, Ensminger discloses wherein an outermost diameter of the port body is between 170% and 130% of an outer diameter of the catheter.
The instant disclosure describes the parameter of the an outermost diameter of the port body as being merely preferable (see ¶0039 of the current application), and does not describe the an outermost diameter of the port body as contributing any unexpected results to the system. As such, parameters such as an outermost diameter of the port body are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the an outermost diameter of the port body would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ensminger in view of Elbe et al. (US 20110034886 A1) (“Elbe“).
Re claim 17, Ensminger fails to disclose further including an insertion tool including a tool head having a sharpened front edge and configured to form a tissue pocket to receive the vascular access device.
However, Elbe discloses a venous access port tool (Fig. 8a-c, abstract) including an insertion tool (29 including a tool head (11) having a sharpened front edge (13) and configured to form a tissue pocket to receive the vascular access device (Fig. 7d, ¶0041, ¶0056).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the port of Ensminger to include including an insertion tool including a tool head having a sharpened front edge and configured to form a tissue pocket to receive the vascular access device as taught by Elbe for the purpose of creating a pocket for placing the access port within the tissue (Elbe , ¶0056).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ensminger in view of Zinn et al. (US 20070219510 A1) (“Zinn“).
Re claim 18, Ensminger fails to disclose further including a cathlock configured to secure the catheter to the outlet.
However, Zinn discloses a venous access port (Fig. 15, abstract) and wherein the outlet (152) is attached to the catheter (202, ¶0034) and including a cathlock (204) configured to secure the catheter to the outlet (¶0034).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the port of Ensminger to include a cathlock configured to secure the catheter to the outlet as taught by Zinn for the purpose of firmly securing the catheter to the stem (Zinn, ¶0034).
Response to Arguments
Applicant's arguments filed 8/27/2026 have been fully considered but they are not persuasive. The applicant argues that Ensminger fails to disclose “ uniform cross-sectional diameter between the inlet and the outlet” and it seems that it has a funnel like shape or it has “ convergently tapered”. This is found not persuasive as inner diameter from 30 to 35 is uniform diameter. Also, the funnel is at 25 which matches the num as claimed in claim 9-10.
Conclusion
THIS ACTION IS MADE FINAL. 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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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