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 .
Information Disclosure Statement
The IDS form(s) submitted on 9877 is/are in compliance with the requirements of the provisions of 37 CFR 1.97. Accordingly, the information disclosure(s) are being considered by the examiner.
Response to Amendment
This office action is responsive to the claim amendments filed on 2/24/2026. As directed by the amendment: claims 1-2, 4-9, 11-12, 16 and 19 have been amended; claims 3 have been cancelled; and no claims have been added. Thus, claims 1-2, and 4-20 are presently pending in this application.
Applicant’s amendments to claims 1, 6, and 19 have overcome Examiner’s objections and are therefore withdrawn.
Applicants’ amendment to claims 11 and 19 have overcome Examiner’s rejections under 35 USC § 112 and are therefore withdrawn.
Response to Arguments
Applicant's arguments filed 01/09/2023 with regards previous interpretation of US 2012/0245551 A1 to Fangrow, Jr. et al. and the newly presented amendments to claims 1, 9, and 16 are considered persuasive. See amended claim rejection below, specifically with regard to the fluid pocket and open position.
Claim Objections
Claim 6 is objected to because of the following informalities: line 2 “when valve is” should read “when the valve is”. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 and 4-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2012/0245551 A1 to Fangrow, Jr. et al.
In regard to claim 1:
A connector assembly for use with a catheter (abstract “A medical connector for use with one or more medical implements”), the connector assembly comprising: a first housing comprising a fluid inlet (Fig. 1 element 16, para. 23 “female connector 16 includes a housing 24. FIG. 2 illustrates a perspective view of the female connector 16. The proximal end 48 of a flexible element 26 is illustrated. The flexible element 26 may include an orifice 27 that is normally closed until a distally directed force is applied to flexible element 26.”); a second housing (Fig. 4 element 33) coupled with the first housing (Fig. 3 element 16), the second housing comprising a fluid outlet (Fig. 5 outlet center of element 22) and a post (Fig. 4 element 28) the post comprising an opening (Fig. 5 elements 38 and 34) and a lumen forming a fluid path from the opening through the lumen to the fluid outlet (Fig. 5 lumen of element 22); and a valve that surrounds the post (Fig. 4 element 26) and comprises a closed position (Fig. 8a element 26 in the closed position) and an open position (Fig. 9a element 26 past the open position. open position considered to be transition or intermediated position between closed position and further displacement position showed in fig. 9a when valve first opens), wherein: in the closed position, the valve is engaged with the post to cover the opening of the post (Fig. 8a elements 52), responsive to an external force provided by a fluid delivery device, the valve is displaced from the closed position to the open position and forms a fluid pocket (See annotated Fig. 9A below, open position considered to be transition or intermediated position between closed position and further displacement position showed in fig. 9a when valve first opens) that can receive a fluid from the fluid delivery device, and upon further displacement, the fluid pocket is sealed off from the fluid path (See annotated Fig. 9a below), and when the external force is removed, the fluid pocket collapses (Figs. 8A and 8B lack of fluid pocket when force removed.) and causes a fluid received from the fluid inlet and stored in the fluid pocket to enter the post through the opening (Para. 37 “FIGS. 9A and 9B, the medical connector 16 is substantially open to fluid flow between the male luer 10 and the distal end 20 of the female connector 16. As shown in FIG. 9A, the protrusions 52 can be partially or completely withdrawn from the openings 38 so that the volume inside of the fluid path 36 during the open stage of the connector 16 is substantially larger than the fluid volume inside of the fluid path 36 when the connector 16 is closed (see, e.g., FIG. 8A). This can diminish, or eliminate, retrograde fluid flow from the patient toward the proximal end 18 of the connector 16, or even produce a positive flow of fluid upon closure in the direction of the distal end 20 of the connector 16 and toward the patient.”. Valve 26 generates a compressive force on the fluid pocket when the external force is withdrawn forcing the fluid within the fluid pocket to enter openings 34 and 38 moving through element 20 downstream).
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Annotated Fig. 9A
In regard to claim 2:
The connector assembly of claim 1, wherein: in the open position of the valve the opening of the post is uncovered by the valve (Fig. 9A elements 38 uncovered by elements 52, para. 37 “As shown in FIG. 9A, the protrusions 52 can be partially or completely withdrawn from the openings 38 so that the volume inside of the fluid path 36 during the open stage of the connector 16 is substantially larger than the fluid volume inside of the fluid path 36 when the connector 16 is closed (see, e.g., FIG. 8A”).
In regard to claim 4:
The connector assembly of claim 1, wherein the valve comprises a first dimension based on the external force (Fig. 9A element 26 longitudinal dimension. See annotated Fig. 8A/9A side by side below, L1), and the valve comprises a second dimension when the external force is removed (Fig. 8A element 26 longitudinal dimensions. See annotated Fig. 8A/9A side by side below, L2), the second dimension greater than the first dimension (See annotated Fig. 8A/9A side by side below, L1 and L2 relative dimensions).
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Annotated Fig. 8A/9A side by side
In regard to claim 5:
The connector assembly of claim 1, wherein the fluid pocket collapses based on a transition of the valve from the open position to the closed position (Figs. 8A through 9B fluid pocket cited in claim 1 rejection above. Para. 37 “In FIGS. 9A and 9B, the medical connector 16 is substantially open to fluid flow between the male luer 10 and the distal end 20 of the female connector 16. As shown in FIG. 9A, the protrusions 52 can be partially or completely withdrawn from the openings 38 so that the volume inside of the fluid path 36 during the open stage of the connector 16 is substantially larger than the fluid volume inside of the fluid path 36 when the connector 16 is closed (see, e.g., FIG. 8A)”).
In regard to claim 6:
The connector assembly of claim 1, wherein the first housing comprises an inner wall (see annotated Fig. 9A above), and the valve contacts the inner wall when valve is displaced from the closed position to the open position (See annotated Fig. 9A above. Rejection made as best understood from Applicant’s disclosure. Applicant’s specification para. 35 “the engagement between the fluid pocket 124 of the valve 110 and the inner wall 130 of the housing”, Applicants Figs. 6 and 8 demonstrate valve 110 and inner wall of the housing 130 as the same part.).
In regard to claim 7:
The connector assembly of claim 1, wherein the post comprises a distal end (Fig. 5 element 31, para. 25 “a proximal end 31”) that extends into the first housing (Figs. 8A through 9B), the distal end of the post is uncovered by the valve in the open position (Figs. 9A and 9B proximal end 31 uncovered by element 26), and the valve covers the distal end in the closed position (Figs. 8A and 8B proximal end 31 covered by element 26)
In regard to claim 8:
The connector assembly of claim 1, wherein the valve comprises a slit (Fig. 4 element 27), and in the open position of the valve, the post protrudes through the slit (Figs. 9A and 9B. Para. 36 “In some embodiments, flexible element 26 can be compressed and/or moved by a distally directed force applied by the male luer 12. As shown, a portion of inner rigid element 30 can extend in a proximal direction beyond orifice 27 during compression”).
In regard to claim 9:
A valve, comprising: a compressible body (Fig. 4 element 26. Para. 36 “In some embodiments, flexible element 26 can be compressed and/or moved by a distally directed force applied by the male luer 12.”), wherein: responsive to an external force provided by a fluid delivery device (see annotated Fig. 9A above), the compressible body reduces from a first dimension (Annotated Fig. 8A/9A side by side above, L2) to a second dimension (Annotated Fig. 8A/9A side by side above, L1) and forms a fluid pocket that receives a fluid from the fluid delivery device ((See annotated Fig. 9A above, open position considered to be transition or intermediated position between closed position and further displacement position showed in fig. 9a when valve first opens), responsive to a further external force provided by the fluid delivery device, the fluid pocket is fluidly separated from the fluid delivery device (See annotated Fig. 9A above); and when the external force is removed, the compressible body increases from the second dimension to the first dimension (Figs. 8A and 8B position) and causes a volume reduction of the fluid pocket, the volume reduction causing the fluid to exit the fluid pocket (Para. 37 “FIGS. 9A and 9B, the medical connector 16 is substantially open to fluid flow between the male luer 10 and the distal end 20 of the female connector 16. As shown in FIG. 9A, the protrusions 52 can be partially or completely withdrawn from the openings 38 so that the volume inside of the fluid path 36 during the open stage of the connector 16 is substantially larger than the fluid volume inside of the fluid path 36 when the connector 16 is closed (see, e.g., FIG. 8A). This can diminish, or eliminate, retrograde fluid flow from the patient toward the proximal end 18 of the connector 16, or even produce a positive flow of fluid upon closure in the direction of the distal end 20 of the connector 16 and toward the patient.”. Valve 26 generates a compressive force on the fluid pocket when the external force is withdrawn forcing the fluid within the fluid pocket to enter openings 34 and 38 moving through element 20 downstream).
In regard to claim 10:
The valve of claim 9, wherein the external force opens the compressible body (Figs. 9A and 9B element 26 open), thereby allowing the fluid from the fluid delivery device to flow in a first direction, and when the external force is removed, the compressible body closes, thereby preventing the fluid from flowing in a second direction opposite the first direction (Fig. 8A and 8B element 26, para. 37 “As shown in FIG. 9A, the protrusions 52 can be partially or completely withdrawn from the openings 38 so that the volume inside of the fluid path 36 during the open stage of the connector 16 is substantially larger than the fluid volume inside of the fluid path 36 when the connector 16 is closed (see, e.g., FIG. 8A”),.
In regard to claim 11:
The valve of claim 9, wherein the compressible body comprises a third dimension when the fluid pocket is fluidly separated from the fluid delivery device (Fig. 9A element 26 longitudinal dimensions. See annotated Fig. 8A/9A side by side above, L3), and wherein the third dimension is less than the second dimension and the first dimension (Fig. 8A element 26 longitudinal dimensions. See annotated Fig. 8A/9A side by side above. L3 is smaller than L1 and L2).
In regard to claim 12:
The valve of claim 9, wherein the external force causes the fluid pocket to define a first volume (See annotated Fig. 9A above, fluid pocket first volume), and removal of the external forces causes the fluid pocket to define a second volume less than the first volume (Figs. 8A and 8B volume of fluid pocket volume between element 26 and 28 reduced relative to that present in Figs. 9A and 9B).
In regard to claim 13:
The valve of claim 9, wherein the compressible body comprises a slit that opens in response to the external force (Fig. 4 element 27, Figs. 9A and 9B slit open. Para. 36 “In some embodiments, flexible element 26 can be compressed and/or moved by a distally directed force applied by the male luer 12. As shown, a portion of inner rigid element 30 can extend in a proximal direction beyond orifice 27 during compression” (emphasis added)).
In regard to claim 14:
The valve of claim 13, wherein the slit closes when the external force is removed (Fig. 4 element 27, Figs. 8A and 8B slit closed. Para. 36 “In some embodiments, flexible element 26 can be compressed and/or moved by a distally directed force applied by the male luer 12. As shown, a portion of inner rigid element 30 can extend in a proximal direction beyond orifice 27 during compression” (emphasis added)).
In regard to claim 15:
The valve of claim 13, wherein the compressible body (Fig. 4 element 26) comprises a channel that receives a post (Fig. 4 element 28), and responsive to the external force the slit opens and is fluidly connected to the channel (Para. 36 “In some embodiments, flexible element 26 can be compressed and/or moved by a distally directed force applied by the male luer 12. As shown, a portion of inner rigid element 30 can extend in a proximal direction beyond orifice 27 during compression”, para. 37 “In FIGS. 9A and 9B, the medical connector 16 is substantially open to fluid flow between the male luer 10 and the distal end 20 of the female connector 16.”).
In regard to claim 16:
A method for regulating a fluid to a catheter (Para. 37 “n FIGS. 9A and 9B, the medical connector 16 is substantially open to fluid flow between the male luer 10 and the distal end 20 of the female connector 16. As shown in FIG. 9A, the protrusions 52 can be partially or completely withdrawn from the openings 38 so that the volume inside of the fluid path 36 during the open stage of the connector 16 is substantially larger than the fluid volume inside of the fluid path 36 when the connector 16 is closed (see, e.g., FIG. 8A). This can diminish, or eliminate, retrograde fluid flow from the patient toward the proximal end 18 of the connector 16, or even produce a positive flow of fluid upon closure in the direction of the distal end 20 of the connector 16 and toward the patient” (emphasis added). Diminishing or eliminating retrograde fluid flow is considered to be regulating fluid flow.), the method comprising, by a valve (Fig. 4 element 26): receiving, at the valve, an external force (See annotated Fig. 9A above); forming, based on the external force, a fluid pocket in the valve (See annotated Fig. 9A above “fluid pocket”); sealing off the fluid pocket from the fluid upon receiving a further external force at the valve (See annotated Fig. 9a above); receiving, at the fluid pocket, the fluid (Para. 37 “In FIGS. 9A and 9B, the medical connector 16 is substantially open to fluid flow between the male luer 10 and the distal end 20 of the female”); when the external force is removed, reducing a volume of the fluid pocket to define a volume reduction (Figs. 8A and 8B fluid pocket between elements 28 and 26 reduced relative to that of annotated Fig. 9A above); and removing, based on the volume reduction, at least some of the fluid from the fluid pocket (Para. 37 “This can diminish, or eliminate, retrograde fluid flow from the patient toward the proximal end 18 of the connector 16, or even produce a positive flow of fluid upon closure in the direction of the distal end 20 of the connector 16 and toward the patient” (emphasis added)).
In regard to claim 17:
The method of claim 16, wherein when the external force is removed, the fluid pocket collapses and causes at least some of the fluid to enter a channel of the valve (Figs. 8A and 8B fluid pocket between elements 28 and 26 reduced relative to that of annotated Fig. 9A above. Para. 37 “This can diminish, or eliminate, retrograde fluid flow from the patient toward the proximal end 18 of the connector 16, or even produce a positive flow of fluid upon closure in the direction of the distal end 20 of the connector 16 and toward the patient” (emphasis added)).
In regard to claim 18:
The method of claim 17, driving, based on the volume reduction, at least some of the fluid downstream through the valve (Figs. 8A and 8B fluid pocket between elements 28 and 26 reduced relative to that of annotated Fig. 9A above. Para. 37 “This can diminish, or eliminate, retrograde fluid flow from the patient toward the proximal end 18 of the connector 16, or even produce a positive flow of fluid upon closure in the direction of the distal end 20 of the connector 16 and toward the patient” (emphasis added)).
In regard to claim 19:
The method of claim 16, further comprising: prior to receiving the fluid at the fluid pocket, receiving, at a slit formed in the valve (Fig. 4 element 27), the fluid (Figs. 8A through 9B element 48 (element 27 is present in element 48) is the first portion of element 26 to receive the fluid as it is the start point of the fluid flow path of element 26 and thus receives the fluid flow from element 12 prior to the fluid pocket receiving fluid); and when the external force is removed, the slit is closed and driving the fluid downstream such that the fluid is prevented from passing through the slit (Para. 37 “This can diminish, or eliminate, retrograde fluid flow from the patient toward the proximal end 18 of the connector 16, or even produce a positive flow of fluid upon closure in the direction of the distal end 20 of the connector 16 and toward the patient” (emphasis added). Force considered to come from the driving of the fluid downstream is considered to come from the compressive force of element 26 when the external force of element 12 is withdrawn.).
In regard to claim 20:
The method of claim 16, wherein receiving the external force comprising receiving contact from a fluid delivery device (Figs. 9A and 9B element 12).
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 Mark A Igel whose telephone number is (571)272-7015. The examiner can normally be reached Monday through Thursday 11 am to 5 pm EST.
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, 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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/M.A.I./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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