DETAILED ACTION
The Response filed 31 March 2026 has been entered. Claims 1, 3-12, and 14-20 remain pending. Claims 2 and 13 have been cancelled.
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 Arguments
Applicant's arguments filed 31 March 2026 have been fully considered but they are not persuasive for the following reasons in view of the previous double patenting rejections and newly applied prior art - Tsai (US 2005/0010177).
The applicant argues with respect to the double patenting rejections on pg. 7 of the Response that “[i]n view of the amendments made herein, Applicant believes that the double patenting rejections may be moot.” However, US Patent No. 11,779,750 (in claims 7 and 8) and US Patent No. 12,168,110 (in claims 7 and 8) both claim that the valve having a narrower cavity portion between the ridge and flange than the cavity extending from the ridge and in the first end portion of the valve, and the protrusion being configured to engage the ridge when the first end portion of the valve is displaced toward the base portion of the housing.
The applicant argues with respect to claim 1 on pgs. 7-8 of the Response that the prior art lacks the “inner surface forming a ridge a first valve cavity portion having a first cross-sectional width and extending through the second end portion, a second valve cavity portion having a second cross-sectional width less than the first cross-sectional width and extending from the first valve cavity portion and along the first end portion, and a ridge formed between the first and second valve cavity portions.” However, Tsai discloses in Figs. 1-5 that the valve 40 has an inner surface forming a first valve cavity portion (comprising the frustoconical bottom half) having a first cross-sectional width (in the frustoconical bottom half) and extending through the second end portion, a second valve cavity portion 43 having a second cross-sectional width less than the first cross-sectional width and extending from the first valve cavity portion and along the first end portion, and a ridge (comprising the internal shoulder in the plug 40) formed between the first and second valve cavity portions,
The applicant argues with respect to claim 1 on pg. 8 of the Response that the prior art lacks the “protrusion is positioned within the first valve cavity portion and the proximal end of the protrusion is longitudinally aligned with the ridge such that displacement of the first end portion of the valve towards the base portion is configured to engage the ridge against the proximal end of the protrusion.” However, Tsai discloses in Figs. 1-5 that the protrusion 35 is positioned within the first valve cavity portion 43 and the proximal end of the protrusion 35 is longitudinally aligned with the ridge such that displacement of the first end portion of the valve 40 towards the base portion 30 is configured to engage the ridge against the proximal end of the protrusion 35 (Fig. 5).
The applicant argues with respect to claim 10 on pg. 9 of the Response that the prior art lacks the “valve comprising a first end portion, a second end portion, and an inner surface forming a ridge, a first valve cavity portion having a first cross-sectional width and extending from the ridge and along the second end portion of the valve, a second valve cavity portion having a second cross-sectional width less than the first cross-sectional width and extending from the ridge and along the first end portion.” However, Tsai discloses in Figs. 1-5 the valve 40 comprising a first end portion 42, a second end portion (extending from the internal shoulder of the valve 42 to the bottom of the valve 40 with the bottom-most flange), and an inner surface forming a ridge (comprising the internal shoulder in the plug 40), a first valve cavity portion (comprising the frustoconical bottom half) having a first cross-sectional width and extending from the ridge and along the second end portion of the valve 40, a second valve cavity portion 43 having a second cross-sectional width less than the first cross-sectional width and extending from the ridge and along the first end portion 42.
The applicant argues with respect to claim 10 on pgs. 9-10 of the Response that “when the valve moves from the closed configuration toward the open configuration, a portion of the ridge engages against the proximal end of the protrusion such that further movement of the first end portion of the valve toward the base portion is resisted and the first end portion of the valve is transversely biased relative to the central longitudinal axis.” However, Tsai discloses in Figs. 1-5 that when the valve 40 moves from the closed configuration (Fig. 2) toward the open configuration (Fig. 5), a portion of the ridge (comprising the internal shoulder of the plug 40) engages against the proximal end of the protrusion 35 such that further movement of the first end portion 42 of the valve 40 toward the base portion 30 is resisted and the first end portion 42 of the valve 40 is transversely biased relative to the central longitudinal axis (as shown by the shifting of the neck 42 in Fig. 5).
The applicant argues with respect to claim 17 on pg. 10 of the Response that the prior art lacks “providing a valve having a first valve cavity portion having a first cross-sectional width, a second valve cavity portion having a second cross-sectional width less than the first cross-sectional width and extending away from the first valve cavity portion, and a ridge formed between the first and second valve cavity portions, the valve positioned within the internal cavity with a protrusion of the base portion extending within…the first valve cavity portion, a flange of the valve coupled to the base portion, and a proximal end of the protrusion longitudinally aligned with the ridge.” However, Tsai discloses in Figs. 1-5 providing a valve 40 having a first valve cavity portion (comprising the frustoconical bottom half) having a first cross-sectional width (in the frustoconical bottom half), a second valve cavity portion 43 having a second cross-sectional width less than the first cross-sectional width and extending away from the first valve cavity portion, and a ridge (comprising the internal shoulder in the plug 40) formed between the first and second valve cavity portions, the valve 40 positioned within the internal cavity (of the housing 50, 30) with a protrusion 35 of the base portion 30 extending within…the first valve cavity portion, a flange (comprising the bottom-most annular flange on the valve 40) of the valve 40 coupled to the base portion 30, and a proximal end of the protrusion 35 longitudinally aligned with the ridge.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-12, and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,779,750 (hereinafter ‘750) in view of -Newton et al. (US 2005/0038397). ‘750 claims a needless connector comprising a housing with a projection extending in a first direction from a base portion through a valve cavity of a movable valve in the housing, wherein the proximal end of the projection is positioned between a central longitudinal axis of the housing and the inner surface of the valve, and when the valve is moved to in a second direction, the projection engages a ridge on the valve and the valve moves in a third/transverse direction that is different from the first and second directions. The resistance of the first end portion of the valve toward the base portion when the ridge engages the protrusion, and the movement of the first end portion in the third/transverse direction, claimed in claim 10 of the application, is claimed by ‘750 in claims 3 and 16. The existence of the structures claimed in ‘750 read on the method claims of “providing” said structures in the application.
‘750 lacks a flange coupled to the base portion.
Newton teaches in Figs. 1-3 and 5-8 a flange 48 on the valve and coupled to the base portion 20/50.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the valve disclosed by ‘397 to include flange coupled to the base portion, while being sandwiched between the base and body portions of the housing, to secure the valve in the assembly, as Newton teaches (paragraph 35, 67, and 70).
Claims 1, 3-12, and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,168,110 (hereinafter ‘110) in view of Newton et al. (US 2005/0038397). The patent claims a needless connector comprising a housing with a projection extending in a first direction from a base portion through a valve cavity of a movable valve in the housing, wherein the proximal end of the projection is positioned between a central longitudinal axis of the housing and the inner surface of the valve, and when the valve is moved to in a second direction, the projection engages a ridge on the valve and the valve moves in a third/transverse direction that is different from the first and second directions. The resistance of the first end portion of the valve toward the base portion when the ridge engages the protrusion, and the movement of the first end portion in the third/transverse direction, claimed in claim 10 of the application, is claimed by ‘110 in claims 10 and 17. The existence of the structures claimed in ‘110 read on the method claims of “providing” said structures in the application.
‘110 lacks a flange coupled to the base portion.
Newton teaches in Figs. 1-3 and 5-8 a flange 48 on the valve and coupled to the base portion 20/50.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the valve disclosed by ‘110 to include flange coupled to the base portion, while being sandwiched between the base and body portions of the housing, to secure the valve in the assembly, as Newton teaches (paragraph 35, 67, and 70).
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, 3-7, 9-12, and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsai (US 2005/0010177).
Regarding claim 1, Tsai discloses in Figs. 1-5 a needleless connector comprising:
a housing 50, 30 comprising a body portion 50, a base portion 30, an inner surface forming an internal cavity between the body portion 50 and the base portion 30, and a first port 54 through the body portion 50 to the internal cavity, the base portion 30 comprising a top end section, a second port 32, and a protrusion 35 extending from the top end section of the base portion 30 in a first direction toward the first port 52 to a proximal end of the protrusion 35; and
a valve 40 comprising a first end portion 42, a flange (comprising the bottom-most annular flange on the valve 40), a second end portion extending from the first end portion to the flange, and an inner surface forming a first valve cavity portion (comprising the frustoconical bottom half) having a first cross-sectional width (in the frustoconical bottom half) and extending through the second end portion, a second valve cavity portion 43 having a second cross-sectional width less than the first cross-sectional width and extending from the first valve cavity portion and along the first end portion, and a ridge (comprising the internal shoulder in the plug 40) formed between the first and second valve cavity portions, wherein the flange of the valve 40 is coupled to the base portion 30 such that the protrusion 35 is positioned within the first valve cavity portion and the proximal end of the protrusion 35 is longitudinally aligned with the ridge such that displacement of the first end portion of the valve 40 towards the base portion 30 is configured to engage the ridge against the proximal end of the protrusion 35 (Fig. 5).
Regarding claim 3, Tsai discloses in Figs. 1-5 that the protrusion 35 extends from the top end section of the base portion 30 in the first direction, the first end portion of the valve 40 is movable toward the base portion 30 in a second direction, and the first end portion of the valve 40 is configured to be biased a third direction (transverse to the first and second directions, as shown by the shifting of the neck 42 in Fig. 5), and wherein the third direction is different than the first direction and the second direction.
Regarding claim 4, Tsai discloses in Figs. 1-5 that the first end portion of the valve 40 is configured to move laterally, relative to a central longitudinal axis of the housing 50, 30, when the ridge engages against the proximal end of the protrusion 35 (Fig. 5).
Regarding claim 5, Tsai discloses in Figs. 1-5 that a fluid path extends through the internal cavity, between the first port 54 and the second port 32 formed by the base portion 30.
Regarding claim 6, Tsai discloses in Figs. 1-5 that the fluid path extends between an outer surface of the valve 40 and the inner surface of the housing 50, 30 (at least because a portion of the fluid path does).
Regarding claim 7, Tsai discloses in Figs. 1-5 that the proximal end of the protrusion 35 is positioned between a central longitudinal axis of the housing 50, 30 and the inner surface of the valve 40.
Regarding claim 9, Tsai discloses in Figs. 1-5 that the inner surface of the housing 50, 30 comprises an internal sealing edge (with which the shoulder 48 on the valve 40 selectively engages) between the first port 54 and the base portion 30, the valve 40 comprises a primary sealing portion 48 between the first end portion and the second end portion, and wherein the primary sealing portion 48 is configured to engage against the internal sealing edge (paragraph 29).
Regarding claim 10, Tsai discloses in Figs. 1-5 a needless connector as discussed in the rejection of claim 1 above, and the housing 50, 30 has a central longitudinal axis, the valve 40 has closed and open configurations depending on whether the first port 54 is obstructed by the first end of the valve 40, and the first end portion of the valve 40 is transversely biased relative to the central longitudinal axis when the valve 40 moves to the open position (Fig. 5).
Regarding claim 11, Tsai discloses in Figs. 1-5 that in the closed configuration of the valve 40 (Fig. 2), the proximal end of the protrusion 35 is spaced apart from the ridge.
Regarding claim 12, Tsai discloses in Figs. 1-5 that in the closed configuration (Fig. 2) and in the open configuration (Fig. 5), the proximal end of the protrusion 35 is positioned within the valve cavity.
Regarding claim 14, Tsai discloses in Figs. 1-5 that the protrusion 35 extends from the top end section of the base portion 30 in a first direction, the first end portion of the valve 40 is movable toward the base portion 30 in a second direction, and, in the open configuration (Fig. 5), the first end portion of the valve 40 is biased in a third direction (transverse to the first and second directions, as shown by the shifting of the neck 42 in Fig. 5), and wherein the third direction is different than the first direction and the second direction.
Regarding claim 15, Tsai discloses in Figs. 1-5 that a fluid path extends through the internal cavity, between the first port 54 and the second port 32 formed by the base 30.
Regarding claim 16, Tsai discloses in Figs. 1-5 that the proximal end of the protrusion 35 is positioned between the central longitudinal axis of the housing 50, 30 and the inner surface of the valve 40.
Regarding claim 17, Tsai discloses in Figs. 1-5 a method of providing a needless connector as discussed in the rejection of claim 1 above, and the flange on the bottom of the valve 40 is coupled to the base portion 30 by the valve 40 being sandwiched between the body portion 50 and base portion 30 in the assembled state.
Regarding claim 18, Tsai discloses in Figs. 1-5 that the first end portion of the valve 40 is configured to move laterally, relative to a central longitudinal axis of the housing 50, 30, when the ridge engages against the proximal end of the protrusion 35 (Fig. 5).
Regarding claim 19, Tsai discloses in Figs. 1-5 providing a fluid path through the internal cavity, between a first port 54 of the body 50 and a second port 32 formed by the base 30.
Regarding claim 20, Tsai discloses in Figs. 1-5 providing a closed configuration (Fig. 2) in which a first port 54 of the body 50 is obstructed by a first end portion of the valve 40, and the proximal end of the protrusion 35 is spaced apart from the ridge.
Allowable Subject Matter
Claim 8 would be allowable if the double patenting rejection is overcome by the filing of a proper terminal disclaimer or if rewritten to overcome the double patenting rejection set forth in this Office action, and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to disclose or render obvious, in combination with the other limitations recited in claim 8, the protrusion extends only partially around the central longitudinal axis.
Tenczar (US 4,019,512) and Barrington (US 3,986,508) each disclose a protrusion whose proximal end extends only partially around the central longitudinal axis and in a valve cavity of a valve, but the remaining portion of each protrusion extends circumferentially around the central longitudinal axis, and the protrusions are designed to piece the valves.
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 Examiner Jonathan Waddy, whose telephone number is 571-270-3146. The examiner can normally be reached on Monday-Friday (10:00AM-6:00PM EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisors can be reached by phone. Kenneth Rinehart can be reached at 571-272-4881 or Craig Schneider can be reached at 571-272-3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J. W./
Examiner, Art Unit 3753
/KENNETH RINEHART/Supervisory Patent Examiner, Art Unit 3753
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