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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/11/2025 has been entered.
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.
Claims 1-2, 4, 9-11 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Dennis et al. (USPGPub 2017/0000999).
Re Claim 1, Dennis teaches a tubing connector system (214) (Dennis Fig. 4; ¶ 0036) for use in connecting two pieces of medical tubing, the tubing connector system (14) comprising: a first tubing adapter (12); a second tubing adapter (16); and a central connector (30, 40) positioned between the first tubing adapter (12) and the second tubing adapter (16) (as seen in Dennis Fig. 4), wherein the central connector (30, 40) comprises: a male module (30); a female module (40); a valve assembly (34, 44), wherein the valve assembly (34, 44) comprises: a first valve member (34) retained within the male module (30) (Dennis Fig. 13; ¶ 0037); wherein the first valve member (34) comprises: a first valve foot (34-1); a first valve head (34-2); a first valve bellows (234) between the first valve foot (34-1) and the first valve head (34-2) (Dennis Annotated Fig. 23 below); and a first valve projection (34-3) extending from the first valve head (34-2) (Dennis Annotated Fig. 23 below); and a second valve member (44) retained within the female module (40) (Dennis Fig. 13; ¶ 0037).
Dennis further teaches wherein the second valve member (44) comprises: a second valve foot (44-1); a second valve head (44-2); a second valve bellows (244) between the second valve foot (44-1) and the second valve head (44-2) (Dennis Annotated Fig. 23 below); and a receiver (44-3) within the second valve head (44-2) that receives the first valve projection (34-3) (Dennis Annotated Fig. 23 below); and wherein the male module (30) and the female module (40) are configured to prevent reconnection once the male module (30) and the female module (40) have been separated (Dennis ¶ 0040). Dennis fails to explicitly teach that when the receiver receives the valve projection, a gimbaled connection between the first valve bellows and the second valve bellows is created. However, a gimbaled connection is implicit in prior art Dennis where connection between the male module and the female module involves a Luer, thus necessitating a gimbaled connection when the receiver receives the valve projection (Dennis ¶ 0047-0060).
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Re Claim 2, Dennis teaches all of the limitations of Claim 1. Dennis teaches wherein the male module (30) comprises: a locking ring (30-1); an abutment ring (30- 2); a plurality of alignment tabs (246-1) extending radially outward from the abutment ring (30- 2); and a plurality of stabilizers (246-2) (Dennis Annotated Figs. 15- 16 below).
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Re Claim 4, Dennis teaches all of the limitations of Claim 22. Dennis further teaches wherein the locking ring (30-1) further comprises: a plurality of alignment tab recesses (237-1) (Dennis Annotated Figs. 17-18 - space between each locking tab 220), wherein each of the plurality of alignment tab recesses (237-1) is configured to accept a corresponding one of the plurality of alignment tabs (246-1) (Dennis ¶ 0054-0056); and a plurality of stabilizer recesses (237-2), wherein each of the plurality of stabilizer recesses (237-2) is configured to accept a corresponding one of the plurality of stabilizers (246-2) (Dennis Annotated Figs. 15-18 above).
Re Claim 9, Dennis teaches all of the limitations of Claim 1. Dennis teaches wherein the male module (30) comprises a male module stem (as seen in Dennis Fig. 4) that includes one or more male module pores (33) (Dennis Fig. 4).
Re Claim 10, Dennis teaches all of the limitations of Claim 9. Dennis teaches wherein the female module (40) comprises a female module stem (as seen in Dennis Fig. 4) that includes one or more female module pores (43) (Dennis Fig. 4).
Re Claim 11, Dennis teaches all of the limitations of Claim 10. Dennis teaches wherein the first valve member (34) selectively seals the one or more male module pores (33) on the male module stem and wherein the second valve member (44) selectively seals the one or more female module pores (43) on the female module stem (Dennis ¶ 0037- 0038).
Re Claim 22, Dennis teaches all of the limitations of Claim 2. Dennis also teaches wherein the female module comprises: a locking collar (237-1) (Dennis Annotated Figs. 17-18 above).
Re Claim 23, Dennis teaches all of the limitations of Claim 22. Dennis teaches wherein the locking collar (237-1) comprises: a plurality of locking tabs (220) (Dennis Annotated Figs. 17-18 above) and the plurality of locking tabs (220) engages the locking ring (30-1) (Dennis Annotated Figs. 17-18 above).
Response to Arguments
Applicant’s arguments filed 11/11/2025 with respect to claim objection has been fully considered and are persuasive. The claim objection in final action dated 06/17/2025 is hereinafter withdrawn due to clarifying amendment.
Applicant's arguments filed 11/11/2025 have been fully considered but they are not persuasive. Applicant’s arguments begin with traversal of restriction dated 05/14/2024. Applicant argues that the present case is directed to a single embodiment. However, including some features in one independent claim while including different features in another independent claim would constitute alternate embodiments. Applicant is welcome to petition the TC director to challenge the restriction. Regardless, an examination burden exists in the present case where applicant is claiming alternate embodiments in the independent claims. Therefore, with all due respect, the restriction is being maintained.
Applicant’s arguments directed to 103 obviousness rejections begin on Page 11 of the response. These arguments are directed to “locking teeth” and secondary reference Barron. In the present case, the “locking teeth” were removed as a limitation, thus precluding Barron as a secondary reference. In the present case, examiner now relies solely upon prior art Dennis to obviate the claims. Therefore, all arguments directed to locking teeth and prior art Barron are hereinafter moot. At the top of Page 12 of the response, applicant’s arguments turn to amendments in the present case and explicitly, the way in which the valve receiver and valve projection interact. Although examiner no longer relies on Dennis Annotated Fig. 4, opting for alternate annotated figures, these arguments are still relevant. In particular, applicant argues that in Dennis Fig. 4, “it can be seen that each of the first bellows sheath (34-4) includes a flat abutment that is intended to contact a corresponding flat abutment of the second bellows sheet (44-4).” It would appear that applicant’s position is that prior art Dennis does not teach “a receiver within the second valve head that receives the first valve projection.” However, applicant concedes in the aforementioned argument above that the flat abutment of the first bellows is intended to contact the flat abutment of the second bellows. Examiner is interpreting the term “receives” broadly. Merriam-Webster defines the term as “to come into possession of.” It is the position of examiner that the flat abutment of the first bellows “come[s] into possession of] the flat abutment of the second bellows.
Examiner recommends being more explicit in how the receiver receives the projection. This may very well be the grounds for allowance in the present case. Something to the effect of ‘receives within.’ Furthermore, such a differentiation would not be mere design choice where one could conceive the design as improving leak prevention. Be that as it may, examiner would like to continue searching and considering the prior art where applicant has entered such a differentiation. Where it is found that said differentiation is grounds for allowance, examiner is amenable to withdrawn claims being rejoined where similar language is included in said withdrawn claims as well. This can be discussed further in interview at applicant’s leisure should applicant desire to pursue such an avenue. With regard arguments on Page 14 of the response, it is examiner’s position that the gimbaled connection is implicitly disclosed in prior art Dennis once the receiver and the projection are press-fit together, as necessitated by Luer connection in the prior art Dennis and the present case. In other words, examiner does not believe the gimbal connection is grounds for allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783