DETAILED ACTION
Claims 2-20 are pending. Claim 1 has been cancelled.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 2, 12-13, and 17-19 are objected to because of the following informalities:
In claim 2, line 8, “the external housing” should be changed to --the first external housing--.
In claim 2, line 20, the period (.) at the end of the line should be changed to a comma (,).
In claim 2, line 24, “second housing” should be changed to –second external housing--.
In claim 2, lines 26-27, “through the fluid conduit and into the conduit passageway” (in reference to the at least one port in the fluid conduit) is redundant and should be changed to --through the side wall and into the conduit passageway--.
In claim 2, line 29, “sidewall” should be changed to --side wall--.
In claim 12, line 2, “the external housing” should be changed to --the first external housing--.
In claim 13, line 2, “the closed and opened configurations” should be changed to --the closed and opened configurations of the first connector-- to clearly distinguish from the configurations of the second connector.
In claim 17, line 2, “between the closed configuration to the opened configuration” should be changed to --from the closed configuration of the first connector to the opened configuration of the first connector-- to clearly distinguish when the valve moves proximally and from the configurations of the second connector.
In claim 18, lines 2-3, “between the opened configuration and the closed configuration” should be changed to --from the opened configuration of the first connector to the closed configuration of the first connector-- to clearly distinguish when the valve moves distally and from the configurations of the second connector.
In claim 19, last line, “biased toward the closed configuration” should be changed to --biased closed in the closed configuration of the first connector-- because the closed configurations is specifically recited in reference to the first connector, but the valve is biased to a closed configuration/position itself that corresponds to the first connector being in the closed configuration.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-20 (wherein claims 2 and 5-20 inherit their rejections due to their dependencies) rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "the male portion" in line 11. There is insufficient antecedent basis for this limitation in the claim. As understood, the recitation is meant to refer to the male protrusion. Note that there is another recitation in line 12 of “the male portion.”
In claim 2, lines 33-34, it is unclear how “the fluid conduit of the second connector contacts the valve of the second connector,” because the valve is in the first connector. As understood, the recitation is meant to recite that the fluid conduit of the second connector contacts the valve of the first connector.
Claim 4 recites the limitation "the male projection" in line 2. There is insufficient antecedent basis for this limitation in the claim. As understood, the recitation is meant to refer to the male protrusion.
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 pre-AIA 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 –
Claims 2-8, 10-11, 13, and 16-20 (as understood: all) are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Tanida (US 6,170,522).
Regarding claim 2, Tanida discloses in Figs. 20-23 a medical fluid system (wherein “medical” is broadly interpreted as a name for the fluid system rather than necessarily further defining function or structure) for facilitating connection between first and second medical fluid connectors (wherein “medical” is broadly interpreted as a name for the fluid system rather than necessarily further defining function or structure), the medical fluid system configured to move between a closed position that inhibits fluid flow and an open position that permits fluid flow, the medical fluid system comprising:
a first connector (with external housing 11) configured to transition between an opened configuration (Fig. 21 or 23) and a closed configuration (Fig. 20 or 22), the first connector comprising:
a first external housing 11;
a distally extending male protrusion 12 positioned entirely within the external housing 11, the male protrusion 12 comprising an internal fluid passageway and a distal opening (in which a valve 31 is disposed in the closed configuration);
a valve 31 positioned within the fluid passageway of the male portion 12, the valve 31 blocking the distal opening of the male portion 12 in the closed configuration of the first connector; and
a first seal (comprised the unlabeled seal ring that the valve 31 engages in the closed configuration) encompassing at least a portion of the valve 31 in the closed position (Fig. 20 or 22) of the first connector; and
a second connector (with external housing 21) being configured to transition between an opened configuration (Fig. 21 or 23) and a closed configuration (Fig. 20 or 22), the second connector comprising:
a second external housing 21, a portion of the second external housing 21 being sized to be receivable within the first external housing 11 of the first connector when the first and second connectors are attached to each other (Fig. 21 or 23).
a first proximal opening (in which the movable walls 61, 62 and the end of the fluid conduit 22 are disposed) in the second external housing 21, the first proximal opening configured to receive the male protrusion 12 of the first connector;
a fluid conduit 22 located at least partially within an interior space of the second housing 21 of the second connector, the fluid conduit 22 comprising a side wall and a conduit passageway extending within the fluid conduit 22, at least one port in the fluid conduit 22 extending through the fluid conduit 22 and into the conduit passageway; and
a second seal (comprising the unlabeled seal ring on the movable wall 61 and between the movable wall 61 and the fluid conduit 22) located at least partially within the second connector, the second seal contacting the sidewall of the fluid conduit 22 in both the closed and opened configurations of the second connector, the second seal configured to block fluid flow out from the conduit passageway through the at least one port of the fluid conduit 22 when the second connector is in the closed configuration (Fig. 20 or 22); and
wherein when the first and second connectors are attached to each other (Fig. 21 or 23), the fluid conduit 22 of the second connector contacts the valve 31 of the second connector;
wherein fluid flow is enabled between the first and second connectors when attached to each other; and
wherein the first and second connectors can be detached from each other through axial motion between the first and second connectors, without requiring rotation of the first and second external housings 11, 21 with respect to each other (because one having ordinary skill in the art would recognize that the connectors are attached and detached, as shown in Figs. 20-21, via a hook on the first external housing 11 that is pushed onto or pulled away from ball bearings on the second external housing 21 that fit in an annular groove on the second external housing 21 during attachment, or as shown in Figs. 22-23, ball bearings in the first external housing 11 being pushed radially into an annular groove of the second external housing 21 via the spring-biased sleeve surrounding the ball bearings and retracting the spring-biased sleeve to pull the connectors apart).
Regarding claim 3, Tanida discloses in Figs. 22-23 that the first seal contacts the valve 31 of the first connector in the closed position.
Regarding claim 4, Tanida discloses in Figs. 22-23 that the first seal forms a seal between an interior surface of the male projection 12 of the first connector and the valve 31 of the first connector in the closed position.
Regarding claim 5, Tanida discloses in Figs. 22-23 that the first seal contacts the fluid conduit 22 of the second connector in the opened position.
Regarding claim 6, Tanida discloses in Figs. 20-23 that the first and second connectors can be attached to each other through axial motion between the first and second connectors, without requiring rotation of the first and second external housings 11, 12 with respect to each other.
Regarding claim 7, Tanida discloses in Figs. 20-23 engagement features on each of the first and second connectors (comprising the hook on the first connector and ball bearings that fit into an annular groove on the second connector, in Figs. 20-21, or the ball bearings on the first connector, the spring-biased sleeve around the ball bearings, and the annular groove in the second connector to receive the ball bearings, in Figs. 22-23, as one having ordinary skill would recognize as being used in connecting the connectors) configured to removably secure the connectors together.
Regarding claim 8, Tanida discloses in Figs. 20-21 that at least one of the engagement features comprises a hook.
Regarding claim 10, Tanida discloses in Figs. 22-23 that the valve 31 of the first connector is made of a rigid material.
Regarding claim 11, Tanida discloses in Figs. 22-23 that the valve 31 is shorter than the distally extending male protrusion 12.
Regarding claim 13, Tanida discloses in Figs. 22-23 that the first seal of the first connector does not move axially between the closed and opened configurations (Figs. 22-23).
Regarding claim 16, Tanida discloses in Figs. 22-23 that the medical fluid system is configured to permit the first and second external housings 11, 21 of the first and second connectors to rotate with respect to each other while securely coupled (because of the ball bearings one having ordinary skill would recognize as being used in connecting the connectors).
Regarding claim 17, Tanida discloses in Figs. 22-23 that the valve 31 of the first connector is configured to move proximally between the closed configuration to the opened configuration.
Regarding claim 18, Tanida discloses in Figs. 22-23 that the valve 31 of the first connector is configured to move distally between the opened configuration and the closed configuration.
Regarding claim 19, Tanida discloses in Figs. 22-23 that the valve 31 of the first connector is biased toward the closed configuration.
Regarding claim 20, Tanida discloses in Figs. 22-23 that in the opened configuration (Fig. 23) of the first connector, fluid can flow around an outer surface of at least a portion of the valve 31 of the first connector.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 9 and 14 (as understood: both) are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tanida in view of Braun et al. (US 6,082,401).
Regarding claim 9, Tanida discloses first and second connectors, as previously discussed, but lacks teaching that an audible sound is produced when the first and second connectors are coupled to each other.
Braun teaches in Figs. 1-3 first and second connectors 42, 44 that can be attached to each other through axial motion between the first and second connectors 42, 44, without requiring rotation of the first and second external housings 46, 88 with respect to each other, corresponding engagement features 60, 94 on each of the first and second connectors 42, 44 configured to removably secure the connectors together, and an audible sound that is produced when the first and second connectors 42, 44 are coupled to each other (col. 3, lines 13-20). The audible sound is produced by the clip assembly 60 of the engagement features 60, 94 engaging the groove 94 of the engagement features.
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 engagement features disclosed by Tanida to comprise a spring-biased clip assembly on one of the connectors that is selectively moved by a pressable tab by the user to disengage a groove on the other connector, and that makes an audible sound when the connectors are coupled to each other, as Braun teaches, because the clip assembly provides an inexpensive and easy-to-understand locking mechanism that also provides audible feedback to indicate to the user successful coupling, as Braun teaches (col. 3, lines 13-20).
Regarding claim 14, Braun teaches in Figs. 1-3 that the first and second connectors 42, 44 are releasable after coupling by pressing on at least one tab 62.
Regarding claim 15, Braun teaches in Figs. 1-3 that the at least one tab 62 is on the connector 44 with the outermost external housing 46 when the connectors 42, 44 are coupled.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the at least one tab taught by Braun be on the first connector disclosed by Tanida, because that is the connector disclosed by Tanida as providing the outermost external housing when the connectors are coupled, like the connectors taught by Braun, and so the tab would be accessible when the connectors are coupled.
Claim 12 (as understood) is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tanida in view of Doyle (US 6,745,998).
Regarding claim 12, Tanida discloses a distally extending male protrusion and an external housing of the first connector, as previously discussed, but lacks teaching that the distally extending male protrusion is unitary with the external housing of the first connector.
Doyle teaches in Figs. 1-7 a first connector 10 comprising a distally extending male protrusion 16 that is unitary with the external housing 12 of the first connector 10 via monolithic construction.
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 distally extending male protrusion and external housing of the first connector to be unitary in the form of monolithic construction, as Doyle teaches, as an obvious integration of parts (MPEP 2144.04(V)(B)). Furthermore, the monolithic construction reduces the number of separate parts, which simplifies how to use the device, assembly, and disassembly.
Conclusion
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.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/J. W./
Examiner, Art Unit 3753
/KENNETH RINEHART/Supervisory Patent Examiner, Art Unit 3753