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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The limitation “wherein the second lumen has a inner diameter equivalent to an inner diameter of the first fluid conduit and the second fluid conduit is not supported in the original disclosure. The original specification states that the second lumen may have an inner diameter substantially equivalent to an inner diameter of the first fluid conduit and the second fluid conduit, see para. [0009]. Additionally, “second lumen 31 has an inner diameter that is substantially equivalent to an inner diameter of first fluid conduit 24 and/or second fluid conduit 34, see para. [0026]. These are the only descriptions of the claimed limitation in the original disclosure. A review of the drawings appears to show that the lumen 31 has a differential diameter than at least conduit 34 and thus it appears that the disclosure never states that the lumens and the fluid conduits are equal in diameter. Rather the disclosure appears to disclose that there are reasonable diameter variations but the diameters are close in size.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 5-7, 9, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz US 2020/0046948 in view of Adams US 2006/0079850.
Regarding claim 1, Burkholz discloses an intravascular catheter assembly, see title, comprising: a catheter adapter 10 comprising: a distal end 38; a proximal end, shown at 34; a first lumen, see para. [0042] lumen of the needle 36, arranged between and in fluid communication with the distal end and the proximal end; a catheter 14 arranged at the distal end of the catheter adapter and in fluid communication with the first lumen; and a first side port 18 in fluid communication with the first lumen; a first fluid conduit 16 having a distal end, connected at 18, and a proximal end, connected at 26, the distal end of the first fluid conduit coupled to the side port; and a connector 24 comprising a proximal end opposite distal end 26, a distal end 26 connected to the first fluid conduit, a connector passageway extending from the proximal end of the connector to the distal end of the connector, the y-adapter has a fluid passageway from 28 to 26, and a second lumen, extending through element 30, extending from the connector passageway. Burkholz does not disclose the connector comprising an actuable valve located distal to an intersection of the second lumen and the connector passageway but does disclose a means for occluding the connector via element 17 distal of the connection between the second lumens and the connector.
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Adams teaches a safety y-port adaptor and medical catheter assembly comprising a similar y-port adaptor taught by Burkholz including a connector passageway 55-1 from the proximal end 53 to a distal end 47, a second lumens 61 and an intersection therebetween, the y-adapter includes an actuable valve 305 located distal to the intersection. Adams teaches that when food or medications are to be administered to the patient, a dispensing tip is inserted into the arms 207, 209 and the stopcock valve 305 is opened. When medication is not necessary, the valve is closed. See para. [0062].
It would have been obvious to an ordinary skilled worker to provide a valve in the assembly of Burkholz, as taught by Adams, in order to provide a means to close the y-adaptor when no medication is being administered. Supra. The Examiner notes that the inclusion of the stopcock valve is consistent with Burkholz since Burkholz discloses a means for inclusion in a similar location.
Regarding claim 5, Burkholz, in view of Adams, discloses the connector is a y-connector. See para. [0034].
Regarding claim 6, Burkholz, in view of Adams, discloses the valve is manually actuable. See para. [0064].
Regarding claim 7, Burkholz, in view of Adams, discloses a second fluid conduit 46 extending from the connector. See Burkholz fig. 1b, element 46 or alternatively the tube connected at 44.
Regarding claim 9, Burkholz, in view of Adams, discloses a first conduit 16, a second conduit 44, and a second lumens 42 which appear to have the same diameters shown in the disclosed application and thus are interpreted as equivalent diameters.
Regarding claim 18, Burkholz, in view of Adams, a needless access connector coupled to the connector. See fig. 1b, element 40.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz, in view of Adams, as applied to claim 1 above, and further in view of Jadhav US 2023/0057569.
Regarding claim 4, Burkholz, in view of Adams, discloses all elements but does not teach the valve comprises a sliding mechanism configured to displace a portion of the second lumen, such that the portion of the second lumen has a longitudinal axis that is offset from a longitudinal axis of the second lumen but rather Adams teaches a stopcock valve for occlusion.
Jadhav teaches a slider mechanism 124 that displaces a portion of the second lumens to offset a portion of the lumen from a longitudinal axis from the remaining portion of the second lumen, see fig. 7 in the displaced state and fig. 8 in the aligned state. The valve is beneficial since it can allow for seamless blood draw, is easily incorporated with minimal impact on clinical settings and operations. See para. [0038].
It would have been obvious to an ordinary skilled worker to substitute the stopcock valve of Burkholz, in view of Adams, with the valve of Jadhav in order to provide for seamless blood draw, with ease of incorporation and minimal impact on the clinical settings and operations. Id. It is also noted that the replacement of the occlusion means (stopcock valve) in Burkholz, in view of Adams, with the valve of Jadhav would be also obvious as a simple substitution of one means of occlusion for another to produce predictable results. See KSR; MPEP 2141 III (A).
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Applicant’s amendments have clarified that the valve occurs at a position distal to the junction of the y-connector in spirit. Jadhav clearly shows the valve is located proximal to the disclosed junction. The prior art is aware of valves downstream of junctions. See Danielsson US 3,934,576, fig. 4, showing a catheter having a T-port shown at about 31 with a valve 9 distal to the junction between the port 33 and the port that comprises the line 32; Hishikawa US 2006/0155249 similar to Danielsson; Dzwonkiewicz US 5,807,312 showing a T connector for a catheter 32 having a junction in a connector 36 and a means for occlusion 156 herein interpreted as a valve that is distal to the junction; Muffly US 2009/0182309 similar to Dzwonkiewicz; Imai US 2010/0030074, see fig. 6; Christensen US 2014/0364833 para. [0028] showing a connector 144 having a valving feature. Thus, it appears that the mere provision of an occlusion means distal to a junction is known in the prior art.
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 GERALD LUTHER SUNG whose telephone number is (571)270-3765. The examiner can normally be reached 9-5 PST.
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/GERALD L SUNG/Primary Examiner, Art Unit 3741
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