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 § 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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2015/0224296 to Winsor (Winsor hereinafter) in view of US Pre-Grant Publication 2011/0028915 to Siopes et al. (Siopes).
Regarding claim 1, Winsor teaches a T-site connector (10) configured to fluidly attach a proximal medical device with a blood vessel of a patient, the T-site connector comprising: a T-site body (12) comprising: a septum housing (16) at a proximal end (right hand side of Fig. 4) having a primary luer body (28) extending distally therefrom and defining a primary fluid passageway (22); and a tube bond stem (30) extending axially from the primary luer body and defining a secondary fluid passageway (32) therein, the primary fluid passageway and the secondary fluid passageway being fluidly coupled at a central fluid chamber; an inner flange (64) with a central bore having a first diameter and a second, outer surface having a larger diameter than the first; and a septum (68) housed within the inner flange and the septum housing, the septum comprising a slit (62) extending longitudinally therethrough, the slit being accessible through the bore. Winsor does not teach an externally threaded cap. Siopes teaches an externally threaded cap (160, 300) comprising: a proximal face (top of Fig. 3A) disposed at a proximal end (110) of the externally threaded cap. Siopes teaches that this cap provides improved sealing against backpressure (see e.g. paragraph 11). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a cap as taught by Siopes to the connector of Winsor in order to improve sealing therein. The examiner notes that the claim does not require that the inner flange be integrally or monolithically formed with the externally threaded cap, and as such there is no need to modify the inner flange (64) to be integral with the cap. The examiner takes no position at this time on the obviousness of such a modification.
Regarding claim 2, Winsor does not teach pockets. Siopes teaches such pockets (530) and their function of increasing sealing (see e.g. paragraph 61). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide pockets as taught by Siopes to the connector of Winsor in order to enhance sealing therein.
Regarding claims 3 and 5, Winsor teaches a recess (118) and a protrusion (118) arranged as claimed.
Regarding claims 4 and 6, Winsor teaches an axial wall (leftward facing surface of 98 in Fig. 5) having a radially inward concave shape.
Regarding claim 7, Siopes teaches at least two threads (see Fig. 2B), but is silent to three. However, the examiner notes that provision of a third thread is merely the duplication of the previously provided threads (MPEP 2144.04 VI. B). The examiner therefore concludes that three threads are an obvious duplication of the previously provided threads.
Regarding claims 8 and 15, as discussed above, Winsor as modified in view of Siopes teaches the T-site connector in claim 8. Furthermore, Winsor teaches a cannula (18). In view of the teachings of Siopes as discussed above, it would have been obvious to provide an internally threaded collar (40, see Fig. 4 and e.g. paragraph 40) in order to securely connect the cannula of Winsor to the connector. Thus provided, such a threaded cannula would constitute a locking cannula as claimed.
Regarding claim 9, Siopes teaches at least two threads (see Fig. 2B), but is silent to three. However, the examiner notes that provision of a third thread is merely the duplication of the previously provided threads (MPEP 2144.04 VI. B). The examiner therefore concludes that three threads are an obvious duplication of the previously provided threads.
Regarding claims 10 and 16, Winsor and Siopes are silent as to a degree of rotation. However, Siopes does illustrate (see Fig. 2B) a thread extending at least 270 degrees, and indicates that securement is achieved thereby. One of ordinary skill in the art would have appreciated that provision of threads as taught by Siopes would have involved at least partial securement at the recited angular range. The examiner notes that further or lesser rotations are not restricted by these claims.
Regarding claim 11, Winsor teaches extension of the cannula through the slit (paragraph 40).
Regarding claims 12 and 18, as discussed above, Winsor teaches the inner flange (64) having a radially inner septum barrier wall.
Regarding claim 13, Winsor does not teach pockets. Siopes teaches such pockets (530) and their function of increasing sealing (see e.g. paragraph 61). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide pockets as taught by Siopes to the connector of Winsor in order to enhance sealing therein.
Regarding claims 14 and 19, Winsor teaches a recess (118) and a protrusion (118) arranged as claimed.
Regarding claim 20, Winsor teaches a cannula tip (56) configured to abut a perimeter of the bore upon securing the internally threaded collar to the externally threaded cap.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 9 January 2026
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