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 .
Acknowledgments
This office action is in response to the reply filed on 1/8/26. In the reply, the applicant amended claims 1-2. Claims 1-23 are pending.
Allowable Subject Matter
Claim 18 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. (see Fig. 6). Claims 19-20 are further objected to based on dependency.
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.
Claims 1, 2, 5, 10, 13, 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Sauer et al. (US 2021/0178142) (“Sauer”).
Sauer discloses: A modular dual-lumen cannula system, comprising: a first drainage cannula having a drainage cannula distal end and a drainage cannula proximal end, and a drainage cannula tip at the drainage cannula distal end, the drainage cannula tip having a drainage tip opening at the drainage cannula distal end, wherein the drainage cannula tip tapers from a first drainage cannula diameter to a second drainage cannula diameter; a plurality of drainage ports through a circumferential wall of the first drainage cannula proximal to the drainage cannula tip; the drainage cannula proximal end having a first drainage branch configured for connection to fluid drainage tubing and a second return cannula branch; a hemostatic access port affixed to a proximal end of the second return cannula branch; a second return cannula having a return cannula distal end and a return cannula proximal end configured for connection to fluid return tubing, and a return cannula tip at the return cannula distal end, the return cannula tip having a tapering portion tapering from a first return cannula diameter to a second return cannula diameter; and a plurality of return ports through a circumferential wall of the return cannula tip; wherein the second return cannula extends through the hemostatic access port into and coaxially through a drainage lumen defined by an interior of the drainage cannula and extending out from the drainage lumen through the drainage cannula tip; wherein the second return cannula is moveable through the hemostatic access port and the drainage lumen such that a distance between the drainage ports and the return ports may be manually adjusted; and wherein the hemostatic access port is adjustable to selectively enable and prevent movement of the second return cannula with respect to the first drainage cannula. See Figs. 4-6
The drainage tip opening being positioned to engage and coaxially position the second return cannula with the first drainage cannula as the second return cannula extends through the drainage cannula tip is not directly disclosed in Sauer’s Figs. 4-6. However, looking to Figs. 9B,C, this arrangement is taught. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the taper in the distal end of the drainage catheter to approximate an outer surface of the second return cannula for engagement to prevent turbulent flow.
With respect to claim 2: as above with Figs. 9B,C the first diameter of the second return cannula approximates the second diameter of the first drainage cannula, and wherein the drainage cannula tip tapers from the first drainage cannula diameter to the second drainage cannula diameter configured to approximate an outer surface of the second cannula.
With respect to claim 5: Sauer discloses wherein the hemostatic access port 10 and the drainage tip opening at the drainage tip distal end are configured to coaxially hold the return cannula within the drainage lumen of the drainage cannula, wherein the drainage tip opening engages an outer surface of the second return cannula to maintain coaxial positioning. Figs. 9B,C
With respect to claim 10: the return ports are arranged in multiple rows around a circumference of the return cannula tip. Fig. 5
With respect to claim 13: the return cannula is formed with a preformed bend between a return cannula proximal end and the return cannula distal end. [0050,0054]
With respect to claims 21-23: Sauer discloses the hemostatic access port further comprises a valved access port such as a Touhey-Borst valve; a torque-limiting valve. See Figs. 6,9a-b,10-11 and inflow compression cap 22
Claims 3-4, 6-9, 11-12, 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sauer.
Sauer discloses the invention as substantially claimed (see above), including the diameters used in experimentation with the inflow or outflow desired of the cannulas, see [0043-0044] (17-34 French). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameters of the return or drainage cannulas as claimed below as a matter of obvious design choice based on the flow rates and pressures to be achieved [0044].
the first diameter of the second return cannula approximates the second diameter of the first drainage cannula. [0044]
the first diameter of the first drainage cannula is 19-31 French.
the second diameter of the first drainage cannula is 12-18 French.
With respect to claims 6-9, the length of the cannulas of Sauer and the tip taper is also a design feature that is well known to be modified based on routine experimentation and optimization.
wherein the drainage cannula has an insertable length of 25 cm.
wherein the return cannula has an insertable length of 50 cm.
wherein the return cannula tip tapers along a length of 20 mm of the return cannula tip.
wherein the return cannula tip tapers from a diameter of 18 French to a diameter of 9-10 French.
With respect to claims 11-12, the dimensions of the ports of Sauer is also a design feature that is well known to be modified based on routine experimentation and optimization. [0037]
each return port has a longest length dimension of 2.15 mm and a width dimension that is less than the length dimension.
the width dimension declines for successive rows of return ports as they approach the distal end of the return cannula tip.
With respect to claims 14-17, the location and the degree of preform bend of the return cannula of Sauer is also a design feature that is well known to be modified based on routine experimentation and optimization. [0050]
wherein said preformed bend is located along a 25 cm length of said return cannula.
wherein said 25 cm length is closer to the return cannula distal end than the return cannula proximal end.
wherein the preformed bend follows a curvilinear path and exhibits an angle of 120 - 160 degrees.
wherein the preformed bend follows an S- shaped curve and exhibits two 40 degree bends.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection was necessitated by amendment (diameters to maintain coaxial positioning, see above). With respect to the routine optimization argument in connection with the dimensional limitations, examiner maintains that Sauer does realize the relationship between the diameters of the inner and outer cannula in affect to flow rates and pressures and thus recognizes this as an optimizable characteristic based on the requirements of the system and patient condition [0044]. Likewise with the preformed bends being shaped depending upon surgical preference, anatomical variations or other conditions [0048,0050].
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 DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783