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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Status of Claims
Claims 15, 5-12, and 37-39 are pending and currently under consideration for patentability.
Claim 15 is newly amended.
Claims 16-36 are withdrawn.
Response to Arguments
Applicant's arguments filed 1/30/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that the motivation in view of Phillips is not obvious, and in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case the argument that it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cannula of Lu so the entire branch assembly is unitary for ease of production and more durability, and to limit extension past the cannula, is an argument also understood by anyone of ordinary skill in the art for someone to produce a unitary assembly.
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 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 15, 5, 7, 10, 12, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Lu (US 11285254 B2) in view of Sorenson (EP0000831) in view of Phillips (US 20070213690 A1).
Regarding Claim 15, Lu teaches an adjustable (column 4, lines 8-10) cannulation assembly (figure 9A and 9B), comprising:
a cannulation coupler (430), comprising:
a primary branch (primary branch, annotated figure 9B) having a cylindrical inner surface having a first diameter (401) (figures 9A-9B);
a side branch (second arm, 432)(side branch, annotated figure 9B) in communication with and integrally formed with the primary branch (via Y- connector; column 12, lines 20-41), wherein the side inflow branch has a cylindrical inner surface having a second diameter that is smaller than the first diameter (figure 9B); and
an outflow branch (outflow, annotated figure 9B) in communication with and integrally formed with the primary branch and in communication with the side branch (figure 9B)
an outer cannula (outer cannula, annotated figure 9B) coupled to the primary branch (figure 9B); and
an inner cannula coupled to the side inflow branch (column 12, lines 22-27), wherein a first portion of the inner cannula passes through the primary branch (figures 9A-9B) (column 12, lines 22-27), wherein a second portion of the inner cannula is disposed within an interior portion of the outer cannula (figures 9A-9B), wherein the inner cannula has a cylindrical outer surface having a third diameter that is approximately equal to the second diameter such that a portion of the cylindrical outer surface of the inner cannula is in direct contact with the cylindrical inner surface of the side inflow branch (figures 9A-9B).
Lu fails to teach that the side branch is an inflow branch as opposed to a drainage/outflow branch. Sorenson teaches an adjustable cannulation assembly (cannula assembly, 10) (figure 1), comprising: a cannulation coupler (hub, 12), comprising: a primary branch (leading end, 16) having a cylindrical inner surface having a first diameter (figure 1 and 2); a side inflow branch (branch, 32)(figure 1 and 2) in communication with the primary branch (leading branch, 16); and an outflow branch (trailing end, 22) (figure 1 and 2) in communication with the primary branch (16) and in communication with the side inflow branch (32)(figure 1-3). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cannula of Lu to include the side branch is an inflow branch similar to that disclosed by Sorenson so that the fluid / air taken out of the system may be replaced.
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The combination further fails to teach an outflow branch in communication with and integrally formed with the primary branch and in communication with the side branch such that the outflow branch, the side inflow branch, and the primary branch form a single, unitary part. Phillips teaches a blood conduit connector. Phillips further teaches that one skilled in the art would recognize that the inflow conduit 50 and the cannula 60 may be unitary in construction (paragraph [0080]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cannula of Lu so the entire branch assembly is unitary for ease of production and more durability, and to limit extension past the cannula (as motivated by Philips, paragraph [0080], and [0158])
Regarding Claim 5, Lu in view of Sorenson and Phillips teaches the adjustable cannulation assembly of claim 15. Lu further teaches wherein the side inflow branch extends in a proximal direction away from the primary branch (figure 8A-9B).
Regarding Claim 7, Lu in view of Sorenson and Phillips teaches the adjustable cannulation assembly of claim 15. Lu further teaches wherein the side inflow branch further comprises a seat configured to hold a sealing element (sealing mechanism, column 12, lines 27-31).
Regarding Claim 10, Lu in view of Sorenson and Phillips teaches the adjustable cannulation assembly of claim 15. The combination further teaches wherein an axis defined by the side inflow branch is disposed at an acute angle relative to an axis defined by the primary branch (figure 8A-9B).
Regarding Claim 12, Lu in view of Sorenson and Phillips teaches the adjustable cannulation assembly of claim 15. Lu further teaches wherein an axis defined by the main branch is parallel to an axis defined by the primary branch (figure 8A-9B).
Regarding Claim 38, Lu in view of Sorenson and Phillips teaches the adjustable cannulation assembly of claim 15. Lu fails to explicitly teach wherein at least a portion of the portion of the inner cannula disposed within the interior portion of the outer cannula is axially aligned with the outer cannula. Sorenson teaches wherein at least a portion of the portion of the inner cannula (98) disposed within the interior portion of the outer cannula (88) is axially aligned with the outer cannula (figure 8) (paragraph [0005]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cannula or Lu wherein at least a portion of the portion of the inner cannula disposed within the interior portion of the outer cannula is axially aligned with the outer cannula, similar to Sorenson, so that the inner cannula is placed that it may easily be controlled and maneuvered (as motivated by Sorenson, paragraph [0005]).
Claim 6, 8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lu (US 11285254 B2) in view of Sorenson (EP0000831) and Phillips as applied to claim 15 above, and further view of Anderson (AU 2016219664 B2).
Regarding Claims 6 and 8, Lu in view of Sorenson and Phillips teaches the assembly of claim 15. Lu and Sorenson fail to directly disclose: (claim 6) wherein the side inflow branch further comprises helical threading on a portion of an inner circumference and (claim 8) and a cap having helical threads on an outer circumference.
Anderson teaches an adjustable syringe assembly for fluid inflow and outflow (abstract) in which the inflow branch (39) further comprises helical threading on a portion of an outer circumference (helical threads, annotated figure 25) and a cap (200 and 86) that has helical threads (Helical threads, annotated figure 24) on the inner circumference (figure 24). Anderson discloses the claimed invention except for the threads are on the inside of the cap and on the outside of the inflow branch. It would have been obvious to one having ordinary skill in the art at the time the invention was made to change the location of the helical threads since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70, and the twisting mechanism to engage the threads would function the same way.
Furthermore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the inflow branch of Lu in view of Sorenson to include helical threading on a portion of an inner circumference similar to that disclosed by Anderson so that the cannula may be adjustable by rotation and that the cap may engage the threading of the inflow branch without having to move the inflow branch.
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Regarding Claim 11, Lu in view of Sorenson, and Anderson teaches the adjustable cannulation assembly of claim 8. The combination further discloses wherein the axis defined by the side inflow branch is disposed at an angle of approximately 25 degrees relative to the axis defined by the primary branch (Sorenson, col. 4, Ins. 13-18).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lu (US 11285254 B2) in view of Sorenson (EP0000831), Phillips and in view of Anderson (AU 2016219664 B2) as applied to claim 8 above, and further view of Garrison (US PGPUB 2020/0215306).
Regarding Claim 9, Lu in view of Sorenson, Phillips and Anderson teach the adjustable cannulation assembly of claim 8. Lu, Sorenson and Anderson fail to explicitly disclose that the cap further comprises apertures. Garrison is in the field of intravascular access systems (Abstract), and teaches a cannulation assembly that includes an obturator cap (proximal extension 210, Fig. 1) that has apertures (suture eyelets 233, Fig 1) (paragraph 0060). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the obturator cap of Lu in view of Sorenson and Anderson to further include an eccentric opening, as taught by Garrison. the motivation being that such a configuration provides means to secure the assembly to the patient to reduce the risk of dislodgement during the case (Garrison, Para. (0060]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Lu (US 11285254 B2) in view of Sorenson (EP0000831), Phillips, as applied to claim 15 above, and further view of Burkhoff (WO 2017027414 A1).
Regarding Claim 37, Lu in view of Sorenson and Phillips teaches the adjustable cannulation coupler assembly of claim 15. Lu and Sorenson fail to teach wherein the inner cannula is axially displaced relative to the outer cannula. In the same field of endeavor, namely a cannulation assembly implanted in the human body, Burkhoff teaches a cannula and kit for improving venous blood flow into the pulmonary arteries (paragraph 0002) wherein the inner cannula (11) is axially displaceable relative to the outer cannula (inserter sheath, 14)(figure 11) (paragraph 0049) . Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cannula alignment of Lu in view of Sorenson so that the inner cannula is axially displaces similar to that disclosed by Burkhoff so that the cannula includes room for outflow (Burkhoff, paragraph 0049).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Lu (US 11285254 B2) in view of Sorenson (EP0000831), Phillips as applied to claim 15 above, and further view of Jones (WO 2015123689 A1).
Regarding Claim 39, Lu in view of Sorenson and Phillips teaches the adjustable cannulation coupler assembly of claim 15. Lu and Sorenson fail to teach wherein the primary branch further comprising at least one attachment eyelet configured to secure the cannulation coupler to a patient. In a similar field of endeavor, namely a multi-lumen catheter system (abstract), Jones teaches wherein the primary branch further comprising at least one attachment eyelet configured to secure the cannulation coupler to a patient (paragraph 0064). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cannulation assembly of Lu in view of Sorenson to include at least one attachment eyelet configured to secure the cannulation coupler to a patient similar to that disclosed by Jones so that the cannula may be secured at the ideal site of use (paragraph 0064).
Conclusion
THIS ACTION IS MADE FINAL. 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 KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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