DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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) 15, 18, 21-24, 26, 35-36, 41 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 5,167,636 (“Clement”) in view of U.S. Patent No. 2,300,584 (“Martin”).
Regarding Claim 15, Clement discloses a system (Fig. 1) comprising:
A first sheath (12, 20) comprising:
A sheath housing (20) comprising a receiving channel (36, 32), wherein the sheath housing has a proximal end (circa 24) and a distal end (circa 22), and wherein the distal end of the sheath housing is configured to face a body of a patient (i.e. when the tube 12 is inserted into a patient the end at 22 will be directed toward the patient);
A tubular section (12) extending into the receiving channel (Fig. 1), wherein the tubular section has a proximal end (circa 22) and a distal end (not shown – i.e. the terminal end which is inserted into the patient), wherein the distal end of the tubular section is configured to be inserted in the patient's body (Background), and wherein the proximal end of the tubular section is configured to remain outside the patient's body (see Fig. 1 – note that the illustrate geometry illustrates a clear handle configuration which is understood to be maintained external to the patient in order to permit manipulation of the system);
A securing element (14, 22) located along the receiving channel at the distal end of the sheath housing, wherein the securing element fixes a location of the sheath housing relative to the tubular section (see Fig. 1) and wherein disconnecting the securing element permits the sheath housing to slide along the tubular section (i.e. the tubular section and sheath housing can be separated via a sliding motion.
Clement discloses the invention substantially as claimed except that the securing element is a “first clamping element” [emphasis added]. Rather Clement broadly recites that the securing element may comprise “Luer locks, friction coupling tab engagement, snap fit attachment, threaded attachment, welded attachment (ultrasonic, RF, or thermal), adhesive attachment, or other conventional attachment methods known to those skilled in the art” [emphasis added] (Col. 3-4). As such, Clement provides clear direction to the ordinary artisan that other “conventional” attachment means should be considered and employed.
Among such conventional attachment mechanisms for securing tubing are known to the art as disclosed by Martin. Specifically, Martin discloses a means (Fig. 2) for permitting the selectively securement of a tubing connection comprising a first clamping element (16, 17, 14, 11, 7) located along a receiving channel (i.e. the interior of 1) at a distal end thereof for selectively securing a length of tubing (15) therein (see Fig. 1). Martin discloses the first clamping element comprises a first stop piece (16) wholly within the receiving channel (see Fig. 1), a first clamping ring (17) wholly within the receiving channel (see Fig. 1), and a first screw element (7) for axially pressing the first clamping ring against the first stop piece (see Fig. 1 – Pg. 2, Cl. 2, Ln. 27-46), wherein the tubular section extends through the first stop piece, the first clamping ring and the first screw element (see Fig. 1), wherein tightening the first clamping element fixes a location of the sheath housing relative to the tubular section, and wherein loosening the first clamping element permits the sheath housing to slide along the tubular section (Pg. 2, Cl. 2, Ln. 27-46).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the invention of Clement with a clamping element type securing element, as disclosed by Martin, as a product of simple substitution of known equivalents to obtain a predictable and expected outcome of using a known species of tubular securement within an identified genus as identified by Clement. Again, Clement provides clear direction to the ordinary artisan that other attachment means should be considered and can be employed to equal effect. As such, there is strong and direct motivation to the ordinary artisan to review and consider attachment mechanisms such as those disclosed by Martin to modify the disclosed invention of Clement.
Clement further discloses a second clamping element (50, 60) located along the receiving channel at the proximal end of the sheath housing (see Fig. 1, 2), wherein the second clamping element comprises a second stop piece (28) wholly within the receiving channel (see Fig. 2), a second clamping ring (60) wholly within the receiving channel (see Fig. 2), and a second screw element (50) for axially pressing the second clamping ring against the second stop piece (Col. 5), wherein the second clamping element is configured to receive a catheter or a second sheath (see generally 80) extending into the receiving channel, wherein tightening the second clamping element fixes a location of the catheter or the second sheath relative to the sheath housing, wherein loosening the second clamping element permits the catheter or the second sheath to slide within the sheath housing, and wherein the first and second clamping elements are coaxial (Col. 5).
Regarding Claim 18, Clement, as modified in view of Martin, discloses the first clamping element ring (17) comprises a first an elastically deformable first clamping ring (re: “the sealing ring 17… is preferably formed of oil-resistant compressive material such as neoprene or other suitable synthetic rubber”, see Martin), and wherein the second clamping element ring comprises a second elastically deformable second clamping ring (re: “The seal 60 is constructed of natural or synthetic polymers (e.g. rubber, neoprene, etc.) that are elastically compressible”.
Regarding Claim 21, Clement, as modified by Martin, discloses the first clamping ring can be radially deformed by the first screw element (see Pg. 2, Col. 2 – Martin), and wherein the second clamping ring can be radially deformed by the second screw element (see Col. 5).
Regarding Claim 22, Clement, as modified by Martin, discloses the first clamping ring surrounds the tubular section (see Fig. 1 – Martin ) and can be pressed by the first screw element such that the first clamping ring contacts and radially clamps the tubular section (see Pg. 2, Col. 2 – Martin).
Regarding Claim 23, Clement discloses a first hemostatic valve (70) located in the flushing space (see Fig. 2).
Regarding Claim 24, Clement discloses that the hemostatic valve is configured to seal around the tubular section (i.e. the hemostatic valve 70 proximally seals around the proximal end of the tubular section by restricting access to the tubular section 50 when closed, thereby ensuring that any fluid introduced via 35 is directed only through the lumen of the tubular section).
Regarding Claim 26, Clement further discloses the catheter (re: cannula 80), wherein the catheter extends through the second clamping element (see Fig. 3).
Regarding Claim 35, Clement, as modified in view of Carpenter, dislcoses the receiving channel comprises a flushing space (see e.g. 32) located between the first clamping element (generally 14, 22 – as modified in view of Carpenter) and the second clamping element (50, 60), flushable via fluid channel (34)
Regarding Claim 36, Clements discloses a flushing inlet (34) for allowing the flushing space to be flushed by a liquid.
Regarding Claim 41, Clements, as modified by Martin, discloses tightening the first clamping element comprises moving the first screw element towards the distal end of the sheath housing (see Fig. 2 and 1 in series – Pg. 2, Col. 2 - Martin), and wherein tightening the second clamping element comprises moving the second screw element towards the proximal end of the sheath housing (see Fig. 2 and 3, Col. 4, Celements).
Claim(s) 27-29, 31, 33, and 34 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 5,167,636 (“Clement”) in view of U.S. Patent No. 2,300,584 (“Martin”) as applied above, and further in view of U.S. Publication No. 2004/0147877 (“Heuser”).
Regarding Claim 27, Clement discloses the invention substantially as claimed except that the system particularly comprises a catheter and a second sheath, wherein the second sheath surrounds the catheter. Rather Clement only explicitly discloses a catheter (see e.g. 80) inserted through the second clamping element (see Fig. 3). However, Heuser discloses a related system which may comprise an introducer sheath (14) with a Tuhy-Borst type valve (20) where the introducer sheath can receive a catheter (34) directly, or a second sheath (56) in further association with the catheter (34 – see Fig. 2). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the device of Clement with a second sheath along with the catheter, as disclosed by Heuser, in order to allow for the practice of more complex procedures which require the use of two sheaths along with the catheter to reach the appropriate locations of the vasculature.
Regarding Claim 28, Clement, as modified by Heuser, the tubular section is configured to receive the catheter from the second sheath into the tubular section, i.e. in functional use the catheter can be received within a corresponding second sheath with the distal end of the catheter extending past the distal end of the second sheath such that the distal end of the catheter can be, in functional use, passed from the second sheath into the tubular section.
Regarding Claim 29, Clement, as modified by Heuser, discloses the second sheath (added in view of Heuser) will be detachably held in the second clamping element (see generally Fig. 13 – Clement with a second sheath being added to facilitate receipt of an appropriate catheter in view of Heuser) with the second clamping element being tightened (see Fig. 3) to fix the location of the second sheath relative to the sheath housing, whereby the degree of tightening, in function, may be minimally applied by adjusting the pressure of the screw element (50) to thereby permit the catheter to slide within the sheath housing without encumbrance.
Regarding Claim 31, the second clamping ring of Clement is radially deformably by an axial pressure action (re: compressing 24 using the threads 58).
Regarding Claim 33, the second clamping element comprises a conical shape (see Fig. 2 and 3 – i.e. the proximal and distal end of the clamping rings have a conical shape) and wherein the mechanical stop has a conical shape which is shaped in a direction opposite to the conical shape of the second clamping ring (see Fig. 2, 3).
Regarding Claim 34, Clement discloses the second clamping ring is axially fixed inside the sheath housing by the mechanical stop (see Fig. 2).
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.
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 WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
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