DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24 January 2025 has been entered.
Election/Restrictions
Newly submitted claim(s) 37-40 is/are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the product could be used to practice a materially different process. For example, the product only functionally requires a “catheter” or “a second sheath”, whereas the method positively recites these components. The product could be used to receive a guidewire, not a catheter or sheath. Furthermore, the method is particularly directed toward use to insert “a first sheath into a body of a patient”, whereas the product could be used for non-medical purposes such as being used as a plumbing fitting or being used to secure an electrical cable as opposed to a medical catheter or sheath. Furthermore, the method particularly requires repositioning the “sheath housing closer to the patient’s body”, i.e. in situ manipulation. Whereas the product could be used, in the medical arts, to be assembled PRIOR to its clinical use wherein the sheath housing and tubular section are maintained in an assembled, fixed position when the apparatus is deployed to treat the patient.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim(s) 37-40 is/are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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, 20-24, 26, 35, 36 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. 3,243,207 (“Carpenter”).
Regarding Claim 15, Clement discloses a system (Fig. 1) comprising:
A first sheath (12, 20), the first sheath 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 circa 22 will be directed toward the patient);
A tubular section (12) extending into then receiving channel (see Fig. 1), wherein the tubular section has a proximal end (circa 22) and a distal end (not shown), wherein the distal end of the tubular section is configured to be inserted into the patient’s body (see Background) and wherein the proximal end of the tubular section is configured to remain outside the patient’s body (see Fig. 1);
A securing element (14, 22) located along the receiving channel at the distal end of the sheath housing, wherein the tubular section extend through the securing element, 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 that the securing element is a “first clamping element”. 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” (Col. 3-4). Among such conventional attachment methods are those described by Carpenter. Here, Carpenter describes a related securing element which comprises a housing (1) having a receiving channel (5, 2) and a tubular section (T) extending into the receiving channel (see Fig. 3, 4), with a first clamping element (9, 11, 12) located along the receiving channel at the distal end of the housing (see Fig. 3 and 4), wherein tightening the first clamping element fixes a location of the housing relative to the tubular section (see Fig. 4) and wherein loosening the first clamping element permits the housing to slide along the tubular section (see Fig. 3 – i.e. with the clamping arrangement loosened the housing can be slid proximally with respect to the proximal end of the tubing to allow the tubing to be removed from the clamping arrangement). 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 Carpenter, 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.
Clement further discloses a second clamping element (50, 60) located along the receiving channel (see Fig. 2) at the proximal end of the sheath housing, wherein the second clamping element is configured to receive a catheter or a second sheath (see generally 80; re: “the secondary cannula shown in FIG. 3, or other conventional medical devices…”) extending into the receiving channel (See Fig. 3), wherein tightening the second clamping element fixes a location of the catheter or second sheath (see Fig. 3 – i.e. the collar (50) compresses the seal (60) to increase the frictional engagement therebetween) relative to the sheath housing, wherein loosening the second clamping element permits the catheter or second sheath to slide within the sheath housing, and wherein the first and second clamping elements are coaxial (see Fig. 1)
Regarding Claim 18, Clement, as modified in view of Carpenter, discloses that the first clamping element comprises an elastically deformable first clamping ring (9 – see Carpenter) and the second clamping element comprises an elastically deformable second clamping ring (60 – Clement).
Regarding Claim 20, Clement, as modified in view of Carpenter, discloses the first clamping element further comprises a first stop piece (see 10, 3 – Carpenter) and a first screw element (8 – Carpenter) for pressing the first clamping ring against the first stop piece (see Fig. 3 and 4 – Carpenter), and wherein the second clamping element (Clement) comprises a second stop piece (28) and a second screw element (50) for axially pressing the second clamping ring against the second stop piece (see Fig. 3).
Regarding Claim 21, Clement, as modified in view of Carpenter, discloses that the first clamping ring can be radially deformed by the first screw element (see Fig. 3 and 4 – Carpenter), and wherein the second clamping ring can be radially deformed by the second screw element (see Fig. 3 – Clement).
Regarding Claim 22, Clement, as modified in view of Carpenter, discloses that the first clamping ring surrounds the tubular section (see Fig. 3 – Carpenter) and can be pressed by the first screw element such that the first clamping ring radially clamps the tubular section (Col. 4 – Carpenter).
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 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 36, Clements discloses a flushing inlet (34) for allowing the flushing space to be flushed by a liquid.
Claim(s) 27-29, 31, 33, 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. 3,243,207 (“Carpenter”) 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 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 second clamping element further comprises a mechanical stop (see the shoulder of 30 at 28 or the shoulder of 62 and 56) and wherein the mechanical stop has a conical shape which is shaped in a direction opposite to the conical shape of the clamping ring (see Fig. 2, 3).
Regarding Claim 34, Clement discloses the 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 the 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
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).
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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 06/05/2025