DETAILED ACTION
Applicant’s arguments, filed 03/16/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1-20 are pending and hereby under examination.
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 .
Allowable Subject Matter
The indicated allowability of claims 14 and 18-20 is withdrawn in view of the newly discovered reference(s) to Meyer and Norris. Rejections based on the newly cited reference(s) follow.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 18, lines 20-23 are unclear. The claim recites that the outer sheath has “ a proximal and a distal end fixedly coupled to the distal hub”. Likewise, the inner sheath has “a proximal end and a distal end fixedly coupled to the distal hub”. It is unclear how both ends of the inner and outer sheaths are coupled to the distal hub. It appears Applicant intends for only the distal end to be coupled to the distal hub. For examination purposes, that is how the claim will be interpreted. However, Applicant should clarify the proximal and distal ends of lines 20-23. Claims 19-20 are also rejected due to their dependence on claim 18.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-15 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer (US 20140180127 – cited by Applicant) and Norris (US 20160324503).
Regarding claims 1-2 and 5, Meyer teaches a telescoping catheter, the telescoping catheter comprising:
a proximal hub adjacent a proximal end of the telescoping catheter (Fig. 7, proximal housing 109);
a drive cable (Fig. 8, drive cable 110);
a telescoping section extending from a proximal end of the telescoping section adjacent the proximal hub to a distal end of the telescoping section (Fig. 7, telescoping section 4), the telescoping section comprising:
an intermediate sheath having a proximal end coupled to the proximal hub and extending distally to a distal end (Figs. 7-8, inner proximal tubular member 102);
an outer sheath disposed over the intermediate sheath, the outer sheath having a proximal end and a distal end (Figs. 7-8, outer tubular member 105);
an inner sheath disposed within the intermediate sheath, the inner sheath having a proximal end and a distal end (Figs. 7-8, catheter body 106); and
wherein the intermediate sheath is configured to be longitudinally displaced relative to the inner and outer sheaths (Paragraph 0039, “inner tubular member 102 of the telescope section 4 is translated relative to the outer tubular member 105 and catheter body 106”).
While Meyer does teach a seal (Figs. 7-8, fluid seal 103), Meyer fails to teach wherein the seal member is disposed between the intermediate sheath and the inner sheath. With regards to the limitations of claims 2 and 5, Meyer fails to explicitly disclose the seal member forming a fluid-tight seal and the seal member comprising an o-ring.
Norris and Meyer are in the same field of catheters. Norris teaches a catheter with a sealing element 158 (Fig. 3). The sealing element may be an o-ring allowing the drive cable to extend through the sealing element while providing a fluid seal between the drive cable 150 and elongate member 112 (Paragraph 0042). As Meyer is concerned with extending the catheter/sheath through a telescoping region (Paragraph 0008), Norris introduces an o-ring that the drive cable extends through to prevent leaking while allowing the drive cable to rotate (Paragraph 0031). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Meyer to incorporate the o-ring as taught by Norris to prevent leaking while allowing the drive cable to rotate.
Regarding claim 3, Meyer as modified further discloses a retainer sleeve secured to an outer surface of the intermediate sheath (Fig. 4, stoppers 133).
Regarding claim 4, Meyer as modified further discloses wherein the intermediate sheath has a constant outer diameter from the proximal end to the distal end (Figs. 7-8, inner tubular member 102 with constant/unchanging diameter).
Regarding claim 6, Meyer as modified further discloses a housing coupled to the proximal end of the outer sheath (Figs. 7-8, anchor housing unit 104).
Regarding claim 7, Meyer as modified further discloses wherein the retainer sleeve is configured to mechanically engage a portion of the housing to limit proximal movement of the intermediate sheath (Paragraph 0044, “the stoppers 133 can be configured to prevent the inner proximal tubular member 102 from exiting a proximal end of the anchor housing 104”).
Regarding claims 8, 11, and 15, Meyer discloses a telescoping catheter, the telescoping catheter comprising:
a drive cable (Fig. 8, drive cable 110);
a telescoping section extending longitudinally along the telescoping catheter and having a distal end (Fig. 7, telescoping section 4), the telescoping section comprising:
an inner sheath coupled to the distal end of the telescoping section and defining a first lumen for housing the drive cable (Figs. 7-8, catheter body 106; Fig. 4, drive cable 110 within catheter body 106);
an outer sheath coupled to the distal end of the telescoping section and defining a second lumen, wherein the outer sheath and the inner sheath are fixed in relationship to each other, and the outer sheath substantially surrounds the inner sheath (Figs. 7-8, outer tubular member 105; Fig. 3, outer tubular member 105 around inner tubular member 102 and catheter body 106);
an intermediate sheath having a proximal end and extending distally to a distal end (Figs. 7-8, inner proximal tubular member 102); and
wherein the intermediate sheath is configured to slide between the inner sheath and the outer sheath for telescoping the telescoping catheter (Paragraph 0039, “inner tubular member 102 of the telescope section 4 is translated relative to the outer tubular member 105 and catheter body 106”).
While Meyer does teach a seal (Figs. 7-8, fluid seal 103), Meyer fails to teach wherein the seal member is disposed between the intermediate sheath and the inner sheath. With regards to the limitations of claim 11 and 15, Meyer fails to explicitly disclose the position of the seal member and the seal member comprising an o-ring.
Norris and Meyer are in the same field of catheters. Norris teaches a catheter with a sealing element 158 (Fig. 3). The sealing element may be an o-ring allowing the drive cable to extend through the sealing element while providing a fluid seal between the drive cable 150 and elongate member 112 (Paragraph 0042). As Meyer is concerned with extending the catheter/sheath through a telescoping region (Paragraph 0008), Norris introduces an o-ring that the drive cable extends through to prevent leaking while allowing the drive cable to rotate (Paragraph 0031). In combination, the inner tubular member of Meyer would necessarily extend from the o-ring when combined with Norris. Examiner notes that the retainer plug is interpreted in light of the instant application’s specification paragraph 0063, wherein the intermediate sheath and retainer plug are formed as a single monolithic structure. Thus, the inner tubular member of Meyer reads on the retainer plug. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Meyer to incorporate the o-ring as taught by Norris to prevent leaking while allowing the drive cable to rotate.
Regarding claim 9, Meyer as modified further discloses wherein the intermediate sheath defines a third lumen configured to surround the inner sheath when the intermediate sheath is in a distally advanced configuration and surround a portion of the drive cable when the intermediate sheath is in a proximally displaced configuration (Figs. 4-5, the lumen of inner proximal tubular member 102 surrounds a portion of the inner tubular member 106 when fully extended and drive cable 110. The lumen of inner proximal tubular member 102 surrounds the drive cable 110).
Regarding claim 10, Meyer as modified further discloses a retainer sleeve secured to an outer surface of the intermediate sheath (Fig. 4, stoppers 133).
Regarding claim 12, Meyer as modified further discloses wherein the intermediate sheath has a constant outer diameter from the proximal end to the distal end (Figs. 7-8, inner tubular member 102 with constant/unchanging diameter).
Regarding claim 13, Meyer as modified further discloses wherein an outer diameter of the retainer plug is the same as an outer diameter of the intermediate sheath (Figs. 7-8, inner tubular member 102 with constant/unchanging diameter; Examiner notes that the retainer plug is interpreted in light of the instant application’s specification paragraph 0063, wherein the intermediate sheath and retainer plug are formed as a single monolithic structure).
Regarding claim 14, Meyer in combination with Norris discloses wherein the retainer sleeve is disposed over and contacting a distal end region of the intermediate sheath, the seal member, and a proximal end region of the retainer plug (Fig. 4 of Meyer, stoppers 133; The stoppers are disposed over and contact a distal end region of the intermediate sheath/retainer plug. In combination with the seal member of Norris, the stoppers would necessarily be disposed over the seal member).
Regarding claim 18, Meyer discloses a telescoping catheter, the telescoping catheter comprising:
a proximal hub adjacent a proximal end of the telescoping catheter (Fig. 7, proximal housing 109);
a drive cable (Fig. 8, drive cable 110);
a telescoping section extending from a proximal end of the telescoping section adjacent the proximal hub to a distal end of the telescoping section (Fig. 7, telescoping section 4), the telescoping section comprising:
a distal hub positioned adjacent to the distal end of the telescoping section (Fig. 7, catheter coupling 107)
an intermediate sheath assembly comprising:
an intermediate sheath having a proximal end coupled to the proximal hub and extending distally to a distal end of the intermediate sheath (Figs. 7-8, inner proximal tubular member 102);
a retainer plug having a proximal end and a distal end, the retainer plug extending colinear with the intermediate sheath (Fig. 8, inner proximal tubular member 102; Examiner notes that the retainer plug is interpreted in light of the instant application’s specification paragraph 0063, wherein the intermediate sheath and retainer plug are formed as a single monolithic structure. Thus, the inner tubular member of Meyer reads on the retainer plug); and
a retainer sleeve disposed over and contacting a distal end region of the intermediate sheath and a proximal end region of the retainer plug (Fig. 4 of Meyer, stoppers 133);
an outer sheath disposed over the intermediate sheath, the outer sheath having a proximal end and a distal end fixedly coupled to the distal hub (Figs. 7-8, outer tubular member 105; Fig. 4, outer tubular member 105 coupled to catheter coupling 107); and
an inner sheath disposed within the intermediate sheath, the inner sheath having a proximal end and a distal end fixedly coupled to the distal hub (Figs. 7-8, catheter body 106);
wherein the intermediate sheath assembly is configured to be longitudinally displaced relative to the inner and outer sheaths (Paragraph 0039, “inner tubular member 102 of the telescope section 4 is translated relative to the outer tubular member 105 and catheter body 106”).
While Meyer does teach a seal (Figs. 7-8, fluid seal 103), Meyer fails to teach wherein the seal member is disposed between the intermediate sheath and the inner sheath.
Norris and Meyer are in the same field of catheters. Norris teaches a catheter with a sealing element 158 (Fig. 3). The sealing element may be an o-ring allowing the drive cable to extend through the sealing element while providing a fluid seal between the drive cable 150 and elongate member 112 (Paragraph 0042). As Meyer is concerned with extending the catheter/sheath through a telescoping region (Paragraph 0008), Norris introduces an o-ring that the drive cable extends through to prevent leaking while allowing the drive cable to rotate (Paragraph 0031). In combination, the inner tubular member of Meyer would necessarily extend from the o-ring when combined with Norris. Examiner notes that the retainer plug is interpreted in light of the instant application’s specification paragraph 0063, wherein the intermediate sheath and retainer plug are formed as a single monolithic structure. Thus, the inner tubular member of Meyer reads on the retainer plug. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Meyer to incorporate the o-ring as taught by Norris to prevent leaking while allowing the drive cable to rotate.
Regarding claim 19, Meyer as modified further discloses wherein the retainer sleeve is configured to mechanically engage a portion of the housing to limit proximal movement of the intermediate sheath (Paragraph 0044, “the stoppers 133 can be configured to prevent the inner proximal tubular member 102 from exiting a proximal end of the anchor housing 104”).
Regarding claim 20, Meyer as modified further discloses wherein the intermediate sheath defines a third lumen configured to surround the inner sheath when the intermediate sheath is in a distally advanced configuration and surround a portion of the drive cable when the intermediate sheath is in a proximally displaced configuration (Figs. 4-5, the lumen of inner proximal tubular member 102 surrounds a portion of the inner tubular member 106 when fully extended and drive cable 110. The lumen of inner proximal tubular member 102 surrounds the drive cable 110).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer as applied to claim 10 above, and further in view of Savastano (US 20190038300).
Regarding claims 16-17, while Meyer discloses the inner sheath / catheter body 106, Meyer fails to disclose an outer jacket disposed over the drive cable, the outer jacket comprising a first layer and a second layer.
However, Savastano teaches an analogous telescoping system with a drive system wherein the design can have jackets of different polymers and thickness (Paragraph 0077), the jacket having first and second layers (Paragraph 0077, “jackets of different polymers and thicknesses” – multiple jackets requires at least two layers, thus Savastano reads on the claim limitation of a first and second layer). Savastano discusses this is useful to optimize torsional strength and bending stiffness.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive cable of Meyer to incorporate the jackets of Savastano to optimize strength and bending stiffness.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 03/16/2026, with respect to the claim objections have been fully considered and are persuasive. Applicant has amended the claims per the suggestion of the Examiner and by clarifying which proximal and distal end belong to each structural component of the telescoping catheter. The objection to the claims has been withdrawn.
Applicant’s arguments, see page 8, filed 03/16/2026, with respect to the 35 U.S.C. §112(b) rejections have been fully considered and are persuasive. Applicant has amended the claims to clarify the proximal and distal ends of the structural components of the telescoping catheter. Applicant also removed “substantially” from claims 8, 9, and 20. The rejection of the claims has been withdrawn. However, a new rejection has been applied.
Applicant’s arguments, see pages 8-10, filed 03/16/2026, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. §102(a)(1) and 35 U.S.C. §103 have been fully considered and are persuasive. As agreed upon in the interview held on 03/03/2026, Meyer fails to teach the claimed structure of a seal member disposed between the intermediate sheath and an outer surface of the inner sheath. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Meyer in view of Norris.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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