DETAILED ACTION
The following Office Action is in response to the Request for Continued Examination filed on April 1, 2026. Claims 1-19 are currently pending.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 1, 2026 has been entered.
Response to Arguments
Concerning the “Rejections under 35 U.S.C. § 102” section on pages 8-11 of the Applicant’s Response filed on April 1, 2026, the applicant’s arguments have been fully considered, and they are persuasive. The applicant argues that the Heuser reference does not teach each and every element set forth in the claim, and the examiner agrees. Therefore, the rejections of the claims under 35 U.S.C. §102 as being anticipated by Heuser are withdrawn.
Concerning the “Rejections under 35 U.S.C. § 103” section on pages 11-16 of the Applicant’s Response filed on April 1, 2026, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection. The applicant argues that the Meyer reference does not teach the newly added limitation of “the telescopic sheath [being] configured for passing an intrabody catheter therethrough to dispose a distal end of the intrabody catheter distal to the distal end of the outer sleeve”. However, the interpretation of the Meyer reference has been modified to interpret the catheter body 106 of the Meyer reference as the intrabody catheter as discussed in the new ground(s) of rejection in the Office Action below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 5, 8, 11-12, 15, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meyer et al. (US 2014/0180127, hereinafter Meyer).
Concerning claim 1, the Meyer et al. prior art reference teaches a telescopic sheath (Figure 7-9; 100), comprising: an outer sleeve (Figure 7-9; 105) extending from a proximal end to a distal end, wherein the distal end is capable of being inserted into a heart, wherein the outer sleeve includes an outer sleeve proximal portion and an outer sleeve distal portion, the outer sleeve proximal portion having a proximal outer-sleeve inner circumference and including the proximal end (Figure 8; 105), and the outer sleeve distal portion having distal outer sleeve inner circumference and including the distal end (Figure 9; 105 before taper portion 107); an inner sleeve having a proximal end, a distal end, and an inner-sleeve outer circumference that is less than or identical to the distal outer sleeve inner circumference (Figure 7; 102), the inner sleeve being disposed in at least a portion of the outer sleeve proximal portion that defines the proximal outer-sleeve inner circumference (Figure 8; 102) such that the inner sleeve telescopically extends proximally from the proximal end of the outer sleeve proximal portion (Figure 7; 102) and such that the telescopic sheath is configured for passing an intrabody catheter therethrough to dispose a distal end of the intrabody catheter distal to the distal end of the outer sleeve (Figure 9; 106); a fluid seal (Figure 7; 103), which is disposed between the inner sleeve and outer sleeve and is configured to prevent back bleeding through a space between the inner sleeve and outer sleeve; and a lock (Figure 3; 104), configured to fix a position of the inner sleeve with respect to the outer sleeve ([¶ 0038]).
Concerning claim 2, the Meyer reference teaches the telescopic sheath according to claim 1, wherein the Meyer reference further teaches a handle (Figure 7; 109) coupled to a proximal end of the inner sleeve.
Concerning claim 5, the Meyer reference teaches the telescopic sheath according to claim 1, wherein the Meyer reference further teaches the lock comprising a ring configured to fix the position of the inner sleeve by clamping the outer sleeve against the inner sleeve (Figure 7; 104 | [¶ 0038]).
Concerning claim 8, the Meyer reference teaches the telescopic sheath according to claim 1, wherein the Meyer reference further teaches the lock being capable of transferring, to the outer sleeve, torque that is applied to the inner sleeve given the lock fixes the relative positions of the sleeves ([¶ 0038]).
Concerning claim 11, the Meyer et al. prior art reference teaches a method for manufacturing a telescopic sheath that is configured to guide an intrabody catheter into the body (Figure 7-9; 100), the method comprising: forming an outer sleeve (Figure 7-9; 105) extending from a proximal end to a distal end, wherein the distal end is capable of being inserted into a heart, wherein the outer sleeve includes an outer sleeve proximal portion and an outer sleeve distal portion, the outer sleeve proximal portion having a proximal outer-sleeve inner circumference and including the proximal end (Figure 8; 105), and the outer sleeve distal portion having distal outer sleeve inner circumference and including the distal end (Figure 9; 105 before taper portion 107); forming an inner sleeve having a proximal end, a distal end, and an inner-sleeve outer circumference that is less than or identical to the distal outer sleeve inner circumference (Figure 7; 102), the inner sleeve being disposed in at least a portion of the outer sleeve proximal portion that defines the proximal outer-sleeve inner circumference (Figure 8; 102) such that the inner sleeve telescopically extends proximally from the proximal end of the outer sleeve proximal portion (Figure 7; 102) and such that the telescopic sheath is configured for passing an intrabody catheter therethrough to dispose a distal end of the intrabody catheter distal to the distal end of the outer sleeve (Figure 9; 106); disposing a fluid seal between the inner sleeve and outer sleeve proximal portion (Figure 7; 103), the fluid seal, being configured to prevent back bleeding through a space between the inner sleeve and outer sleeve; and a lock (Figure 3; 104), providing a lock configured to fix a position of the inner sleeve with respect to the outer sleeve ([¶ 0038]).
Concerning claim 12, the Meyer reference teaches the method according to claim 1, wherein the Meyer reference further teaches a handle (Figure 7; 109) coupled to the proximal end of the inner sleeve.
Concerning claim 15, the Meyer reference teaches the method according to claim 1, wherein the Meyer reference further teaches the lock comprising a ring configured to fix the position of the inner sleeve by clamping the outer sleeve against the inner sleeve (Figure 7; 104 | [¶ 0038]).
Concerning claim 18, the Meyer reference teaches the method according to claim 1, wherein the Meyer reference further teaches the lock being capable of transferring, to the outer sleeve, torque that is applied to the inner sleeve given the lock fixes the relative positions of the sleeves ([¶ 0038]).
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.
Claim(s) 1, 3-4, 11, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Root et al. (US 2014/0249562, hereinafter Root) in view of Meyer et al. (US 2014/0180127, hereinafter Meyer).
Concerning claim 1, the Root et al. prior art reference teaches a telescopic sheath (Figure 4; 480), comprising: an outer sleeve (Figure 4; 450) extending from a proximal end to a distal end, wherein the distal end is capable of being inserted into a heart, wherein the outer sleeve includes an outer sleeve proximal portion (Figure 4; 451) and an outer sleeve distal portion (Figure 4; 450), the outer sleeve proximal portion having a proximal outer-sleeve inner circumference and including the proximal end (Figure 4; 451), and the outer sleeve distal portion having distal outer sleeve inner circumference and including the distal end (Figure 4; 450); an inner sleeve having a proximal end, a distal end, and an inner-sleeve outer circumference that is less than or identical to the distal outer sleeve inner circumference (Figure 4; 420), the inner sleeve being disposed in at least a portion of the outer sleeve proximal portion that defines the proximal outer-sleeve inner circumference (Figure 4; 473) such that the inner sleeve telescopically extends proximally from the proximal end of the outer sleeve proximal portion (Figure 4; 420) and such that the telescopic sheath is configured for passing an intrabody catheter therethrough to dispose a distal end of the intrabody catheter distal to the distal end of the outer sleeve (Figure 7; 730), but it does not specifically teach a fluid seal, which is disposed between the inner sleeve and outer sleeve and is configured to prevent back bleeding through a space between the inner sleeve and outer sleeve, and a lock, configured to fix a position of the inner sleeve with respect to the outer sleeve.
However, the Meyer reference teaches a telescopic sheath similar to that of the Root reference, wherein the Meyer reference teaches a fluid seal (Figure 7; 103), which is disposed between the inner sleeve and outer sleeve and is configured to prevent back bleeding through a space between the inner sleeve and outer sleeve; and a lock (Figure 3; 104), configured to fix a position of the inner sleeve with respect to the outer sleeve ([¶ 0038]).
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 the telescopic sheath of the Root reference include the fluid seal and lock of the Meyer reference to prevent fluid from entering the space between the inner and outer sleeves (Meyer; [¶ 0027]), and to further maintain a relative position of the inner and outer sleeves (Meyer; [¶ 0038]).
Concerning claim 3, the combination of the Root and Meyer references as discussed above teaches the telescopic sheath according to claim 1, wherein the Root reference further teaches the outer sleeve narrowing distally from the proximal portion of the outer sleeve to the distal portion of the outer sleeve (Figure 4; 450, 451).
Concerning claim 4, the combination of the Root and Meyer references as discussed above teaches the telescopic sheath according to claim 1, wherein the Root reference further teaches the inner-sleeve outer circumference being identical to the distal outer-sleeve inner circumference (Figure 4; 473).
Concerning claim 11, the Root et al. prior art reference teaches a method for manufacturing a telescopic sheath that is configured to guide an intrabody catheter into the body (Figure 4; 480), the method comprising: forming an outer sleeve (Figure 4; 450) extending from a proximal end to a distal end, wherein the distal end is capable of being inserted into a heart, wherein the outer sleeve includes an outer sleeve proximal portion (Figure 4; 451) and an outer sleeve distal portion (Figure 4; 450), the outer sleeve proximal portion having a proximal outer-sleeve inner circumference and including the proximal end (Figure 4; 451), and the outer sleeve distal portion having distal outer sleeve inner circumference and including the distal end (Figure 4; 450); forming an inner sleeve having a proximal end, a distal end, and an inner-sleeve outer circumference that is less than or identical to the distal outer sleeve inner circumference (Figure 4; 420), inserting the inner sleeve having a proximal end, a distal end, and an inner-sleeve outer circumference less than or identical to the outer sleeve inner circumference in at least a portion of the outer sleeve proximal portion that defines the proximal outer-sleeve inner circumference (Figure 4; 473) such that the inner sleeve telescopically extends proximally from the proximal end of the outer sleeve proximal portion (Figure 4; 420) and such that the telescopic sheath is configured for passing an intrabody catheter therethrough to dispose a distal end of the intrabody catheter distal to the distal end of the outer sleeve (Figure 7; 730), but it does not specifically teach disposing a fluid seal between the inner sleeve and outer sleeve proximal portion, the fluid seal being configured to prevent back bleeding through a space between the inner sleeve and outer sleeve, and a lock, configured to fix a position of the inner sleeve with respect to the outer sleeve.
However, the Meyer reference teaches a telescopic sheath similar to that of the Root reference, wherein the Meyer reference teaches a fluid seal (Figure 7; 103), which is disposed between the inner sleeve and outer sleeve and is configured to prevent back bleeding through a space between the inner sleeve and outer sleeve; and a lock (Figure 3; 104), configured to fix a position of the inner sleeve with respect to the outer sleeve ([¶ 0038]).
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 the telescopic sheath of the Root reference include the fluid seal and lock of the Meyer reference to prevent fluid from entering the space between the inner and outer sleeves (Meyer; [¶ 0027]), and to further maintain a relative position of the inner and outer sleeves (Meyer; [¶ 0038]).
Concerning claim 13, the combination of the Root and Meyer references as discussed above teaches the telescopic sheath according to claim 11, wherein the Root reference further teaches the outer sleeve narrowing distally from the proximal portion of the outer sleeve to the distal portion of the outer sleeve (Figure 4; 450, 451).
Concerning claim 14, the combination of the Root and Meyer references as discussed above teaches the telescopic sheath according to claim 11, wherein the Root reference further teaches the inner-sleeve outer circumference being identical to the distal outer-sleeve inter circumference (Figure 4; 473).
Claim(s) 6, 7, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Root et al. (US 2014/0249562, hereinafter Root) in view of Meyer et al. (US 2014/0180127, hereinafter Meyer) as applied to claims 1, 3-4, 11, and 13-14 above, and further in view of Mauch (US 2018/0126121).
Concerning claims 6, 7, 16, and 17, the combination of the Root and Meyer references as discussed above teaches the telescopic sheath and the method of manufacturing the telescopic sheath of claims 1 and 11, wherein the Root reference further teaches a handle coupled to the proximal end of the inner sleeve (Figure 4; 410), but does not specifically teach the handle comprising a valve configured to prevent back bleeding through the proximal end of the inner sleeve.
However, the Mauch reference teaches a telescopic sheath and a method of manufacturing the telescopic sheath including a handle that may include a hemostatic valve in the handle ([¶ 0031]).
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 the handle of the Root and Meyer combination reference include a hemostatic valve as in the Mauch reference, that is configured to prevent back bleeding through the proximal end of the inner sleeve, the valve further being associated with the fluid seal, to allow the intrabody catheter introduced through the telescopic sheath to be locked at the proximal ends together along the longitudinal axis (Mauch; [¶ 0031]).
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Root et al. (US 2014/0249562, hereinafter Root) in view of Meyer et al. (US 2014/0180127, hereinafter Meyer) as applied to claims 1, 3-4, 11, and 13-14 above, and further in view of West et al. (US 2001/0001813, hereinafter West).
Concerning claims 9 and 19, the combination of the Root and Meyer references as discussed above teaches the he telescopic sheath and the method of manufacturing the telescopic sheath of claims 1 and 11, but does not specifically teach a length of the inner sleeve, from the distal end to the proximal end of the inner sleeve being less than 50 cm.
However, the West reference teaches a telescoping dilator similar to that of the Root and Meyer references, wherein the West reference teaches that the length of the system may be 10 cm to 25 cm. ([¶ 0014]).
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 the introducer sheath of the Root and Meyer combination be 10 cm to 25 cm, which is less than 50 cm given the West reference teaches that this is an appropriate length for a vascular dilator (West; [¶ 0014]).
Allowable Subject Matter
Claim 10 is 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.
Conclusion
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/MARTIN T TON/Examiner, Art Unit 3771 5/12/2026
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