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 .
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.
Response to Amendment
The Response filed June 26, 2025 has been entered. Claims 1-11 and 17-26 are pending in the application. The rejections of claims under 35 U.S.C. 112(b) are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 12, 2025 was filed after the mailing date of the non-final Office Action on March 14, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 26 is 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.
Claim 26 recites the limitation “the looped shape” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 11, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18666046 to Nelson et al. (hereinafter “Nelson”) in view of Asleson et al. (U.S. Patent Application Publication No. 20120109079; hereinafter “Asleson”).
This is a provisional nonstatutory double patenting rejection.
Regarding application claim 1, claim 1 of Nelson recites the invention substantially as claimed except for the sheath including a bend portion, the sheath and dilator being configured to be percutaneously inserted into a blood vessel and passed into a cardiac left ventricle together.
Application claim 1
Nelson claim 1
Examiner Notes
1. A catheter delivery system, comprising:
a sheath comprising a sheath body comprising:
a distal end;
a proximal end;
a bend portion disposed proximal to the distal end; and
a sheath lumen extending through the sheath body from the distal end to the proximal end of the sheath body; and
a dilator comprising a dilator body comprising:
a distal end:
a proximal end; and
a loop portion disposed proximal to the distal end of the dilator body,
wherein the dilator body is co-axially disposable within the sheath lumen, and
wherein the loop portion extends from the distal end of the sheath body when the dilator body is disposed within the sheath lumen;
wherein the sheath and the dilator are configured to be percutaneously inserted into a blood vessel together; and
wherein the sheath and dilator are configured to be passed into a cardiac left ventricle together.
1. A catheter delivery system, comprising:
a sheath comprising a sheath body comprising:
a distal end;
a proximal end;
a sheath lumen extending through the sheath body from the distal end to the proximal end of the sheath body; and
a dilator comprising a dilator body comprising:
a distal end:
a proximal end; and
a loop portion disposed proximal to the distal end of the dilator body,
wherein the dilator body is co-axially disposable within the sheath lumen, and
wherein the loop portion extends from the distal end of the sheath body when the dilator body is disposed within the sheath lumen;
and
wherein the dilator body comprises a reinforcement member.
Asleson, a reference in the vascular catheter delivery system field of endeavor, teaches configuring a sheath (102) to include a bend portion (206) disposed proximal to the distal end (Fig. 2A-2B) and configuring the sheath (102) and a dilator (106) to be percutaneously inserted into a blood vessel together and to be passed into a cardiac left ventricle together (Figs. 5A-5F; as the delivery catheter (102) and the dilator (106) are structured and dimensioned for transvascular advancement “through the mitral valve” into a patient’s left ventricle (para. [0035]), they are structured to be capable of being percutaneously inserted together and structured to be capable of being passed into a cardiac left ventricle together) to facilitate delivering a medical instrument to the left heart while minimizing patient trauma (para. [0035]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of claim 1 of Nelson such that the sheath comprises a bend portion disposed proximal to the distal end; wherein the sheath and the dilator are configured to be percutaneously inserted into a blood vessel together; and wherein the sheath and dilator are configured to be passed into a cardiac left ventricle together, in view of Asleson, in order to minimize trauma to a patient during a procedure to treat the patient’s heart.
Regarding claim 11, Asleson discloses wherein the bend portion of the sheath body comprises an angle ranging from 10 degrees to 90 degrees (Figs. 2A-2B; para. [0040]-[0043]).
Regarding claim 21, claim 2 of Nelson recites wherein the dilator comprises a reinforcement member disposed in a wall of the dilator body.
Claims 2-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Nelson in view of Asleson, as applied to claim 1 above, and further in view of Fuimaono et al. (U.S. Patent Application Publication No. 20040044277; hereinafter “Fuimaono”).
Regarding claim 2, the modified invention of claim 1 of Nelson recites the invention substantially as claimed except for the loop portion including an arc ranging from 180 degrees to 720 degrees.
Fuimaono, a reference in the vascular catheter delivery system field of endeavor, teaches providing a dilator (54) with a loop portion (58) including an arc ranging from 180 degrees to 720 degrees (Fig. 6; para. [0033]) to facilitate placement of a device within a left ventricle without puncturing flaps of a valve (para. [0033]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the loop portion to include an arc ranging from 180 degrees to 720 degrees (Fig. 6), in view of Fuimaono, in order to prevent puncturing a heart valve during advancement of the catheter delivery system.
Regarding claim 3, the modified invention of claim 1 of Nelson recites the invention substantially as claimed, except for the loop portion comprising a diameter ranging from 10 millimeters to 25 millimeters.
However, Asleson teaches that the dimensions and curvature of curved portion of a catheter may be selected to achieve a desired shape for positioning within a patient (paras. [0042]-[0044]). Thus, a person having ordinary skill in the art would understand that the dimension (e.g., diameter) of a loop portion would be a result-effective variable for providing a device with a desired shape for positioning within a patient.
Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter of the looped portion of the modified device to have a diameter within the claimed range, as it involves only adjusting the dimensions and/or curvature of the looped portion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a diameter of the looped portion to range 10 millimeters to 25 millimeters as a matter of routine optimization to facilitate positioning within a patient and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, the modified invention meets the recitation wherein the diameter of the loop portion is smaller than a diameter of an aortic valve (e.g., the diameter in the range of 10 millimeters to 25 millimeters is smaller than a diameter of an aortic valve sized greater than 25 millimeters).
Regarding claim 5, the modified invention meets the recitation wherein the diameter of the loop portion is larger than a cusp of an aortic valve (e.g., the diameter in the range of 10 millimeters to 25 millimeters is larger than a cusp of an aortic valve sized less than 10 millimeters).
Claims 6-10 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Nelson in view of Asleson, as applied to claim 1 above, and further in view of Thomspon Smith et al. (U.S. Patent Application Publication No. 20190015644; hereinafter “Thomspon”).
Regarding claim 6, the modified invention of claim 1 of Nelson recites the invention substantially as claimed, except for a diameter of the dilator body within the loop portion tapering distally from an 8 French diameter to a 6 French diameter.
Thomspon, a reference in the vascular catheter delivery system field of endeavor, teaches that the outer diameter of a dilator body may be selected to facilitate tissue penetration and dilation (paras. [0041]-[0043]). Thus, a person having ordinary skill in the art would understand that the outer diameter of the dilator body would be a result-effective variable for providing a device with a desired shape for penetration and dilation of tissue.
Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter of the dilator body within the loop portion to taper distally to have a diameter within the claimed range, as it involves only adjusting the dimensions of the dilator body.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameter of the dilator body within the loop portion to taper distally from an 8 French diameter to a 6 French diameter as a matter of routine optimization to facilitate tissue penetration and dilation and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 7, the modified invention of claim 1 of Nelson recites the invention substantially as claimed, except for the dilator body having a material having a durometer hardness ranging from 40 Shore D to 74 Shore D.
Thomspon teaches constructing a dilator body with a material (high density polyethylene) having a durometer hardness from about 55 Shore D to 70 Shore D (para. [0039]) to provide the dilator body with appropriate functional characteristics, such as flexibility, pushability, and torqueability (para. [0084]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to form the dilator body to include a material having a durometer hardness ranging from 40 Shore D to 74 Shore D, in view of Thomspon, in order to provide the dilator body with sufficient flexibility, pushability, and/or torqueability for advancement within a patient to treat the patient’s heart.
Regarding claim 8, the modified invention of claim 1 of Nelson recites the invention substantially as claimed, except for the dilator including a dilator connector body, a dilator hemostasis valve, and a dilator connector port.
The modified device discloses the invention substantially as claimed, except for the dilator connector including a dilator hemostasis valve and a dilator connector port.
Thomspon teaches providing a dilator with a dilator connector body (210) coupled to the proximal end of a dilator body comprising a dilator connector lumen in communication with a dilator body lumen (Figs. 5A-5D); a dilator hemostasis valve (213) disposed at a proximal end of a dilator connector body configured to selectively close a dilator connector lumen (Figs. 5A-5D; paras. [0068]-[0070]); and a dilator connector port (217) in communication with the dilator connector lumen (Fig. 5D) allowing for flushing and aspiration of fluid in the dilator (para. [0070]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the dilator with a dilator connector body coupled to the proximal end of the dilator body comprising a dilator connector lumen in communication with a dilator body lumen; a dilator hemostasis valve disposed at a proximal end of the dilator connector body configured to selectively close the dilator connector lumen; and a dilator connector port in communication with the dilator connector lumen, in view of Thomspon, in order to prevent blood from leaking from the dilator during a procedure while also allowing for blood or other fluid to be removed from the dilator.
Regarding claim 9, Thomspon teaches wherein the dilator connector further comprises:
a dilator connector tube (219; Fig. 5D) coupled to the dilator connector port at a distal end; and
a dilator connector adaptor (228) coupled to a proximal end of the dilator connector tube,
wherein the dilator connector adaptor is in communication with the dilator connector lumen (para. [0070]).
Regarding claim 10, the modified invention of claim 1 of Nelson recites the invention substantially as claimed except for including a guidewire.
Thomspon teaches providing a system with a guidewire co-axially disposable within a dilator body lumen and wherein the distal end of the dilator body is configured to fit tightly, without a gap, around the guidewire, wherein the distal end is configured to pass through tissue without catching on the tissue (paras. [0037]-[0038]) to limit extension of the guidewire from the dilator body (para. [0038]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the system with a guidewire co-axially disposable within a dilator body lumen and configure the inner diameter of the dilator body such that the distal end of the dilator body is configured to fit tightly, without a gap, around the guidewire, wherein the distal end of the dilator is configured to pass through tissue without catching on the tissue, in view of Thomspon, in order to prevent mispositioning the guidewire or harming a patient by overextending the guidewire during a procedure.
Regarding claim 22, the modified invention of claim 1 of Nelson recites the invention substantially as claimed, except for the reinforcement member being a braid.
Thomspon teaches configuring a reinforcement member as a braid (paras. [0059]-[0060]) to improve torqueability of a device (para. [0059]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the reinforcement member as a braid, in view of Thomspon, in order to facilitate steering the system within a patient’s vasculature.
Claims 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Nelson in view of Asleson, as applied to claim 1 above, and further in view of Vidovich (U.S. Patent Application Publication No. 20130158396).
Regarding claim 25, the modified invention of claim 1 of Nelson recites the invention substantially as claimed, except for the loop portion of the dilator including a material configured to return to a pre-formed shape upon deployment from the sheath.
Vidovich, a reference in the vascular catheter field of endeavor, teaches forming a catheter from a material configured to return to a pre-formed shape during use (col. 6, ll. 40-43) to allow the catheter to change shape to facilitate advancement within a patient (col. 6, ll. 32-39).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to form the dilator such that the loop portion comprises a material configured to return to a pre-formed shape upon deployment from the sheath, in view of Vidovich, in order to allow the loop portion to change shapes during use to facilitate advancement through a patient’s vasculature.
Regarding claim 26, the modified invention of claim 1 of Nelson recites the invention substantially as claimed, except for the loop portion being configured to assume the looped shape upon removal of a guidewire from the dilator lumen.
Vidovich, a reference in the vascular catheter field of endeavor, teaches configuring a catheter to assume a bend shape upon removal of a guidewire to allow the catheter to change shape to facilitate advancement within a patient (col. 6, ll. 32-39).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the dilator such that the loop portion is configured to assume the looped shape upon removal of a guidewire from the dilator lumen, in view of Vidovich, in order to allow the loop portion to change shapes during use to facilitate advancement through a patient’s vasculature.
Claims 17-19, 23, and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15 and 18 of Nelson in view of Asleson.
This is a provisional nonstatutory double patenting rejection.
Regarding application claim 17, claim 13 of Nelson recites the invention substantially as claimed except for the sheath including a bend portion, the sheath and dilator being configured to be percutaneously inserted into a blood vessel and passed into a cardiac left ventricle together.
Application claim 17
Nelson claim 13
Examiner Notes
17. A catheter delivery system kit, comprising:
a sheath comprising a sheath body comprising:
a bend portion disposed proximal to a distal end; and
a sheath lumen extending through the sheath body from the distal end to a proximal end of the sheath body;
a first dilator comprising a first dilator body comprising:
a loop portion disposed proximal to a distal end,
wherein the dilator body is co-axially disposable within the sheath lumen, and
wherein the loop portion extends from the distal end of the sheath body when the dilator body is disposed within the sheath lumen;
wherein the bend portion of the sheath body is straightened by the dilator body;
wherein the sheath and the first dilator are configured to be percutaneously inserted into a blood vessel together; and
wherein the sheath and the first dilator are configured to be passed into a cardiac left ventricle together.
13. A catheter delivery system kit, comprising:
a sheath comprising a sheath body comprising:
a sheath lumen extending through the sheath body from a distal end to a proximal end of the sheath body;
a first, proximal section comprising a first stiffness;
a second section, distal to the first, proximal section comprising a second stiffness; and
a third section, distal to the second section comprising a third stiffness,
wherein the first stiffness is greater than the second stiffness and the third stiffness,
wherein the second stiffness is greater than the third stiffness but less than the first stiffness, and
wherein the third stiffness is less than the stiffness of the first stiffness and the second stiffness; and
a first dilator comprising a first dilator body comprising:
a loop portion disposed proximal to a distal end of the first dilator body,
wherein the dilator body is co-axially disposable within the sheath lumen, and
wherein the loop portion extends from the distal end of the sheath body when the dilator body is disposed within the sheath lumen.
Asleson, a reference in the vascular catheter delivery system field of endeavor, teaches configuring a sheath (301) to include a bend portion (306) disposed proximal to the distal end (Fig. 3A-3B) wherein the bend portion of the sheath body is straightened by a dilator body (106; para. [0037]) and configuring the sheath (301) and a dilator (106) to be percutaneously inserted into a blood vessel together and to be passed into a cardiac left ventricle together (Figs. 5A-5F; as the delivery catheter (301) and the dilator (106) are structured and dimensioned for transvascular advancement “through the mitral valve” into a patient’s left ventricle (para. [0035]), they are structured to be capable of being percutaneously inserted together and structured to be capable of being passed into a cardiac left ventricle together) to facilitate delivering a medical instrument to the left heart while minimizing patient trauma (para. [0035]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of claim 1 of Nelson such that the sheath comprises a bend portion disposed proximal to the distal end; wherein the bend portion of the sheath body is straightened by the dilator body; and wherein the sheath and the dilator are configured to be percutaneously inserted into a blood vessel together; and wherein the sheath and dilator are configured to be passed into a cardiac left ventricle together, in view of Asleson, in order to minimize trauma to a patient during a procedure to treat the patient’s heart.
Regarding application claim 18, claim 18 of Nelson recites the same limitations as application claim 18.
Regarding application claim 19, the modified invention of claim 18 of Nelson recites the invention substantially as claimed except for including a guidewire.
Asleson teaches providing a kit with a guidewire (508) disposable within a lumen of the fist dilator and a lumen of the second dilator (Figs. 5A-5F) to facilitate penetration of tissue to treat a patient (paras. [0052]-[0056]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the kit with a guidewire disposable within a lumen of the first dilator and a lumen of the second dilator, in view of Asleson, in order to facilitate guiding the dilator within a patient during a procedure.
Regarding application claims 23 and 24, claims 14 and 15 of Nelson respectively recite the same limitations as application claims 23 and 24.
Claim 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of Nelson in view of Asleson, as applied to claim 17 above, and further in view of Thomspon.
Regarding claim 20, the modified invention of claim 13 of Nelson recites the invention substantially as claimed, except for the kit including a hemostasis valve.
Thomspon, a reference in the vascular catheter delivery system field of endeavor, teaches providing a dilator with a dilator hemostasis valve (213) disposed at a proximal end of a dilator (Figs. 5A-5D; paras. [0068]-[0070]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the catheter delivery system kit with a hemostasis valve disposed at a proximal end of the first dilator, in view of Thomspon, in order to prevent blood from leaking from the dilator during a procedure.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Asleson in view of Fuimaono.
Regarding claim 1, Asleson discloses a catheter delivery system (100; Fig. 1), comprising:
a sheath (102; annotated Fig. 2A below) comprising a sheath body comprising:
a distal end; (204)
a proximal end (202);
a bend portion disposed proximal to the distal end; and
a sheath lumen extending through the sheath body from the distal end to the proximal end of the sheath body (para. [0036]); and
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a dilator (106; Fig. 1) comprising a dilator body comprising:
a distal end (e.g., received in telescoping fashion through catheter (102); para. [0032]);
a proximal end (Fig. 1); and
wherein the dilator body is co-axially disposable within the sheath lumen (Fig. 1; para. [0032]), and
wherein the sheath and the dilator are configured to be percutaneously inserted into a blood vessel together (para. [0035]); and
wherein the sheath and dilator are configured to be passed into a cardiac left ventricle together (para. [0035]; as the delivery catheter (102) and the dilator (106) are structured and dimensioned for transvascular advancement “through the mitral valve” into a patient’s left ventricle (para. [0035]), they are structured to be capable of being passed into a cardiac left ventricle together)).
Asleson discloses the invention substantially as claimed, except for the dilator including a loop portion.
Fuimaono, a reference in the vascular catheter delivery system field of endeavor, teaches providing a dilator (54) with a loop portion (58) disposed proximal to the distal end of the dilator body (Fig. 6), wherein the loop portion extends from the distal end of a sheath body when the dilator body is disposed within a sheath lumen (Fig. 6; para. [0033]) to facilitate placement of a device within a left ventricle without puncturing flaps of a valve (para. [0033]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the dilator to include a loop portion disposed proximal to the distal end of the dilator body, wherein the loop portion extends from the distal end of the sheath body when the dilator body is disposed within the sheath lumen, in view of Fuimaono, in order to prevent puncturing a heart valve during advancement of the catheter delivery system.
Regarding claim 2, Fuimaono teaches wherein the loop portion comprises an arc ranging from 180 degrees to 720 degrees (Fig. 6).
Regarding claim 3, the modified device discloses the invention substantially as claimed, except for the loop portion comprising a diameter ranging from 10 millimeters to 25 millimeters.
However, Asleson teaches that the dimensions and curvature of curved portion of a catheter may be selected to achieve a desired shape for positioning within a patient (paras. [0042]-[0044]). Thus, a person having ordinary skill in the art would understand that the dimension (e.g., diameter) of a loop portion would be a result-effective variable for providing a device with a desired shape for positioning within a patient.
Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter of the looped portion of the modified device to have a diameter within the claimed range, as it involves only adjusting the dimensions and/or curvature of the looped portion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify a diameter of the looped portion range 10 millimeters to 25 millimeters as a matter of routine optimization to facilitate positioning within a patient and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, the modified device discloses the invention substantially as claimed, except for the diameter of the loop portion being smaller than a diameter of an aortic valve. However, Fuimaono teaches wherein the diameter of the loop portion is smaller than a diameter of an aortic valve in order to allow passage through the aortic valve (para. [0033]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the diameter of the loop portion to be smaller than a diameter of an aortic valve, in view of Fuimaono, to facilitate passage of the loop portion through the aortic valve for desired atraumatic placement during a procedure.
Regarding claim 5, the modified device discloses wherein the diameter of the loop portion is larger than a cusp of an aortic valve (e.g., the diameter in the range of 10 millimeters to 25 millimeters is larger than a cusp of an aortic valve sized less than 10 millimeters).
Regarding claim 11, Asleson discloses wherein the bend portion of the sheath body comprises an angle ranging from 10 degrees to 90 degrees (Figs. 2A-2B; para. [0040]-[0043]).
Claims 6-10, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Asleson in view of Fuimaono, as applied to claim 1 above, and further in view of Thomspon.
Regarding claim 6, the modified device discloses the invention substantially as claimed, except for a diameter of the dilator body within the loop portion tapering distally from an 8 French diameter to a 6 French diameter.
Thomspon, a reference in the vascular catheter delivery system field of endeavor, teaches that the outer diameter of a dilator body may be selected to facilitate tissue penetration and dilation (paras. [0041]-[0043]). Thus, a person having ordinary skill in the art would understand that the outer diameter of the dilator body would be a result-effective variable for providing a device with a desired shape for penetration and dilation of tissue.
Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter of the dilator body within the loop portion to taper distally to have a diameter within the claimed range, as it involves only adjusting the dimensions of the dilator body.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameter of the dilator body within the loop portion to taper distally from an 8 French diameter to a 6 French diameter as a matter of routine optimization to facilitate tissue penetration and dilation and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 7, the modified device discloses the invention substantially as claimed, except for the dilator body having a material having a durometer hardness ranging from 40 Shore D to 74 Shore D.
Thomspon teaches constructing a dilator body with a material (high density polyethylene) having a durometer hardness from about 55 Shore D to 70 Shore D (para. [0039]) to provide the dilator body with appropriate functional characteristics, such as flexibility, pushability, and torqueability (para. [0084]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to form the dilator body to include a material having a durometer hardness ranging from 40 Shore D to 74 Shore D, in view of Thomspon, in order to provide the dilator body with sufficient flexibility, pushability, and/or torqueability for advancement within a patient to treat the patient’s heart.
Regarding claim 8, Asleson discloses wherein the dilator further comprises a dilator connector (annotated Fig. 1 below) coupled to the proximal end of the dilator body, comprising:
a dilator connector body coupled to the proximal end of the dilator body comprising a dilator connector lumen (e.g., lumen passing puncturing tool (108)) in communication with a dilator body lumen.
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The modified device discloses the invention substantially as claimed, except for the dilator connector including a dilator hemostasis valve and a dilator connector port.
Thomspon teaches providing a dilator connector with a dilator hemostasis valve (213) disposed at a proximal end of a dilator connector body configured to selectively close a dilator connector lumen (Figs. 5A-5D; paras. [0068]-[0070]) and with a dilator connector port (217) in communication with the dilator connector lumen (Fig. 5D) allowing for flushing and aspiration of fluid in the dilator (para. [0070]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the dilator connector with a dilator hemostasis valve disposed at a proximal end of the dilator connector body configured to selectively close the dilator connector lumen and a dilator connector port in communication with the dilator connector lumen, in view of Thomspon, in order to prevent blood from leaking from the dilator during a procedure while also allowing for blood or other fluid to be removed from the dilator.
Regarding claim 9, Thomspon teaches wherein the dilator connector further comprises:
a dilator connector tube (219; Fig. 5D) coupled to the dilator connector port at a distal end; and
a dilator connector adaptor (228) coupled to a proximal end of the dilator connector tube,
wherein the dilator connector adaptor is in communication with the dilator connector lumen (para. [0070]).
Regarding claim 10, Asleson discloses the system further comprising a guidewire (108; Fig. 1; para. [0034]) co-axially disposable within a dilator body lumen and wherein the distal end of the dilator body is configured to fit around the guidewire, wherein the distal end is configured to pass through tissue without catching on the tissue (para. [0035]). The modified device discloses the invention substantially as claimed, except for the distal end of the dilator body being configured to fit tightly, without a gap, around the guidewire.
Thomspon teaches configuring the inner diameter of a dilator body to fit tightly, without a gap, around a guidewire to limit extension of the guidewire from the dilator body (para. [0038]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the inner diameter of the dilator body such that the distal end of the dilator body is configured to fit tightly, without a gap, around the guidewire, in view of Thomspon, in order to prevent mispositioning the guidewire or harming a patient by overextending the guidewire during a procedure.
Regarding claim 21, the modified device discloses the invention substantially as claimed, except for the dilator including a reinforcement member.
Thomspon teaches providing a dilator with a reinforcement member (704) disposed in a wall of a dilator body (Fig. 8) to improve torqueability of a device (para. [0059]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the dilator body with a reinforcement member disposed in a wall of the dilator body, in view of Thomspon, in order to facilitate steering the system within a patient’s vasculature.
Regarding claim 22, Thomspon teaches wherein the reinforcement member is a braid (paras. [0059]-[0060]).
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Asleson in view of Fuimaono.
Regarding claim 17, Asleson discloses a catheter delivery system kit (100; Fig. 1; para. [0035]), comprising:
a sheath (301; Fig. 3A) comprising a sheath body (301) comprising:
a bend portion (306) disposed proximal to a distal end (304); and
a sheath lumen extending through the sheath body from the distal end to a proximal end (308) of the sheath body;
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a first dilator (106; Fig. 1) comprising a first dilator body comprising:
wherein the dilator body is co-axially disposable within the sheath lumen (Fig. 1; para. [0032]),
wherein the bend portion of the sheath body is straightened by a dilator body (106; para. [0037])
wherein the sheath and the first dilator are configured to be percutaneously inserted into a blood vessel together (para. [0035]); and
wherein the sheath and the first dilator are configured to be passed into a cardiac left ventricle together (para. [0035]).
Asleson discloses the invention substantially as claimed, except for the dilator including a loop portion.
Fuimaono, a reference in the vascular catheter delivery system field of endeavor, teaches providing a dilator (54) with a loop portion (58) disposed proximal to the distal end of the dilator body (Fig. 6), wherein the loop portion extends from the distal end of a sheath body when the dilator body is disposed within a sheath lumen (Fig. 6; para. [0033]) to facilitate placement of a device within a left ventricle without puncturing flaps of a valve (para. [0033]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the dilator to include a loop portion disposed proximal to the distal end of the dilator body, wherein the loop portion extends from the distal end of the sheath body when the dilator body is disposed within the sheath lumen, in view of Fuimaono, in order to prevent puncturing a heart valve during advancement of the catheter delivery system.
Regarding claim 18, Asleson discloses the kit further comprising a second dilator comprising:
a second dilator body (504; Fig. 5F; para. [0052]) comprising a straight portion (505; Fig. 5F) disposed proximal to a distal end (delivery catheter (104) is capable of functioning as a dilator such as by passing through tissue),
wherein the second dilator body is co-axially disposable within the sheath lumen (Figs. 5A-5F; paras. [0052]-[0054]), and
wherein the straight portion extends from the distal end of the sheath body when the second dilator body is disposed within the sheath lumen (Fig. 5F).
Regarding claim 19, Asleson discloses the kit further comprising a guidewire (508) disposable within a lumen of the fist dilator and a lumen of the second dilator (Figs. 5A-5F).
Claims 20, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Asleson in view of Fuimaono, as applied to claim 17 above, and further in view of Thomspon.
Regarding claim 20, the modified device discloses the invention substantially as claimed, except for the kit including a hemostasis valve.
Thomspon, a reference in the vascular catheter delivery system field of endeavor, teaches providing a dilator with a dilator hemostasis valve (213) disposed at a proximal end of a dilator (Figs. 5A-5D; paras. [0068]-[0070]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the catheter delivery system kit with a hemostasis valve disposed at a proximal end of the first dilator, in view of Thomspon, in order to prevent blood from leaking from the dilator during a procedure.
Regarding claim 23, the modified device discloses the invention substantially as claimed, except for the dilator including a reinforcement member.
Thomspon teaches providing a dilator with a reinforcement member (704) disposed in a wall of a dilator body (Fig. 8) to improve torqueability of a device (para. [0059]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the dilator body with a reinforcement member disposed in a wall of the first dilator body, in view of Thomspon, in order to facilitate steering the system within a patient’s vasculature.
Regarding claim 24, Thomspon teaches wherein the reinforcement member is a braid (paras. [0059]-[0060]).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Asleson in view of Fuimaono, as applied to claim 1 above, and further in view of Vidovich.
Regarding claim 25, the modified device discloses the invention substantially as claimed, except for the loop portion of the dilator including a material configured to return to a pre-formed shape upon deployment from the sheath.
Vidovich, a reference in the vascular catheter field of endeavor, teaches forming a catheter from a material configured to return to a pre-formed shape during use (col. 6, ll. 40-43) to allow the catheter to change shape to facilitate advancement within a patient (col. 6, ll. 32-39).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to form the dilator of the modified device such that the loop portion comprises a material configured to return to a pre-formed shape upon deployment from the sheath, in view of Vidovich, in order to allow the loop portion to change shapes during use to facilitate advancement through a patient’s vasculature.
Regarding claim 26, the modified device discloses the invention substantially as claimed, except for the loop portion being configured to assume the looped shape upon removal of a guidewire from the dilator lumen.
Vidovich, a reference in the vascular catheter field of endeavor, teaches configuring a catheter to assume a bend shape upon removal of a guidewire to allow the catheter to change shape to facilitate advancement within a patient (col. 6, ll. 32-39).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the dilator such that the loop portion is configured to assume the looped shape upon removal of a guidewire from the dilator lumen, in view of Vidovich, in order to allow the loop portion to change shapes during use to facilitate advancement through a patient’s vasculature.
Response to Arguments
Applicant's arguments filed June 26, 2025 have been fully considered but they are not persuasive.
On pages 9-11 of the Response, Applicant argues that Asleson does not disclose “the sheath and dilator are configured to be passed into a cardiac left ventricle together,” as recited in claim 1. This argument is not persuasive.
As explained above in this Office Action, Asleson discloses a sheath (102) including a bend portion (annotated Fig. 2A below) and a dilator (106) including a dilator body (Fig. 1).
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Furthermore, as the delivery catheter (102) and the dilator (106) are structured and dimensioned for transvascular advancement “through the mitral valve” into a patient’s left ventricle (para. [0035]), they are structured to be capable of being passed into a cardiac left ventricle together)).
Although Asleson describes an exemplary sequence of steps to use the system in the right atrium (paras. [0052]-[0056]), such exemplary steps do not render the structure of the sheath and dilator from being capable of passage into a cardiac left ventricle together. Indeed, Asleson does disclose any structure of the sheath and dilator that would prevent the sheath and dilator from being passed into a cardiac left ventricle together.
On pages 9-10 of the Response, Applicant argues that Asleson does not disclose the sheath including “a bend portion disposed proximal to the distal end,” as recited in claim 1. This argument is not persuasive.
As explained above in this Office Action, Asleson discloses delivery catheter (102) including an adjustable portion (206) that achieving bent or deflected states (annotated Fig. 2A above). Asleson further discloses that adjustable portion (206) may include “a resilient, flexible curve in its initial relaxed state that can also be deflected.” (para. [0037]).
Thus, adjustable portion (206) bends during use and may include a pre-formed bend. Therefore, the delivery catheter of Asleson includes a “bend portion,” as claimed.
Furthermore, Applicant attempts to distinguish the claimed “bend portion” from that disclosed by Asleson catheter (102) of Asleson by pointing out that catheter (102) bends or deflects in response to manipulation of a handle (Response pg. 9). This argument is not persuasive because the claims do not recite any particular structure for the “bend portion” that distinguishes it from the portion of catheter (102) that bends during use. In other words, the scope of the claimed “bend portion” encompasses the bend portion disclosed by Asleson.
On page 10 of the Response, Applicant argues that Asleson does not disclose a dilator with a “loop portion disposed proximal to the distal end of the dilator body,” as recited in claim 1. This argument is not persuasive.
In response to applicant's arguments against Asleson individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As explained above in this Office Action, Fuimaono discloses a dilator (54) with a loop portion (58) disposed proximal to the distal end of the dilator body (Fig. 6) to facilitate placement of a device within a left ventricle without puncturing flaps of a valve (para. [0033]).
Thus, the combination of Asleson and Fuimaono meets the limitation of a dilator including “a loop portion disposed proximal to the distal end of the dilator body,” as claimed.
On page 10 of the Response, Applicant argues that substitution of the dilator of Fuimaono for the dilator of Asleson would not be feasible because the dilator of Asleson allegedly functions exclusively as a stiffening member. This argument is not persuasive.
The proposed combination of Asleson and Fu