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 .
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 2/27/26. The claims 1-19 are pending. The claims 1 and 2 are amended. Claims 4-19 are new.
Response to Arguments
Applicant’s arguments, filed 2/27/26 with respect to the rejections of claims 1-2 under 35 U.S.C. 103 as being unpatentable over Ramee (US10321933) in view of Salahieh (US2005/0137690) have been fully considered but they are not persuasive. Applicant argues Ramee does not teach a replaceable seal insert. Examiner disagrees, since Ramee teaches valve hubs that can be selected and connected to the system and is described as modular (C3:L5-9; C4:L18-20). Applicant further argues, Salahieh is designed for catheters with large diameters and comprises a large bore valve delivery system to support 17-23 Fr sized catheters. Examiner makes notice, Salahieh is relied upon for a delivery catheter to hold the prosthetic heart valve within the catheter for delivery to the delivery site. One having ordinary skill in the art would understand the sizing requirements when using a catheter holding a prosthetic heart valve into the system of Ramee.
Applicant’s arguments, filed 2/27/26 with respect to the rejections of claims 3-4 under 35 U.S.C. 103 as being unpatentable over Ramee (US10321933) in view of Salahieh (US2005/0137690) and Roach (US2022/0134056) have been fully considered but are not persuasive. Applicant argues, Roach does not disclose a sheath bending component positioned around a circumference of the access sheath. Applicant further argues, the bending component is a distinct feature that surrounds the access sheath whereas the tubular device of Roach is not comparable. Examiner disagrees, the device of Roach can be a passage for a surgical accessory implement into the surgical device (such as an access sheath through the device) as stated in paragraph [0043]. Therefore, the device of Roach is a distinct feature from a possible access sheath that would be inserted through the device of Roach.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: bending component…configured to controllably bend the access sheath in claim 3.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Where the limitation is interpreted as “a proximal component 960 and a distal component 962 connected at a hinge 964” from the specification paragraph [0039] and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-2, 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ramee (US10321933) in view of Salahieh (US2005/0137690).
Regarding claim 1, Ramee discloses a delivery system for delivering a valve prosthesis, the delivery system comprising:
one or more catheters (catheters, C9:L2-3),
an access sheath (10) having an inner lumen for accommodating the one or more catheters (C9:L66-C10:L14); and
a handle (20, where the sheath hub 20 is interpreted as a handle by having a series of ports and connectors that are manipulated by a surgeon, C10:L1-5) coupled to a proximal end of the access sheath (see Fig. 1), the handle comprising a seal assembly (30) configured to accommodate the one or more catheters therethrough; wherein the seal assembly comprises a replaceable seal insert (hub 30 is replaceable, C10:L15-20) configured to provide a hemostatic seal between an outer environment and the inner lumen of the access sheath (access ports 36 receive different size catheters, C6:L46-50; the access ports 36 includes a valve component to provide a fluid tight seal, C6:L64-66).
Ramee discloses the access sheath can be used for introducing a plurality of medical devices or instruments within a patient’s body, such as, during aortic valve replacement (C9:L12). However, Ramee does not explicitly disclose the one or more catheters holding at least a portion of the valve prosthesis therein. Salahieh teaches a delivery system for delivering a prosthetic heart valve by using a delivery catheter to hold the prosthetic heart valve within the catheter for delivery to the delivery site ([0016], [0149]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the one or more catheters of Ramee for the catheter holding at least a portion of valve prosthesis therein as taught by Salahieh, since the substitution would have the same predictable result of delivering a valve prosthesis to a desired site.
Regarding claim 2, Ramee/Salahieh makes obvious the delivery system of claim 1, Ramee further discloses wherein the replaceable seal insert is a disk-shaped (31) having a first opening (36, see Figs. 1, 4A) and a second opening (36, see Figs. 1, 4A), wherein the first opening has a first diameter that is configured to accept and seal with a first catheter (C6:L56-61), wherein the second opening has a second diameter that is configured to accept and seal with a second catheter (C6:L56-61).
Regarding claim 5, Ramee/Salahieh makes obvious the delivery system of claim 1, Ramee discloses wherein the delivery system further comprises a shut-off valve (valve 26 that is distal to valve hub 20, see Fig. 1) distal to the seal insert and configured to allow the seal insert to be removed and replaced while maintaining hemostasis (the valve 26 maintains hemostasis by providing a fluid tight seal during exchange of hub 30, C5:L32-40).
Regarding claim 6, Ramee/Salahieh makes obvious the delivery system of claim 5, Ramee discloses wherein the shut-off valve can be configured as a stopcock or a pinch-clamp mechanism (side port 23 of the sheath hub 20 includes a stopcock, C5:L46-50).
Regarding claim 7, Ramee/Salahieh makes obvious the delivery system of claim 1, Ramee discloses wherein the seal assembly comprises a valve body (proximal opening of the sheath hub 20) and the seal insert is configured to fit within a proximal opening of the valve body (hub 30 includes external threads that thread into the sheath hub 20, C7:L11-14).
Regarding claim 8, Ramee/Salahieh makes obvious the delivery system of claim 7, Ramee discloses wherein the seal assembly comprises a proximal nut (proximal nut is interpreted as the part of the sheath hub 20 that includes the threads), wherein a distal end of the proximal nut is configured to fit within the proximal opening of the valve body to capture the seal insert within the valve body (hub 30 includes external threads that thread into the sheath hub 20, C7:L11-14).
Regarding claim 9, Ramee/Salahieh makes obvious the delivery system of claim 1, Ramee discloses wherein the seal insert comprises a compliant material (seal would comprise a compliant material by providing a fluid tight seal and allowing passage of instruments, C6:L63-67).
Regarding claim 10, Ramee/Salahieh makes obvious the delivery system of claim 2, Ramee discloses wherein the first and second openings can be spaced a distance apart to prevent the first and second catheters from contacting each other within the seal assembly (see Fig. 4A, C6:L56-61)
Regarding claim 11, Ramee/Salahieh makes obvious the delivery system of claim 7, Ramee discloses wherein the seal insert comprises an alignment tab (tab is formed by external threads of the hub 30) and the valve body comprises a groove (groove is formed by the internal threads of the sheath hub 20, C7:L11-14), and wherein the alignment tab is configured to mate with the groove within the valve body (hub 30 includes external threads that thread into the sheath hub 20, C7:L11-14), locking a rotational orientation of the seal insert with respect to the valve body (locking is interpreted as when the components are fully threaded to a stop and can longer rotate, C7:L11-14).
Claims 3-4, 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ramee (US10321933) in view of Salahieh (US2005/0137690) and Roach (US2022/0134056).
Regarding claims 3 and 4, Ramee discloses a delivery system for delivering a valve prosthesis, the delivery system comprising:
one or more catheters (catheters, C9:L2-3);
an access sheath (11) having an inner lumen for accommodating the one or more catheters (C5:L8-14, introducer sheath 10 is advanced through tubular member 11 for guiding the medical devices into the body);
a handle (20, where the sheath hub 20 is interpreted as a handle by having a series of ports and connectors that are manipulated by a surgeon, C10:L1-5) coupled to a proximal end of the access sheath (see Fig. 1), the handle configured to provide access for the one or more catheters distally through the access sheath (access ports 36 within hub 20 receive different size catheters, C6:L46-50).
Ramee does not explicitly disclose the one or more catheters holding at least a portion of the valve prosthesis therein. Ramee discloses the catheter can be used for aortic valve replacement (C9:L12). Salahieh teaches a delivery system for delivering a prosthetic heart valve by using a delivery catheter to hold the prosthetic heart valve within the catheter for delivery to the delivery site ([0016], [0149]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the one or more catheters of Ramee for the catheter holding at least a portion of valve prosthesis therein as taught by Salahieh, since the substitution would have the same predictable result of delivering a valve prosthesis to a desired site.
Ramee is silent regarding a sheath bending component positioned around a circumference of the access sheath, the sheath bending component configured to controllably bend the access sheath, wherein the sheath bending component includes a hinge and a cable, wherein tensioning of the cable causes the hinge to bend, thereby causing the access sheath to bend accordingly. Ramee teaches a desire for bending the sheath for navigating the tortuous anatomy of the body (C5:L16-17). Roach teaches a steerable device that delivers a device through it to a target site ([0024]), where the device is adapted for use in access into the body ([0043]). Where the lumens of the first tube portion 1023 (interpreted as the proximal component under 112(f) interpretation) and the second tube portion 1026 (interpreted as the distal component under 112(f) interpretation) may be used to guide a device through the lumen ([0024]) and would therefore be capable of guiding an access sheath of an appropriate size. Where the device can include a control wire (cable) to steer the device by pulling on a portion of the device to effect bending (where the hinge is interpreted as the section 1024) (see Fig. 1, [0026]). It would have been obvious to one having ordinary skill in the art to have modified the system of Ramee to include the bending component as taught by Roach in order to provide an adjustable guide for access into the body which would be desirable for navigating the tortuous anatomy of the body ([0026], [0043]). Where the modified invention of Ramee with Roach teaches a sheath bending component as interpreted under 112(f) by having a distal component 1026 and proximal component 1023 that are joined at a hinge 1024 that is adjusted by a control wire (cable) ([0024]-[0026]).
Regarding claim 12, Ramee/Salahieh/Roach makes obvious the delivery system of claim 3, Roach further teaches wherein the sheath bending component is configured to transition between a first configuration and a second configuration ([0026]).
Regarding claim 13, Ramee/Salahieh/Roach makes obvious the delivery system of claim 12, Roach further teaches wherein the first configuration is a straight configuration, and the second configuration is a bent configuration ([0026]).
Regarding claim 14, Ramee/Salahieh/Roach makes obvious the delivery system of claim 3, Roach further teaches wherein the sheath bending component is configured to bend the access sheath the access sheath to an extent to improve entry and maneuvering of the access sheath ([0043]).
Regarding claim 15, Ramee/Salahieh/Roach makes obvious the delivery system of claim 3, wherein the sheath bending component comprises a central lumen for accepting the access sheath (lumen of the first 1046 and second tube 1048, [0024]).
Regarding claim 16, Ramee/Salahieh/Roach makes obvious the delivery system of claim 3, Roach further teaches wherein the sheath bending component comprises a proximal component (first tube portion 1023) and a distal component (second tube portion 1026), and the proximal and distal components are connected at the hinge (1024).
Regarding claim 17, Ramee/Salahieh/Roach makes obvious the delivery system of claim 16, Roach further teaches wherein each of the proximal and the distal components of the sheath bending component comprises two openings on opposing sides of the central lumen (openings at the ends of the first tube portion 1023 and the second tube portion 1026, see Fig. 1).
Regarding claim 18, Ramee/Salahieh/Roach makes obvious the delivery system of claim 17, Roach further teaches wherein when the openings of proximal component align with openings of distal component (in a straightened state the openings would be aligned, [0025]), a bolt may be positioned within the sheath bending component to hingeably couple the proximal and distal components (since the bolt may be positioned, the bolt is not required by the claim).
Regarding claim 19, Ramee/Salahieh/Roach makes obvious the delivery system of claim 16, Roach further teaches wherein each of the proximal and distal components comprises a cable-holding portion (conduit 1031), wherein the cable-holding portion comprises a hole for accepting a cable (control wire can be used with conduit 1031, [0025]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached on (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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