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 7/23/25. The claims 1-6, 8, 9, 13-20 are pending. The claims 1 and 14 are amended. The claims 7, 10-12 are canceled.
Response to Arguments
Applicant’s arguments, filed 7/23/25 with respect to the rejections of claims 1-3, 6, 8, 9, and 13 under 35 U.S.C. 103 as being unpatentable over Oepen (US2018/0055637) in view of Burriesci (US2013/0296999) have been fully considered but they are not persuasive. Applicant argues, there is no teaching, suggestion, or reasonable disclosure for “a plurality of loops attached to pairs of crests of the interventional device". Examiner respectfully disagrees, where the specification does not provide a special definition for the term “crests”. Therefore, Examiner interprets the term “crest” as “something suggesting a crest especially in being an upper prominence, edge, or limit: such as a peak” as provided by merriam-webster dictionary cited reference U in the PTO-892. Therefore, the “pair of crests” are interpreted as a pair of peaks or apexes 11 of the loops of the support structure of the prosthesis as shown in Fig. 2 and discussed in paragraph [0044].
Applicant’s arguments, filed 7/23/25 with respect to the rejections of Claims 14-16 under 35 U.S.C. 102(a)(1) as being anticipated by Oepen (US2018/0028305) have been fully considered and the amendment overcomes the previous rejection. Applicant argues, Oepen fails to disclose “the inner catheter comprising a threaded portion that has a terminal distal end at a location proximal a distal end of the inner catheter and proximal a connecting ring of the inner catheter operatively connected to a proximal end of the interventional device”. However, Oepen under a new interpretation discloses the claimed limitation as set forth in the rejection below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the claimed “pairs of crests” in claim 1 and “a threaded portion that has a terminal distal end at a location proximal a distal end of the inner catheter” in claim 14 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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: “guiding feature” in claim 20. The guiding feature has been interpreted as a “tapered portion of the cover, rounded edges, or other structures to aid with retrieval of the valve 10” as described in paragraph [0101] and equivalents thereof.
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.
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 § 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.
Claims 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oepen (US2018/0028305) (“Oepen-2”).
Regarding claim 14, Oepen-2 discloses a system for delivering an interventional device to a targeted anatomical site (see Abstract), the system comprising:
an elongated delivery member (102) having a proximal end and a distal end configured for housing the interventional device (110), and including a plurality of coaxially positioned delivery member components ([0037]), the plurality of delivery member components including:
a delivery catheter (outer sheath 112) having a bending portion (see Fig. 1, any portion where the sheath 112 bends to navigate the vasculature), an inner catheter (inner catheter 116) coaxially positioned within the delivery catheter and being adapted configured to maintain a connection with the interventional device until deployment of the interventional device (the threaded coil 122 is connected to the IV device 110 with bearing 126, [0051], where the coil 122 of the drive cable 118 is capable of maintaining a connection with the IV until deployment), the inner catheter (116) comprising a threaded portion (threaded coil 122, where coil threads 122 may engage threads on inner catheter, [0050]) that has a terminal distal end (see Fig. 3-1, the terminal end of coil 122 that attaches to bearing 126) at a location proximal a distal end of the inner catheter (where the threaded coil 122 is capable of being unthreaded from the inner catheter 116 so that the terminal distal end of the threaded coil 122 is proximal to a distal end of the inner catheter 116, [0050]) and proximal a connecting ring (bearing 126 distal of 122) of the inner catheter operatively connected to a proximal end of the interventional device ([0051]); and
a handle assembly (108) for controlling movement of the delivery catheter and inner catheter ([0029]).
Regarding claim 15, Oepen-2 discloses the system of claim 14, further comprising a retrieval catheter (114) selectively mounted to the inner catheter when the delivery catheter is removed from coaxial positioning around the inner catheter (outer sheath 112 is removed by being moved in a proximal direction, [0046]).
Regarding claim 16, Oepen-2 discloses the system of claim 15, wherein the retrieval catheter comprises: a first catheter (114) comprising a threaded portion ([0050]) complementary to the threaded portion of the inner catheter ([0050]); and a second catheter (friction reducing layer, [0041]) disposed on the first catheter ([0041]) and being rotatable in relation to the first catheter (the catheter 114 is rotatable and is capable of being rotated relative to the friction reducing layer, [0031]).
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 of this title, 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 1-3, 6, 8, 9, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Oepen (US2018/0055637) in view of Burriesci (US2013/0296999).
Regarding claim 1, Oepen discloses a delivery system for delivering an interventional device to a targeted anatomical site, the delivery system comprising:
an elongated delivery member (102) having a proximal end and a distal end configured for housing the interventional device (houses replacement valve device 126, [0041]), and including a plurality of coaxially positioned delivery member components (112/114/116/120/130, see Fig. 3A), the plurality of delivery member components including:
a delivery catheter (delivery sheath 112);
an inner catheter (120) coaxially positioned within the delivery catheter and being adapted to maintain a connection with the interventional device until deployment of the interventional device ([0059]); and
a handle assembly (108) for controlling movement of the delivery catheter and inner catheter ([0009], [0065], [0070]).
Oepen, in the embodiment of Fig. 1, does not explicitly disclose a delivery catheter having a bending portion having a coil section coaxially positioned with a braided section, wherein the coil section and the braided section of the delivery catheter are fixed relative to a distal end of the delivery catheter with a proximal end of the coil section being independently movable from a proximal end of the braided section. Oepen according to another embodiment teaches a delivery catheter (delivery sheath 412) having a bending portion (434) having a coil section (436) coaxially positioned with a braided section (438, [0100]), wherein the coil section and the braided section of the delivery catheter are fixed relative to a distal end of the delivery catheter with a proximal end of the coil section being independently movable from a proximal end of the braided section (the braided sleeve 438 may be fixed to the coil 436 at a center point, [0105]; this would leave a proximal section of the braided sleeve 438 and the coil 436 which would be capable of being moved independently). 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 delivery sheath 112 for the delivery sheath embodiment 412, since the substitution would have yielded the same result of providing a delivery sheath and provide the added benefit of a delivery sheath with desirable bending properties while also being resilient ([0100]-[0101]).
Oepen is silent regarding an elongate member configured to extend circumferentially around the interventional device, threaded through a plurality of loops attached to pair of crests of the interventional device, with both ends of the elongate member exiting through a center of the interventional device to the handle assembly, the elongate member being configured to be moved proximally to draw the plurality of loops, and so the pairs of crests of the interventional device, centrally towards a central axis of the interventional device to symmetrically collapse the interventional device. Oepen discloses a desire to compress the interventional device ([0053]) and that the interventional device is engaged with a distal end cap 130, such that the distal end cap 130 has retention features that engage with complimentary retention features on the interventional device 126 and the end cap 130 may limit or prevent proximal movement of the replacement device 126 ([0051], [0055]). Where the loading and retention of the replacement device 126 is aided by tensioning element 128 (elongate member) connected to the distal end cap 130 ([0056]). Where the tension elements 128 are connected to replacement device 126 in a way that the suture loop are looped over connection member (hooks, prongs) ([0059]).
Burriesci teaches an elongate member (tethers 4) extending circumferentially around the IV device (Fig. 2), threading through a plurality of loops of the IV device ([0044]) attached to a pair of crests (pairs of crests are interpreted as a pair of apexes 11 of the support structure of the prosthesis 10, [0044], see Fig. 2; the term “crest” as “something suggesting a crest especially in being an upper prominence, edge, or limit: such as a peak” as provided by merriam-webster dictionary cited reference U in the PTO-892; the apexes are attached to the loops by being an integral structure). Both ends of the elongate member exiting through a center of the IV device (the tethers 4 exit the apexes 11/loops of IV device at a center of the device, see Fig. 2). The elongate member being configured to be moved proximally to draw the plurality of loops centrally towards a central axis of the interventional device to symmetrically collapse the interventional device ([0041], [0043]). Where the connection member of Burriesci is a loop of the IV device by being a cell of the IV device that forms an apex that the loops 4 of the elongate member thread through ([0043], [0044]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have substituted the tension element and connection member of the IV device of Oepen for the elongate member/tether threaded through the connection member/loops of the IV device, since the substitution would have the same predictable result of engaging the IV device to prevent movement and also provide the added benefit of selectively deploying the proximal portion of the IV device.
Regarding claim 2, Oepen/Burriesci makes obvious the delivery system of claim 1, Oepen further discloses further comprising an interventional device (126) formed from nitinol configured to be housed within an outer sheath of the elongated delivery member ([0118]).
Regarding claim 3, Oepen/Burriesci makes obvious the delivery system of claim 1, Oepen further discloses wherein the coiled section comprises a plurality of coil elements (each coil of the coiled section are interpreted as a coil element, [0101]) with at least one elongate member extending through the plurality of coil elements (elongate member 114 within sheath 112 substituted with 412, see Fig. 2).
Regarding claim 6, Oepen/Burriesci makes obvious the delivery system of claim 1, Oepen further discloses wherein the coil section is a stacked coil with substantially no space between adjacent coil elements (Fig. 16 illustrates no space between the adjacent windings; additionally, or alternatively, the coil is capable of being compressed to have no space between coil elements, [0101]).
Regarding claim 8, Oepen/Burriesci makes obvious the delivery system of claim 1, Oepen further discloses wherein the proximal end of the braid section is mounted to a first movable tubular member (114, where examiner interprets the braid section as being mounted to 114, by 114 being within the braid section of the substituted delivery sheath 412) and the proximal end of the coil section is mount to a second movable tubular member (116, where examiner interprets the coil section as being mounted to 116 by being within the coil section of substituted delivery sheath 412), the first movable tubular member being movable independently from the second movable tubular member ([0050]).
Regarding claim 9, Oepen/Burriesci makes obvious the delivery system of claim 1, Oepen further teaches wherein the braid section is selectively locked against an outer surface of the coil section (interlocking feature between coil 436 and braided structure 438 of substituted delivery sheath 412 is interpreted as when the structures are stretched and the braided structure 438 locks down on coil 436, [0110]; where the structures are unlocked when stretching is released).
Regarding claim 13, Oepen/Burriesci makes obvious the delivery system of claim 1, the modified invention discloses wherein the elongate member extends (see Fig. 3B; where the elongate member 128 of Oepen would be replaced by the elongate member of Burriesci and extend in the same manner to the IV device) to a compression resistant tube (where the compression resistant tube is interpreted as the end cap 130 of the interventional device; it is a tube since it is cylindrical with an opening, [0056], [0058], [0085]; the end cap 130 is capable of resisting compression to at least some degree and therefore meets a broadest reasonable interpretation of “compression resistant”) disposed within the interventional device (end cap 130 has retention features that extend into the valve 126, [0051]). The modified invention does not explicitly disclose the elongate member extends through the compression resistant tube. Oepen according to another embodiment teaches the elongate member/tether extends through an opening in the end cap 130 ([0085]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the elongate member extend through the compression resistant tube as taught by the alternate embodiment of Oepen in order to thread the elongate member through the compression tube for securing to another element ([0085] of Oepen).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Oepen (US2018/0055637) in view of Burriesci (US2013/0296999) as applied to claim 3 above, and further in view of Jacobsen (US6478778).
Regarding claim 4, Oepen/Burriesci makes obvious the delivery system of claim 3, yet, is silent regarding wherein each coil element comprises a plurality of holes organized in pairs circumferentially around the coil element. Jacobsen teaches a delivery sheath for deployment into a vessel for a device with a coiled portion 14 that includes holes 16 to provide an outlet for fluid based agents through the coiled portion 14 (C13:L38-42). Where the holes 16 are organized in pairs circumferentially around the coil element (holes 16 are around the entire periphery of the tube 15 that makes up the coiled portion 14, C14:L3-5, and are spaced along the circumference of the coil shape, C13:L39; and are interpreted as being organized in pairs by each adjacent pair of holes being paired). It would have been obvious to one having ordinary skill in the art to have modified the coil element to have a plurality of holes organized in pairs circumferentially around the coil element as taught by Jacobsen in order to provide an outlet for fluid based agents to be delivered for diagnostic and/or therapeutic purposes (C6:L46-50 of Jacobsen).
Regarding claim 5, Oepen/Burriesci/Jacobsen makes obvious the delivery system of claim 4, Jacobsen further teaches wherein each hole has walls that are parallel in a cross-section (holes are formed into the tubing 15 by processes such as punching, drilling; which would form parallel walls, C13;L40-42 of Jacobsen).
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Oepen-2 (US2018/0028305) in view of Desrosiers (US2019/0231520).
Regarding claim 17, Oepen-2 discloses the system of claim 16; yet, does not explicitly disclose wherein the first catheter and the second catheter are drivingly engaged so that rotational movement of the second catheter longitudinally displaces the second catheter in relation to the first catheter. Oepen-2 teaches combinations of a longitudinal direction and rotational direction are contemplated ([0031]).
Desrosiers teaches a catheter assembly (104) for delivery a prosthetic valve (see Abstract). The first catheter (124) and the second catheter (126 or 128) are drivingly engaged so that rotational movement of the second catheter longitudinally displaces the second catheter in relation to the first catheter ([0055]). Desrosiers teaches relative rotational movement between two or more catheters 124, 126, 128 can cause relative axial movement at the distal end of assembly 104 ([0055]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the relation between the first and second catheter to be drivingly engaged so that rotational movement of the second catheter longitudinally displaces the second catheter in relation to the first catheter as taught by Desrosiers to move one catheter relative to another for a purpose such as delivering an implant ([0031] of Oepen-2).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Oepen-2 (US2018/0028305) in view of Desrosiers (US2019/0231520) as applied to claim 17, and further in view of Oepen (US2018/0028177) (Oepen-3).
Regarding claim 18, Oepen-2/Desrosiers makes obvious the system of claim 17; yet, is silent regarding wherein a distal end of the second catheter has a keyed relationship with an outer catheter in that rotational movement of the second catheter is not translated to the outer catheter. Oepen-3 teaches distal end of the second catheter (steering catheter 80) has a keyed relationship with an outer catheter (outer sheath 82) in that rotational movement of the second catheter is not translated to the outer catheter ([0088]). Where the keyed features are for providing particular bending directions ([0088]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included an outer catheter that has a keyed relationship with the second catheter as taught by Oepen-3 in order to provide particular bending directions ([0088] of Desrosiers). Where the keyed features may be cuts that would not translate rotational movement ([0088] of Desrosiers).
Regarding claim 19, Oepen-2/Desrosiers/Oepen-3 makes obvious the system of claim 18, the modified invention discloses wherein the outer catheter comprising a cavity (opening at the distal end of included outer catheter 82 of Oepen-3) configured to receive the interventional device (see Fig. 3-1 of Oepen-2, where IV is received at distal end 106 and the outer catheter 82 of Oepen-3 would be capable of extending to this distal end to cover the IV).
Regarding claim 20, Oepen-2/Desrosiers/Oepen-3 makes obvious the system of claim 19, the modified invention discloses wherein the cavity is formed in a valve cover (opening at the distal end of the included outer catheter 82 of Oepen-3 would be capable of extending over IV device 110 to be considered to be a valve cover, [0045]) having guiding feature to aid with retrieval of the interventional device (the guiding feature is interpreted as the surfaces of outer catheter 82 that would assist with the IV being recaptured as described in [0033] of Oepen; where the guiding feature is interpreted under 112(f), where the surfaces of the wall are an equivalent structure to a structure for aiding in retrieval as disclosed in the application).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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, Melanie Tyson can be reached on (571)272-9062. 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
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774