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 3/13/26. The claims 1-20 are pending. The claims 1, 13, 17 are amended. Claims 10-12, 15 are withdrawn.
Response to Arguments
Applicant’s arguments, filed 3/13/26 with respect to the rejections of claims 1-3, 5-7, and 9 under 35 U.S.C. 102(a)(1) as being anticipated by Grayhack (US4611594) have been fully considered but they are not persuasive. Applicant argues, Grayhack does not disclose a medical device implant and that the tubular member has a distal region that is “configured to shift between an enlarged configuration when the medical device implant is in a first position in which the medical device implant is disposed within the lumen and a collapsed configuration when the medical device implant is in a second position in which the medical device is not disposed within the lumen”. Examiner disagrees, since Grayhack discloses a medical device implant (16) that is advanced and retracted and, where the medical device 16 can be in the lumen in the enlarged configuration as shown see Fig. 14 which is a different embodiment but shows the implant within the enlarged configuration; and in a collapsed configuration the medical device 16 is capable of being not disposed within the lumen by being extended out of the lumen and the body collapsed. Therefore, the rejection has been maintained.
Applicant’s arguments, filed 3/13/26 with respect to the rejections of claims 17-20 under 35 U.S.C. 102(a)(1) as being anticipated by Sherburne (US2020/0214859) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection has been made in view of Sherburne (US2020/0214859) in view of Drasler (US2009/0240202).
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:
“compression element” in claims 1, 13, and 17. From the specification page 10, line 18-19; the “compression element” is “may be wires, and in other embodiments, they may be polymer fibers” and equivalents thereof.
“coupling member” in claims 6 and 17. From the specification page 11, line 16; the “coupling members” are interpreted as “sutures, ribbons, cables, or wires” 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 1-3, 5-7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grayhack (US4611594).
Regarding claim 1, Grayhack discloses an outer sheath (312) in Figures 19-21, comprising:
a medical device implant (16);
a tubular member (body 312) defined by a circumferential wall and having a distal end, a proximal end, and a lumen extending therebetween along a central longitudinal axis of the tubular member, the tubular member having a distal region being configured to shift between an enlarged configuration when the medical device implant is in a first position in which the medical device implant is disposed within the lumen (C6:L47-58, where the medical device can be in the lumen in the enlarged configuration, see Fig. 14 which is a different embodiment but shows the implant within the enlarged configuration) and a collapsed configuration when the medical device implant is in a second position in which the medical device implant is not disposed within the lumen (the implant 16 is capable of being not disposed within the lumen by being extended out of the lumen and the body collapsed); and
at least one compression element (struts 350, where the struts 350 are interpreted as at least one “compression element” under 112(f) by being an elongate member that is in the form of a wire or fiber) disposed in the distal region, the at least one compression element configured to automatically radially collapse the distal region when the lumen of the distal region is empty (the struts 350 assume a converging position when basket is closed, and have to be flexed to the expanded position, C6:L30-38, therefore would be capable of automatically radially collapsing when the region is empty).
Regarding claim 2, Grayhack discloses the outer sheath of claim 1, wherein the at least one compression element includes a plurality of compression elements that are oriented longitudinally (see Figs. 19-21).
Regarding claim 3, Grayhack discloses the outer sheath of claim 2, wherein the plurality of compression elements includes axial reinforcement fibers (fibers are interpreted as the struts 350 by being elongated and fiber-like in shape) embedded within the tubular member (the struts 350 are embedded within the tubular member by being joined to the outer tube 354,).
Regarding claim 5, Grayhack discloses the outer sheath of claim 3, wherein the axial reinforcement fibers are a plurality of wires (the struts 350 are interpreted as wires by being elongate wire-like structures).
Regarding claim 6, Grayhack discloses the outer sheath of claim 2, further comprising coupling members (each coupling member is interpreted as the part of webbing 351 in between the struts and not the part that is joined to the strut, C4:L58; where the part of the webbing 351 is interpreted as a “coupling member” under 112(f) by being a ribbon shape portion that connects to the strut) coupling each of the plurality of compression elements to adjacent compression elements (C6:L46-47).
Regarding claim 7, Grayhack discloses the outer sheath of claim 6, wherein the coupling members extend circumferentially between adjacent compression elements (C6:46-47).
Regarding claim 9, Grayhack discloses the outer sheath of claim 1, wherein a first outer diameter of the distal region in the enlarged configuration is larger than a second outer diameter of a remainder of the tubular member (see Figs. 19-21).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Grayhack (US4611594).
Regarding claim 4, Grayhack discloses the outer sheath of claim 3; yet, does not explicitly disclose wherein at least some of the axial reinforcement fibers have different lengths, such that distal ends of the axial reinforcement fibers are positioned at a common distance from the distal end of the tubular member, and proximal ends of at least some of the axial reinforcement fibers are positioned at different distances from the distal end of the tubular member. It would have been an obvious matter of design choice to one having ordinary skill in the art at the effective filing date of the claimed invention to have the axial reinforcement fibers have different lengths, because Applicant has not disclosed the reinforcement fibers having different lengths provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the length of the fibers of Grayhack and Applicant’s invention, to perform equally well with either the length of the fibers of Grayhack or the claimed different length fibers since the fibers would perform the same function of capturing an object and collapsing inward.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Grayhack (US4611594) in view of Skillrud (US2018/0325532)
Regarding claim 8, Grayhack discloses the outer sheath of claim 6; yet, does not explicitly disclose wherein the coupling members are sutures. Skillrud teaches a capture device 100 for capturing an object, having an outer covering 200 that is made of a mesh of suture that is knitted together ([0290]). 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 coupling members being a mesh of sutures of Skillrud for the coupling members of Grayhack, since the substitution would have yielded predictable results of capturing an object with a material that connects the capture structure.
Claims 13, 14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sherburne (US2020/0214859) in view of Drasler (US2009/0240202).
Regarding claim 13, Sherburne discloses an outer sheath (1802), comprising:
a tubular member (body of 1802) defined by a circumferential wall and having a distal end, a proximal end, and a lumen extending therebetween along a central longitudinal axis of the tubular member (see Fig. 20A), the tubular member having a distal region being configured to shift between an enlarged configuration when a medical device is disposed within the lumen (a medical device is capable of being within the lumen in the enlarged configuration as shown in Fig. 20C, where the medical device is not positively recited) and a collapsed configuration when the medical device is not disposed within the lumen (a medical device is capable of not being within the lumen in the collapsed configuration as shown in Fig. 20F, where the medical device is not positively recited, [0127], see Figs. 20A-20F); and
at least one compression element (1810A, 1810B, 1810C, where the compression elements 1810A, 1810B, 1810C are interpreted as at least one “compression element” under 112(f) by being a loop of material that is in the form of a wire or fiber, see Figs. 20A-20F) embedded within the circumferential wall in at least the distal region, the at least one compression element configured to radially collapse the distal region when the lumen of the distal region is empty.
The embodiment of Figs. 20A-20F does not explicitly disclose the compression element embedded within the circumferential wall. Sherburne according to other embodiments teaches the adjustable structure embedded within the distal section 5 of catheter 2 ([0057]). 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 compression elements being embedded within the circumferential wall of the tubular member for the arrangement of the compression elements with the tubular member of the embodiment of Figs. 20-20F, since the substitution would have yielded the same predictable result of compression elements connected with the tubular member for capturing an object.
Sherburne does not explicitly disclose at least one compression element as axially extending. Drasler teaches an introducer sheath that is expanded and contracted back to its original state (see Fig. 2A, 2C; [0035]), with a braided internal tubular structure with circumferential and axial fibers connected to its distal end, interleaved in the axial direction with the braided fibers extending from a proximal end to a distal end ([0016], [0038]). 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 compression elements of Sherburne for the compression element with circumferential and axial fibers as taught by Drasler, since the substitution would have yielded the same predictable result of a sheath that expands and contracts back to its original state.
Regarding claim 14, Sherburne/Drasler makes obvious the outer sheath of claim 13, the modified invention further discloses wherein the at least one compression element is configured to automatically collapse the distal region when the lumen is empty (the elements 1810A, 1810B, 1810C are contracted back to the original state to move an object through, [0127] of Sherburne; therefore, the elements are at least capable of automatically radially collapsing; where the modified invention would function in the same manner as in Sherburne).
Regarding claim 16, Sherburne/Drasler makes obvious the outer sheath of claim 13; yet, does not explicitly disclose wherein the at least one compression element extends along an entirety of the distal region. Sherburne according to other embodiments teaches the compression element extends along the entire distal section of the catheter (see Fig. 2C-2D). 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 compression elements extending along the entirety of the distal section of the catheter for the arrangement of the compression elements with the distal section of the catheter of the embodiment of Figs. 20-20F, since the substitution would have yielded the same predictable result of compression elements on a distal section of a catheter for capturing an object.
Regarding claim 17, Sherburne discloses a medical device system, comprising:
a replacement heart valve delivery system (object, [0127]; where the object can be a prosthetic heart valve, [0121]); and
an outer sheath (1802) comprising:
a tubular member (body of 1802) defined by a circumferential wall and having a distal end, a proximal end, and a lumen extending therebetween along a central longitudinal axis of the tubular member (see Fig. 20A), the tubular member having a distal region being configured to shift between an enlarged configuration to a collapsed configuration ([0127], see Figs. 20A-20F); and
a plurality of compression elements (1810A, 1810B, 1810C, where the compression elements 1810A, 1810B, 1810C are interpreted as at least one “compression element” under 112(f) by being a loop of material that is in the form of a wire or fiber, see Figs. 20A-20F) disposed in the distal region (see Fig. 20A-20F), the plurality of compression elements configured to automatically radially collapse the distal region when the lumen of the distal region is empty (the elements 1810A, 1810B, 1810C are contracted back to the original state to move an object through, [0127]; therefore, the elements are at least capable of automatically radially collapsing);
wherein the replacement heart valve delivery system is configured to slide within the lumen of the tubular member ([0127]).
Sherburne does not explicitly disclose each of the plurality of compression elements comprising longitudinally oriented axial reinforcement fibers, a plurality of coupling members extending between adjacent compressive elements of the plurality of compression elements. Drasler teaches an introducer sheath that is expanded and contracted back to its original state (see Fig. 2A, 2C; [0035]), with a braided internal tubular structure with circumferential (coupling members, where the circumferential fibers are a “coupling member” under 112(f) by being a wire that connects with the axial fibers) and axial fibers connected to its distal end, interleaved in the axial direction with the braided fibers extending from a proximal end to a distal end ([0016], [0038]). 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 compression elements of Sherburne for the compression element with circumferential and axial fibers as taught by Drasler, since the substitution would have yielded the same predictable result of a sheath that expands and contracts back to its original state.
Regarding claim 18, Sherburne/Drasler makes obvious the medical device system of claim 17, the modified invention further discloses wherein a distal section of the replacement heart valve delivery system includes a replacement heart valve implant disposed therein (object, [0127] of Sherburne; where the object can be a prosthetic heart valve and therefore has a valve inside, [0121]), when in the enlarged configuration, the distal region of the tubular member is configured to extend over the distal section of the replacement heart valve delivery system containing the replacement heart valve implant (in the enlarged configuration, the distal region is capable of extending over the heart valve delivery system containing a heart valve implant, see Fig. 20C, [0127] of Sherburne).
Regarding claim 19, Sherburne/Drasler makes obvious the medical device system of claim 18, the modified invention further discloses wherein a first outer diameter of the distal region of the tubular member when extended over the distal section of the replacement heart valve delivery system containing the replacement heart valve implant (distal section 1805 is expanded to a larger first outer diameter as shown in Fig. 20C, [0127] of Sherburne; where the modified invention would have the same diameter as in Sherburne), is larger than a second outer diameter of a remainder of the outer sheath (second outer diameter is diameter of remainder of catheter 1802, see Fig. 20A of Sherburne; where the modified invention would have the same diameter as in Sherburne).
Regarding claim 20, Sherburne/Drasler discloses the medical device system of claim 19, the modified invention further discloses wherein when the replacement heart valve delivery system is moved distally out of the outer sheath and the replacement heart valve implant is deployed, the plurality of compression elements is configured to radially collapse the distal region of the tubular member (the compression elements are capable of being collapsed after deploying a heart valve, see paragraph [0127] of Sherburne).
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, 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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