DETAILED ACTION
Claims 1-19 are pending in this application.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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:
“control device” in claim 1.
“locking mechanism” in claim 16.
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 § 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.
Claims 8, 15-18 are 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 8, line 1 recites the limitation "the shaft". There is insufficient antecedent basis for this limitation in the claim.
Claim 15, line 1 recites the limitation "the adjustment tool has a jack screw". However, in Claim 13, upon which Claim 15 depends, recites in line 5 “an adjustment tool configured for rotating the jack screw”. It is unclear if the adjustment tool has a jack screw or the jack screw is a separate element from the adjustment tool, wherein the adjustment tool rotates the jack screw.
Claim 15, line 2 recites the limitation "at least some of the threaded bores". There is insufficient antecedent basis for this limitation in the claim.
Claim 16, line 1 recites the limitation "the locking mechanism". There is insufficient antecedent basis for this limitation in the claim.
Claim 16, line 2 reads “the lock configuration” and in line 3 “the release configuration.” There is insufficient antecedent basis for these limitations in the claim.
Claim 17, line 2 recites the limitation "the shaft". There is insufficient antecedent basis for this limitation in the claim.
Claim 18 is rejected due to its dependency on Claim 17.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 9, 11-13, 15, 19 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by White (WO 2010/011699 A2), cited in IDS filed 10/24/25.
Regarding claim 9, White discloses an assembly comprising:
a lattice structure (stented portions of valves, wherein the stented portions have crossing linkages; Figures 11-15), wherein the lattice structure is circumferentially expandable and contractible (page 9, lines 5-8 and Figures 5-6; rotating rod 32/32’ in one direction will urge anchor points 25-3, 25-5 outwardly to compress linkages and contract the lattice, and rotating the rod in the opposite direction will urge the anchor points inwardly to expand the linkages and expand the lattice);
a torque wire 32 or 32’ (Figures 5-6; page 8, line 26 to page 9, line 20), wherein the torque wire is coupled to the lattice structure at two points (threaded support mounts 35-3, 35-5 or 35-3’, 35-5’ at anchor points 25-3, 25-5; Figures 5-6) longitudinally separate from one another on the lattice structure and configured for circumferentially expanding and contracting the lattice structure (Id.); and
an adjustment tool (hex head 37-3, 37-5 or hex driver [not shown in drawings]; Id.), wherein when the adjustment tool is rotated, the torque wire correspondingly rotates to expand or contract the lattice structure (Id.).
Regarding claim 11, White discloses the torque wire 32 or 32’ has exterior threads 34R/34L or 34’ that correspond to threaded bores (threaded support mounts 35-3, 35-5) of one of the two points.
Regarding claim 12, White discloses wherein when the torque wire 32 or 32’ is rotated, the two points of the lattice structure either approach one another or retreat from one another (page 9, lines 5-8 and Figures 5-6).
Regarding claim 13, White discloses an assembly comprising:
a radially expandable and contractible stent (stented portions of valves in Figures 11-15; page 9, lines 5-8 and Figures 5-6: rotating rod 32/32’ in one direction will urge anchor points 25-3, 25-5 outwardly to compress linkages and contract the lattice, and rotating the rod in the opposite direction will urge the anchor points inwardly to expand the linkages and expand the lattice);
a jack screw 32 or 32’ (Figures 5-6; page 8, line 26 to page 9, line 20) coupled to the stent, wherein rotating the jack screw in a first direction relative to the stent radially expands the stent, and wherein rotating the jack screw in a second direction relative to the stent radially contracts the stent (page 9, lines 5-8); and
an adjustment tool (hex head 37-3, 37-5 or hex driver [not shown in drawings]; page 9, lines 4-20) configured for rotating the jack screw.
Regarding claim 15, White discloses the adjustment tool has a jack screw 32 disposed within at least some of threaded bores (“threaded low-profile support mounts 35-3, 35-5”; page 9, lines 1-8 and Figure 5) and have exterior threads 34R, 34L corresponding to interior threads of the threaded bores (Id.), wherein rotating the jack screw in a first direction relative to the threaded bores moves the threaded bores axially closer together, and rotating the jackscrew in a second direction relative to the threaded bores moves the threaded bores axially apart (Id.).
Regarding claim 19, White discloses the adjustment tool is a cable (hex driver [not shown in drawings] can be considered as a cable, or elongate wire; page 9, lines 4-20).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-7 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-7 of prior U.S. Patent No. 12,329,630 (see chart below showing corresponding claims with corresponding subject matter). This is a statutory double patenting rejection.
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 8-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 7-11 of U.S. Patent No. 12,329,630 (see chart below showing corresponding claims with corresponding subject matter) in view of Oktay (U.S. Pub. No. 2003/0040791), cited in IDS filed 10/24/25, and/or White (WO 2010/011699 A2). Claim 7 of the patent encompasses claim 8, except for features that are merely obvious. Oktay teaches having multiple circumferentially distributed shafts 103 (Figures 1-1C, 3) and plurality of mechanisms for coupling to respective jack screws (Figures 7-8) in order to adjust individual trusses of a lattice (stent) structure. It would have been obvious to one of ordinary skill at the time of invention to modify the patent claim to have the shaft comprising a plurality of shafts and the locking mechanism comprising a plurality of locking mechanisms coupled to respective shafts, and the locking mechanisms configured for selectively coupling the shafts to respective jack screws, in order to adjust the circumferentially distributed jack screws around the lattice structure in a controlled manner that prevents trauma to tissue (Oktay; [0028]). Claim 11 of the patent encompasses claims 15 and 19, except for features that are merely obvious. White teaches an adjustment tool has a jack screw 32 disposed within at least some of threaded bores (“threaded low-profile support mounts 35-3, 35-5”; page 9, lines 1-8 and Figure 5) and have exterior threads 34R, 34L corresponding to interior threads of the threaded bores (Id.), wherein rotating the jack screw in a first direction relative to the threaded bores moves the threaded bores axially closer together, and rotating the jackscrew in a second direction relative to the threaded bores moves the threaded bores axially apart (Id.). White teaches the adjustment tool is a cable (hex driver [not shown in drawings] can be considered as a cable, or elongate wire; page 9, lines 4-20). It would have been obvious to one of ordinary skill at the time of invention to modify the patent claim with the above features in order to precisely control expansion and contraction of the stent.
Claims 1 and 7 of the patent encompasses claims 16-18, except for features that are merely obvious. White teaches than a rotatable adjustment tool can be a jack screw 32 that expands or contracts a stent (page 9, lines 5-8 and Figures 5-6). Oktay teaches having multiple circumferentially distributed/spaced shafts 103 (Figures 1-1C, 3) and plurality of mechanisms for coupling to respective jack screws (Figures 7-8) in order to adjust individual trusses of a lattice (stent) structure. It would have been obvious to one of ordinary skill at the time of invention to modify the patent claim to have a shaft comprising a plurality of shafts and the locking mechanism comprising a plurality of locking mechanisms coupled to respective shafts, and the locking mechanisms configured for selectively coupling the shafts to respective jack screws, in order to adjust the circumferentially distributed jack screws around the lattice structure in a
controlled manner that prevents trauma to tissue (Oktay; [0028]).
Application No.
19/217,218
claims
U.S. Patent No.
12,329,630
claims
U.S. Patent No.
11,540,911 claims
(in view of White)
U.S. Patent No.
10,507,097 claims
(in view of White)
1
1
6, 15
4, 10, 16
2
2
6, 15
10, 16
3
3
5, 6, 15
16
4
4
6, 8, 15
4, 10, 16
5
5
6, 15
4, 10, 16
6
6
6, 15
16, 17
7
7
6, 15
17
8
7 in view of Oktay
6, 15 further in view of Oktay
17 further in view of Oktay
9
8
3, 17
15
10
8
11
9
3, 17
15
12
10
3, 17
15
13
11
3, 17
15
14
11
15
11 in view of White
3, 17
15
16
1 in view of White
3, 17
15
17
1 in view of White and Oktay
3, 17
15
18
7 in view of White and Oktay
3, 17
15
19
11 in view of White
3, 17
15
Claims 1-9, 11-13, 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 5, 6, 8, 15, 17 of U.S. Patent No. 11,540,911 in view of White (WO 2010/011699 A2) and Oktay (U.S. Pub. No. 2003/0040791); see chart above showing corresponding claims with corresponding subject matter. Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that elements of the claims can be found in the patent claims. The difference lies in the fact that the patent claims lack features that are merely obvious. White teaches a lattice structure (stented portions of valves, wherein the stented portions have crossing linkages; Figures 11-15), an adjustment member being a micro-threaded cable 32/32’ (Figures 5-6; page 8, line 26 to page 9, line 20) in one direction will urge anchor points 25-3, 25-5 outwardly to compress linkages and contract the lattice, and rotating the rod in the opposite direction will urge the anchor points inwardly to expand the linkages and expand the lattice); and a control device being a microcylinder comprising a threaded aspect configured to receive the adjustment member (threaded support mounts 35-3, 35-5 or 35-3’, 35-5’ at anchor points 25-3, 25-5; Figures 5-6) or a jack screw 32 or 32’ (Figures 5-6; page 8, line 26 to page 9, line 20) coupled to the stent, wherein rotating the jack screw in a first direction relative to the stent radially expands the stent, and wherein rotating the jack screw in a second direction relative to the stent radially contracts the stent (page 9, lines 5-8). White also teaches an adjustment tool (hex head 37-3, 37-5 or hex driver [not shown in drawings]; Id.), wherein when the adjustment tool is rotated, a torque wire 32/32’ correspondingly rotates to expand or contract the lattice structure. It would have been obvious to one of ordinary skill at the time of invention to modify the patent claims to have a lattice structure, adjustment member, and control device as claims, as taught by White, in order to provide a structure and mechanism that is readily retrieved and repositioned in the body (White; page 3, lines 23-25). White teaches an adjustment tool has a jack screw 32 disposed within at least some of threaded bores (“threaded low-profile support mounts 35-3, 35-5”; page 9, lines 1-8 and Figure 5) and have exterior threads 34R, 34L corresponding to interior threads of the threaded bores (Id.), wherein rotating the jack screw in a first direction relative to the threaded bores moves the threaded bores axially closer together, and rotating the jackscrew in a second direction relative to the threaded bores moves the threaded bores axially apart (Id.). White teaches the adjustment tool is a cable (hex driver [not shown in drawings] can be considered as a cable, or elongate wire; page 9, lines 4-20). It would have been obvious to one of ordinary skill at the time of invention to modify the patent claim with the above features in order to precisely control expansion and contraction of the stent. Oktay teaches having multiple circumferentially distributed/spaced shafts 103 (Figures 1-1C, 3) and plurality of mechanisms for coupling to respective jack screws (Figures 7-8) in order to adjust individual trusses of a lattice (stent) structure. It would have been obvious to one of ordinary skill at the time of invention to modify the patent claim to have a shaft comprising a plurality of shafts and the locking mechanism comprising a plurality of locking mechanisms coupled to respective shafts, and the locking mechanisms configured for selectively coupling the shafts to respective jack screws, in order to adjust the circumferentially distributed jack screws around the lattice structure in a controlled manner that prevents trauma to tissue (Oktay; [0028]).
Claims 1-9, 11-13, 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 10, 15, 16, 17 of U.S. Patent No. 10,507,097 in view of White (WO 2010/011699 A2) and Oktay (U.S. Pub. No. 2003/0040791); see chart above showing corresponding claims with corresponding subject matter. Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that elements of the claims can be found in the patent claims. The difference lies in the fact that the patent claims lack features that are merely obvious. White teaches a lattice structure (stented portions of valves, wherein the stented portions have crossing linkages; Figures 11-15), an adjustment member being a micro-threaded cable 32/32’ (Figures 5-6; page 8, line 26 to page 9, line 20) in one direction will urge anchor points 25-3, 25-5 outwardly to compress linkages and contract the lattice, and rotating the rod in the opposite direction will urge the anchor points inwardly to expand the linkages and expand the lattice); and a control device being a microcylinder comprising a threaded aspect configured to receive the adjustment member (threaded support mounts 35-3, 35-5 or 35-3’, 35-5’ at anchor points 25-3, 25-5; Figures 5-6). White also teaches an adjustment tool (hex head 37-3, 37-5 or hex driver [not shown in drawings]; Id.), wherein when the adjustment tool is rotated, a torque wire 32/32’ correspondingly rotates to expand or contract the lattice structure. It would have been obvious to one of ordinary skill at the time of invention to modify the patent claims to have a lattice structure, adjustment member, and control device as claims, as taught by White, in order to provide a structure and mechanism that is readily retrieved and repositioned in the body (White; page 3, lines 23-25). White teaches an adjustment tool has a jack screw 32 disposed within at least some of threaded bores (“threaded low-profile support mounts 35-3, 35-5”; page 9, lines 1-8 and Figure 5) and have exterior threads 34R, 34L corresponding to interior threads of the threaded bores (Id.), wherein rotating the jack screw in a first direction relative to the threaded bores moves the threaded bores axially closer together, and rotating the jackscrew in a second direction relative to the threaded bores moves the threaded bores axially apart (Id.). White teaches the adjustment tool is a cable (hex driver [not shown in drawings] can be considered as a cable, or elongate wire; page 9, lines 4-20). It would have been obvious to one of ordinary skill at the time of invention to modify the patent claim with the above features in order to precisely control expansion and contraction of the stent. Oktay teaches having multiple circumferentially distributed/spaced shafts 103 (Figures 1-1C, 3) and plurality of mechanisms for coupling to respective jack screws (Figures 7-8) in order to adjust individual trusses of a lattice (stent) structure. It would have been obvious to one of ordinary skill at the time of invention to modify the patent claim to have a shaft comprising a plurality of shafts and the locking mechanism comprising a plurality of locking mechanisms coupled to respective shafts, and the locking mechanisms configured for selectively coupling the shafts to respective jack screws, in order to adjust the circumferentially distributed jack screws around the lattice structure in a controlled manner that prevents trauma to tissue (Oktay; [0028]).
Allowable Subject Matter
Claims 1-7 would be allowable if a Terminal Disclaimer is filed to address the double patenting rejections set forth in this office action.
Claims 10, 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and if a Terminal Disclaimer is filed to address the double patenting rejections set forth in this office action.
Claims 8, 16-18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims, as well as if a Terminal Disclaimer is filed to address the double patenting rejections set forth in this office action.
The following is a statement of reasons for the indication of allowable subject matter:
None of the prior art of record, alone or in combination, teaches or renders obvious an assembly including, inter alia, an assembly including an implant body comprising a lattice structure, a control device, and an adjustment member when actuated results in circumferential expansion or contraction of the lattice structure, and a controllable catch of a locking mechanism being configured to selectively couple a rotatable adjustment tool to the adjustment member of the implant body, as in claim 1.
None of the prior art of record, alone or in combination, teaches or renders obvious an assembly including, inter alia, a radially expandable and contractible stent, a jack screw and an adjustment tool configured for rotating the jack screw, wherein a locking mechanism comprises a catch member that engages the jack screw when the locking mechanism is in a lock configuration and that disengages the jack screw when the locking mechanism is in a release configuration, as in claim 16.
White (WO 2010/011699 A2) does not teach or render obvious having a controllable catch or catch member of locking mechanism that selectively couples a rotatable adjustment tool to the adjustment member, or engages the jack screw in a lock configuration and disengages the jack screw in a release configuration.
Cabiri (U.S. Pub. No. 2010/0161047), cited in IDS filed 10/24/25, teaches an assembly 20, comprising: an implant body 22 (Figures 1-3) having a lattice structure ([0185]: body portion 24 may comprise stent-like struts, or a braided mesh) wherein the lattice structure is circumferentially expandable and contractible (Figures 12A-14C, [0263]; via a rotatable adjustment tool 170 or 70), an adjustment member 30 ([0185], [0263]); and a delivery apparatus having a rotatable adjustment tool 170/70 and a coupling mechanism 175 and 256 coupled to an end portion of the tool (Figures 14B-14C), wherein the tool is configured to actuate the adjustment member of the implant body upon rotation of the tool, and the coupling mechanism is configured to selectively couple the tool to the adjustment member of the implant body. However, Cabiri does not disclose a controllable catch or a catch member of a locking mechanism that selectively couples the rotatable adjustment tool to the adjustment member, or engages the jack screw in a lock configuration and disengages the jack screw in a release configuration. It also would not have been obvious to one of ordinary skill in the art at the time of invention to modify Cabiri with a locking mechanism as claimed, since Cabiri already discloses a coupling mechanism 175 and 256 to selectively couple the tool to the adjustment member of the implant body, and there is a lack of articulated reasoning with rational underpinning to support the legal conclusion of obviousness for the modification.
None of the prior art of record, alone or in combination, teaches or renders obvious an assembly including, inter alia, an assembly including a lattice structure, a torque wire coupled to the lattice structure at two points longitudinally separate from one another and configured for circumferentially expanding and contracting the lattice structure, and a smooth-bored collar through which the torque wire extends, as in claim 10.
None of the prior art of record, alone or in combination, teaches or renders obvious an assembly including, inter alia, a radially expandable and contractible stent, a jack screw and an adjustment tool configured for rotating the jack screw, wherein the stent has a plurality of bores longitudinally separate from each other, wherein at least one bore of the plurality of bores is a threaded bore and at least one other bore of the plurality of bores is a non-threaded bore, and wherein the jack screw extends longitudinally through the threaded bore and the non-threaded bore, as in claim 14.
White (WO 2010/011699 A2) teaches two threaded bores (support mounts 35-3, 35-5 or 35-3’, 35-5’ at anchor points 25-3, 25-5; Figures 5-6) that receive a jack screw 32 (Figure 5; page 8, line 26 to page 9, line 20), but does not teach or render obvious having both a threaded bore and a smooth or non-threaded bore through which the torque wire/jack screw extends.
Mews et al. (U.S. Pub. No. 2012/0089217), cited in IDS filed 10/24/25, teaches an adjustable stent (Figure 1) having a smooth or non-threaded bore (unthreaded section 58a having a smooth cylindrical sleeve for centering components which are separate and then screwed together; Figures 2, 3, [0038], [0041]) through which a jack screw 56a extends. However, Mews et al. is silent with regards to the stent being contractible, and one of ordinary skill in the art would not have found it obvious to modify White with a smooth, non-threaded bore, as taught by Mews et al., since the jack screw 32 or 32’ in White is already coupled and aligned and centered with the threaded bores 35-3/35’-3, 35-5/35’-5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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