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 Arguments
Applicant’s arguments filed 11/11/2025 have been considered but are not persuasive. Applicant has amended claim 1 to recite the stent comprises an angled opening having a leading edge, claim 10 to recite a leading edge of an angled opening and wherein the tube extends parallel to a longitudinal axis of the implantable device, and claim 18 to recite the stent comprises an angled opening and a leading edge positioned at a radial lower end of the angled opening, and that the elongated member extends parallel to the longitudinal axis of the stent proximally from the leading edge of the angled opening. In response to Applicant’s amendments, Examiner now cites Grandfield et al. (Pub. No.: US 2011/0184456) in view of Cunningham et al. (Pub. No.: US 2017/0209268), alone or in further combination with Licata et al. (Pub. No.: US 2007/0100419).
Applicant argues that Grandfield is directed to a retrievable self-expandable member, with wire 40 that is not attached to a pusher and that is permanently affixed to the self expandable member. This is not persuasive, Grandfield discloses pusher 40 is connected to single elongate member 42 connected to and linearly extending from the stent.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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.
Here, pusher means, connection interface means, and means for severing are interpreted under Section 112(f). The pusher means is described as a pusher, the connection interface means is described as a wire or tube, and the means for severing the ring member are described as electrolytic or thermolytic severing.
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 1-4, 10, 14-15, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Grandfield et al. (Pub. No.: US 2011/0184456) in view of Cunningham et al. (Pub. No.: US 2017/0209268)
Grandfield et al. (hereinafter, Grandfield) discloses a stent delivery system (e.g., fig. 1A), comprising: a pusher 40 having a first ring member positioned at a distal portion of the pusher (not disclosed); and a single elongated member 42 connected to and extending linearly from a proximal end of a stent (e.g., fig. 1A), wherein the stent comprises an angled opening having a leading edge (e.g., fig. 1A-1B) ,wherein the single elongated member comprises a wire attached to a flare of the leading edge of the angled opening of the stent (e.g., fig. 1A), and wherein the single elongated member comprises a second ring member (not disclosed); and wherein in an attached configuration, the second ring member is engaged with the first ring member.
As provided in italicized text above, Grandfield lacks a first ring member and second ring member which engage in an attached configuration. Instead, Grandfield discloses “flexible wire 40 may be joined to wire segment 42 by the use of solder, a weld, an adhesive, or other known attachment method.” Cunningham et al. (hereinafter, Cunningham) teaches (e.g., fig. 6) a first ring member 226 on a pusher and a second ring member 276 attached to a stent as a suitable interconnection between a delivery catheter and the implant. Because Grandfield teaches known attachment methods may be used to interconnect the flexible wire 40 and wire segment 42, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have utilized a first and second ring member as taught by Cunningham. This would provide a releasable interconnection suitable for manipulating the stent during delivery and implantation. This modification would have occurred using known methods and would have yielded predictable results.
For claim 2, Cunningham teaches the first ring member and the second ring member are interlocked with each other in the attached configuration (e.g., fig. 6).
For claim 3, Cunningham teaches the first ring member is comprised of a thread (e.g., para. 44).
For claim 4, Cunningham teaches the first ring member is comprised of a suture (e.g., para. 44, noting that an elongate filament of nylon or polypropylene is considered suture).
For claim 10, Grandfield discloses an implantable device delivery system, comprising: an implantable device (stent, e.g., fig. 1A); a pusher 40 for delivering the implantable device, wherein a distal portion of the pusher includes a first ring member (not disclosed); and a connection interface 42 positioned between the pusher 40 and the implantable device 12, the connection interface being proximally linked to the pusher and distally linked to the implantable device (e.g., fig. 1A), the connection interface comprising a tube (not disclosed) extending proximally from a leading edge of an angled opening at a proximal end of the implantable device (e.g., fig. 1A, 1B), and a proximal end of the tube comprising a second ring member (not disclosed); and, wherein the first ring member and the second ring member are capable of engagement or disengagement (not disclosed).
As provided in italicized text above, Grandfield lacks a first ring member and second ring member which engage in an attached configuration. Grandfield further lacks a connection interface in the form of a tube. Instead, Grandfield discloses “flexible wire 40 may be joined to wire segment 42 by the use of solder, a weld, an adhesive, or other known attachment method.” Cunningham et al. (hereinafter, Cunningham) teaches (e.g., fig. 6) a first ring member 226 on a pusher and a second ring member 276 attached to a stent as a suitable interconnection between a delivery catheter and the implant. Cunningham further teaches that the connection interface wire can be of any cross-sectional shape (see para. 44), thus it would have been obvious to have provided the wire in tube form as an obvious alternate design suitable for the intended purpose of interfacing with the stent. Because Grandfield teaches known attachment methods may be used to interconnect the flexible wire 40 and wire segment 42, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have utilized a first and second ring member as taught by Cunningham. This would provide a releasable interconnection suitable for manipulating the stent during delivery and implantation. This modification would have occurred using known methods and would have yielded predictable results.
For claim 14, Grandfield discloses the connection interface extends proximally from the implantable device (e.g., fig. 1A).
For claim 15, Grandfield in view of Cunningham results in the implantable device being distally spaced away from the pusher by the connection interface (Grandfield fig. 1A) when the first ring member and the second ring member are engaged (based on the teaching for interconnecting rings from Cunningham).
For claim 21, Cunningham teaches the first ring member and the second ring member intersect in a jewelry chain-like manner in the attached configuration (e.g., fig. 6).
Claims 5-9, 12-13, 16-17, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Grandfield et al. (Pub. No.: US 2011/0184456) in view of Cunningham et al. (Pub. No.: US 2017/0209268), further in view of Licata et al. (Pub. No.: US 2007/0100419).
Grandfield in view of Cunningham is explained supra, however, the combination lacks an electrode connected to the pusher for severing the first ring member, positioned proximal the first ring member, wherein the first ring member is electrolytically or thermolytically disengaged from the second ring member. Licata teaches a ribbon or wire ring member 182 interconnecting a prosthesis 88 and pusher 180. The ring member has an erodible section 184 (e.g., fig. 7B) that electrolytically degrades. The pusher member includes an electrode 186 for electrolytically degrading the wire to release the implant (e.g., fig. 7A, 7Bpara. 149). Licata teaches that an electrolytic connection between the implant and delivery device desirably restrains the implant so as to reduce sleeve hold down and/or withdrawal forces (para. 23). Therefore it would have been obvious to one of ordinary skill in the art to have provided an electrolytically erodible release on the Grandfield and Cunningham ring member 151a as an alternate means of releasing the components from one another which desirably reduces sleeve hold down and/or withdrawal forces. Use of thermolysis is considered an obvious expedient in using an electrolytical degradation in that one of ordinary skill in the art would find it obvious to select a thermolytically degradable wire as obvious selection of an electrolytically degradable wire (in other words, using the same electrical current to degrade the wire by heat).
For claim 7 and 17, Cunningham teaches the first ring member is comprised of a thread or suture (e.g., para. 44).
For claims 18-20, Grandfield discloses a stent delivery system, comprising: a pusher means 40 for delivering a stent, wherein a distal portion of the pusher means includes a first ring member (not disclosed); and wherein the stent comprises an angled opening and a leading edge positioned at a radial lower end of the angled opening (fig. 1A, 1B); a connection interface means 42 for linking the pusher means with the stent (e.g., fig. 1A), the connection interface means comprising an elongated member extending parallel to a longitudinal axis of the stent proximally from the leading edge of the angled opening at a proximal end of the stent (e.g., fig. 1A, 1B), a proximal end of the elongated member including a second ring member (not disclosed) positioned between the pusher means and the stent, and the connection interface means being proximally linked to the pusher means and distally linked to the stent (e.g., fig. 1A); a means for severing the first ring member; wherein, in a first configuration, the first ring member is engaged with the second ring member; and, wherein, in a second configuration, the first ring member is severed by the means for severing the first ring member and thereby disengaged from the second ring member (not disclosed).
As provided in italicized text above, Grandfield lacks a first ring member and second ring member which engage in an attached configuration. Grandfield further lacks a connection interface in the form of a tube. Instead, Grandfield discloses “flexible wire 40 may be joined to wire segment 42 by the use of solder, a weld, an adhesive, or other known attachment method.” Cunningham et al. (hereinafter, Cunningham) teaches (e.g., fig. 6) a first ring member 226 on a pusher and a second ring member 276 attached to a stent as a suitable interconnection between a delivery catheter and the implant. Cunningham further teaches that the connection interface wire can be of any cross-sectional shape (see para. 44), thus it would have been obvious to have provided the wire in tube form as an obvious alternate design suitable for the intended purpose of interfacing with the stent. Because Grandfield teaches known attachment methods may be used to interconnect the flexible wire 40 and wire segment 42, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have utilized a first and second ring member as taught by Cunningham. This would provide a releasable interconnection suitable for manipulating the stent during delivery and implantation. This modification would have occurred using known methods and would have yielded predictable results.
Grandfield in view of Cunningham is explained supra, however, the combination lacks an electrode connected to the pusher for severing the first ring member, positioned proximal the first ring member, wherein the first ring member is electrolytically or thermolytically disengaged from the second ring member. Licata teaches a ribbon or wire ring member 182 interconnecting a prosthesis 88 and pusher 180. The ring member has an erodible section 184 (e.g., fig. 7B) that electrolytically degrades. The pusher member includes an electrode 186 for electrolytically degrading the wire to release the implant (e.g., fig. 7A, 7Bpara. 149). Licata teaches that an electrolytic connection between the implant and delivery device desirably restrains the implant so as to reduce sleeve hold down and/or withdrawal forces (para. 23). Therefore it would have been obvious to one of ordinary skill in the art to have provided an electrolytically erodible release on the Grandfield and Cunningham ring member 151a as an alternate means of releasing the components from one another which desirably reduces sleeve hold down and/or withdrawal forces. Use of thermolysis is considered an obvious expedient in using an electrolytical degradation in that one of ordinary skill in the art would find it obvious to select a thermolytically degradable wire as obvious selection of an electrolytically degradable wire (in other words, using the same electrical current to degrade the wire by heat).
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.
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/SUBA GANESAN/Primary Examiner, Art Unit 3774