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 .
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:
1. "a buckle-reducing member that is adapted to reduce collapsibility" in claims 1, 11.
2. “stretch-reducing member that is adapted to reduce stretchability within the deployment sheath” in claims 1, 11.
3.” Wherein the buckle-reducing braided member is adapted to resist crumpling in response to an applied compressive force” in claim 18.
4. “Wherein the stretch-reducing braided member is adapted to resist elongation in response to an applied tensile force” in claim 19.
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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Munsinger et al. US 20130110223 A1, herein referred to as Munsinger, in view of Adams et al. US 8574219 B2, herein referred to as Adams, as evidenced by Nargatti K, Ahankari S. Advances in enhancing structural and functional fatigue resistance of superelastic NiTi shape memory alloy: A Review. Journal of Intelligent Material Systems and Structures. 2021;33(4):503-531. doi:10.1177/1045389X211023582, herein referred to as Nargatti.
Regarding claim 1, Munsinger discloses a stent delivery system (Annotated Fig. 1, stent delivery system 10 below) adapted to deliver and release a self-expanding stent (Annotated Fig. 3, stent 34 below, [0004], lines 1-4) with reduced energy loss within the stent delivery system ([0041], lines 11-14, Musinger teaches using lubrication in system), the stent delivery system, comprising: an inner member (Annotated Fig. 3, inner shaft 20 below) including a stent receiving region (Annotated Fig. 3, below) adapted to accommodate a self-expanding stent therein [0034]; a proximal member (Fig. 5, outer member 50) extending coaxially about the inner member ([0041]), the proximal member having a distal end terminating near the stent receiving region (Annotated Fig. 1 below, [0026]); a deployment sheath (Fig. 4, deployment sheath 16) extending coaxially about the inner member and the proximal member ([0041], “Thus, along at least a portion of the length of system 10, system 10 may include four tubular structures that may be coaxially arranged--namely outer member 50, deployment sheath 16, intermediate tube 36, and inner member 20”, Annotated Fig 1 below, elements share the same axis), the deployment sheath movable between a distal position in which the deployment sheath constrains the self-expanding stent (Fig. 4) and a proximal position ([0041], [0042], abstract, [26], [36] slidable deployment sheath which moves from a distal position to a proximal position) in which the self-expanding stent is no longer constrained by the deployment sheath ([0026]), the deployment sheath including a stretch-reducing member (Fig. 5, reinforcement 51; this element is interpreted under 112(f) as a “stainless steel braid, coil, mesh”, see [0070] of the instant application, and equivalents thereof [0041]) that is adapted to reduce stretchability within the deployment sheath [0041]; wherein a reduced collapsibility of the proximal member and a reduced stretchability of the deployment sheath together reduce energy loss within the stent delivery system ([0057] & [0064], Musinger uses superelastic material. As evidenced by Nargatti, see page 505 ¶ 0002 & page 521 ¶0001, superelastic materials have reduced stretchability, collapsibility and energy loss by lowering strain in system when compared to non-superelastic materials.
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Musinger et al. Annotated Figure 1.
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Musinger et al. Annotated Figure 3.
Munsinger fails to disclose the proximal member including a buckle-reducing member that is adapted to reduce collapsibility within the proximal member
But Adams discloses a similar stent delivery system (Fig 1, catheter 10). Adams teaches the proximal member (Fig 2, strain relief member 32) including a buckle-reducing member (Fig 1, metallic tubular member 40, slotted hypotube; this element is interpreted under 112(f) as a “slotted hypotube” or “stainless steel braid flat wire ribbon” or “formed of a flat wire” or a “ribbon wire”, see [0065] of the instant application, and equivalents thereof) that is adapted to reduce collapsibility within the proximal member (Col 4, lines 23-42, Adams teaches flexibility in member, member would be capable of reducing collapsibility).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify Musinger to incorporate the proximal member including a buckle-reducing member that is adapted to reduce collapsibility within the proximal member as taught and suggested by Adams in order to provide flexibility (Adams Col 4, lines 23-42).
Regarding claim 2, the combination of Musinger and Adams as discussed above with regards to claim 1 teaches a gear rack assembly (Musinger Fig. 6, gear rack assembly 52) coupled to the deployment sheath (Musinger Fig. 4, deployment sheath 16, [0042]); and a handle (Musinger Fig. 1, handle 14) coupled to the inner member and to the deployment sheath [0006]; wherein the handle includes an actuation member (Musinger Fig 1, actuation member 18), the actuation member being coupled to the gear rack assembly so that actuation of the actuation member shifts the longitudinal position of the gear rack assembly and the deployment sheath relative to the stent receiving region (Musinger Annotated Fig. 3 above, [0026], retraction caused by the thumb actuator longitudinal shift as claimed).
Regarding claim 3, the combination of Musinger and Adams as discussed above with regards to claim 1 teaches wherein the deployment sheath (Musinger Fig. 4, deployment sheath 16) comprises: an inner polymeric layer (Adams Fig 3B, metallic tubular member 40, Col. 4, lines 6-22, alloys described meet the polymeric definition) and an outer polymeric layer (Adams Fig 3B, polymeric member 50), with the stretch-reducing member (Musinger Fig. 5, reinforcement 51) disposed between the inner polymeric layer and the outer polymeric layer (Musinger [0040]).
Regarding claim 4, the combination of Musinger and Adams as discussed above with regards to claim 3 teaches wherein the stretch-reducing member (Musinger Fig. 5, reinforcement 51) comprises a first braided member [0041].
Regarding claim 5, the combination of Musinger and Adams as discussed above with regards to claim 4 teaches the first braided member (Musinger Fig. 5, reinforcement 51) is adapted to resist elongation in response to an applied tensile force ([0038] & [0026]; Musinger teaches using an elongation member coupled to the deployment sheath to deliver stent, device cause elongation via tensile force as claimed).
Regarding claim 6, the combination of Musinger and Adams as discussed above with regards to claim 3 teaches wherein the buckle-reducing member (Adams Fig 3B, metallic tubular member 40), but does explicitly disclose wherein the buckle-reducing member is encapsulated within a polymeric layer.
However, Adams in another embodiments discloses a similar stent delivery system. Adams teaches wherein the buckle-reducing member is encapsulated within a polymeric layer (Adams Fig 3B, polymeric member 50).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify the combination of Musinger and Adams to incorporate wherein the buckle-reducing member is encapsulated within a polymeric layer as taught and suggested by Adams in order to tightly fit around the buckle-reducing member (Col 5, lines 32-49)
Regarding claim 7, the combination of Musinger and Adams as discussed above with regards to claim 6 teaches wherein the buckle-reducing member (Adams Fig 3B, metallic tubular member 40) extends a substantial fraction of a length of the proximal member (Musinger Fig 2, strain relief member 32, meets claimed limitation coverage).
Regarding claim 8, the combination of Musinger and Adams as discussed above with regards to claim 6 teaches wherein the buckle-reducing member (Adams Fig 3B, metallic tubular member 40) comprises a second braided member (Adams, Fig 3B, inner tubular member 24, figure shows braiding similar to other braided elements in disclosure).
Regarding claim 9, the combination of Musinger and Adams as discussed above with regards to claim 8 fails to disclose wherein the second braided member is adapted to resist buckling in response to an applied compressive force.
However, Musinger in another embodiment discloses a similar stent delivery system including a braided member. Musinger also teaches wherein the second braided member is adapted to resist buckling (Fig 4, reinforcement member 42; in response to an applied compressive force (Fig 4, reinforcement member 42, [0038], Reinforcement member 42 supports deployment sheath in applied to constrained force, i.e., compressive).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify the combination of Musinger and Adams to incorporate wherein the second braided member is adapted to resist buckling in response to an applied compressive force as taught and suggested by Musinger in order to provide reinforcement [0040].
Regarding claim 10, the combination of Musinger and Adams as discussed above with regards to claim 1 teaches wherein the stent delivery is adapted for delivering self-expanding stents (stent 34 above, [0033]).
Regarding Claim 11, Munsinger discloses: A stent delivery system (Annotated Fig. 1, stent delivery system 10 above) adapted to deliver and release a self-expanding stent (Annotated Fig. 3, stent 34 above, [0004], lines 1-4) with improved force transmission efficiency within the stent delivery system ([0041], lines 11-14, Musinger teaches using lubrication in system), the stent delivery system, comprising: an inner member (Annotated Fig. 3, inner shaft 20 above) including a stent receiving region (Annotated Fig. 3, above) adapted to accommodate a self- expanding stent therein [0034]; a proximal member extending coaxially about the inner member [0041], the proximal member (Fig. 5, outer member 50) extending proximally from near the stent receiving region (Annotated Fig. 1 above); a deployment sheath (Fig. 4, deployment sheath 16) extending coaxially about the inner member and the proximal member ([0041], “Thus, along at least a portion of the length of system 10, system 10 may include four tubular structures that may be coaxially arranged--namely outer member 50, deployment sheath 16, intermediate tube 36, and inner member 20”, Annotated Fig 1 above, elements share the same axis), the deployment sheath movable between a distal position in which the deployment sheath constrains the self-expanding stent and a proximal position in which the self-expanding stent is no longer constrained by the deployment sheath ([0041], [0042], abstract, [26], [36] slidable deployment sheath which moves from a distal position to a proximal position) the deployment sheath including a stretch-reducing member (Fig. 5, reinforcement 51 ; this element is interpreted under 112(f) as a “stainless steel braid, coil, mesh”, see [0070] of the instant application, and equivalents thereof [0041]) that is adapted to reduce stretchability within the deployment sheath [0041]; wherein a reduced collapsibility of the proximal member and the reduced stretchability of the deployment sheath together improve force transmission efficiency within the stent delivery system ([0057] & [0064],Musinger teaches using superelastic materials, as evidenced by Nargatti, see page 505 ¶ 0002 & page 521 ¶0001, superelastic materials have reduced stretchability, collapsibility and energy loss by lowering strain in system when compared to non-superelastic materials).
But Musinger fails to discloses wherein the proximal member including a buckle-reducing member that is adapted to reduce collapsibility within the proximal member.
But Adams discloses a similar stent delivery system (Fig 1, catheter 10). Adams teaches wherein the proximal member (Fig 2, strain relief member 32) including a buckle-reducing member (Fig 1, metallic tubular member 40, slotted hypotube; this element is interpreted under 112(f) as a “slotted hypotube” or “stainless steel braid flat wire ribbon” or “formed of a flat wire” or “a ribbon wire”, see [0065] of the instant application, and equivalents thereof) that is adapted to reduce collapsibility within the proximal member (Col 4, lines 23-42, Adams teaches flexibility in member, member would be capable of reducing collapsibility).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify the combination of Musinger and Adams to incorporate the proximal member including a buckle-reducing member that is adapted to reduce collapsibility within the proximal by Adams in order to provide flexibility (Adams Col 4, lines 23-42)
Regarding claim 12, the combination of Musinger and Adams as discussed above with regards to claim 11, but fails to disclose an outer polymeric layer; with the stretch-reducing member disposed between the inner polymeric layer and the outer polymeric layer.
However, in another embodiment Adams discloses a similar stent delivery system. Adams teaches an outer polymeric layer (Adams Fig 3B, polymeric member 50) with the stretch-reducing member (Musinger Fig. 5, reinforcement 51) disposed between the inner polymeric layer and the outer polymeric layer [0040].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify the combination of Musinger and Adams to incorporate an outer polymeric layer within the stretch-reducing member disposed between the inner polymeric layer and the outer polymeric layer as taught and suggested by Musinger in order to provide reinforcement [0040].
Regarding claim 13, the combination of Musinger and Adams as discussed above with regards to claim 12 teaches wherein the stretch-reducing member Musinger Fig. 5, reinforcement 51) comprises a first braided member [0041].
Regarding claim 14, the combination of Musinger and Adams as discussed above with regards to claim 11 teaches wherein the buckle-reducing member (Adams Fig 3B, metallic tubular member 40) is encapsulated within a polymeric layer (Fig 3B, polymeric member 50).
Regarding claim 15, the combination of Musinger and Adams as discussed above with regards to claim 14 teaches wherein the buckle-reducing member (Adams Fig 3B, metallic tubular member 40) extends a substantial fraction of a length of the proximal member (Adams Fig 2, strain relief member 32, meets claimed limitation coverage).
Regarding claim 16, the combination of Musinger and Adams as discussed above with regards to claim 15 teaches wherein the buckle-reducing member (Adams Fig 3B, metallic tubular member 40) comprises a second braided member (Adams, Fig 3B, inner tubular member, figure shows braiding similar to other braided elements in disclosure).
Regarding claim 17, Musinger discloses: A stent delivery system adapted to deliver and release a self-expanding stent, the stent delivery system, comprising: an inner member (Annotated Fig. 3, inner shaft 20 above) including a stent receiving region (Annotated Fig. 3, above) adapted to accommodate a self- expanding stent therein; a proximal bumper (Fig. 3, bumper 38) extending coaxially about the inner member (Fig 3, Bumper is proximal and coaxial to inner member as claimed), the proximal bumper including a buckle-reducing braided member (Fig 10, intermediate shaft 336) encapsulated within a polymeric layer ([0055-0056]); and a deployment sheath (Fig. 4, deployment sheath 16) extending coaxially about the inner member and the proximal member ([0041], “Thus, along at least a portion of the length of system 10, system 10 may include four tubular structures that may be coaxially arranged--namely outer member 50, deployment sheath 16, intermediate tube 36, and inner member 20”, Annotated Fig 1 below, elements share axis, the deployment sheath including a stretch-reducing braided member (Fig. 5, reinforcement 51, [41]) disposed between an inner polymeric layer and an outer polymeric layer ([0056]), the deployment sheath movable between a distal position in which the deployment sheath constrains the self-expanding stent and a proximal position ([0041], [0042], abstract, [26], [36] slidable deployment sheath which moves from a distal position to a proximal position) in which the self-expanding stent is no longer constrained by the deployment sheath ([0033], stent is biased to outwardly expand, when sheath is retracted as described from the stent receiving region stent would expand as claimed).
Regarding claim 18, the combination of Musinger and Adams as discussed above with regards to claim 17 teaches wherein the buckle-reducing braided member (Adams Fig 1, metallic tubular member 40, slotted hypotube; this element is interpreted under 112(f) as a “slotted hypotube” or “stainless steel braid flat wire ribbon” or “formed of a flat wire” or a “ribbon wire”, see [0065] of the instant application, and equivalents thereof) is adapted to resist crumpling in response to an applied compressive force (Col. 4, lines 23-41).
Regarding claim 19, the combination of Musinger and Adams as discussed above with regards to claim 17 teaches wherein the stretch-reducing braided member is adapted to (Musinger Fig. 5, reinforcement 51; this element is interpreted under 112(f) as a “stainless steel braid, coil, mesh”, see [0070] of the instant application, and equivalents thereof [0041]) resist elongation in response to an applied tensile force ([0038] & [0026] (Musinger teaches an elongation member coupled to the deployment sheath to deliver stent, device cause elongation via tensile force as claimed).
Regarding 20, the combination of Musinger and Adams as discussed above with regards to claim 17 teaches wherein the stent delivery (Musinger Fig 1, stent delivery system 10) is adapted for delivering peripheral stents (Musinger [0026]; stent delivery device is capable of delivering stents in the peripheral vasculature).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (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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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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