DETAILED ACTION
The following Office Action is in response to the Non-Provisional Patent Application filed on November 21, 2024. Claims 1-20 are currently pending.
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.
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.
Claim 16 is 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. Line 1 of the claim recites “the one or more steering wires”. However, there is a lack of antecedent basis for this limitation in the claim. For the purposes of compact prosecution, the claim will be interpreted as being dependent on claim 15.
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.
Claim(s) 1-6, 8, and 10-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maslanka et al. (US 2012/0143301, hereinafter Maslanka) in view of Quinn et al. (US 2007/0162048, hereinafter Quinn).
Concerning claim 1, the Maslanka et al. prior art reference teaches a medical assembly for treating a left atrial appendage (LAA) ([¶ 0043]), the medical assembly comprising: a delivery device (Figure 1; 1) adapted to deliver an occlusive implant to the LAA, the delivery device including: one or more steering wires adapted to releasably engage an occlusive implant (Figure 1; 100); an engagement member (Figure 6; 40, 41) movable between an engaged position in which the one or more engagement steering wires are held engaged with the occlusive implant (Figure 5 | Figure 9) and a disengaged position in which the one or more steering wires are released from engagement with the occlusive implant (Figure 6 | Figure 9), an occlusive implant adapted to be delivered via the delivery device (Figure 1; 2), the occlusive implant including: an expandable frame configured to shift between a first configuration and an expanded configuration ([¶ 0047]); and a steering interface coupled to the expandable frame (Figure 7; 200), the steering interface adapted to releasably engage the one or more steering wires when the engagement member is in the engaged position (Figure 8), but it does not specifically teach an occlusive covering extending over at least a part of the expandable frame.
However, the Quinn reference teaches an occlusive implant for treating a left atrial appendage, therein being in the same field of endeavor as the Maslanka reference, wherein the Quinn reference teaches the occlusive implant including an expandable frame configured to shift between a first configuration and an expanded configuration (Figure 4; 46) and an occlusive covering extending over at least part of the expandable frame (Figure 4; 48).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the occlusive implant of the Maslanka reference include the occlusive covering of the Quinn reference to facilitate rapid endothelialization and healing within the LAA (Quinn; [¶ 0055]).
Concerning claim 2, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 1, wherein the Maslanka reference further teaches the steering interface comprising an at least hemispherical interface (Figure 7; 200).
Concerning claim 3, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 1, wherein the Maslanka reference further teaches the at least hemispherical interface comprising an outer surface and one or more indentations formed within the outer surface (Figure 9; distal indentation of the interface 200 engages wire).
Concerning claim 4, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 2, wherein the Maslanka reference further teaches the distal end of each of the one or more steering wires comprising an enlarged diameter distal tip (Figure 13; distal tip 140 tapers wider than wire 100 therein defining an enlarged diameter).
Concerning claim 5, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 1, wherein the Maslanka reference further teaches an outer shaft through which the one or more steering wires extend ([¶ 0047], delivery catheter may define outer shaft).
Concerning claim 6, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 1, wherein the Maslanka reference further teaches the delivery device further comprising a deployment member extending through the outer shaft ([¶ 0047]), proximal portion of the steering wire 100 attached to the handle, which is introduced through a delivery catheter may be interpreted as a deployment member).
Concerning claim 8, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 1, wherein the Maslanka reference further teaches that the deployment member may be interpreted as a midshaft, given it is a portion of the shaft of the delivery wire that exists in the middle of the distal end and handle.
Concerning claim 10, the Maslanka et al. prior art reference teaches a medical assembly for treating a left atrial appendage (LAA) ([¶ 0043]), the medical assembly comprising: an occlusive implant adapted to be delivered via the delivery device (Figure 1; 2), the occlusive implant including: an expandable frame configured to shift between a first configuration and an expanded configuration ([¶ 0047]); and a spherical interface coupled to the expandable frame (Figure 7; 200); and a delivery device (Figure 1; 1) adapted to deliver an occlusive implant to the LAA, the delivery device including: an elongate deployment mechanism (Figure 7; 150) having a distal anchor point (Figure 2; distal end of 150 coupled to interface 140); a basket secured to the distal anchor point of the elongate deployment mechanism (Figure 6; 141), the basket movable between an engaged position in which the spherical interface is trapped within the basket (Figure 8), and a disengaged position in which the spherical interface is released from the basket (Figure 7); and a sheath slidingly disposed relative to the basket (Figure 6; 40), the sheath holding the basket in the engaged position when the sheath extends over the basket (Figure 8; 140), the sheath adapted to be withdrawn proximally in order to allow the basket to regain the disengaged position (Figure 6; arrow), but it does not specifically teach an occlusive covering extending over at least a part of the expandable frame.
However, the Quinn reference teaches an occlusive implant for treating a left atrial appendage, therein being in the same field of endeavor as the Maslanka reference, wherein the Quinn reference teaches the occlusive implant including an expandable frame configured to shift between a first configuration and an expanded configuration (Figure 4; 46) and an occlusive covering extending over at least part of the expandable frame (Figure 4; 48).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the occlusive implant of the Maslanka reference include the occlusive covering of the Quinn reference to facilitate rapid endothelialization and healing within the LAA (Quinn; [¶ 0055]).
Concerning claims 11-13, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 10, wherein the Maslanka reference further teaches the delivery device being adapted to allow the occlusive implant to pivot passively relative to the delivery device (Figure 10) and to also allow the distal anchor point to be steered given the delivery device is a torqueable wire that may direct and therein steer the implant through the vasculature, wherein said torque may be transferred to the interface to the implant via the distal anchor point.
Concerning claim 14, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 10, wherein the Maslanka reference further teaches the spherical interface being adapted to be free to rotate within the basket when the basket is in the engaged position, thereby allowing the occlusive implant to pivot relative to the delivery device (Figure 11).
Concerning claim 15, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 10, wherein the Maslanka reference further teaches delivery device further comprising one or more steering wires (Figure 2; 103) that are adapted to engage the distal anchor point given the distal anchor port is connected to the locking wire which is fed through the steering wire.
Concerning claim 16, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 15, wherein the Maslanka reference further teaches the one or more steering wires being secured to the distal anchor point (Figure 2; 103, 151 are secured relative to one another via the handle).
Concerning claim 17, the Maslanka et al. prior art reference teaches a left atrial appendage closure (LAAC) device, comprising: an expandable frame configured to shift between a first configuration and an expanded configuration ([¶ 0047]); and a spherical interface coupled to the expandable frame (Figure 7; 200), the spherical interface adapted to allow the LAAC device to pivot relative to the delivery device (Figure 11), but it does not specifically teach an occlusive covering extending over at least a part of the expandable frame.
However, the Quinn reference teaches an occlusive implant for treating a left atrial appendage, therein being in the same field of endeavor as the Maslanka reference, wherein the Quinn reference teaches the occlusive implant including an expandable frame configured to shift between a first configuration and an expanded configuration (Figure 4; 46) and an occlusive covering extending over at least part of the expandable frame (Figure 4; 48).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the occlusive implant of the Maslanka reference include the occlusive covering of the Quinn reference to facilitate rapid endothelialization and healing within the LAA (Quinn; [¶ 0055]).
Concerning claim 18, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 17, wherein the Maslanka reference further teaches an outer surface and one or more indentations formed within the outer surface (Figure 9; distal indentation of the interface 200 engages wire) each of the one or more indentations adapted to releasably engage each of one or more steering wires (Figure 10; 141).
Concerning claim 19, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 17, wherein the Quinn reference further teaches a steering interface including a radiopaque alloy ([¶ 0067]), wherein it would be further obvious to make the spherical interface of the Maslanka reference comprise a radiopaque alloy to allow the spherical interface to be tracked via imaging.
Concerning claim 20, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 17, wherein the Maslanka reference further teaches the medical implant being formed of Nitinol ([¶ 0091]), which is a nickel-titanium alloy, therein comprising titanium.
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maslanka et al. (US 2012/0143301, hereinafter Maslanka) in view of Quinn et al. (US 2007/0162048, hereinafter Quinn) as applied to claims 1-6, 8, and 10-20 above, and further in view of Lorenzo et al. (US 2007/0203519, hereinafter Lorenzo).
Concerning claims 7 and 9, the combination of the Maslanka and Quinn references as discussed above teaches the medical assembly of claim 1, but does not specifically teach the engagement member comprising a helical structure or a cylindrical coil extending from a distal end of the deployment member.
However, the Lorenzo reference teaches an occlusive implant (Figure 1; 40) having engagement member for engaging an interface of the occlusion implant (Figure 1; 34), therein being in the same field of endeavor as the Maslanka and Quinn combination, wherein the Lorenzo reference teaches that the engagement member comprises a helical structure of a cylindrical coil (Figure 1; 26) extending from a distal end of a deployment member (Figure 1; 14).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the engagement member of the Maslanka and Quinn combination be a helical structure of a cylindrical coil as in the Lorenzo reference as a simple substitution of one known steering interface structure (the holding structure of the Maslanka reference) for another known steering interface structure (the constriction component of the Lorenzo reference) which would yield the predictable result of providing for a steering interface structure that works in the same manner as that of the Lorenzo reference.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The West reference (US 2007/0179520) teaches an occlusive implant including a spherical interface that engages with an engagement member; the Morsi reference (US 2016/0051263) teaches an expandable framed implant including a steering wire and a pivoting spherical interface; and the Monstadt et al. reference (US 2023/0039773) teaches an expandable occlusive implant including a spherical interface.
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/MARTIN T TON/Examiner, Art Unit 3771 5/30/2026
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