DETAILED ACTION
The following Office Action is in response to the Non-Provisional Patent Application filed on April 25, 2025. Claims 1-15 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 Objections
Claims 2, 10, and 12 are objected to because of the following informalities:
Concerning claim 2, lines 2-3 of the claim recite the phrase “to the target area expandable during and after deployment”, wherein the word “expandable” appears to be mistakenly added.
Concerning claim 10, lines 1-2 of the claim recite the phrase “two tethers arranged configured to couple”, wherein the word “arranged” appears to be mistakenly added.
Concerning claim 12, line 1 of the claim recites the phrase “the sleeve comprises layer”, wherein the word “layer” should be preceded by an article.
Appropriate correction is required.
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 5, 10, and 14 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.
Concerning claim 5, line 2 of the claim recites the limitation of “the at least one tether” and line 3 of the claim recites the limitation of “the portion of the expandable device”. There is a lack of antecedent basis for both of these limitations in the claim. For the purposes of compact prosecution, the limitations will be interpreted as “at least one tether” and “a portion of the expandable device”, respectively.
Concerning claim 10, line 2 of the claim recites the limitation of “the two or more locations”. There is a lack of antecedent basis for this limitation in the claim. For the purposes of compact prosecution, the limitation will be interpreted as reading “two or more locations”.
Concerning claim 14, line 1 of the claim recites the limitation of “the actuation lines”, wherein only one actuation line has been claimed, therein making it indefinite as whether a plurality of actuation lines exist. For the purposes of compact prosecution, the limitation will be interpreted as being “the actuation line”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baylis (WO 2012/136984).
Concerning claim 1, the Baylis prior art reference teaches a delivery system (Figure 5) comprising: a catheter having a leading end and a trailing end (Figure 2; 10); an expandable device arranged near the leading end of the catheter (Figure 5; 200), and including a proximal end (Figure 5; proximal end may be interpreted as the end towards the nose cone 100), a distal end, and a flow lumen extending therebetween, an actuation line (Figure 1; 20) including a first branch and a second branch (Figure 1; 30) coupled to the expandable device at different locations (Figure 5; 31) configured to facilitate maintaining at least a portion of the expandable device substantially perpendicular to a target area (Figure 5; arms 30 hold open proximal end of expandable device to keep it perpendicular to the longitudinal axis of a vessel).
Concerning claim 2, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line is configured to maintain the portion of the expandable device substantially perpendicular to the target area during and after deployment (the arms will hold the proximal end of expandable device in a perpendicular orientation when the expandable device is in both a collapsed and expanded configuration).
Concerning claim 3, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line is configured to mitigate against non-perpendicular, angled, or flat deployment, given the abutment of the arms pushing open the proximal end of the expandable member (Figure 5).
Concerning claim 4, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line is configured to maintain the proximal end of the expandable device approximately perpendicular to an inflection point in a curvature of a tortious vessel during delivery of the expandable device.
Concerning claim 5, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line is coupled to the expandable device adjacent the proximal end via at least one tether (Figure 5; 50) arranged through the actuation wire and a portion of the expandable device (Page 7, Lines 28-33).
Concerning claim 6, the Baylis reference teaches the delivery system of claim 1, wherein the first branch and the second branch are coupled to the expandable device near the proximal end thereof (Figure 5; 30).
Concerning claim 7, the Baylis reference teaches the delivery system of claim 1, wherein the first branch and second branch are configured to steer the expandable device by distributing forces that result from a user manipulating or applying force to the actuation line to steer the expandable device (expandable device is steered via catheter 10 which in turn transmits a pushing force to the first and second branch of actuation line 20 which in turn transmits a force to a proximal end of the expandable device).
Concerning claim 8, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line is configured to remain in tension through a length thereof when force is applied to the actuation line by the user (thread 60 may be pulled to keep the actuation line in a collapsed configuration, which may be interpreted as the actuation line being in tension while the actuation line is being pushed | Page 7, Lines 14-20).
Concerning claim 9, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line includes a stiffness such that the actuation line does not become relaxed or slacked in response to the user applying force to steer the expandable device proximally or distally (Page 6, Lines 22-27, actuation line is formed of nitinol, which is a stiff material that does not become relaxed or slack).
Concerning claim 10, the Baylis reference teaches the delivery system of claim 1, further comprising two tethers configured to couple the actuation wire to two locations on the expandable device (Figure 3; 50).
Concerning claim 11, the Baylis reference teaches the delivery system of claim 1, further comprising a sleeve attached to an exterior portion of the expandable device through which the actuation wire is arranged (Figure 5; flexible sheet material forming graft of 200 defines a sleeve).
Concerning claim 12, the Baylis reference teaches the delivery system of claim 11, wherein the sleeve comprises a layer of graft material that forms a lumen between the sleeve and the expandable device (Figure 5; 200 flexible sheet defines graft to form lumen).
Concerning claim 13, the Baylis reference teaches the delivery system of claim 1, wherein the sleeve includes a shorter length than the expandable device (Figure 5; sleeve may be interpreted as only being the proximal portion of stent graft material, and not including the legs).
Concerning claim 14, the Baylis reference teaches the delivery system of claim 1, wherein the actuation line includes a bifurcation including the first branch and the second branch (Figure 1; 30).
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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baylis (WO 2012/136984) in view of Trout, III et al. (US 2003/0195607, hereinafter Trout).
Concerning claim 15, the Baylis reference teaches the delivery system of claim 1, but does not specifically teach the first branch and the second branch being coupled to the expandable device by an adhesive.
However, the Trout reference includes an expandable graft including attachment wires, therein being in the same field of endeavor as the Baylis reference, wherein the Trout reference teaches that adhesives may be an alternative for attaching and releasing attachment wires to a graft, which is an obvious alternative to other suitable release mechanisms ([¶ 0077]).
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 first branch and the second branch of the Baylis reference be coupled to the expandable device by an adhesive as in the Trout reference as an obvious alternative for attaching and releasing the first and second branch to the expandable device (Trout; [¶ 0077]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Furst et al. reference (US 2007/0043381) teaches a delivery system with an actuation line including a first branch and second branch; the Goddard et al. reference (US 2011/0125252) teaches a delivery system including an expandable device held open by two elongate structures; the Ryan et al. reference (US 2016/0296352) teaches a delivery system including an expandable device with multiple branching attachment sutures; and the Arbefeuille et al. reference (US 2018/0071123) teaches a delivery system including an actuation line including a first branch and second branch.
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/MARTIN T TON/Examiner, Art Unit 3771 6/9/2026
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