DETAILED ACTION
The following Office Action is in response to the Non-Provisional Patent Application filed on October 18, 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 § 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, 5-9, 11-15, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Straub et al. (US 2012/0179181, hereinafter Straub).
Concerning claim 1, the Straub et al. prior art reference teaches a catheter assembly for removal of material from hollow bodies (Figures 1-3 & 12AB), comprising: an outer sheath (Figure 12A; 12); an inner thrombectomy catheter disposed inside of the outer sheath (Figure 3; 3), the inner thrombectomy catheter including a distal end and a conveyor (Figures 4-10), the distal end having a distal tip being closed (Figure 4; distal tip 8 is closed by guidewire 11) and a lateral opening such that the lateral opening receives a removed material (Figure 4; 8a), and the conveyor conveying the removed material toward a proximal end of the inner thrombectomy catheter (Figure 4; 10); and an expandable member disposed between the outer sheath and the inner thrombectomy catheter expanding radially when deployed from the outer sheath and contracting when retracted in the outer sheath (Figures 1-3 & 12AB; 5).
Concerning 5, the Straub reference teaches the catheter assembly of claim 1, wherein an end portion of the expandable member is configured to be substantially parallel to a longitudinal direction of the inner thrombectomy catheter when the expandable member is deployed and expanded (Figure 3; 3, 5).
Concerning claim 6, the Straub reference teaches the catheter assembly of claim 1, wherein the expandable member is substantially symmetric around an axis of the inner thrombectomy catheter (Figures 3 & 5; 5).
Concerning claim 7, the Straub reference teaches the catheter assembly of claim 1, wherein the expandable member is capable of being rotated around an axis of the inner thrombectomy catheter independently of the inner thrombectomy catheter given the inner thrombectomy catheter and expandable member are independent catheters (Figures 1-3).
Concerning claim 8, the Straub reference teaches the catheter assembly of claim 1, wherein the distal end of the inner thrombectomy catheter and the expandable member are capable of being radially overlapped when the expandable member is deployed from the outer sheath while performing removal of the material given the thrombectomy catheter is capable of independent advancement through the expandable member.
Concerning claim 9, the Straub et al. prior art reference teaches a method of using a catheter assembly for removal of material from hollow bodies (Figures 1-3), comprising: positioning the catheter assembly at a remote site (Figures 1-3 | [¶ 0059]), the catheter assembly comprising: an outer sheath (Figure 12A; 12); an inner thrombectomy catheter disposed inside of the outer sheath (Figure 3; 3), the inner thrombectomy catheter including a distal end and a conveyor (Figures 4-10), the distal end having a distal tip being closed (Figure 4; distal tip 8 is closed by guidewire 11) and a lateral opening such that the lateral opening receives a removed material (Figure 4; 8a), and the conveyor conveying the removed material toward a proximal end of the inner thrombectomy catheter (Figure 4; 10); and an expandable member disposed between the outer sheath and the inner thrombectomy catheter expanding radially when deployed from the outer sheath and contracting when the retracted in the outer sheath (Figures 1-3 & 12AB; 5); and advancing the expandable member in a distal direction of the inner thrombectomy catheter such that the expandable member is deployed and expanded radially ([¶ 0059], expandable member is advanced distally into hollow body and deployed before the inner thrombectomy catheter is then advanced in the same direction).
Concerning claim 11, the Straub reference teaches the method of claim 9, further comprising applying aspiration forces through the lateral opening ([¶ 0035]).
Concerning claim 12, the Straub reference teaches the method of claim 9, further comprising receiving the removed material through the lateral opening, and conveying the removed material toward the proximal end of the inner thrombectomy catheter by the conveyor ([¶ 0057-0058]).
Concerning claim 13, the Straub reference teaches the method of claim 9, further comprising retracting the expandable member in the outer sheath ([¶ 0054]).
Concerning claim 14, the Straub et al. prior art reference teaches a catheter assembly for removal of material from hollow bodies (Figures 1-3 & 12AB), comprising: an outer sheath (Figure 12A; 12); an inner thrombectomy catheter disposed inside of the outer sheath (Figure 3; 3), the inner thrombectomy catheter including a distal end and a conveyor (Figures 4-10), the distal end having a distal tip (Figure 4; 8) and a lateral opening such that the lateral opening receives a removed material (Figure 4; 8a), and the conveyor conveying the removed material toward a proximal end of the inner thrombectomy catheter (Figure 4; 10); and an expandable member disposed between the outer sheath and the inner thrombectomy catheter expanding radially when deployed from the outer sheath and contracting when retracted in the outer sheath (Figures 1-3 & 12AB; 5); and a guidewire extendable through the inner thrombectomy catheter (Figure 3; 11).
Concerning claim 15, the Straub reference teaches the surgical device of claim 14, wherein the expandable member is capable of being rotated around an axis of the inner thrombectomy catheter independently of the inner thrombectomy catheter given the inner thrombectomy catheter and expandable member are independent catheters (Figures 1-3).
Concerning claim 19, the Straub reference teaches the surgical device of claim 14, wherein the distal end of the inner thrombectomy catheter and the expandable member are capable of being radially overlapped when the expandable member is deployed from the outer sheath while performing removal of the material given the thrombectomy catheter is capable of independent advancement through the expandable member.
Concerning claim 20, the Straub reference teaches the surgical device of claim 14, further comprising an aspiration device coupled to the inner thrombectomy catheter to create suction within the inner thrombectomy catheter ([¶ 0057], aspiration provided by feed screw 10).
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) 2-4 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Straub et al. (US 2012/0179181, hereinafter Straub) in view of Garcia et al. (US 2008/0269774, hereinafter Garcia).
Concerning claims 2-4 and 17-18, the Straub reference teaches the catheter assembly of claim 1 and the surgical device of claim 14, but does not specifically teach the expandable member including at least one prong that extends axially in a distal direction of the inner thrombectomy catheter.
However, the Garcia reference teaches a catheter assembly for removal of material from hollow bodies similar to that of the Straub reference, wherein the Garcia reference teaches an outer sheath (Figure 16A; 30), an inner thrombectomy catheter disposed inside the outer sheath (Figure 16A; 123), and an expandable member (Figure 16A; 121) disposed between the outer sheath and the inner thrombectomy catheter expanding radially when deployed from the outer sheath (Figure 5) and contracting when retracted in the outer sheath (Figure 4), wherein the expandable member may include six prongs that extend axially in a distal direction of the inner thrombectomy catheter (Figure 17A; 20).
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 replace the expandable member of the Straub reference with an expandable member including prongs as in the Garcia reference to allow the expandable member to be used to grasp and clamp down on an object to be removed (Garcia; [¶ 0086]).
Claim(s) 10 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Straub et al. (US 2012/0179181, hereinafter Straub) in view of Dryden (US 2015/0327876).
Concerning claim 10, the Straub reference teaches the method of claim 9, but does not specifically teach rotating the expandable member around an axis of the thrombectomy catheter.
However, the Dryden reference teaches a method of using a catheter assembly at a removal site including an expandable capture basket similar to that of the Straub reference, wherein the Straub reference teaches that the expandable capture basket may be rotated around an axis ([¶ 0019]).
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 method of the Straub reference include rotating the expandable member around an axis of the inner thrombectomy catheter as in the Dryden reference to assist in approaching, engaging, ensnaring, and removing the material from a hollow body (Dryden; [¶ 0019]).
Concerning claim 16, the Straub reference teaches the surgical device of claim 15, but does not specifically teach a driving mechanism to rotate the expandable member.
However, the Dryden reference teaches a catheter assembly for removal of material from hollow bodies including an expandable capture basket similar to that of the Straub reference, wherein the Dryden reference teaches that the expandable capture basket may be rotated around an axis by a drive mechanism such as a knob ([¶ 0011]).
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 surgical device of the Straub reference include a driving mechanism to rotate the expandable member as in the Dryden reference to assist in approaching, engaging, ensnaring, and removing the material from a hollow body by transferring rotation from the handle to the expandable member (Dryden; [¶ 0019]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Follmer et al. reference (US 2021/0267613) teaches a catheter assembly for obstruction removal including an inner thrombectomy catheter comprising a conveyor and an expandable member; the Syed reference (US 2019/0357926) teaches a catheter assembly for obstruction removal including an inner thrombectomy catheter and an expandable member including prongs; the Scarpine et al. reference (US 2017/0119407) teaches a thrombectomy catheter including a distal end having a distal tip being closed and a lateral opening; and the Noriega et al. reference (US 2013/0289578) teaches a catheter assembly for removal of material from hollow bodies including an expandable member comprising prongs, the expandable member being rotatable about an axis via a drive mechanism.
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/MARTIN T TON/Examiner, Art Unit 3771 1/8/2026