DETAILED ACTION
The following Office Action is in response to the Amendment filed on April 27, 2026. Claims 1-22 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 .
Response to Arguments
Concerning the “Rejections under 35 U.S.C. § 102(a)(1) and § 103: Rejection of Independent claim 1” section on pages 7-8 of the Applicant’s Response filed on April 27, 2026, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
Concerning the “Rejections under 35 U.S.C. § 102(a)(1) and § 103: Rejection of Independent claim 9” section on pages 8-9 of the Applicant’s Response filed on April 27, 2026, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
Concerning the “Rejections under 35 U.S.C. § 102(a)(1) and § 103: Rejection of Independent claim 9” section on pages 9-10 of the Applicant’s Response filed on April 27, 2026, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the Straub reference does not teach or suggest “wherein a distal end of the expandable member is positioned proximal to a portion of the thrombectomy catheter when retracted in the outer sheath”, arguing that the Straub reference instead teaches the reducing catheter is deployed after deployment of the expandable member. However, the examiner asserts that this limitation is an intended use limitation, drawn to the functionality or intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the Straub reference teaches that the inner thrombectomy catheter and the expandable member are completely independent catheters as indicated by the methods of introducing the catheters (Figure 1-3), wherein given they are independent and separate catheters, the catheters may be inserted, withdrawn, and moved relative to each other in any way desired by the user. Thus, the inner thrombectomy catheter is completely capable of being deployed first within the blood vessel, and then having the expandable member and outer sheath translated over the inner thrombectomy catheter such that a distal end of the expandable member is positioned proximal to a portion of the inner thrombectomy catheter when retracted in the sheath, therein resulting in the same structure as claimed despite using the Straub device in a manner different as disclosed. Therefore, the rejection of claims 14 and its dependent claims stand.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim recites the limitation of “wherein the expandable member is rotatable around an axis of the inner thrombectomy catheter independently of the inner thrombectomy catheter”, which has already been claimed in independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 14-15 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 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), wherein a distal end of the expandable member is capable of being positioned proximal to a portion of the thrombectomy catheter when retracted in the outer sheath (thrombectomy catheter and expandable member are completely independent catheters (Figure 1-3), wherein given they are independent and separate catheters, the catheters may be inserted, withdrawn, and moved relative to each other in any way desired by the user).
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) 1, 5-8, 16, and 21 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 claims 1 and 7, 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), 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), but does not specifically teach a rotational mechanism coupled to 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 rotational 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 rotational 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]).
Concerning 5, the combination of the Straub and Dryden references as discussed above teaches the catheter assembly of claim 1, wherein the Straub reference further teaches an end portion of the expandable member being 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 combination of the Straub and Dryden references as discussed above teaches the catheter assembly of claim 1, wherein the Straub reference further teaches wherein the expandable member being substantially symmetric around an axis of the inner thrombectomy catheter (Figures 3 & 5; 5).
Concerning claim 8, the combination of the Straub and Dryden references as discussed above teaches the catheter assembly of claim 1, wherein the Straub reference further teaches the distal end of the inner thrombectomy catheter and the expandable member being 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 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]).
Concerning claim 21, the combination of the Straub and Dryden references as discussed above teaches the catheter assembly of claim 1, wherein the Straub reference further teaches a distal end of the expandable member being capable of being positioned proximal to a portion of the thrombectomy catheter when retracted in the outer sheath (thrombectomy catheter and expandable member are completely independent catheters (Figure 1-3), wherein given they are independent and separate catheters, the catheters may be inserted, withdrawn, and moved relative to each other in any way desired by the user).
Claim(s) 2-4 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) as applied to claims 1, 5-8, and 21 above, and further in view of Garcia et al. (US 2008/0269774, hereinafter Garcia).
Concerning claims 2-4, the combination of the Straub and Dryden references as discussed above teaches the catheter assembly of claim 1, 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 and Dryden references, 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 and Dryden combination 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) 9, 11-13, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Straub et al. (US 2012/0179181, hereinafter Straub) in view of Sepetka et al. (US 2002/0072764, hereinafter Sepetka).
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), but does not specifically teach a distal end of the expandable member passing a portion of the inner thrombectomy catheter.
However, the Sepetka reference teaches a method of using a catheter assembly for removal of material from hollow bodies, comprising: positioning the catheter assembly at a removal site (Figure 10), the catheter assembly comprising: an outer sheath (Figure 10; 4), an inner thrombectomy catheter disposed inside of the outer sheath (Figure 10; 106), 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 (Figure 10; 102); and advancing the expandable member in a distal direction of the inner thrombectomy catheter such that the expandable member is deployed and expanded radially and a distal end of the expandable member passes a portion of the inner thrombectomy catheter (Figures 11 & 12; [¶ 0107-0108]).
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 have the expandable member advanced over the inner thrombectomy catheter such that a distal end of the expandable member passes a portion of the inner thrombectomy catheter as in the Sepetka reference as a simple substitution of one known method of inserting a catheter assembly for removal of material from hollow bodies (expandable member is inserted first and the inner thrombectomy catheter is advanced through the lumen of the expandable member as in the Straub reference) for another known method of inserting a catheter assembly for removal of material from hollow bodies (inner thrombectomy catheter is advanced first and the expandable member is advanced over the inner thrombectomy catheter as in the Sepetka reference), which would yield the predictable result of ultimately leading to the same procedural outcome and operating in essentially the same manner.
Concerning claim 11, the combination of the Straub and Sepetka references as discussed above teaches the method of claim 9, wherein the Straub reference further teaches applying aspiration forces through the lateral opening ([¶ 0035]).
Concerning claim 12, the combination of the Straub and Sepetka references as discussed above teaches the method of claim 9, wherein the Straub reference further teaches 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 combination of the Straub and Sepetka references as discussed above teaches the method of claim 9, wherein the Straub reference further teaches retracting the expandable member in the outer sheath ([¶ 0054]).
Concerning claim 22, the combination of the Straub and Sepetka references as discussed above teaches the method of claim 9, wherein the combination results in the portion of the inner thrombectomy catheter being exposed external to the outer sheath while advancing the expandable member in the distal direction of the inner thrombectomy catheter (Sepetka; [¶ 0107-0108]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Straub et al. (US 2012/0179181, hereinafter Straub) in view of Sepetka et al. (US 2002/0072764, hereinafter Sepetka) as applied to claims 9, 11-13, and 22 above, and further in view of Dryden (US 2015/0327876).
Concerning claim 10, the combination of the Straub and Sepetka references as discussed above 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 and Sepetka combination 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]).
Claim(s) 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 17-18, the Straub reference teaches 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]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARTIN T TON/Examiner, Art Unit 3771 7/10/2026
Prosecution Insights