DETAILED ACTION
This Office Action is in response to the Amendment filed 5 February 2026. Claim(s) 1-16 and 22-26 are currently pending. The Examiner acknowledges the amendments to claim(s) 1, 13, 22 and 23, and cancelled claim(s) 17-21.
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 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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Samuels (US 5,908,435).
Regarding claim 13, Samuels discloses a medical aspiration device including an internal elongated element (60; Fig. 3) having an outer diameter small enough to enable fluids to flow between the internal elongated element and a catheter (9; C3:L42-44) within which the internal elongated element is positioned. The internal elongated element has a lumen with an inner diameter sufficient to receive a guide wire (44; Fig. 3). A bulbous tip (62; Fig. 3; C5:L5-7) is disposed at or adjacent to a distal end of the internal elongated element. The bulbous tip has a maximum outer diameter that is at least as large as an inner diameter (Fig. 3E) of a lumen of the catheter within which the internal elongated element is positioned. Fig. 3E shows that the maximum outer diameter of the bulbous tip is as large as the inner diameter of the lumen of the catheter. It is noted that the claims do not require the inner diameter to be maintained or constant. The bulbous tip includes a lumen with an inner diameter sufficient to receive the guide wire (Fig. 3D). While maintaining the maximum outer diameter, the bulbous tip is capable of being retracted into the lumen of the catheter (Fig. 3E).
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 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson (US 2014/0276644A1) in view of Samuels (US 5,908,435).
Regarding claims 1, Nelson discloses a medical aspiration device including an internal elongated element (106; Fig. 2) having an outer diameter small enough to enable fluids to flow between the internal elongated element and a catheter (104) within which the internal elongated element is positioned. Nelson discloses a bulbous tip (108) that may be an implant or a device used to provide therapeutic treatment [0011, 0017, it is noted that it is known to use a balloon or inflatable element as a therapeutic treatment]. The catheter is radially expandable when an implant or similar device is moved through it. Once the implant has passed, the tube contracts back to its native diameter, thus devices/implants larger than the catheter’s native diameter are capable of passing through [0011]. The elastic nature of the catheter prevents the larger devices/implants from damaging the catheter or from being damaged themselves [0011, 0017]. The bulbous tip having a maximum outer diameter that is at least as large as an inner diameter of a lumen of the catheter within which the internal elongated element is positioned, as shown in Fig. 3, while maintaining the maximum outer diameter the bulbous tip is capable of being retracted into the lumen of the catheter. A size and shape of the bulbous tip is capable of causing the implant/device to seal against a distal end of the catheter upon pulling the bulbous tip partially into and against the distal end of the catheter upon pulling the bulbous tip at least partially into the distal end of the catheter (Fig. 3; [0011, 0017, 0018]). However, Nelson does not expressly disclose that the internal elongated element has a lumen with an inner diameter sufficient to receive a guide wire.
In the same field of endeavor, catheters for delivering devices of providing therapeutic treatment [0002], Samuels teaches an internal elongated element (60; Fig. 3) and a catheter (9; C3:L42-44) within which the internal elongated element is positioned. The internal elongated element has a lumen with an inner diameter sufficient to receive a guide wire (44; Fig. 3). A bulbous tip (62; Fig. 3; C5:L5-7) is disposed at or adjacent to a distal end of the internal elongated element. The bulbous tip has a maximum outer diameter that is at least as large as an inner diameter (Fig. 3E) of a lumen of the catheter within which the internal elongated element is positioned. Since both Nelson and Samuels are directed to inner catheters having bulbous distal ends, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the internal elongated element of Nelson with a guide wire lumen, as taught by Samuels, for the predictable result of providing means to utilize and facilitate the movement of a guide wire while the internal elongated element is in use to ensure the correct placement or location of a treatment.
Regarding claim 6, the combination of Nelson and Samuels discloses that the bulbous tip includes a proximal side that is capable of sealing against the distal end of the catheter within which the internal elongated element positioned (Figs. 3; Nelson).
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Samuels, as applied to claim 1 above, and further in view of Zadno-Azizi et al. (US 6,068,623, “Zadno-Azizi”).
Regarding claims 2-4, the combination of Nelson and Samuels does not disclose that the internal elongated element is a hypotube. In the same field of endeavor, balloon catheters, Zadno-Azizi teaches a balloon catheter formed of a metal hypotube formed of nitinol, a shape memory alloy (C4:L40-45). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the catheter of the combination of Nelson and Samuels with the material, as taught by Zadno-Azizi, as this modification involves the simple substitution of one material for another for the predictable result of providing torqueability, flexibility and pushability characteristics to the catheter to enhance the handleability while maneuvering the elongated element through vasculature (C13:L5-10, 20-28, 64-68).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson, Samuels and Zadno-Azizi, as applied to claim 4 above, and further in view of Cribier et al. (US 4,777,951, “Cribier”).
Regarding claim 5, the combination of Nelson, Samuels and Zadno-Azizi does not disclose that the shape memory allow includes at least one bend. In the same field of endeavor, balloon catheters, Cribier teaches a catheter including a bend or curve in the shaft of the catheter forming an angle between 20 and 30 degrees (C5:L50-55, C12; L25-30) to provide means for facilitating movement within vasculature. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the catheter of the combination of Nelson, Samuels and Zadno-Azizi with a bend, as taught by Cribier, to assist in facilitating the passage of the element through vasculature (C5:L55-60).
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Samuels, as applied to claim 1 above, and further in view of Savastano et al. (US 2019/0038300A1, “Savastano”).
Regarding claims 7 and 8, the combination of Nelson and Samuels discloses a medical aspiration device as discussed above in claim 1, but does not disclose positioner is associated with a proximal portion of the internal elongated element to enable proximal and distal movement of the internal elongated element relative to the catheter.
In the same field of endeavor, movement of inner shafts of catheters, Savastano teaches a device having the concept of utilizing a positioner (28) that is spring-loaded (37) to move the internal elongate element (12) distally and proximally (Figs. 20A-23A, [0064]). Utilizing this concept with the device of the Wise would allow the positioner to enable the proximal and distal movement of the internal elongated element and bulbous tip with respect to the catheter. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to combine the concept of advancing the internal elongated element with a spring-loaded positioner, as taught by Savastano, with the device of the combination of Nelson and Samuels, for the purpose of fine tuning the distance between the internal elongated element and catheter [0066], as well as to better engage the material that is to be removed [0065].
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Samuels (US 5,908,435), as applied to claim 1 above, and further in view of Yamaguchi et al. (US 2005/0065544A1, “Yamaguchi”).
Regarding claims 9 and 10, the combination of Nelson and Samuels does not disclose that the bulbous tip includes a slant. In the same field of endeavor, balloon catheters, Yamaguchi teaches a bulbous tip including a proximal side having a slant that is flat and a circumferential taper (Fig. 5). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the shape of the bulbous tip of the internal elongated element of the combination of Nelson and Samuels with a bulbous tip having a proximal side that is flat, slanted and/or includes a circumferential taper, as taught by Yamaguchi, as this modification involves the simple substitution of one shape of a bulbous tip with another for the predictable result of facilitating retrieval.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of Samuels (US 5,908,435), as applied to claim 1 above, and further in view of Zadno-Azizi et al. (US 2001/0049517A1, “Zadno-Azizi”).
Regarding claims 11, the combination of Nelson and Samuels does not disclose a proximal side of the bulbous tip having one or more recesses in an outer surface of the proximal side.
In the same field of endeavor, catheters, Zadno-Azizi teaches a bulbous tip having one or more recesses (450; [0138]) in an outer surface of the proximal side (Fig. 27). The recesses expel irrigation fluid. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the proximal side of the bulbous tip of the combination of Nelson and Samuels with recesses, as taught by Zadno-Azizi, to provide means for flushing the treated area to remove particles and debris from the vessel [0138].
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samuels in view of Cribier et al. (US 4,777,951, “Cribier”).
Regarding claim 14, Samuels does not disclose that the shape memory allow includes at least one bend. In the same field of endeavor, balloon catheters, Cribier teaches a catheter including a bend or curve in the shaft of the catheter forming an angle between 20 and 30 degrees (C5:L50-55, C12; L25-30) to provide means for facilitating movement within vasculature. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the internal elongated element of Samuels with a bend, as taught by Cribier, to assist in facilitating the passage of the element through vasculature (C5:L55-60).
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samuels in view of Shah et al. (US 2007/0255255A1, “Shah”).
Regarding claims 14-16, Samuels does not disclose that the internal elongated element includes at least one bend. In the same field of endeavor, catheters, Shah teaches inner and outer catheters (14, 16; [0031]) including pre-shaped bends or curves, wherein the inner catheter is capable of counteracting the at least one bend of the outer catheter. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the catheter and internal elongated element of Samuels with bends and means for the internal elongated element to counteract the at least one bend, as taught by Shah, to assist in conforming to the natural shape of the vasculature.
Claim(s) 22 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samuels in view of Savastano et al. (US 2019/0038300A1, “Savastano”).
Regarding claims 22 and 25, Samuels discloses a medical aspiration device including an internal elongated element (60; Fig. 3) having an outer diameter small enough to enable fluids to flow between the internal elongated element and a catheter (9; C3:L42-44) within which the internal elongated element is positioned. The internal elongated element has a lumen with an inner diameter sufficient to receive a guide wire (44; Fig. 3). A bulbous tip (62; Fig. 3; C5:L5-7) is disposed at or adjacent to a distal end of the internal elongated element. The bulbous tip has a maximum outer diameter that is at least as large as an inner diameter (Fig. 3E) of a lumen of the catheter within which the internal elongated element is positioned. Fig. 3E shows that the maximum outer diameter of the bulbous tip is as large as the inner diameter of the lumen of the catheter. It is noted that the claims do not require the inner diameter to be maintained or constant. The bulbous tip includes a lumen with an inner diameter sufficient to receive the guide wire (Fig. 3D). While maintaining the maximum outer diameter, the bulbous tip is capable of being retracted into the lumen of the catheter. However, Samuels does not disclose that a positioner is associated with a proximal portion of the internal elongated element to enable proximal and distal movement of the internal elongated element relative to the catheter.
In the same field of endeavor, movement of inner shafts of catheters, Savastano teaches a device utilizing a positioner (28) that is spring-loaded (37) to move the internal elongate element (12) distally and proximally (Figs. 20A-23A, [0064]). Utilizing this concept with the device of the Wise would allow the positioner to enable proximal and distal movement of the internal elongated element and bulbous tip with respect to the catheter. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the concept of advancing the internal elongated element of Samuels with a spring-loaded positioner, as taught by Savastano, with the device of Samuels, for the purpose of fine tuning the distance between the internal elongated element and catheter [0066], as well as to better engage the material that is to be removed [0065].
Claim(s) 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samuels (US 5,908,435) in view of Savastano et al. (US 2019/0038300A1, “Savastano”), as applied to claim 22 above, and further in view of Zadno-Azizi et al. (US 6,068,623, “Zadno-Azizi”).
Regarding claims 23 and 24, the combination of Samuels and Savastano does not disclose that the internal elongated element is a hypotube. In the same field of endeavor, balloon catheters, Zadno-Azizi teaches a balloon catheter formed of a metal hypotube formed of nitinol, a shape memory alloy (C4:L40-45). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the catheter of Samuels with the material, as taught by Zadno-Azizi, as this modification involves the simple substitution of one material for another for the predictable result of providing torqueability, flexibility and pushability characteristics to the catheter to enhance the handleability while maneuvering the elongated element through vasculature (C13:L5-10, 20-28, 64-68).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samuels in view of Savastano, as applied to claim 22 above, and further in view of Zadno-Azizi et al. (US 2001/0049517A1, “Zadno-Azizi”).
Regarding claims 26, the combination of Samuels and Savastano does not disclose a proximal side of the bulbous tip having one or more recesses in an outer surface of the proximal side. In the same field of endeavor, bulbous tipped catheters, Zadno-Azizi teaches a bulbous tip having one or more recesses (holes, 450; [0138]) in an outer surface of the proximal side (Fig. 27). The recesses expel irrigation fluid. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the proximal side of the bulbous tip of the combination of Samuels and Savastano with recesses, as taught by Zadno-Azizi, to provide means for flushing the treated area to remove particles and debris from the vessel [0138].
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 13 and 22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bowe et al. (US 2003/0144657A1) discloses a device that includes varying stiffness and bends.
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 JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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, Jackie Ho can be reached on (571)272-4696. 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.
/JOCELIN C TANNER/Primary Examiner, Art Unit 3771