DETAILED ACTION
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 Amendment
The claims filed on December 23rd, 2025, have been entered. Claims 1, 3-5, 7-9, and 21-33 remain pending in the Application. Claims 2 and 6 have been canceled by the Applicant. Claims 31-33 have been added by the Applicant. The amendment to the Specification overcomes the specification objection. The claim amendments overcome the previous claim objection.
Response to Arguments
Examiner would like to note that claim 27 should be labeled as “previously presented” in the claims, rather than “new.” Failure to correct this discrepancy will lead to a non-compliant action under MPEP 714 and 37 CFR 1.121.
Applicant's arguments filed December 23rd, 2025, have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues that Walther et al. (U.S. Patent No. 6,419,639) does not disclose the limitation “when the first rod rotates from the first position to the second position, the first rod rotates at least 350 degrees” because Walther et al. does not explicitly disclose that the rotating rod is rotated 180 degrees twice in the same direction from a closed deployment position to a half-open position to a fully closed position in C8:L33-48, and it is equally or more plausible that Walther et al. rotates 180 degrees in a first direction and then 180 degrees in the opposite direction based on FIG. 3 and the bag/sac/drawstring/mouth terminology implying an enclosure of sufficient depth. Examiner respectfully disagrees. The rotation of the first rod between the first and second positions is a functional limitation, and the rotating rod of Walther et al. only needs to be capable of rotating 350 degrees to satisfy the claim limitation. Since the two rods 52 and 54 are disclosed as overlapping each other in the closed configuration, and no stops or other structural elements prevent the overlap from coming in either direction, 52 is capable of rotating at least 360 degrees relative to 54.
Regarding claim 21, Applicant argues that the surgical bags/sacs of Walther et al. disclosed in C6:L46-49 do not satisfy the limitation of “a net” because the bag is disclosed as being waterproof in C7:L4-7 and would not have a porous nature. Examiner respectfully disagrees. C7:L4-7 only states that it is desirable for the bag to be waterproof, not as a requirement, and the sac/bag/pouch is used to remove both solid and liquid elements, where removing solid elements would not require the waterproof quality. Further, C7:L21-28 states that when very high strength is desired, the bag can be constructed from fibers, which would require a braided/woven/knitted structure that would necessarily be porous.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “coupling member” in claim 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 7, 9, 21-27, 29-30, and 33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walther et al. (U.S. Patent No. 6,419,639).
Regarding claim 1, Walther et al. discloses an atraumatic thrombectomy device (10; C4:L3-5; FIGs. 1-3) for use in removing a clot from a vessel of a patient (C1:L25-29: pieces of cancerous mass, blood, and other objects are being removed from within a body cavity), the atraumatic thrombectomy device comprising:
a handle (20; C4:L5-6; FIG. 1) configured to be disposed exterior to the patient (at least part of the handle is capable of remaining in the hands of the operator and outside of the patient);
a knob (46) rotatably coupled to the handle (C4:L24-31: 46 is used to rotate the inner rod 40 within the tubular member 22; FIG. 1) and configured to be disposed exterior to the patient (the knob is capable of remaining in the hands of the operator and outside of the patient);
a net (C6:L46-49: surgical bags/sacs can be used with the device) configured to move between a collapsed position (C8:L25-28: the bag can have an initial closed configuration when being deployed into the body) and an open position (C8:L33-36: the bag can have an open configuration to allow for capture of the tissue mass), the net being configured to encapsulate the clot within the vessel of the patient when in the open position (C8:L33-36: the open configuration allows for tissue masses, such as a clot, to be encapsulated within the bag; this occurs after either one 180 degree rotation to open the bag, or two 180 degree rotations to enclose the tissue mass within the bag);
a first rod (52) coupled to the knob (C4:L49-53: 52 is attached to 46 through connection to 40) and the net (C6:L46-49: the surgical bag can be coupled to the leaf element 52); and
a second rod (54) coupled to the handle (C4:L60-63: 54 is attached to 22, which is part of 20; FIG. 1) and the net (C6:L46-49: the surgical bag can be coupled to the leaf element 54),
wherein each of the first and second rods comprise a linear segment and a curved segment extending from the linear segment (Annotated FIG. 1 below), the linear segment of the first rod being disposed parallel to the linear segment of the second rod (Annotated FIG. 1), the linear segment of the first rod being connected to the knob (Annotated FIG. 1: the first linear segment of 52 is connected to 46 through 40), the linear segment of the second rod be connected to the handle (Annotated FIG. 1: the first linear segment of 54 is connected to the outside of 22), the curved segment of the first rod being disposed parallel to the curved segment of the second rod (Annotated FIG. 3 below: when 52 is rotated to the closed position, the curved segments are parallel to each other), the curved segment of each of the first and second rods being configured to be disposed in the vessel of the patient (C6:L46-49 and C8:L33-36: since the curved segments hold the surgical bag that captures tissue masses from within the body, the curved segments are capable of being disposed within a vessel of a patient), and
wherein, responsive to the knob rotating with respect to the handle, the first rod is configured to rotate between a first position corresponding to the net being in the collapsed position (Annotated FIG. 3: in the initial closed position, 52 and 54 are overlapping each other with the surgical bag being unopened between them) and a second position corresponding to the net being in the open position (Annotated FIG. 3: when 52 is rotated, the bag opens until the bag is open and can be used to capture tissue masses, which can include a second rotation to fully enclose the tissue mass);
the device further comprising a coupling member (as noted above, this limitation is being interpreted under 112f because the generic placeholder “member” is coupled with the functional language “coupling” without reciting any structure to perform the “coupling” function; in the present Specification [0025], the coupling member is described as constriction ring 300, and therefore, any rings or equivalent structures for allowing rotation while keeping the rods aligned will be considered sufficient to satisfy the claim limitation; in Walther et al., 56 keeps 52 and 54 aligned while allowing for rotation between them) wherein the linear segment of the first and second rods is a first linear segment (Annotated FIG. 3), wherein each of the first and second rods further comprises a second linear segment (Annotated FIG. 3), wherein the curved segment of the first and second rods extends from the first linear segment to the second linear segment (Annotated FIG. 3), and wherein the coupling member connects the second linear segment of the first rod to the second linear segment of the second rod (Annotated FIG. 3) in order to allow rotation of the first rod while maintaining alignment between the first and second rods (C4:L66-C5:L4: 56 allows 52 to be rotated relative to 54 to move between open and closed configurations); and
the first rod rotates from the first position to the second position, the first rod rotates at least 350 degrees (C8:L33-39: the rotating rod 52 is first rotated 180 degrees to go from the closed deployment position to a half-open position where the surgical bag is held open and can capture the tissue masses; then, C8:L40-44: the rotating rod 52 can then be rotated a further 180 degrees in the same direction, for a total of 360 degrees, to a fully open position where the rods are back in alignment to close the surgical bag around the tissue mass for extraction; this is further supported by the feature noted in C8:L44-48 where the bag rotation isolates the tissue mass from the body cavity, but retains the ability to reopen to receive additional tissue masses).
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Regarding claim 7, Walther et al. further discloses the curved segment of the first rod and the curved segment of the second rod are configured to oppose a wall of the vessel of the patient (Annotated FIG. 1).
Regarding claim 9, Walther et al. further discloses the first linear segments and the second linear segments of the first and second rods extend from the curved segments of the first and second rods at corresponding junctions (Annotated FIG. 3), and wherein the net extends from each of the corresponding junctions in order to allow the clot to be encapsulated by the net in the open position (C6:L46-49: the surgical bag can be coupled to the leaf elements, which includes at the portions where the segments go from linear to curved).
Regarding claim 21, Walther et al. discloses a thrombectomy device (10; C4:L3-5; FIGs. 1-3), comprising in combination:
a pair of elongate rods including a first rod (54) and a second rod (40 and 52);
each of said rods extending from first ends to second ends (Annotated FIGs. 1 and 3 below: 40/52 and 54 extend from their proximal end linear segments to their distal linear segments), said second ends of said rods opposite said first ends (Annotated FIGs. 1 and 3: the proximal and distal linear segments of 40/52 and 54 are on opposite sides);
a net (C6:L46-49: surgical bags/sacs can be used with the device) between said first rod and said second rod and coupled to said first rod and said second rod (C6:L46-49: the surgical bag can be coupled to the leaf elements, placing the bag between 52 and 54, and coupled to both);
said net closer to said second ends of said rods than to said first ends of said rods (Annotated FIGs. 1 and 3: the bag is attached to the curved segments of 52 and 54, and the proximal linear segments are longer relative to the longitudinal axes of 40/52 and 54 than the distal linear segments, so the bag is closer to the distal end of 52 and 54 than the proximal end); and
at least one of said rods being a rotating rod (Annotated FIG. 3 below: 40/52 rotates) shaped to follow an orbital path for at least a portion of said rotating rod where said net is coupled thereto (Annotated FIG. 3: 52 follows the path illustrated by the arrow, which is where the bag is coupled to 52), when said rotating rod is rotated about a central axis of said rotating rod (Annotated FIG. 3: the curved portion of 52 rotates around the central axis formed by the linear elements of 52).
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Regarding claim 22, Walther et al. further discloses said rotating rod includes a curved segment (Annotated FIG. 3 above) with said net coupled to said rotating rod on at least a portion of said curved segment (C6:L46-49: the surgical bag can be coupled to the leaf elements, placing the bag on the curved segment in Annotated FIG. 3).
Regarding claim 23, Walther et al. further discloses each of said rods includes a curved segment (Annotated FIG. 3) with said net coupled to at least portions of each curved segment of each of said rods (C6:L46-49: the surgical bag can be coupled to the leaf elements, placing the bag on the curved segment in Annotated FIG. 3).
Regarding claim 24, Walther et al. further discloses said curved segment is curved with a concave side of said curved segment opposite a vessel wall when the device is located within the vessel (Annotated FIG. 1).
Regarding claim 25, Walther et al. further discloses at least two grippable structures (26, 46) are coupled to separate ones of said first ends of said pair of rods (C4:L24-31: 46 is used to rotate the inner rod 40 within the tubular member 22, which keeps the proximal ends of 52 and 54 apart; Annotated FIG. 1).
Regarding claim 26, Walther et al. further discloses said grippable structures include a handle (20) coupled to said first rod (C4:L60-63: 54 is attached to 22, which is part of 20; FIG. 1) and a knob (46) coupled to said second rod (C4:L49-53: 52 is attached to 46 through connection to 40), said second rod being said rotating rod with rotation of said knob causing rotation of said second rod about said central axis of said second rod to cause said second rod to follow said orbital path for said second rod (C4:L66-C5:L4: 56 allows 52 to be rotated relative to 54 to move between open and closed configurations).
Regarding claim 27, Walther et al. further discloses said handle surrounds said second rod (FIG. 1: 26 surrounds 40) and rotatably supports said second rod without fixation to said second rod (FIG. 1: 20 allows 52 to rotate by use of 46 rotating 40, despite no fixation between 20 and 40), and allowing rotation of said second rod relative to said handle (FIG. 3: 52 rotates relative to 20), and with said first rod fixed to said handle (FIG. 1: 54 is fixed to 20).
Regarding claim 29, Walther et al. further discloses said pair of rods are similar in shape (FIG. 1: 40/52 and 54 are almost identical).
Regarding claim 30, Walther et al. further discloses said pair of rods extend parallel from each other from said first ends to said second ends (FIG. 2: when 40/52 and 54 are rotated into alignment, they are parallel to each other along their entire length).
Regarding claim 33, Walther et al. further discloses said rotating rod rotates an amount greater than 180 degrees (as explained in the Response to Arguments above, the rotating rod rotates a total of 360 degrees in two 180-degree rotations).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walther et al. in view of Porter et al. (Pub. No. 2020/0085453).
Regarding claims 3-5, Walther et al. discloses the invention as claimed in claim 2, as discussed above. Walther et al. does not disclose the second rod has a channel and a plurality of holes, wherein the channel of the second rod is configured to receive medication for delivery to the clot via the plurality of holes, wherein the handle has a channel extending therethrough and in fluid communication with the channel of the second rod in order to allow the medication to be delivered through the handle to the channel of the second rod, and an attachment port disposed on the handle and configured to be connected to a syringe containing the medication such that the syringe injects the medication through the channels of the handle and the second rod and through the plurality of holes of the second rod.
Porter et al. teaches in the same field of endeavor of thrombectomy devices (Abstract), and discloses a handle (58; [0064]; FIGs. 7A and 8) comprising a channel (28) and an attachment port (56), and a rod (36; [0059]; FIG. 7A) comprising a channel (44) and a plurality of holes (46), wherein the attachment port is configured to be connected to a syringe containing the medication (16; [0066] 16 can be a syringe) such that the syringe injects the medication through the channels of the handle and the second rod and through the plurality of holes of the rod ([0066] 16 injects fluid into 28 and then 44, and out of 46), wherein the channel of the rod is configured to receive medication for delivery to the clot via the plurality of holes ([0066] 16 injects fluid into 44 to go out of 46), and wherein the channel of the handle is in fluid communication with the channel of the rod to allow the medication to be delivered through the handle to the channel of the rod ([0066] fluid from 16 passes through 28 and 44, meaning they are in fluid communication) for the purpose of dissolving clots that are too big to be removed ([0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the second rod and handle of Walther et al. to allow for the dispersion of medication to the clot to be removed, as taught by Porter et al., for the purpose of dissolving clots that are too big to be removed.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walther et al. in view of Kitaoka et al. (Pub. No. 2021/0000494).
Regarding claim 8, Walther et al. discloses the invention as claimed in claim 6, as discussed above, and further discloses the second linear segment of the first rod and the second linear segment of the second rod are bounded by the coupling member (Annotated FIG. 3). Walther et al. does not disclose the coupling member is a ring.
Kitaoka et al. teaches in the same field of endeavor of thrombectomy devices (Abstract), and discloses a medical device (10) comprising two rotational elements (20, 60; FIG. 2) coupled at their distal end by a coupling member (40), where the coupling member is a ring ([0024] 40 is a tubular member in the shape of a ring around 20 and 60) for the purpose of allowing for rotation of the rotational elements while preventing relative radial movement between the rotational elements ([0023-24]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the coupling member of Walther et al. (hinge) for the coupling member of Kitaoka et al. (ring) because both coupling members are disclosed as equivalent structures for connecting two rotational elements without preventing rotation between the elements, and the substitution of one coupling member for the other would have had the predictable result of allowing for rotation of the rotational elements while preventing relative radial movement between them.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walther et al. in view of Beulke et al. (U.S. Patent No. 7,875,051).
Regarding claim 32, Walther et al. discloses the invention as claimed in claim 21, as discussed above. Walther et al. is silent regarding the net includes stent-type netting.
Beulke et al. teaches in the same field of endeavor of embolic filtering devices (Abstract), and discloses a net (22) made of stent-type netting (FIG. 1) for the purpose of allowing blood flow while restricting the flow of debris or emboli floating in the body lumen or cavity (C2:L43-47).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the distal ends of Walther et al. to have the net include stent-type netting, as taught by Beulke et al., for the purpose of allowing blood flow while restricting the flow of debris or emboli floating in the body lumen or cavity.
Allowable Subject Matter
Claims 28 and 31 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 28, the prior art does not disclose, in combination with the remaining claim limitations, that the parallel linear segments are parallel with an axis of rotation of said rotating rod.
The closest prior art reference, Walther et al. (U.S. Patent No. 6,419,639), does not disclose, alone or in combination, that the parallel linear segments are parallel with an axis of rotation of said rotating rod. Instead, the parallel linear segments at their second end are perpendicular to the axis of rotation of the rotating rod 52 in FIGs. 1 and 3, and modifying the rods 52 and 54 to have the distal linear segments be parallel to both each other and the axis of rotation of 52 would prevent the rotation from occurring.
Claim 31 is allowable for their dependency on claim 28.
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 JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771