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 Amendment filed 8/20/25 has been entered. Claim 1 is amended. Claim 2 is canceled. Claims 1 and 3- 9 are being addressed by this Action.
Election/Restrictions
Applicant’s amendment has obviated the Restriction Requirement set forth in the Office Action mailed, 6/23/25. As such, the Restriction Requirement set forth in the Office Action mailed, 6/23/25 is withdrawn.
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: said grasping mechanism comprising a plurality of outwardly and inwardly movable grasping elements in claim 8.
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 § 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 3- 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Courtney et al. (US Pub. No. 2002/0016564 A1) in view of Ahn (US Pub. No. 2015/0005792 A1).
Regarding claim 1, Courtney discloses a device comprising:
an inner tube (120) (Figs. 1A- 3D, 5A- 7, 9, 11- 14, 17) linearly movable in an outer shaft (102) (Figs. 1A- 4, 8- 11, 17), said inner tube (120) being formed with nozzle holes (152) (Figs. 5A- 5C, 6- 7, 13- 15);
an aspiration device (110) (Figs. 1A- 1B) (P. [0038] - - efflux port 110 of the outer catheter 102 may be connected to a suction pump for active aspiration) coupled to a proximal portion of said outer shaft (102); and
a lytic agent introduced through said nozzle holes (152) (Ps. [0041], [0123] - - The distal tip 128 of the inner sheath 120 comprises a rinse nozzle 150, which supplies a rinsing fluid to the vessel distal to the induced occlusion; the rinsing step may involve thrombolytic agents introduced in the volume exchange model for a localized bathing of the site).
Courtney further discloses many different configurations for the rinse nozzle 150 having nozzle holes (152) at the distal end of the inner tube (120) (Figs. 5A- 5D) (P. [0050]), but Courtney does not disclose
(claim 1) disruption elements extendable in slots as claimed.
However, Ahn teaches manual thrombectomy devices having a plurality of elastic wires to form one or more cages and/or soft brushes connected to a lumen shaft along a longitudinal direction to easily detach thrombi from a vessel wall by manually rotating the lumen shaft right and left in the same field of endeavor (Abstract)
(claim 1) an inner tube (10) (Figs. 1- 2, 3(b)- 7, 9- 17) linearly and rotationally movable in an outer shaft (20) (Figs. 2, 3(b)- 3(c)) (See Fig. 3(c)) (P. [0064] - - As shown in FIG. 3(c), the sheath 20 is pulled down by one hand to expand the elastic wires 15 into a cage. In this expanded state, the lumen shaft 10 is left and right rotated by the other hand), said inner tube (10) being formed with nozzle holes (13) (Figs. 1, 2(c), 3(c)- 4) and slots (14, 44) (Figs. 1, 2(c), 3(c)- 4, 6, 9, 13- 17) (P. [0068] - - FIG. 4 shows that the wire guide track 14 according to the present invention may be longitudinally formed at the lumen shaft 10, preferably formed as a long groove with a predetermined depth from the outside surface);
disruption elements (15, 60) (Figs. 1, 2(c), 3 (c)- 9, 10- 17) extendable outwards through said slots (14, 44) (Ps. [0051], [0073] - - a plurality of elastic wires 15 connected to the distal end portion of the lumen shaft 10 in a longitudinal direction of the lumen shaft 10 to form one or more cages wrapping around the holes 12 and 13; and a sheath 20 configured to wrap around the elastic wires 15 and the lumen shaft 10 … wherein the sheath 20 is configured to move back and forth along the lumen shaft 10 for collapsing and expanding the elastic wires 15 to the cages; FIGS. 10 to 12 show different-shaped embodiments having brushes attached to the lumen shaft 10 according to the present invention, each of which consists of a plurality of bristles 60 instead of a plurality of elastic wires 15 shown in FIG. 1); and
an aspiration device (18) (Figs. 2(a)- 2(c), 3(c)) coupled to a proximal portion of said outer shaft (20) (Ps. [0003], [0038], [0065] - - The present invention relates to thrombectomy devices, and more particularly to manual thrombectomy devices for inexpensively and easily detaching, macerating and removing thrombi organized in not only native vessels, but also graft prostheses such as arterio-venous grafts (AVG) or other vessel grafts; A manual thrombectomy device according to the present invention can easily detach thrombi from a blood vessel wall by manually rotating a lumen shaft right and left because a plurality of elastic wires are connected to the lumen shaft to form one or more cages longitudinally and the torque of the lumen shaft can be wholly transmitted to the elastic wires of the cages; the torque of the lumen shaft by manually applying is wholly transmitted to the elastic wires 15. The thrombi 2 attached on vessel wall are efficiently fragmented and detached without damage to the vessel wall).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the distal end of the inner tube associated with Courtney so as to include rotationally movable disruption elements extendable outwards through slots according to the teachings of Ahn because they would allow for easily and efficiently fragmenting, detaching, macerating and removing thrombi without damage to the vessel wall (Ahn - - Ps. [0003], [0038], [0065]).
Regarding claim 3, Courtney in view of Ahn discloses the apparatus of claim 1, Courtney further disclosing further comprising an expandable balloon (114) (Figs. 1A, 2- 3D, 8- 10B, 17) coupled to said outer shaft (102) (P. [0041] - - FIG. 3a is a longitudinal cross-sectional drawing of the distal tip 106 of the outer catheter 102 with the occluder 114 in the inflated configuration within a vessel).
Regarding claim 4, Courtney in view of Ahn discloses the apparatus of claim 1, Courtney further disclosing wherein said aspiration device (110) comprises an oscillating pressure aspiration device (P. [0051] - - Either or both of the rinsing and aspiration actions can be controlled such that they occur in pulsatile and/or directionally varying manners. The goal of such a variation in flow within the vessel lumen adjacent to the treatment site is to better dislodge any particles that may get stuck along the surfaces of the vessel under what would otherwise be a strictly unidirectional constant flow).
Regarding claim 5, Courtney in view of Ahn discloses the apparatus of claim 1, Courtney further disclosing further comprising a mesh assembly (180) (Figs. 8- 10B) coupled to said outer shaft (102) (P. [0059] - - When the funnel-shaped structure 180 is in the form of a lined self-expanding mesh funnel).
Regarding claim 6, Courtney in view of Ahn discloses the apparatus of claim 5, Courtney further disclosing wherein said mesh assembly comprises a self- expanding mesh cone (P. [0059] - - When the funnel-shaped structure 180 is in the form of a lined self-expanding mesh funnel).
Regarding claim 7, Courtney in view of Ahn discloses the apparatus of claim 5, Courtney further disclosing wherein said mesh assembly (180) comprises a proximal capture mesh tube (186) (Fig. 10A), a capture mesh (182) (Figs. 10A, 10B) and a distal capture mesh tube (144) (Fig. 17) (Ps. [0055], [0059], [0092] - - the lined self-expanding mesh funnel 180 may be constructed with braided strands 182 of a highly elastic material, such as spring-tempered stainless steel or a superelastic or shape-memory NiTi alloy; a separate delivery sheath 186 may be provided for the funnel-shaped structure 180 so that it can travel longitudinally and independently of the outer catheter 102 and the inner sheath 120 (shown in FIG. 9) to deliver the funnel-shaped structure 180; FIG. 17 shows an embolic protection device 100 combined with a distal embolic protection device 144 in the form of an embolic filter).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Courtney et al. (US Pub. No. 2002/0016564 A1) in view of Ahn (US Pub. No. 2015/0005792 A1) as applied to claim 1 above, and further in view of Garcia et al. (US Pub. No. 2010/0331853 A1).
Regarding claim 8, Courtney in view of Ahn discloses the apparatus of claim 1, Courtney further disclosing further comprising a cone (180) (Figs. 8- 10B) (P. [0059] - - When the funnel-shaped structure 180 is in the form of a lined self-expanding mesh funnel), but Courtney in view of Ahn does not disclose
(claim 8) a grasping mechanism coupled to said outer shaft, said grasping mechanism comprising a plurality of outwardly and inwardly movable grasping elements.
However, Garcia teaches an elongated core member including a grasping configuration for capturing a clot (Abstract)
(claim 8) a grasping mechanism (17) coupled to said outer shaft (14), said grasping mechanism (17) comprising a plurality of outwardly and inwardly movable grasping elements (20) (Ps. [0051], [0062] - - The grasping assembly 17 may be any suitable grasping assembly. As depicted in FIGS. 1 and 2, the grasping assembly 17 has a plurality of arms 20 disposed about the longitudinal axis 21 of the device 11 with proximal arm sections 22 secured to the distal end 16 of the core member 14 and distal arm sections 23 which extend essentially parallel to the longitudinal axis 21 e.g. not more than 5.degree. from a line parallel to longitudinal axis when the grasping assembly 17 is in an expanded configuration as shown; Grasping device 11 is advanced through the inner lumen 36 of the delivery catheter in the contracted configuration as shown in FIG. 5, until it exits through distal port 35 into the blood vessel 51 where the grasping assembly 17 self-adjusts to the expanded configuration with arms 20 in a radially expanded position. Grasping assembly 17 is then advanced, as indicated by the arrow 52, in the expanded configuration distally so that arms 20 advance around the thromboembolism 50 as shown in FIG. 5. Then, delivery catheter 12 is advanced distally to press against proximal arm sections 22 to force distal arm sections 23 to rotate radially inwardly to a partially contracted configuration so that the object engaging members 24 engage the thromboembolism 50 as shown in FIG. 7. Thereafter, the grasping device 11, delivery catheter 12, and thromboembolism 50 may be removed from the location and further from the body, either through guide catheter 13 or together in combination with guide catheter). It is noted that the arms 20 are interpreted under 35 U.S.C. 112(f) as a structural equivalent of a grasping element (See P. [0084] of applicant’s pre-grant publication - - “grasping arms (struts)”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the outer shaft associated with modified Courtney to include a grasping mechanism according to the teachings of Garcia because they would allow for directly engaging or grasping a thromboembolism for subsequent removal (Garcia - - Ps. [0051], [0062]).
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 9, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein said aspiration device comprises an aspiration hub, an aspiration port and an aspiration tube; and an expander element inserted into said aspiration device through said aspiration hub, said expander element having a size that plastically deforms and enlarges a cross-section of a portion of said aspiration device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, (Jackie) Tan-Uyen Ho can be reached at 571 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771