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 4/16/26 has been entered. Claim 1 is amended. Claims 4 and 8- 13 are canceled. Claims 14- 25 are added. Claims 1, 3, 5- 7 and 14- 25 are being addressed by this Action.
Response to Arguments
Applicant’s arguments, see p. 9 of applicant’s Remarks, filed 4/16/26, with respect to the rejection of claim 1 under 35 U.S.C. 103 as being unpatentable by Courtney in view of Ahn have been fully considered and are persuasive because Courtney in view of Ahn does not disclose the newly added limitations regarding (i) a first configuration in which the capture elements of the pair are spaced apart; and(ii) a second configuration in which the capture elements of the pair are positioned closer to one another. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Irie et al. (US Pub. No. 2020/0146701 A1). It is noted applicant’s arguments against Courtney in view of Ahn are directed to the capture element configurations feature upon which the new reference Irie is relied.
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:
torsional element being configured to bias the capture elements toward one another in claim 21; and
expander element having a size that plastically deforms and enlarges a cross-section of a portion of said aspiration device in claim 24.
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 Objections
Claim 19 is objected to because of the following informalities: line 1- “The device according to claim 18, wherein the pairs of capture elements” should be amended to - - The device according to claim 18, wherein the plurality of pairs of capture elements - - to maintain consistent claim terminology. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: line 5- “upon release of a compressive force applied to the capture elements” should be amended to - - upon release of [[a]] the compressive force applied to the capture elements - - since it is clear that the same compressive force is being applied to and released from the capture elements, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: “further comprising a lytic agent introduced through said nozzle holes and configured to at least pariatlly dissolve the obstruction” should be amended to - - further comprising a lytic agent introduced through said nozzle holes and configured to at least . Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 5- 7 and 14- 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Amended claim 1 recites “wherein a pair of capture elements from the plurality of capture elements is arranged to define:
(i) a first configuration in which the capture elements of the pair are spaced apart in a circumferential direction; and
(ii) a second configuration in which the capture elements of the pair are positioned closer to one another in a circumferential direction” in lines 8- 11. The term “circumferential” is not found in the original disclosure. It is noted that p. 13 of applicant’s Specification explains that radial arms 307 deform radially to move apart from each other and that each pair of radial arms 307 is set in a position so that the radial arms 307 are touching or nearly touching one another in their radially undeformed state.
Claims 3, 5- 7 and 14- 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as being dependent off claim 1.
Claims 1, 3, 5- 7 and 14- 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Amended claim 1 recites “wherein a pair of capture elements from the plurality of capture elements is arranged to define:
(i) a first configuration in which the capture elements of the pair are spaced apart in a circumferential direction; and
(ii) a second configuration in which the capture elements of the pair are positioned closer to one another in a circumferential direction” in lines 8- 11. Since the word “circumferential” is not found in the Specification and since the Specification discusses radial deformation, it is not clear that the separating motion between pairs of radial arms 307 is truly in a circumferential direction. For the purposes of examination, amended claim 1 is interpreted as reciting - - wherein a pair of capture elements from the plurality of capture elements is arranged to define:
(i) a first configuration in which the capture elements of the pair are spaced apart
(ii) a second configuration in which the capture elements of the pair are positioned closer to one another
Claims 3, 5- 7 and 14- 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 1.
Claims 1, 3, 5- 7 and 14- 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are:
Amended claim 1 fails to include the necessary structural cooperative relationships of elements described by the applicant(s) as necessary to practice the invention. Specifically, amended claim 1 recites, “an inner tube linearly movable in an outer shaft” but does not disclose the relationship with the inner tube and/or outer shaft with “a plurality of capture elements radially extendable outwards.” It is noted that p. 13 of applicant’s specification describes the necessary structural connections: “Sleeve elements 305 are rigidly connected to inner shaft 303 and have similar diameter dimensions to medial shaft 306 such that they cannot move over or into the medial shaft 306. Obstruction capture elements 304 are located over inner shaft 303 and they can move freely with respect to inner shaft 303 in an axial direction. Once inner shaft 303 is moved in an axial direction against medial shaft 306, sleeve elements 305 compress obstruction capture elements 304 so that they deform (e.g., buckle outward) radially.” For the purposes of examination, amended claim 1 is interpreted as reciting - - a plurality of capture elements radially extendable outwards from the inner tube - - .
Claims 3, 5- 7 and 14- 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 14- 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Irie et al. (US Pub. No. 2020/0146701 A1).
Regarding claim 1 in view of the rejections under 35 U.S.C. 112(a) and 112(b) above, Irie discloses device comprising:
an inner tube (50) (Figs. 1- 3, 7) linearly movable in an outer shaft (5) (Fig. 7),
a plurality of capture elements (31, 32, 33) (Figs. 1- 7) radially extendable outwards
wherein a pair of capture elements (39 – it is noted all capturing members 39 have the same reference number) (Figs. 1- 7) from the plurality of capture elements (31, 32, 33) (See Fig. 7 - - showing at least a portion of an obstruction (M) in between a pair of capture elements (39)) is arranged to define:
(i) a first configuration (Fig. 4) in which the capture elements of the pair (39) are spaced apart
(ii) a second configuration (Fig. 5) in which the capture elements of the pair (39) are positioned closer to one another
Regarding claim 14, Irie further discloses wherein the capture elements of the pair (39) of capture elements are arms (See Fig. 4).
Regarding claim 15, Irie further discloses wherein the arms (39) are elongated (See Fig. 2).
Regarding claim 16, Irie further discloses wherein arms (39) are curved outwardly relative to the inner tube (50) (See Fig. 3).
Regarding claim 17, Irie further discloses wherein each arm (39) is coupled to the inner tube (50) at a proximal portion (39b) and a distal portion (39a).
Regarding claim 18, Irie further discloses wherein the plurality of capture elements (31, 32, 33) comprises a plurality of pairs of capture elements (39) (See Fig. 7 - - showing at least a portion of an obstruction (M) in between a pair of capture elements (39)).
Regarding claim 19, Irie further discloses wherein the pairs of capture elements (39) are spaced apart along a longitudinal axis of the inner tube (50), such that a plurality of portions of the obstruction (M) are receivable between respective pairs (See Fig. 7).
Regarding claim 20, Irie further discloses further comprising sleeve elements (35) (Figs. 1- 7) configured to apply a compressive force to the capture elements in response to linear movement of the inner tube (50), thereby causing the capture elements (31, 32, 33) to move apart in a radial direction (See Fig. 3); and wherein the capture elements (39) are configured to move toward one another upon release of a compressive force applied to the capture elements (31, 32, 33) (P. [0024] - - As an axial pressing force acts on the capturing member 30, the axially tip end-side link portion 35 and the axially base end-side link portion 35 become closer to each other, and the deforming portions 39 of the capturing portions 31, 32, 33 contract axially and expand in diameter (see FIG. 3). On the other hand, as the axially tip end-side link portion 35 and the axially base end-side link portion 35 of the capturing member 30 are spaced apart from each other, the deforming portions 39 of the capturing portions 31, 32, 33 extend axially and are reduced in diameter (see FIG. 2)).
Regarding claim 21, Irie further discloses wherein the capture elements of the pair are coupled to respective support members (35) disposed around the inner tube (50), and the device further comprises a torsional element (60) coupling the support members (35), the torsional element (60) being configured to bias the capture elements (39) toward one another (Ps. [0037], [0053] - - In the present embodiment, the control members 60 are each made of a closely wound coil spring. However, the control members may be coil springs of wire material having a wire-to-wire gap. The control members may not be coil springs and may be instead tube-like bodies or the like having a predetermined length; the control members only need to be able to control the amount of axial contraction of the capturing member; when the control members 60 are made of coil springs of wire material formed with a wire-to-wire gap, as the capturing member 30 expands in diameter, the coil springs contract against elastic force and the gap between the wires becomes narrower, thereby producing a recovery force. Accordingly, when the capturing member 30 is brought back to the diameter-reduced state, it becomes easier to cause the capturing member 30 to become reduced in diameter; the term “torsional element” is interpreted under 35 U.S.C. 112(f) as a torsional spring 319 and its functional equivalents (See p. 14 of applicant’s Specification); since control members 60 is a coil spring and/or any structure that is able to control the amount of axial contraction of the capturing member, control members 60 falls within the structural and functional interpretations of torsional element).
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) 3, 5- 7, 22- 23 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Irie et al. (US Pub. No. 2020/0146701 A1) in view of Courtney et al. (US Pub. No. 2002/0016564 A1).
Regarding claim 3, Irie discloses the apparatus of claim 1, but Irie does not disclose
(claim 3) further comprising an expandable balloon coupled to said outer shaft.
However, Courtney teaches an apparatus for effective removal of emboli during vascular procedures in the same field of endeavor (Abstract)
(claim 3) further disclosing further comprising an expandable balloon (114) (Figs. 1A, 2- 3D, 8- 10B, 17) coupled to said outer shaft (102) (Ps. [0014], [0041], [0055] - - The current invention describes tools and methods that enable the effective removal of emboli during a wide variety of vascular procedures, such as, but not limited to, angiography, balloon angioplasty, stent deployment, laser angioplasty, atherectomy, endarterectomy, intravascular ultrasonography and other similar therapeutic and diagnostic procedures. In general, a hollow catheter with a similarly hollow tip, creates an occlusion proximal to the lesion site. The inner lumen of the catheter communicates with the site of treatment which is distal to the occluder and provides a pathway through which the tools of the procedure, such as balloon catheters and stents, may be delivered; 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; FIG. 8 shows a configuration of the distal end 106 of the extended shaft 104 of the outer catheter 102 where there is a balloon 114 to create the occlusion of flow and a separate funnel-shaped structure 180, which directs debris into the suction lumen 160).
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 Irie in order to include an expandable balloon according to the teachings of Courtney because it would create an occlusion proximal to the lesion site necessary for vascular procedures such as angiography, balloon angioplasty, stent deployment, laser angioplasty, atherectomy, endarterectomy, intravascular ultrasonography and other similar therapeutic and diagnostic procedures (Courtney - - Ps. [0014], [0041], [0055]).
Regarding claims 5- 7, Irie discloses the apparatus of claim 1, but Irie does not disclose
(claim 5) further comprising a mesh assembly coupled to said outer shaft;
(claim 6) wherein said mesh assembly comprises a self-expanding mesh cone;
(claim 7) wherein said mesh assembly comprises a proximal capture mesh tube, a capture mesh and a distal capture mesh tube.
However, Courtney teaches an apparatus for effective removal of emboli during vascular procedures in the same field of endeavor (Abstract)
(claim 5) further comprising a mesh assembly (180) (Figs. 8- 10B) coupled to said outer shaft (102) (Ps. [0028], [0059] - - an independent component is used to produce a funnel shape and direct the flow of debris into the suction lumen; When the funnel-shaped structure 180 is in the form of a lined self-expanding mesh funnel);
(claim 6) wherein said mesh assembly comprises a self- expanding mesh cone (Ps. [0055], [0059] - - FIG. 8 shows a configuration of the distal end 106 of the extended shaft 104 of the outer catheter 102 where there is a balloon 114 to create the occlusion of flow and a separate funnel-shaped structure 180, which directs debris into the suction lumen 160; When the funnel-shaped structure 180 is in the form of a lined self-expanding mesh funnel);
(claim 7) 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).
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 Irie in order to include a proximal capture mesh tube, a self-expanding capture mesh cone and a distal capture mesh tube according to the teachings of Courtney because it would allow for a separate funnel-shaped structure, which directs debris into the suction lumen and provides for a distal embolic protection device (Courtney - - Ps. [0028], [0055], [0059]).
Regarding claims 22 and 23, Irie discloses the apparatus of claim 1, but Irie does not disclose
(claim 22) further comprising an aspiration device coupled to a proximal portion of said outer shaft;
(claim 23) wherein said aspiration device comprises an oscillating pressure aspiration device.
However, Courtney teaches an apparatus for effective removal of emboli during vascular procedures in the same field of endeavor (Abstract)
(claim 22) further comprising an aspiration device (110) (Figs. 1A- 1B) coupled to a proximal portion of said outer shaft (102) (Figs. 1A- 4, 8- 11, 17) (Ps. [0039], [0042] - - efflux port 110 of the outer catheter 102 may be connected to a suction pump for active aspiration; The treatment device 130 is then activated. Simultaneously, there may be aspiration occurring through the suction lumen 160 and/or rinsing fluid being ejected through the rinse nozzle 150. Aspiration and the ejection of rinsing fluid will cause a flow of fluids proximally through the suction lumen 160 and out the suction port 110 at the proximal end of the outer catheter 102, taking debris with it);
(claim 23) 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).
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 Irie in order to include an oscillating pressure aspiration device according to the teachings of Courtney because it would better dislodge any particles that may get stuck along the surfaces of the vessel under what would otherwise be a strictly unidirectional constant flow of fluid and debris (Courtney - - Ps. [0039], [0042], [0051]).
Regarding claim 25, Irie discloses the apparatus of claim 1, but Irie does not disclose
(claim 25) wherein the inner tube is formed with nozzle holes.
However, Courtney teaches an apparatus for effective removal of emboli during vascular procedures in the same field of endeavor (Abstract)
(claim 25) wherein the inner tube (120) (Figs. 1A- 3D, 5A- 7, 9, 11- 14, 17) is formed with nozzle holes (152) (Figs. 5A- 5C, 6- 7, 13- 15) (Ps. [0042], [0050] - - In the application where emboli produced by a treatment are to be collected by aspiration, … Simultaneously, there may be aspiration occurring through the suction lumen 160 and/or rinsing fluid being ejected through the rinse nozzle 150. Aspiration and the ejection of rinsing fluid will cause a flow of fluids proximally through the suction lumen 160 and out the suction port 110 at the proximal end of the outer catheter 102, taking debris with it; FIGS. 5a-5d show many different configurations for the rinse nozzle 150 at the distal end 128 of the shaft 118 of the inner sheath 120. FIG. 5a shows a rinse nozzle 150 with perforations 152 that are generally perpendicular to the longitudinal axis of the sheath 120. FIG. 5b and 5c show rinse nozzles 150 with perforations 152 that are angled such that the fluid is ejected with a component of its flow in the proximal direction to assist in producing the desired flow pattern. FIG. 5d shows another configuration with an umbrella-shaped flow diverter 154 that is integrated with the distal wall 118 of the inner sheath 120).
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 inner tube associated with Irie such that it is formed with nozzle holes according to the teachings of Courtney because aspiration and the ejection of rinsing fluid will cause a flow of fluids proximally through the suction lumen and out the suction port at the proximal end of the outer catheter, taking debris with it (Courtney - - Ps. [0042], [0050]).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Irie et al. (US Pub. No. 2020/0146701 A1) in view of Courtney et al. (US Pub. No. 2002/0016564 A1) as applied to claim 25 above, and further in view of Merk et al. (US Pub. No. 2016/0199080 A1).
Regarding claim 26, Irie in view of Courtney discloses the apparatus of claim 25, but modified Irie does not explicitly disclose
(claim 26) further comprising a lytic agent introduced through said nozzle holes and configured to at least partially dissolve the obstruction.
However, Merk teaches an expandable basket for capturing thrombus in the same field of endeavor (Abstract, P. [0006])
(claim 26) further comprising a lytic agent introduced through said nozzle holes (18) and configured to at least partially dissolve the obstruction (30) (Ps. [0006], [0022], [0033] - - It is further desirable that the thrombolytic agent may be capable of being applied while the retrieval device is attempting to capture the thrombus; The catheter 12 shown in FIG. 1 is adapted to release a thrombolytic agent in the vicinity of a thrombus 30 (shown in FIGS. 4 and 5). Thrombolytic agent is supplied through the agent lumen 36 of the catheter 12 and is dispersed to the thrombus 30 through a plurality of openings 18 arranged on the outer surface of the catheter 12 which are in fluid communication with the agent lumen 36; Referring to FIGS. 5A-5C, an alternative method of using a thrombus retrieval device 10 is shown. In some instances, it may be difficult to advance the catheter 12 through the thrombus 30 before application of the thrombolytic agent. This may be because the thrombus 30 is either too hardened or too brittle. In such situations, the wire guide 22 may be advanced around the thrombus 30 on one sides of the intraluminal passage 28. A catheter 12 may be advanced over the wire guide 22 and be aligned so that openings 18 in the catheter 12 overlap with at least a portion of the thrombus 30. The thrombolytic agent may be applied to soften or dissolve the thrombus 30).
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 inner tube associated with modified Irie such that it further comprises a lytic agent introduced through nozzle holes according to the teachings of Merk because, after and/or during the capturing the thrombus with the device associated with modified Irie, the thrombolytic agent may then be applied to soften or dissolve the thrombus (Merk - - Ps. [0006], [0022], [0033]).
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 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
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