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 Arguments
Applicants amendments to claims 30 and 31 are acknowledged and the 112(b) rejections of claims 30 and 31 are withdrawn.
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive.
Regarding claims 1 and 2, Applicant argues that the plurality of openings 50 of Anderson are not capable of assisting in complete ingestion of the clot, as required by claim 1, and therefore fails to meet the limitation “configured to assist in complete ingestion of the clot capturable into the inner lumen of the intravascular catheter”. Applicant explains that the holes 50 are small in size to allow “infusion fluid to weep or exude slowly from the guidewire lumen 36 from the inflation lumen 34” in para. 0037 of Anderson.
The examiner respectfully disagrees. The claim does not state any structural differences between the openings of Anderson verses applicant’s openings such as a diameter size that would further distinguish applicant’s openings over Anderson’s. Anderson is only used to teach that it is known in the art to have a plurality of openings in fluid communication between an annular chamber and an inner lumen of the catheter such that fluid may flow into the inner lumen of the catheter (Fig. 3, para. 0046 of Anderson). The functional limitation “configured to assist in complete ingestion of the clot capturable into the inner lumen of the intravascular catheter” is dependent on other factors outside of the device itself such as fluid pressure or as stated in the action the type of fluid being delivered. The language of the limitation “to assist” only means to help, aid, or support complete ingestion of the clot. For example, if the user delivers a drug used for clot break down through holes 50, the infusion fluid flowing through holes 50 and out of unobstructed openings 40 would be capable of assisting in complete ingestion of a captured clot into the intravascular catheter during aspiration because breaking clot into smaller pieces would increase the ease of capturing the clot via. aspiration. As previously stated, “A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim”.
In regards to applicant stating that Anderson “must be specifically designed or configured to accomplish the specified objective i.e. assist in complete ingestion of the clot capturable into the inner lumen of the intravascular catheter”, the openings 50 of Anderson are designed to deliver fluid into the inner lumen of the intravascular catheter. As stated above, the claims are directed to an apparatus, not a method. Therefore, the structure recited in the claim is what is focused on. Structurally, the claim only requires a plurality of openings in fluid communication between an annular chamber and an inner lumen of the catheter which is taught by Anderson (see Fig. 3, para. 0046 of Anderson). If the fluid is a drug used for clot break down, the device of Anderson meets the claim limitation. Therefore, the use of the Anderson reference is maintained.
Applicant argues that Anderson’s fluid holes are not located in a distal porous cuff as required by independent claims 1 and 2. The examiner notes that MacMahon is relied upon to disclose the distal porous cuff section as required by independent claims 1 and 2. Anderson is only used to teach that it is known in the art to have a plurality of openings in fluid communication between an annular chamber and an inner lumen of the catheter such that fluid may flow into the inner lumen of the catheter (Fig. 3, para. 0046). However, Anderson does teach “a distal porous cuff section” such that the distal section of the catheter of Anderson comprises a balloon (interpreted as the cuff) comprising a plurality of pores/openings to allow fluid to flow out of the balloon (Fig. 3, para. 0043-0045) which is similar in function to the distal porous cuff section of MacMahon (Figs. 20, 23A, para. 0150, 0187, 0191 of MacMahon).
Claim Objections
Claims 1-2, and 22 are objected to because of the following informalities:
Claim 1 (lines 16 and 21) and claim 2 (line 21): "the inner lumen of the intravascular catheter" which should recite “the inner lumen of the distal porous cuff section”.
Claim 1 (line 19), claim 2 (line 19) and claim 22 (line 2): “the inner lumen” which should recite “the inner lumen of the distal porous cuff section”.
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.
Claim 22 is 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.
Claim 22 recites “wherein there being no fluid communication between the inner lumen and the annular chamber”. The written description supports this embodiment in para. 0035-0037 and is shown in Fig. 7. However, claim 1, from which claim 22 depends, recites “wherein the distal porous cuff section has a plurality of openings in fluid communication between the annular chamber and the inner lumen”. The written description supports this embodiment in para. 0038 and is shown in Fig. 4. Therefore, the written description has support for two different embodiments, one having fluid communication between the annular chamber and the inner lumen and one without fluid communication. However, the written description does not have support for one embodiment that requires both fluid communication and no fluid communication between the annular chamber and the inner lumen.
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 2 and 31 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.
Claim 2 (line 20) recites the limitation "the clot". There is insufficient antecedent basis for this limitation in the claim. For examination purposes, "the clot" is interpreted as "a clot".
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, 9, 23, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over MacMahon et al. (US 20050085769) [hereinafter MacMahon] in view of Ngo-Chu et al. (US 20180104404) [hereinafter Ngo-Chu] and Anderson et al. (US 20140323887) [hereinafter Anderson].
The examiner notes that the embodiment of Figs. 23A-B is relied upon for the rejection. However, other embodiments are relied upon as well for like features not shown in Figs. 23A-B. The examiner further notes that para. 0243 discloses “Many features have been listed with particular configurations, options, and embodiments. Any one or more of the features described may be added to or combined with any of the other embodiments or other standard devices to create alternate combinations and embodiments”.
MacMahon discloses an intravascular catheter 7 (Figs. 20A, 23A-B, para. 0041, 0244-0245) having a proximal end (interpreted as end connected to aspiration/irrigation source, Fig. 4C, para. 0155) and an opposite distal end (see Figs. 23A-B, para. 0191), the intravascular catheter comprising:
a tubular body (interpreted as portion of catheter 7 without openings 200, 201) having a sidewall extending from a proximal end to a distal end (see annotated Fig. 23A below, Fig. 20, para. 0187, 0191);
a distal porous cuff section (interpreted as portion of catheter 7 with openings 200, 201) disposed distally of the tubular body with an inner lumen defined axially therethrough the tubular body and the distal porous cuff section (see annotated Fig. 23A below, Fig. 20, para. 0187, 0191);
the distal porous cuff section having a sidewall (see annotated Fig. 23A below, para. 0191; The examiner notes that the in the instant application, the sidewall of the distal porous cuff section is the same as the tubular body sidewall (see Fig. 7C, para. 0035 of the instant application));
a plurality of unobstructed openings 200, 201 defined in the sidewall of the distal porous cuff section and the distal porous cuff section being non-rotatable (Figs. 23A-B, para. 0191; method of use described in para. 0150, 0247);
wherein the distal porous cuff section is radially non-expandable and a distal end of the distal porous cuff section is not expandable distally in the axial direction (Figs. 23A-B, para. 0191; method of use described in para. 0150, 0247);
wherein the plurality of unobstructed openings 200, 201 are arranged to prevent degradation of a clot capturable therein the inner lumen of the intravascular catheter (Figs. 23A-B, para. 0191, 0247, see note below);
wherein no inflatable balloon is attached to the tubular body to occlude blood flow (Figs. 23A-B, para. 0191).
Note: The limitation “wherein the plurality of unobstructed openings are arranged to prevent degradation of a clot capturable therein” is interpreted as functional language, not structural language. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. MacMahon discloses a plurality of unobstructed openings 200, 201 arranged circumferentially around a distal end of catheter (Figs. 23A-B, para. 0191) which is analogous to the arrangement of the plurality of unobstructed openings of applicant’s. Since MacMahon discloses the structural component required i.e. the plurality of unobstructed openings arranged circumferentially around the distal end of the catheter for the functional limitation, MacMahon thereby discloses the functional limitation of the arrangement of plurality of unobstructed openings capable of preventing degradation of a clot capturable therein. This functional language interpretation is supported by para. 0034 of the specifications in the instant application. Para. 0034 of the instant application explains that the “cuff of fluid jets produced from the inflation fluid being injected at a pressure sufficient to produce a fluid boundary between the outer surface of the catheter and inner wall of the vessel to minimize friction therebetween, without degrading or breaking-up the clot”. Therefore, structurally having the plurality of unobstructed holes arranged circumferentially around the distal end of the catheter in combination with the functionality of delivering fluid at a “sufficient pressure” prevents clot degradation. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since, the device of MacMahon meets the structural limitations required in claim 1, the device of MacMahon also meets the functional limitation.
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Annotated Fig. 23 of MacMahon
MacMahon further discloses a multi-lumen catheter system (Figs. 20A-B, para. 0243-0244) for the purpose of allow the device to aspirate debris through one lumen and irrigate fluid in another (para. 0245).
However, MacMahon fails to disclose, in this particular embodiment, the distal porous cuff section having an inner wall disposed radially inward of a sidewall defining an annular chamber therebetween, the sidewall of the tubular body having a fluid supply channel extending in a direction parallel to an axial direction of the intravascular catheter, and wherein the sidewall of the distal porous cuff section is integral with an outer wall of the fluid supply channel and serves as an outer wall of the annular chamber.
Ngo-Chu in the same field of endeavor of catheters teaches a dual lumen catheter 200 comprising a distal porous cuff section see annotated Fig. 8 of Ngo-Chu below, para. 0043) and a tubular body (interpreted as the elongate flexible tube body of catheter 200, Fig. 8, para. 0042). The reference teaches that it is known in the art when forming a dual lumen catheter (see Fig. 8) that an inner wall of the distal porous cuff section disposed radially inward of a sidewall of the distal porous cuff section defining an annular chamber 208 therebetween (see annotated Fig. 8[a] of Ngo-Chu below, see Fig. 9 which illustrates lumen 208 having an annular shape, para. 0043-0044); a sidewall of the tubular body having a fluid supply channel (interpreted as portion of lumen 208 located within the tubular body of the catheter 200) extending in a direction parallel to an axial direction of the catheter 200 (Figs. 8-9, para. 0043-0044; The examiner notes that in the instant application, see Figs. 7 and 7C, the fluid supply channel and the annular chamber are the same element, para. 0035); and wherein the sidewall of the distal porous cuff section is integral with an outer wall of the fluid supply channel 208 and serves as an outer wall of the annular chamber 208 (Figs. 8-9, para. 0043-0044, 0051);
Thus, one skilled in the art would have readily recognized that providing the catheter of MacMahon with the dual lumen construction of the Ngo-Chu catheter such that the distal porous cuff section has the inner wall disposed radially inward of the sidewall defining the annular chamber therebetween, the sidewall of the tubular body having the fluid supply channel extending in the direction parallel to the axial direction of the intravascular catheter; and wherein the sidewall of the distal porous cuff section serves as the outer wall of the annular chamber, as taught by Ngo-Chu, would provide the catheter of MacMahon with an aspiration lumen and an irrigation lumen, thereby allowing simultaneous aspiration and irrigation as desired by MacMahon (para. 0075 of MacMahon; para. 0042, 0044, 0052 of Ngo-Chu).
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Annotated Fig. 8 of Ngo-Chu
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Annotated Fig. 8[a] of Ngo-Chu
Modified MacMahon further discloses that the inner lumen may be used for aspiration and/or irrigation in a body cavity (Figs. 20A-B, para. 0247 of MacMahon; Figs. 8, 14, para. 0051-0053 of Ngo-Chu). However, modified MacMahon fails to disclose wherein the distal porous cuff section has a plurality of openings in fluid communication between the annular chamber and the inner lumen; and the plurality of openings in the distal porous cuff section are configured to assist in complete ingestion of the clot capturable into the inner lumen of the intravascular catheter.
Anderson in the same field of endeavor teaches a catheter 110 comprising a distal porous cuff section (interpreted as balloon 120, Fig. 3) including a plurality of unobstructed openings 140 defined in a sidewall of the distal porous cuff section 120 (Fig. 3, para. 0043), wherein the plurality of unobstructed openings 140 permit discharge therethrough of saline injectable under pressure into an annular chamber 34 (para. 0043-0045); wherein the distal porous cuff section 120 has a plurality of openings 50 in fluid communication between an annular chamber (interpreted as the space within the balloon 120) and an inner lumen of the catheter 36 (Fig. 3, para. 0046); and the plurality of openings 50 in the distal porous cuff section are configured to assist in complete ingestion of the clot capturable into the inner lumen of catheter (see note below about functional language) for the purpose of allowing an infusion fluid to weep or exude slowly into the inner lumen of the catheter 36 (para. 0046).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal porous cuff section in modified MacMahon to include the plurality of openings between the annular chamber and the inner lumen of the catheter, as taught by Anderson, in order to allow the device allow the infusion fluid to weep or exude slowly into the inner lumen of the catheter, thereby providing another means of introducing a therapeutic solution to the bloodstream without the need to switch between aspiration and irrigation as discussed in modified MacMahon (para. 0064 of MacMahon).
Note: The limitation “configured to assist in complete ingestion of the clot capturable into the inner lumen of catheter” is functional language. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Anderson expressly discloses the structural components (i.e. a plurality of openings 50 between an annular chamber and an inner lumen of the catheter, see Fig. 3, para. 0046) required for the functional limitation. Therefore, the combination teaches the functional limitation of the plurality of openings capable of assisting “in complete ingestion of the clot capturable into the inner lumen of the intravascular catheter”. For example, if the user delivers a drug used for clot break down through holes 50, the infusion fluid flowing through holes 50 and out of unobstructed openings 40 would be capable of assisting in complete ingestion of a captured clot into the intravascular catheter during aspiration because breaking clot into smaller pieces would increase the ease of capturing the clot via. aspiration. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since, the device of modified MacMahon in view of Anderson meets the structural limitations required in claim 6, the device of modified MacMahon in view of Anderson also meets the functional limitation.
Regarding claim 3, modified MacMahon discloses wherein the sidewall of the tubular body comprises two walls including an inner wall and an outer wall (see annotated Fig. 9 of Ngo-Chu below, para. 0043-0044 of Ngo-Chu); and the fluid supply channel 208 is an annular fluid supply channel defined between the two walls separated radially a predetermined distance from one another (see annotated Fig. 9 of Ngo-Chu below, para. 0043-0044 of Ngo-Chu).
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Annotated Fig. 9 of Ngo-Chu
Regarding claim 4, modified MacMahon discloses wherein at least some of the plurality of unobstructed openings 200, 201 in the distal porous cuff section are arranged perpendicular to the axial direction of the intravascular catheter (Figs. 23A-B, para. 0191 of MacMahon).
Regarding claim 5, modified MacMahon discloses all of the limitations set forth above in claim 1. However, modified MacMahon fails to disclose wherein at least some of the plurality of unobstructed openings in the distal porous cuff section are arranged at a non-perpendicular angle to the axial direction of the intravascular catheter; wherein the non-perpendicular angle is an inclined angle towards the proximal end of the intravascular catheter.
The embodiment of Fig. 57A of MacMahon teaches that it is known in the are to design a catheter 7 with at least some of a plurality of unobstructed openings 200 arranged at a non-perpendicular angle to the axial direction of the intravascular catheter 7 (Fig. 57A, para. 0223), wherein the non-perpendicular angle is an inclined angle towards a proximal end of the intravascular catheter 7 (Fig. 57A, para. 0223) for the purpose of directing fluid flowing out of the openings 200 in a proximal direction (para. 0223).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the plurality of unobstructed openings in modified MacMahon to be arranged at the non-perpendicular angle towards the proximal end of the intravascular catheter, as taught by the embodiment of Fig. 57A of MacMahon in order to direct fluid and debris or other matter in a blood vessel in the proximal direction and thereby rinse and clear the vessel of debris or emboli (para. 0004, 0223 of MacMahon).
Regarding claim 9, modified MacMahon discloses wherein the plurality of unobstructed openings 200, 201 remain uncovered exteriorly (Figs. 23A-B, para. 0191 of MacMahon).
Regarding claim 23, modified MacMahon discloses wherein the sidewall of the tubular body being integral with the distal porous cuff section (see annotated Fig. 23A of MacMahon above, para. 0191 of MacMahon); the distal porous cuff section is not a separate inflatable balloon joined, connected, attached or welded to the tubular body (see annotated Fig. 23A of MacMahon above, para. 0191 of MacMahon).
Regarding claim 30, modified MacMahon discloses wherein the plurality of unobstructed openings 200, 201 are unobstructed when fluid is supplied to the fluid supply channel and when no fluid is supplied to the fluid supply channel (Figs. 23A-B, para. 0191 of MacMahon; method of use described in para. 0150, 0247 of MacMahon).
Claims 2 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over MacMahon et al. (US 20050085769) [hereinafter MacMahon] in view of Ngo-Chu et al. (US 20180104404) [hereinafter Ngo-Chu], Vale et al. (WO 2018033401) [hereinafter Vale], and Anderson et al. (US 20140323887) [hereinafter Anderson].
The examiner notes that the embodiment of Figs. 23A-B is relied upon for the rejection. However, other embodiments are relied upon as well for like features not shown in Figs. 23A-B. The examiner further notes that para. 0243 discloses “Many features have been listed with particular configurations, options, and embodiments. Any one or more of the features described may be added to or combined with any of the other embodiments or other standard devices to create alternate combinations and embodiments”.
Regarding claim 2, MacMahon discloses an intravascular catheter 7 (Figs. 20A, 23A-B, para. 0041, 0244-0245) having a proximal end (interpreted as end connected to aspiration/irrigation source, Fig. 4C, para. 0155) and an opposite distal end (see Figs. 23A-B, para. 0191), the intravascular catheter comprising:
a tubular body (interpreted as portion of catheter 7 without openings 200, 201) having a sidewall extending from a proximal end to a distal end (see annotated Fig. 23A below, Fig. 20, para. 0187, 0191);
a distal porous cuff section (interpreted as portion of catheter 7 with openings 200, 201) disposed distally of the tubular body with an inner lumen defined axially therethrough the tubular body and the distal porous cuff section (see annotated Fig. 23A below, Fig. 20, para. 0187, 0191);
the distal porous cuff section having a sidewall (see annotated Fig. 23A below, para. 0191; The examiner notes that the in the instant application, the sidewall of the distal porous cuff section is the same as the tubular body sidewall (see Fig. 7C, para. 0035 of the instant application));
a plurality of unobstructed openings 200, 201 defined in the sidewall of the distal porous cuff section and the distal porous cuff section being non-rotatable (Figs. 23A-B, para. 0191; method of use described in para. 0150, 0247);
wherein the distal porous cuff section is radially non-expandable and a distal end of the distal porous cuff section is not expandable distally in the axial direction (Figs. 23A-B, para. 0191; method of use described in para. 0150, 0247);
wherein the plurality of unobstructed openings 200, 201 are arranged to prevent degradation of a clot capturable therein the inner lumen of the intravascular catheter (Figs. 23A-B, para. 0191, 0247, see note below);
wherein no inflatable balloon is attached to the tubular body to occlude blood flow (Figs. 23A-B, para. 0191).
Note: The limitation “wherein the plurality of unobstructed openings are arranged to prevent degradation of a clot capturable therein” is interpreted as functional language, not structural language. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. MacMahon discloses a plurality of unobstructed openings 200, 201 arranged circumferentially around a distal end of catheter (Figs. 23A-B, para. 0191) which is analogous to the arrangement of the plurality of unobstructed openings of applicants. Since MacMahon discloses the structural component required i.e. the plurality of unobstructed openings arranged circumferentially around the distal end of the catheter for the functional limitation, MacMahon thereby discloses the functional limitation of the arrangement of plurality of unobstructed openings capable of preventing degradation of a clot capturable therein. This functional language interpretation is supported by para. 0034 of the specifications in the instant application. Para. 0034 of the instant application explains that the “cuff of fluid jets produced from the inflation fluid being injected at a pressure sufficient to produce a fluid boundary between the outer surface of the catheter and inner wall of the vessel to minimize friction therebetween, without degrading or breaking-up the clot”. Therefore, structurally having the plurality of unobstructed holes arranged circumferentially around the distal end of the catheter in combination with the functionality of delivering fluid at a “sufficient pressure” prevents clot degradation. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since, the device of MacMahon meets the structural limitations required in claim 1, the device of MacMahon also meets the functional limitation.
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Annotated Fig. 23 of MacMahon
MacMahon further discloses a multi-lumen catheter system (Figs. 20A-B, para. 0243-0244) for the purpose of allow the device to aspirate debris through one lumen and irrigate fluid in another (para. 0245).
However, MacMahon fails to disclose, in this particular embodiment, the distal porous cuff section having an inner wall disposed radially inward of a sidewall defining an annular chamber therebetween, the sidewall of the tubular body having a fluid supply channel extending in a direction parallel to an axial direction of the intravascular catheter, and wherein the sidewall of the distal porous cuff section is integral with an outer wall of the fluid supply channel and serves as an outer wall of the annular chamber
Ngo-Chu in the same field of endeavor of catheters teaches a dual lumen catheter 200 comprising a distal porous cuff section see annotated Fig. 8 of Ngo-Chu below, para. 0043) and a tubular body (interpreted as the elongate flexible tube body of catheter 200, Fig. 8, para. 0042). The reference teaches that it is known in the art when forming a dual lumen catheter (see Fig. 8) that an inner wall of the distal porous cuff section disposed radially inward of a sidewall of the distal porous cuff section defining an annular chamber 208 therebetween (see annotated Fig. 8[a] of Ngo-Chu below, see Fig. 9 which illustrates lumen 208 having an annular shape, para. 0043-0044); a sidewall of the tubular body having a fluid supply channel (interpreted as portion of lumen 208 located within the tubular body of the catheter 200) extending in a direction parallel to an axial direction of the catheter 200 (Figs. 8-9, para. 0043-0044; The examiner notes that in the instant application, see Figs. 7 and 7C, the fluid supply channel and the annular chamber are the same element, para. 0035); and wherein the sidewall of the distal porous cuff section is integral with an outer wall of the fluid supply channel 208 and serves as an outer wall of the annular chamber 208 (Figs. 8-9, para. 0043-0044, 0051);
Thus, one skilled in the art would have readily recognized that providing the catheter of MacMahon with the dual lumen construction of the Ngo-Chu catheter such that the distal porous cuff section has the inner wall disposed radially inward of the sidewall defining the annular chamber therebetween, the sidewall of the tubular body having the fluid supply channel extending in the direction parallel to the axial direction of the intravascular catheter; and wherein the sidewall of the distal porous cuff section serves as the outer wall of the annular chamber, as taught by Ngo-Chu, would provide the catheter of MacMahon with an aspiration lumen and an irrigation lumen, thereby allowing simultaneous aspiration and irrigation as desired by MacMahon (para. 0075 of MacMahon; para. 0042, 0044, 0052 of Ngo-Chu).
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Annotated Fig. 8 of Ngo-Chu
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Annotated Fig. 8[a] of Ngo-Chu
Modified MacMahon further discloses wherein the sidewall of the tubular body is a single wall comprising a single layer (see annotated Fig. 9 of Ngo-Chu below, para. 0043 of Ngo-Chu) and wherein the fluid supply channel 208 is structured concentrically within the tubular body (see annotated Fig. 9 of Ngo-Chu below, para. 0043 of Ngo-Chu).
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Annotated Fig. 9 of Ngo-Chu
However, modified MacMahon fails to disclose wherein the sidewall of the tubular body is a single wall comprising a single layer or a laminate of multiple layers; and the fluid supply channel is molded in the single wall.
Vale in the same field of endeavor teaches an intravascular catheter (100, 300) (Figs. 1,3, abstract comprising a distal cuff section 101, 301 disposed distally of a tubular body (Fig. 1) with an inner lumen defined axially therethrough the tubular body and the distal cuff section (Fig. 1, page. 17 lines 6-18). Figs. 2a-d of Vale illustrate different inflation lumens (151, 161, 171, 181) extending in a direction parallel to an axial direction of the intravascular catheter (pg. 5 lines 5-8 and pg. 14 lines 21-23) that the device of Fig. 1 may include. Vale further teaches that a concentric inflation lumen (see Fig. 2d of Vale which illustrates a lumen configuration analogous to the lumen configuration shown in Fig. 7C of Philips) (pg. 17 lines 27-34) is a known alternative to an eccentric inflation lumen (see Fig. 2a-c); wherein in the eccentric style, an fluid supply channel 151 is molded in the sidewall of the tubular body (Fig. 2a of Vale).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the concentric lumen in modified MacMahon for the eccentric lumen of Vale, since such a modification is a substitution for one lumen structure for another and would yield the predictable result of a way to deliver fluid to the distal cuff section; KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Modified MacMahon further discloses that the inner lumen may be used for aspiration and/or irrigation in a body cavity (Figs. 20A-B, para. 0247 of MacMahon; Figs. 8, 14, para. 0051-0053 of Ngo-Chu). However, modified MacMahon fails to disclose wherein the distal porous cuff section has a plurality of openings in fluid communication between the annular chamber and the inner lumen; and the plurality of openings in the distal porous cuff section are configured to assist in complete ingestion of the clot capturable into the inner lumen of the intravascular catheter.
Anderson in the same field of endeavor teaches a catheter 110 comprising a distal porous cuff section (interpreted as balloon 120, Fig. 3) including a plurality of unobstructed openings 140 defined in a sidewall of the distal porous cuff section 120 (Fig. 3, para. 0043), wherein the plurality of unobstructed openings 140 permit discharge therethrough of saline injectable under pressure into an annular chamber 34 (para. 0043-0045); wherein the distal porous cuff section 120 has a plurality of openings 50 in fluid communication between an annular chamber (interpreted as the space within the balloon 120) and an inner lumen of the catheter 36 (Fig. 3, para. 0046); and the plurality of openings 50 in the distal porous cuff section are configured to assist in complete ingestion of the clot capturable into the inner lumen of catheter (see note below about functional language) for the purpose of allowing an infusion fluid to weep or exude slowly into the inner lumen of the catheter 36 (para. 0046).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal porous cuff section in modified MacMahon to include the plurality of openings between the annular chamber and the inner lumen of the catheter, as taught by Anderson, in order to allow the device allow the infusion fluid to weep or exude slowly into the inner lumen of the catheter, thereby providing another means of introducing a therapeutic solution to the bloodstream without the need to switch between aspiration and irrigation as discussed in modified MacMahon (para. 0064 of MacMahon).
Note: The limitation “configured to assist in complete ingestion of the clot capturable into the inner lumen of catheter” is functional language. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Anderson expressly discloses the structural components (i.e. a plurality of openings 50 between an annular chamber and an inner lumen of the catheter, see Fig. 3, para. 0046) required for the functional limitation. Therefore, the combination teaches the functional limitation of the plurality of openings capable of assisting “in complete ingestion of the clot capturable into the inner lumen of the intravascular catheter”. For example, if the user delivers a drug used for clot break down through holes 50, the infusion fluid flowing through holes 50 and out of unobstructed openings 40 would be capable of assisting in complete ingestion of a captured clot into the intravascular catheter during aspiration because breaking clot into smaller pieces would increase the ease of capturing the clot via. aspiration. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since, the device of modified MacMahon in view of Anderson meets the structural limitations required in claim 6, the device of modified MacMahon in view of Anderson also meets the functional limitation.
Regarding claim 31, modified MacMahon discloses wherein the plurality of unobstructed openings are unobstructed when fluid is supplied to the fluid supply channel 712 and when no fluid is supplied to the fluid supply channel (Figs. 23A-B, para. 0191 of MacMahon; method of use described in para. 0150, 0247 of MacMahon).
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.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771