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 .
Information Disclosure Statement
The information disclosure statement, filed January 16, 2025, March 20, 2025, July 19, 2025 and March 21, 2026, were received and entered into the record. Applicant should note that the large number of references in the attached IDSs have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search because it is impractical for the examiner to review the references thoroughly with the number of references cited in this case. By initializing each of the cited references on the accompanying 1449 forms, the examiner is merely acknowledging the submission of the cited references and indicating that only a cursory review has been made of the cited references. See MPEP 609.05(b).
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: “an actuation mechanism” in claim 1, line 7.
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 34 objected to under 37 CFR 1.75 as being a substantial duplicate of claim 33. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 21, 36, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quick (US 2015/0352325, which is cited in the IDS, hereinafter “Quick”) in view of Johnson et al. (US 6,719,717, which is cited in the IDS, hereinafter “Johnson”).
Referring to claim 21, Quick discloses a system for aspirating clot material from a blood vessel of a patient (Figs. 4A-5G, para. [0028]. Fig. 4A is reproduced below), comprising:
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a handle body 102 having a connector 208 configured to be coupled to an aspiration catheter 206 intravascularly positioned in the patient proximate to the clot material PE (Fig. 5A);
a pump assembly 106 (Figs. 3A-3B, para. [0032]: “The pressure source 106 can be mounted at least partially within the housing 102 and configured to generate negative and/or positive pressure…As shown in FIG. 1B, in some embodiments the pressure source 106 is a syringe having a barrel 108 (e.g., a 20 cc barrel), a plunger 110, and a piston (not visible) coupled to an end portion of the plunger 110.”) carried by the handle body 102, wherein the pump assembly includes a barrel 108 and a plunger 106 slidably positioned in the barrel;
an actuation mechanism 104 carried by the handle body 102 and coupled to the pump assembly 106, wherein the actuation mechanism is actuatable by a user to move the plunger in (a) a first direction A1 (Figs. 3A and 4A) through the barrel to generate negative pressure in the barrel (paras. [0053]-[0054]) and (b) a second direction A2 (Fig. 4B) through the barrel to generate positive pressure in the barrel (paras. [0053]-[0054]);
a reservoir 320 (para. [0052]: “The tubing system 300 fluidly couples the pressure source 106 to an aspiration lumen of the catheter 200 (e.g., the lumen of the guide catheter 206). The tubing system 300 has a first portion 314 coupled to the pressure source 106, a second portion 316 coupled to the catheter 200, and a drainage portion 318 coupled to a reservoir 320 (e.g., a vinyl bag).”);
a flow system including:
a first one-way valve configured to (a) inhibit fluid flow from the aspiration catheter to the barrel when the actuation assembly is actuated to move the plunger in the first direction and to (b) prevent fluid flow from the barrel to the aspiration catheter when the actuation assembly is actuated to move the plunger in the second direction (para. [0052]: “For example, the first portion 314 can include tubing section 302a, the drainage portion 318 can include tubing section 302b, first valve 304, and tubing section 302c, and the second portion 316 can include tubing section 302d, second valve 306, tubing section 302e, stop-cock 310, and tubing section 302f. The first valve 304 can be a one-way valve (e.g., a check valve) that only allows fluid flow from the first portion 314 to the drainage portion 318 (and not vice-versa). The second valve 306 can also be a one-way valve (e.g., a check valve) that only allows flow from the second portion 316 to the drainage portion 318 (and not vice-versa).” (emphasis added), para. [0055]: “As shown in FIG. 4B, moving the lever 104 from the second position to the first position (indicated by arrow A2) creates a positive pressure (indicated by arrows F in FIG. 4B) in the first portion 314 and drainage portion 318 of the tubing system 300. The second valve 306 prevents the positive pressure from affecting the aspiration lumen, thereby preventing the backflow of fluid into the blood vessel BV at the treatment site.” (emphasis added));
a second one-way valve configured to (a) inhibit fluid flow from the reservoir to the barrel when the actuation assembly is actuated to move the plunger in the first direction and to (b) permit fluid flow from the barrel to the reservoir when the actuation assembly is actuated to move the plunger in the second direction (para. [0052]: “For example, the first portion 314 can include tubing section 302a, the drainage portion 318 can include tubing section 302b, first valve 304, and tubing section 302c, and the second portion 316 can include tubing section 302d, second valve 306, tubing section 302e, stop-cock 310, and tubing section 302f. The first valve 304 can be a one-way valve (e.g., a check valve) that only allows fluid flow from the first portion 314 to the drainage portion 318 (and not vice-versa). The second valve 306 can also be a one-way valve (e.g., a check valve) that only allows flow from the second portion 316 to the drainage portion 318 (and not vice-versa).” (emphasis added), para. [0055]: “As shown in FIG. 4B, moving the lever 104 from the second position to the first position (indicated by arrow A2) creates a positive pressure (indicated by arrows F in FIG. 4B) in the first portion 314 and drainage portion 318 of the tubing system 300. The second valve 306 prevents the positive pressure from affecting the aspiration lumen, thereby preventing the backflow of fluid into the blood vessel BV at the treatment site.” (emphasis added)); and
Quick discloses wherein sequential actuation of the actuation mechanism 104 to move the plunger in the first direction and the second direction is configured to (a) aspirate blood and at least a portion of the clot material through the aspiration catheter (paras. [0043]-[0047]),
Quick discloses the invention substantially as claimed except for disclosing a filter assembly, wherein sequential actuation of the actuation mechanism 104 to move the plunger in the first direction and the second direction is configured to, (b) drive the blood and the portion of the clot material into the filter assembly to filter the blood from the portion of the clot material, and (c) drive the filtered blood to the reservoir.
However, in the same field of endeavor, which is a system for aspirating occlusive material from a blood vessel of a patient (Abstract), Johnson discloses application of suction from suction source 110 (Fig. 1) withdraws blood clots 120 and any accompanying blood from the patient through the catheter 20 into blood filtration device 90. The filtration device 90 comprises a housing, a filter 100 for capturing and separating blood clots 120 from the withdrawn blood, and a one-way valve 102 for preventing withdrawn blood entering the suction source 110 (FIG. 1, col. 3, ln 30-48). Johnson also discloses the filter 100 is positioned upstream from valve 102 (FIG. 1). Johnson discloses the filtered blood, which is collected in the filtration device 90, is reinfused back into the patient via a reinfuser 140 (col. 5, ln 29-47).
In view of Johnson’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have substitute valve 306 of Quick with a filter assembly, which includes one-way valve and a blood filter, as suggested by Johnson, and couple a reinfuser to the reservoir of Quick system to allow the surgeon to perform infusion of the filtered blood back into the patient in the event that a substantial amount of blood is withdrawn from the patient during the procedure. Quick/Johnson would discloses the step of sequential actuation of the actuation mechanism 104 to move the plunger in the first direction and the second direction is configured to, (b) drive the blood and the portion of the clot material into the filter assembly to filter the blood from the portion of the clot material, and (c) drive the filtered blood to the reservoir.
Referring to claim 36, the modified system of Quick discloses the system of claim 21 wherein: the flow system further comprises a valve 310 (FIGS. 4A-4B, para. [0052]) between the pump assembly and the aspiration catheter; the valve is actuatable by the user between (a) a closed position inhibiting fluid flow from the aspiration catheter to the pump assembly and (b) an open position permitting fluid flow from the aspiration catheter to the pump assembly; the valve is configured to be in the closed position when the actuation mechanism is actuated by the user to move the plunger in the first direction to store the negative pressure in the barrel; and the valve is configured to be moved to the open position to apply the stored negative pressure to the aspiration catheter (Quick fails to disclose the function of stop-cock 310. However, examiner contends that the location of the stop-cock 310 is similar to the location of stop-cock 310 of the present application (see FIG. 1A), function of the lever 104 and syringe (pressure source) 106 are similar to the function of lever 104 and pressure source (syringe) of the present application, thus, the stop-cock 310 of Quick device is capable of performing the functional language as required in claim 36).
Referring to claim 37, examiner notes that the difference between claim 21 and claim 37 is claim 37 claimed “a filter blood tube” (lines 11 and 18-19) while claim 21 claimed “a reservoir” (lines 11 and 18-19). The device of Quick as modified by Johnson includes a filter assembly, which is a combination of one-way valve and a blood filter at lead line 306. Thus, the tubing portions 302b and/or 302c and/or 302d for coupling the one-way valve and filter assembly (FIG. 3A, which is reproduced above) read on the limitation of “filtered blood tube” as required in claim 37.
Claim(s) 22-27 and is/are rejected under 35 U.S.C. 103 as being unpatentable over Quick in view of Johnson et al. as applied to claims 2 and 10 above and further in view of Grooters (US 5,197,485, which is cited in IDS, hereinafter “Grooters”).
Referring to claim 22, the modified system of Quick discloses the system of claim 21 but fails to disclose wherein the filter assembly comprises a housing and a filter removably positioned within the filter assembly, and wherein the filter is configured to filter the blood from the portion of the clot material.
Referring again to claim 22, Grooters discloses a clot collection and blood filtration system (Figs. 2-7) includes a filter housing (components 14 and 24 as shown in Fig. 2) having a first end portion 14 or 24d and a second end portion 24d or 14, the filter housing having a port 14 or 24d at the first end portion configured to be fluidically coupled to the catheter and a cap 24d or 14 at the second end portion fluidically coupled to the vacuum source, a filter 26 positioned within the housing between the first end portion and the second end portion, and wherein the first one-way valve 16 is positioned in the filter housing. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have arranged the filtration system of Quick/Johnson to have a port on each end for coupling to the tubes of the second portion 316 of Quick system and a cap for removing the filter to provide the surgeon the ability to remove the filter from the housing for cleaning and/or examining the clot material or replacing the entire filtration system in the event that the filter is full with the clot material (“The handle can be quickly disassembled to allow the trap to be removed for examining any particulate collected.” (col. 2, lns. 25-50)).
Referring to claim 23, the modified system of Quick discloses the system of claim 21 wherein the filter assembly has a first port fluidly coupling the filter assembly to the aspiration catheter 316 and a second port fluidly coupling the filter assembly to the pump assembly (see rejection of claim 22 above).
Referring to claim 24, the modified system of Quick discloses the system of claim 21 wherein the sequential actuation of the actuation mechanism to move the plunger in the first direction and the second direction is configured to pull the blood and the portion of the clot material into the filter assembly via the negative pressure generated in the barrel (see rejection claim 21 above and paras. [0032], [0043]-[0047] and [0053]-[0054]).
Referring to claim 25, the modified system of Quick discloses the system of claim 21 wherein the actuation mechanism 104 comprises a lever 104 coupled to the handle body and to the plunger (Figs. 3A-3B shows barrel is moved with respect to plunger, para [0030] and [0043]-[0047], para [0032]: “As shown in FIG. 1B, in some embodiments the pressure source 106 is a syringe having a barrel 108 (e.g., a 20 cc barrel), a plunger 110, and a piston (not visible) coupled to an end portion of the plunger 110. One of the plunger 110 or the barrel 108 can be fixed relative to the housing 102, while the other of the plunger 110 or the barrel 108 is moveable relative to the housing 102.” Quick discloses lever 104 coupled to the outer housing and the plunger if the barrel is fixedly attached to the housing or the lever 104 coupled to the outer housing and the barrel if the plunger is fixedly attached to the housing).
Referring to claim 26, the modified system of Quick discloses the system of claim 21 wherein the reservoir comprises a bag (para. [0052]: “The tubing system 300 has a first portion 314 coupled to the pressure source 106, a second portion 316 coupled to the catheter 200, and a drainage portion 318 coupled to a reservoir 320 (e.g., a vinyl bag).”)
Referring to claim 27, the modified system of Quick discloses the system of claim 21 wherein the filter has a substantially cylindrical shape (Grooters discloses the filter has a substantially cylindrical shape (Figs. 2 and 5-6)).
Referring to claim 39, the modified system of Quick discloses the system of claim 37 wherein the filter assembly comprises a housing and a filter removably positioned within the filter assembly, and wherein the filter is configured to filter the blood from the portion of the clot material (see rejection of claim 22 above).
Referring to claim 40, the modified system of Quick discloses the system of claim 37 wherein the filter assembly has a first port fluidly coupling the filter assembly to the aspiration catheter and a second port fluidly coupling the filter assembly to the pump assembly (see rejection of claim 23 above).
Allowable Subject Matter
Claims 28-35 and 38 are 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.
Conclusion
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
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