DETAILED ACTION
Notice of Pre-AIA or AIA Status
This Office Action is in response to the Amendment filed 5 August 2026. Claim(s) 21-40 are currently pending. The Examiner acknowledges the amendments to claim(s) 21, 23, 28, 31, 35, 36, and cancelled claim(s) 1-20.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation
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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘helical macerator member’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 7 please change “the distal portion” to “a distal portion”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in line 11, please change “the helical macerator” to “the helical macerator member”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 35 is 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 35 recites that the intermediate shaft includes a rounded distal-most end and is closed. However, claim 35 further requires that the intermediate shaft is capable of being coaxially inserted over the inner shaft, as recited in claims 23 and 25 from which claim 35 depends. It is not clear how the intermediate shaft coaxially slides over the inner shaft when the distal-most end is closed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 21, 23-27, 31-34, 36-40 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Damarais et al. (US 6,454,775, “Damarais”).
Regarding claim 21, Damarais discloses a system including an intermediate shaft (22; Fig. 2) that is capable of being coaxially inserted into a lumen of an outer shaft (12; C7:L21-25). The intermediate shaft is capable of being uncoupled at a distal end from the outer shaft and rotated relative to the outer shaft, wherein the intermediate shaft is not coupled at a distal end to the outer shaft when introduced or withdrawn therefrom. The intermediate shaft includes a helical macerator member (42, 48) at a distal portion of the intermediate shaft. The helical macerator member is supported by and wrapped around the intermediate shaft (Fig. 2). A vacuum (C3:L27-30, C8:L67, C9:L1, C11:L50-53) is capable of being in operative fluid communication with the lumen of the outer shaft. The helical macerator member is capable of operatively breaking up at least a portion of an undesirable material upon rotation (C3:L18-20, C4:L50-55, C5:L63-67, C7:L56-65) of the intermediate shaft and capable of providing an aspiration flow path around the helical macerator member within the lumen of the outer shaft.
Regarding claim 23, Damarais discloses an inner shaft (20, guidewire) wherein the intermediate shaft is capable of being coaxially inserted over the inner shaft and capable of being rotated relative to the inner shaft (C7:L21-25,C9:L5-11).
Regarding claim 24, Damarais discloses that the rotation of the helical macerator member relative to the outer shaft is capable of pulling the portion of the undesirable material within the lumen (30) of the outer shaft (abs; C3:L18-21, C4:L50-55).
Regarding claim 25, Damarais discloses that the intermediate shaft is capable of moving coaxially relative to the inner shaft (C8:L17-20, 55-58, C9:L5-11).
Regarding claim 26, Damarais discloses that the vacuum source is capable of being activated simultaneously with rotation of the helical macerator member wherein the user is capable of aspirating material through port (62) while activating the drive unit (14) to rotate the helical macerator member (C7:L17-20).
Regarding claim 27, Damarais discloses that the helical macerator member is capable of being rotated in a clock-wise direction (C9:L50-52, Fig. 5B).
Regarding claim 31, Damarais discloses a system including a macerator shaft (22; Fig. 2) that is capable of being coaxially inserted into a lumen of an aspiration cannula (12; C7:L21-25) and coaxially over a guidewire (20; it is noted that the guidewire is not positively recited). The macerator shaft is capable of moving coaxially relative to the guidewire and aspiration cannula (C8:L17-20, 55-58, C9:L5-11). The macerator shaft is capable of being rotated clock-wise relative to the aspiration cannula and the guidewire (C9:L50-52, Fig. 5B). The helical macerator (42, 48) is coupled at the distal end of the macerator shaft. A vacuum (C3:L27-30, C8:L67, C9:L1, C11:L50-53) is capable of being in operative fluid communication with the lumen of the aspiration cannula. The helical macerator member is capable of operatively breaking up at least a portion of an undesirable material within the lumen of the aspiration cannula upon clock-wise rotation of the macerator shaft (C3:L18-20, C4:L50-55, C5:L63-67, C7:L56-65) and capable of providing an aspiration flow path around the helical macerator member within the lumen of the outer shaft.
Regarding claim 32, Damarais discloses that the helical macerator is capable of being advanced towards the undesirable material to mechanically disrupt the undesirable material into smaller pieces (C4:L18-40, 50-53, C5:L59-67).
Regarding claim 33, Damarais discloses that the vacuum is capable of aspirating pieces of undesirable material that are broken up by the helical macerator through the lumen of the aspiration cannula (C3:L27-29).
Regarding claim 34, Damarais discloses that the guidewire (20) is capable of being advanced through the undesirable material to a position distally beyond the undesirable material (C7:L54-55).
Regarding claims 36-38, Damarais discloses a system including a shaft (22; Fig. 2) that is capable of being coaxially inserted and retracted into a lumen of a cannula (12; C7:L21-25) and coaxially over a guidewire (20; it is noted that the guidewire is not positively recited) by moving the entire system over the guidewire. The distal end of the shaft is capable of moving coaxially relative to the guidewire and cannula (C8:L17-20, 55-58, C9:L5-11). The shaft is capable of being rotated clock-wise relative to the aspiration cannula and the guidewire and around a central axis (C9:L50-52, Fig. 5B). A macerator (42, 48) defined by a helical shape is coupled at the distal end of the shaft. A vacuum (a source of aspiration, C3:L27-30, C8:L67, C9:L1, C11:L50-53) is capable of being in operative fluid communication with the lumen of the cannula. The macerator is capable of operatively macerating at least a portion of an undesirable material within the lumen of the cannula upon movement of the shaft (C3:L18-20, C4:L50-55, C5:L63-67, C7:L56-65) and capable of providing an aspiration flow path around the helical shape of the macerator within the lumen of the outer shaft.
Regarding claim 39, Damarais discloses that the source of aspiration includes a pump (C3:L28-29).
Regarding claim 40, Damarais discloses that the shaft is capable of being manually rotated by rotating the entire system.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Damarais.
Regarding claim 22, Damarais discloses the helical macerator member is capable of extending from a distal end of the outer shaft (Fig. 2A). As seen in Damarais, the distance the helical macerator member extends from a distal end of the outer shaft is disclosed as a result effective variable in that changing the distance affects the capability of reaching obstructions. It appears that one of ordinary skill in the art would have had a reasonable expectation of success in Damarais to extend from the outer shaft at a distance of approximately 0.25 inches to 5.0 inches, as it involves only adjusting the dimension of a component disclosed to require adjustment, e.g. intermediate shaft. Therefore, it would have been obvious to one of ordinary skill in the art before the claimed invention was made to modify the device of Damarais by making the distance of the extension of the helical macerator member from the distal end of the outer shaft approximately 0.25inches to 5.0inches, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 28 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Damarais in view of Evans et al. (US 2001/0031981A1, “Evans”).
Regarding claim 28, Damarais does not disclose that the intermediate shaft includes a rounded distal most end. In the same field of endeavor, occlusion removal devices, Evans teaches a system including an outer member (161), an inner shaft (GW) and an intermediate shaft (12; [0079]). The intermediate shaft includes a rounded distal most end (Fig. 11). Therefore, it would have been obvious to one of ordinary skill in the art before the invention was made to have formed the distal most end of the intermediate shaft of Damarais to be rounded, as taught by Evans, to provide means for atraumatic use which avoids and prevents perforation of vessel walls while allowing smooth advancement.
Regarding claim 29, the combination of Damarais and Evans discloses a helical macerator member having two helical members (141, 142; Fig. 21). However, the combination of Damarais and Evans does not disclose that the helical macerator member includes a pitch in the range of 0.5 helical members per inch to 10 helical members per inch. As seen in the combination of Damarais and Evans, the pitch of the helical macerator member is disclosed as a result effective variable in that changing the pitch affects the capability of macerating obstructions. It appears that one of ordinary skill in the art would have had a reasonable expectation of success in the combination of Damarais and Evans of a pitch in the range of 0.5 helical members per inch to 10 helical members per inch, as it involves only adjusting the dimension of a component disclosed to require adjustment, e.g. helical macerator member. Therefore, it would have been obvious to one of ordinary skill in the art before the claimed invention was made to modify the device of the combination of Damarais and Evans by making the pitch of the helical macerator member within the range of 0.5 helical members per inch to 10 helical members per inch, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Damarais in view of Trerotola (US 5,766,191).
Regarding claim 30, Damarais does not disclose that the helical macerator member is capable of being rotated up to 5,000 rotations per minute. In the same field of endeavor, rotating fragmentation device, Trerotola teaches a catheter system including a cage or basket attached to a rotational drive motor, wherein the basket is capable of being rotated at approximately 3000-4500rpm (C4:L5-12), which is within the claimed range. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the helical macerator member of Damarais with a motor capable of being rotated up to 5000 rotations per minute, as taught by Trerotola, to provide means for rotating the macerator at a high speed to fragment an obstruction to form a homogenized thrombotic material that is easily aspirated.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21, 31 and 36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. West (US 2006/0047286A1) discloses a clot retrieval device including a helical wired basket and a vacuum source. Leeflang et al. (US 2002/0173819A1) discloses a capture device that includes an outer shaft, an intermediate shaft and a vacuum but does not disclose an inner shaft.
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 JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie 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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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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