DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
In response to the amendment filed on 01/28/2026, Claims 1-117 and 120 have been cancelled, and Claims 118-119 and 121-137 are pending.
Response to Arguments
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that Helm does not teach the claim limitations, there was an apparent typographical error for the Helm US Patent number, however Helm was cited correctly on the PTO-892 and was provided to the Applicant. Applicant could have found the correct prior art number (7,488,302) on the PTO-892. The claim mapping has not changed from the previous office action to this current office action and there are no new grounds of rejections. The applicant is reminded that the reply must be made with candor and good faith under 37 CFR 1.56. Where the applicant does not have or cannot readily obtain an item of required information, a statement that the item is unknown or cannot be readily obtained may be accepted as a complete reply to the requirement for that item. In this case, the prior art document was provided with the correct patent number on the PTO-892.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 118, 132, 133 and 137 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 21 of U.S. Patent No. 9,457,172 (referred to as Pat ‘172). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding Claim 118, Claim 21 (which includes the subject matter of Claim 1) of Pat ‘172 teaches a blood clot removal system for removing blood clots of a patient, comprising:
a blood clot removal device having
a blood flow passageway to be connected to the patient's vascular system to allow circulation of the patient's blood through the blood flow passageway,
a filter provided in the blood flow passageway for collecting blood clots occurring in the blood flowing through the blood flow passageway, and
a cleaning device for moving blood clots collected by the filter out of the blood flow passageway; and
a heart pump connected to the blood flow passageway.
Regarding Claim 132, Claim 21 of Pat’ 172 (which includes the subject matter of Claim 17) teaches the system according to claim 118, comprising a sensor sensing a parameter.
Regarding Claim 133, Claim 21 of Pat ‘172 teaches the system according to claim 132, wherein the sensor is a functional parameter sensor sensing a functional parameter of the blood clot removal system.
Regarding Claim 137, Claim 1 of Pat ‘172 teaches a blood clot removal system for removing blood clots of a patient, comprising:
a blood flow passageway to be connected to the patient's vascular system to allow circulation of the patient's blood through the blood flow passageway,
a filter provided in the blood flow passageway for collecting blood clots occurring in the blood flowing through the blood flow passageway, and
a cleaning device for moving blood clots collected by the filter out of the blood flow passageway.
Claim 137 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,729,894 (now referred to as Pat ‘894). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding Claim 137, Claim 1, 11 and 12 of Pat ‘894 teaches a blood clot removal system for removing blood clots of a patient, comprising:
a blood flow passageway to be connected to the patient's vascular system to allow circulation of the patient's blood through the blood flow passageway,
a filter provided in the blood flow passageway for collecting blood clots occurring in the blood flowing through the blood flow passageway, and
a cleaning device for moving blood clots collected by the filter out of the blood flow passageway.
Claim 137 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,291,808. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding Claim 137, Claim 1 of Pat ‘172 teaches a blood clot removal system for removing blood clots of a patient, comprising:
a blood flow passageway to be connected to the patient's vascular system to allow circulation of the patient's blood through the blood flow passageway,
a filter provided in the blood flow passageway for collecting blood clots occurring in the blood flowing through the blood flow passageway, and
a cleaning device for moving blood clots collected by the filter out of the blood flow passageway.
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 118-119, 121-122, 124, 128, 129, 132, 133, and 135-137 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thornton (US Patent 5,147,281) in view of Helm (US Patent 7,488,302)
Regarding Claim 118, Thornton teaches a blood clot removal system for removing blood clots of a patient, comprising (Figure 1):
a blood clot removal device (10) having
a blood flow passageway (18, 20, 22, and 28) to be connected to the patient's vascular system to allow circulation of the patient's blood through the blood flow passageway (Figure 1),
a filter (22) provided in the blood flow passageway for collecting blood clots occurring in the blood flowing through the blood flow passageway (Figure 1), and
a heart pump (16) connected to the blood flow passageway (Figure 1).
Thornton fails to disclose:
a cleaning device for moving blood clots collected by the filter out of the blood flow passageway.
Helm teaches a device allowing for serial use of clean and alternative blood filters during blood filtration (abstract) comprising a cleaning device (75/76 Figure 5A-5B), the cleaning device (75/76) moves blood clots collected by the filter out of the blood flow passage way (70; Figure 5B) by moving the dirty filter out of the blood passageway and rotating a new filter in its place (Column 4, Lines 34-48).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the blood clot removal device of Thornton to include a cleaning device, as taught by Helm, for the advantage of running the blood clot removal device for a longer duration without comprising the filtering aspect of the invention.
Regarding Claim 119, the combination of references disclosed above teaches the system of claim 118 wherein Thornton teaches further comprising a tube for connecting the heart pump to the left ventricle of the patient's heart (see the needles in Figure 1 which are tubes that can be attached to the left ventricle).
Regarding Claim 121, the combination of references disclosed above teaches the system of claim 118, wherein Thornton further teaches comprising a tube for connecting the heart pump connected to the patient's aorta (see the needles in Figure 1 which are tubes that can be attached to the patients aorta).
Regarding Claim 122, the combination of references disclosed above teaches the system of claim 118, wherein Thornton teaches comprising a switch, the switch being adapted to manually and non-invasively control a function of the blood clot removal device (Column 7, Lines 24-34).
Regarding Claim 124, the combination of references disclosed above teaches the system of claim 122, wherein Thornton teaches the switch is an electric switch (Column 7, Lines 24-34).
Regarding Claim 128, the combination of references disclosed above teaches the system according to claim 118, comprising wherein Thornton teaches an energy source adapted to power the blood clot removal device (Column 4, Lines 18-24).
Regarding Claim 129, the combination of references disclosed above teaches the system according to claim 128, wherein Thornton teaches the energy source comprises an internal energy source (30; Figure 1; Column 4, Lines 18-24).
Regarding Claim 132, the combination of references disclosed above teaches the system according to claim 118, wherein Thornton teaches comprising a sensor sensing a parameter (32 or 34, flow meter or pressure monitor).
Regarding Claim 133, the combination of references disclosed above teaches the system according to claim 132, wherein Thornton teaches the sensor is a functional parameter sensor sensing a functional parameter of the blood clot removal system (fluid pressor and flow rates are functional parameters (Figure 1; 32 34).
Regarding Claim 135, the combination of references disclosed above teaches the system according to claim 118, wherein Thornton teaches comprising a feedback device (pressure monitor) for sending information from inside the patient's body to the outside thereof to give feedback information related to a functional parameter of the blood clot removal device (the pressure monitor would also be taking the pressure of the fluid within both the device and the patient’s body) (Figure 1).
Regarding Claim 136, the combination of references disclosed above teaches the system according to claim 132, wherein Thornton teaches comprising an internal control unit acting in response to a functional parameter sensed by the sensor (Column 7, Lines 24-24).
Regarding Claim 137, Thornton teaches a blood clot removal system for removing blood clots of a patient, comprising (Figure 1):
a blood flow passageway (18, 20, 22, and 28) to be connected to the patient's vascular system to allow circulation of the patient's blood through the blood flow passageway (Figure 1),
a filter (22) provided in the blood flow passageway for collecting blood clots occurring in the blood flowing through the blood flow passageway (Figure 1)
Thornton fails to disclose:
a cleaning device for moving blood clots collected by the filter out of the blood flow passageway.
Helm teaches a device allowing for serial use of clean and alternative blood filters during blood filtration (abstract) comprising a cleaning device (75/76 Figure 5A-5B), the cleaning device (75/76) moves blood clots collected by the filter out of the blood flow passage way (70; Figure 5B) by moving the dirty filter out of the blood passageway and rotating a new filter in its place (Column 4, Lines 34-48).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the blood clot removal device of Thornton to include a cleaning device, as taught by Helm, for the advantage of running the blood clot removal device for a longer duration without comprising the filtering aspect of the invention.
Allowable Subject Matter
Claims 123, 125-127, 130, 131, and 137 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
THIS ACTION IS MADE FINAL. 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 MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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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) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771