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 .
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., ‘aspiration pump’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.”
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,318,098 in view of Brady et al. (US 2019/0239910A1, “Brady”). Claim 1 of the reference patent recites all of the limitations of claim 1 of the instant application except “a flexible pump extension tube” and describes an operable mode wherein the aspiration pump moves between first and second operable modes that generate a cyclic pressure waveform formed by cycling negative and positive pressure modes. Brady et al. teaches a clot retrieval system including a flexible extension tube (504; [0063]) that connects a vacuum (aspiration) pump (502) and a catheter (503). 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 formed the extension tube of the instant claim to be flexible, as taught by Brady, for the predictable result of maintaining a steady vacuum connection, ensuring reliable fluid and debris removal while reducing kinking and without restricting movement.
Instant Application
U.S. Patent No. 12,318,098
1. A thrombus removal system for use in performing thrombectomy procedures comprising: an elongate catheter having proximal and distal ends, a length and an inner diameter; an aspiration pump having a housing, a user interface, a microprocessor controller, a pump assembly, an aspiration container, a pump sensor and a data storage module; and a flexible pump extension tube having first and second ends and a length extending there between, said extension tube first end being connected to said aspiration pump and said second end being connected to a coupler, wherein said coupler is coupled to the proximal end of said catheter; said aspiration pump further having an operable mode that generates a cyclic pressure waveform such that when said aspiration pump is coupled to said catheter positioned within a vessel adjacent a thrombus and operated, said pump controllably cycles supplying negative pressure to said catheter to aspirate a thrombus through the catheter to the pump aspiration container.
1. A thrombus removal system for use in performing thrombectomy procedures comprising: an elongate catheter having proximal and distal ends, a length and an inner diameter; an aspiration pump having a housing, a user interface, a microprocessor controller, a pump assembly, an aspiration container, a pump sensor and a data storage module; and a pump extension tube having first and second ends and a length extending there between, said extension tube first end being connected to said aspiration pump and said extension tube second end being connected to a coupler, wherein said coupler is coupled to the proximal end of said catheter; said aspiration pump further having a first operable mode that generates a negative pressure condition such that when said aspiration pump is coupled to said catheter positioned within a vessel adjacent a thrombus and operated, said aspiration pump controllably supplies negative pressure to said catheter to aspirate a thrombus through the catheter to the pump aspiration container 11. and a second operable mode that generates negative and positive pressure conditions such that when said aspiration pump is coupled to the catheter positioned within a vessel adjacent a thrombus and operated, said pump controllably supplies negative and positive pressure to said catheter to aspirate a thrombus through the catheter to the pump aspiration container, said aspiration pump being moveable between said first and second operable modes.
2. A thrombus removal system as in claim 1 wherein said pump sensor takes the form of a pressure sensor and measures fluid pressure distal to said tubing first end and proximal to said second end when in said operable mode.
2. The thrombus removal system as in claim 1, wherein said pump sensor takes the form of a pressure sensor and measures fluid pressure distal to said extension tube first end and proximal to said extension tube second end when in said first and second operable modes.
6. A thrombus removal system as in claim 1 wherein said aspiration pump user interface includes a data display.
3. The thrombus removal system as in claim 1, wherein said aspiration pump user interface includes a data display.
7. A thrombus removal system as in claim 1 wherein said aspiration pump user interface includes a wireless data transmission and receiving module.
4. The thrombus removal system as in claim 1, wherein said aspiration pump user interface includes a wireless data transmission and receiving module.
8. A thrombus removal system as in claim 1 wherein said pump assembly includes a motor coupled to a rotor that rotates in a first direction to generate a negative pressure and rotates in a second direction opposite from said first direction to generate a positive pressure.
5. The thrombus removal system as in claim 1, wherein said pump assembly includes a motor coupled to a rotor that rotates in a first direction to generate a negative pressure and rotates in a second direction opposite from said first direction to generate a positive pressure.
9. A thrombus removal system as in claim 8 wherein said rotor controllably cycles between rotating in said first and second directions.
6. The thrombus removal system as in claim 5, wherein said rotor controllably cycles between rotating in said first and second directions.
10. A thrombus removal system as in claim 9 wherein said cyclic pressure waveform is a substantially square waveform.
7. The thrombus removal system as in claim 6, wherein said negative and positive pressure conditions take the form of a substantially square waveform.
12. A thrombus removal system as in claim 11 wherein said catheter includes a catheter sensor positioned at the catheter distal end said catheter sensor having a sensor conductor removably coupled to said aspiration pump.
8. The thrombus removal system as in claim 1, wherein said catheter includes a catheter sensor positioned at the catheter distal end said catheter sensor having a sensor conductor removably coupled to said aspiration pump.
15. A thrombus removal system as in claim 12 wherein said aspiration pump is moveable between said first and second operable modes upon an input signal from said catheter sensor or said pump sensor.
9. The thrombus removal system as in claim 8, wherein said aspiration pump is moveable between said first and second operable modes upon an input signal from said catheter sensor or said pump sensor.
13. A thrombus removal system as in claim 11 wherein said aspiration pump is moveable between said first and second operable modes upon an input signal from said user interface.
10. The thrombus removal system as in claim 1, wherein said aspiration pump is moveable between said first and second operable modes upon an input signal from said user interface.
14. A thrombus removal system as in claim 11 wherein said aspiration pump is moveable between said first and second operable modes upon an input signal from said pump sensor.
11. The thrombus removal system as in claim 1, wherein said aspiration pump is moveable between said first and second operable modes upon an input signal from said pump sensor.
16. A thrombus removal system as in claim 11 wherein said second operable mode includes a plurality of pre-programmed discreet wave forms.
12. The thrombus removal system as in claim 1, wherein said second operable mode includes a plurality of pre-programmed discreet pressure conditions.
17. A thrombus removal system as in claim 11 wherein said aspiration pump in said second operable mode supplies positive pressure above atmospheric pressure.
15. The thrombus removal system as in claim 1, wherein said aspiration pump in said second operable mode supplies positive pressure above atmospheric pressure.
18. A thrombus removal system as in claim 11 wherein said aspiration pump in said second operable mode supplies positive pressure above blood pressure.
16. The thrombus removal system as in claim 1, wherein said aspiration pump in said second operable mode supplies positive pressure above blood pressure.
19. A thrombus removal system as in claim 16 wherein said aspiration pump supplies a selected discreet waveform from said plurality of pre-programmed discreet wave forms upon input from said user interface.
13. The thrombus removal system as in claim 12, wherein said aspiration pump supplies a selected discreet condition from said plurality of pre-programmed discreet conditions upon input from said user interface.
20. A thrombus removal system as in claim 16 wherein said aspiration pump automatically supplies a sequence of pre-programmed discreet waveforms from said plurality of pre-programmed discreet wave forms upon input from said pump sensor.
14. The thrombus removal system as in claim 12, wherein said aspiration pump automatically supplies a sequence of pre-programmed discreet conditions from said plurality of pre-programmed discreet conditions upon input from said pump sensor.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities: Please change “that generates” in line 10 to “that is configured to generate”. Appropriate correction is required.
Claim(s) 2 is/are objected to because of the following informalities: Please change “measures fluid” in line 2 to “is configured to measure fluid”. Appropriate correction is required.
Claim(s) 8 is/are objected to because of the following informalities: Please change “rotor that rotates” in line 2 to “rotor that is configured to rotate”. Appropriate correction is required.
Claim(s) 11 is/are objected to because of the following informalities: Please change “that generates” in line 2 to “that is configured to generate”. Appropriate correction is required.
Claim(s) 11 and 16 is/are objected to because of the following informalities: Please change “wave form” in line 2 to “waveform”. Appropriate correction is required.
Claim(s) 11 is/are objected to because of the following informalities: Please change “wave forms” in line 6 to “waveforms”. Appropriate correction is required.
Claim(s) 18 is/are objected to because of the following informalities: Please change “operable mode supplies” in line 2 to “operable mode configured to supply”. Appropriate correction is required.
Claim(s) 19 is/are objected to because of the following informalities: Please change “aspiration pump automatically supplies” in line 2 to “aspiration pump is configured to automatically supply”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saroha et al. (US 2022/0040394A1, “Saroha”) in view of Brady et al. (US 2019/0239910A1, “Brady”) in view of Cancilla et al. (US 2006/0142972A1, “Cancilla”).
Regarding claims 1 and 4, Saroha discloses a thrombus removal system including an elongate catheter (230; [0037]; Fig. 2) having proximal and distal ends, a length an inner diameter. An aspiration pump (200; [0034]) having a housing (210), a user interface (electronic input; 213), a microprocessor controller [0036, processing component], a pump assembly (pump displacement mechanics; [0034]), an aspiration container (228; [0038]; Fig. 2, 229; [0049; Fig. 6]), a pump sensor (216; [0035]). The aspiration pump includes an operable mode that generates a cyclic pressure waveform, wherein variations in pressure are formed by the generated pulses [0036], such that when the aspiration pump is coupled to the catheter positioned within a vessel adjacent a thrombus and operated, the pump is capable of controllably cycling supplying negative pressure to the catheter to aspirate a thrombus through the catheter to the pump aspiration container [0028, 0036, 0038]. However, Saroha does not disclose a flexible pump extension tube coupled to the aspiration pump and connected to the proximal end of the catheter via a coupler and a data storage module.
In the same field of endeavor, aspiration system, Brady discloses a system including flexible pump extension tube (504, [0063]) is coupled to an elongate catheter (503; Fig. 19) by a coupler (505) and is coupled to an aspiration/vacuum pump (502). The extension tube is non-expanding when the aspiration pump is in operable mode. 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 system of Saroha with a flexible pump extension tube coupled to the aspiration pump and connected to the proximal end of the catheter via a coupler, as taught by Brady, to provide smoother fluid flow and to reduce kinking.
In the same field of endeavor, processors for pumps, Cancilla teaches a vacuum pump (102; [0021]) that includes a processor, user interface (110) and a data storage module (108). 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 microprocessing controller of the system of Saroha with a data storage module, as taught by Cancilla, to retain data in easily accessible means.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saroha in view of Brady and Cancilla, as applied to claim 1 above, and further in view of Janardhan et al. (US 8,715,317, “Janardhan”).
Regarding claim 3, the combination of Saroha, Brady and Cancilla does not disclose that the extension tube has a length less than 16 inches. In the same field of endeavor, suction devices, Janardhan teaches a suction tube (extension tube) that connection between a vacuum pump and microcatheter (504). The suction tube has a length that ranges from 15 cm (5.9inches) and 150cm (59.05inches). 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 extension tube of the combination of Saroha, Look and Cancilla with a length less than 16 inches, as taught by Janardhan. The extension tube protrudes from the aspiration pump such the length of the extension tube is disclosed to be a result effective variable in that changing the length of the extension tube changes the distance which affects the distance of the pump from the catheter. Therefore, it would have been obvious to one having ordinary skill before the effective filing date of the claimed invention to modify the extension tube of the combination of Saroha, Brady and Cancilla by making the length less than 16 inches 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(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saroha in view of Brady in view of Cancilla, as applied to claim 1 above, and further in view of Look et al. (US 2017/0056032A1, “Look”).
Regarding claim 5, the combination of Saroha, Brady, and Cancilla does not disclose that the aspiration pump user interface includes audible feedback
In the same field of endeavor, aspiration systems, Look discloses a system including an elongate catheter (516; Fig. 15) having proximal and distal ends, a length an inner diameter. An aspiration pump (510) having a housing (512), a user interface(506), a microprocessor controller [0060], and a pump assembly (526). The aspiration pump has an operable mode that generates a cyclic pressure waveform by way of pulses that create a sinusoidal pressure map with variations between the peaks and valleys of each wave, such that when the aspiration pump is coupled to the catheter positioned within a vessel adjacent a thrombus and operated, the pump controllably cycles supplying negative pressure to the catheter to aspirate a thrombus through the catheter [0054]. The proximal end of the catheter is connected to a second end of a flexible pump extension tubing (514) via a coupler (518) and the first end of the extension tube is connected to the aspiration pump [0140-0141]. The aspiration pump user interface includes audible feedback [0061, 0067]. 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 aspiration pump user interface includes audible feedback of the system of Saroha, as taught by Look, to confirm user input and improve accessibility.
Regarding claim 7, the combination of Saroha, Brady, Cancilla and Look discloses that the aspiration pump user interface includes wireless transmission and a receiving module [0135; Look].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saroha in view of Brady and Cancilla, as applied to claim 1 above, and further in view of Odland (US 2003/0181824A1).
Regarding claim 6, the combination of Saroha, Brady and Cancilla does not disclose that the aspiration pump user interface includes a data display. In the same field of endeavor, vacuum devices, Odland teaches that the aspiration pump user interface includes a data display (Fig. 17; Odland). 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 aspiration pump user interface of the combination of Saroha, Brady and Cancilla with a data display, as taught by Odland, to provide the user with efficient visual indicators during use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kataishi et al. (US 2005/0015073A1) discloses a thrombus suction catheter.
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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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
