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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/19/25 has been entered.
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 2, 5-10, 12-14, and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, and 10 of U.S. Patent No. 12,478,390. Although the conflicting claims are not identical, they are not patentably distinct from each other because each of the structural limitation recited in the claims of the instant application are also recited in claims 1, 3-6, and 10 of U.S. Patent No. 12,478,390. The difference in the terminology used would be obvious to one of ordinary skill in the art.
Specifically, the claimed limitations of claims 2, 5, 6, and 8 are found in claims 1, 5, 3, and 4 of U.S. Patent No. 12,478,390, respectively. The claimed limitations of claims 7, 12, 13, and 18 are found in the combination of claims 1 and 3 of U.S. Patent No. 12,478,390. The claimed limitations of claims 9 and 16 are found in claims 1 or 6 of U.S. Patent No. 12,478,390. The claimed limitations of claims 10 and 14 are found in claims 11 and 10 of U.S. Patent No. 12,478,390, respectively. The claimed limitations of claims 17 and 19 are found in claims 10 and 5 of U.S. Patent No. 12,478,390, respectively.
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.
Claim(s) 2-10, and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Noriega et al. (2005/0020974) in view of Nayak (2004/0049152).
Claims 2, 4, and 6:
Noriega discloses a catheter (combination 10 and 20) (Fig. 1-2) and [0046]) comprising: a working lumen (36) (Fig. 3 and [0049]), wherein the working lumen so as to facilitate application of suction through the working lumen ([0046]) (the lumen is empty and has a dead space prior to suction) and wherein the working lumen of a distal end of the catheter is configured to be positioned proximate the clot or lesion (where the device is capable of performing this function), and wherein at least the distal end of the catheter is flexible ([0055]); and a suction device (vacuum source in [0046]) configurable to generate at least one suction output for removal of the clot or lesion using suction ([0046]).
Noriega teaches all the claimed limitations discussed above however, Noriega does not disclose that wherein the at least one suction output comprises a plurality of intensity levels, and wherein the plurality of intensity levels comprises a first intensity level and a second intensity level.
Nayak discloses a suction catheter which has control means to allow the user to control suction paramaters/suction outputs which comprises a plurality of intensity levels (degrees of suctioning such as suction pressure or different intensities as stated in [0035]), and wherein the plurality of intensity levels comprises a first intensity level (a low degree of suction or intensity) and a second intensity level (a higher degree of suction or intensity) ([0035]).
Nayak further discloses that activation of the at least one suction output is enabled using at least one of an external control panel, a valve or a switch by controlling at least one parameter selected from the group consisting of: pressure, velocity, flow, and duration ([0035]); wherein the at least one suction output is configured to be generated or changed at a location between the suction device and the distal end of the catheter ([0035]);
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Noriega with control means in view of the teachings of Nayak, in order to allow the user to control suction paramaters/suction outputs such as the pressure of the suction by using a programmed control ([0035]).
Claim 3: Noriega further discloses that the suction device is configured to be fluidically connected to the working lumen of the catheter and to flush fluid through the working lumen of the catheter before, during, and after advancing the catheter ([0049])
Claim 8: Noriega further discloses that the catheter comprises at least one of a variably slotted hypotube (12) comprising a plurality of interspersed cut patterns (48) or filaments having variable braiding or coiling parameters (Fig. 4-5).
Claims 9, 10, and 14:
Noriega discloses a flexible catheter (combination 10 and 20) (Fig. 1-2, [0046], [0055]) comprising an open lumen (36) (Fig. 3 and [0049]), wherein a distal end of the open lumen of the flexible catheter is configured to be positioned proximate to the material (where it is capable of being placed proximate the material); and a suction device (vacuum source in [0046]) configured to generate one or a plurality of suction outputs for removal of the material using suction ([0046])
Noriega teaches all the claimed limitations discussed above however, Noriega does not disclose wherein at least one suction output of the plurality of suction outputs comprises a plurality of intensity levels prior to achieving a desired suction.
Nayak discloses a suction catheter which has control means to allow the user to control suction paramaters/suction outputs which comprises a plurality of intensity levels (degrees of suctioning such as suction pressure or different intensities as stated in [0035]) prior to achieving desired suction (the parameters can be changed until the appropriate conditions are found) ([0035]); wherein the at least one suction output is configured to be generated or changed at a location between the suction device and the distal end of the catheter ([0035]); wherein activation of the at least one suction output is enabled using at least one of an external control panel, valve or switch by controlling at least one parameter selected from the group consisting of: pressure, velocity, flow, and duration ([0035])
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Noriega with control means in view of the teachings of Nayak, in order to allow the user to control suction paramaters/suction outputs such as the pressure of the suction by using a programmed control ([0035]).
Claim 15: Noriega further discloses that the suction device is configured to be fluidically connected to the working lumen of the catheter and to flush fluid through the working lumen of the catheter before, during, and after advancing the catheter ([0049])
Claims 16, 17, 19, and 20: See the rejections above where Noriega in view of Nayak appear to teach the claimed limitations.
Claims 6, 7, 12, 13, 18:
It would have been obvious for the first intensity level to be in a range of between -551 and -769 mm Hg and for the second intensity level is between -100 and -350 mm Hg or between -351 and -550 mm Hg. Noriega in view of Nayak discloses the claimed invention, including using control means in order to control suction parameters such as suction pressure or flow (Nayak, [0035]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize the intensity levels of the pulses to break up the tissue, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 2-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Noriega et al. (2005/0020974) in view of Hodge (4,830,047).
Claims 2, 4-7, 9-14, 16-19, and 21:
Noriega discloses a catheter (combination 10 and 20) (Fig. 1-2) and [0046]) comprising: a working lumen (36) (Fig. 3 and [0049]), wherein the working lumen so as to facilitate application of suction through the working lumen ([0046]) (the lumen is empty and has a dead space prior to suction) and wherein the working lumen of a distal end of the catheter is configured to be positioned proximate the clot or lesion (where the device is capable of performing this function), and wherein at least the distal end of the catheter is flexible ([0055]); and a suction device (vacuum source in [0046]) configurable to generate at least one suction output for removal of the clot or lesion using suction ([0046]); wherein the flexible catheter is selected from the group consisting of: a microcatheter, a distal access microcatheter, a guide catheter, and a balloon catheter (Abstract).
Noriega teaches all the claimed limitations discussed above however, Noriega does not disclose that wherein the at least one suction output comprises a plurality of intensity levels, and wherein the plurality of intensity levels comprises a first intensity level and a second intensity level.
Hodge discloses a system for facilitating aspiration of material within a body (system with intermittent suction for removing fluids; Abstract; Column 1, line 66 to Column 2, line 28), the system comprising: a catheter (catheter 26; Figure 1; Column 3, lines 3-21); and a suction device (positive pulse device 22 with control unit 12; Figure 1; Column 3, lines 3-21) configured to generate one or a plurality of suction outputs (pulse device 22 with control unit 12 can generate a pattern of different suction modes based on signal from control unit 12 and where the modes can be continuously repeated as the control unit 12 continues onto further cycles; Figures 4A-4B; Column 6, lines 9-14 and Column 8, lines 34-44); wherein at least one suction output comprises a plurality of intensity levels (suction pattern is from vacuum off to vacuum on with the vacuum range from 300-600 mmHg in vacuum on mode and 0 mmHg on vacuum off mode; Figure 4A-4D; Column 2, line 64 to Column 3, line 2 and Column 6, line 9-14, Column 7, lines 1-4 and 30-39, Column 8, line 10-13), wherein the plurality of intensity levels comprises a first intensity level and a second intensity level (first intensity level is vacuum off mode at 0 mmHg and second intensity level is vacuum on mode at 300-600 mmHg; Figure 4A-4D; Column 2, line 64 to Column 3, line 2 and Column 6, line 9-14, Column 7, lines 1-4 and 30-39, Column 8, line 10-13).
Hodge further discloses wherein activation of the at least one suction output is enabled using at least one of an external control panel (12) (Fig. 1 and Col. 3 Lines 3-5), a valve or a switch by controlling at least one parameter selected from the group consisting of: pressure, velocity, flow, and duration (Col. 3 Lines 22-32); wherein the at least one suction output is configured to be generated or changed at a location between the suction device and the distal end of the catheter (Fig. 1); wherein the at least one suction output is configured to be generated or changed at a location between the suction device and the distal end of the open lumen of the flexible catheter (Fig. 1); wherein the suction device is connected through a suction tubing directly to a hub of the flexible catheter or indirectly through a hemostatic valve to the hub of the flexible catheter (Fig. 1)
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Noriega with a plurality of intensity levels in view of the teachings of Hodge, in order to have more than one output signal from an intermittent suction regulator, which would allow one vacuum signal to be regulated in accordance with the desired vacuum to be applied to the patients cavity while the other vacuum signal may be uneffected by changes in the suction level to the patient and thus can independently control the timing of the positive pulse device. In addition, the use of a control unit or suction regulator having two output signals, one signal can be delayed or altered with respect to time with reference to the other signal (Col. 1 Lines 50-63).
Claims 3, 15, and 20: Noriega further discloses that the suction device is configured to be fluidically connected to the working lumen of the catheter and to flush fluid through the working lumen of the catheter before, during, and after advancing the catheter ([0049])
Claim 8: Noriega further discloses that the catheter comprises at least one of a variably slotted hypotube (12) comprising a plurality of interspersed cut patterns (48) or filaments having variable braiding or coiling parameters (Fig. 4-5).
Response to Arguments
Applicant’s arguments filed 12/19/25 have been considered but are moot in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771