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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1 – 6) in the reply filed on 03/28/2025 is acknowledged.
Claims 7 – 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/27/2025.
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 25 of U.S. Patent No. 11,383,068 in view of Janardhan (U.S. 2014/0260928).
Regarding claim 1 of the application, claim 25 of the patent recites every limitation of claim 1 including: advancing an aspiration catheter into a patient distally of an obstruction, the aspiration catheter comprising a flexible and hollow shaft including a proximal end and a distal end, the flexible and hollow shaft including a slotted portion with a plurality of slotted openings, wherein the slotted portion includes a first segment with a first pattern of slotted openings and a second segment extending proximally relative to the first segment with a second pattern of slotted openings different from the first pattern; bending the slotted portion of the flexible and hollow shaft in at least two spaced apart locations while advancing the aspiration catheter through the vasculature of the patient.
However, claim 25 of the patent does not recite the step of aspirating the obstruction out of the patient through the flexible and hollow shaft.
Janardhan teaches a method similar to claim 25 of the patent and claim 1 of the application, further including the step of aspirating the obstruction out of the patient through the flexible and hollow shaft (thrombus aspiration can be performed through microcatheter 504 as discussed in paragraph [0782]).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Janardhan with the method of claim 25 of the patent in order to allow thrombus aspiration depending on the extent of the clot (Janardhan, paragraph [0782]).
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 – 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Janardhan (U.S. 2014/0260928).
Regarding claim 1, Janardhan teaches a method for aspirating an obstruction from a vasculature of a patient (see Figures 19B and 27D showing the vascular treatment device), the method comprising:
advancing an aspiration catheter (microcatheter 504, Figure 27D) into a patient distally of an obstruction (microcatheter 504 is advanced distally of obstruction 500 as shown in Figure 27D and discussed in paragraph [0762]), the aspiration catheter comprising a flexible and hollow shaft including a proximal end and a distal end (paragraph [0766] discusses the distal flexibility, proximal end and distal end of microcatheter 504),
the flexible and hollow shaft including a slotted portion with a plurality of slotted openings (paragraph [0766] discusses slots with varying pitch; see examples of slotted opening in Figure 19B),
wherein the slotted portion includes a first segment with a first pattern of slotted openings and a second segment extending proximally relative to the first segment with a second pattern of slotted openings different from the first pattern (paragraph [0766] discloses different pitch between slots from the distal end to the proximal end of microcatheter 504, also see Figure 19B showing different sections with different slot pitch; also see annotated Figure 19B below); Examiner notes that the first pattern of slotted openings is different than the second pattern of slotted openings since the have different pitch slots as discussed in paragraph [0766];
bending the slotted portion of the flexible and hollow shaft in at least two spaced apart locations while advancing the aspiration catheter through the vasculature of the patient (See Figure 27D showing microcatheter 504 following the bends of the vessel proximal of obstruction 500 as the aspiration catheter is advanced);
and aspirating the obstruction out of the patient through the flexible and hollow shaft (thrombus aspiration can be performed through microcatheter 504 as discussed in paragraph [0782]).
Regarding claim 2, Janardhan teaches advancing the aspiration catheter into the patient distally of an obstruction (microcatheter 504 is advanced distally of obstruction 500 as shown in Figure 27D and discussed in paragraph [0762])
Regarding claim 3, Janardhan teaches that the first pattern includes a repeating helical pattern of cut and uncut portions extending circumferentially around and along a length of the first segment (see pattern of 8510 and 8520 in Fig. 19B, which is a spiral; note that the online dictionary at www.thefreedictionary.com defines “helical” as “of or having the shape of a helix; spiral”; it is the Examiner’s position that the patterns in Fig. 19B are helical as they are in a shape of a spiral around tube 8500), and wherein the second pattern includes a repeating helical pattern of cut and uncut portions extending circumferentially around and along a length of the second segment (see pattern of 8530 and 8540 in Fig. 19B).
Regarding claim 4, Janardhan teaches that a longitudinal spacing between the slotted openings of the first pattern (see “longitudinal spacing first pattern” in the annotated Figure below) at a distal portion (8510, Fig. 19B) of the first segment (8510 and 8520, Fig. 19B) is smaller relative to a longitudinal spacing between the slotted openings of the second pattern (see “longitudinal spacing second pattern” in the annotated Figure below) at a proximal portion (8540, Fig. 19B) of the second segment (8530 and 8540, Fig. 19B) such that a density of the slotted openings at the distal portion is greater relative to a density of the slotted openings at the proximal portion (see Fig. 19B, also see Col. 132, lines 30-37).
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Annotated Fig. 19B of Janardhan
Regarding claim 5, Janardhan teaches a combined arc length of circumferentially adjacent cut and uncut portions along the helical pattern of the first pattern or second pattern is between 100 degrees and 180 degrees (see discussion of stem 213a and stem 213b on opposite sides of slit 212a and are circumferentially spaced apart about 180 degrees from each other). Examiner notes that since stem 213a and stems 213b are circumferentially spaced apart about 180 degrees and that stem 213a and stems 213b are adjacent to slit 212a, the combined arc length of circumferentially adjacent cut and uncut portions (slit 212a and stem 213a) along the helical pattern of the first pattern or second pattern is about 180 degrees.
Regarding claim 6, Janardhan teaches that the shaft comprises a hypotube (microcatheter 504 may comprise a hypotube as discussed in paragraph [0758]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH T BUI whose telephone number is (571)270-1028. The examiner can normally be reached M - F 8 - 5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANH T. BUI
Examiner
Art Unit 3783
/Anh Bui/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783