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 .
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 2 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,540,847. Although the claims at issue are not identical, they are not patentably distinct from each other because they disclose an aspiration catheter comprising: a tubular aspiration member having a proximal end, a distal end, and a lumen, and configured to at least partially extend out of the lumen of an elongate tubular member at the distal end of the elongate tubular member and into the vasculature of a subject; an elongate support member coupled to the tubular aspiration member and extending between the proximal end of the aspiration catheter and the proximal end of the tubular aspiration member; and a composite annular sealing member carried by the tubular aspiration member and configured to create a liquid seal against an inner surface of the elongate tubular member, wherein the composite annular sealing member comprises an 0-ring and a coating, the 0-ring carried on an outer surface of the tubular aspiration member and the coating covering an outer diameter of the 0-ring and covering the outer surface of the tubular aspiration member immediately proximal to the 0-ring and immediately distal to the 0-ring, the coating extending continuously from the outer surface of the tubular aspiration member proximal to the o -ring to the outer surface of the tubular aspiration member distal to the 0-ring. Further they disclose inserting the elongate tubular member inserted within the vasculature of a subject; inserting the aspiration catheter through the elongate tubular member and into the vasculature of the subject; sealingly engaging the composite annular sealing member or having a liquid seal with the inner surface of the elongate tubular member; and aspirating at least some thrombus from the vasculature of the subject. Examiner notes it would be known and obvious for the aspiration catheter to have the step of aspirating from the vasculature of the subject as known in the art.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anthracite US 4329995 in view of Odland et al. US 7935092.
Regarding claim 1, Anthracite discloses an aspiration system for removal of material from a lumen, cavity or duct of a patient comprising (figure 1, column 2, lines 50-55) : an aspiration catheter 10 having a proximal end and a distal end (figure 1; proximal end at a the syringe 20 and distal end at 18) and comprising: an expandable aspiration lumen (figures 3-5, column 4, lines 28-40; expandable lumen within flexible portion 18, moves from rolled up configuration 28 to expanded configuration, figure 5); a high pressure injection lumen (pressure forces expandable portion 18 to expand, column 4, lines 19-21 and lines 41-50); at least one orifice located at the distal end of the high pressure injection lumen configured to allow liquid injected through the high pressure injection lumen to be released at or adjacent a distal end of the expandable aspiration lumen (column 4, lines 11-22, air or fluid is configured to be forced into the catheter lumen from the high-pressure injection lumen within syringe 20 to expand the aspiration lumen and unseal the passageway).
Anthracite discloses introducing fluid under pressure into the lumen of the catheter to expand the expandable aspiration lumen, the fluid pressure introducing means may be a suitable plunger pump, such as a syringe (column 2, line 65-column 3, line 3), but fails to disclose the injection lumen being within an elongate support member having a proximal end adjacent the proximal end of the aspiration catheter and a distal end adjacent the distal end of the aspiration catheter.
Odland et al. discloses a similar injection or aspiration device 100 having an aspiration catheter (figure 6), the catheter having a high pressure injection lumen 132 extending within an elongate support member 102 and having a proximal end adjacent the proximal end of the aspiration catheter and a distal end adjacent the distal end of the aspiration catheter (figure 6, with orifice 114 for liquid to be injected at a distal end 112, column 7, lines 16-24), the device 100 may be connected with a vacuum or aspirating device such as a mechanical pump or hand operated syringe when the device 100 is used for aspirating fluids (column 7, lines 44-48).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Anthracite with an elongate member extending from the proximal end to the distal end, as taught by Odland et al., and as known in the art to allow the liquid injected to be directly released at a proximal end or distal end of the aspiration lumen with a pump or syringe high pressure lumen.
Allowable Subject Matter
Claims 2 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claim 1 of US Patent No. 11,540,847 as discussed above in more detail, but would be allowable if a proper terminal disclaimer is filed and the claims are rewritten to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Look et al. US 20150282821 discloses an aspiration catheter 306 having an elongate tubular member, a tubular aspiration member 314, and a composite sealing member.
However, Look et al. fails to disclose wherein the composite annular sealing member comprises an 0-ring and a coating, the 0-ring carried on an outer surface of the tubular aspiration member and the coating covering an outer diameter of the 0-ring and covering the outer surface of the tubular aspiration member immediately proximal to the 0-ring and immediately distal to the 0-ring, the coating extending continuously from the outer surface of the tubular aspiration member proximal to the o -ring to the outer surface of the tubular aspiration member distal to the 0-ring.
Tupper US 2008/0079221 discloses a composite O-ring 39’ having a dip coating that’s a soft material surrounding the o-ring (paragraph 0063, figure 3).
However, Tupper fails to disclose the elastomeric coating extending continuously from the outer surface of the tubular aspiration member proximal to the o-ring to the outer surface of the tubular aspiration member distal to the o-ring.
Vaillancourt US 4743243 discloses a needle and filter assembly (figure 9) comprising a shrink wrap 210 over on o-ring 212 seal (figure 9), the )-ring placed within a molded retainer 216, the shrink wrap placed over the molded retainer (figure 9).
However, Vaillancourt fails to disclose the o-ring being carried on the outer surface of an aspiration member, specifically the coating covering an outer diameter of the O-ring and covering the outer surface of the tubular aspiration member immediately proximal to the O-ring and immediately distal to the 0-ring, the coating extending continuously from the outer surface of the tubular aspiration member proximal to the o -ring to the outer surface of the tubular aspiration member distal to the 0-ring.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hayden US 2003/0212384 discloses a similar aspiration system having an aspiration catheter with an expandable aspiration lumen (figures 8-13, paragraph 0068).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771