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 .
Response to Arguments
Applicant's arguments filed 4/10/26 with regards to double patenting have been fully considered but they are not persuasive. Examiner notes that although the claims at issue are not identical, they are not patentably distinct from each other because they disclose overlapping subject matter as discussed below. Further, Hayden US 2003/0212384 discloses a similar aspiration system having an aspiration catheter for creating a suction to remove a thrombus (paragraph 0060). 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 and taught by Hayden, to provide the step of aspiration with the aspiration catheter to remove a thrombus. Additionally, applicant argues that a patent issuing from the instant application would not be able to “extend the life” of Look ‘847. However, this is not a reason to remove the double patenting rejection and is therefore maintained.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection over Look et al. US 20150282821 as discussed below.
Look et al. discloses an aspiration system 300 for removal of material from a lumen, cavity or duct of a patient (paragraph 0115), comprising: an aspiration catheter 306 having a proximal end 318 and a distal end 316 (figure 29) and comprising:
an expandable aspiration lumen (for example, within expandable section 430, aspiration lumen extending from proximal end 316 to distal end 318, paragraph 0120, figure 36);
a high-pressure injection lumen extending within an elongate support member (paragraph 0115, support/supply tube 368 having a lumen conduit for the high pressure saline) and having a proximal end at or adjacent to the proximal end of the aspiration catheter and a distal end at or adjacent to the distal end of the aspiration catheter (paragraph 0115, high pressure saline injected from the proximal end 372 to the distal end 374, figure 29);
at least one orifice 390 located at a distal portion of the high-pressure injection lumen (figure 32), the at least one orifice configured to allow liquid injected through the high pressure injection lumen to be released as a jet within a distal end of the expandable aspiration lumen (paragraph 0117, saline is forced through one or more orifices 390 and into the aspiration lumen, saline forms one or more jets 402, figure 32).
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, 11, 12, 13, 14, 15, 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 5, 7 and 8 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. The newly added dependent claims further have overlapping subject matter as discussed below.
Claims of application 18/772,813
Rejected over Claims of U.S. Patent No. 11,540,847
2
1
11
1
12
3
13
4
14
5
15
7
16
8
Claims 3 and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5 and 7 of U.S. Patent No. 11,540,847 in view of Hayden US 2003/0212384.
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. U.S. Patent No. 11,540,847 fails to explicitly disclose the step of aspirating at least some thrombus from the vasculature of the subject. However, Hayden discloses a similar aspiration system having an aspiration catheter for creating a suction to remove a thrombus (paragraph 0060). 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 and taught by Hayden, to provide the step of aspiration with the aspiration catheter to remove a thrombus. The newly added dependent claims further have overlapping subject matter as discussed below.
Claims of application 18/772,813
Rejected over Claims of U.S. Patent No. 11,540,847 in view of Hayden US 2003/0212384.
3
1
17
1
18
3
19
5
20
7
Claim Rejections - 35 USC § 102
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, 4-8 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Look et al. US 20150282821.
Regarding claim 1, Look et al. discloses an aspiration system 300 for removal of material from a lumen, cavity or duct of a patient (paragraph 0115), comprising: an aspiration catheter 306 having a proximal end 318 and a distal end 316 (figure 29) and comprising:
an expandable aspiration lumen (for example, within expandable section 430, aspiration lumen extending from proximal end 316 to distal end 318, paragraph 0120, figure 36);
a high-pressure injection lumen extending within an elongate support member (paragraph 0115, support/supply tube 368 having a lumen conduit for the high pressure saline) and having a proximal end at or adjacent to the proximal end of the aspiration catheter and a distal end at or adjacent to the distal end of the aspiration catheter (paragraph 0115, high pressure saline injected from the proximal end 372 to the distal end 374, figure 29);
at least one orifice 390 located at a distal portion of the high-pressure injection lumen (figure 32), the at least one orifice configured to allow liquid injected through the high pressure injection lumen to be released as a jet within a distal end of the expandable aspiration lumen (paragraph 0117, saline is forced through one or more orifices 390 and into the aspiration lumen, saline forms one or more jets 402, figure 32).
Regarding claim 4, Look et al. discloses wherein the elongate support member extends completely through the expandable aspiration lumen (figure 31, coupled within the distal tube 314 within lumen 330).
Regarding claim 5 and 6, Look et al. discloses wherein the proximal end of the elongate support member is coupled to a connector, wherein the connector comprises a y-connector (paragraph 0121, y-connector 148, figure 29).
Regarding claim 7, Look et al. discloses wherein the expandable aspiration lumen is defined by an expandable member (expandable tubular mesh 428, figure 36).
Regarding claim 8, Look et al. discloses wherein the expandable member is formed integrally with a non-expandable member (figure 36, formed integrally with member 426 at the distal end of the distal tube 314). Examiner further notes, although the combination of references does not disclose how “the expandable member is formed” explicitly, it is noted that “[E]ven though product‑by‑process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product‑by‑process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2. Therefore, because Look et al. discloses the expandable portion 430 being attached to the non-expandable portion 426, it results in the limitation of the expandable member being formed integrally with a non-expandable member.
Regarding claim 10, Look et al. discloses wherein the distal end of the high-pressure lumen includes a curved portion configured to change a direction of liquid flow through the high-pressure injection lumen by at least about 90 degrees (figure 32, curved closed distal end 394, changes direction of flow through orifice 390 which is perpendicular, or about 90 degrees, from the proximal to distal direction, with jets 402).
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Look et al. US 20150282821 in view of Vale et al. US 2015/0359547.
Regarding claim 9, Look et al. discloses an expandable section, but fails to explicitly disclose wherein the expandable member is configured to be foldable into two or more wings.
Vale et al. discloses a device for aspiration (paragraph 0003) comprising distal expandable member 30 (figure 3-7b), the expandable member being configured to be foldable into two or more wings (figures 4, 6a, wings folded to a suitable profile to fit into the lumen of the catheter, wings may be considered each folded or pleated portion, paragraphs 0069, 0071) to form a collapsed configuration for delivery (paragraphs 0069, 0071).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Look et al. with an expandable section being configured to be foldable into two or more wings, as taught by Vale et al. to provide the expandable section to be collapsible into a suitable profile within the catheter for delivery.
Allowable Subject Matter
Claims 2, 3 and 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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 O-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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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