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 .
Priority
This application is a CON of 18/079,500 12/12/2022 PAT 12376979
18/079,500 is a CON of 16/450,070 06/24/2019 PAT 11523924
16/450,070 is a CON of 15/140,028 04/27/2016 PAT 10327933
15/140,028 has PRO 62/153,814 04/28/2015 is acknowledged.
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 1-4, 6-8, 10-12, 14-17, 19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8, 14-16 of U.S. Patent No. US 10327933. Although the claims at issue are not identical, they are not patentably distinct from each other because the narrow claims of the patent anticipate the broader claims of the instant application.
Claim 1 of the Patent anticipates claim 1 of the instant application.
Claim 2 of the Patent anticipates claim 2 of the instant application.
Claim 3 of the Patent anticipates claim 3 of the instant application.
Claim 4 of the Patent anticipates claim 4 of the instant application.
Claim 15 of the Patent anticipates claims 6-7 of the instant application.
Claim 16 of the Patent anticipates claim 8 of the instant application.
Claim 1 of the Patent anticipates claims 10-12 of the instant application.
Claim 8 of the Patent anticipates claim 14 of the instant application.
Claim 14 of the Patent anticipates claim 15 of the instant application.
Claim 1 of the Patent anticipates claim 16 of the instant application.
Claim 1 of the Patent anticipates claim 17 of the instant application.
Claims 1 and 8 of the Patent anticipates claim 19 of the instant application.
Claims 1 and 14 of the Patent anticipates claim 20 of the instant application.
Claims 1-3, 6, 8, 10-12, 14-17, 19-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 8-9 of U.S. Patent No. 10675057. Although the claims at issue are not identical, they are not patentably distinct from each other because the narrower claims of the patent anticipate the broader claims of the instant application.
Claim 1 of the Patent anticipates claim 1 of the instant application.
Claim 2 of the Patent anticipates claim 2 of the instant application.
Claim 3 of the Patent anticipates claim 3 of the instant application.
Claim 9 of the Patent anticipates claims 6, 8 of the instant application.
Claim 1 of the Patent anticipates claims 10-12 of the instant application.
Claim 5 of the Patent anticipates claim 14 of the instant application.
Claim 8 of the Patent anticipates claim 15 of the instant application.
Claim 1 of the Patent anticipates claim 16 of the instant application.
Claim 1 of the Patent anticipates claim 17 of the instant application.
Claims 1 and 14 of the Patent anticipates claim 19 of the instant application.
Claims 1 and 15 of the Patent anticipates claim 20 of the instant application.
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) 1-2, 6, 9, 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2013/0123768 to Harlan.
Harlan teaches:
Claim 1: A medical cannula comprising:
an elongate tubular member (hypotube 9, Fig. 2) having a lengthwise axis and a circumferential wall extending between a proximal end and a distal end and defining an interior lumen (where 11 and 31 extending through, Fig. 2);
the elongate tubular member having an intermediate axial portion extending between a proximal axial portion that includes the proximal end and a distal axial portion that includes the distal end (Fig. 7 reproduced with annotation below); and
a pattern of openings (27, Fig. 2, para. 0037) (Fig. 7 reproduced with annotation below) in the circumferential wall of the elongate tubular member, the pattern of openings comprising a plurality of openings arranged in an interrupted spiral (Fig. 8) that extends circumferentially along the intermediate axial portion of the elongate tubular member;
wherein the proximal axial portion and the distal axial portion are free of the pattern of openings (Fig. 7 below); and
wherein the proximal axial portion is longer than the distal axial portion (Fig. 7 below).
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Claim 2: The circumferential wall of the elongate tubular member has a thickness; and wherein each opening of the plurality of openings (27) comprises an elongate slit that extends through the entire thickness of the circumferential wall of the elongate tubular member (Fig. 2).
Claim 6: A distal tip secured to the distal end of the elongate tubular member (at the distal axial portion, Fig. 7 above).
Claim 9: The elongate tubular member comprises a nickel-titanium alloy (para. 0038).
Claim 16: The interrupted spiral extends circumferentially along the intermediate axial portion (Fig. 7 above).
Claim 17: The proximal axial portion and the distal axial portion comprises an uninterrupted circumferential wall (Fig. 7 above).
Claim 18: The proximal axial portion and the distal axial portion are relatively stiffer than the intermediate axial portion (the intermediate axial portion with the cuts are more flexible, hence less stiff than the proximal and distal axial portions).
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) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlan.
Claim 3: Harlan discloses that a portion of the circumferential wall is disposed between openings in immediately adjacent revolutions of the interrupted spiral (Fig. 7). Each opening of the plurality of openings has an axial width.
Harlan discloses the claimed invention except for expressly discloses that the portion has a length along the lengthwise axis of the elongate tubular member that is between about 0.5 times and about 40 times the axial width of the openings in the immediately adjacent revolutions of the interrupted spiral.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have formed the portion having a length along the lengthwise axis of the elongate tubular member that is between about 0.5 times and about 40 times the axial width of the openings in the immediately adjacent revolutions of the interrupted spiral, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 4: Harlan discloses the medical cannula of claim 3 (see rejection of claim 3 above).
Harlan discloses the claimed invention except for expressly discloses that the portion has a length along the lengthwise axis of the elongate tubular member that is between about 1 time and about 5 times the axial width of the openings in the immediately adjacent revolutions of the interrupted spiral.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have formed the portion having a length along the lengthwise axis of the elongate tubular member that is between about 1 times and about 5 times the axial width of the openings in the immediately adjacent revolutions of the interrupted spiral, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 5: Harlan discloses that a portion of the circumferential wall is disposed between openings in immediately adjacent revolutions of the interrupted spiral (Fig. 7). Each opening of the plurality of openings has an axial length.
Harlan discloses the claimed invention except for expressly discloses that the portion has a circumferential length along the elongate tubular member that is between about 0.1 times and about 2 times the axial length of the immediately adjacent openings within a revolution of the interrupted spiral.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have formed the portion has a circumferential length along the elongate tubular member that is between about 0.1 times and about 2 times the axial length of the immediately adjacent openings within a revolution of the interrupted spiral, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 7-8, 10-12, 14-15, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlan in view of US 2006/0100687 to Fahey et al. (Fahey).
Claims 7-8, 10-11: Harlan discloses a delivery system as discussed above in claim 1 but does not disclose the distal tip is a conical distal tip (Claim 7), the distal tip is a double-tapered distal tip (Claim 8), an outer member circumferentially about the elongate tubular member (Claims 10, 19-20). The outer member covers the pattern of openings (claim 11). The outer member comprises a sheath (claim 12). Portions of the circumferential wall have carrying lengths along the lengthwise axis of the elongate tubular member (Claims 14, 19). Portions of the circumferential wall have varying circumferential lengths along the elongate tubular member (Claims 15, 20).
Fahey teaches a cannula including an elongate tubular member (9; Fig. 2, 6). The cannula includes an intraluminal medical device (29; Fig. 16) disposed on the tubular member [0072]. An elongate outer tubular member (2, Fig. 2) defines an outer tubular member lumen (Fig. 2). The cannula is disposed within the outer tubular member lumen such that the intraluminal medical device is circumferentially disposed about the cannula and within the outer tubular member and a conical double-tapered distal tip (8, Fig. 2).
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 distal tip of Harlan with a double-tapered distal tip and an intraluminal medical device disposed on the tubular member within an outer tubular member, as taught by Fahey, to provide protection to the medical device and means for atraumatic entry into a procedure site.
Regarding claim 14: Fahey teaches a cannula including an elongate tubular member having a pattern of openings wherein the portions of the circumferential wall disposed between immediately adjacent openings within a revolution of the interrupted spiral have varying lengths along the lengthwise axis of the elongate tubular member (Figs. 10-14).
Regarding claim 15: Fahey teaches a cannula including an elongate tubular member having a pattern of openings wherein the portions of the circumferential wall disposed between immediately adjacent openings within a revolution of the interrupted spiral have varying circumferential lengths along the elongate tubular member (Figs. 10-14).
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 substituted the interrupted spiral of Harlan with the interrupted spiral of Fahey, as this modification involves the simple substitution of one interrupted spiral with another for the predictable result of providing flexibility to the cannula.
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harlan in view of US 2010/0036364 to Wubbeling.
Harlan teaches:
The medical cannula of claim 1 above but fails to disclose an outer member disposed circumferentially about the elongate tubular member. The outer member covers the pattern of openings. The outer member comprises a sheath. The sheath comprises a length of tubing heat shrunk onto a circumferential.
Wubbeling teaches:
A catheter introducer comprises an elongate tubular member (40, Fig. 4, para. 0025) defining a lumen (para. 0027) and a circumferential wall having an outer circumferential surface defining a pattern of opening (Fig. 4) arranged in an interrupted spiral (para. 0012-0013). An outer member (42, Fig. 4, para. 0025) disposed circumferentially about the elongate tubular member.
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to modify the heat shrunk tube as taught by Wubbeling into Harlan in order to provide sealing function that restrains fluid flow through the openings (abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHONG SON DANG whose telephone number is (571)270-5809. The examiner can normally be reached Mon-Fri 8-5.
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/PHONG SON H DANG/Primary Examiner, Art Unit 3771
