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 .
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.
Claims 1-5, 9, 11-15, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2005/0283246 (Cauthen, III et al.).
Regarding claim 1, Cauthen, III teaches an anchoring system (Figures 15A-C) comprising:
a first anchoring device comprising a first plug (702) ([0156]; [0163]; Figure 16C); and
a second anchoring device comprising a first anchor (one of 709) ([0156]; [0163]; Figure 16C);
wherein:
each of the first anchoring device (702) and the second anchoring device (one of 709) is configured to enter a tissue wall at a proximal side of the tissue wall (Figures 16A-C);
the first plug (702) is configured to exit the tissue wall at a first point of a distal side of the tissue wall (Figures 16A-C);
the first anchor (one of 709) is configured to exit the tissue wall at a second point of the distal side of the tissue wall and attach to the first plug (702) outside of the distal side of the tissue wall at a first entry point of the first plug (Figures 16A-C); and
the first plug is configured to at least partially cover the second point of the distal side of the tissue wall (Figures 16A-C).
Regarding claims 2 and 3, Cauthen, III teaches the first anchor (one of 709) is configured to extend through and puncture the proximal side of the tissue wall ([0156]; [0163]; Figures 16A-C).
Regarding claim 4, Cauthen, III teaches the first anchor (one of 709) comprises at least one of a barb and a corkscrew (barb: [0156]; [0163]).
Regarding claim 5, Cauthen, III teaches the first anchor (one of 709) is configured to extend entirely through the first plug (702) ([0163]; Figures 16A-C).
Regarding claim 9, Cauthen, III teaches a third anchoring device comprising a second anchor (other of 709), the second anchor configured to: enter the tissue wall at the proximal side of the tissue wall; exit the tissue wall at a third point of the distal side of the tissue wall; and attach to the first plug (702) outside of the distal side of the tissue wall at a second entry point of the first plug ([0156]; [0163]; Figures 16A-C).
Regarding claim 11, Cauthen, III teaches the first plug (702) is to at least partially unfold outside of the distal side of the tissue wall ([0156]; Figures 15A-C).
Regarding claim 12, Cauthen, III teaches a method for anchoring to a tissue wall (barbs passing through annulus wall and patch, [0163]), comprising:
delivering a first anchoring device (702) and a second anchoring device (one of 709) adjacent to the tissue wall, the first anchoring device comprising a first plug and the second anchoring device comprising a first coupler ([0156]; [0163]; Figures 15A-C);
driving the first anchoring device (702) and the second anchoring device (one of 709) through a proximal side of the tissue wall;
driving the first plug (702) through a first point of a distal side of the tissue wall (Figures 16A-C); and
driving the first coupler (one of 709) through a second point of the distal side of the tissue wall and through the first plug (702) outside of the distal side of the tissue wall at a first entry point of the first plug (Figures 16A-C);
wherein the first plug (702) is configured to at least partially cover the second point of the distal side of the tissue wall (Figures 16A-C).
Regarding claim 13, Cauthen, III teaches driving the first coupler (one of 709) through the tissue wall (Figures 16A-C).
Regarding claim 14, Cauthen, III teaches the first coupler (one of 709) comprises at least one of a barb and a corkscrew (barb: [0156]; [0163]).
Regarding claim 15, Cauthen, III teaches driving the first coupler (one of 709) entirely through the first plug (702) ([0156]; [0163]; Figures 16A-C)..
Regarding claim 19, Cauthen, III teaches driving a third anchoring device (other of 709) through the proximal side of the tissue wall, the third anchoring device comprising a second coupler (other of 709); and driving the second coupler through a third point of the distal side of the tissue wall and through the first plug (702) outside of the distal side of the tissue wall at a second entry point of the first plug ([0156]; [0163]; Figures 16A-C).
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 6-8 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2005/0283246 (Cauthen, III et al.).
Regarding claims 6, 7, 16, and 17, Cauthen, III teaches all the limitations of claims 1 and 12. Cauthen, III does not specify the first plug includes one or more hardened portions relative to other portions of the first plug; wherein at least one of the one or more hardened portions is disposed distally from the first entry point of the first anchor to prevent the first anchor from passing entirely through the first plug.
However, Cauthen, III teaches an alternative embodiment wherein the first plug (702) includes one or more hardened portions relative to other portions of the first plug (“hardened portion(s)” construed as metal frame, “other portions” construed as mesh, [0165]; Figure 19). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first plug of Figures 15A-16C to include one or more hardened portions relative to other portions of the first plug of Figure 19 in order to provide a secure frame with “windows” through which the anchor may be passed and retained ([0165]). Consequently, at least one of the one or more hardened portions of the modified first plug is disposed distally from the first entry point of the first anchor to prevent the first anchor from passing entirely through the first plug ([0163]; [0165]; Figures 16A-C; Figure 19; the frame extending along the top/back side of the plug 702 as oriented and depicted in Figure 19 is construed as being “disposed distally” from the first anchor 709 entry point, wherein the entire anchor 709 does not pass through the plug 702 as portions of the anchor 709 extend on both sides of the plug 702, see Figure 16C).
Regarding claims 8 and 18, Cauthen, III teaches all the limitations of claims 1 and 12. Cauthen, III does not teach the first anchoring device comprises a second plug configured to lay against the proximal side of the tissue wall.
However, Cauthen, III teaches an alternative embodiment wherein the first anchoring device comprises a second plug (716) configured to lay against the proximal side of the tissue wall ([0162]; Figure 17). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first anchoring device of Figures 15A-16C to include a second plug configured to lay against the proximal side of the tissue wall as taught by Figure 17 in order to occlude the aperture left from insertion of the first plug and anchor(s) ([0162]).
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2005/0283246 (Cauthen, III et al.) in view of U.S. Patent Application Publication No. 2004/0049211 (Tremulis et al.).
Regarding claims 10 and 20, Cauthen, III teaches all the limitations of claims 9 and 19. Cauthen, III does not specify the third anchoring device is shorter than the second anchoring device to apply increased pulling force at the second entry point relative to the first entry point.
However, Tremulis teaches a method for anchoring to a tissue wall (abstract), comprising: a plurality of anchors to retain a plug in place on the tissue wall, wherein the anchors may be pulled in different directions to result in different lengths ([0058]; Figure 14D). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second and third anchoring devices of Cauthen, III such that the third anchoring device is shorter than the second anchoring device in order to apply different pulling forces, such as an increased pulling force at the second entry point relative to the first entry point, in light of the teachings of Tremulis, in order to securely retain the plug to accommodate a tissue wall of a varied thickness (Tremulis: [0058]).
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 1-6 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,950,773. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is merely broader in scope than all that is recited in claim 1 of the ‘773 patent. That is, claim 1 is anticipated by claim 1 of the ‘773 patent. Once applicant has received a patent for a species or a more specific embodiment, applicant is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)). Claims 2-6 and 9 of the instant application are anticipated by claims 1-13 of the ‘773 patent, by the same reasoning.
Conclusion
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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