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 .
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13, 16 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites the limitation "the U-shaped fabric body". There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the tension line". There is insufficient antecedent basis for this limitation in the claim.
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) 1-6, 17, 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gittings (WO2010132310).
With regards to claim 1, Gittings discloses a soft tissue anchor system for implantation in soft body tissue to secure an artificial line (FIG 26A, [0003]), the anchor system comprising: a line (S); and a tubular cap member (2104); wherein an end of the line is fixed to the tubular cap member (FIG 26B) and extends from a central portion thereof (FIG 26B) such that, in use, the tubular cap member is configured to extend in a plane parallel to a surface of the soft body tissue when implanted in the soft body tissue and under tension of the line when it is passing through the tissue in a direction away from the surface thereof (FIG 26B, 27C); and wherein the tubular cap member (2104) comprises an opening (2129) configured to receive a wire guide member (2114) for passing the tubular cap member through the soft body tissue during implantation ([0105]).
With regards to claim 2, Gittings discloses the soft tissue anchor system as claimed in claim 1, wherein the tubular cap member (2104) comprises an outer tubular member (2124) and an inner tubular member (2122), wherein the outer tubular member (2124) is configured to receive (FIG 26G) the inner tubular member (2122); and wherein the inner tubular member (2122) defines the opening configured to receive the wire guide member (2129).
With regards to claim 3, Gittings discloses the soft tissue anchor system as claimed in claim 3, wherein the inner tubular member (2122) comprises a flared inlet (2130) defining the opening configured to receive the wire guide member (FIG 26B).
With regards to claim 4, Gittings discloses the soft tissue anchor system as claimed in claim 3, wherein the flared inlet (2130) is configured to mate with a corresponding portion of the wire guide member (FIG 26G).
With regards to claim 5, Gittings discloses the soft tissue anchor system as claimed in claim 2, wherein the outer tubular member (2124) comprises a side wall (2123) and an aperture formed in the side wall (2121), wherein the aperture receives the line ([0107]); and wherein the end of the line is fixed to the tubular cap member between the outer tubular member and the inner tubular member ([0107]).
With regards to claim 6, Gittings discloses the soft tissue anchor system as claimed in claim 2, wherein the tubular cap member (2104) comprises a pointed tip (2116) configured to pierce the body tissue ([0104]), wherein the pointed tip is located at an end of the tubular cap member distal to the opening configured to receive the wire guide member (FIG 26C).
With regards to claim 17, Gittings discloses the soft tissue anchor system as claimed in claim 2, wherein the soft tissue anchor system is a leaflet anchor system for implantation in a heart valve leaflet to secure an artificial chordae line (the system is capable of being used in a heart valve leaflet to secure an artificial chordae line).
With regards to claim 31, Gittings discloses a method of manufacturing a soft tissue anchor system as claimed in claim 1, the method comprising: fabricating the tubular cap member (Gittings discloses a tubular cap member, which has been fabricated); and fixing the line to the tubular cap member with the line extending from the central portion thereof (FIG 26A).
Claim(s) 1, 8, 14-15, 18-19, 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stone (20080140092).
With regards to claim 1, Stone discloses a soft tissue anchor system for implantation in soft body tissue to secure an artificial line (350), the anchor system comprising: a line (304); and a tubular cap member (150, [0062]); wherein an end of the line is fixed to the tubular cap member (FIG 10) and extends from a central portion thereof (FIG 10) such that, in use, the tubular cap member is configured to extend in a plane parallel to a surface of the soft body tissue when implanted in the soft body tissue and under tension of the line when it is passing through the tissue in a direction away from the surface thereof (FIG 11); and wherein the tubular cap member (150, [0062]) comprises an opening (158) configured to receive a wire guide member (bore 158 extends the entire length thereof) for passing the tubular cap member through the soft body tissue during implantation (FIG 11).
With regards to claim 8, Stone discloses the soft tissue anchor system as claimed in claim 1, wherein the tubular cap member comprises a dulled and/or rounded tip (FIG 9B), wherein the dulled and/or rounded tip is located at an end of the tubular cap member distal to the opening configured to receive the wire guide member (FIG 9B).
With regards to claim 14, Stone discloses the soft tissue anchor system as claimed in claim 1, wherein the line is the artificial line (350).
With regards to claim 15, Stone discloses the soft tissue anchor system as claimed in claim 1, comprising the artificial line (350); wherein the artificial line is joined to a portion of the line (304) distal to the end fixed to the central portion (FIG 10); and wherein the artificial line is configured to apply tension to the line ([0069]).
With regards to claim 18, Stone discloses a catheter device for implanting a soft tissue anchor system in heart tissue (104), the catheter device comprising: a housing section (FIG 10), wherein the housing section extends from a distal end of the catheter device along the length of the catheter device toward a proximal end of the catheter device (FIG 10); and a soft tissue anchor system as claimed in claim 1 located within the housing section (FIG 10).
With regards to claim 19, Stone discloses the catheter device as claimed in claim 18, wherein the soft tissue anchor system comprises a plurality of tubular cap members (150, [0062]); the catheter device comprising: a deployment system configured to simultaneously implant each of the tubular cap members in the heart tissue ([0067]); wherein the deployment system comprises a plurality of wire guide members (102), wherein each wire guide member comprises a guide portion located at a distal end of the wire guide members and configured to engage a respective tubular cap member (FIG 10); and wherein the deployment system is configured to maintain a coplanar alignment between the guide portions of the plurality of wire guide members during implantation of the tubular cap members (FIG 11).
With regards to claim 30, Stone discloses a method of implanting a soft tissue anchor system as claimed in claim 1, the method comprising: engaging the tubular cap (150, [0062]) member using a wire guide member (102) (FIG 10); pushing the tubular cap member through the body tissue using the wire guide member (FIG 11); withdrawing the wire guide member (FIG 14); and applying tension to the line when it is passing through the tissue in a direction away from the surface thereof, such that the tubular cap member sits against the soft body tissue ([0078]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone (20080140092) as applied to claim 1 above, and further in view of Sugimoto (WO2007005394A1).
With regards to claim 9, Stone discloses the soft tissue anchor system as claimed in claim 1, but fails to discloses a fabric body having a base portion and an arm portion extending from the base portion; wherein the arm portion is configured to collapse in folds towards the base portion such that, in use, the body tissue is sandwiched between the base portion and the arm portion; wherein the tubular cap member is fixed at an end of the arm portion distal to the base portion.
Sugimoto discloses a soft tissue anchor system with a member configured to extend in a plane parallel to a surface of the soft body tissue when implanted (70, FIG 8D), a line (72a), and a tubular cap portion (76). Sugimoto teaches a fabric body (FIG 8D, [0010]) having a base portion and an arm portion extending from the base portion (see annotated FIG 8B); wherein the arm portion is configured to collapse in folds towards the base portion (FIG 8B) such that, in use, the body tissue is sandwiched between the base portion and the arm portion (FIG 8E); wherein the tubular cap member is fixed at an end of the arm portion distal to the base portion (FIG 8E). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Stone’s soft tissue anchor system to include a fabric body having a base portion and an arm portion extending from the base portion; wherein the arm portion is configured to collapse in folds towards the base portion such that, in use, the body tissue is sandwiched between the base portion and the arm portion; wherein the tubular cap member is fixed at an end of the arm portion distal to the base portion, as taught by Sugimoto, in order to be able to compress the tissue, as well as adjust to the thickness of the tissue being anchored ([0005]).
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With regards to claim 10, Stone as modified by Sugimoto discloses the soft tissue anchor system as claimed in claim 9, wherein the arm portion is configured to collapse in folds towards the base portion by action of the line threaded through the arm portion and the base portion (FIG 8B); wherein the line is configured to collapse the arm portion in folds towards the base portion when a tensile force is applied to the line (FIG 8B).
With regards to claim 11, Stone as modified by Sugimoto discloses the soft tissue anchor system as claimed in claim 9, wherein the tubular cap member is configured to extend collinearly with the arm portion during implantation and/or retrieval of the fabric body (FIG 8A); and wherein the tubular cap member is configured to extend parallel to a plane of each fold of the arm portion when a tensile force is applied to the line (FIG 8B).
With regards to claim 12, Stone as modified by Sugimoto discloses the soft tissue anchor system as claimed in claim 9, but fails to disclose wherein the fabric body is a U-shaped fabric body comprising the base portion and at least two arm portions extending from the base portion; wherein each arm portion comprises a tubular cap member fixed at an end of the arm portion distal to the base portion.
In an alternate embodiment, Sugimoto teaches the fabric body is a U-shaped fabric body (FIG 9A) comprising the base portion and at least two arm portions extending from the base portion (FIG 9A); wherein each arm portion comprises a tubular cap member fixed at an end of the arm portion distal to the base portion (76, FIG 9A). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Stone’s soft tissue anchor system to include the fabric body is a U-shaped fabric body comprising the base portion and at least two arm portions extending from the base portion; wherein each arm portion comprises a tubular cap member fixed at an end of the arm portion distal to the base portion, as taught by Sugimoto, in order to be able to further manipulate the tissue ([0048], FIG 9C).
With regards to claim 13, Stone as modified by Sugitomo discloses the soft tissue anchor system as claimed in claim 9, wherein the base portion defines a maximum width of the U-shaped fabric body (FIG 8B, where the arms do not extend beyond the base portion).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stone (20080140092) as applied to claim 1 above, and further in view of Miller (WO2011148374A2).
With regards to claim 16, Stone discloses the soft tissue anchor system as claimed in claim 1, wherein there is provided a plurality of tubular cap members (FIG 10); but fails to disclose wherein the tension line comprises a plurality of bridle lines, wherein each bridle line is associated with a respective tubular cap member; and wherein each bridle line is connected to a common bridle point, wherein the bridle point is configured to place each bridle line under tension when each bridle line is passing through the tissue in a direction away from the surface of the soft body tissue and when the bridle point itself is under tension.
Miller discloses a soft tissue anchor system (132) comprising a tension line (162) and anchor members (172a-d). Miller teaches the tension line (132) comprises a plurality of bridle lines (168a-d), wherein each bridle line (168a-d) is associated with a respective anchor member (FIG 5); and wherein each bridle line (168a-d) is connected to a common bridle point (166, 164), wherein the bridle point (166, 164) is configured to place each bridle line (168a-d) under tension when each bridle line is passing through the tissue in a direction away from the surface of the soft body tissue and when the bridle point itself is under tension (FIG 5). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Stone’s soft tissue anchor system to include that the tension line comprises a plurality of bridle lines, wherein each bridle line is associated with a respective tubular cap member; and wherein each bridle line is connected to a common bridle point, wherein the bridle point is configured to place each bridle line under tension when each bridle line is passing through the tissue in a direction away from the surface of the soft body tissue and when the bridle point itself is under tension, as taught by Miller, in order to distribute the force applied to the leaflet during adjustment (pg 18, line 27).
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 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 of copending Application No. 18/842,714 (reference application) as shown in the table below and claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 of copending Application No. 18/842,714 (reference application) in view of Stone (20080140092).
Instant Application
18/842,714 Claim 1
18/842,714 Claim 9
Claim 1:
A soft tissue anchor system for implantation in soft body tissue to secure an artificial line, the anchor system comprising:
A soft tissue anchor system for implantation in soft body tissue, comprising
a line; and
a plurality of bridle lines
a tubular cap member;
a tubular cap member
wherein an end of the line is fixed to the tubular cap member
wherein an end of one of the bridle lines is fixed to the tubular cap member
and extends from a central portion thereof
and extends from a central portion thereof
such that, in use, the tubular cap member is configured to extend in a plane parallel to a surface of the soft body tissue when implanted in the soft body tissue and under tension of the line when it is passing through the tissue in a direction away from the surface thereof;
such that, in use, the tubular cap member is configured to extend in a plane parallel to a surface of the soft body tissue when implanted in the soft body tissue and under tension of the line when it is passing through the tissue in a direction away from the surface thereof;
and wherein the tubular cap member comprises an opening
wherein the tubular cap member comprises an opening
configured to receive a wire guide member
configured to receive a wire guide member
for passing the tubular cap member through the soft body tissue during implantation.
for passing the tubular cap member through the soft body tissue during implantation
Claim 16:
wherein there is provided a plurality of tubular cap members;
a plurality of anchor members
wherein the tension line comprises a plurality of bridle lines,
comprising a plurality of bridle lines
wherein each bridle line is associated with a respective tubular cap member;
wherein each bridle line is associated with a respective anchor member
and wherein each bridle line is connected to a common bridle point,
and is connected to the common bridle point
wherein the bridle point is configured to place each bridle line under tension when each bridle line is passing through the tissue in a direction away from the surface of the soft body tissue and when the bridle point itself is under tension.
wherein the bridle point is configured to place each bridle line under tension when the soft tissue anchor system is implanted in the soft body tissue and the bridle point itself is under tension
As shown in the mapping above, claims 1, 9 of the reference application 18/842,714 includes all of the limitations of claims 1 of the instant application. Claim 1 of the reference application differ from claim 1 of the instant application in that it recites “bridle lines” instead of “line”. However, “bridle lines” are interpreted as a type of “line”. Therefore the reference claims anticipate claim 1.
Claims 1, 9 of the reference application differ from claim 16 of the instant application in that it recites “anchor member” instead of “tubular cap member”. Stone (20080140092) teaches an anchor member that is a tubular cap member (150, [0062]) for a soft tissue anchor system. 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 modified the anchor member of reference application 18/842,714 to be tubular cap members, as taught by Stone, in order to be able to fix lines inside of the member ([0062]). Thus, claims 1 and 16 of the instant application are anticipated by claims 1 and 9 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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