DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 23, 24, 28, 31-36, 42-46 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication 2007/0112425 to Schaller in view of U.S. Patent Publication 2005/0107811 to Starksen and U.S. Patent Publication 2005/0203552 to Laufer.
As to claim 23, Schaller discloses a system for securing anchors into tissue comprising: an outer catheter (204 figure 58;54 figure 2), an inner catheter (206/56) comprising a distal end slidably disposed within the outer catheter (figure 28, paragraph 28; figure 2, paragraph 80), the distal end comprising a second opening (opening of 204, figure 28, 30; figure 2), and an anchor delivery catheter (208, paragraph 120; 58, figure 2) advanceable within the inner catheter and comprising one or more anchors (226; 62), wherein an opening of the outer catheter is configured to position the one or more anchors for deployment into a target tissue of a heart when aligned with the second opening of the inner catheter (figure 30; figure 5a-c, the openings will be coaxial and/or similarly axially spaced, which can at least read on the being aligned), but is silent about an outer catheter comprising a plurality of first openings spaced along a length thereof. Schaller discloses multiple embodiments of a catheter system which can read on an outer, inner, and anchor delivery catheter capable of delivering one or more anchors into a target a tissue of a heart. However, the systems are silent about the outer catheter have the plurality of first openings along a length thereof.
Starksen teaches a similar system (cardiac treatment devices, abstract) having a catheter with a plurality of first openings along a length thereof (557, figure 11a) for the purpose of helping to orient the catheter system to the intended tissue location for anchor delivery. Laufer teaches a similar system (surgical fastener system, abstract) where the anchor delivery catheter can have the openings on the distal end or along a side wall (paragraph 40, 44, 48). Further, Laufer can teach aligning openings of inner and outer catheter to help deliver the anchors (figure 8d,e, paragraph 51). Having the outer catheter of Schaller comprise a plurality of openings along a length thereof will allow the system to deliver anchor effectively into target tissue as desired. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the outer catheter of Schaller comprise a plurality of openings along a length thereof to align with the opening of the inner catheter to position the one or more anchors for deployment in order for orienting the catheter system to the intended tissue location for anchor delivery.
As to claim 24, with the system of Schaller, Starken, and Laufer above, Schaller discloses a releasable retaining structure between at least two adjacent first openings of the plurality of first openings (212; 228). Without further limitations to the function or structure of releasable retaining structure, the suture can read on the releasable retaining structure since it is releasably retained.
As to claim 28, with the system of Schaller, Starken, and Laufer above, Schaller discloses the outer catheter comprises a longitudinal lumen and the releasably retaining structure has a transverse orientation with respect to the longitudinal lumen (figure 2, 30).
As to claim 31, with the system of Schaller, Starken, and Laufer above, Schaller discloses the outer catheter has a curved distal portion (figure 1).
As to claim 32, with the system of Schaller, Starken, and Laufer above, Schaller discloses the plurality of first openings is uniformly spaced apart along the length of the outer catheter (figure 11a). The openings are aligned and can be uniformly spaced based on the length of the anchors. If it would not be known that the plurality of openings is uniformly spaced apart the length of the outer catheter, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the uniform spacing since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Schaller would not operate differently with the claimed uniform spacing and since system would function appropriately having the claimed opening spacing. Further, applicant places no criticality on the range claimed, indicating simply that openings can have uniform spacing or be varied as desired (paragraph 67 of the published application).
As to claim 33, with the system of Schaller, Starken, and Laufer above, Schaller discloses the one or more anchors is coupled to a tether (212; 228).
As to claim 34, with the system of Schaller, Starken, and Laufer above, Schaller discloses a termination device (304, figure 39h).
As to claim 35, Schaller discloses a method for securing anchors into tissue comprising: positioning an outer catheter (204 figure 58;54 figure 2) along a target tissue of a heart (figure 30; 5a-c), advancing an inner catheter (206/56) within the outer catheter (paragraph 118, 120-123; paragraph 87, 92), wherein the inner comprising a distal end including a second opening (opening of 204, figure 28, 30; figure 2); advancing an anchor delivery catheter (208, paragraph 120; 58, figure 2) within the inner catheter, the anchoring delivery catheter comprising one or more anchors (226; 62), aligning at least an opening of the outer catheter with the second opening (figure 30; figure 5b), and deploying the or more anchors from the anchor delivery catheter into the target tissue of the heart (figure 30; figure 5a-c), but is silent about an outer catheter comprising a plurality of first openings spaced along a length thereof. Schaller discloses multiple embodiments of a catheter system which can read on an outer, inner, and anchor delivery catheter capable of delivering one or more anchors into a target a tissue of a heart. However, the systems in the method are silent about the outer catheter have the plurality of first openings along a length thereof.
Starksen teaches a similar system in a method (cardiac treatment devices, abstract) having a catheter with a plurality of first openings along a length thereof (557, figure 11a,) for the purpose of helping to orient the catheter system to the intended tissue location for anchor delivery. Laufer teaches a similar system in a method (surgical fastener) where the anchor delivery catheters can have the openings on the distal end or along a side wall (paragraph 40, 44, 48). Further, Laufer can teach aligning openings of inner and outer catheter to help deliver the anchors (figure 8d,e, paragraph 51). Having the outer catheter of Schaller comprise a plurality of openings along a length thereof will allow the system to deliver anchor effectively into target tissue as desired. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the outer catheter of Schaller comprise a plurality of openings along a length thereof to align with the opening of the inner catheter to position the one or more anchors for deployment in order for orienting the catheter system to the intended tissue location for anchor delivery.
As to claim 36, with the method of Schaller, Starken, and Laufer above, Schaller discloses positioning the outer catheter comprises placing the outer catheter partially or entirely about a circumference of the target tissue (figure 39e).
As to claim 42, with the method of Schaller, Starken, and Laufer above, Schaller discloses deploying the one or more anchors through the aligned at least one first opening and second opening (figure 5b, 30).
As to claim 43, with the method of Schaller, Starken, and Laufer above, Schaller discloses advancing the anchor delivery catheter through the aligned at least one first opening and second opening (figure 5b).
As to claim 44, with the method of Schaller, Starken, and Laufer above, Schaller discloses the deployed one or more anchors temporarily secure the outer catheter to the target tissue (figure 5c-d).
As to claim 45, with the method of Schaller, Starken, and Laufer above, Schaller discloses the target tissue is a heart valve (paragraph 77).
As to claim 46, with the method of Schaller, Starken, and Laufer above, Schaller discloses the target tissue is left ventricular tissue (paragraph 77).
Claims 29, 30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication 2007/0112425 to Schaller in view of U.S. Patent Publication 2005/0107811 to Starksen and U.S. Patent Publication 2005/0203552 to Laufer as applied to claims 23, 24, 28, 31-36, 42-46 above, and further in view of U.S. Patent Publication 2006/0282161 to Huynh.
As to claims 29, 30, Schaller as modified by Starken and Laufer discloses the system above but is silent about the radiopaque markers between the plurality of first openings or on one or more sides of the second openings would be useful to visualize the placement of the openings.
Huynh teaches a similar system (heart treatment system, abstract) having a radiopaque marker included on any portion of the device that would be useful to visualize (paragraph 51). Therefore, having radiopaque markers between the plurality of first openings or on one or more sides of the second openings would be useful to visualize the placement of the openings. It would have been obvious to one of ordinary skill in the art before the effective filing date to have radiopaque markers between the plurality of first openings or on one or more sides of the second opening of the system of Schaller, Starken, and Laufer in order for helping to visualize the placement of the openings.
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 23-25, 27-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. U.S. Patent 8,790,367 in view of U.S. Patent Publication 2005/0203552 to Laufer.
As to the instant application’s claim 23, the reference patent claims a system for securing anchors into tissue comprising: an outer catheter (claim 1, the multi-aperture catheter) comprising a plurality of first openings (claim 1) spaced along a length thereof; and an anchor delivery catheter (claim 1) advanceable within the inner catheter and comprising one or more anchors, but is silent about an inner catheter comprising a distal end slidably disposed within the outer catheter, the distal end comprising a second opening, and at least one of the first openings is configured to position the one or more anchors for deployment into a target tissue of a heart when aligned with the second opening of the inner catheter the second opening of the inner catheter.
Laufer teaches a similar system (surgical fastener systems, abstract) having an inner catheter (170/172, figure 8d,e) comprising a distal end slidably disposed within the outer catheter, the distal end comprising a second opening (162), and at least one of the first openings is configured to position the one or more anchors for deployment into a target tissue of a heart when aligned with the second opening of the inner catheter the second opening of the inner catheter (figure 8d,e, paragraph 48, 51-51) in order controlling how the system to deliver an anchor into tissue. The reference patent does claim that the anchors are delivered and an inner catheter is used in deepened claims. It would have been obvious to one of ordinary skill in the art before the effective filing date for the reference patent to use the inner catheter of Laufer in order for controlling how the system delivers an anchor into tissue.
As to the instant application’s claim 24, see reference patent claim 1.
As to the instant application’s claim 25, 27, see reference patent claim 2.
As to the instant application’s claim 28, see reference patent claim 1. The outer catheter has a lumen through the anchor delivery catheter is advanced, and the releasably retaining structure is on the catheter, so will have a transverse orientation since the device is in 3D.
As to the instant application’s claim 29, 30, see reference patent claim 17. Since the radiopaque markers will be between the apertures of the outer catheter, they will be an (outer) side of the second opening.
As to the instant application’s claim 31, see reference patent claim 14.
As to the instant application’s claim 32, the reference patent is silent about the plurality of openings are uniformly spaced. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the uniform spacing since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of reference patent would not operate differently with the claimed uniform spacing and since system would function appropriately having the claimed opening spacing. Further, applicant places no criticality on the range claimed, indicating simply that openings can have uniform spacing or be varied as desired (paragraph 67).
As to the instant application’s claim 33, see reference patent claim 5.
As to the instant application’s claim 34, see reference patent claim 16. An atraumatic tip “terminates” the extent of the device.
Allowable Subject Matter
Claims 26, 37-41 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771