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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/14/2025 has been entered.
Response to Arguments
Applicant argues in the response filed 07/14/2025 that the claim amendments would overcome Bloom as modified by Belef. The rejection has been withdrawn. New rejections with respect to Abbott in view of Belef and Frazier/Biggs/Bloom have been made below.
With respect to the double patenting rejection, the application argues to hold the double patenting rejection in abeyance until an indication of allowable subject matter. The examiner acknowledges the request, but the double patenting still is maintained below.
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.
Claims 1, 5-16, 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2008/0154286 to Abbott in view U.S. Patent Publication 2007/0049970 to Belef, and in view of U.S. Patent 6,231,561 to Frazier, U.S. Patent 6,599,311 to Biggs, or U.S. Patent Publication 2004/00260317 to Bloom.
As to claim 1, Abbott discloses an anchor for implantation in body tissue in combination with a line (paragraph 61), the anchor (302, figure 21a) comprising: a plurality of hooks (314-1,314-2) for engagement with the body tissue, wherein the anchor comprises a folded position (figure 21a) and an unfolded position (figure 21b), and wherein the anchor is made of an elastic material (paragraph 164) such that the anchor can be elastically deformed into the folded position by application of a constraining force (paragraph 164), and will return to the unfolded position when no constraining force is applied (paragraph 164); and a locking mechanism (316, 317, paragraph 162-164) for clamping the line when no force is applied, and being elastically deformable to release the line from the locking mechanism for adjustment of a length of the length (paragraph 64), wherein the locking mechanism comprising a resiliently deformable locking segment (317) integrated within the wall of the anchor and divided from the wall by at least one slit (317), wherein the anchor comprises a tubular body section defining said wall of the anchor (figure 21a,b); and wherein the tubular body section, the locking mechanism and the plurality of hooks comprise a single, unitary structure comprising the elastic material (figure 21a-b, paragraph 162-164), but is silent about the locking mechanism being elastically deformable to release the line from the locking mechanism is arranged so that when no force is applied, the at least one slit is closed with no gap or a relatively narrow gap in order to clamp the line securely in place, whereas when a suitable force is applied to the resilient deformable locking segment and/or the wall, then the resilient deformable locking segment and/or the wall will elastically deform to widen an opening provided by the at least one slit so that the line is released and wherein the at least one slit is arranged to be held open such that the length of the line can be shortened and lengthened by passing the line through the opening. Abbott does disclose the struts and openings 316,317 can assume other patterns, and other similar types of locking mechanisms can be used (paragraph 163-165).
Belef teaches a similar device (lock devices, abstract) having an anchor (302, any of the embodiments of figure 12a-f) with a locking mechanism (the slits 347 and/or bands 359) for clamping the line when no force is applied (paragraph 196, 200-201) being elastically deformable to release the line from the locking mechanism for adjustment of a length of the line (309), wherein the locking mechanism comprises a resiliently deformable locking segment (either the areas that are defined by the slits 347 in figure 12a-c or the bands 359, figure 12d-f) integrated with a wall of the anchor (figure 12a-f) and divided from the wall by at least one slit (347), wherein the anchor is arranged so that when no force is applied, the at least one slit is closed with no gap or a relatively narrow gap in order to clamp the line securely in place (figure 12a,d,f) whereas when a suitable force is applied to the resilient deformable locking segment and/or the wall, then the resilient deformable locking segment and/or the wall will elastically deform to widen an opening provided by the at least one slit so that the line is released (figure 12b,e, paragraph 196,197,200-201) and wherein the at least one slit is arranged to be held open such that the length of the line can be shortened and lengthened by passing the line through the opening (figure 12b,e, paragraph 196,197,200-201) for the purpose of using a known pinching or clamping type suture lock to allow adjustments on the suture and the locking force thereof (paragraph 238, 239). Belef teaches an alternative locking mechanism with a different arrangement of the slits with respect to the suture which can help to secure the suture as desired. Using the locking mechanism (arrangement of slits, where the suture can pass through the opening defined by the slits) of Belef as the locking mechanism of the anchor of Abbott would yield the predictable results of allowing the device to secure the tether and maintain tension when desired while also allowing readjustment when needed. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the locking mechanism of Belef as the locking mechanism of Abbott in order for using a suture lock that allows for adjustment on the suture and the locking force thereof as desired.
If, it would not be known that the anchor legs 314-1 and 314-2 of Abbott would be able to read on hooks, Frazier teaches a similar device (anchor, abstract) having a plurality of hooks (94, the barbs can read on hooks, figure 12a, b, d, col. 11 ll. 34-col. 12 ll. 8) extending from a tissue anchor for engagement with the body tissue for the purpose of securing the device in place. Biggs also teaches a similar device (suture anchor, abstract) having a plurality of hooks (142, figure 9, 14, barbs as seen in figure 7d, the barbs can read on hooks, col. 11 ll. 65-col. 12 ll. 15-col. 12 ll. 8) extending from a tissue anchor for engagement with the body tissue for the purpose of performing an anchoring function of the tissue. Bloom further teaches a similar device (anchor, abstract) having a plurality of hooks (114/115, figure 3, paragraph 33, 34) extending from a tissue anchor for engagement with the body tissue for the purpose of securing the device to tissue. Frazier, Biggs, and Bloom all teach similar device that have anchoring mechanism which can read on a “hook” which help secure the device in place. Having the anchoring arms 314-1 and 314-2 of Abbott be hooks can help anchor the device in place. It would have been obvious to one of ordinary skill in the art before the effective filing date for the plurality of anchoring arms of Abbott be a plurality of hooks in order for helping secure the device in place.
As to claim 5, with the device of Abbot, Belef, and Frazier/Biggs/Bloom above, Abbot discloses the plurality of hooks extend from one end of the tubular body section (figure 21b).
As to claim 6, with the device of Abbot, Belef, and Frazier/Biggs/ Bloom above, Frazier (figure 12b), Biggs (figure 7d, 14), and Bloom (paragraph 34, figure 4a,b) each teach the plurality of hooks are formed as sharpened and bent tines at the one end of the tubular body section. Abbott does disclose the arms are bent into the deployed configuration (figure 21a,b). Each of Frazier/Biggs/Nakao teaches that the hooks can be sharp or other embodiments which can be dull. Therefore having the hooks be sharp can be rendered obvious for the desired result of how the hooks will engage tissue. Frazier/Biggs/Nakao will be able to render obvious the hooks can be sharp and be bent.
As to claim 7, with the device of Abbott, Belef, and Frazier/Biggs/Bloom above, Abbott discloses the wall defines the resiliently deformable locking segment (figure 21a,b). Belef further teaches the wall defines the resiliently deformable locking segment (figure 12a-f).
As to claim 8, with the device of Abbott, Belef, and Frazier/Biggs/Bloom above, Abbott discloses the resiliently deformable locking segment constitutes a portion of the wall (figure 21a,b,). Belef further teaches the resiliently deformable locking segment constitutes a portion of the wall (figure 12a-f).
As to claim 9, 11, with the device of Abbott, Belef, and Frazier/Biggs/Bloom above, Abbott discloses the wall defines the resiliently deformable locking segment (figure 21a,b). Belef further teaches the wall defines the resiliently deformable locking segment (figure 12a-f).
As to claim 10, 13, with the device of Abbott, Belef, and Frazier/Biggs/Bloom above, Abbott discloses the anchor is cut from a single tube such that the locking mechanism, the tubular body section and the plurality of hooks are formed of the same tube comprising the elastic material (paragraph 162, 164). A comparison of the recited process with the prior processes does not serve to resolve the issue concerning patentability of the product. Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. Abbott discloses the device is a tubular and can be cut from an elastic material. Bloom can further provide evidence that an unitary anchor can be made from tubing paragraph 46). Abbott will be able to disclose the claimed limitation.
As to claim 12, with the device of Abbott, Belef, and Frazier/Biggs/Bloom above, Abbott discloses the wall is a side wall of the tubular body section of the anchor (figure 21a,b). Belef further teaches the wall is a side wall of the tubular body section of the anchor (figure 12a-f).
As to claim 14, with the device of Abbott, Belef, and Frazier/Biggs/Bloom above, Abbott discloses the anchor comprising shape memory metal (paragraph 164), and wherein the locking mechanism is configured to apply a clamping force to the line when the locking mechanism is not elastically deformed (paragraph 164). Belef further teaches the locking mechanism is configured to apply a clamping force to the line when the locking mechanism is not elastically deformed (paragraph 196).
As to claim 15, with the device of Abbott, Belef, and Frazier/Biggs/Bloom above, Abbott discloses the anchor comprises a body including the tubular body section defining said wall of the anchor, and the anchor comprises at least one hole defined through the body for routing the line (figure 21a,b). Alternatively, Belef further teaches openings (other openings formed by the slots) that allow for sliding of the suture for the purpose of allowing the tether to freely slide therethrough.
As to claim 16, with the device of Abbott, Belef, and Frazier/Biggs/Bloom above, Belef further teaches the line is looped once or multiple times through the at least one slit (figure 12b). There is at least one loop of suture through the slit. Frazier (figure 5) and Biggs (23a) provide evidence of the a suture being looped around at least once around the anchor.
As to claim 21, with the device of Abbott, Belef, and Frazier/Biggs/Bloom above, Belef further teaches the at least one slit extends part way around the circumference of the anchor (figure 12a-f).
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, 3-5, 7-9, 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,945,718. Although the claims at issue are not identical, they are not patentably distinct from each other because with respect to claim 1, the reference patent claims an anchor for implantation in body tissue in combination with a line (claim 1), the anchor comprising: a plurality of hooks (claim 1) for engagement with the body tissue, wherein the anchor comprises a folded position (claim 1) and an unfolded position (claim 1), and wherein the anchor is made of an elastic material (claim 1) such that the anchor can be elastically deformed into the folded position by application of a constraining force (claim 1), and will return to the unfolded position when no constraining force is applied (claim 1); and a locking mechanism (claim 1) for clamping the line when no force is applied, and being elastically deformable to release the line from the locking mechanism for adjustment of a length of the line (claim 1), wherein the locking mechanism comprises a resiliently deformable locking segment (claim 1) integrated with a wall of the anchor (claim 1) and divided from the wall by at least one slit (claim 1); wherein the anchor comprises a tubular body section defining said wall of the anchor (claim 1); and wherein the tubular body section, the locking mechanism and the plurality of hooks comprise a single, unitary structure comprising the elastic material (claim 1), wherein the anchor is arranged so that when no force is applied, the at least one slit is closed with no gap or a relatively narrow gap in order to clamp the line securely in place (claim 2) whereas when a suitable force is applied to the resilient deformable locking segment and/or the wall, then the resilient deformable locking segment and/or the wall will elastically deform to widen an opening provided by the at least one slit so that the line is released (claim 2) and wherein the at least one slit is arranged to be held open such that the length of the line can be shortened and lengthened by passing the line through the opening (claim 1, 2, the force will widen the opening, which will allow for adjustment, since a force is applied, it can be held and allow for the line to be shortened and lengthened).
As to the instant application’s claim 3, see reference patent claim 1.
As to the instant application’s claim 4, see reference patent claim 4.
As to the instant application’s claim 5, see reference patent claim 1.
As to the instant application’s claim 7, 9, see reference patent claim 1. Since the wall deforming segment is integrated into the wall, the wall can define the segment.
As to the instant application’s claim 8, 11, see reference patent claim 1. The wall includes the locking segment.
Claims 6, 10, 12-17, 21, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. U.S. Patent No. 10,945,718 in view of U.S. Patent Publication 2007/0049970 to Belef.
As to the instant application’s claims 6, 10, 12-17, the reference patent claims the limitations in claims 1, 5-8, 11, 12, respectively. However, the instant application’s claim 1 has the claim limitations of the reference patent claim 2. The dependent claims 6, 10, 12-17 of the reference patent, which the instant applications claims 5-8, 10-17 would read on, are not dependent off of claim 2. Therefore, the reference patent claim 1 is silent about the scope of the at least one slit is closed with no gap or a relatively narrow gap in order to clamp the line whereas when a suitable force is applied to the resilient deformable locking segment and/or the wall, then the resilient deformable locking segment and/or the wall will elastically deform to widen an opening provided by the at least one slit so that the line is released and wherein the at least one slit is arranged to be held open such that the length of the line can be shortened and lengthened by passing the line through the opening with respect to the instant applications claims 5-8, 10-17.
Belef teaches a similar device (locking device, abstract), having an anchor (302, any of the embodiments of figure 12a-f) with a locking mechanism (the slits 347 and/or bands 359) for clamping the line when no force is applied (paragraph 196, 200-201) being elastically deformable to release the line from the locking mechanism for adjustment of a length of the line (309), wherein the locking mechanism comprises a resiliently deformable locking segment (either the areas that are defined by the slits 347 in figure 12a-c or the bands 359, figure 12d-f) integrated with a wall of the anchor (figure 12a-f) and divided from the wall by at least one slit (347), wherein the anchor is arranged so that when no force is applied, the at least one slit is closed with no gap or a relatively narrow gap in order to clamp the line (figure 12a,d,f) whereas when a suitable force is applied to the resilient deformable locking segment and/or the wall, then the resilient deformable locking segment and/or the wall will elastically deform to widen an opening provided by the at least one slit so that the line is released (figure 12b,e, paragraph 196,197,200-201) and wherein the at least one slit is arranged to be held open such that the length of the line can be shortened and lengthened by passing the line through the opening ( figure 12b,e, paragraph 196,197,200-201) for the purpose of using a knock pinching or clamping type suture lock to allow adjustments on the suture and the locking force thereof (paragraph 238, 239). In other words, Belef teaches the missing limitations of reference patent claim 1 with respect to the instant application’s claim 1. Therefore the reference patent dependent claims would be able to read on the instant applications claims. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the locking mechanism of the reference patent have the configuration as taught by Belef in a similar locking mechanism in order for using a suture lock that allows adjustments on the suture and the locking force thereof. Therefore, the reference patent claims 1-12 will be able to read on the instant application’s claims 6, 10, 12-17.
As to the instant application’s claim 21, see reference patent claim 1. The reference patent has parallel slits that make up the band, the band is configured to move out of the plane of the wall, therefore the band is in the plane of the wall when the anchor is in a natural state. Based on the formation of the band, the slits can extend at least part way around the circumference of the anchor since the slits will be on the wall which will be a be a part of the circumference and create the band which will add the dimension that can be part way around the circumference.
If it would not be known that the claimed slits of the reference patent would be able to extend at least part way around the circumference, Belef teaches the slits to extend at least part way around the circumference (figure 12a, d, paragraph 196) for the purpose of using any shaped slot which can help accommodate and secure the suture as desired. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the at least one slit of the reference patent extend part way around the circumference of the anchor in order to help accommodate and secure the suture as desired.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771