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 Objections
Claims 11 and 18-20 are objected to because of the following informalities:
In claim 11, line 6, the phrase “that the first cleat and the second cleat in partial contact” should read “that the first cleat and the second cleat are in partial contact” or similar language for readability purposes.
In claim 18, line 1, the phrase “the spacer blocks” should read “the plurality of spacer blocks”, to properly refer to the plurality of spacer blocks previously introduced.
In claim 18, line 2, the phrase “between each cleat pair” should read “between each of the cleat pairs” or similar language.
In claim 19, the phrase “each of the spacer blocks” should read “each of the plurality of spacer blocks”.
In claim 20, lines 5, 6 and 9, the phrase “each first cleat” should read “each of the plurality of first cleats”.
In claim 20, lines 8-10, the phrase “each second cleat” should read “each of the plurality of second cleats”.
In claim 20, lines 11-12, the phrase “each indicator biasing element” should read “each of the plurality of indicator biasing elements”.
Appropriate correction is required.
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.
Claims 11-12 and 16-20 are 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.
Regarding claim 11, the claim recites “the device for holding suture” in lines 4, 7 and 10. There is insufficient antecedent basis for this limitation in the claim, since a device for holding suture has not been previously introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the device for tensioning suture previously introduced.
Regarding claim 16, the claim recites “the cleat array further comprising six first cleats and six second cleats”. It is unclear whether the phrase includes the previously introduced first cleat and second cleat, or is introducing new, separate first and second cleats. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the six first cleats including the first cleat previously introduced, and the six second cleats including the second cleat previously introduced.
Regarding claim 20, line 12, the claim recites “the first cleat and the second cleat”. It is unclear whether the phrase is referring to the plurality of first cleats and the plurality of second cleats, each of the plurality of first cleats and each of the plurality of second cleats, or a first cleat of the plurality of first cleats and a second cleat of the plurality of second cleats. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to at least one cleat of the plurality of first cleats and at least one cleat of the plurality of second cleats.
Claims 12 and 17-19 are indefinite due to their dependency on indefinite base claims 11 and 16.
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) 1-7, 9-11 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gadlage (US 2014/0163615 A1).
Regarding claim 1, Gadlage discloses (abstract; paras. [0027]-[0044]; figs. 1-16) a device for tensioning suture (120) comprising:
a housing (base member 130, para. [0036]; fig. 8);
a first cleat (146, para. [0038]; fig. 10) having a first gripping surface (150), the first cleat movably connected to the housing (translatable along rods 138 of base member 130, para. [0039]);
a second cleat (148) which is colinear with the first cleat (figs. 10 and 13) and having a second gripping surface (152), the second cleat connected to the housing (via rods 138), wherein the second gripping surface is opposing the first gripping surface (figs. 10 and 13);
an indicator biasing element (spring 182, considered to be a biasing element and function as an indicator, because the level of biasing of spring 182 indicates an unlocked/locked configuration of the device, paras. [0043]-[0044]) connected to the housing (figs. 13-16) and colinear with the first cleat and the second cleat (figs. 13-16); and
an actuator (key 170, para. [0036]) connected to the housing and in contact with the first cleat (in contact with jaw 146 at least in the unlocked configuration, fig. 13).
Regarding claim 2, Gadlage discloses the device of claim 1. Gadlage further discloses wherein the housing further comprises a suture channel (upper hole 162, para. [0041]).
Regarding claim 3, Gadlage discloses the device of claim 1. Gadlage further discloses wherein the housing further comprises a plurality of suture channels (includes upper hole 162 and lower hole 161, para. [0041]).
Regarding claim 4, Gadlage discloses the device of claim 1. Gadlage further discloses wherein the first cleat further comprises a plurality of recesses (recesses of teeth 151, para. [0038]).
Regarding claim 5, Gadlage discloses the device of claim 1. Gadlage further discloses wherein the first cleat further comprises a plurality of flat spots (edge of teeth 151 considered to be flat, annotated fig. 13).
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Annotated Figure 13 of Gadlage
Regarding claim 6, Gadlage discloses the device of claim 1. Gadlage further discloses wherein the second cleat further comprises a plurality of protrusions (protruding portion of teeth 153, fig. 13).
Regarding claim 7, Gadlage discloses the device of claim 6. Gadlage further discloses wherein the plurality of protrusions are teeth (para. [0038]).
Regarding claim 9, Gadlage discloses the device of claim 1. Gadlage further discloses wherein the second cleat further comprises a plurality of recesses (recesses of teeth 153, para. [0038]; fig. 13).
Regarding claim 10, Gadlage discloses the device of claim 1. Gadlage further discloses further comprising a cam (178, key 170 is rotated for locking tabs 178 to be aligned with wings 164 and allow vertical movement of key 170) coupled to the actuator (para. [0044]; fig. 14).
Regarding claim 11, Gadlage discloses the device of claim 1. Gadlage further discloses wherein the actuator is movable between an unlocked position (fig. 13), a tensioned position (fig. 15), and a locked position (fig. 16) and configured such that: a) that the first cleat and the second cleat are not in contact (fig. 13) and suture passage through the device for holding suture is not restricted when the actuator is in the unlocked position (suture extends through housing, fig. 13); b) that the first cleat and the second cleat in partial contact (position in which key 170 vertically lifted and transitions device into locked configuration, note the instant spec. does not specifically define “partial contact”, such that broadest reasonable interpretation is contact of at least one part; since key 170 is moved vertically, jaws 146 and 148 are considered to have at least one portion contacting the opposite jaw during the transition to the locked configuration, para. [0044]; fig. 15) and suture passage through the device for holding suture is partially restricted when the actuator is in the tensioned position (suture 100 fed through device until desired tension is applied, tension is considered to partially restrict the suture, para. [0044]); and c) that the first cleat and the second cleat are in full contact (fig. 16) and suture passage through the device for holding suture is fully restricted when the actuator is in the locked position (second jaw slides fully against first jaw, considered to fully restrict the suture, para. [0044]).
Regarding claim 15, Gadlage discloses the device of claim 1. Gadlage further discloses further comprising a cleat array (includes first and second cleats, considered to be a cleat array).
Regarding claim 1, Gadlage discloses (abstract; paras. [0027]-[0044]; figs. 1-16), under an alternative interpretation with respect to the indicator biasing element and the actuator, a device for tensioning suture (120) comprising:
a housing (base member 130, para. [0036]; fig. 8);
a first cleat (148) having a first gripping surface (152), the first cleat movably connected to the housing (translatable along rods 138 of base member 130, para. [0039]);
a second cleat (146, para. [0038]; fig. 10) which is colinear with the first cleat (figs. 10 and 13) and having a second gripping surface (150), the second cleat connected to the housing (via rods 138), wherein the second gripping surface is opposing the first gripping surface (figs. 10 and 13);
an indicator biasing element (key 170, para. [0036]) connected to the housing (fig. 9) and colinear with the first cleat and the second cleat (figs. 13-16); and
an actuator (spring 182, paras. [0043]-[0044]) connected to the housing (figs. 13-16) and in contact with the first cleat (para. [0043]).
Regarding claim 13, Gadlage discloses the device of claim 1. Gadlage further discloses wherein the indicator biasing element further comprises a suture channel (176).
Regarding claim 14, Gadlage discloses the device of claim 13. Gadlage further discloses wherein the indicator biasing element is configured such that the indicator biasing element is actuated when: a) the actuator is in a locked position (key 170 moved upward when spring 182 moved into locked position, considered to be actuated when moved upward, para. [0044]; figs. 13-16); and b) a suture held between the first cleat and the second cleat is under tension (suture under tension when key 170 is actuated and moved upward, moving the device into the locked configuration, figs. 15-16).
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.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gadlage in view of Gadlage (US 2013/0218206 A1) (hereinafter ‘Gadlage2’).
Regarding claim 8, Gadlage discloses the device of claim 7.
However, Gadlage fails to disclose wherein the teeth are asymmetric.
Gadlage2 teaches (para. [0033]; figs. 5 and 10), in the same field of endeavor, a device for tensioning suture (abstract; fig. 1) comprising a second cleat (sliding body 68) comprising a plurality of protrusions (gripping surface 32), wherein the plurality of protrusions are asymmetric teeth (para. [0033]), for the purpose of requiring the sliding body to be oriented in a particular way (para. [0033]).
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 teeth of Gadlage to be asymmetric, in order to orient the second cleat in a particular way when desired, based on the teachings of Gadlage2 (para. [0033]).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gadlage.
Regarding claim 12, Gadlage discloses the device of claim 11.
However, Gadlage fails to specifically disclose wherein a holding force on a suture between the first cleat and the second cleat is at least 1 kg.
Gadlage discloses (abstract, para. [0044]) that the amount of tension/holding force applied to the suture needs to be optimized to “lock the suture to the device and maintain tension on the suture while affixed to the skin.” As such, the amount of holding force on the suture is disclosed to be a result effective variable in that changing the holding force on the suture changes the ability of the suture to lock to the device and the ease and success of the procedure. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Gadlage to have a holding force within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gadlage by making the holding force on the suture between the first cleat and the second cleat at least 1 kg, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 16-19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gadlage in view of Hu (US 2007/0156027 A1).
Regarding claim 16, Gadlage discloses the device of claim 15.
However, Gadlage fails to disclose the cleat array further comprising six first cleats and six second cleats, each of the first cleats opposing each of the second cleats and wherein each of the first cleats and second cleats comprise a cleat pair.
Hu teaches (paras. [0115]-[0119]; figs. 2 and 7-12), in the same field of endeavor, a device for tensioning suture (fig. 2) comprising a cleat array (bifurcated channels 70, depicted in fig. 2 as multiple bifurcated channels 70), the cleat array further comprising six first cleats (suture lock provided in each exit channel 72, exit channel 72 formed in each bifurcated channel 70, paras. [0115]-[0116]; fig. 2) and six second cleats (suture lock provided in each exit channel 73, fig. 2), each of the first cleats opposing each of the second cleats (figs. 7-12) and wherein each of the first cleats and second cleats comprise a cleat pair (considered to be a cleat pair formed in bifurcated channels 70), for the purpose of adjusting the tension of multiple sutures, allowing the surgeon to positively identify and unlock a desired suture for further tension adjustments without loosening the other end of the suture, and increasing the maximum amount of tension that can be applied to a given suture (para. [0116]).
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 device of Gadlage to have multiple cleat pairs of the first and second cleats of Gadlage, such that the device of Gadlage comprises six first cleats and six second cleats spaced similarly to the bifurcated channels 70 of Hu, in order to adjust the tension of multiple sutures, allowing the surgeon to positively identify and unlock a desired suture for further tension adjustments without loosening the other end of the suture, and increasing the maximum amount of tension that can be applied to a given suture, based on the suggestions and teachings of Hu (para. [0116]).
Regarding claim 17, Gadlage (as modified) teaches the device of claim 16. Gadlage (as modified) further teaches further comprising a plurality of spacer blocks (annotated fig. 2 of Hu, combination considered to further teach spacing between each of the cleat pairs in Gadlage (as modified) which would function as a plurality of spacer blocks).
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Annotated Figure 2 of Hu
Regarding claim 18, Gadlage (as modified) teaches the device of claim 17. Gadlage (as modified) further teaches wherein the spacer blocks are interposed between each cleat pair (combination considered to further teach spacing between each cleat pair, annotated fig. 2 of Hu).
Regarding claim 19, Gadlage (as modified) teaches the device of claim 17. Gadlage (as modified) further teaches each of the spacer blocks further comprising a plurality of relief recesses (annotated fig. 2 of Hu, combination further teaches cleat pairs spaced similarly to bifurcated channels 70 via spacer blocks, which include recesses for receipt of housing/cleat pairs).
Regarding claim 20, Gadlage discloses (abstract; paras. [0027]-[0044]; figs. 1-16) a device for tensioning suture (120) comprising:
a housing (base member 130, para. [0036]; fig. 8) comprising a plurality of suture channels (includes upper hole 162 and lower hole 161, para. [0041]; fig. 15);
a cleat array (includes jaw members 146 and 148, para. [0038]) comprising:
a first cleat array portion (148) movably connected to the housing (translatable along rods 138 of base member 130, para. [0039]), the first cleat array portion comprising a first cleat (148), the first cleat comprising a first gripping surface (152); and
a second cleat array portion (146, para. [0038]; fig. 10) fixedly connected to the housing (may be formed unitarily and/or integrally with base member 130, para. [0039]), the second cleat array portion comprising a second cleat (146), the second cleat comprising a second gripping surface (150), wherein the second cleat is colinear with the first cleat (figs. 10 and 13);
an indicator biasing element (key 170, para. [0036]), the indicator biasing element connected to the housing (fig. 9) and colinear with the first cleat and the second cleat (figs. 13-16) and the indicator biasing element comprising a suture channel (176); and
an actuator (spring 182, paras. [0043]-[0044]) connected to the housing (figs. 13-16) and in contact with the first cleat array portion (para. [0043]) wherein the actuator is movable between an unlocked position (fig. 13), a tensioned position (fig. 15), and a locked position (fig. 16, paras. [0043]-[0044]).
However, Gadlage fails to disclose the first cleat array portion comprising a plurality of first cleats, each first cleat comprising a first gripping surface, and a plurality of spacer blocks interposed between each first cleat; the second cleat array portion comprising a plurality of second cleats, each second cleat comprising a second gripping surface, wherein each second cleat is colinear with each first cleat, and a plurality of spacer blocks interposed between each second cleat; a plurality of indicator biasing elements, each indicator biasing element connected to the housing and colinear with the first cleat and the second cleat and each indicator biasing element comprising a suture channel.
Hu teaches (paras. [0115]-[0119]; figs. 2 and 7-12), in the same field of endeavor, a device for tensioning suture (fig. 2) comprising a first cleat array portion (first exit channel 72 formed in each bifurcated channel 70 and therefore considered to have multiple first exit channels 72 formed in an array portion, para. [0115]) comprising a plurality of first cleats (suture lock provided in each exit channel 72, para. [0116]), each first cleat comprising a first gripping surface (surface of free end 84, para. [0119]; fig. 12), and a plurality of spacer blocks (annotated fig. 2) interposed between each first cleat (at least one spacer block positioned between each of the first cleats, collectively forming a plurality of spacer blocks, which appears to be consistent with fig. 5 of the instant spec., figs. 2 and 7-12); a second cleat array portion (second exit channel 73 formed in each bifurcated channel 70 and therefore considered to have multiple second exit channels 73 formed in an array portion, para. [0115]) comprising a plurality of second cleats (suture lock provided in each exit channel 73, para. [0116]; fig. 10), each second cleat comprising a second gripping surface (surface of free end 84, para. [0119]; fig. 12), wherein each second cleat is colinear with each first cleat (figs. 7-12), and a plurality of spacer blocks interposed between each second cleat (at least one spacer block positioned between each of the second cleats, collectively forming a plurality of spacer blocks, which appears to be consistent with fig. 5 of the instant spec., annotated fig. 2), for the purpose of adjusting the tension of multiple sutures, allowing the surgeon to positively identify and unlock a desired suture for further tension adjustments without loosening the other end of the suture, and increasing the maximum amount of tension that can be applied to a given suture (para. [0116]).
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 device of Gadlage to have a plurality of first cleats and a plurality of second cleats forming multiple cleat pairs, such that the device of Gadlage comprises multiple base members 130 spaced similarly to the bifurcated channels 70 of Hu, in order to adjust the tension of multiple sutures, allowing the surgeon to positively identify and unlock a desired suture for further tension adjustments without loosening the other end of the suture, and increasing the maximum amount of tension that can be applied to a given suture, based on the suggestions and teachings of Hu (para. [0116]).
Gadlage (as modified) further teaches a plurality of indicator biasing elements, each indicator biasing element connected to the housing and colinear with the first cleat and the second cleat and each indicator biasing element comprising a suture channel (combination further teaches multiple base members 130 to accommodate multiple jaw members 146 and 148, such that one of ordinary skill would’ve understood the structure of each base member 130 to include the structure of key 170 in Gadlage).
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 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,310,579 B2 to Sauer. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-13 would anticipate current claims 1-14.
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Corresponding U.S. 12,310,579 B2 claims
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Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,310,579 B2 to Sauer in view of Gadlage.
Regarding claim 15, Sauer claims the device of claim 15 (claim 1), but fails to claim further comprising a cleat array.
Gadlage teaches (fig. 13), in the same field of endeavor, a device for tensioning suture (abstract) comprising a cleat array (includes first and second cleats, considered to be a cleat array), for the purpose of providing structures that lock and unlock the suture (paras. [0038]-[0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim further comprising a cleat array, in order to provide structures that lock and unlock the suture, based on the teachings of Gadlage (paras. [0038]-[0040]).
Claims 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,310,579 B2 to Sauer in view of Gadlage as applied to claim 15 above, and further in view of Hu.
Regarding claim 16, Sauer (as modified) claims the device of claim 16 (claim 1), but fails to claim the cleat array further comprising six first cleats and six second cleats, each of the first cleats opposing each of the second cleats and wherein each of the first cleats and second cleats comprise a cleat pair.
Hu teaches (paras. [0115]-[0119]; figs. 2 and 7-12), in the same field of endeavor, a device for tensioning suture (fig. 2) comprising a cleat array (bifurcated channels 70, depicted in fig. 2 as multiple bifurcated channels 70), the cleat array further comprising six first cleats (suture lock provided in each exit channel 72, exit channel 72 formed in each bifurcated channel 70, paras. [0115]-[0116]; fig. 2) and six second cleats (suture lock provided in each exit channel 73, fig. 2), each of the first cleats opposing each of the second cleats (figs. 7-12) and wherein each of the first cleats and second cleats comprise a cleat pair (considered to be a cleat pair formed in bifurcated channels 70), for the purpose of adjusting the tension of multiple sutures, allowing the surgeon to positively identify and unlock a desired suture for further tension adjustments without loosening the other end of the suture, and increasing the maximum amount of tension that can be applied to a given suture (para. [0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the cleat array further comprising six first cleats and six second cleats, each of the first cleats opposing each of the second cleats and wherein each of the first cleats and second cleats comprise a cleat pair, in order to adjust the tension of multiple sutures, allowing the surgeon to positively identify and unlock a desired suture for further tension adjustments without loosening the other end of the suture, and increasing the maximum amount of tension that can be applied to a given suture, based on the suggestions and teachings of Hu (para. [0116]).
Regarding claim 17, Sauer (as modified) claims the device of claim 17 (claim 1). Sauer (as modified) further teaches further comprising a plurality of spacer blocks (annotated fig. 2 of Hu, combination considered to further teach spacing between each of the cleat pairs which would function as a plurality of spacer blocks).
Regarding claim 18, Sauer (as modified) claims the device of claim 18 (claim 1). Sauer (as modified) further teaches wherein the spacer blocks are interposed between each cleat pair (combination considered to further teach spacing between each cleat pair, annotated fig. 2 of Hu).
Regarding claim 19, Sauer (as modified) claims the device of claim 19 (claim 1). Sauer (as modified) further teaches each of the spacer blocks further comprising a plurality of relief recesses (annotated fig. 2 of Hu, combination further teaches cleat pairs spaced similarly to bifurcated channels 70 via spacer blocks, which include recesses for receipt of housing/cleat pairs).
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,310,579 B2 to Sauer in view of Hu.
Regarding claim 20, Sauer claims the device of claim 20 (claim 3), but fails to claim a cleat array comprising: a first cleat array portion movably connected to the housing, the first cleat array portion comprising a plurality of first cleats, each first cleat comprising a first gripping surface, and a plurality of spacer blocks interposed between each first cleat; and a second cleat array portion fixedly connected to the housing, the second cleat array portion comprising a plurality of second cleats, each second cleat comprising a second gripping surface, wherein each second cleat is colinear with each first cleat, and a plurality of spacer blocks interposed between each second cleat; a plurality of indicator biasing elements, each indicator biasing element connected to the housing and colinear with the first cleat and the second cleat and each indicator biasing element comprising a suture channel; and the actuator in contact with the first cleat array portion.
Hu teaches (paras. [0115]-[0119]; figs. 2 and 7-12), in the same field of endeavor, a device for tensioning suture (fig. 2) comprising a first cleat array portion (first exit channel 72 formed in each bifurcated channel 70 and therefore considered to have multiple first exit channels 72 formed in an array portion, para. [0115]) comprising a plurality of first cleats (suture lock provided in each exit channel 72, para. [0116]), each first cleat comprising a first gripping surface (surface of free end 84, para. [0119]; fig. 12), and a plurality of spacer blocks (annotated fig. 2) interposed between each first cleat (at least one spacer block positioned between each of the first cleats, collectively forming a plurality of spacer blocks, which appears to be consistent with fig. 5 of the instant spec., figs. 2 and 7-12); a second cleat array portion (second exit channel 73 formed in each bifurcated channel 70 and therefore considered to have multiple second exit channels 73 formed in an array portion, para. [0115]) comprising a plurality of second cleats (suture lock provided in each exit channel 73, para. [0116]; fig. 10), each second cleat comprising a second gripping surface (surface of free end 84, para. [0119]; fig. 12), wherein each second cleat is colinear with each first cleat (figs. 7-12), and a plurality of spacer blocks interposed between each second cleat (at least one spacer block positioned between each of the second cleats, collectively forming a plurality of spacer blocks, which appears to be consistent with fig. 5 of the instant spec., annotated fig. 2), for the purpose of adjusting the tension of multiple sutures, allowing the surgeon to positively identify and unlock a desired suture for further tension adjustments without loosening the other end of the suture, and increasing the maximum amount of tension that can be applied to a given suture (para. [0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim a cleat array comprising: a first cleat array portion movably connected to the housing, the first cleat array portion comprising a plurality of first cleats, each first cleat comprising a first gripping surface, and a plurality of spacer blocks interposed between each first cleat; and a second cleat array portion fixedly connected to the housing, the second cleat array portion comprising a plurality of second cleats, each second cleat comprising a second gripping surface, wherein each second cleat is colinear with each first cleat, and a plurality of spacer blocks interposed between each second cleat, in order to adjust the tension of multiple sutures, allowing the surgeon to positively identify and unlock a desired suture for further tension adjustments without loosening the other end of the suture, and increasing the maximum amount of tension that can be applied to a given suture, based on the suggestions and teachings of Hu (para. [0116]).
Sauer (as modified) further teaches a plurality of indicator biasing elements, each indicator biasing element connected to the housing and colinear with the first cleat and the second cleat and each indicator biasing element comprising a suture channel (combination further teaches multiple base members 130 to accommodate multiple jaw members 146 and 148); and the actuator in contact with the first cleat array portion (combination considered to further teach actuator in contact with first cleat array portion).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2012/0226310 A1 to Frankland, disclosing a suture retention device.
US 5364407 to Poll, disclosing a laparoscopic suturing system.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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