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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/29/26 has been entered.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 23, 29, and 31-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koch et al. (2013/0261625) in view of Ebert (4,535,764) and further in view of Weier et al. (2007/0260251).
Claim 23:
Koch discloses a tie comprising: a body (22, 38) (Fig. 1 and 3a) extending along a longitudinal length (Fig. 1 and 3a) and comprising a needle (34) (Fig. 1 and 3a and [0035]) positioned near a distal end of the body (Fig. 1 and 3a) and a locking mechanism (26) (Fig. 1 and 3a and [0035]) positioned near a proximal end of the body (Fig. 1 and 3a and [0035]), wherein a proximal end of the locking mechanism further comprises a curvature (see figure below) corresponding to the expected size of the loop (76) formed by the tie in the locked configuration (Fig. 3f where it has the expected size of the loop 76 formed); and a series of recessed teeth (42) (Fig. 3c-f and [0039]) positioned on a first face of the body (see figure below and Fig. 3c-f) and along at least a portion of the longitudinal length (Fig. 3c-f and [0039]), each tooth of the series of teeth comprising a tooth slope (see figure below) falling into the body (see figure below) and a tooth edge (see figure below) rising vertically relative to the body (see figure below) to a tooth point (see figure below) converging with a neighboring tooth slope (see figure below), wherein each tooth point converges within a recessed portion (46) (Fig. 3d and [0040]) of a surface of the first face of the body (Fig. 3d and figure below and [0040]), the portion of the surface extending longitudinally to the neighboring tooth slope (Fig. 3d and figure below and [0040]), such that an outer edge of each tooth is recessed within the body and a second face of the body oriented toward an external volume of the loop is smooth relative to the first face minimizing trauma to surrounding fascial tissues (Fig. 3d and figure below and [0040]), wherein the locking mechanism comprises an inner passage (74) (Fig. 3e and [0043]) oriented to receive the distal end of the body (Fig. 3e-f); a locking engagement (78) (Fig. 3e and [0043]) arranged in the inner passage (Fig. 3e and [0043]) and responsive to an applied force of the tie passing through to bend from a hinge (see figure above) towards the sidewall of the locking mechanism (Fig. 3e-f and [0042-44]), wherein the locking engagement is configured to mate with the series of recessed teeth on the first face of the body with a responsive force, fully grasping a tooth and restricting translational movement backwards through the inner passage (Fig. 3e-f and [0042-44]) when the tie is moved into the locked configuration (Fig. 3a-f and [0042]), thereby forming a loop (76) (Fig. 3f and [0042]) comprising the first face of the body oriented toward an internal volume of the loop (see figure below).
Koch discloses the claimed invention except for the body having a width of between 1.7 mm and 2.0 mm.
Ebert discloses another tie device which has a body (20) (Fig. 1) where the body has a width of between 1.7 mm and 2.0 mm (Col. 4 Lines 30-35).
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide Koch with a body having a width of between 1.7 mm and 2.0 mm in view of the teachings of Ebert, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Koch discloses all the claimed limitations discussed above however Koch does not disclose that the device is made of a biodegradable material comprising PLA or PGA material.
Weier discloses another sternum tie which uses biodegradable material ([0044]) comprising PLA or PGA material ([0045]).
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a biodegradable material comprising PLA and/or PGA material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a biodegradable material comprising PLA and/or PGA material in view of Weier, in order to have ties that can provide adequate strength to close the sternum and to resist the typical physiological forces encountered during daily activities while the bone is healing for a period of at least 6-8 months and then degrade without the need of removing it from the patient ([0044]).
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Claim 29: Kohn discloses that the locking engagement comprises a tongue (see figure above) comprising one or more locking teeth (82) on a first face (Fig. 3e-f and [0043-44]), and a slanted back (see figure above) on a second face (see figure above), wherein the slanted back of the tongue allows for the tongue to displace as the tip is pulled through the locking mechanism and snap back into place once the one or more locking teeth of the tongue align with the series of recessed teeth on the first face of the body (Fig. 3e-f and [0043-44]).
Claim 31: Kohn discloses that the body passed through the locking mechanism is ratcheted to hold a target tension (Fig. 3a-f).
Claims 32-34:
Koch in view of Ebert and Weier discloses the claimed invention except for the mixture being of PLA and/or PLGA being from 0:200 to 200:0. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have a mixture being of PLA and/or PLGA being from 0:200 to 200:0, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claims 33 and 34, Koch discloses that the tie is moved from a delivery configuration to form the loop (Fig. 3a-f) and that it is cut ([0053]) (note that it is capable of being cut by scissors).
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
It has been held that the recitation that an element is "capable of" performing a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138.
Claim 35: Kohn discloses that the tie further comprises an increased surface area (teeth area has an increased surface area) on the first face of the body configured to be directly applied against a target and better supports surgical closure (Fig. 3a-f).
Claim 36: Kohn discloses that the tie is for use in surgical closure in a procedure selected from the following group: to stitch through fascial layers; to perform spinal closures to support the high tensile strength and force needed to hold closed the wound; cranial closures; laparoscopic surgery; endoscopic surgery; to stitch bones together; sternum closure in open heart and other applicable surgeries; emergency situations and applications by the military; and combinations thereof (Fig. 7a, [0002-0003] and [0035]).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koch et al. (2013/0261625) in view of Ebert (4,535,764) and Weier et al. (2007/0260251) and further in view of Sutherland et al. (4,730,615).
Koch in view of Ebert and Weier discloses the claimed invention except for the needle having a diameter equal to or greater than a width of the body; an outer radius configured to match with the first face of the body; and an inner radius configured to match a second face of the body.
Southerland discloses a tie with a needle (16) (Fig. 1-2 and Col. 2 Lines 45-61), wherein the needle comprises: a diameter equal to or greater than a width of the body (Fig. 1-2 and Col. 3 Lines 31-45); an outer radius configured to match with the first face of the body (Fig. 1-2 and Col. 3 Lines 31-45); and an inner radius configured to match a second face of the body (Fig. 1-2 and Col. 3 Lines 31-45).
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide Koch in view of Ebert and Weier with the needle having a diameter equal to or greater than a width of the body; an outer radius configured to match with the first face of the body; and an inner radius configured to match a second face of the body, in view of the teachings of Southerland, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 37 and 40-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koch et al. (2013/0261625) in view of Ebert (4,535,764) and Weier et al. (2007/0260251) and further in view of Chin et al. (2019/0365364).
Koch in view of Ebert and Weier discloses all the claimed limitations discussed above including a method of using the device for closing bone where the tie is tensioned and cut as described in Fig. 3a-5c and [0053-60]. However, Koch in view of Ebert and Weier does not disclose that the device is used for surgical fascia closure.
Chin discloses a tie used to close a fascia opening as described in [0043]. It would have been obvious to one of ordinary skill in the art to use the device of Koch in view of Ebert and Weier for Fascia closure method in view of Chin, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Response to Arguments
Applicant's arguments filed 6/29/26 have been fully considered but they are not persuasive.
Applicant argues that a biodegradable sternum tie would not be biodegradable since it would ruin it and defeat its purpose.
The examiner disagrees, as seen in the rejection above Weier discloses another sternum tie which uses biodegradable material ([0044]) comprising PLA or PGA material ([0045]). Weier further discloses that the biodegradable sternum strap made of PLA or PGA has an advantage of being able to resist forces encountered during daily activity while the bone is healing as well as being able to maintain this for a period of 6-8 months before degrading ([0044]). Therefore a person of ordinary skill in the art in view of Weier would have looked into making the tie biodegradable.
In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a biodegradable material comprising PLA and/or PGA material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a biodegradable material comprising PLA and/or PGA material in view of Weier, in order to have ties that can provide adequate strength to close the sternum and to resist the typical physiological forces encountered during daily activities while the bone is healing for a period of at least 6-8 months and then degrade without the need of removing it from the patient ([0044]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771
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