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
Claim 25 is objected to because of the following informalities: in line 1, “wherein a proximal end” should be –wherein the proximal end--. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: in line 2, “comprises a curvature” should be –comprises the curvature--. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: in line 1, “wherein a proximal end” should be –wherein the proximal end--. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: in line 2, “comprises a curvature” should be –comprises the curvature--. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: in line 2, “an expected size” should be –the expected size--. Appropriate correction is required.
Claim 39 is objected to because of the following informalities: in line 1, “wherein a proximal end” should be –wherein the proximal end--. Appropriate correction is required.
Claim 39 is objected to because of the following informalities: in line 2, “comprises a curvature” should be –comprises the curvature--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 23, 25-27, 29, 31-37, and 39-42 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 23 and 37 recites a body having “a width of between 1.7 mm and 2.0 mm”, this is considered new matter since the original disclosure does not appear to teach the width as claimed.
In applicant’s response filed 1/5/26 on page 11, applicant states that support for this limitation is in paragraph [0053] of applicant’s specification. However, the original disclosure does not appear to state that the body has a width of between 1.7 mm and 2.0 mm; hence it is considered new matter.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 25 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 25 recites “wherein a proximal end of the locking mechanism further comprises a curvature” which is also found in the amendment to claim 23 in lines 6-7; therefore, the claim fails to further limit the independent claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 26 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 26 recites “wherein a proximal end of the locking mechanism further comprises a curvature corresponding to an expected size of the loop formed by the tie in the locked configuration” which is also found in the amendment to claim 23 in lines 6-8; therefore, the claim fails to further limit the independent claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 39 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 39 recites “wherein a proximal end of the locking mechanism further comprises a curvature” which is also found in the amendment to claim 23 in lines 6-7; therefore, the claim fails to further limit the independent claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 25, 26, 29, 31, 35, and 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).
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.
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Claim 25: Kohn discloses that the proximal end of the locking mechanism further comprises a curvature (see figure above).
Claim 26: Kohn discloses that the proximal end of the locking mechanism further comprises a curvature corresponding to the expected size of the loop formed by the tie in the locked configuration (Fig. 3f).
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).
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 further in view of Sutherland et al. (4,730,615).
Koch in view of Ebert 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 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) 32-34 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 Dai et al. (2017/0035480).
Koch discloses all the claimed limitations discussed above however Koch does not disclose that the device is made of a PLA or PGA material.
Dai discloses another closure device which uses a bioabsorbable material such as PLA, or mixture of PLA and PGA.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a mixture of 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.
Koch in view of Dai 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(s) 37 and 39-42 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 Dai et al. (2017/0035480) and further in view of Chin et al. (2019/0365364).
Koch in view of Ebert and Dai 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 Dai 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 Dai 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 1/5/26 with respect to Koch have been fully considered but they are not persuasive.
Applicant’s arguments rely on language solely recited in preamble recitations in claim(s) 23 and 37. When reading the preamble in the context of the entire claim, the recitation “A tie made of a biodegradable material comprising PLA and/or PLGA configured for fascial closure, the tie configured to move from a delivery configuration to a locked configuration” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
In response to applicant's argument that the device of Koch is used for bone fixation not facial closure, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant further argues that Koch does not disclose the width as claimed. This is found moot in view of Ebert as seen in the rejection above.
Applicant also argues that Koch does not disclose the curvature corresponding to an expected size as claimed. The examiner disagrees, as seen in the rejection above, Koch discloses a curvature (see figure above) corresponding to the expected size of the loop (76) formed by the tie in the locked configuration as best seen in Fig. 3f where it has the expected size of the loop 76 formed.
Additionally, applicant argues that Koch does not disclose the recessed tooth configuration as claimed. The examiner disagrees, as seen in the rejection above, where Koch discloses that 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]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771