DETAILED ACTION
Claim 12 which was previously withdrawn is canceled. Claim 1 is amended. Claims 9-11 remain withdrawn. A complete action on the merits of pending claims 1, 4, 6-8, and 13-14 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
Acknowledgment is made to applicant's amendments filed on 08/08/2025.
Claim Rejections - 35 USC § 103
Claim(s) 1, 4, 6-8, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindh (US PGPUB No. 20160106422 A1), in view of Beroff (US Patent No. 4490326), and further in view of Hoffman (US Patent No. 4054144).
Regarding claim 1, Lindh teaches, a medical thread (Figure 1, self-retaining suture device (100); Paragraph [0052]) comprising:
a body (Figure 1, monofilament fiber (110); Paragraph [0052]) having one end (Figure 1, tailing end (150); Paragraph [0053]), an other end (Figure 1, leading end (115); Paragraph [0053]), a surface (Figure 1), a cross section (Figure 1; where the cross section is, “ the surface or shape that is or would be exposed by making a straight cut through fiber (110), especially at right angles to an axis”), and a length in a longitudinal direction (Figure 1); and
at said one end of the body (tailing end (150)), a stopper (Figure 1, termination feature (120); Paragraphs [0053]-[0054]) having a center, an edge angle, and a cross section (As disclosed in Paragraph [0054], “The termination feature (120) may be produced in a variety of geometries, including having a circular, triangular, rectangular (including, for example, diamond or square shaped), or other geometric cross section. Edges and corners of the termination feature (120) may be rounded or smooth, if desired. The termination feature (120) may have any desired thickness, and may have varying degrees of thickness throughout the termination feature (120) if desired.” Taking this in view of Figure 1, then termination feature (120) does indeed include a center, an edge angle, and a cross section),
wherein the cross section of the stopper (termination feature (120)) is larger than the cross section of the body (monofilament fiber (110)) (As seen in Figure 1 and disclosed in Paragraph [0056], “It is particularly desirable that the cross-sectional diameter of the termination feature (120) be greater than the largest measured diameter of the suture (100)”),
wherein the stopper (termination feature (120)) is placed perpendicularly to the longitudinal direction of the body (monofilament fiber (110)) adjacent thereto (Paragraph [0055]),
wherein the stopper (termination feature (120)) has a shape of triangular prism (As disclosed in Paragraph [0054], “The termination feature (120) may be produced in a variety of geometries, including having a circular, triangular, rectangular (including, for example, diamond or square shaped), or other geometric cross section. Edges and corners of the termination feature (120) may be rounded or smooth, if desired. The termination feature (120) may have any desired thickness, and may have varying degrees of thickness throughout the termination feature (120) if desired.” Given that one of the possible geometries is triangular and the termination feature (120) may have an desired thickness and may have varying degrees of thickness throughout the termination feature (120), then it is capable of forming a triangular prism),
wherein the stopper has a thickness of 0.1 mm to 5.0 mm, and a side of the stopper has a length of 2 mm to 5 mm (Lindh does not explicitly teach, “wherein the stopper has a thickness of 0.1 mm to 5.0 mm, and a side of the stopper has a length of 2 mm to 5 mm.” However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the stopper have a thickness of 0.1 mm to 5.0 mm, and a side of the stopper has a length of 2 mm to 5 mm, 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 involve only routine skill in the art. This is further supported by the disclosure of paragraph [0054] of Lindh, which discloses in part, “The termination feature (120) may have any desired thickness, and may have varying degrees of thickness throughout the termination feature 120 if desired.” Further, paragraph [0056] of Lindh discloses in part, “It is particularly desirable that the cross-sectional diameter of the termination feature (120) be greater than the largest measured diameter of the suture (100). Thus, the ratio of the diameter of the termination feature (120) to the largest diameter of the suture (100) should be greater than 1.1:1, and may be up to about 10:1. More desirably, the ratio of the diameter of the termination feature (120) to the largest diameter of the suture 100 may be about 4:1 to about 8:1.” and “As used herein, the term “diameter” does not necessarily refer to a circular cross-section, and the term “diameter” can refer to the largest distance from opposing ends of device, such as opposing corners of a square.” As such, discovering the optimum or workable ranges involve only routine skill in the art to achieve what is stated in the last sentence of paragraph [0054], “The termination feature (120) abuts the tissue into which the suture is inserted, having an anchoring effect.” In re Aller.),
wherein the stopper (termination feature (120)) and said one end (tailing end (150)) of the body (monofilament fiber (110)) have been formed as one by melting and molding said one end (tailing end (150)) of the body (monofilament fiber (110)) (Paragraph [0012]), and
wherein the body (monofilament fiber (110)) and the stopper (termination feature (120)) are connected (Figure 1; Paragraph [0053]).
Lindh fails to teach, a temperature of 50 to 400°C; and an attachment strength of 1.1 kgf to 10 kgf.
Beroff discloses, a process for molding surgical devices and more particularly to molding surgical device from polymers of p-dioxanone. Beroff teaches, PDO polymers-identical or materially equivalent to those used in applicant’s medical thread-are melted and molded at 105-140°C, preferably 110-115°C, in order to achieve adequate shape stability and mechanical performance (Col. 2, line 32-55 and Col. 3, line 35-47; This falls within the claimed temperature range of 50 to 400°C).
Hoffman discloses, controlled pull-out forces for needle-suture attachments. Hoffman teaches, pull-out forces for needle-suture attachments with maximum values up to ~3lbs (~1.36kgf) for size 0 and larger (Col. 16, line 16-18; Within the claimed attachment strength range of 1.1 kgf to 10 kgf; Further pull-out strength is being described in Hoffman as a design-tunable parameter adjusted through manufacturing tolerances).
A person of ordinary skill in the art before the effective filing date of the claimed invention confronted with Lindh’s molded termination feature, would have been motivated to apply known processing conditions of PDO from Beroff – operating in the 105-140°C range, well within the claimed 50 to 400°C limits – to reliably achieve a triangular-shaped stopper with predictable strength. Further, they would have understood from Hoffman that pull-out/attachment strength in the range of ~1.36kgf (and by extension up to ~10kgf) is typical and controllable in surgical threading devices. It would have been a routine matter under In re Aller/In re Paterson to tune temperature and molding conditions to fall within these workable ranges for improved geometry and retention performance. Thus, the temperature and strength limitations are neither critical nor inventive, but rather are predictable results of routine optimization of known variables.
Regarding claim 4, Lindh in view of Beroff and further in view of Hoffman teach, wherein the body (monofilament fiber (110)) is connected to the center of the stopper (termination feature (120)) (Figure 1). Further, Lindh discloses the claimed invention except for, “the edge angle of the stopper is 60°.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the edge angle of the stopper be 60°, especially when the termination feature (120) is triangular in shape as disclosed in Paragraph [0046], 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 involve only routine skill in the art. In re Aller.
Regarding claim 6, Lindh further teaches, wherein each of the body (monofilament fiber (110)) and the stopper (termination feature (120)) independently comprises one or more polymers selected from polydioxanone (PDO), polycaprolactone (PCL), polylactic acid (PLA), polyglycolic acid (PGA), polytrimethylcarbonate (PTMC), polypropylene (PP), Nylon and polytetrafluoroethylene (PTFE), and copolymers of thereof (Paragraph [0045]; Further given that termination feature (120) is made from the monofilament fiber (110) as disclosed in Paragraph [0012], it is also comprised from any of the listed materials).
Regarding claim 7, Lindh further teaches, wherein the other end (leading end (115)) of the body (monofilament fiber (110)) is combined with a surgical needle (Figure 1, needle (130) (not labeled); Paragraph [0053]) that can be inserted into a surgical site (Paragraph [0046] discloses, “The first end of the resulting termination feature-containing suture is the “insertion” or “leading” end, and may include a component to allow for insertion into tissue, such as a needle.”).
Regarding claim 8, Lindh further teaches, wherein the surface (Figure 1) of the body (monofilament fiber (110)) comprises plural barbs (Figure 1, retainer elements (140); Paragraph [0052]) protruding outward (Figure 1).
Regarding claim 13, Lindh in view of Beroff and further in view of Hoffman teach teaches the claimed invention except for, “wherein the stopper and said one end of the body are formed by injecting the melted said one end of the body into the mold at a rate of 0.1 to 2.0 mm/s.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the stopper and said one end of the body be formed by injecting the melted said one end of the body into the mold at a rate of 0.1 to 2.0 mm/s, 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 involve only routine skill in the art. Further support is found in paragraph [0048], describing the method of making the termination feature of Lindh, where it is stated that a sufficient length of fiber needs to be wound into the cavity into a spiraled coil, the resulting coils of fiber is subjected to an energy source.” Also, paragraphs [0111]-[0117] of Lindh, provide two different examples of the formation of the terminal features using two different energy sources, in both examples Polydioxanone was used as the fiber material, which is known to have an injection time of 3 seconds. Taking this injection time along with a sufficient length of the fiber, results in a rate of 0.1 to 2.0 mm/s. In re Aller.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindh, in view of Beroff, further in view of Hoffman, and even further in view of Genova (US PGPUB No. 20100294105 A1).
Regarding claim 14, Lindh teaches, the plural barbs (retainer elements (140); Paragraph [0052]) protrude outward (Figure 1).
Lindh fails to teach, wherein the plural barbs protrude outward at an angle in a range of 10° to 45° relative to the longitudinal direction of the body.
Beroff teaches, aspects of the medical thread according to claim 1 (See above rejection of claim 1).
Hoffman teaches, other aspects of the medical thread according to claim 1 (See above rejection of claim 1).
Genova discloses, a method of barbing suture filament by varying the blade geometry and/or the movement of a blade when cutting a suture filament. Genova teaches, forming plural barbs that protrude outward at varying angles (Paragraph [0020]) relative to the longitudinal direction of the body (Figures 1-5; Paragraphs [0047]-[0058]; Where in these paragraphs it is disclosed the blade geometry and/or the movement of a blade when cutting a suture filament influences the length and depth of the barb that is then formed, which according to paragraph [0020] allows for the formation of multiple barbs with varying angles, including ones that range of 10° to 45° relative to the longitudinal direction of the body).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Lindh such that the plural barbs are formed to protrude outward at an angle in a range of 10° to 45° relative to the longitudinal direction of the body as taught by Genova, as all the references and the claimed invention are directed to surgical devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lindh such that the plural barbs are formed to protrude outward at an angle in a range of 10° to 45° relative to the longitudinal direction of the body as taught by Genova, as such a modification would have been predictable, namely, so that in tissue repair, the random configuration may be ideal to anchor tissues in as many barb angles as possible to provide superior wound holding properties.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Temperature Range (50–400 °C):
Applicant argues the claimed temperature range is critical, relying on the Declaration under 37 CFR 1.132 to allege unexpected results. This argument is not persuasive.
As set forth in the rejection, Beroff (US 4,490,326) teaches molding PDO surgical devices at 105–140°C, and further explains that temperature selection governs strength and shape stability. This directly establishes temperature as a result-effective variable. The claimed range of 50–400 °C fully overlaps and subsumes the ranges disclosed in the art. Per In re Aller, 220 F.2d 454 (CCPA 1955), and In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), discovery of an optimum or operable range within a known range is prima facie obvious, absent evidence of criticality or unexpected results commensurate in scope.
The Declaration evidence is not persuasive because it fails to demonstrate any criticality across the full scope of the claimed range. The data at most shows limited differences at select points, which are attributable to routine optimization of molding conditions. The art already recognized that temperature controls strength/geometry (326), and thus the results alleged are merely the expected outcomes of adjusting a known process variable.
Attachment Strength (1.1–10 kgf):
Hoffman (US 4,054,144) discloses surgical thread/needle attachments exhibiting pull-out strengths up to ~3lbs (≈1.36kgf), and explicitly teaches tuning pull-out force by adjusting crimping parameters. This falls within the lower portion of the claimed 1.1–10 kgf range.
Thus, attachment strength was a recognized design parameter subject to routine adjustment for reliable surgical performance. As with temperature, per In re Aller, varying a known parameter within a known range is not inventive. Applicant’s Declaration does not show that the full claimed range produces unexpected properties relative to the art. Instead, it confirms that strength is a continuum influenced by processing variables already disclosed as adjustable in the prior art.
Combination of References:
Lindh discloses the stopper/termination feature. Beroff provides recognized processing temperatures for PDO molded devices, directly relevant to Lindh’s material and manufacturing process. Hoffman provides recognized attachment strength ranges and expressly teaches control of pull-out force as a design variable in surgical threading devices.
Under KSR v. Teleflex, 550 U.S. 398 (2007), a person of ordinary skill would have been motivated to combine these teachings to achieve predictable results in molded surgical stoppers with reliable retention.
Therefore, applicant’s arguments and declaration have been considered but are not persuasive and do not overcome the prima facie case of obviousness.
See updated rejections above.
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.
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771