DETAILED ACTION
Claims 22-24 are newly added claims. Claim 1 is amended. A complete action on the merits of pending claims 1-10, 13-17, and 21-24 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 10/11/2025 which are now entered. With regards to the 35 U.S.C. 112(b) rejection documented in the Non-Final Office Action sent on 07/11/2025, it is overcome through Applicant’s amendment to claim 1 and is now withdrawn.
Claim Rejections - 35 USC § 103
Claim(s) 1-10 and 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meehan (US Patent No. 3543353), in view of Browne (US Patent No. 8732914).
Regarding claim 1, Meehan discloses, a flexible plastic fastener. Meehan teaches, a surgical constricting device (Figure 1, fastener (10); Col. 1, line 8-11, discloses, that fastener (10) is used for maintaining two workpieces in side-by-side parallel axis relationship, as such it is indeed capable of being used for surgical purposes), comprising:
an elongated body (Figure 2, body (12); Col. 1, line 42-46) the elongated body configured to maintain its position when wrapped around itself (Col. 2, line 29-36);
a first grasping pad (Figure 2, enlarged protuberance (18)) disposed at a first end of the elongated body (Col. 1, line 62-66) and configured to be engaged by a surgical instrument (Col. 2, line 18-22, discloses, “By application of finger pressure on the protuberances (18-20) the end portions are moved laterally and thence toward one another in a rotating or twisting motion to bring their concave or hook-like segments into opposed relationship, as shown in FIGS. 1, 4 and 5.” As such, protuberance (18) is also capable of being engaged by a surgical instrument); and
a second grasping pad (Figure 2, enlarged protuberance (20)) disposed at a second end of the elongated body (Col. 1, line 62-66) and configured to be engaged by the surgical instrument (Col. 1, line 62-66) and configured to be engaged by a surgical instrument (Col. 2, line 18-22, discloses, “By application of finger pressure on the protuberances (18-20) the end portions are moved laterally and thence toward one another in a rotating or twisting motion to bring their concave or hook-like segments into opposed relationship, as shown in FIGS. 1, 4 and 5.” As such, protuberance (20) is also capable of being engaged by the surgical instrument),
wherein the elongated body (body (12)) is cylindrical between the first grasping pad and the second grasping pad (As seen in Figures 2, 4, and disclosed in Col. 1, line 44-46, body (12) is a relatively loop-shaped and is a segment of a circular arc, thus under the BRI of “cylindrical,” the body (12) is indeed cylindrical between protuberance (18) and protuberance (20)),
wherein each of the first grasping pad and the second grasping pad is in the shape of a rectangular prism (Col. 1, line 66-68, discloses, “It should be noted, however, that other surface form such as ellipsoids, oblate spheroids, or prisms will operate satisfactorily.” Thus, the shape of a rectangular prism is indeed possible for protuberances (18 & 20)), such that a cross-sectional shape of the cylindrical elongated body changes at each of the first grasping pad and the second grasping pad (Given Figures 1-5 and the cited disclosures, the cross-sectional shape of the cylindrical body (12) does indeed change at the protuberances (18 & 20)),
wherein the rectangular prism of the first grasping pad (enlarged protuberance (18)) comprises first and second planar surfaces facing in opposite directions and the rectangular prism of the second grasping pad (enlarged protuberance (20)) comprises third and fourth planar surfaces facing in opposite directions (Examiner notes, the pads inherently possess planar surfaces if they are rectangular prisms in the alternative embodiment described by Col. 1, line 66-68, where, “It should be noted, however, that other surface form such as ellipsoids, oblate spheroids, or prisms will operate satisfactorily.”), and
wherein the first and second grasping pads are stackable between jaws of the surgical instrument with the first and third planar surfaces contacting each other and the second and fourth planar surfaces facing outwardly toward the jaws for engagement by the surgical instrument during a surgical procedure (The function of these surfaces being "stackable between jaws of the surgical instrument" during a surgical procedure is simply the expected function of two flat surfaces brought together, which is an inherent characteristic of the structure and thus obvious to one of ordinary skill in the art. This functional limitation does not overcome the structural obviousness of the pads' shape).
Meehan fails to teach, the elongated body including a central core and an outer sheath surrounding the central core, the central core made from a first material, the outer sheath made from a second material.
Browne discloses cable ties and twist ties. Browne teaches, an elongated body (Figure 4, twist tie (90); Col. 11, line 6-10) including a central core (Figure 5, elongated member (92)) and an outer sheath (Figure 5, flexible sheath (94)) surrounding the central core (Col. 11, line 6-10), the central core (elongated member (92)) made from a first material (Col. 11, line 17-20, line 32-34, line 42-43, line 53-56, and Col. 11, line 66-Col. 12, line 1), the outer sheath (flexible sheath (94)) made from a second material (Col. 11, line 15-17, line 34-36, line 43-44, line 57, and Col. 12, line 1).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the elongated body of Meehan to include a central core and an outer sheath, with the core made from a first material and the sheath made from a second material, as taught by Browne, as both references and the claimed invention are directed to twist ties. 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 elongated body of Meehan to include a central core and an outer sheath, with the core made from a first material and the sheath made from a second material, as taught by Browne, as such a modification would have been predictable, namely, to provide enhanced security against loosening and dynamic adjustment capabilities.
Regarding claim 2, modified Meehan teaches, wherein the central core (elongated member (92)) defines a circular cross-section (Col. 11, line 8 of Browne, discloses “elongated member (92)” is a wire and along with Figure 5, elongated member (92) clearly defines a circular cross-section. Further, although Meehan expresses a preference for non-circular cross-sections (Col. 1, line 46-49) in the context of its monolithic fastener (Col. 1, line 69-Col. 2, line1), such preference does not amount to a teaching away. As stated in In re Gurley and W.L. Gore v. Garlock, a reference teaches away only when it criticizes, discredits, or discourages the claimed modification. Meehan does not do so here. Therefore, one of ordinary skill in the art would still have found it obvious to apply Browne’s circular-core construction to Meehan’s fastener to achieve improved flexibility and strength in a multi-material device).
Regarding claim 3, modified Meehan teaches the claimed invention except for, “wherein the circular cross-section of the central core defines a diameter of between 0.035 inches and 0.065 inches.” 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 circular cross-section of the central core define a diameter of between 0.035 inches and 0.065 inches, 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 4, modified Meehan teaches, wherein the outer sheath (flexible sheath (94)) defines a ring-like cross-section (Col. 11, line 9-10 of Browne, discloses the flexible sheath (94) encloses elongated member (92), which is a clear indication that flexible sheath (94) defines a ring-like cross-section).
Regarding claim 5, modified Meehan teaches the claimed invention except for, “wherein the outer sheath defines a thickness of between 0.014 inches and 0.045 inches.” 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 outer sheath define a thickness of between 0.014 inches and 0.045 inches, 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, modified Meehan teaches, wherein the first material is stainless steel (In the disclosure of Browne, Col. 7, line 43-50 and Col. 11, line 66-Col. 12, line 1).
Regarding claim 7, modified Meehan teaches, wherein the second material is polyurethane (In the disclosure of Browne, Col. 11, line 34-36, line 43-44, line 57, and Col. 12, line 1, disclose that the flexible sheath (94) is a shape memory polymer (SMP), polyurethane is an SMP).
Regarding claim 8, modified Meehan teaches, wherein the second material is silicone (In the disclosure of Browne, Col. 11, line 34-36, line 43-44, line 57, and Col. 12, line 1, disclose that the flexible sheath (94) is a shape memory polymer (SMP) and Col. 7, line 23-31 along with Col. 8, line 5-17, disclose that exemplary polymers include silicone).
Regarding claim 9, modified Meehan teaches, wherein the second material is silicone (In the disclosure of Browne, Col. 11, line 34-36, line 43-44, line 57, and Col. 12, line 1, disclose that the flexible sheath (94) is a shape memory polymer (SMP) and Col. 7, line 23-31 along with Col. 8, line 5-17, disclose that exemplary polymers include silicone).
Regarding claim 10, modified Meehan teaches the claimed invention except for, “wherein a length of the surgical constricting device is between 1.75 inches and 2.5 inches.” 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 length of the surgical constricting device be between 1.75 inches and 2.5 inches, 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 13, modified Meehan teaches, wherein the outer sheath (flexible sheath (94)) has a ring-like cross-section taken across the outer sheath (Col. 11, line 9-10 of Browne, discloses the flexible sheath (94) encloses elongated member (92), which is a clear indication that flexible sheath (94) defines a ring-like cross-section), and wherein the first material comprises stainless steel (In the disclosure of Browne, Col. 7, line 43-50 and Col. 11, line 66-Col. 12, line 1), and
wherein the second material is polyurethane (In the disclosure of Browne, Col. 11, line 34-36, line 43-44, line 57, and Col. 12, line 1, disclose that the flexible sheath (94) is a shape memory polymer (SMP), polyurethane is an SMP).
Regarding claim 14, modified Meehan teaches, wherein the second material is silicone (In the disclosure of Browne, Col. 11, line 34-36, line 43-44, line 57, and Col. 12, line 1, disclose that the flexible sheath (94) is a shape memory polymer (SMP) and Col. 7, line 23-31 along with Col. 8, line 5-17, disclose that exemplary polymers include silicone).
Regarding claim 15, modified Meehan teaches, wherein the central core (elongated member (92)) defines a circular cross-section (Col. 11, line 8 of Browne, discloses “elongated member (92)” is a wire and along with Figure 5, elongated member (92) clearly defines a circular cross-section. Further, although Meehan expresses a preference for non-circular cross-sections (Col. 1, line 46-49) in the context of its monolithic fastener (Col. 1, line 69-Col. 2, line1), such preference does not amount to a teaching away. As stated in In re Gurley and W.L. Gore v. Garlock, a reference teaches away only when it criticizes, discredits, or discourages the claimed modification. Meehan does not do so here. Therefore, one of ordinary skill in the art would still have found it obvious to apply Browne’s circular-core construction to Meehan’s fastener to achieve improved flexibility and strength in a multi-material device).
Regarding claim 16, modified Meehan teaches the claimed invention except for, “wherein the circular cross-section of the central core defines a diameter of between 0.035 inches and 0.065 inches.” 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 circular cross-section of the central core define a diameter of between 0.035 inches and 0.065 inches, 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 17, modified Meehan teaches the claimed invention except for, “wherein the outer sheath defines a thickness of between 0.014 inches and 0.045 inches.” 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 outer sheath define a thickness of between 0.014 inches and 0.045 inches, 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.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meehan, in view of Browne, and further in view of Dauner (WO 2015176993 A1 (See attached document)).
Regarding claim 21, Meehan teaches, aspects of the surgical constricting device according to claim 1 (See above rejection of claim 1).
Meehan fails to teach, wherein a thickness of the outer sheath varies along the elongated body.
Browne teaches, the outer sheath (flexible sheath (94)) of the elongated body (twist tie (90)).
Dauner discloses, a thread, comprising a thread core and a sheath surrounding the thread core. Dauner teaches, wherein a thickness of the outer sheath varies along the elongated body (Abstract).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the elongated body of Meehan to include a central core and an outer sheath, with the core made from a first material and the sheath made from a second material, as taught by Browne, and to further modify the thickness of the outer sheath such that it varies along the elongated body, as taught by Dauner, as all references and the claimed invention are directed to twist ties (Paragraph [0134 ] of Dauner). 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 elongated body of Meehan to include a central core and an outer sheath, with the core made from a first material and the sheath made from a second material, as taught by Browne, and to further modify the thickness of the outer sheath such that it varies along the elongated body, as taught by Dauner, as such a modification would have been predictable, namely, to improve grip.
Claim(s) 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meehan, in view of Browne, and further in view of Yacoubian (US Patent No. 5683405).
Regarding claim 22, Meehan discloses, the first planar surface of the rectangular prism (Col. 1, line 66-68) of the first grasping pad (enlarged protuberance (18)) and the third planar surface of the rectangular prism (Col. 1, line 66-68 ) of the second grasping pad (enlarged protuberance (20)).
Meehan fails to teach, wherein the first planar surface and the third planar surface each comprise a plurality of ribs thereon.
Browne teaches, the outer sheath (flexible sheath (94)) of the elongated body (twist tie (90)).
Yacoubian discloses, a vascular occluder clip. Yacoubian teaches, a vascular occluder clip (Figures 7-8, clip (110); Col. 5, line 42-46) comprising grasping pads (Figures 7-8, gripping pads (136); Col. 5, line 65-Col. 6, line 10, where it is disclosed that the gripping pads (136) have an arcuate perimeter extending perpendicularly from plastic sleeve (134) molded over the base (114) and proximal legs (116), with smooth or grooved surfaces for gripping), wherein the pads comprise planar surfaces each comprising plurality of ribs thereon (As seen in Figure 8, the pads (136) extend transversely and have planar gripping surfaces. As stated, given that Col. 6, line 2-8 disclose, “grooved surfaces” of pads (136), the “grooved surfaces” indicate a plurality grooves, which create alternating raised portions (ribs) between them for enhanced grippability by a surgical instrument. The pads are on both proximal ends of the clip, and the grooved surfaces are described for gripping on the exposed faces, which can inherently include multiple planar surfaces (e.g., front and back of each pad, totaling four)).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the grasping pads of Meehan to incorporate a plurality of ribs on the first planar surface and the third planar surface of the grasping pads as taught by Yacoubian, as all references and the claimed invention are directed to fasteners. 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 grasping pads of Meehan to incorporate a plurality of ribs on the first planar surface and the third planar surface of the grasping pads as taught by Yacoubian, as such a modification would have been predictable, namely, to facilitate gripping (Col. 6, line 2-8 of Yacoubian).
Regarding claim 23, modified Meehan teaches, wherein the ribs of each plurality of ribs comprise raised portions grippable by the surgical instrument (Col. 5, line 65-Col. 6, line 10 of Yacoubian, “grooved surfaces” of pads (136), the “grooved surfaces” indicate a plurality grooves, which create alternating raised portions (ribs) between them for enhanced grippability by a surgical instrument).
Regarding claim 24, modified Meehan teaches, wherein the first, second, third, and fourth planar surfaces each comprise a plurality of ribs thereon (Col. 5, line 65-Col. 6, line 10 of Yacoubian, The pads are on both proximal ends of the clip, and the grooved surfaces are described for gripping on the exposed faces, which can inherently include multiple planar surfaces (e.g., front and back of each pad, totaling four)).
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meehan, in view of Browne, and further in view of Tiefenbrum (US Patent No. 6331182).
Regarding claim 1, Meehan discloses, a flexible plastic fastener. Meehan teaches, a constricting device (Figure 1, fastener (10); Col. 1, line 8-11, discloses, that fastener (10) is used for maintaining two workpieces in side-by-side parallel axis relationship, as such it is indeed capable of being used for surgical purposes), comprising:
an elongated body (Figure 2, body (12); Col. 1, line 42-46) the elongated body configured to maintain its position when wrapped around itself (Col. 2, line 29-36);
a first grasping pad (Figure 2, enlarged protuberance (18)) disposed at a first end of the elongated body (Col. 1, line 62-66); and
a second grasping pad (Figure 2, enlarged protuberance (20)) disposed at a second end of the elongated body (Col. 1, line 62-66),
wherein the elongated body (body (12)) is cylindrical between the first grasping pad and the second grasping pad (As seen in Figures 2, 4, and disclosed in Col. 1, line 44-46, body (12) is a relatively loop-shaped and is a segment of a circular arc, thus under the BRI of “cylindrical,” the body (12) is indeed cylindrical between protuberance (18) and protuberance (20)),
wherein each of the first grasping pad and the second grasping pad is in the shape of a rectangular prism (Col. 1, line 66-68, discloses, “It should be noted, however, that other surface form such as ellipsoids, oblate spheroids, or prisms will operate satisfactorily.” Thus, the shape of a rectangular prism is indeed possible for protuberances (18 & 20)), such that a cross-sectional shape of the cylindrical elongated body changes at each of the first grasping pad and the second grasping pad (Given Figures 1-5 and the cited disclosures, the cross-sectional shape of the generally cylindrical body (12) does indeed change at the protuberances (18 & 20)),
wherein the rectangular prism of the first grasping pad (enlarged protuberance (18)) comprises first and second planar surfaces facing in opposite directions and the rectangular prism of the second grasping pad (enlarged protuberance (20)) comprises third and fourth planar surfaces facing in opposite directions (Examiner notes, the pads inherently possess planar surfaces if they are rectangular prisms in the alternative embodiment described by Col. 1, line 66-68, where, “It should be noted, however, that other surface form such as ellipsoids, oblate spheroids, or prisms will operate satisfactorily.”), and
wherein the first and second grasping pads are stackable between jaws of the surgical instrument with the first and third planar surfaces contacting each other and the second and fourth planar surfaces facing outwardly toward the jaws for engagement by the surgical instrument during a surgical procedure (The function of these surfaces being "stackable between jaws of the surgical instrument" during a surgical procedure is simply the expected function of two flat surfaces brought together, which is an inherent characteristic of the structure and thus obvious to one of ordinary skill in the art. This functional limitation does not overcome the structural obviousness of the pads' shape).
Meehan does not explicitly teach, the constricting device as a surgical constricting device; and the first grasping pad and the second grasping pad as being configured to be engaged by the surgical instrument. Also, Meehan fails to teach, the elongated body including a central core and an outer sheath surrounding the central core, the central core made from a first material, the outer sheath made from a second material.
Tiefenbrum discloses, a tie member manipulated by a twisting instrument. Tiefenbrum teaches a surgical constricting device comprising an elongated, at least partially flexible tie member for closing tissues at a surgical site, where opposite ends of the flexible tie element are entrained by a twisting instrument, which is inserted through a surgical access point and rotated to twist the ends of the tie around themselves, thereby constricting tissue and locking the tie in place (Abstract). Tiefenbrum further teaches that the twisting instrument engages and rotates the tie ends from outside the patient, thus demonstrating that the tie ends are configured to be engaged by a surgical instrument (Abstract).
Browne discloses cable ties and twist ties. Browne teaches, an elongated body (Figure 4, twist tie (90); Col. 11, line 6-10) including a central core (Figure 5, elongated member (92)) and an outer sheath (Figure 5, flexible sheath (94)) surrounding the central core (Col. 11, line 6-10), the central core (elongated member (92)) made from a first material (Col. 11, line 17-20, line 32-34, line 42-43, line 53-56, and Col. 11, line 66-Col. 12, line 1), the outer sheath (flexible sheath (94)) made from a second material (Col. 11, line 15-17, line 34-36, line 43-44, line 57, and Col. 12, line 1).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the elongated body of Meehan to include a central core and an outer sheath, with the core made from a first material and the sheath made from a second material, as taught by Browne, and to further modify the grasping pads of Meehan’s fastener to be configured for engagement with a surgical instrument, as taught by Tiefenbrum, as all the references and the claimed invention are directed to twist ties. 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 elongated body of Meehan to include a central core and an outer sheath, with the core made from a first material and the sheath made from a second material, as taught by Browne, and to further modify the grasping pads of Meehan’s fastener to be configured for engagement with a surgical instrument, as taught by Tiefenbrum, as such a modification would have been predictable, namely, to provide enhanced security against loosening and dynamic adjustment capabilities. Additionally, to enable precise deployment, manipulation, and tightening of the constricting device in surgical environments, particularly in minimally invasive procedures where direct manual access is limited, where one of ordinary skill in the art would have applied this concept to Meehan’s fastener to adapt it to surgical applications, especially since Meehan already suggests adaptability to various forms and functionalities.
Response to Arguments
Applicant's arguments filed on 10/11/2025 have been fully considered but they are not persuasive. The applicant has amended claim 1 to include limitations related to the "stackable" nature and "planar surfaces" of the grasping pads, arguing that Meehan and Browne do not teach this specific structure and function, and thus lack the motivation to combine the references to arrive at the claimed invention.
However, the prior art already discloses grasping pads (protuberances (18) and (20)) that could be rectangular prisms (Col. 1, line 66-68 of Meehan). A rectangular prism inherently possesses planar surfaces. The discovery of an unappreciated property or inherent function of a known prior art structure does not make the old structure patentably new. The following is noted:
An examiner can use inherency in an obviousness analysis if a limitation "necessarily must be present, or the natural result" of the disclosed prior art combination. Here, the flat surfaces and their stackability are the natural outcome of a rectangular prism shape disclosed in Meehan. It is not relevant if the prior art did not explicitly recognize this.
Functional language not tied to a specific structure covers any device capable of performing the function. If the prior art discloses a device that can inherently perform that function, a rejection under 35 U.S.C. § 103 is proper.
A motivation to combine Meehan and Browne exists due to their shared field of endeavor, as supported by MPEP § 2141. KSR International Co. v. Teleflex Inc. allows examiners to rely on common sense and routine practices, such as changes in shape, as a basis for obviousness. The new functional limitation, being inherent, does not overcome this rationale.
The prima facie case of obviousness is established and unrebutted because the added limitations are inherent properties of the prior art and do not present an "unexpected result". Thus, the rejections are maintained.
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