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 .
Response to Amendment
This office action is responsive to the amendment filed on 02/05/2026. As directed by the amendment: claims 1-3 and 6-11 have been amended, claims 4-5 have been cancelled and claim 11 remains withdrawn. Thus, claims 1-3 and 6-11 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 02/05/2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 102(a)(1) as being anticipated by Yeung et al (US 20130289599 A1), herein referenced to as “Yeung” have been fully considered and are persuasive.
The applicant amended claim 1. Specifically, the amendment of “an assembly comprising: a thread-like implantable body; where: the assembly is in a first state in which positions of the first insertion hole and the second insertion hole coincide with each other in a circumferential direction and the implantable body extends through the first insertion hole and the second insertion hole in a direction perpendicular to the axial direction” overcomes Yeung. Yeung does not explicitly disclose the thread-like implantable body extending through the first insertion hole and the second insertion hole in a direction perpendicular to the axial direction.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yeung in view of Heneveld (US 20130253543 A1).
The applicant amended claim 10 to depend from claim 1, thereby rejoining the claims and no longer directed towards a separate invention.
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) 1-3 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeung et al (US 20130289599 A1), herein referenced to as “Yeung” in view of Heneveld (US 20130253543 A1), herein referenced to as “Heneveld”.
Claim 1
Yeung discloses: An assembly (see Figs. 24-27, [0125]-[0128]) comprising: a thread-like implantable body 126A/B/C (see Figs. 24-30, [0126]); and an operation device (Figs. 24-27, [0125]-[0128]) comprising: an outer cylinder 230 (see Figs. 24-27, [0125]) defining a lumen 268 (see Figs. 24-27, [0196]) extending in an axial direction the axial length/direction of 230 (see Figs. 24-27, [0196], longitudinal lumen 268), and a first insertion hole 110 (see Fig. 19, [0196]) extending through a side portion the side of the 230 (see Fig. 19) of the outer cylinder 230 in a radial direction the first insertion hole 110 extends radially through 230, a shaft 101 (see Figs. 24-27, [0196]) disposed in the lumen 268, the shaft 101 defining a second insertion hole 269 (see Fig. 21, [0196]) located in the shaft 101 at a portion (see Figs. 23 and 27, 269, lines up with 110 when not rotated to block 110) corresponding to the first insertion hole 110 and extending through a side portion side portion of 101 (see Fig. 21) of the shaft 101 in the radial direction the second insertion hole 269 extends radially through 101, a rotation mechanism 130 (see Fig. 26, [0201]) configured to rotate (see [0201], facilitate rotation of 101) the shaft 101 relative to the outer cylinder 230; wherein: the assembly (see Fig. 27) is in a first state (see Fig. 27) in which positions of the first insertion hole 110 and the second insertion hole 269 coincide with each other in a circumferential direction (see Fig. 27, in the releasing state, the insertion holes overlap with one another, the holes overlapping in the circumferential direction); and the assembly is switchable from the first state (Fig. 27) to a second state (see Fig. 29) in which positions of the first insertion hole 110 and the second insertion hole 269 are shifted in the circumferential direction (see Fig. 29, the positions of the 110 and 259 are no longer aligned, thus gripping the implantable body 126A/B/C) and the implantable body is sandwiched between the shaft and the outer cylinder.
The language, " and the implantable body is sandwiched between the shaft and the outer cylinder," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations, see also claim 1, the implantable body is claimed functionally in conjunction with the operation device, which is the elected invention of Group I, the operation device by the applicant, see restriction requirement mailed 08/13/2025. The Office submits that the device of Yeung meets the structural limitations of the claim, and is capable of the implantable body to be sandwiched between the shaft and the outer cylinder when the shaft is rotated, as there is a gap in between 230 and 101 in which the 126 can be pinched and twisted, see also Fig. 32.
Yeung does not explicitly disclose: in the first state, the implantable body extends through the first insertion hole and the second insertion hole in a direction perpendicular to the axial direction.
However, Heneveld in a similar field of invention teaches an assembly (see Figs. 1-4B) with an implantable body 125 (see Figs. 4A-4B), an outer cylinder 111 (see Figs. 1-4B) extending in an axial direction the longitudinal/axial direction of 111 (see Figs. 3-4B) with a first insertion hole 113 (see Figs. 3-4B) and a shaft 114 (see Figs. 3-4B) disposed in the lumen the lumen of 111 (see Figs. 3-4B) with a second insertion hole 115 (see Figs. 3-4B) with a first state (see Fig. 4A) in which the positions of the first insertion hole 113 and the second insertion hole 115 coincide with each other in a circumferential direction (see Fig. 4A, circumferentially, 113 and 115 are aligned). Heneveld further teaches: in the first state (see Fig. 4A), the implantable body 125 extends through the first insertion hole 113 and the second insertion hole 115 in a direction perpendicular (see annotated Fig. 4A below) to the axial direction (see annotated Fig. 4A below).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yeung to incorporate the teachings of Heneveld and teach an assembly with in the first state, the implantable body extends through the first insertion hole and the second insertion hole in a direction perpendicular to the axial direction. Motivation for such can be found in Heneveld as this allow suture to capture passively without actuation at the device handle (see [0009])to be used as a suture passer for suturing wound sites (see [0008]).
Claim 2
The combination of Yeung and Heneveld teaches: The assembly according to claim 1, see 103 rejection above. Yeung further discloses: wherein: the first insertion hole 110 and the second insertion hole 269 are formed in a groove shape opened at a distal end (see Figs. 19 and 21, the openings are a grooved, pronged shape at the distal end of 101 and 230).
Claim 3
The combination of Yeung and Heneveld teaches: The assembly according to claim 1, see 103 rejection above. Yeung further discloses: wherein: circumferential dimensions (see Fig. 27, the circumferential dimensions of 110 and 269 to allow 126A/B/C to be pushed out of 101/230) of the first insertion hole 110 and the second insertion hole 269 are larger than a diameter the diameter of 126A/B/C (see Fig. 27) of the implantable body 126A/B/C, and axial dimensions the axial dimensions of 110 and 269 are longer than the circumferential dimensions of 110 and 269 (see Fig. 21 and Fig. 23) of the first insertion hole 110 and the second insertion hole 269 are larger than the circumferential dimensions (see Fig. 21 and Fig. 23).
Claim 10
The combination of Yeung and Heneveld teaches: The assembly according to claim 1, see 103 rejection above. Yeung does not explicitly disclose: further comprising a puncture needle having an outer needle into which the outer cylinder of the operation device can be inserted in a state in which the implantable body is gripped.
However, Heneveld in a similar field of invention teaches an assembly (see Figs. 1-4B) with an implantable body 125 (see Figs. 4A-4B), an operation device 111 + 114 (see Figs. 1-4B) with an outer cylinder 111 (see Figs. 1-4B) extending in an axial direction the longitudinal/axial direction of 111 (see Figs. 3-4B) with a first insertion hole 113 (see Figs. 3-4B) and a shaft 114 (see Figs. 3-4B) disposed in the lumen the lumen of 111 (see Figs. 3-4B) with a second insertion hole 115 (see Figs. 3-4B). Heneveld further teaches: further comprising a puncture needle 108 (see Figs. 1-4B, [0056]) having an outer needle 109 (see Figs. 1-B, [0056]) into which the outer cylinder 111 of the operation device 111 + 114 can be inserted (see Figs. 3-4B, 111 is within 109) in a state (see Fig. 4B) in which the implantable body 125 is gripped (see Fig. 4B, 125 is gripped by 111 + 114).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yeung to incorporate the teachings of Heneveld and teach an assembly with a puncture needle having an outer needle into which the outer cylinder of the operation device can be inserted in a state in which the implantable body is gripped. Motivation for such can be found in Heneveld as this ease the passage of the device through tissue and then allows the user to grab a suture within the body cavity without risk of tissue being caught in the insertion holes (see [0058])
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeung in view of Heneveld as applied to claim 1 above, and further in view of Marks et al (US 20180221013 A1), herein referenced to as “Marks”.
Claim 6
The combination of Yeung and Heneveld teaches: The assembly according to claim 1, see 103 rejection above. Yeung further discloses: further comprising: an outer cylinder hub 132 (see Fig. 26, [0127]) joined to a proximal end the proximal end of 230 (see Fig. 26, [0127]) of the outer cylinder 230; and a shaft hub 130 (see Fig. 26, [0127]) that supports a proximal end the proximal end of 101 (see Fig. 26, [0127]) of the shaft 101 and is attached (see Fig. 26, [197], 130 is attached to 132 via latch 495, which limits the distance 130 and 101 can move in relation to 132, but still allows some movement) to the outer cylinder hub 132 so as to be movable in an axial direction (see [0197]), wherein the shaft hub 130 comprises: a rotation shaft portion the portion of 101 that includes 493 and is inside of 130 but outside of 230 (see Fig. 26, [0196]) that is joined to the proximal end the proximal end of 101 within 230 (see Fig. 26) of the shaft 101 and rotates integrally with the shaft 101 (see Fig. 26, the portion of 101 within 230 is integral with the portion within 132, hence it rotates together), and an operation portion 500 (see Fig. 26, [0201]) having a rotation shaft portion housing hole the lumen of 500/130, 269 (see Fig. 26, [0196]) that slidably accommodates (see [0197], 101 can move, in a limited amount, in relation to 130) the rotation shaft portion the portion of 101 that includes 493 and is inside of 130 but outside of 230 (see Fig. 26) in the axial direction (see Fig. 26).
The combination of Yeung and Heneveld does not explicitly teach: and the rotation mechanism comprises a screw mechanism that is formed by an inner wall of the rotation shaft portion housing hole and an outer periphery of the rotation shaft portion and converts axial displacement of the operation portion into rotational displacement of the rotation shaft portion.
However, Marks in a similar field of invention teaches an operation device 82 + 86 (see Fig. 10) with a rotation mechanism 82 (see Fig. 10), an operation portion 86 (see Fig. 10), a rotation shaft portion housing hole 90 (see Fig. 10) and a rotation shaft portion 80 + 82 (see Figs. 9-10, [0113]). Marks further teaches: and the rotation mechanism 82 comprises a screw mechanism 84 + 88 (see Fig. 10, [0114]) that is formed by an inner wall inner wall of 90 (see Fig. 10) of the rotation shaft portion housing hole 90 and an outer periphery 88 (see Fig. 10, [0114]) of the rotation shaft portion 80 + 82.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yeung to incorporate the teachings of Marks and teach an assembly with the rotation mechanism comprises a screw mechanism that is formed by an inner wall of the rotation shaft portion housing hole and an outer periphery of the rotation shaft portion and converts axial displacement of the operation portion into rotational displacement of the rotation shaft portion. Motivation for such can be found in Marks as this allows the prevention of the rotation shaft portion from being removed from the lumen of another portion with a single type of motion (see [0008]).
The language, " and converts axial displacement of the operation portion into rotational displacement of the rotation shaft portion," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Yeung and Marks meets the structural limitations of the claim, and is capable of using axial displacement to cause rotational displacement of the shaft, as the operational part moves axially, the threads would cause the shaft to rotate while moving axially.
Claim 7
The combination of Yeung, Heneveld, and Marks teaches: The assembly according to claim 6, see 103 rejection above. Yeung further discloses: further comprising: a rotation restricting portion 494 (see Fig. 26, [0197]) that restricts a rotation range of the rotation shaft portion the portion of 101 that includes 493 and is inside of 130 but outside of 230.
The language, " that restricts a rotation range of the rotation shaft portion," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Yeung and Marks meets the structural limitations of the claim, and is capable of the portion 494 restricting a rotational range, as 495 is connected to 130 and 132, via 494, and as 130 rotates, 494 would wind up, until it can longer rotate due to the limitations of the length of 494, hence restricting a rotation range.
Claim 8
The combination of Yeung, Heneveld, and Marks teaches: The assembly according to claim 7, see 103 rejection above. Yeung further discloses: wherein: the rotation restricting portion 494 comprises: a rotation restricting projection 494 (see Fig. 26, [0197], 494 projects from 132, hence it is a projection) located on the outer cylinder hub 132.
The combination of Yeung and Heneveld does not explicitly teach: a first blade projecting outward from the rotation shaft portion.
However, Marks in a similar field of invention teaches an operation device 82 + 86 (see Fig. 10) with a rotation mechanism 82 (see Fig. 10), an operation portion 86 (see Fig. 10), a rotation shaft portion housing hole 90 (see Fig. 10) and a rotation shaft portion 80 + 82 (see Figs. 9-10, [0113]). Marks further teaches: a first blade projecting 92 (see Fig. 10, [0114]) outward from the rotation shaft portion 82 + 80 (see Fig. 10).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yeung to incorporate the teachings of Marks and teach an assembly with a first blade projecting outward from the rotation shaft portion. Motivation for such can be found in Marks as this allows creates a spring force that keeps the rotation shaft portion locked when necessary (see [0114]).
Claim 9
The combination of Yeung, Heneveld, and Marks teaches: The assembly according to claim 6, see 103 rejection above. The combination of Yeung and Heneveld does not explicitly teach: wherein: the rotation shaft portion comprises a second blade projecting outward; and the outer cylinder hub comprises a wall that abuts on the second blade from the axial direction to inhibit axial displacement of the rotation shaft portion with respect to the outer cylinder hub.
However, Marks in a similar field of invention teaches an operation device 200 + 202 (see Fig. 22) with a rotation shaft portion 206 + 208 (see Fig. 22) and an outer cylinder hub 202 (see Fig. 22) with an outer cylinder 212 (see Fig. 22). Marks further teaches: wherein: the rotation shaft portion 206 + 208 comprises a second blade 222 (see Fig. 22, [0124]) projecting outward (see Fig. 22, 222 projects outwards from 208); and the outer cylinder hub 202 comprises a wall proximal wall of 202 (see Fig. 22) that abuts on the second blade 222 from the axial direction 222 abuts on the proximal wall of 202 to prevent further distal axial displacement in relation to 202 (see Fig. 22) to inhibit axial displacement of the rotation shaft portion with respect to the outer cylinder hub.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yeung to incorporate the teachings of Marks and teach an assembly with the rotation shaft portion comprises a second blade projecting outward; and the outer cylinder hub comprises a wall that abuts on the second blade from the axial direction to inhibit axial displacement of the rotation shaft portion with respect to the outer cylinder hub. Motivation for such can be found in Marks this externally projecting tab/blade can be actuated to allow for a quick release feature (see [0124]).
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771