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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 29th, 2026 has been entered.
Response to Amendment
Claims filed on January 29th, 2026 have been entered. Claims 1 and 3- 24 are pending in the application. The amendment to claims 3, 6, and 7 have overcome the previous claim objections. Claims 11- 17 remain withdrawn for being drawn to an unelected invention.
Election/Restrictions
Claims 23 and 24 are withdrawn from consideration based on the restriction issued March 25th, 2025. Applicant elected Group I, directed to a suture anchor system and a suturing kit, without traverse. Therefore, claims 23 and 24, directed to a method are withdrawn for being drawn to an unelected invention.
Claim Objections
Claims 1, 3- 10, and 18- 22 are objected to because of the following informalities:
Claim 1, Lines 7-9 states “tissue. .”, it is suggested to change this to “tissue.”.
Claims 3- 10 and 20- 22 are objected to for being dependent on or from objected claim 1.
Claim 18, Lines 12- 13 states “needle. .”, it is suggested to change this to “needle.”.
Claims 19 is objected to for being dependent on or from objected claim 18.
Claim 22, Line 1 states “rigid tap”, it is suggested to change this to “rigid tab”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation “allow the first suture anchor to be bent, via the rigid tab, toward the second suture in response to a force applied by the suture”. It is unclear if applicant is intending to recite a second suture, or if applicant is intending to recite the second suture anchor, which has support within claim 1. For purposes of examination, this limitation is herein interpreted as “allow the first suture anchor to be bent, via the rigid tab, toward the second suture anchor in response to a force applied by the suture”.
Claim 22 recites the limitation “wherein separation of the first suture anchor from the second suture anchor is achieved by breaking the second rigid tab”. It is unclear how the separation of the first suture anchor and the second suture anchor is achieved by breaking the second rigid tab, when the first rigid tab is established within claim 1 as connecting the first suture anchor and the second suture anchor, while the second rigid tab is established in claim 22 as connecting the pusher and the second suture anchor. For purposes of examination, this limitation is herein interpreted as “wherein separation of the pusher from the second suture anchor is achieved by breaking the second rigid tab” or “wherein separation of the first suture anchor from the second suture anchor is achieved by breaking the first rigid tab”, as both interpretations have support within the claims.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Regarding claim 10, it is noted that no prior art reads on the limitation of claim 10.
The rejection of claims 3-8 and 18- 22 under 35 U.S.C. 102(a)(1) over Vargas (US 2015/0250470) has been withdrawn in light of applicant’s amendments; specifically Vargas does not anticipate claims 3-8 and 18-22 with one embodiment.
Claim(s) 1 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vargas (U.S. 2015/0250470).
Regarding claim 1, Vargas teaches a suture anchor system (abstract)(Figs. 8A-8D)(Paragraphs 0104- 0105) comprising:
A rigid one- piece structure (suture anchors 201a and 201b, connectors 202)(As Vargas teaches in Paragraph 0104 that suture anchors connected through a frangible connection can be formed from a single piece of material, such as stainless steel, then the suture anchors form a rigid one-piece structure.) comprising:
A first suture anchor (201a); and
A second suture anchor (201a) frangibly connected to the first suture anchor (Paragraphs 0104- 0105).
Regarding the frangible connection being via a rigid tab, the rigid tab being configured to break when force is exerted thereon, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue, in Paragraphs 0104- 0105, Vargas teaches that the frangible connectors 202 has a force enacted upon it where it experiences strain until the point of fracture. Therefore the rigid tab, which is herein interpreted as the frangible connector 202, breaks when force is exerted on it and allows the first suture anchor to separate from the second suture anchor for deployment.
Regarding claim 20, Vargas teaches the suture anchor system of claim 1 as discussed above.
Vargas further teaches a notch that extends between the first suture anchor and the second suture anchor, wherein a nadir of the notch is aligned with the rigid tab (see annotated Figs. 8A and 8B below).
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Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Regarding claim 10, it is noted that no prior art reads on the limitation of claim 10.
Claim(s) 3- 9 and 18- 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vargas (U.S. 2015/0250470) as evidenced by Merriam- Webster Dictionary.
Regarding claim 3, Vargas teaches the suture anchor system of claim 1 as discussed above.
Vargas does not teach in the current embodiment a suture connected to the first and second suture anchors.
Vargas teaches in a second embodiment, a structure (suture anchors 270, 280, pushrod 250)(Paragraph 0118) comprising: a first suture anchor (270), a second suture anchor (280) frangibly connected to the first suture anchor (Paragraphs 0104- 0105 and 0117), and a suture (275) connected to the first and second suture anchors (Paragraphs 0116 and 0119).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first embodiment as taught by Vargas to have a suture connected to the first and second suture anchors as taught by Vargas since Vargas teaches that the suture provides tension and compresses the tissue walls when the suture anchors are deployed and Vargas teaches that a way to deliver the frangible assembly of suture anchors into a patient’s tissue (Paragraphs 0117- 0119).
Regarding claim 4, Vargas teaches the suture anchor system of claim 1 as discussed above.
Vargas does not teach in the current embodiment a hypodermic needle.
Vargas teaches in a second embodiment, a structure (suture anchors 270, 280, pushrod 250)(Paragraph 0118) comprising: a first suture anchor (270), a second suture anchor (280) frangibly connected to the first suture anchor (Paragraphs 0104- 0105 and 0117), and a hypodermic needle (delivery needle 210)(A hypodermic needle is interpreted as “a hollow needle used to inject solutions subcutaneously”. Vargas teaches in Paragraph 0118 that the needle holds a suture anchor, a pushrod, and other features, which requires for the needle to be hollow. Vargas also shows in Fig. 2I that the needle delivers the suture anchor subcutaneously (Paragraphs 0108, 0118 and 0119), which accomplishes the function of the hypodermic needle as claimed in claim 4. Therefore, Vargas teaches a hypodermic needle.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first embodiment as taught by Vargas to comprise a hypodermic needle as taught by Vargas, as Vargas teaches that the first embodiment is a frangible assembly of suture anchors (Paragraph 0104) and Vargas teaches that a needle provides a way to deliver the frangible assembly of suture anchors into a patient’s tissue (Paragraphs 0117- 0119).
Regarding claim 5, Vargas makes obvious the suture anchor system of claim 4 as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first embodiment as taught by Vargas to comprise a hypodermic needle as taught by Vargas, as Vargas teaches that the first embodiment is a frangible assembly of suture anchors (Paragraph 0104) and Vargas teaches that a needle provides a way to deliver the frangible assembly of suture anchors into a patient’s tissue (Paragraphs 0117- 0119).
The combination further teaches wherein the rigid one- piece structure is configured to be positioned inside the hollow hypodermic needle (see annotated Fig. 2I below).
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Regarding claim 6, Vargas teaches the suture anchor system of claim 1 as discussed above.
Vargas does not teach in the current embodiment wherein the first and second suture anchors are configured to be sequentially deployed into the subject’s tissue.
Vargas teaches in a second embodiment, a structure (suture anchors 270, 280, pushrod 250)(Paragraph 0118) comprising: a first suture anchor (270) and a second suture anchor (280) frangibly connected to the first suture anchor (Paragraphs 0104- 0105 and 0117), wherein the first and second suture anchors are configured to be sequentially deployed into the subject’s tissue (Paragraphs 0118 and 0119).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first embodiment as taught by Vargas to have the first and second suture anchors be configured to be sequentially deployed as taught by the second embodiment of Vargas, as Vargas teaches that the first embodiment is a frangible assembly of suture anchors (Paragraph 0104) and Vargas teaches a way to deliver the frangible assembly of suture anchors into a patient’s tissue (Paragraphs 0117- 0119).
Regarding claim 7, Vargas makes obvious the suture anchor system of claim 6 as discussed above.
The combination does not teach wherein the first and second suture anchors house a suture that is configured to cooperate with the first and second suture anchors once deployed in the subject’s tissue to pull and/or hold the subject’s tissue together.
Vargas teaches in a second embodiment, a structure (suture anchors 270, 280, pushrod 250)(Paragraph 0118) comprising: a first suture anchor (270) and a second suture anchor (280) frangibly connected to the first suture anchor (Paragraphs 0104- 0105 and 0117), wherein the first and second suture anchors are configured to be sequentially deployed into the subject’s tissue (Paragraphs 0118 and 0119) and wherein the first and second suture anchors house a suture (275)(see Fig. 2J) that is configured to cooperate with the first and second suture anchors once deployed in the subject’s tissue to pull and/or hold the subject’s tissue together (Paragraph 0119).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first embodiment as taught by Vargas to have the first and second suture anchors be configured to be sequentially deployed as taught by the second embodiment of Vargas as Vargas teaches that the second embodiment is an example of delivery a frangible assembly of suture anchors (Paragraphs 0117- 0119) and the first embodiment is a frangible assembly of suture anchors (Paragraph 0104) and since Vargas teaches that the suture provides tension and compresses the tissue walls when the suture anchors are deployed and Vargas provides a way of delivering a frangible assembly of suture anchors (Paragraphs 0117- 0119).
Regarding claim 8, Vargas teaches the suture anchor system of claim 1 as discussed above.
Vargas does not teach in the current embodiment wherein the suture anchor system is configured to insert the first and second suture anchors into the subject’s tissue as needed to suture an opening in the subject’s tissue.
Vargas teaches in a second embodiment, a structure (suture anchors 270, 280, pushrod 250)(Paragraph 0118) comprising: a first suture anchor (270) and a second suture anchor (280) frangibly connected to the first suture anchor (Paragraphs 0104- 0105 and 0117), wherein the suture anchor system is configured to insert the first and second suture anchors into a subject’s tissue as needed to suture an opening in the subject’s tissue (Paragraph 0119).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first embodiment as taught by Vargas to have the first and second suture anchors be configured to be sequentially deployed as taught by the second embodiment of Vargas, as Vargas teaches that the first embodiment is a frangible assembly of suture anchors (Paragraph 0104) and Vargas teaches a way to deliver the frangible assembly of suture anchors into a patient’s tissue (Paragraphs 0117- 0119).
Regarding claim 9, Vargas teaches the suture anchor system of claim 1 as discussed above.
Vargas does not teach in the current embodiment the system comprising: a hypodermic needle; and a handle configured to house a portion of the hypodermic needle and control deployment of the first and second anchors into the subject’s tissue.
Vargas teaches in a second embodiment, a structure (suture anchors 270, 280, pushrod 250)(Paragraph 0118) comprising: a first suture anchor (270), a second suture anchor (280) frangibly connected to the first suture anchor (Paragraphs 0104- 0105 and 0117), and a hypodermic needle (delivery needle 210)(A hypodermic needle is interpreted as “a hollow needle used to inject solutions subcutaneously”. Vargas teaches in Paragraph 0118 that the needle holds a suture anchor, a pushrod, and other features, which requires for the needle to be hollow. Vargas also shows in Fig. 2I that the needle delivers the suture anchor subcutaneously (Paragraphs 0108, 0118 and 0119), which accomplishes the function of the hypodermic needle as claimed in claim 4. Therefore, Vargas teaches a hypodermic needle.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first embodiment as taught by Vargas to comprise a hypodermic needle as taught by Vargas, as Vargas teaches that the first embodiment is a frangible assembly of suture anchors (Paragraph 0104) and Vargas teaches that a needle provides a way to deliver the frangible assembly of suture anchors into a patient’s tissue (Paragraphs 0117- 0119).
Vargas is silent in the current embodiment to a handle, wherein the handle is configured to house a portion of the pusher and a portion of the hypodermic needle.
Vargas teaches in a different embodiment, a similar suture anchor system (1100)(Fig. 14)(Paragraph 0144) comprising: a hypodermic needle (1110)(Paragraph 0144), an assembly of suture anchors (1140, pushrod 1120) comprising suture anchors (1140) and a pusher (pushrod 1120), and a handle (1150, 1125, 1116) configured to house the pusher (pushrod 1120) and the hypodermic needle (1110)(Paragraph 0146, Paragraph 0144, and Paragraph 0148).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the suture anchor system as taught by the first embodiment of Vargas to have a handle as taught by the second embodiment of Vargas, since Vargas teaches that a handle enables manual actuation of the suture anchor system and to provides a way to deliver the suture anchors into a patient’s tissue (Paragraphs 0144- 0146).
Regarding claim 18, Vargas teaches a suturing kit (abstract)(Figs. 2I- 2J) comprising:
A hypodermic needle (delivery needle 210)(A hypodermic needle is interpreted as “a hollow needle used to inject solutions subcutaneously”. Vargas teaches in Paragraph 0118 that the needle holds a suture anchor, a pushrod, and other features, which requires for the needle to be hollow. Vargas also shows in Fig. 2I that the needle delivers the suture anchor subcutaneously (Paragraphs 0108, 0118 and 0119), which accomplishes the function of the hypodermic needle as claimed in claim 4. Therefore, Vargas teaches a hypodermic needle.),
A structure (suture anchors 270, 280, pushrod 250)(Paragraph 0118) positioned within a lumen of the hypodermic needle (see annotated Fig. 2I below), the rigid one- piece structure comprising:
A first suture anchor (270);
A second suture anchor (280) frangibly connected to the first suture anchor (Paragraph 0117); and
A suture (275), wherein a first portion of the suture is in communication with the first suture anchor and the second suture anchor and a second portion of the suture extends through the lumen of the hypodermic needle (see annotated Figs. 2I and 2J below)(When the suture anchors and the suture are disposed within the needle, then a second portion (see annotated Fig. 2J below) would extend through the lumen of the hypodermic needle.).
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Vargas does not teach in the current embodiment a second suture anchor frangibly connected to the first suture anchor via a rigid tab, the rigid tab being configured to break when force is exerted thereon, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue.
Vargas teaches a suture anchor system (abstract)(Figs. 8A-8D)(Paragraphs 0104- 0105) comprising: a rigid one- piece structure (suture anchors 201a and 201b, connectors 202)(As Vargas teaches in Paragraph 0104 that suture anchors connected through a frangible connection can be formed from a single piece of material, such as stainless steel, then the suture anchors form a rigid one-piece structure.) comprising: a first suture anchor (201a); and a second suture anchor (201a) frangibly connected to the first suture anchor (Paragraphs 0104- 0105).
Regarding the frangible connection being via a rigid tab, the rigid tab being configured to break when force is exerted thereon, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue, in Paragraphs 0104- 0105, Vargas teaches that the frangible connectors 202 has a force enacted upon it where it experiences strain until the point of fracture. Therefore the rigid tab, which is herein interpreted as the frangible connector 202, breaks when force is exerted on it and allows the first suture anchor to separate from the second suture anchor for deployment.
It would have been obvious to one of ordinary skill in the art to modify the first embodiment of Vargas to have a rigid tab as taught by the second embodiment of Vargas, as Vargas teaches that the first embodiment has a frangible connection between the suture anchors and the pusher (Paragraph 0119) and Vargas teaches in the second embodiment an example of a frangible connection.
Regarding claim 19, Vargas makes obvious the suture anchor system of claim 4 as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first embodiment as taught by Vargas to comprise a hypodermic needle as taught by Vargas, as Vargas teaches that the first embodiment is a frangible assembly of suture anchors (Paragraph 0104) and Vargas teaches that a needle provides a way to deliver the frangible assembly of suture anchors into a patient’s tissue (Paragraphs 0117- 0119).
Vargas further teaches wherein the hypodermic needle is an endoscopic needle (In Paragraph 0011, Vargas teaches that the delivery system “may fit within the instrument channel or lumen of an endoscope”, therefore the needle, which is a part of the delivery system, is considered an endoscopic needle.).
Regarding claim 21, Vargas teaches the suture anchor system of claim 20 as discussed above.
Vargas does not teach in the current embodiment a suture in communication with the first and second suture anchors, wherein the notch is configured to allow the first suture anchor to be bent, via the rigid tab, toward the second suture anchor in response to a force applied by the suture, thereby allowing for sufficient force to be applied to the rigid tab to break it.
Vargas teaches in a second embodiment, a structure (suture anchors 270, 280, pushrod 250)(Paragraph 0118) comprising: a first suture anchor (270), a second suture anchor (280) frangibly connected to the first suture anchor (Paragraphs 0104- 0105 and 0117), and a suture (275) connected to the first and second suture anchors (Paragraphs 0116 and 0119). Vargas further teaches a suture (275) in communication with the first and second suture anchors (see annotated Fig 2J below)(Paragraph 0119).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first embodiment as taught by Vargas to have a suture connected to the first and second suture anchors as taught by Vargas since Vargas teaches that the suture provides tension and compresses the tissue walls when the suture anchors are deployed and Vargas teaches that a way to deliver the frangible assembly of suture anchors into a patient’s tissue (Paragraphs 0117- 0119).
Regarding wherein the notch is configured to allow the first suture anchor to be bent, via the rigid tab, toward the second suture anchor in response to a force applied by the suture, thereby allowing for sufficient force to be applied to the rigid tab to break it, for the notch being configured to allow the first suture anchor to be bent, see annotated Fig. 8D below. For this occurring in response to a force applied by the suture, thereby allowing for a sufficient force to be applied to the rigid tab to break it, as Vargas teaches that the suture is attached to the first suture anchor and the second suture anchor (Paragraph 0117), and that the frangible connector has a force that is enacted upon it that causes it to break (Paragraphs 0104 and 0105), when the first suture anchor is applied to the patient’s tissue, and then the device is pulled back, a force is enacted upon the suture and then the suture applies said force to the anchors and the rigid tab. As Vargas teaches that the anchors are separated and then applied (Paragraphs 0118 and 0119), then the force applied to the rigid is sufficient to break it.
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Regarding claim 22, Vargas teaches the suture anchor system of claim 1 as discussed above.
Vargas does not teaches in the current embodiment wherein the rigid tab is a first rigid tab, the system further comprising: a pusher frangibly connected to a second end of the second suture anchor via a second rigid tab, wherein separation of the pusher from the second suture anchor is achieved by breaking the second rigid tab.
Vargas teaches in a second embodiment, a structure (suture anchors 270, 280, pushrod 250)(Paragraph 0118) comprising: a first suture anchor (270) and a second suture anchor (280) frangibly connected to the first suture anchor (Paragraphs 0104- 0105 and 0117), wherein the rigid tab is a first rigid tab, the system further comprising: a pusher (pushrod 250) frangibly connected to a second end of the second suture anchor (Paragraphs 0104- 0105 and 0117)(see annotated Fig. 2I below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system as taught by the first embodiment of Vargas to have a pusher that is frangibly connected to the suture anchors as taught by the second embodiment of Vargas, since Vargas teaches that the pusher is a way of delivering the first and second suture anchors and that their connection allows for the anchors pairs to be “advanced or withdrawn as a single, more controllable unit” (Paragraph 0118 and 0119).
Regarding the frangible connection occurring via a second rigid tab, wherein separation of the pusher from the second suture anchor is achieved by breaking the second rigid tab, in Paragraph 0117, Vargas teaches that the first and second suture anchors and the pusher are coupled through frangible connectors, which are described in further detail in Paragraphs 0104- 0105. In Paragraphs 0104- 0105, Vargas teaches that the frangible connectors 202 has a force enacted upon it where it experiences strain until the point of fracture. Therefore the second rigid tab, which is herein interpreted as the frangible connector 202 between the pusher and the second anchor, breaks when force is exerted on it and achieves separation of the pusher from the second suture anchor.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
The nonstatutory double patenting rejection of claims 1, 4-5, and 8- 10 over claims 1- 9 of copending Application No. 18/643,191 (‘191) in view of Vargas (U.S. 2015/0250470) has been withdrawn in light of the amendment to claim 1. It is noted that this rejection has been withdrawn as ‘191 now teaches the limitations of the claims fully.
Claims 1, 3- 5, and 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,178,424 (‘424) in view of Vargas (U.S. 2015/0250470).
Regarding claim 1, ‘424 claims a suture anchor system (claim 1 of ‘424), comprising: a rigid one- piece structure (the anchor strip of linear disposition formed from a single continuous section of material of claim 1 of ‘424), and plurality of connected suture anchors (A plurality of suture anchors as claimed in claim 1 of ‘424).
‘424 does not claim a rigid one-piece structure or wherein a second suture anchor frangibly connected to the first suture anchor via a rigid tab, the rigid tab being configured to break when force is exerted thereon, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue.
Vargas teaches a suture anchor system (abstract)(Figs. 8A-8D)(Paragraphs 0104- 0105) comprising: a rigid one- piece structure (suture anchors 201a and 201b, connectors 202)(As Vargas teaches in Paragraph 0104 that suture anchors connected through a frangible connection can be formed from a single piece of material, such as stainless steel, then the suture anchors form a rigid one-piece structure.) comprising: a first suture anchor (201a); and a second suture anchor (201a) frangibly connected to the first suture anchor (Paragraphs 0104- 0105).
Regarding the frangible connection being via a rigid tab, the rigid tab being configured to break when force is exerted thereon, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue, in Paragraphs 0104- 0105, Vargas teaches that the frangible connectors 202 has a force enacted upon it where it experiences strain until the point of fracture. Therefore the rigid tab, which is herein interpreted as the frangible connector 202, breaks when force is exerted on it and allows the first suture anchor to separate from the second suture anchor for deployment.
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the connection between a first suture anchor and a second suture anchor of the plurality of suture anchors as claimed by ‘424 to have the frangibly connection as taught by Vargas, since Vargas teaches that it is a known connection type of suture anchors (Paragraphs 0104 and 0105).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plurality of suture anchors as claimed by ‘424 to be made of a rigid material as taught by Vargas, since Vargas teaches that it is a known material to be used in suture anchors (Paragraph 0104).
Regarding claim 3, ‘424 and Vargas claim the suture anchor system of claim 1.
The combination further claims wherein a suture is connected to the first and second suture anchors (claim 1 of ‘424).
Regarding claim 4, ‘424 and Vargas claim the suture anchor system of claim 1.
‘424 further claims a hypodermic needle (claim 1 of ‘424).
Regarding claim 5, ‘424 and Vargas claim the suture anchor system of claim 4.
As discussed above, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the connection between a first suture anchor and a second suture anchor of the plurality of suture anchors as claimed by ‘424 to have the frangibly connection as taught by Vargas, since Vargas teaches that it is a known connection type of suture anchors (Paragraphs 0104 and 0105).
‘424 further claims wherein the rigid one-piece structure is configured to be positioned inside the hollow hypodermic needle (the plurality of sutures and the drive rod)(Claim 3 of ‘424, which depends on claim 2 of ‘424).
Regarding claim 8, ‘424 and Vargas claim the suture anchor system of claim 1.
‘424 further claims wherein the suture anchor system is configured to insert the first and second suture anchors into the subject’s tissue as needed to suture an opening in the subject’s tissue (Claim 7 of ‘424, which depends on claim 6 of ‘424).
Regarding claim 9, ‘424 and Vargas claim the suture anchor system of claim 1.
‘424 further claims a hypodermic needle (claim 1 of ‘424), and a handle (claim 1 of ‘424), wherein the handle is configured to house a portion of the hypodermic needle and control deployment of the first and second anchors into the subject’s tissue (Claim 8 of ‘424, as discussed above, the drive hub of ‘424 is considered the pusher. As claim 1 of ‘424 claims that the handle is configured to allow manual operation of the suture anchor system, then it would be capable of controlling deployment of the first and second anchors into the subject’s tissue.).
Regarding claim 10, ‘424 and Vargas claim the suture anchor system of claim 9.
‘424 further claims wherein a ball plunger protrudes from the handle allowing manual operation of the suture anchor system (Claim 1 of ‘424).
Claims 1, 4- 5, and 8- 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, and 9 of copending Application No. 18/643,191 (‘191).
Regarding claim 1, ‘191 claims a suture anchor system (claim 1 of ‘191) comprising: a single unitary structure (frangibly assembled plurality of suture anchors is a single monolithically manufactured structure of claim 1 of ‘191) comprising: a plurality of suture anchors, each suture anchor being connected to an adjacent suture anchor via a tab and separation of a first suture anchor of the two adjacent suture anchors from a second suture anchor of the two adjacent suture anchors is achieved by breaking the tab (claim 1 of ‘191).
Regarding claim 4, ‘191 claims the suture anchor system of claim 1.
‘191further claims a hypodermic needle (Claim 1 of ‘191). Regarding claim 5, ‘191 claims the suture anchor system of claim 4.
‘191 further claims wherein the single unitary structure is configured to be positioned inside the hollow hypodermic needle (Claim 3 of ‘191, which depends on claim 2 of ‘191).
Regarding claim 8, ‘191 claims the suture anchor system of claim 1.
‘191 further claims wherein the suture anchor system is configured to insert the plurality of suture anchors into the subject’s tissue as needed to suture an opening in the subject’s tissue (Claim 7 of ‘191, which depends on claim 1 of ‘191).
Regarding claim 9, ‘191 claims the suture anchor system of claim 1.
‘191 further claims a hypodermic needle (claim 1 of ‘191), and a handle (claim 1 of ‘191) configured to house a portion of the hypodermic needle (Claim 1 of ‘191) and control deployment of the first and second anchors into the subject’s tissue (claim 9 of ‘191, which depends from claim 1 of ‘191).
Regarding claim 10, ‘191 claims the suture anchor system of claim 9.
‘191 further claims wherein a ball plunger protrudes from the handle allowing manual operation of the suture anchor system (Claim 9 of ‘191, which depends on claim 1 of ‘191).
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claim 10 is rejected currently under non-statutory double patenting. If this issue is overcome and the claim is rewritten in independent form including all of the limitations of the base claim and any intervening claims, it would be allowable.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Vargas (U.S. 2015/0250470). Vargas teaches a suture anchor system (1100) comprising: a hypodermic needle (1100), a plurality of suture anchors (1140), a suture (1130) connected to the plurality of suture anchors (Paragraph 0144), a drive hub (1121, 1122) and a handle (1116, 1125, 1150).
However, the prior art does not teach or suggest a ball plunger that protrudes from the handle and allows manual operation of the suture anchor system. Furthermore, even though there exists a prior art reference, Livneh U.S. 2008/0015566, that teaches a ball plunger protruding from a handle of a surgical system, there is no motivation to combine Vargas and Livneh, due to how the handle of Vargas is configured.
Response to Arguments
Applicant's arguments filed January 29th, 2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument, see Page 7, that Vargas does not disclose a suture anchor system comprising a rigid one- piece structure, this argument has been fully considered but is not persuasive. As discussed above, Vargas teaches a rigid one- piece structure (suture anchors 270, 280, pushrod 250), as Vargas teaches in Paragraph 0104 that suture anchors connected through a frangible connection can be formed from a single piece of material, such as stainless steel, and then in Paragraph 0118 teaches that the anchors and the pushrod are connected through frangible connectors and form a “single, more controllable unit”, then the suture anchors and the pushrod form a rigid one-piece structure.
Regarding applicant’s argument, see Pages 7- 8, that Vargas does not disclose a second suture anchor frangibly connected to the first suture anchor via a rigid tab, the rigid tab being configured to break when force is exerted thereon, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue, this argument has been fully considered but is not persuasive. As discussed above, Vargas teaches a second suture anchor (280) frangibly connected to the first suture anchor (Paragraphs 0104- 0105 and 0117). Regarding the frangible connection being via a rigid tab, the rigid tab being configured to break when force is exerted thereon, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue, in Paragraph 0117, Vargas teaches that the first and second suture anchors are coupled through a frangible connector, which is described in further detail in Paragraphs 0104- 0105. In Paragraphs 0104- 0105, Vargas teaches that the frangible connectors 202 has a force enacted upon it where it experiences strain until the point of fracture. Therefore the rigid tab, which is herein interpreted as the frangible connector 202, breaks when force is exerted on it and allows the first suture anchor to separate from the second suture anchor for deployment.
Regarding applicant’s argument, see Pages 8- 10, that the nonstatutory double patenting rejection as being unpatentable over claims 1- 8 of US Patent No. 12,178,424 (‘424) in view of Vargas is different from amended claim 1 of the present applicant, this argument has been fully considered but is not persuasive. As ‘424 claims the claim limitations of the present application, there is no distinction between them in view of Vargas, and therefore the nonstatutory double patenting rejection remains in place. All that is required of ‘424 for a nonstatutory double patenting rejection is that it claims the limitations within the application, even if there are extra limitations within claim 1 of ‘424.
Conclusion
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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