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
The claims filed on July 15th, 2026 have been entered. Claims 1 and 3- 24 are pending in the application. Claims 11- 17 and 23- 24 remain withdrawn for being drawn to an unelected invention. The amendments to the claims overcome the previous claim objections and the previous 112(b) rejection.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1 and 20 under 35 U.S.C. 102(a)(1) over Vargas (US 20115/0250470) has been withdrawn in light of applicant’s amendments; specifically Vargas does not anticipate claim 1 with one embodiment.
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) 1, 3-9 and 18- 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vagas (US 2015/0250470) as evidenced by Merriam- Webster Dictionary.
Regarding claims 1 and 3, 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).
Vargas does not teach in the current embodiment a suture in communication with the first and second suture anchors, wherein the rigid tab is configured to break in response to a force applied by the suture that bends the first suture anchor toward the second suture anchor, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue, or wherein the suture is 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 in communication with and 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 rigid tab is configured to break in response to a force applied by the suture that bends the first suture anchor toward the second suture anchor, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue, as Vargas teaches in Paragraph 0105 that tension on the suture causes the connection to break and demonstrates that the first suture anchor bends toward the second suture anchor during this tension in Figure 8D), Vargas teaches that the rigid tab breaks in response to this force and allows for the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue.
Regarding claim 4, Vargas makes obvious 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 makes obvious 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.
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 have a suture in communication with and 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).
The combination further teaches wherein the first and second suture anchors house the 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).
Regarding claim 8, Vargas makes obvious 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 makes obvious 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 rigid one- piece 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, wherein the rigid tab is configured to break in response to a force applied by the suture that bends the first suture anchor toward the second suture anchor, thereby allowing the first suture anchor to separate from the second suture anchor.
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) via a rigid tab (frangible connector 202).
Regarding wherein the rigid tab is configured to break in response to a force applied by the suture that bends the first suture anchor toward the second suture anchor, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue, as Vargas teaches in Paragraph 0105 that tension on the suture causes the connection to break and demonstrates that the first suture anchor bends toward the second suture anchor during this tension in Figure 8D), Vargas teaches that the rigid tab breaks in response to this force and allows for the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue.
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 20, Vargas makes obvious 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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Regarding claim 21, Vargas makes obvious the suture anchor system of claim 20 as discussed above.
Vargas does not teach in the current embodiment 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 makes obvious the suture anchor system of claim 1 as discussed above.
Vargas does not teach 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 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) has been withdrawn in light of applicant’s amendments; specifically ‘191 does not claim a suture in communication with the first and second suture anchors, wherein the rigid tab is configured to break in response to a force applied by the suture that bends the first suture anchor toward the second suture anchor, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue.
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), a suture in communication with the anchors (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, wherein a second suture anchor frangibly connected to the first suture anchor via a rigid tab; and wherein the rigid tab is configured to break in response to a force applied by the suture that bends the first suture anchor toward the second suture anchor, 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) through a rigid tab (frangible connector 202).
Regarding wherein the rigid tab is configured to break in response to a force applied by the suture that bends the first suture anchor toward the second suture anchor, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue, as Vargas teaches in Paragraph 0105 that tension on the suture causes the connection to break and demonstrates that the first suture anchor bends toward the second suture anchor during this tension in Figure 8D), Vargas teaches that the rigid tab breaks in response to this force and allows for the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue.
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 the 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).
Claim 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 31 of copending Application No. 18/643,191 (‘191).
Regarding claims 1 and 3, ‘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); a suture in communication with the first and second suture anchors, wherein the rigid tab is configured to break in response to a force applied by the suture that bends the first suture anchor toward the second suture anchor, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue and wherein the suture is connected to the first and second suture anchors (claim 31 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 July 15th, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments, see Pages 8-10, regarding that Vargas does not teach a rigid tab, this argument has been fully considered but is not persuasive. As discussed above, Vargas teaches that a frangible connector 202 connects a first and second suture anchor and in Paragraph 0104 that the suture anchors connected through a frangible connection are formed from a single piece of material, such as stainless steel, so therefore the frangible connector is rigid. Vargas also teaches in Paragraph 0104 that the frangible connectors are able to mechanically strain to the point of fracture, thereby causing the rigid tab to break. Furthermore, regarding wherein the rigid tab is configured to break in response to a force applied by the suture that bends the first suture anchor toward the second suture anchor, thereby allowing the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue, as Vargas teaches in Paragraph 0105 that tension on the suture causes the connection to break and demonstrates that the first suture anchor bends toward the second suture anchor during this tension in Figure 8D, Vargas teaches that the rigid tab breaks in response to this force and allows for the first suture anchor to separate from the second suture anchor for deployment in a subject’s tissue.
Applicant’s arguments regarding the double patenting rejection of 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) have been fully considered but are moot as the rejection has been withdrawn in light of applicant’s amendments.
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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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
