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 January 29th, 2026 have been entered. Claims 1-4, 7, 9, 17- 21, 24, and 28-35 are pending in the application. The amendment to claims 7, 9, and 24 overcome the previous 35 U.S.C. 112(b) rejections.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 30 and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claim 30 states “wherein the first angle is approximately 45 degrees and the second angle is approximately 45 degrees”, there is nothing in the original disclosure that mentions a first angle or second angle being approximately 45 degrees, as the figures show only a first angle and a second angle without a value, and there is no support within the specification for 45 degrees. So, a person of ordinary skill in the art would not consider applicant to have been in possession of this feature at the time of filing. Claim 33 is rejected for the same new matter issue regarding the first and second angle being approximately 45 degrees.
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 31 and 35 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 31, Line 4 states “to pull the first suture toward the second suture, thereby breaking the tab”, it is unclear if applicant is intending to establish a first suture and a second suture, or if applicant is intending to refer to the first suture anchor and the second suture anchor established within claim 1. For purposes of examination, this limitation is herein interpreted as “to pull the first suture anchor toward the second suture anchor, thereby breaking the tab”. Claim 35 is rejected for a similar reason regarding the first suture and the second suture.
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.
Examiner’s Note: The limitation “frangibly assembled plurality of suture anchors” is herein considered to be what is set forth in applicant’s specification, Paragraphs 0063 and 0064, wherein the suture anchors are formed on an anchor strip and can be separated during use.
The rejection of claims 26 and 27 under 35 U.S.C. 103 as being unpatentable over Vargas (US 2015/0250470) in view of Makower et al. (WO 99/21490) has been withdrawn as claims 26 and 27 have been canceled.
Regarding claim 9, it is noted that no prior art reads on the limitation of claim 9.
Claim(s) 1-4, 7, 17- 21, 24, and 28-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vargas (US 2015/0250470).
Regarding claim 1, Vargas teaches a suture anchor system (Fig. 14, Paragraph 0144), comprising:
A hypodermic needle (needle 1110)(According to dictionary.com, a hypodermic needle is defined as “a hollow needle used to inject solutions subcutaneously”. Vargas teaches in Paragraph 0144 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. 14 that the needle delivers the suture anchor subcutaneously (see annotated Fig. 14 below), which accomplishes the function of the hypodermic needle as claimed in claim 1. Therefore, Vargas teaches a hypodermic needle.);
A plurality of suture anchors (suture anchors 1140)(Paragraph 0144)(Fig. 14);
A suture (1130)(Fig. 14) connected to the plurality of suture anchors (Paragraph 0144);
A drive hub (pushrod slider 1121, pushrod pawl 1122), the drive hub including a coupling (pushrod pawl 1122) configured to couple to a second end of a pusher (Paragraph 0146)(see annotated Fig. 14 below);
the pusher (pushrod 1120)(Fig. 14); and
A handle (1116, 1125, 1150)(Fig. 14) configured to house the drive hub and the hypodermic needle (Paragraph 0146, Paragraph 0144).
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Vargas does not teach in this embodiment a frangibly assembled plurality of suture anchors, a proximal end of the frangibly assembled plurality of suture anchors including a connector end configured to connect to a first end of a pusher, each suture anchor of the plurality being connected to an adjacent suture anchor via a tab with no intervening joints or articulating pieces, wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the 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.
Vargas teaches in a separate embodiment a frangibly assembled plurality of suture anchors (270,280)(Fig. 2I)(Paragraphs 0117- 0118), the plurality of suture anchors including a connector end (frangible connector 288) configured to connect to a first end of a pusher (pushrod 250)(Paragraph 0118)(see annotated Fig. 2I below).
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It would be obvious to one of ordinary skill in the art before the effective filing date to modify the lockable suture anchors of the suture anchor system and the connection to the pushrod as taught by Vargas in the first embodiment to have the frangibly assembled plurality of suture anchors and the connector as taught by Vargas in the second embodiment since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired (Paragraph 0117).
Vargas does not teach in the current embodiment wherein each suture anchor of the plurality being connected to an adjacent suture anchor via a tab with no intervening joints or articulating pieces, wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the 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.
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), a second suture anchor (201a) frangibly connected to the first suture anchor (Paragraphs 0104- 0105) via a tab (frangible connector 202), wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the tab (see annotated Fig. 8A below).
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Regarding the tab having no intervening joints or articulating pieces, as Vargas teaches in Paragraph 0104 that the anchors are “formed from a single piece of material” and that the frangible connectors connect the anchors, then the tab of the frangible connectors are also integrally formed with the suture anchors and therefore has no intervening joints or articulating pieces.
Regarding 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, in Paragraphs 0104 and 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 separation of the adjacent suture anchors occurs when the tab is broken.
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the lockable suture anchors of the suture anchor system of the combination to have the frangibly assembled plurality of suture anchors and the frangible connector as a tab as taught by Vargas in the third embodiment since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired (Paragraphs 0104- 0105).
Regarding claim 2, Vargas makes obvious the device as discussed above for claim 1.
Vargas further teaches wherein the hypodermic needle is a hollow hypodermic needle (see Fig. 14)(Paragraph 0144) comprising 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 3, Vargas makes obvious the device as discussed above for claim 2.
The combination further teaches wherein the frangibly assembled plurality of suture anchors is configured to be positioned inside the hollow hypodermic needle (Paragraph 0144).
Regarding claim 4, Vargas makes obvious the device as discussed above for claim 1.
The disclosed device further teaches wherein the drive hub is configured to drive the frangibly assembled plurality of suture anchors into a subject’s flesh (Paragraph 0146 teaches that the push rod 1120 advances the suture anchor through the device, therefore, as the device is taught to be used on a subject (Paragraph 0003 and 0010), it would drive the suture anchor through the subject’s flesh.).
Regarding claim 7, Vargas makes obvious the device as discussed above for claim 1.
Vargas further teaches wherein the suture anchor system is configured to insert the plurality of suture anchors into the subject’s flesh as needed to suture an opening in the subject’s flesh (Paragraphs 0138, 0144).
Regarding claim 17, Vargas makes obvious the device as discussed above for claim 1.
Vargas further teaches wherein the connector end connects to the pusher via a mechanical coupling (In Paragraph 0117, Vargas teaches that a frangible connector is a mechanical coupling, therefore as the connector end is frangibly connected to the pusher (Paragraph 0118), it is connected via a mechanical coupling).
Regarding claim 18, Vargas teaches a device (Fig. 2I)(Paragraph 0117) comprising:
A frangibly assembled plurality of suture anchors (270, 280)(Paragraph 0118); and
A connector end (frangible connector 288) extending from a proximal end of the frangibly assembled plurality of suture anchors (see annotated Fig. 2I below), the connector end being configured to connect to a pusher (pushrod 250) configured to advance the frangibly assembled plurality of suture anchors through a distal end of a hypodermic needle (delivery needle 210) of a suture anchor system (delivery needle 210, pushrod 250)(Paragraph 0117- 0118).
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Vargas does not teach in this embodiment wherein each suture anchor of the plurality being connected to an adjacent suture anchor via a tab with no intervening joints or articulating pieces, wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the 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.
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), a second suture anchor (201a) frangibly connected to the first suture anchor (Paragraphs 0104- 0105) via a tab (frangible connector 202), wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the tab (see annotated Fig. 8A below).
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Regarding the tab having no intervening joints or articulating pieces, as Vargas teaches in Paragraph 0104 that the anchors are “formed from a single piece of material” and that the frangible connectors connect the anchors, then the tab of the frangible connectors are also integrally formed with the suture anchors and therefore has no intervening joints or articulating pieces.
Regarding 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, in Paragraphs 0104 and 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 separation of the adjacent suture anchors occurs when the tab is broken.
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the lockable suture anchors of the suture anchor system and the connection to the pushrod as taught by Vargas in the first embodiment to have the frangibly assembled plurality of suture anchors and the frangible connector as a tab as taught by Vargas in the second embodiment since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired (Paragraphs 0104- 0105).
Regarding claim 19, Vargas teaches the device as discussed above for claim 18.
Vargas further teaches wherein the hypodermic needle (delivery needle 210) is a hollow hypodermic needle (see Fig. 2I)(Paragraph 0117) comprising 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 teaches the device as discussed above for claim 19.
Vargas further teaches wherein the frangibly assembled plurality of suture anchors (270, 280) is configured to be positioned inside the hollow hypodermic needle (delivery needle 210)(Paragraph 0117).
Regarding claim 21, Vargas teaches the device as discussed above for claim 18.
Vargas does not teach in the current embodiment a drive hub configured to drive the frangibly assembled plurality of suture anchors into a subject’s flesh.
Vargas teaches in a different embodiment a suture anchor system (Fig. 14, Paragraph 0144), comprising: a needle (1110), a plurality of suture anchors (suture anchors 1140), a suture (1130)(Fig. 14) connected to the plurality of suture anchors (Paragraph 0144), a drive hub (pushrod slider 1121, pushrod pawl 1122), a pusher (pushrod 1120)(Fig. 14); and a handle (1116, 1125, 1150)(Fig. 14) configured to allow manual operation of the suture anchor system (Paragraph 0146).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by the first embodiment of Vargas to have a drive hub as taught by the second embodiment of Vargas, since Vargas teaches that the drive hub drives the plurality of suture anchors and operates the device (Paragraphs 0144, 0146, and 0148).
Regarding claim 24, Vargas teaches the device as discussed above for claim 18.
Vargas further teaches wherein the suture anchor system is configured to insert the plurality of suture anchors into the subject’s flesh as needed to suture an opening in the subject’s flesh (Paragraphs 0138 and 0144).
Regarding claim 28 and 32, Vargas makes obvious the device as discussed above for claims 1 and 18.
Vargas further teaches wherein the notch is V-shaped (see annotated Fig. 8A below).
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Regarding claims 29 and 33, Vargas makes obvious the device as discussed above for claims 1 and 18.
Vargas further teaches wherein a portion of a proximal end of the first suture anchor is oriented at a first angle, thereby forming a first side of the notch and a portion of a distal end of the second suture anchor is oriented at a second angle, thereby forming a second side of the notch (Paragraph 0103)(see annotated Fig. 8A below).
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Regarding claim 30 and 34, Vargas makes obvious the device as discussed above for claims 29 and 33.
Vargas is silent to wherein the first angle is approximately 45 degrees and the second angle is approximately 45 degrees.
However, since Vargas teaches a first angle and a second angle (see annotated Fig. 8A below) and a suture anchor for insertion into the body (abstract, Paragraphs 0117 and 0118), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first and second angle to be approximately 45 degrees, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
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Regarding claim 31, Vargas makes obvious the device as discussed above for claim 1.
Vargas further teaches the system further comprising: a suture (1130)(Fig. 14) extending through, and in communication with, each suture anchor of the frangibly assembled plurality of suture anchors (Paragraph 0144).
Regarding wherein pulling the suture taut acts to pull the first suture anchor toward the second suture anchor, thereby breaking the tab, as discussed above, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the lockable suture anchors of the suture anchor system to have the frangibly assembled plurality of suture anchors and the frangible connector as a tab as taught by Vargas in the second embodiment since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired (Paragraphs 0104- 0105). As Vargas teaches that tension on the suture causes the connection to break (Paragraph 0105) and bends the first suture anchor toward the second suture anchor (see Fig. 8D), Vargas teaches this limitation.
Regarding claim 35, Vargas makes obvious the device as discussed above for claim 18.
Vargas does not teach in the current combination the system further comprising: a suture extending through, and in communication with, each suture anchor of the frangibly assembled plurality of suture anchors, wherein pulling the suture taut acts to pull the first suture anchor toward the second suture anchor, thereby breaking the tab.
Vargas teaches in a different embodiment a suture anchor system (Fig. 14, Paragraph 0144), comprising: a needle (1110), a plurality of suture anchors (suture anchors 1140), a suture (1130)(Fig. 14) extending through, and in communication with, each suture anchor of the frangibly assembled plurality of suture anchors (Paragraph 0144), a drive hub (pushrod slider 1121, pushrod pawl 1122), a pusher (pushrod 1120)(Fig. 14); and a handle (1116, 1125, 1150)(Fig. 14) configured to allow manual operation of the suture anchor system (Paragraph 0146).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by the combination of Vargas to have a suture extending through, and in communication with, each suture anchor of the frangibly assembled plurality of suture anchors as taught by the third embodiment of Vargas, since Vargas teaches that the suture is part of a delivery system that aids in operating the device (Paragraphs 0144, 0146, and 0148).
Regarding wherein pulling the suture taut acts to pull the first suture anchor toward the second suture anchor, thereby breaking the tab, as discussed above, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the lockable suture anchors of the suture anchor system to have the frangibly assembled plurality of suture anchors and the frangible connector as a tab as taught by Vargas in the second embodiment since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired (Paragraphs 0104- 0105). As Vargas teaches that tension on the suture causes the connection to break (Paragraph 0105) and bends the first suture anchor toward the second suture anchor (see Fig. 8D), Vargas teaches this limitation.
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 26 and 27 over claim 1, 8, and 18 of U.S. Patent No. 12178424 (‘424) in view of Vargas (US 2015/0250470) and in view of Makower et al. (WO 99/21490) has been withdrawn as claims 26 and 27 have been canceled.
The nonstatutory double patenting rejection of claims 26 and 27 over claims 1 and 9- 10 of copending Application No. 18/121,949 (‘949) in view of Vargas (US 2015/0250470) and in view of Makower et al. (WO 99/21490) has been withdrawn as claims 26 and 27 have been canceled.
Claims 1, 9, 17- 21, 24- 25, 28-30, and 32-33 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 8, and 18 of U.S. Patent No. 12178424 (‘424) in view of Vargas (US 2015/0250470).
Regarding claim 1, ‘424 claims a suture anchor system, comprising: a hypodermic needle (claim 1 of ‘424); an anchor strip of linear disposition formed from a single continuous section of material, comprising: a plurality of suture anchors with breakaway sections between adjacent suture anchors; a suture connected to the plurality of suture anchors (claim 1 of ‘424)( Applicant sets forth in their application that the frangibly assembly plurality of suture anchors are a “molded strip of anchors” (Paragraph 0063) and that they have notches between them (Paragraph 0072). Therefore, as the plurality of suture anchors set forth in ‘424 is a molded strip of anchors with notches, or breakaway sections, between them, the plurality of suture anchors are considered to be a frangibly assembly plurality of suture anchors as required by the pending application and a single monolithically manufacture structure.); a drive hub, configured to advance the suture anchors out of the hypodermic needle when pushed (claim 1 of ‘424); and a handle configured to house the drive hub and hypodermic needle (claim 8 of ‘424, which depends from claim 1 of ‘424).
‘424 does not claim a pusher, the drive hub including a coupling configured to couple to a second end of the pusher, or wherein each suture anchor of the plurality being connected to an adjacent suture anchor via a tab with no intervening joints or articulating pieces, wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the 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.
Vargas teaches a device (Fig. 2I)(Paragraph 0117) comprising: a frangibly assembled plurality of suture anchors (270, 280)(Paragraph 0118) and a connector end (frangible connector 288) extending from a proximal end of the frangibly assembled plurality of suture anchors (see annotated Fig. 2I below), the connector end being configured to connect to a pusher (pushrod 250) configured to advance the frangibly assembled plurality of suture anchors through a hypodermic needle (delivery needle 210) of a suture anchor system (delivery needle 210, pushrod 250)(Paragraph 0117- 0118).
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It would be obvious to one of ordinary skill in the art before the effective filing date to modify the system as claimed by ‘424 to have a pusher, a proximal end of the frangibly assembled plurality of suture anchors including a connector end configured to connect to a first end of a pusher, and the drive hub including a coupling configured to couple to a second end of the pusher as taught by Vargas since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired and the pusher allows for the device to be operated (Paragraphs 0104- 0105 and 0117).
The combination of ‘424 and the first embodiment of Vargas do not claim wherein each suture anchor of the plurality being connected to an adjacent suture anchor via a tab with no intervening joints or articulating pieces, wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the 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.
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), a second suture anchor (201a) frangibly connected to the first suture anchor (Paragraphs 0104- 0105) via a tab (frangible connector 202), wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the tab (see annotated Fig. 8A below).
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Regarding the tab having no intervening joints or articulating pieces, as Vargas teaches in Paragraph 0104 that the anchors are “formed from a single piece of material” and that the frangible connectors connect the anchors, then the tab of the frangible connectors are also integrally formed with the suture anchors and therefore has no intervening joints or articulating pieces.
Regarding 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, in Paragraphs 0104 and 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 separation of the adjacent suture anchors occurs when the tab is broken.
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the lockable suture anchors of the suture anchor system of the combination to have the frangibly assembled plurality of suture anchors and the frangible connector as a tab as taught by Vargas in the third embodiment since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired (Paragraphs 0104- 0105).
Regarding claim 9, ‘424 and Vargas claim the system of claim 1, as discussed above.
‘424 further claims a ball plunger that protrudes from the handle and allows manual operation of the suture anchor system (claim 1 of ‘424) and wherein the handle is configured to house the drive hub and hypodermic needle (claim 8 of ‘424).
Regarding claim 17, ‘424 and Vargas claim the system of claim 1, as discussed above.
The combination of ‘424 and Vargas further teaches wherein the connector end connects to the pusher via a mechanical coupling (In Paragraph 0117, Vargas teaches that a frangible connector is a mechanical coupling, therefore as the connector end is frangibly connected to the pusher (Paragraph 0118), it is connected via a mechanical coupling)(As discussed above, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the lockable suture anchors of the suture anchor system and the connection to the pushrod as taught by Vargas in the first embodiment to have the frangibly assembled plurality of suture anchors and the connector as taught by Vargas in the second embodiment since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired (Paragraphs 0104- 0105 and 0117)).
Regarding claim 18, ‘424 claims a device (claim 1 of ‘424) comprising: an anchor strip of linear disposition formed from a single continuous section of material, comprising: a plurality of suture anchors with breakaway sections between adjacent suture anchors; a suture connected to the plurality of suture anchors (claim 1 of ‘424)(Applicant sets forth in their application that the frangibly assembly plurality of suture anchors are a “molded strip of anchors” (Paragraph 0063) and that they have notches between them (Paragraph 0072). Therefore, as the plurality of suture anchors set forth in ‘424 is a molded strip of anchors with notches, or breakaway sections, between them, the plurality of suture anchors are considered to be a frangibly assembly plurality of suture anchors as required by the pending application and the assembly is a single monolithically manufactured structure.) and a hypodermic needle of a suture anchor system (claim 1 of ‘424).
‘424 does not claim a connector end extending from a proximal end of the frangibly assembled plurality of suture anchors, the connector end being configured to connect to a pusher configured to advance the frangibly assembled plurality of suture anchors through the hypodermic needle or wherein each suture anchor of the plurality being connected to an adjacent suture anchor via a tab with no intervening joints or articulating pieces, wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the 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.
Vargas teaches a device (Fig. 2I)(Paragraph 0117) comprising: a frangibly assembled plurality of suture anchors (270, 280)(Paragraph 0118) and a connector end (frangible connector 288) extending from a proximal end of the frangibly assembled plurality of suture anchors (see annotated Fig. 2I below), the connector end being configured to connect to a pusher (pushrod 250) configured to advance the frangibly assembled plurality of suture anchors through a hypodermic needle (delivery needle 210) of a suture anchor system (delivery needle 210, pushrod 250)(Paragraph 0117- 0118).
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It would be obvious to one of ordinary skill in the art before the effective filing date to modify the system as claimed by ‘424 to have a pusher, a proximal end of the frangibly assembled plurality of suture anchors including a connector end configured to connect to a first end of a pusher, and the drive hub including a coupling configured to couple to a second end of the pusher as taught by Vargas since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired and the pusher allows for the device to be operated (Paragraphs 0104- 0105 and 0117).
The combination of ‘424 and the first embodiment of Vargas do not claim wherein each suture anchor of the plurality being connected to an adjacent suture anchor via a tab with no intervening joints or articulating pieces, wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the 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.
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), a second suture anchor (201a) frangibly connected to the first suture anchor (Paragraphs 0104- 0105) via a tab (frangible connector 202), wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the tab (see annotated Fig. 8A below).
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Regarding the tab having no intervening joints or articulating pieces, as Vargas teaches in Paragraph 0104 that the anchors are “formed from a single piece of material” and that the frangible connectors connect the anchors, then the tab of the frangible connectors are also integrally formed with the suture anchors and therefore has no intervening joints or articulating pieces.
Regarding 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, in Paragraphs 0104 and 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 separation of the adjacent suture anchors occurs when the tab is broken.
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the lockable suture anchors of the suture anchor system of the combination to have the frangibly assembled plurality of suture anchors and the frangible connector as a tab as taught by Vargas in the third embodiment since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired (Paragraphs 0104- 0105).
Regarding claim 19, ‘424 and Vargas claim the system of claim 18, as discussed above.
‘424 further claims wherein the hypodermic needle is a hollow hypodermic needle comprising an endoscopic needle or an endoscopic ultrasound needle (claim 2 of ‘424).
Regarding claim 20, ‘424 and Vargas claim the system of claim 19, as discussed above.
‘424 further claims wherein the plurality of suture anchors is configured to be positioned inside the hollow hypodermic needle (claim 3 of ‘424)(As discussed above, the plurality of suture anchors of ‘424 are considered to be frangible.).
Regarding claim 21, ‘424 and Vargas claim the system of claim 18, as discussed above.
‘424 further claims a drive hub that is configured to drive the plurality of suture anchors into a subject’s flesh (claim 4 of ‘424)( As discussed above, the plurality of suture anchors of ‘424 are considered to be frangible.).
Regarding claim 24, ‘424 and Vargas claim the system of claim 18, as discussed above.
‘424 further claims wherein the suture anchor system is configured to insert the plurality of suture anchors into the subject's flesh as needed to suture an opening in the subject's flesh (claim 7 of ‘424)(As discussed above, the plurality of suture anchors of ‘424 are considered to be frangible.).
Regarding claim 25, ‘424 and Vargas claim the system of claim 18, as discussed above.
The combination of ‘424 and Vargas further teaches wherein the connector end connects to the pusher via a mechanical coupling (In Paragraph 0117, Vargas teaches that a frangible connector is a mechanical coupling, therefore as the connector end is frangibly connected to the pusher (Paragraph 0118), it is connected via a mechanical coupling)(As discussed above, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the lockable suture anchors of the suture anchor system and the connection to the pushrod as taught by Vargas in the first embodiment to have the frangibly assembled plurality of suture anchors and the connector as taught by Vargas in the second embodiment since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired (Paragraphs 0104- 0105 and 0117)).
Regarding claim 28 and 32, ‘424 and Vargas claim the system of claims 1 and 18, as discussed above.
Vargas further teaches wherein the notch is V-shaped (see annotated Fig. 8A below).
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Regarding claims 29 and 33, ‘424 and Vargas claim the system of claims 1 and 18, as discussed above.
Vargas further teaches wherein a portion of a proximal end of the first suture anchor is oriented at a first angle, thereby forming a first side of the notch and a portion of a distal end of the second suture anchor is oriented at a second angle, thereby forming a second side of the notch (Paragraph 0103)(see annotated Fig. 8A below).
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Regarding claim 30 and 34, ‘424 and Vargas claim the system of claims 29 and 33, as discussed above.
Vargas is silent to wherein the first angle is approximately 45 degrees and the second angle is approximately 45 degrees.
However, since Vargas teaches a first angle and a second angle (see annotated Fig. 8A below) and a suture anchor for insertion into the body (abstract, Paragraphs 0117 and 0118), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first and second angle to be approximately 45 degrees, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
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Claims 1, 7, 9, 17- 18, 28- 30 and 32-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9- 10 of copending Application No. 18/121,949 (‘949) in view of Vargas (US 2015/0250470).
This is a provisional nonstatutory double patenting rejection.
Regarding claims 1 and 4, ‘949 claims a suture anchor system comprising: a hypodermic needle (claim 9 of ‘949, which depends from claim 1 of ‘949), a frangibly assembled plurality of suture anchors (first and second suture anchors, claim 1 of ‘949), and a handle, wherein the handle is configured to house a portion of the pusher and a portion of the hypodermic needle (claim 9 of ‘949, which depends from claim 1 of ‘949).
‘949 does not claim a drive hub, a pusher, the drive hub including a coupling configured to couple to a second end of the pusher, or wherein each suture anchor of the plurality being connected to an adjacent suture anchor via a tab with no intervening joints or articulating pieces, wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the 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 or wherein the drive hub is configured to drive the frangibly assembled suture anchors into a subject’s flesh as recited in claim 4.
Vargas teaches a device (Fig. 2I)(Paragraph 0117) comprising: a frangibly assembled plurality of suture anchors (270, 280)(Paragraph 0118) and a connector end (frangible connector 288) extending from a proximal end of the frangibly assembled plurality of suture anchors (see annotated Fig. 2I below), the connector end being configured to connect to a pusher (pushrod 250) configured to advance the frangibly assembled plurality of suture anchors through a hypodermic needle (delivery needle 210) of a suture anchor system (delivery needle 210, pushrod 250)(Paragraph 0117- 0118).
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Regarding wherein the frangibly assembled plurality of suture anchors are monolithically manufactured as a unitary structure, this claim limitation is a product by process limitation and therefore is only considered as it affects the final product, in the instant case the claimed method imparts to the product a unitary structure. Since Vargas teaches that the plurality of connected suture anchors are frangibly connected through a frangible connector (288) and form a unitary structure (Paragraph 0117), Vargas teaches this claim limitation.
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the system as claimed by ‘949 to have a pusher and the drive hub including a coupling configured to couple to a second end of the pusher as taught by Vargas since Vargas teaches that the pusher allows for the device to be operated (Paragraphs 0104- 0105 and 0117).
The combination of ‘949 and the first embodiment of Vargas do not claim the drive hub including a coupling configured to couple to a second end of the pusher, or wherein each suture anchor of the plurality being connected to an adjacent suture anchor via a tab with no intervening joints or articulating pieces, wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the 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.
Vargas teaches in a second embodiment a suture anchor system (Fig. 14, Paragraph 0144), comprising: a needle (1110), a plurality of suture anchors (suture anchors 1140)(Paragraph 0144)(Fig. 14), a suture (1130)(Fig. 14) connected to the plurality of suture anchors (Paragraph 0144), a drive hub (pushrod slider 1121, pushrod pawl 1122), the drive hub including a coupling (pushrod pawl 1122) configured to couple to a second end of a pusher (Paragraph 0146)(see annotated Fig. 14 below), the pusher (pushrod 1120)(Fig. 14), and a handle (1116, 1125, 1150)(Fig. 14) configured to allow manual operation of the suture anchor system (Paragraph 0146).
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It would have been obvious to one of ordinary skill in the art to modify the drive hub of the combination to include a coupling configured to couple to a second end of a pusher as taught by the second embodiment of Vargas, since Vargas teaches that this connection allows for the device to be operated (Paragraphs 0144 and 0146).
The combination of ‘424 and the first embodiment of Vargas do not claim wherein each suture anchor of the plurality being connected to an adjacent suture anchor via a tab with no intervening joints or articulating pieces, wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the 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.
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), a second suture anchor (201a) frangibly connected to the first suture anchor (Paragraphs 0104- 0105) via a tab (frangible connector 202), wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the tab (see annotated Fig. 8A below).
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Regarding the tab having no intervening joints or articulating pieces, as Vargas teaches in Paragraph 0104 that the anchors are “formed from a single piece of material” and that the frangible connectors connect the anchors, then the tab of the frangible connectors are also integrally formed with the suture anchors and therefore has no intervening joints or articulating pieces.
Regarding 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, in Paragraphs 0104 and 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 separation of the adjacent suture anchors occurs when the tab is broken.
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the lockable suture anchors of the suture anchor system of the combination to have the frangibly assembled plurality of suture anchors and the frangible connector as a tab as taught by Vargas in the second embodiment since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired (Paragraphs 0104- 0105).
Regarding claim 9, ‘949 and Vargas claim the system of claim 8, as discussed above.
‘949 further claims wherein a ball plunger protrudes from the handle allowing manual operation of the suture anchor system (claim 10 of ‘949).
Regarding claim 17, ‘949 and Vargas claim the system of claim 1, as discussed above.
The combination of ‘949 and Vargas further teaches wherein the connector end connects to the pusher via a mechanical coupling (In Paragraph 0117, Vargas teaches that a frangible connector is a mechanical coupling, therefore as the connector end is frangibly connected to the pusher (Paragraph 0118), it is connected via a mechanical coupling)(As discussed above, it would be obvious to one of ordinary skill in the art before the effective filing date to modify the lockable suture anchors of the suture anchor system and the connection to the pushrod as taught by Vargas in the first embodiment to have the frangibly assembled plurality of suture anchors and the connector as taught by Vargas in the second embodiment since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired (Paragraphs 0104- 0105 and 0117)).
Regarding claim 18, ‘949 claims a device (claim 18 of ‘949) comprising: a frangibly assembled plurality of suture anchors (claim 18 of ‘949) and a pusher connected to the plurality of suture anchors (claim 18 of ‘949).
‘949 does not claim a connector end extending from a proximal end of the frangibly assembled plurality of suture anchors, the connector end being configured to connect to a pusher configured to advance the frangibly assembled plurality of suture anchors through the hypodermic needle.
Vargas teaches a device (Fig. 2I)(Paragraph 0117) comprising: a frangibly assembled plurality of suture anchors (270, 280)(Paragraph 0118) and a connector end (frangible connector 288) extending from a proximal end of the frangibly assembled plurality of suture anchors (see annotated Fig. 2I below), the connector end being configured to connect to a pusher (pushrod 250) configured to advance the frangibly assembled plurality of suture anchors through a hypodermic needle (delivery needle 210) of a suture anchor system (delivery needle 210, pushrod 250)(Paragraph 0117- 0118).
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Regarding wherein the frangibly assembled plurality of suture anchors are monolithically manufactured as a unitary structure, this claim limitation is a product by process limitation and therefore is only considered as it affects the final product, in the instant case the claimed method imparts to the product a unitary structure. Since Vargas teaches that the plurality of connected suture anchors are frangibly connected through a frangible connector (288) and form a unitary structure (Paragraph 0117), Vargas teaches this claim limitation.
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the system as claimed by ‘949 to have a pusher, a frangibly monolithically manufacture plurality of suture anchors and the drive hub including a coupling configured to couple to a second end of the pusher as taught by Vargas since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired and the pusher allows for the device to be operated (Paragraphs 0104- 0105 and 0117).
The combination of ‘949 and the first embodiment of Vargas do not claim The combination of ‘424 and the first embodiment of Vargas do not claim wherein each suture anchor of the plurality being connected to an adjacent suture anchor via a tab with no intervening joints or articulating pieces, wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the 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.
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), a second suture anchor (201a) frangibly connected to the first suture anchor (Paragraphs 0104- 0105) via a tab (frangible connector 202), wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the tab (see annotated Fig. 8A below).
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Regarding the tab having no intervening joints or articulating pieces, as Vargas teaches in Paragraph 0104 that the anchors are “formed from a single piece of material” and that the frangible connectors connect the anchors, then the tab of the frangible connectors are also integrally formed with the suture anchors and therefore has no intervening joints or articulating pieces.
Regarding 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, in Paragraphs 0104 and 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 separation of the adjacent suture anchors occurs when the tab is broken.
It would be obvious to one of ordinary skill in the art before the effective filing date to modify the lockable suture anchors of the suture anchor system of the combination to have the frangibly assembled plurality of suture anchors and the frangible connector as a tab as taught by Vargas in the third embodiment since Vargas teaches that the frangible connectors allow for rotation or break depending on what is desired (Paragraphs 0104- 0105).
Regarding claim 28 and 32, ‘424 and Vargas claim the system of claims 1 and 18, as discussed above.
Vargas further teaches wherein the notch is V-shaped (see annotated Fig. 8A below).
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Regarding claims 29 and 33, ‘424 and Vargas claim the system of claims 1 and 18, as discussed above.
Vargas further teaches wherein a portion of a proximal end of the first suture anchor is oriented at a first angle, thereby forming a first side of the notch and a portion of a distal end of the second suture anchor is oriented at a second angle, thereby forming a second side of the notch (Paragraph 0103)(see annotated Fig. 8A below).
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Regarding claim 30 and 34, ‘424 and Vargas claim the system of claims 29 and 33, as discussed above.
Vargas is silent to wherein the first angle is approximately 45 degrees and the second angle is approximately 45 degrees.
However, since Vargas teaches a first angle and a second angle (see annotated Fig. 8A below) and a suture anchor for insertion into the body (abstract, Paragraphs 0117 and 0118), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first and second angle to be approximately 45 degrees, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
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Response to Arguments
Applicant's arguments filed January 29th, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments, see Pages 7-8, regarding that Vargas does not teach two adjacent suture anchors connected by a tab or a notch extending approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the tab, this argument has been fully considered but is not persuasive. As discussed above, Vargas teaches: a first suture anchor (201a), a second suture anchor (201a) frangibly connected to the first suture anchor (Paragraphs 0104- 0105) via a tab (frangible connector 202), wherein a notch extends approximately orthogonally between two adjacent suture anchors and a nadir of the notch is proximate to the tab (see annotated Fig. 8A below). Regarding the tab having no intervening joints or articulating pieces, as Vargas teaches in Paragraph 0104 that the anchors are “formed from a single piece of material” and that the frangible connectors connect the anchors, then the tab of the frangible connectors are also integrally formed with the suture anchors and therefore has no intervening joints or articulating pieces. Regarding 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, in Paragraphs 0104 and 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 separation of the adjacent suture anchors occurs when the tab is broken.
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Regarding applicant’s argument, see Pages 9- 11, that the nonstatutory double patenting rejection as being unpatentable over claims 1, 8, and 18 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
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
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