DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4, 5 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 4 recites the limitation "a bore of the anchor body" in lines 1-2. Claim 4 is dependent off of claim 1 which claims “a central bore”. It is unclear if “a bore” of claim 4 is supposed to be referring back to the central bore of claim 1 or if it is its own suture path. Based on the specification, the loop is located within the central bore as well as other “lumens” of the anchor body. For examination purposes, the limitation “a bore” of claim 4 will be interpreted to be a given passage within the suture anchor, where the suture extends that can be at least the central bore and other passages/bores. See rejections below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-5, 8, 9, are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by U.S. Patent 5,571,139 to Jenkins.
As to claim 1, Jenkins discloses a suture anchor comprising an anchor body (2, figure 2) having a longitudinal axis, a proximal end, and a distal end (figure 2), wherein the anchor body includes a coaxial central bore (73/76 the proximal portion 73 and socket 76 can together define the central bore which is located at the proximal end) located at the proximal end and a coaxial central passage (74) extending between the central bore and the distal end (figure 2), wherein the central bore has a first dimension substantially perpendicular to the longitudinal axis (figure 2, the diameter/width of the cavity 76/73), and the central passage has a second dimension (diameter/width of the central passage 74) substantially perpendicular to the longitudinal axis that is less than the first dimension (figure 2, the passageway 74 had a smaller width/diameter than both the passageways 76/73), a loop (portion of suture 29 that extends between 28-27) disposed at least partially within the anchor body (figure 2), the loop having ends tied together in a knot (27) disposed at the distal end of the anchor body (figure 2, the distal end of the anchor can be defined by the distal portion 75 of the passageway where the knot is located). Of note, the central bore and the central passage can share the same axis, so they can read on the coaxial central bore and coaxial central passage.
As to claim 2, Jenkins discloses the loop is disposed completely within the anchor body (figure 2). The loop can be defined by the portion of the first suture 29 that extends between the knots, which will be disposed completely within the anchor body.
As to claim 3, Jenkins discloses the knot is located within a socket (75) disposed at the distal end of the anchor body (figure 2)
As to claim 4, Jenkins discloses the loop is located within a bore of the anchor body (figure 2). Without further distinctions of the bore or the loop (vs the coaxial central passage and/or the coaxial central bore), the loop extends within the passageway 73, 74,75, which can read on the “bore”.
As to claim 5, Jenkins discloses the bore has an opening (opening to 31, which can be a part of the bore ) configured to receive a driver head for driving the anchor (col. 6 ll. 42-45, figure 2).
As to claim 8, Jenkins discloses the anchor body comprises the anchor body is threaded from the proximal end to the distal end (figure 2).
As to claim 9, Jenkins discloses the anchor body comprises a bioabsorbable material (col. 3 ll. 42, col. 7 ll. 5-18).
Claims 1, 3, 4-6, 8 are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by U.S. Patent Publication 2003/0065361 to Dreyfuss.
As to claim 1, Dreyfuss discloses a suture anchor (110) comprising an anchor body (the body of the anchor 108 that ends where the openings 117 are, see annotated figure below) having a longitudinal axis, a proximal end, and a distal end (figure 1-3, 5, see annotated figure below), wherein the anchor body includes a coaxial central bore (132, see annotated figure below) located at the proximal end and a coaxial central passage (134, see annotated figure below) extending between the central bore and the distal end (figure 1-3, 5), wherein the central bore has a first dimension substantially perpendicular to the longitudinal axis (figure 3, the diameter/width of 134), and the central passage has a second dimension (diameter/width of 136) substantially perpendicular to the longitudinal axis that is less than the first dimension (figure 3), a loop (122) disposed at least partially within the anchor body (figure 5), the loop having ends tied together in a knot (125) disposed at the distal end of the anchor body (figure 5, see annotated figure below). Of note, the central bore and the central passage can share the same axis, so they can read on the coaxial central bore and coaxial central passage.
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As to claim 3, Dreyfuss discloses the knot is located within a socket (117/118) disposed at the distal end of the anchor body (figure 5, see annotated figure above).
As to claim 4, Dreyfuss discloses the loop is located within a bore (at least 126, as well as 132) of the anchor body (figure 5).
As to claim 5, Dreyfuss discloses the bore has an opening configured to receive a driver head for driving the anchor (paragraph 31).
As to claim 6, Dreyfuss discloses at least one suture strand (138) threaded through the loop (figure 5).
As to claim 8, Dreyfuss discloses the anchor body comprises the anchor body is threaded from the proximal end to the distal end (figure 2, 5, see annotated figure above, the length of the anchor body defined in the annotated figure above, is threaded from proximal end to distal end).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 7 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication 2003/0065361 to Dreyfuss in view of U.S. Patent 5,002,550 to Li.
As to claim 7, Dreyfuss discloses the device above but is silent about the needle attached to one end of the suture strand.
Li teaches a similar device having a needle attached to one end of the suture strand (col. 15 ll. 57-59, col. 17 ll. 14-17) for the purpose of aiding in attaching the suture to tissue efficiently. It would have been obvious to one of ordinary skill in the art at the time of the invention to have the suture of Dreyfuss be attached to a needle in order for aiding in attaching the suture to tissue efficiently.
Claim 10 is rejected under 35 U.S.C. 103(a) as being unpatentable U.S. Patent 5,571,139 to Jenkins in view of U.S. Patent 6,716,234 to Grafton.
As to claim 10, Jenkins discloses the device above except for the loop comprising a suture formed from ultrahigh molecular weight polyethylene.
Grafton teaches a similar device having a suture comprising the ultrahigh molecular weight polyethylene (col. 1, ll. 24-29) for the purpose that ultrahigh molecular weight polyethylene provides a high strength and excellent tie down characteristics (col. 1, ll. 6-10). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the loop of Jenkins by composing it of ultrahigh molecular weight polyethylene suture as taught by Grafton in order for having a suture with a high strength and excellent tie down characteristics.
Claim 10 is rejected under 35 U.S.C. 103(a) as being unpatentable U.S. Patent Publication 2003/0065361 to Dreyfuss in view of U.S. Patent 6,716,234 to Grafton.
As to claim 10, Dreyfuss discloses the device above except for the loop comprising a suture formed from ultrahigh molecular weight polyethylene.
Grafton teaches a similar device having a suture comprising the ultrahigh molecular weight polyethylene (col. 1, ll. 24-29) for the purpose that ultrahigh molecular weight polyethylene provides a high strength and excellent tie down characteristics (col. 1, ll. 6-10). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the loop of Dreyfuss by composing it of ultrahigh molecular weight polyethylene suture as taught by Grafton in order for having a suture with a high strength and excellent tie down characteristics.
Claim 11 is rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication 2003/0065361 to Dreyfuss (herein Dreyfuss ‘361) in view of U.S. Patent 6,652,563 to Dreyfuss (herein Dreyfuss ‘563).
As to claim 11, Dreyfuss ‘361 discloses the device above but is silent about the knot being coated with a glue material.
However, Dreyfuss ‘563 teaches a similar suture anchor comprising a loop having a knot coated with an adhesive to seal and fortify the knot (col. 4, ll. 27-37) for the purpose of sealing and fortifying the knot. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the knot of Dreyfuss ‘361 with the glue coating in order for sealing and fortifying the knot.
Claim 11 is rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent 5,571,139 to Jenkins in view of U.S. Patent 6,652,563 to Dreyfuss (herein Dreyfuss ‘563).
As to claim 11, Jenkins discloses the device above but is silent about the knot being coated with a glue material.
However, Dreyfuss ‘563 teaches a similar suture anchor comprising a loop having a knot coated with an adhesive to seal and fortify the knot (col. 4, ll. 27-37) for the purpose of sealing and fortifying the knot. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the knot of Jenkins with the glue coating in order for sealing and fortifying the knot.
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.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,521,999. Although the claims at issue are not identical, they are not patentably distinct from each other because:
As to the instant application’s claim 1, the reference patent claims a suture anchor (claim 1) comprising an anchor body (claim 1) having a longitudinal axis, a proximal end, and a distal end (claim 1), wherein the anchor body includes a coaxial central bore (“longitudinal bore”, claim 1) located at the proximal end and a coaxial central passage (“central passage”, claim 1) extending between the central bore and the distal end (claim 1, the central passage is in communication with the knot socket which is at the distal end, so the central passage can be between the central bore and the distal end ), wherein the central bore has a first dimension substantially perpendicular to the longitudinal axis (claim 1), and the central passage has a second dimension (claim 1) substantially perpendicular to the longitudinal axis that is less than the first dimension (claim 1), a loop (claim 1) disposed at least partially within the anchor body (claim 1), the loop having ends tied together in a knot (claim 1) disposed at the distal end of the anchor body (claim 1).
As to the application’s claim 2, see reference patent claim 2.
As to the application’s claim 3, see reference patent claim 1.
As to the application’s claim 4, see reference patent claim 1, 8.
As to the application’s claim 5, see reference patent claim 1.
As to the application’s claim 6, see reference patent claim 1.
As to the application’s claim 7, see reference patent claim 4.
As to the application’s claim 8, see reference patent claim 2. A fully threaded anchor body will have a thread from the proximal end to the distal end.
As to the application’s claim 9, see reference patent claim 1.
As to the application’s claim 10, see reference patent claim 6.
As to the application’s claim 11, see reference patent claim 7.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,595,847. Although the claims at issue are not identical, they are not patentably distinct from each other because:
As to the instant application’s claim 1, the reference patent claims a suture anchor (claim 1) comprising an anchor body (claim 1) having a longitudinal axis, a proximal end, and a distal end (claim 1), wherein the anchor body includes a coaxial central bore (claim 1) located at the proximal end and a coaxial central passage (claim 1) extending between the central bore and the distal end (claim 1), wherein the central bore has a first dimension substantially perpendicular to the longitudinal axis (claim 1), and the central passage has a second dimension (claim 1) substantially perpendicular to the longitudinal axis that is less than the first dimension (claim 1), a loop (“closed loop” claim 1) disposed at least partially within the anchor body (claim 1), the loop having ends tied together in a knot (claim 1) disposed at the distal end of the anchor body (claim 1).
As to the application’s claim 2, see reference patent claim 2.
As to the application’s claim 3, see reference patent claim 1. The “second central bore” can read on the knot socket.
As to the application’s claim 4, see reference patent claim 1. The strand extends through the central passage which can read on “a bore” of the anchor body”.
As to the application’s claim 5, see reference patent claim 4.
As to the application’s claim 6, see reference patent claim 5.
As to the application’s claim 7, see reference patent claim 6.
As to the application’s claim 8, see reference patent claim 7.
As to the application’s claim 9, see reference patent claim 8.
As to the application’s claim 10, see reference patent claim 9.
As to the application’s claim 11, see reference patent claim 10.
Claims 1, 2, 4-6, 8-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,324,493. Although the claims at issue are not identical, they are not patentably distinct from each other because:
As to the instant application’s claim 1, the reference patent claims a suture anchor (claim 1) comprising an anchor body (claim 1) having a longitudinal axis, a proximal end, and a distal end (claim 1), wherein the anchor body includes a coaxial central bore (“central bore”, claim 1) located at the proximal end and a coaxial central passage (“passage”, claim 1) extending between the central bore and the distal end (claim 1), wherein the central bore has a first dimension substantially perpendicular to the longitudinal axis (claim 1), and the central passage has a second dimension (claim 1) substantially perpendicular to the longitudinal axis that is less than the first dimension (claim 1), a loop ( “closed loop” 1) disposed at least partially within the anchor body (claim 1), the loop having ends tied together in a knot (claim 1) disposed at the distal end of the anchor body (claim 1).
As to the application’s claim 2, see reference patent claim 2.
As to the application’s claim 4, see reference patent claim 1.
As to the application’s claim 5, see reference patent claim 4.
As to the application’s claim 6, see reference patent claim 5.
As to the application’s claim 8, see reference patent claim 6.
As to the application’s claim 9, see reference patent claim 7.
As to the application’s claim 10, see reference patent claim 8.
As to the application’s claim 11, see reference patent claim 9.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,324,493 in view of U.S. Patent 5,002,550 to Li.
As to the application’s claim 7, the reference patent claims the device above but is silent about the needle attached to one end of the suture strand.
Li teaches a similar device having a needle attached to one end of the suture strand (col. 15 ll. 57-59, col. 17 ll. 14-17) for the purpose of aiding in attaching the suture to tissue efficiently. It would have been obvious to one of ordinary skill in the art at the time of the invention to have the suture of reference patent be attached to a needle in order for aiding in attaching the suture to tissue efficiently.
Claims 1-4, 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,064,104. Although the claims at issue are not identical, they are not patentably distinct from each other:
As to the instant application’s claim 1, the reference patent claims a suture anchor (claim 1) comprising an anchor body (claim 1) having a longitudinal axis, a proximal end, and a distal end (claim 1), wherein the anchor body includes a coaxial central bore (“first central bore”, claim 1) located at the proximal end and a coaxial central passage (“passage”, claim 1) extending between the central bore and the distal end (claim 1), wherein the central bore has a first dimension substantially perpendicular to the longitudinal axis (claim 1), and the central passage has a second dimension (claim 1) substantially perpendicular to the longitudinal axis that is less than the first dimension (claim 1), a loop (“closed loop” claim 1) disposed at least partially within the anchor body (claim 1), the loop having ends tied together in a knot (claim 1) disposed at the distal end of the anchor body (claim 1).
As to the application’s claim 2, see reference patent claim 2.
As to the application’s claim 3, see reference patent claim 1. The second central passage can read on the knot socket
As to the application’s claim 4, see reference patent claim 1.
As to the application’s claim 6, see reference patent claim 8.
Claim 5, 8, 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,064,104 in view of U.S. Patent 5,571,139 to Jenkins.
As to the application’s claim 5, the reference patent claims the device above but is silent about the bore has an opening configured to receive a driver’s head for driving the anchor.
Jenkins teaches a similar device (suture anchor, abstract) having an opening to a bore configured to receive a driver’s head for driving the anchor for the purpose being able to insert the anchor without contacting the suture (col. 5 ll. 5-15). It would have been obvious to one of ordinary skill in the art at the time of the invention to have the reference patent have the opening configured to receive a driver head for driving the anchor in order for being able to insert the anchor without contacting the suture.
As to the application’s claim 8, the reference patent claims the device above but is silent about the anchor body is threaded from the proximal end to the distal end.
Jenkins teaches a similar device (suture anchor, abstract) having the anchor body is threaded from the proximal end to the distal end (figure 2, col. ll. 28-44) for the purpose of inserting the anchor through bone. It would have been obvious to one of ordinary skill in the art at the time of the invention to have the reference patent have the anchor body be threaded from the proximal end the distal end in order to allow the anchor to be inserted through bone.
As to the application’s claim 9, the reference patent claims the device above but is silent about the anchor body comprises a bioabsorbable material.
Jenkins teaches a similar device (suture anchor, abstract) having an anchor body comprises a bioabsorbable material (col. 3 ll. 38-42) for the purpose of using a biocompatible material. It would have been obvious at the time of the invention to have the anchor body of the reference patent comprise a bioabsorbable material in order to use a biocompatible material.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,064,104 in view of in view of U.S. Patent 5,002,550 to Li.
As to the application’s claim 7, the reference patent claims the device above but is silent about the needle attached to one end of the suture strand.
Li teaches a similar device having a needle attached to one end of the suture strand (col. 15 ll. 57-59, col. 17 ll. 14-17) for the purpose of aiding in attaching the suture to tissue efficiently. It would have been obvious to one of ordinary skill in the art at the time of the invention to have the suture of reference patent be attached to a needle in order for aiding in attaching the suture to tissue efficiently.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,064,104 in view of U.S. Patent 6,716,234 to Grafton.
As to application’s claim 10, the reference patent discloses the device above except for the loop comprising a suture formed from ultrahigh molecular weight polyethylene.
Grafton teaches a similar device having a suture comprising the ultrahigh molecular weight polyethylene (col. 1, ll. 24-29) for the purpose that ultrahigh molecular weight polyethylene provides a high strength and excellent tie down characteristics (col. 1, ll. 6-10). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the loop of reference patent by composing it of ultrahigh molecular weight polyethylene suture as taught by Grafton in order for having a suture with a high strength and excellent tie down characteristics.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,064,104 in view of 6,652,563 to Dreyfuss (herein Dreyfuss ‘563).
As to application’s claim 11, the reference patent discloses the device above but is silent about the knot being coated with a glue material.
Dreyfuss ‘563 teaches a similar suture anchor comprising a loop having a knot coated with an adhesive to seal and fortify the knot (col. 4, ll. 27-37) for the purpose of sealing and fortifying the knot. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the knot of Jenkins with the glue coating in order for sealing and fortifying the knot.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771