DETAILED ACTION
Notice of 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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 10 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 2 recites the limitation “the outer protector tube" in claim 2. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret this to refer to the “outer tube” introduced in claim 1.
Claim 10 recites “wherein the O-ring is configured to hold the wound at least part of the at least one flexible strand in the handle”. This language is not grammatically correct and it is not clear how Applicant intends to limit the claim. For the purpose of examination, the limitation will be interpreted to recite ““wherein the O-ring is configured to hold
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Dependent claim 8 recites “the outer tube consists of a tube”. This language is already recited independent claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-8 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heaven et al. (US Patent Publication 2010/0198258).
Claims 1, 8: Heaven’258 discloses a surgical inserter assembly, comprising:
a bone anchor (100) having a proximal end (towards arrow 215 in Figure 1b) and a distal end (towards element 350 in Figure 1b);
at least one flexible strand (550) pre-loaded through the distal end of the bone anchor (Figures 1a);
an inserter (500, 800) having a handle (900) and a cannulated shaft (800, 500) extending from the handle, a distal end of the cannulated shaft being engaged with the bone anchor (505; paragraph [0140]), and the at least one flexible strand (550) extending through the cannulated shaft (paragraph [0149]); and
an outer tube (600, 700) pre-assembled on the cannulated shaft of the inserter (Figure 10),
wherein the outer tube (600, 700) consists of a tube with opposite first and second open ends (600, 700 are connected to each other to form a unitary element – paragraph [0143], [0144]; Figure 7a, 7b shows element 700 is open on both ends; Figure 6 shows element 600 is a tube having open ends) the first end (proximal end of 700) abuts the handle (900) of the inserter (Figure 10; paragraph [0144]) and the second end (distal end of 600) abuts the proximal end of the bone anchor (Figure 10; paragraph [0151] states “the outer tube is flush with the anchor body 200”).
Claim 2: Heaven’258 discloses the inner diameter of the outer tube is smaller than an outer diameter of the proximal end of the bone anchor (Figure 4, 10; paragraph [0138]).
Claim 3: Heaven’258 discloses the outer tube (600, 700) covers substantially the entire length of the cannulated shaft (800, 500) (Figure 10).
Claim 5: Heaven’258 discloses the bone anchor has outer threads (230) configured to anchor into a bone hole, tunnel or other crevice.
Claim 6: Heaven’258 discloses the at least one flexible strand is a suture (paragraph [0142]).
Claim 7: Heaven’258 discloses the at least one flexible strand (550) is coupled to the distal end of the suture anchor using a knot (350; paragraph [0110]).
Claim 13: Heaven’258 discloses the at least one flexible strand extends through a lateral opening in the distal end of the bone anchor (Figure 1a).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Heaven’258.
Claim 4: Heaven’258 discloses the claimed invention except for that the outer protection tube is made of plastic. However, it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to make the outer protector tube out of plastic, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 11, 12: Heaven’258 does not explicitly show that the inserter is removable from the outer tube and therefore does not teach the flexible strand remains within the outer tube after the inserter is removed from the outer tube or that the outer tube is configured to remain in contact with the anchor after the inserter is removed from the outer tube.
In an alternate embodiment (Figure 12a-12d), Heaven’258 teaches an outer tube consisting of a tube (1210), an inserter (1207) with a distal end engaged with an anchor (portion 1205 of anchor 1201, 1205; paragraph [0165]) such that the flexible strand (1203) passes through a cannulation in the inserter (Figure 12a; paragraph [0164]). In this embodiment, the inserter can be removed from the outer tube while the flexible strand remains in place (paragraph [0165] describes removing 1207 from the outer tube 1210; the flexible strand 1203 is attached to 1205, which remains in in place). The outer tube remains in contact with the anchor (1201) when the inserter is removed from the outer tube (paragraph [0165]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Heaven’258 Figures 4-11, such that the inserter can be removed from the outer tube, as taught in the embodiment of Figure 12, because this will allow manual manipulation of the suture by the surgeon (paragraph [0164]).
In the resulting device, the outer tube is configured to remain in contact with the anchor and the flexible strand remains within the outer tube after the inserter is removed from the outer tube.
Claims 9, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Heaven’258, as applied to claim 1, further in view of Pierce (US Patent 5,908,426).
Claim 9: Heaven’258 teaches the at last one flexible strand is wound around a cleat on the outer tube (cleat 750 on tube 700). Therefore Heaven’258 does not teach the flexible strand is wound around the handle (900).
Like Heaven’258, Pierce’426 teaches an assembly having an outer tube (130) with a cleat (150; Figure 2) for wrapping a flexible strand, an inserter (120) having a handle (110). However, Pierce’426 alternately teaches the cleat can be located anywhere else on the device, including handle (110) (column 4, lines 56-60).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Heaven’258, by placing the cleat on the handle 900, as taught by Pierce’426, in order to allow the flexible strand to move with the handle rather than wrap around the outer tube when the handle is rotated.
Claim 10: Pierce’426 teaches the cleat is has an o-ring (“rubber washer 154”) such that the flexible strand is secured to the cleat by sliding the flexible strand under the o-ring so the flexible strand is removably attached to the cleat (column 4, lines 48-55).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Heaven’258 by providing the cleat with an o-ring, as taught by Pierce’426, to aid in securing the flexible strand to the cleat.
Claims 1-6, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Trenhaile et al. (US Patent Publication 2012/0029562) in view of Bracy et al. (US Patent Publication 2019/0090868).
Claims 1, 8: Trenhaile’562 teaches a surgical inserter assembly, comprising:
a bone anchor (102) having a proximal end (towards 210 in Figure 1) and a distal end (towards 212 in Figure 1);
at least one flexible strand (“suture #1”, “suture #2” – Figures 1, 2) pre-loaded through the distal end of the bone anchor (Figures 1, 2);
an inserter (104) having a handle (316) and a cannulated shaft (312 with cannulation 302) extending from the handle, a distal end of the cannulated shaft being engaged with the bone anchor (distal end 308 engages with anchor 102), and the at least one flexible strand extending through the cannulated shaft (Figure 1); and
an outer tube (106) pre-assembled on the cannulated shaft of the inserter (Figure 1 shows the outer tube on the cannulated shaft before use),
wherein the outer tube has opposite first and second open ends (first end is towards element 416), the first end (towards 416) abuts the handle of the inserter (Figure 1) and the second end abuts the proximal end of the bone anchor (at 406, see Figure 1).
Trenhaile’562 does not teach the outer tube consists of a tube.
Like Trenhaile’562, Bracy’868 teaches a device (Figure 12) with an inserter (1204) that engages with a fixation device (1208). Bracy’868 teaches providing an outer protector tube (1250) that consists of a tube.
In light of these teachings, It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to provide the outer tube consisting of a tube, as taught by Bracy’868, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed (replacing a tube with a handle with a tube without a handle) with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art as of the effective filing date of the invention, i.e., one skilled in the art would have recognized that the device of Trenhaile’562, as modified by Bracy’688, would be performed equally well regardless of whether or not the proximal end of the protector has additional elements.
Claim 2: Trenhaile’562 teaches an inner diameter of the outer protector tube is smaller than the outer diameter of the proximal end of the fixation device (see Figure 1).
Claim 3: Trenhaile’562 teaches the cannulated shaft of the inserter has a length (Figure 1) and the outer protector tube (106) covers substantially the entire length of the cannulated shaft (Figure 1).
Claim 4: Trenhaile’562, as modified, discloses the claimed invention except for that the outer protection tube is made of plastic. However, it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to make the outer protector tube out of plastic, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 5: Trenhaile’562 teaches the fixation device (102) has outer threads (206) configured to anchor into the bone.
Claim 6: Trenhaile’562 teaches the flexible strand is a suture (Figure 1 labeled as “suture”).
Claim 11: Trenhaile’562 teaches the outer tube is configured to remain engaged with the bone anchor after the inserter is removed from the outer tube (Figure 8).
Claim 12: Trenhaile’562 teaches the at least one flexible strand remains within the outer tube after the inserter is removed from the outer tube (Figure 8).
Claim 13: Trenhaile’562 teaches the at least one flexible strand extends through a lateral opening (212) in the distal end of the bone anchor (Figure 1).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Trenhaile’562 in view of Bracy’868, as applied to claim 1, further in view of Lantz et al. (US Patent Publication 2013/0006276).
Claim 7: Trenhaile’562, as modified, teaches the limitations of claim 9 except that the flexible strand is coupled to the distal end of the fixation device via a knot.
Lantz’276 teaches a suture anchor (10; Figure 20) that is coupled to a suture 95 via a knot (paragraph [0094]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Trenhaile’562 by coupling the fixation device to the flexible strand via a knot, as taught by Lantz’276, because all of the claimed elements were known in the prior art and one skilled in the art could have combined these elements with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill as of the effective filing date of the invention because Trenhaile’562 teaches a suture attached to the distal end of a fixation device (Figure 1) and the use of a knot to attach sutures to fixation devices is taught by Lantz’276. One of ordinary skill in the art would understand that the use of a knot, such as that taught by Lantz’276 would prevent the suture from accidently sliding off the fixation device.
Claims 9, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Trenhaile’562 in view of Bracy’868, as applied to claim 1, further in view of Pierce’426.
Claim 9: Trenhaile’562 teaches the at least one flexible strand is wound around a cleat on the outer tube (cleat 412 on tube 106). Therefore Trenhaile’562 does not teach the flexible strand is wound around the handle (316).
Like Trenhaile’562, Pierce’426 teaches an assembly having an outer tube (130) with a cleat (150; Figure 2) for wrapping a flexible strand, an inserter (120) having a handle (110). However, Pierce’426 alternately teaches the cleat can be located anywhere else on the device, including handle (110) (column 4, lines 56-60).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Trenhaile’562, by placing the cleat on the handle 900, as taught by Pierce’426, in order to allow the flexible strand to move with the handle rather than wrap around the outer tube when the handle is rotated.
Claim 10: Pierce’426 teaches the cleat is has an o-ring (“rubber washer 154”) such that the flexible strand is secured to the cleat by sliding the flexible strand under the o-ring so the flexible strand is removably attached to the cleat (column 4, lines 48-55).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Trenhaile’562 by providing the cleat with an o-ring, as taught by Pierce’426, to aid in securing the flexible strand to the cleat.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
The claims of the patent "anticipate" the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claim. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 1-4, 6, 8 11 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6, 14, 20 of U.S. Patent No. 12,256,918. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application are anticipated by the claims of the ‘821 patent, as outlined in the chart below:
Claims of present application 19/090198
Anticipated by claims of 12,256,918
1
6 and 14
2
6 and 14
3
6 and 14
4
20
6
6 and 14
8
6 and 14
11
limitations of claim 11 are recited in claims 1 and 14
12
limitations of claim 12 are recited in claims 1 and 14
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Wednesday 9:30 am-5 pm and alternating Thursdays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 20 September 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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