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 .
Election/Restrictions
Applicant's election with traverse of species A in the reply filed on 01 July 2026 is acknowledged. The traversal is on the ground(s) that the overlapping scope of species A and B would not be overly burdensome to conduct a search. The examiner agrees with such traversal. Therefore, the restriction requirement between species A and B has been withdrawn. Claims 4 and 19 will be examined on the merits along with claims 1-3, 5-18 and 20.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: fixation device(s) in claims 5-8, 11-14, 16, 17 and 20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 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.
Claims 1, 11 and 17 recites the limitation "the approximation" in line 1. There is insufficient antecedent basis for this limitation in the claims.
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 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.
Claim(s) 1, 2, 4-8, 10-14, 16, 17, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moore et al. U.S. PG-Pub 2019/0069890 in view of Donate et al., U.S. PG-Pub 2013/0030480.
Regarding claim 1, Moore et al. discloses a method for approximation of two bones, the method comprising: engaging a first anchor (82) with a first bone (6); fixating a second anchor (38) to a second bone (4); fixating a flexible segment (32) between the first anchor and the second anchor, wherein the flexible segment is configured to adjust a distance between the first and second bones, and wherein the flexible segment comprises one or more suture ends (both 26b) extending from the second anchor and proximally from the second bone; and fixating both suture ends to the first bone (via anchors 40a, 40b) at a first distance from the first anchor (Fig. 7 and paragraph [0035]).
Moore et al. does not disclose the flexible segment extending proximally from the second anchor.
Donate et al. discloses a device for approximating two bones with a first anchor (22) engaged with a first bone (84); a second anchor (24) fixated to a second bone (82); and a flexible segment (40) with a suture end that extends proximally from the second anchor and the second bone (Figs. 4B and 6F) as such configuration allows the flexible segment to be pulled through the second anchor in the direction of arrow 66 (Fig. 4B) to pull the first and second anchors closer to one another, but also allows one-way passage of the flexible segment such that the flexible segment is prevented from being pulled in the opposite direction to permit the system to hold whatever tension is created by the surgeon pulling on the flexible segment (paragraphs [0022]-[0023]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flexible segment of Moore et al. to extend proximally from the second anchor in view of Donate et al. such that the flexible segment allows for one-way passage through the second anchor thus preventing the flexible segment from being pulled in an opposite direction to permit the system to hold whatever tension is created by the surgeon.
Regarding claims 2 and 4, Moore et al. discloses wherein engaging the first anchor (82) with the first bone (6) comprising fixating the first anchor to the first bone (via flexible segment 34); wherein engaging the first anchor (82) with the first bone comprising engaging the first anchor with a first side of the first bone (6) (examiner annotated Fig. 7 below).
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Regarding claims 5-8 and 10, Moore et al. discloses wherein fixating the suture ends (both 26b) to the first bone (6) comprises fixating a first suture end with a first fixation device (40a); fixating the first fixation device to a posterior side of the first bone; engaging a second suture end with a second fixation device (40b); and fixating the second fixation device to an anterior side of the first bone; wherein fixating the suture ends to the first bone restricts rotation of the second bone (4) with respect to the first bone (6) (examiner annotated Fig. 7 above and paragraphs [0025], [0035], [0037]).
Regarding claims 11-14, 16, 17, and 20 Moore et al. discloses a method for approximation of two bones, the method comprising: engaging a first anchor (82) with a first bone (6); fixating a second anchor (38) to a second bone (4); fixating a flexible segment (32) between the first anchor and the second anchor, wherein the flexible segment is configured to adjust a distance between the first and second bones, and wherein the flexible segment comprises one or more suture ends (both 26b) extending from the second anchor and proximally from the second bone; engaging a first suture end (26b) with a first fixation device (40a); engaging a second suture end (also 26b) with a second fixation device (40b); fixating the first fixation device to a posterior side of the first bone; and fixating the second fixation device to an anterior side of the first bone at a first distance from the first anchor; and wherein fixating the fixation devices to the anterior and posterior sides of the first bone restricts rotation of the second bone with respect to the first bone (examiner annotated Fig. 7 and paragraphs [0025], [0035], [0037]).
Moore et al. does not disclose the flexible segment extending proximally from the second anchor.
Donate et al. discloses a device for approximating two bones with a first anchor (22) engaged with a first bone (84); a second anchor (24) fixated to a second bone (82); and a flexible segment (40) with a suture end that extends proximally from the second anchor and the second bone (Figs. 4B and 6F) as such configuration allows the flexible segment to be pulled through the second anchor in the direction of arrow 66 (Fig. 4B) to pull the first and second anchors closer to one another, but also allows one-way passage of the flexible segment such that the flexible segment is prevented from being pulled in the opposite direction to permit the system to hold whatever tension is created by the surgeon pulling on the flexible segment (paragraphs [0022]-[0023]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flexible segment of Moore et al. to extend proximally from the second anchor in view of Donate et al. such that the flexible segment allows for one-way passage through the second anchor thus preventing the flexible segment from being pulled in an opposite direction to permit the system to hold whatever tension is created by the surgeon.
Regarding claim 19, Moore et al. discloses wherein engaging the first anchor (82) with the first bone (6) comprising engaging the first anchor with a first side of the first bone (examiner annotated Fig. 7 above).
Claim(s) 9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moore et al. U.S. PG-Pub 2019/0069890 in view of Donate et al., U.S. PG-Pub 2013/0030480 as applied to claims 5 and 11 above, and further in view of Choinski, U.S. PG-Pub 2014/0243892.
Regarding claims 9 and 15, Moore et al. in view of Donate et al. discloses the invention essentially as claimed except for wherein the fixation devices are knotless anchors.
Choinski discloses using knotless (zero profile) anchors for fixation of ligaments (paragraph [0060]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the fixation devices of Moore et al. to be knotless anchors further in view of Choinski to permit zero profile fixation of soft tissue to the bones.
Claim(s) 1, 3, 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donate et al., U.S. PG-Pub 2013/0030480 in view of Moore et al. U.S. PG-Pub 2019/0069890.
Regarding claims 1, 3, 17, and 18, Donate et al. discloses a method for approximation of two bones, the method comprising: engaging a first anchor (22) with a first bone (84); fixating a second anchor (24) to a second bone; fixating a flexible segment (40) between the first anchor and the second anchor, wherein the flexible segment comprises a suture end extending proximally from the second anchor and the second bone (along direction 66); and wherein engaging the first anchor with the first bone comprises inserting a distal end (34) of the first anchor into a first hole (86) in a first side of the first bone (84) such that there is a first distance between the distal end of the first anchor and a second side of the first bone (Figs. 4A-4B and examiner annotated Fig. 6F below).
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Donate et al. does not disclose engaging the suture end with a first fixation device; and fixating the first fixation device to an anterior side of the first bone at a first distance from the first anchor.
Moore et al. discloses a system having first (82) and second (38) anchors with a flexible segment (32), wherein the flexible segment has suture ends (26b) engaged with fixation devices (40a, 40b) that are fixated to anterior and/or posterior sides of a first bone (6) at a first distance from the first anchor (examiner annotated Fig. 7 above) as such permits coupling soft tissue to the bone at a substantially anatomically correct position to facilitate repair and/or reattachment of soft tissue (paragraph [0028]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Donate et al. to include a first fixation device engaged with the suture end and fixated to an anterior side of the first bone at a first distance from the first anchor in view of Moore et al. to permit coupling soft tissue to the bone at a substantially anatomically correct position to facilitate repair and/or reattachment of soft tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775
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