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 of Group I, claims 1-18, in the reply filed on 12/2/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 19-31 are withdrawn and their claim status should accordingly be changed to “withdrawn”.
Drawings
The drawings are objected to because the drawings are not provided in a clear black and white format. The gray shading throughout the drawings renders the features unclear. See MPEP 608.02 and 37 CFR 1.84.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the interposition material of claims 16 and 17 and its use in the method as claimed must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2, 4, 5 and 6 are objected to because of the following informalities:
Claims 2 and 3 recite “the first passing step” and claims 5 and 6 recite the second passing step”. These terms are not defined in claim 1 as “a first passing step” and “a second passing step” even though there are two instances of “passing”. Claim 1 should be amended to recite - - a first passing step of passing one of the free arm and the loop arm through a hole in the first bone segment - - in line 7, and claim 1 should further recite - - a second passing step of passing the free arm through the suture loop of the loop arm” in line 8 to provide proper antecedent basis for these passing steps. Appropriate correction is required.
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 16 and 17 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 16 recites the limitation "the excision of a trapezium bone" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is therefore unclear if the step of excising a trapezium bone is required by the claim.
Claim(s) 17 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent 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, 7, 9, 10, 13 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al (US 2010/0016892) in view of Gordon et al (US 2013/0172893).
Claim 1. A method (Figs. 1-11) comprising:
securing at least a part of a middle portion of a suture construct (15) to a second bone segment (B), wherein the suture construct further includes a loop arm (L) and a free arm (55, 60) positioned such that the middle portion extends from the loop arm to the free arm, and a suture loop (L) at a terminal end of the loop arm (see annotated figure below);
passing one of the free arm (55) and the loop arm through a hole in a first tissue segment (T) (Fig. 8; [0060]);
passing the free arm (55) through the suture loop of the loop arm; and
sliding the suture loop (L) along the free arm (55) toward the first tissue segment (T) so as to draw together the first tissue segment and the second bone segment (B) to establish a reduced position of the first tissue segment and the second bone segment (Figs. 8-11; [0061], [0062]; i.e. pulling on tightening end 60 slides the loop L downward in the figures, along the free arm 55).
Kaiser et al fails to disclose the method is for positioning a first bone segment relative to a second bone segment within a subject's body and that the free arm is passed through a hole in the first bone segment. Instead, Kaiser et al disclose a first tissue segment and the free arm (55) being passed through the hole in the first tissue segment (T). However, Kaiser et al does disclose the first tissue segment (T) in the method does not necessarily need to be soft tissue and that instead the method can be used to secure “substantially any object to substantially any bone” ([0105], [0106]).
In the same field of endeavor, Gordon et al teaches a method for positioning a first bone segment (106) relative to a second bone segment (108) within a wrist of a subject's body using a suture construct (500) with a free arm that is passed through a hole in the first bone segment (Fig. 5, 6a) to therefore form a closed loop of approximating the two bone segments ([0040]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to before the effective filing date of the invention to modify the “any object” or soft tissue (T) in Kaiser et al to be a first bone segment instead as taught by Gordon et al to perform repairs of acute wrist injuries ([0002]).
PNG
media_image1.png
608
553
media_image1.png
Greyscale
Claim 2. The combination as modified discloses the invention substantially as claimed above, wherein Kaiser et al discloses the securing step is performed prior to the first passing step (Fig. 7; [0058]).
Claim 4. The combination as modified discloses the invention substantially as claimed above, wherein Kaiser et al discloses contracting the suture loop (L) around the free arm (55) (Fig. 9) following the step of passing the free arm through the suture loop (Fig. 8) ([0061]).
Claim 7. The combination as modified discloses the invention substantially as claimed above, wherein Kaiser et al as modified with Gordon et al above results in the tissue (T) being replaced with a first bone segment, Kaiser et al then further discloses the step of securing the first bone segment relative to the second bone segment in the reduced position (Fig. 11; [0061]).
Claim 9. The combination as modified discloses the invention substantially as claimed above, wherein Kaiser et al discloses the middle portion of the suture construct is secured to the second bone segment using a suture anchor (10) ([0043]-[0046]).
Claim 10. The combination as modified discloses the invention substantially as claimed above, wherein Kaiser et al discloses the suture construct (15) is formed from suture thread ([0045]; i.e. strand).
Claim 13. The combination as modified discloses the invention substantially as claimed above, wherein Gordon et al discloses the first bone segment (106) and the second bone segment (108) are of different bones ([0013]).
Claim 18. The combination as modified discloses the invention substantially as claimed above, but fails to explicitly disclose each of the loop arm, free arm, and middle portion of the suture construct comprises two or more suture strands. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the single strand of Kaiser et al to two or more suture strands, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Furthermore, Applicant has not provided evidence of the criticality of the claimed “two or more strands” in the instant specification. In paragraph [0021] of the instant specification as published, Applicant discloses exemplary numbers of strands including just a single (“one”) suture strand. However, Applicant has not provided evidence, such as how the claimed two or more strands have unexpected results over the prior art.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al in view of Gordon et al as applied to claim 1 above, and further in view of Sengun et al (US 2018/0303475).
Claim 3. The combination as modified discloses the invention substantially as claimed above but fails to disclose the securing step is performed after the first passing step. Kaiser et al instead discloses the opposite, wherein the securing step is performed before the first passing step.
However, in a field of similar endeavor, Sengun et al teaches a method of coupling a first element (62) to a second element (60) together using a suture construct (40) having a free arm (48a) and a loop end (46, 50), wherein a middle portion of the suture construct is secured to the second element (60) after passing the loop arm through the first element (Figs. 8-15). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to switch the order of the steps such that the securing step is performed after the first passing step as taught by Sengun et al because it is noted that to switch the order of the method steps would be obvious absent any clear and convincing evidence and/or arguments to the contrary because both orders of the method would result in securing of at least a part of a middle portion of the suture construct to the second bone segment (MPEP 2144.04 [R-1]). “Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al in view of Gordon et al as applied to claim 1 above, and further in view of Breslich (US 2017/0181739).
Claim 11. The combination as modified discloses the invention substantially as claimed above, but fails to disclose the suture construct is formed from suture tape. However, in a field of similar endeavor, Breslich teaches a suture construct formed of suture tape ([0005]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to have the suture construct formed of suture tape as taught by Breslich since suture tape advantageously can more evenly distribute pressured ([0005]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al in view of Gordon et al as applied to claim 1 above, and further in view of Corrao et al (US 2012/0143215).
Claim 12. The combination as modified discloses the invention substantially as claimed above, but fails to disclose the first bone segment and the second bone segment are of the same bone. However, in a field of similar endeavor, Corrao et al teaches a suture construct for coupling two elements together, wherein the elements are first (24a) and second (24b) bone segments of the same bone (Figs. 52-55; [0566]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to have the first and second bone segment be of the same bone to allow the method to repair a fracture (24c) in a bone ([0566]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser et al in view of Gordon et al as applied to claim 1 above, and further in view of Choinski (US 2013/0245700).
Claim 14. The combination as modified discloses the invention substantially as claimed above, but fails to disclose the first bone segment is a first metacarpal bone, and the second bone segment is a second metacarpal bone. Instead, Gordon et al teaches the bones are from the wrist ([0013]). However, in the same field of endeavor, Choinski teaches a method for repairing the hand using a suture construct (112, 114) to approximate a first metacarpal bone (310) and a second metacarpal bone (320) (Figs. 5-13). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first and second bone segments of the combination to a first metacarpal bone and a second metacarpal bone as taught by Choinski to allow the method to repair a carpometacarpal joint from arthritis ([0002]-[0004]).
Allowable Subject Matter
Claims 5, 6, 8 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, as detailed above discloses the invention substantially as claimed.
In regards to claim 5, the prior art prior art of record does not disclose or fairly suggest either singly or in combination the claimed method comprising, inter alia, the second passing step further comprises sliding the suture loop along the free arm until it contacts the first bone segment. Instead, Kaiser et al discloses sliding the suture loop along the free arm to pull it away from the first bone segment to jam tightly the loop and free arm between the suture anchor body (10) and the second bone segment (B) (Figs. 9-11; [0061]). Therefore, it would not have been obvious to modify the prior art as claimed as Kaiser et al teaches away from the claimed invention
In regards to claim 6, the prior art prior art of record does not disclose or fairly suggest either singly or in combination the claimed method comprising, inter alia, the hole extends from a first side of the first bone segment to an opposed second side of the first bone segment, and the second passing step comprises sliding the suture loop along the free arm toward the second side of the first bone segment. Instead, Kaiser et al discloses sliding the suture loop along the free arm away from the second side (right side) of the first bone segment to jam tightly the loop and free arm between the suture anchor body (10) and the second bone segment (B). Therefore, it would not have been obvious to modify the prior art as claimed as Kaiser et al teaches away from the claimed invention
In regards to claim 8, the prior art prior art of record does not disclose or fairly suggest either singly or in combination the claimed method comprising, inter alia, the securing first bone segment relative to the second bone segment in the reduced position comprises forming a knot using the free arm proximate to a location where the suture loop engages the free arm. Instead, Kaiser et al discloses its method as allowing the surgeon to not have to tie a knot due to the ability to hole the suture construct in place by jamming tightly the loop and free arm between the suture anchor body (10) and the second bone segment (B) (Figs. 9-11; [0061]). Therefore, it would not have been obvious to modify the prior art as claimed as Kaiser et al teaches away from the claimed invention
In regards to claim 15, the prior art prior art of record does not disclose or fairly suggest either singly or in combination the claimed method comprising, inter alia, the middle portion of the suture construct is secured to the second metacarpal facet of the second metacarpal bone. Instead, Choinski teaches the suture construct secured to the lateral side of the second metacarpal bone (Fig. 11).
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE M SHI/Primary Examiner, Art Unit 3771