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 without traverse of Group I, claims 1-11, in the reply filed on 12/2/2025 is acknowledged. Claims 12-20 are withdrawn.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the provisional application). The disclosure of the invention in the provisional application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed provisional application, Application No. 63/460,480, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim 1 recites “wherein stitching the passing loop construct at the second location wraps a strand of the passing loop construct around and over the length of the adjustable loop construct and holds the length of the adjustable loop [construct] against the graft adjacent the second location.” This feature was not disclosed until the filing of the instant application on 4/17/2024. This feature can be seen in Figs. 7A-7C, wherein the strand of the passing loop (755) wraps around and over the lengths (706a, 706, 707a, 707b, 709a, 709b) of the adjustable loop construct and holds these lengths against the graft (1655) adjacent the second location (2). The provisional application has only disclosed the strand of the passing loop construct going under the length of the adjustable loop construct and does not disclose holding the length of the adjustable loop construct against the graft adjacent the second location (akin to Figs. 3-5) of the instant application. Therefore, the earliest disclosure for the subject matter of claims 1-11 and thus the effective filing date for the subject matter of is 4/17/2024.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: static legs 707A and 709A as mentioned repeatedly on page 11 is not shown in the corresponding Fig. 2C; end 710 as mentioned on page 16, adjustable loop strands 708a, 708b as mentioned on page 18 is not shown in the corresponding Figs. 5A-5C.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 718A and 728A in Fig. 2C
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. 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.
Specification
The disclosure is objected to because of the following informalities: “cortical button 750” on page 19 should instead recite - - cortical button 740 - - to keep the reference number consistent.
Appropriate correction is required.
Claim Objections
Claims 3-11 are objected to because of the following informalities: a comma should be inserted after the reference claim (see for example claim 2 which is written properly: “The method of claim 1,”. 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 1-11 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, 3-5, 8, 9, 11 recite the limitation "the passing construct" numerous times. There is insufficient antecedent basis for this limitation in the claims. It is unclear if the passing construct is referring to the previously introduced passing loop construct or another separate passing construct. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret “the passing construct” as - - the passing loop construct - - that was previously introduced in claim 1.
Claim 1 recites the limitation "the adjustable loop" at the end of the claim. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the adjustable loop is referring to the previously introduced adjustable loop construct or another separate adjustable loop. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret “the adjustable loop” as - - the adjustable loop construct - - that was previously introduced in claim 1.
Claim(s) 2, 6, 7, 10 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) 1-3, 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hosseini et al (WO 2022/232126) in view of Spenciner (US 2021/0007840).
Claim 1. Hosseini et al discloses a method (Figs. 17-18) of coupling a suspensory fixation system to a graft (1655), the suspensory fixation construct including an adjustable loop construct (1700) and a passing loop construct (1750) linked thereto, the method comprising:
stitching the adjustable loop construct through (Fig. 17B) and around (Fig. 17D) the graft at a first location (1) along the graft, using the passing loop construct (p. 43-p. 44);
stitching the passing loop construct through the graft adjacent the first location to secure the adjustable loop construct to the graft (Fig. 17F; p. 45);
with the adjustable loop construct secured, laying a length of the adjustable loop along an outer surface of the graft and stitching the passing loop construct around and through the graft at a second location along the graft (p. 45; running whipstitch), the second location (3) disposed between the first location (1) and a free end (right side; 1660) of the graft (Fig. 17I; p. 45-48).
Hosseini et al fails to disclose stitching the passing loop construct at the second location (3) wraps a strand of the passing loop construct around and over the length of the adjustable loop construct and holds the length of the adjustable loop construct against the graft adjacent the second location. Instead, Hosseini et al teaches the passing loop construct being under the length of the adjustable loop (Figs. 17A-17J). However, in the same field of endeavor, Spenciner teaches a method of graft preparation of coupling a fixation system to a graft (402), the fixation system having a passing loop construct (strands 106, 108 used to form whipstitch loops 110; akin to the passing loop construct 1750 of Hosseini et al used to make a running whipstitch) and strands (116, 118) running longitudinally along the graft (akin to the length of the adjustable loop construct in Hosseini et al; see the portion labeled 700 in Figs. 18A-18B). Hosseini et al teaches stitching the passing loop construct at the second location (114) wraps a strand (110) of the passing loop construct around and over the length (116, 118) of the adjustable loop construct and holds the length of the adjustable loop construct against the graft adjacent the second location (Fig. 2; [0032]). 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 method of Hosseini et al such that stitching the passing loop construct at the second location wraps a strand of the passing loop construct around and over the length of the adjustable loop construct and holds the length of the adjustable loop construct against the graft adjacent the second location as taught by Spenciner to allow the length of the adjustable loop to function like a spine extending along the graft, thus improving the strength of the construct ([0035]).
Claim 2. The combination discloses the invention substantially as claimed above, wherein Hosseini et al further discloses the first location (1) is spaced away from the graft free end (1660) (Fig. 1).
Claim 3. The combination discloses the invention substantially as claimed above, wherein Hosseini et al further discloses stitching the passing loop construct around and through the graft at a third location (4) along the graft, the third location disposed between the second location (3) and the free end (1660) of the graft (Fig. 17J) and Spenciner discloses stitching the passing loop construct at the third location wraps the passing loop construct again around and over the length of the adjustable loop construct and holds the length of the adjustable loop against the graft adjacent the third location (Fig. 2; wherein the third location is the location below second location 114; [0032], [0035]).
Claim 10. The combination discloses the invention substantially as claimed above, wherein Hosseini et al further discloses drawing the adjustable loop construct along a bone tunnel, and thereby drawing the graft free end along the bone tunnel (p. 46).
Claim 11. The combination discloses the invention substantially as claimed above, wherein Hosseini et al further discloses the length of the adjustable loop construct includes multiple loop lengths (each of the six strands extending upward from location (1) in Figs. 18A-18B) of the adjustable loop construct and Spenciner discloses wherein stitching the passing loop construct at the second location inserts the passing loop construct through the graft at the second location (114) and splits the multiple loop lengths so that they extend along both sides of the second location (length 118 is on the left side of the loop (110) of the passing loop construct and length 116 is on the right side).
Allowable Subject Matter
Claims 4-9 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: In regards to claim 4, the closest prior art of record, Hosseini et al in view of Spenciner discloses the invention substantially as claimed above. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed method comprising, inter alia, coupling an end of the passing loop construct to the adjustable loop construct after stitching the passing construct around and through the graft at the second location. Instead, the end of the passing loop construct remains uncoupled to the adjustable loop construct after stitching the passing construct around and through the graft at the second location. Applicant discloses the advantage of such a configuration as shown in Figs. 5C and 5D and discussed in [0045]-[0046] of the published application. There is concomitant tension on a portion of the graft adjacent the first location (1) where the saddle end 704 extends around graft 1660 and also where the passing construct ends extend from graft 1660 (location (4)), closer to the free end 1660. By pulling on tool 725 (F) this concomitant tension helps to prevent the graft 1650 from folding.
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.
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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.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771