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 .
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 1-2, 4-5, 9-11, 16-18, 22, 28, and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stone, US 5,902,338, which innately discloses dissecting or cutting on both sides of a ligament-derived graft sample along its length in order to remove “adhering tissue” and thereby reduce its width (column 3, lines 30-31) so as to be capable of repairing a small to mid-sized joint or a less load bearing joint (column 3, lines 2-10), “small to mid-sized” and “less load bearing” being relative terminology (MPEP §§ 2173.05(b) and 2111.01) and the “subject” (Applicant’s claim 1, line 5) not being limited to humans, which themselves vary widely in size and weight, from infants to giants. In some embodiments, “ligament alone is harvested” with no bone attached (column 3, lines 24-26). Applicant’s claim 2 is drawn to a graft (single product), and in some variants of Stone, a portion of a ligament may be removed from an animal (abstract; column 2, lines 56-58; column 5, lines 19-20); even though cutting approximately in half is not mentioned, “[the] patentability of a product does not depend on its method of production” (MPEP § 2113).
Regarding claims 4-5, the obtained graft is structurally capable (MPEP § 2114) of repairing, for example, a talocrural joint or an elbow joint of a human or animal, particularly due to the diversity of sources (paragraph bridging columns 2 and 3) and the graft potentially being dissected and/or segmented (column 2, lines 56-58; column 3, lines 30-31). Regarding claims 9-11, joint repairing method steps are described at column 4, line 59, to column 5, line 5 (“anatomic insertion sites”, “interference screws”, etc.); the knee joint of a small child is viewed as small or mid-sized in comparison to the knee joint of an adult male or large mammal, and method claim 9 does not even require that “a joint” (at line 1) be small or mid-sized. Regarding claims 16-18, further resizing may involve the dissecting of an opposite side of the ligament-derived graft, after a first side has been dissected (column 3, lines 30-31), and then segmenting (column 2, lines 56-58); the “irreparably damaged ligament is removed” (column 4, line 67) and replaced (column 5, lines 3-4).
Regarding claim 22, one or more of the dissected and/or segmented ligament portions have dimensions suitable for repairing a small to mid-sized joint or a less load bearing joint (abstract; column 2, lines 19-21 and 49-58; column 3, lines 24-31; column 4, line 59, to column 5, line 5). Regarding claim 28, a ligament portion may be resized (as noted above), cleaned (column 3, lines 32-34), sterilized (column 3, lines 34-36), and so forth (column 3, line 38, et seq.). Regarding claims 30-31, the further limitations are not positively recited as method steps, and at least some of the ligament portions are structurally capable of being implanted across such joints, as explained above relative to Applicant’s claims 4-5.
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.
Claims 6, 8, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Stone, US 5,902,338. Regarding claims 6 and 26, values within the specified ranges would have been obvious to the ordinary practitioner at the effective filing date of the present invention from the range of donor sizes (column 2, line 59, to column 3, line 10) in order to provide for a diversity of dimensions among patients and knee joints. Regarding claim 8, a ligament-derived allograft from a human cadaver would have been obvious in order to serve as a control in experiments on immunogenic response characteristics and would have been obvious in order to provide a more appropriately sized ligament replacement.
Allowable Subject Matter
Claim 7 is allowed.
Claims 12-15, 20-21, 23-24, and 27 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.
Response to Arguments
Applicant’s remarks have been considered but are deemed moot in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure:
US 6,235,057 B1: Figures 10-11; column 2, lines 28-33 and 40-41; column 3, lines 48-59.
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL (MPEP § 706.07(a)). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David H. Willse, whose telephone number is 571-272-4762. The examiner can normally be reached on Monday through Thursday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Melanie Tyson can be reached at telephone number 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID H WILLSE/ Primary Examiner, Art Unit 3774
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