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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/11/25 has been entered.
Response to Arguments
Applicant's arguments filed 09/11/25 have been fully considered but they are not persuasive.
On pages 10-11 regarding 112 rejections, Applicant argues support for “without tunneling the plurality of lengths of soft-tissue graft within the first bone” is found in page 7 lines 1-6 and 9-11, and Figure 1c, 2b, and 4a.
The Examiner respectfully disagrees, noting none of these locations in the specification or figures references “without tunneling the plurality of lengths of soft-tissue graft within the first bone” as would be required to show support. The Examiner agrees page 7 lines 1-11 describes how drilling a tunnel has drawbacks. The specification is mute with regards to “tunneling” generally, and none of the figures of the instant invention discuss tunneling one way or another. The specification is also mute with regards to a plurality of lengths being tunneled through the bone.
On pages 12-17 Applicant argues the amendment overcomes the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 7, 12-14, 17-20, 23, 26-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 13, and 28 are rejected for having new matter for claiming a “plurality of lengths of the soft-tissue graft” “extend from the first bone to a second bone…without tunneling the plurality of lengths of soft-tissue graft within the first bone”. Notably, the disclosure does not discuss how the “plurality of lengths” of the graft relate to the first bone at all. While the specification page 7 lines 1-9 appears to state negative outcomes from placing “a biologic soft-tissue graft” within “tunnels 22, 23 to replace the spanning ligament 1”, this does not appear to relate to the plurality of lengths in any way. It also only appears to relate to drilling in the bone, and does not refer to tunneling.
Claim 29 is rejected for having new matter, for claiming “ arranging the plurality of lengths of the soft-tissue graft to extend from the first bone to the second bone…without tunneling the plurality of lengths…within the second bone”. Notably, there is no support for this in the originally filed disclosure, since it does not discuss whether or not the soft tissue graft can/should extend within the second bone at all, or whether/how the “plurality of lengths” could extend relating to either the first or second bone. The Examiner refers Applicant to MPEP 2173.05(i) which states that “[t]he mere absence of a positive recitation is not basis for an exclusion. Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement.”
Remaining claims are rejected for depending on a claim with new matter.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 7, 13, 17-19, 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jurgutis (US 4592346 A) in view of Hlavacek et al. (US 4792336 A) hereinafter known as Hlavacek, and further in view of Wevers (US 4246660 A).
Regarding claims 1 and 13 Jurgutis discloses a method of intra-articular ligament reconstruction (Column 1 lines 6-8, 11-13; Figure 1 shows an anterior cruciate ligament (ACL) reconstruction) comprising:
fixing/capturing a soft-tissue graft (Column 2 lines 36-38) on a native cortical bone surface of a native first bone of a joint within a human body (see Figure 1 where ligament 11 is fixed on the top outer surface of bone 10) between a first two sites of the first bone (Figures 1-2 show the graft 11 fixed between sites corresponding to legs 24/21/20/25; two of the legs and their corresponding locations where they dig into the bone 10 are considered to be the first two sites) with a first loop extending over the bone surface and engaging the first two sites (Figures 1-2 shows the top surface 15 of the loop extending over the surface of the bone to join the two sites represented at the legs 24/21/20/25);
arranging a length of the graft to extend from the first bone to a second bone of the joint (Figure 1 shows the ligament 11 extending between the two bones of the knee joint) to restore an anatomy of a native intra-articular ligament with the soft-tissue graft (Figure 1; Column 1 lines 6-11); and
fixing/connecting the graft to the second bone (Figure 1; Column 2 lines 42-44),
but is silent with regards to the graft having a plurality of lengths,
and the method including fixing the graft at a native intra-articular ligament attachment site of the first bone and the second bone,
and extending the soft-tissue graft without tunneling within the first bone.
However, regarding claims 1 and 13 Wevers teaches that methods of ligament reconstruction can include fixing a graft at a native ligament attachment site (Column 5 lines 19-22) so the graft extends without tunneling a first bone (Figure 4). Jurgutis and Wevers are involved in the same field of endeavor, namely ligament reconstruction methods. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Jurgutis by securing the tendon in place without tunneling at a native site as is taught by Wevers since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the securement of the ligaments without tunneling, to native attachment sites would have been obvious to try in order to mimic native anatomy. Considering the Combination is repair an ACL, the person of ordinary skill in the art understands the obviousness of securing the ligament of the Combination at the native intra-articular ACL attachment sites of the two bones.
Further, regarding claims 1 and 13 Hlavacek teaches that ligament reconstruction with a soft-tissue graft (Column 1 lines 11-13) can include a plurality of lengths of graft (Figures 1-2, Column 4 lines 58-59). Jurgutis and Hlavacek are involved in the same field of endeavor, namely soft-tissue grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Jurgutis Wevers Combination so that the graft included multiple lengths as is taught by Hlavacek since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). In this case, the use of a graft made of multiple fibers (or lengths) of material is considered obvious to try and substitute for the ligament 11 of Jurgutis.
Regarding claim 7 the Jurgutis Wevers Hlavacek Combination teaches the method of claim 1 substantially as is claimed,
wherein Jurgutis further discloses the graft is unfolded (Figure 1 shows an unfolded ligament 11), and wherein Hlavacek further teaches their graft is unfolded (Figures 2 and 4; Column 4 lines 59-61 parallel fibers).
Regarding claims 17-18 the Jurgutis Wevers Hlavacek Combination teaches the method of claim 1 substantially as is claimed,
wherein Hlavacek further teaches at least two of the plurality of lengths of soft-tissue graft are discontinuous from each other (Figures 2, 4;Column 4 lines 58-59).
Regarding claim 19 the Jurgutis Wevers Hlavacek Combination teaches the method of claim 1 substantially as is claimed,
wherein Jurgutis further discloses fixing the graft to the second bone includes the graft being fixed on a native cortical bone surface of the second bone between a second two sites of the second bone with a second loop extending over the surface and engaging the second two sites (Figure 1; Column 2 lines 42-44; the ligament 11 extends to the second bone of the knee joint with staple 13 including four attachment sites at four respective legs (Fig 2 items 20/21/24/25), two of which are considered to be the second two sites, with the loop being represented by the legs and surface 15 of the staple 12).
Regarding claim 29 the Jurgutis Wevers Hlavacek Combination teaches the method of claim 1 substantially as is claimed,
wherein Wevers further teaches the graft can extend from the first to the second bone without tunneling within the second bone (Figure 4).
Regarding claim 30 the Jurgutis Wevers Hlavacek Combination teaches the method of claim 1 substantially as is claimed,
wherein Jurgutis further teaches the ligament being reconstructed is an intra-articular ligament (Figure 1 – as is best understood this ligament is intra-articular), and wherein Hlaveck further teaches the ligament is intra-articular (Column 1 lines 13-14).
Regarding claim 28 Jurgutis discloses a method of intra-articular ligament reconstruction (Column 1 lines 6-8, 11-13; Figure 1 shows an anterior cruciate ligament (ACL) reconstruction) comprising:
fixing a soft-tissue graft (Column 2 lines 36-38; Figure 1 item 11) on a first location of a native cortical bone surface of a native first bone of a joint within a human body, and fixing the graft on a second location of the surface so the graft is captured on the surface between the first and second locations (Figure 1 shows the graft 11 fixed at four locations with legs 20/21/24/25 of the connector 12 representing each fixation point);
arranging a length of the graft to extend from the first bone to a second bone of the joint (Figure 1 shows the ligament 11 extending between the two bones of the knee joint) to restore an anatomy of a native intra-articular ligament with the soft-tissue graft (Figure 1; Column 1 lines 6-11); and
fixing the graft to the second bone (Figure 1; Column 2 lines 42-44),
but is silent with regards to the graft having a plurality of lengths,
and the method including fixing the graft at a native intra-articular ligament attachment site,
and extending the soft-tissue graft without tunneling within the first bone.
However, regarding claims 28 Wevers teaches that methods of ligament reconstruction can include fixing a graft at a native ligament attachment site (Column 5 lines 19-22) so the graft extends without tunneling a first bone (Figure 4). Jurgutis and Wevers are involved in the same field of endeavor, namely ligament reconstruction methods. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Jurgutis by securing the tendon in place without tunneling at a native site as is taught by Wevers since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the securement of the ligaments without tunneling, to native attachment sites would have been obvious to try in order to mimic native anatomy. Considering the Combination is repair an ACL, the person of ordinary skill in the art understands the obviousness of securing the ligament of the Combination at the native intra-articular ACL attachment sites of the two bones.
However, regarding claim 28 Hlavacek teaches that ligament reconstruction with a soft-tissue graft (Column 1 lines 11-13) can include a plurality of lengths of graft (Figures 1-2, Column 4 lines 58-59). Jurgutis and Hlavacek are involved in the same field of endeavor, namely soft-tissue grafts. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Jurgutis Wevers Combination so that the graft included multiple lengths as is taught by Hlavacek since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). In this case, the use of a graft made of multiple fibers (or lengths) of material is considered obvious to try and substitute for the ligament 11 of Jurgutis.
Claims 12, 14, 20, 23, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jurgutis, Wevers, and Hlavacek as is applied above, further in view of Frazier (US 5968045 A).
Regarding claims 12, 23, and 26 the Jurgutis Wevers Hlavacek Combination teaches the method of ligament reconstruction of claim 13 substantially as is claimed,
but is silent with regards to the graft being captured on the surface with a second loop so the graft is on the bone surface between the two loops.
However, regarding claims 12, 23, and 26, Frazier teaches a method of ligament reconstruction that includes capturing a soft-tissue graft (Figure 3 item 1) on a bone surface (Figure 3 item 31) in two locations on the bone surface (Figure 3 shows two staples 37 securing the graft on two locations on one bone surface), so that the graft is fixed on the surface between the second two sites of the first bone (clm 12) (Figure 3). Jurgutis and Frazier are involved in the same field of endeavor, namely soft-tissue repair. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Jurgutis Wevers Hlavacek Combination so that the graft is captured at two locations as is taught by Frazier so that the Combination captures the graft with a second loop, since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known pattern of securement, including that shown by Frazier, would have been obvious to try. The Examiner notes that the Combination results in the use of two staples, which each fix the graft on the bone surface, and each engaging in (at least) two sites (claim 12).
Regarding claim 14 the Jurgutis Wevers Hlavacek Combination teaches the method of claim 13 substantially as is claimed,
but is silent with regards to capturing the graft on the bone surface with a second loop so the graft is on the surface between the two loops.
However, regarding claim 14 Frazier teaches a method of ligament reconstruction that includes capturing a soft-tissue graft (Figure 3 item 1) on a bone surface (Figure 3 item 31) in two locations on the bone surface so the graft extends over the surface between the two locations (Figure 3 shows the two locations of securement at staples 37 with the graft extending therebetween). Jurgutis and Frazier are involved in the same field of endeavor, namely soft-tissue repair. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Jurgutis Wevers Hlavacek Combination so that the graft is captured at two locations as is taught by Frazier so that the Combination captures the graft with a second loop, since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known pattern of securement, including that shown by Frazier, would have been obvious to try.
Regarding claim 20 the Jurgutis Wevers Hlavacek Frazier Combination teaches the method of claim 14 substantially as is claimed,
wherein Jurgutis further discloses the graft is captured on a cortical bone surface of the second bone between a third two sites of the second bone, with a third loop extending over the surface of the second bone and engaging the third two sites (Figure 1; Column 2 lines 42-44; the ligament 11 extends to the second bone of the knee joint with staple 13 including four attachment sites at four respective legs (Fig 2 items 20/21/24/25)).
Claim 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jurgutis, Wevers, and Hlavacek as is applied above, further in view of Del Medico (US 4913144 A).
Regarding claim 27 the Jurgutis Wevers Hlavacek Combination teaches the method of claim 1 substantially as is claimed,
but is silent with regards to the loop having an adjustable length.
However, regarding claim 27 Del Medico teaches a bone fastener (Abstract) which secures at (at least) two sites (represented by legs Figure 1 items 12, 14)) and includes an adjustable length (Abstract). Jurgutis and Del Medico are involved in the same field of endeavor, namely bone fasteners. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Jurgutis Wevers Hlavacek Combination so that the loop has an adjustable length as is taught by Del Medico in order to ensure the loop can be fit to whatever size, diameter, or bulk of ligament is desired, thus ensuring greater compatibility with fibers of different make/models and increasing the number of patients the method can help.
Conclusion
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 10/27/25