DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
2. Applicant’s amendment of claims 1, 6, 10, 15, and 17 in the reply filed on 05 September 2025 is acknowledged.
3. Applicant’s addition of claim 18 in the reply filed on 05 September 2025 is acknowledged.
Terminal Disclaimer
4. The terminal disclaimer filed on 05 September 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 9,283,077 B2 and U.S. Patent No. 10,022,230 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
5. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
6. Claims 1-10, 12, 15, and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weissberg (US PG Pub No. 2008/0255665 A1; cited in Applicants’ IDS) in view of Tipirneni (US 7,591,823 B2; cited in Applicants’ IDS).
Regarding independent claim 1 and dependent claim 2, and referring to Figures 1-6, Weissberg ‘665 discloses an implant system for implantation at a joint, the implant system including an implant device, the implant device comprising:
a body portion (5) having first (50) and second (51) ends,
a first elongate member (first interpretation - member 20; second interpretation – since the claim language is silent regarding the particular structure, metes, and bounds for said “elongate member”, then said “elongate member” could also be broadly interpreted to include a part of the first end of the crescent-shaped body, along with the "connection point", and anchoring member 20) extending from the first end of the body portion, the first elongate member comprising at least one cooperating element (Figures 1, 2, and 6 - cooperating elements 30, 35; Figure 3 – cooperating element 150), the first elongate member terminating in a free end, and
a second elongate member (first interpretation - member 21; second interpretation – since the claim language is silent regarding the particular structure, metes, and bounds for said “elongate member”, then said “elongate member” could also be broadly interpreted to include a part of the second end of the crescent-shaped body, along with the "connection point", and anchoring member 21) extending from the second end of the body portion, the second elongate member comprising at least one cooperating element (Figures 1, 2, and 6 - cooperating elements 31, 36; Figure 3 – cooperating element 250), the second elongate member terminating in a free end.
The first elongate member is insertable in a tunnel (101) in a subject's bone, the tunnel having first (a) and second (b) open ends. As clearly shown in Figures 4B, 4C, 5A, 5B, and 6, tunnel 101 comprises a fixation area (bore section 111; anchoring surface 115; and bore section 121) for securing the first elongate member to a subject. Said fixation area comprising at least one latching element (at least anchoring surface 115; however, paragraph [0048] teach that a stepped locking system is also contemplated). The at least one cooperating element of the first elongate member is clearly shown in the figures as being capable of cooperating with said at least one latching element of the fixation area in use.
Weissberg ‘665 does not teach said fixation area as a fixation device insertable in said tunnel in a subject's bone. As shown in Figures 1-4G, Tipirneni ‘823 teaches an implant system comprising a body portion having a first elongate member (12) extending from the first end of the body portion and a corresponding fixation device (20) insertable in a tunnel in a subject’s bone, wherein the fixation device comprises at least one latching element (saw teeth of interface 22) capable of cooperating with at least one cooperating element (saw teeth of interface 14) of the first elongate member such that the first elongate member is restricted from backwards movement in order to fix said first elongate member of said body portion in said tunnel in a subject’s bone (Abstract; C4:L35-50; claim 1).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to have combined the teaching of an implant system comprising a body portion having a first elongate member extending from the first end of the body portion and a corresponding fixation device for securing the elongate member to a subject, wherein the fixation device comprises at least one latching element capable of cooperating with at least one cooperating element of the elongate member, as taught by Tipirneni ‘823, with the implant system of Weissberg ‘665, such that the elongate member is restricted from backwards movement in order to fix said first elongate member of said body portion to a subject (e.g., in said tunnel in a subject’s bone).
As noted by the United States Supreme Court, if a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. KSR, 127 S. Ct. at 1740. "When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product is not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show it was obvious under 35 U.S.C. 103." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82USPQ2d 1385, 1396 (2007).
Regarding claim 3, it would have been obvious to a person having ordinary skill in the art to have used a second corresponding fixation device with the implant system of Weissberg ‘665, as modified by Tipirneni ‘823, for securing the second elongate member to a subject, said fixation device comprising at least one latching element (saw teeth), the second elongate member comprising at least one cooperating element (Figures 1, 2, and 6 - cooperating elements 31, 36; Figure 3 – cooperating element 250), the at least one cooperating element of the second elongate member being capable of cooperating with said at least one latching element of said fixation device in use, 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. A mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 4, Weissberg ‘665, as modified by Tipirneni ‘823, teach wherein said at least one latching element and said at least one corresponding cooperating element comprise a ratchet mechanism (Tipirneni ‘823 ratchet mechanism defined by teeth and inversed teeth of interfaces 14 and 22; see Abstract; C4:L35-50; claim 1).
Regarding claim 5, Weissberg ‘665, as modified by Tipirneni ‘823, teach wherein the ratchet mechanism comprises at least one ratchet element (tooth of sawteeth) and at least one ratchet stop (inverse tooth of sawteeth), the at least one ratchet element being capable of cooperating with the at least one ratchet stop in use (Tipirneni ‘823 - Abstract; C4:L35-50; claim 1).
Regarding claim 6, Weissberg ‘665, as modified by Tipirneni ‘823, teach wherein the first and/or second elongate member has a plurality of ratchet teeth (Tipirneni ‘823 - teeth 14; see Abstract; C4:L35-50; claim 1).
Regarding claim 7, Weissberg ‘665, as modified by Tipirneni ‘823, teach wherein the first and/or second elongate member terminates in a free end and wherein each ratchet tooth comprises a first surface angled relative to said elongate member, the first surface sloping towards said elongate member in a direction towards the free end of said elongate member, and a second surface which slopes towards said elongate member in a direction away from the free end of said elongate member, said second surface being more steeply sloped than said first surface (Tipirneni ‘823 - Abstract; C4:L35-50; claim 1).
Regarding claim 8, at least Figures 1-3 of Weissberg ‘665 show wherein at least a portion of the first and/or second elongate member is strap-shaped or substantially crescent-shaped in cross-section.
Regarding claim 9, Weissberg ‘665, as modified by Tipirneni ‘823, teach wherein the first and/or second fixation device is adapted to be secured to a subject's bone in use (as explained above, in the rejection of claim 1).
Regarding claim 10, Weissberg ‘665, as modified by Tipirneni ‘823, teach wherein said fixation device is adapted to be screwed to bone (Tipirneni ‘823 - see outer threads 22 or outer threads 26).
Regarding claim 12, Weissberg ‘665 teach wherein the first and/or second elongate member is insertable in a tunnel (101) in a subject's bone, the tunnel having first (a) and second (b) open ends. As clearly shown in Figures 4B, 4C, 5A, 5B, and 6, tunnel 101 comprises a fixation area (bore section 111; anchoring surface 115; and bore section 121) for securing the first elongate member to a subject. Said fixation area comprising at least one latching element (at least anchoring surface 115; however, paragraph [0048] teach that a stepped locking system is also contemplated). The at least one cooperating element of the first elongate member is clearly shown in the figures as being capable of cooperating with said at least one latching element of the fixation area in use. Weissberg ‘665, as modified by Tipirneni ‘823, teach the corresponding fixation device being insertable in the second end of the tunnel, such that the at least one latching element of said fixation device engages with the at least one cooperating element on said elongate member, the corresponding fixation device being securable non-movably relative to the tunnel, preventing the elongate member from being withdrawn from the tunnel via the first open end (Tipirneni ‘823 - Abstract; C4:L35-50; claim 1).
Regarding claim 15, Weissberg ‘665 teaches wherein the reinforcing element extends through the first elongate member, through the body portion of the implant device, and through the second elongate member ([0019]; [0024]; [0026]; [0038] - “and reinforcing fibers structured and arranged within the body portion and the elongated anchor leads”; “The prosthetic meniscus implant may further comprise reinforcing fibers incorporated into the body and the elongate members”; “The prosthetic meniscus also preferably includes reinforcing fibers to provide durability and further mimic the characteristics of natural meniscus under stresses and loads typical of a human knee joint”).
Regarding claim 17, the figures of Weissberg ‘665 clearly show the implant system for implantation at a subject's knee joint, one of the first and second elongate members being a posterior insertion for securing at a posterior region of the subject's tibia and the other of the first and second elongate members being an anterior insertion for securing at an anterior region of the subject's tibia in use.
7. Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weissberg (US PG Pub No. 2008/0255665 A1; cited in Applicants’ IDS), as modified by Tipirneni (US 7,591,823 B2; cited in Applicants’ IDS) as applied to claim 1 above, and further in view of Steininger (US 5,425,767 A; cited in Applicants’ IDS).
Regarding claim 11, Weissberg ‘665, as modified by Tipirneni ‘823, teach wherein the first and/or second fixation device is externally threaded (26), the threading forming a plurality of latching elements capable of cooperating (indirectly) with said at least one cooperating element of the corresponding elongate member, said fixation device preferably being an externally helically threaded screw (Tipirneni ‘823 – helical screw 20).
This is also taught by Steininger ‘767, which reference discloses an implant system comprising an elongated member (1) of an implant device and a fixation device (10) that is externally threaded (Figure 2 – threads 4), the threading forming a plurality of latching elements capable of cooperating (directly) with at least one cooperating element (surface of elongate member 1 and/or threads of elongate member 1) of the corresponding elongate member in order to securely fix said first elongate member of said implant device in a tunnel in a subject’s bone (Abstract). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to have combined the teaching of an implant system comprising an elongated member of an implant device and a fixation device that is externally threaded, the threading forming a plurality of latching elements capable of cooperating (directly) with at least one cooperating element of the corresponding elongate member, as taught by Steininger ‘767, with the implant system of Weissberg ‘665, as modified by Tipirneni ‘823, in order to securely fix said first elongate member of said implant device in a tunnel in a subject’s bone.
8. Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Weissberg (US PG Pub No. 2008/0255665 A1; cited in Applicants’ IDS), as modified by Tipirneni (US 7,591,823 B2; cited in Applicants’ IDS) as applied to claim 1 above, and further in view of Sklar et al. (US 6,932,841 B2).
Regarding claim 18, Weissberg ‘665, as modified by Tipirneni ‘823, teaches:
wherein the implant device is a prosthetic meniscus (Weissberg ‘665 – Abstract and Figures); and
wherein the first elongate member is insertable in a bone tunnel in the subject's bone, the bone tunnel having first (Figures 4A-4C, 5A, and 5B of Weissberg ‘665 – first end “b”; first end “d”) and second (Figures 4A-4C, 5A, and 5B of Weissberg ‘665 – second end “a”; second end “c”) open ends and a bone tunnel wall (clearly shown in the figures),
the first elongate member being configured for insertion in the first end of the bone tunnel so that it extends through the bone tunnel between the first and second ends of the bone tunnel (Figure 5B of Weissberg ‘665).
Weissberg ‘665, as modified by Tipirneni ‘823, did not particularly disclose the first fixation device being configured for insertion in the second end of the bone tunnel such that the first fixation device engages the first elongate member on a first area of an exterior surface of the first fixation device and engages the bone tunnel wall on a second area of the exterior surface of the first fixation device. However, this subject matter is already well-known in the art. For example, Sklar et al. ‘841 teaches the subject matter of a first fixation device (Figures 1 and 2 – device 32/34; Figures 8 and 11 – device 46) being configured for insertion in an end of a bone tunnel (24) such that the first fixation device engages an elongate member (Figures 1 and 2 – elongate member 20/22, or additionally, elongate member 28; Figures 8 and 11 – elongate member 20/22, or additionally, elongate member 28) on a first area of an exterior surface of the first fixation device and engages the bone tunnel wall on a second area of the exterior surface of the first fixation device (shown in the figures) in order to securely fix said elongate member in a tunnel in a subject’s bone (Abstract). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the first fixation device being configured for insertion in the second end of the bone tunnel such that the first fixation device engages the first elongate member on a first area of an exterior surface of the first fixation device and engages the bone tunnel wall on a second area of the exterior surface of the first fixation device, as taught by Sklar et al. ‘841, with the implant system of Weissberg ‘665, as modified by Tipirneni ‘823, in order to securely fix said elongate member in a tunnel in a subject’s bone.
Response to Arguments
9. Applicant's arguments filed 05 September 2025 have been fully considered but they are not persuasive.
a. The Applicant argues “The Office Action proposed a modification of Weissberg that an artisan would avoid. The cap 20 of Tipirneni must be sufficiently wide so that it can accommodate wire 12 within its central bore, with cap walls all around the central bore. To adopt Tipirneni’s cap for the elongate anchoring Weissberg’s leads 20, 21, the cap would need to be wider, enough so that the leads would fit inside the cap. This in turn would require a larger outer diameter and, thus, a larger hole in the bone to accommodate the larger cap”. The Examiner respectfully disagrees.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “minimizing amount of bone removed”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The particular (i) structure and particular (ii) metes and bounds (including size and/or diameter) of the broadly-claimed “a first corresponding fixation device” are NOT recited in the claim language. Additionally, there is no mention in the claim language about minimizing amount of bone removed. Therefore, Applicant’s arguments about the size of the bone hole are moot. Further, Applicant’s arguments recite “would need to be wider”, “would require a larger outer diameter and, thus, a larger hole”, etc., without presenting scientific proof/fact to back said assertions.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
b. The Applicant argues “Weissberg would not be improved by the proposed combination” and “The proposed modification would result in redundant features in Weissberg with no benefit”. The Examiner respectfully disagrees.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, the recited “a first corresponding fixation device for securing the first elongate member to a subject, characterised in that the fixation device comprises at least one latching element” and “the at least one cooperating element being capable of cooperating with said at least one latching element of the fixation device in use” is taught by Weissberg ‘665 in view of Tipirneni ‘823. The combination of Weissberg ‘665 in view of Tipirneni ‘823 is a predictable variation since the “a first corresponding fixation device” of Tipirneni ‘823 will improve on Weissberg ‘665 fixation area (bore section 111; anchoring surface 115; and bore section 121) for securing the first elongate member to a subject. When compared to just a bone hole, the “a first corresponding fixation device” of Tipirneni ‘823 will withstand forces on the bone. And the “a first corresponding fixation device” of Tipirneni ‘823 will restrict the elongate member from backwards movement in order to fix said first elongate member of said body portion to a subject (e.g., in said tunnel in a subject’s bone).
c. The Applicant argues “Applicant submits that Tipirneni is non-analogous art. Though both are used by surgeons, they are used in specialties that are so distinct that an artisan looking for a better meniscus prosthesis would not look to Tipirneni for solutions.”. The Examiner respectfully disagrees.
In response to applicant's argument, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Tipirneni ‘823 is reasonably pertinent to the particular problem with which the inventor was concerned. The solution provided by Tipirneni ‘823 is not trivial, since it is applicable to most bone implants requiring “a first corresponding fixation device”.
d. Regarding claim 11, the Applicant argues “To adopt Steininger's fixation means for the elongate anchoring leads 20, 21 of Weissberg, wider bone tunnels than those shown in Figs. 4a to 6 of Weissberg would be needed, to accommodate the socket 3 to be received around the corresponding lead 20, 21. As explained above, an artisan would naturally want to minimize the amount of bone removed to accommodate the anchoring leads, and would therefore avoid use of a socket with a diameter larger than the anchoring leads. For this reason, an artisan would avoid making the proposed modification of Weissberg”. The Examiner respectfully disagrees.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “minimizing amount of bone removed”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The particular (i) structure and particular (ii) metes and bounds (including size and/or diameter) of the broadly-claimed “a first corresponding fixation device” are NOT recited in the claim language. Additionally, there is no mention in the claim language about minimizing amount of bone removed. Therefore, Applicant’s arguments about the size of the bone hole are moot. Further, Applicant’s arguments recite “would need to be wider”, “would require a larger outer diameter and, thus, a larger hole”, etc., without presenting scientific proof/fact to back said assertions.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
10. THIS ACTION IS MADE FINAL. 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 Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774