Detailed Action
This office action for US application number 18/170,703 evaluates the claims as filed on July 21, 2026.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 21, 2026 has been entered.
Response to Arguments
Applicant's arguments filed July 21, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Aeschlimann’276, Aeschlimann’341, Beck, Jarvinen, and Bolton teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that independent claim 1 is supported by Figs. 9A, 9B, 25, and 38 as well as pages 31-32 and 46 (Remarks p. 15), Examiner notes that there appears to be no disclosure of an integral/integrated part on pages 32 or 46 and the structures shown in Figs. 25 and 38 are not disclosed to be integrated and are shown to be inconsistent with Applicant’s usage of the term on pages 30, 31, and 34 with respect to Figs. 8 and 9A. That is, while Applicant has not expressly defined the term integral/integrated, Applicant has disclosed that the anchoring element 6 is constituted by an integrated central part of fastener 3 which is fully made of the liquifiable material (page 30 lines 21-23 and page 31 lines 16-19).
With regards to Applicant’s argument that Aeschlimann’341 comprises no teaching of how to fasten a tendon or ligament to bone using this technique but is instead directed to fixing an implant, prosthetic pin, or a fixator in bone (Remarks p.16), Examiner notes that a method that includes how to fasten a tendon or ligament to bone has not been claimed nor has it been asserted that Aeschlimann’341 discloses such a method; thus, this argument is moot. Instead, the instant independent claims provide a set capable of use for fastening a ligament, tendon, or graft, which it appears Aeschlimann’341 would be capable of doing, e.g. if one were to insert the embodiment of Fig. 8 into a bone hole alongside a ligament, tendon, or graft, it appears evident that such would be capable of fixing such similar to if it were fixing another structure.
With regards to Applicant’s argument that there is no implant in Aeschlimann’341 having two different surface portions of the circumferential surface (Remarks p. 16-17), Examiner disagrees and notes that any surface can be reasonably interpreted under BRI as comprising multiple portions that differ in at least that they are in different locations. For example, a coffee mug with a handle has many different portions of the circumferential surface such as: a first portion connected to the top of the handle, as second portion connected to the bottom of the handle, a third portion at least partially defining a rim configured for drinking, a fourth portion opposite the first portion, etc.
With regards to Applicant’s argument that in Aeschlimann’341 the sonotrode acts upon the implant as a whole to press it against or into the tissue (Remarks p. 16-17), Examiner notes that Fig. 26 of Aeschlimann’341 very clearly shows that sonotrode 6 is sized such that it does not need to contact the fastener. Examiner notes that additional explanation can be found on page 3 of the final office action dated April 23, 2026 where paragraph 71 specifically discloses that the resonator is applied only to the liquifiable material.
With regards to Applicant’s argument that Aeschlimann’341 does not disclose the groove arrangement of claim 15 or the inner cavity arrangement of claim 19 (Remarks p. 17-18), Examiner notes that such has not been asserted and is therefore moot.
With regards to Applicant’s argument that Jarvinen does not teach how to design an implant to fasten a tendon or ligament by fixation using ultrasound to liquefy a fastener (Remarks p. 18), Examiner notes that such has not been asserted and is therefore moot.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent 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 application, Application No. 61/298,746, 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. Application No. 61/298,746 fails to provide adequate support at least “the fastener comprises an inner cavity that is open at the proximal fastener face and extends to the open distal end; wherein the fastener is adapted for fixation of the ligament, the tendon, or the graft in the opening by threading a first suture end of the ligament, the tendon, or the graft through the inner cavity of the fastener and further through the open distal end, while a second suture end of the ligament, the tendon, or the graft extends along the circumferential surface of the fastener, and wherein the at least one anchoring element is adapted to fit into said inner cavity of the fastener” of claims 19-25.
Claim Objections
Claim(s) 15 is/are objected to because of the following informalities:
Claim 15 lines 7-8 should read “and a circumferential surface extending around the fastener axis, [[and ]]the fastener further comprising”.
Claim 15 line18 should read “towards the distal end of the fastener[[,]] and into which the anchoring element”.
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.
Claim(s) 1, 3-5, and 13-25 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 1 is/are unclear with regards to “a sonotrode as an anchoring tool” in line 15 and how the disclosed sonotrode can be reasonably construed as “an anchoring tool”, i.e. a tool capable of anchoring. Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 1 is unclear with regards to “the anchoring element is provided as an integral part of the at least one first portion of the circumferential surface of the fastener” in lines 18-19 and how such can be supported by the disclosure to have the sonotrode be capable of advancing the anchoring element relative to the fastener as provided in lines 15-16 when the embodiments disclosed as having the anchoring element “integrated in the fastener” are on page 30 line 21-22 for Fig. 8 and page 31 line18 for Fig. 9A, where Figs. 8 and 9A have the same structure labeled as both the fastener and the anchoring element. That is, it is unclear how these claim limitations can be interpreted as supported by the original disclosure when considered in light of Applicant’s specification and drawings as it is not readily apparent how one can reasonably construe a part such as that of Figs. 8 and 9A-9B to be able to advance relative to itself. Alternately, such constitutes new matter. Further, it is unclear how, for the disclosure of Figs. 8 and 9A-9B, how the same structure can be reasonably mapped to two claim terms, i.e. the claimed fastener and the claimed anchoring member. Examiner is interpreting this broadly “the fastener forming at least one anchoring element comprising a liquifiable material, and a sonotrode
Claim(s) 13 is unclear with regards to “the opening provided in a human or animal bone” in line 4 and how an opening in a structure can have previously established antecedent basis support without the same being true for the structure. That is, it is unclear how “the opening” can be reasonably construed to rely upon claim 1 line 5 for antecedence support while “a human or animal bone” introduces a new bone that the fastener is adapted for use therein. Examiner is interpreting this as referring to, and suggests amending as, “the opening provided in [[a]]the human or animal bone”.
Claim(s) 14 recites/recite the limitations "the proximal face of the opening” in line 5 and “the distal end of the opening" in lines 5-6. There is insufficient antecedent basis for these limitations in the claim. Further, it is unclear as to how an opening can be reasonably construed to have a face. Examiner is interpreting this as referring to, and suggests amending as, “extending from [[the]]a proximal [[face]]end of the opening towards [[the]]a distal end of the opening”.
Claim(s) 15 is/are unclear with regards to “a sonotrode as an anchoring tool” in line 13 and how the disclosed sonotrode can be reasonably construed as “an anchoring tool”, i.e. a tool capable of anchoring. Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 19 is/are unclear with regards to “a sonotrode as an anchoring tool” in line 13 and how the disclosed sonotrode can be reasonably construed as “an anchoring tool”, i.e. a tool capable of anchoring. Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 3-5, 16-18, and 20-25 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base and/or intervening claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 4, 13, and 14 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Aeschlimann et al. (WO 2008/034276, hereinafter “Aeschlimann’276”).
The claimed phrase “forming” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claim 1, Aeschlimann’276 discloses a set (Fig. 13) capable of use for fastening tissue a ligament, a tendon, or a graft (21, Fig. 13) capable of use for replacing a tendon or ligament in an opening provided in a human or animal bone (Fig. 13, page 24 line 21-26 – page 25 line 7), the set comprises: a fastener (1) capable of use for fixing a ligament, a tendon, or a graft (21, Fig. 13, page 24 line 21-26 – page 25 line 7) replacing a tendon or ligament in an opening provided in a human or animal bone (Fig. 13, page 24 line 21-26 – page 25 line 7), the fastener comprising a proximal face (upper face as shown in Fig. 13, Fig. 13), a distal end (lower end as shown in Fig. 13, Fig. 13), a fastener axis (vertical as shown in Fig. 13, Fig. 13) extending between the proximal face and the distal end (Fig. 13), and a circumferential surface (Fig. 13) extending around the fastener axis (Fig. 13), the fastener further comprising at least one first portion of the circumferential surface (portion of 1 shown below the windings of 21 in Fig. 13, Fig. 13, page 24 line 27 - page 25 line 2 discloses that suture 21 is wound an possibly knotted around 1 which has a groove 32 for passing the suture from the lateral surface to the proximal face) and at least one second portion of the circumferential surface (portion of 1 shown within the windings of 21 in Fig. 13, Fig. 13, page 24 line 27 - page 25 line 2 discloses that suture 21 is wound an possibly knotted around 1 which has a groove 32 for passing the suture from the lateral surface to the proximal face), said at least one second portion of the circumferential surface being different from the at least one first portion of the circumferential surface (as defined, Fig. 13), the fastener forming at least one anchoring element (1) comprising a liquefiable material (page 24 line 24-26 and page 24 lines 3-7), and a sonotrode (12, page 4 line 4 discloses that the vibrating tool is a sonotrode of an ultrasonic device) capable of simultaneously advancing relative to the fastener and transmit energy needed for liquefaction of the anchoring element (as 1 melts, e.g. page 15 lines 8-11 and page 19 lines 4-16 disclose that 12 is pressed upon the distal face of 1, liquefying 1 so that it interpenetrates the bone tissue), and wherein the anchoring element is provided as an integral part of the at least one first portion of the circumferential surface of the fastener (as defined, Fig. 13, page 24 line 21-26 – page 25 line 7) and the at least one second portion of the circumferential surface of the fastener is capable of fixing the ligament, the tendon, or the graft in the opening (Fig. 13, page 24 line 21-26 – page 25 line 7).
As to claim 4, Aeschlimann’276 discloses that the anchoring element comprises a composite material or is made from a composite material (page 11 lines 14-24 disclose that liquifiable materials are thermoplastic polymers or composites and fillers such as fibers and whiskers).
As to claim 13, Aeschlimann’276 discloses that the fastener is adapted in cross section for being capable of press-fitting the ligament, the tendon, or the graft for replacing a tendon or ligament in the opening provided in the human or animal bone (Fig. 13, page 5 lines 16-17).
As to claim 14, Aeschlimann’276 discloses that the fastener is capable of being positioned in the opening provided in the human or animal bone in a way that the fastener axis extending between the proximal face and the distal end runs generally parallel to a longitudinal axis of the opening provided in the human or animal bone extending from a proximal end of the opening towards a distal end of the opening (Fig. 13, page 25 lines 2-7).
Claim Rejections - 35 USC § 103
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 of this title, 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 negatived by the manner in which the invention was made.
Claim(s) 3 and 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Aeschlimann’276 in view of Aeschlimann et al. (US 2004/0030341, hereinafter “Aeschlimann’341”).
As to claim 3, Aeschlimann’276 discloses the invention of claim 1 as well as that the at least one anchoring element is strengthened by admixed fibers or whiskers (page 11 lines 14-24 disclose that liquifiable materials are thermoplastic polymers or composites and fillers such as fibers and whiskers).
Aeschlimann’276 is silent to the fibers or whiskers comprise calcium phosphate ceramics or glasses or are made of calcium phosphate ceramics or glasses.
Aeschlimann’341 teaches a similar set (Figs. 1, 8, 23, and 26, ¶s 65 and 95, where ¶65 discloses that the liquefiable material is mechanically strengthened by admixture of fibers or whiskers, e.g. calcium phosphate ceramics or glasses, and ¶95 discloses use of Fig. 26 in the application shown in Fig. 23 and the end of the implant being designed as in Fig. 8) capable of use in an opening provided in a human or animal bone (abstract), the set comprises: a fastener (7, Figs. 8, 23, and 26, ¶95) capable of fixing in an opening provided in a human or animal bone (Figs. 23 and 26, ¶s 93-95; where ¶95 discloses use of Fig. 26 in the application shown in Fig. 23, ¶93 discloses use on a tubular bone of a human arm having cortical bone and marrow space, and ¶94 discloses drilling a threaded opening through the tubular bone and into the marrow space with a bore diameter corresponding to the diameter of the implant 7), the fastener comprising a proximal face (upper facing face as shown in Figs. 8 and 26), a distal end (lower end as shown in Figs. 8 and 26), a fastener axis (vertical central axis as shown in Figs. 8 and 26) extending between the proximal face and the distal end (as defined, Figs. 8 and 26) and a circumferential surface (radially outward facing surface as shown in Figs. 8 and 26, Figs. 8 and 26, ¶94 discloses that the implant has a diameter) extending around the fastener axis (as defined), and the fastener further comprising at least one first portion of the circumferential surface (left portion as shown in Figs. 8 and 26, Figs. 8 and 26) and at least one second portion (right portion as shown in Figs. 8 and 26, Figs. 8 and 26) different from the first portion of the circumferential surface (at least in position as shown in Figs. 8 and 26, Figs. 8 and 26), at least one anchoring element (liquefiable material as shown in Figs. 8 and 26 per ¶s 95 and 71, Figs. 8 and 26, ¶s 65, 71, and 95) comprising a liquefiable material (liquefiable material of ¶s 65, 71, and 95, Figs. 8 and 26, ¶s 65, and 71, and 95), and a sonotrode (6, Figs. 1 and 26, ¶s 18, 52, 71, 94, and 95) capable of use to advance relative to the fastener (Figs. 1 and 26, abstract and at least ¶26 discloses mechanical oscillation, ¶54 discloses use of sonotrode/resonator to press against the implant held in tissue, ¶71 discloses that the sonotrode/resonator is applied only on the liquefiable material, ¶94 discloses pressing the liquefiable material against the implant under the effect of ultrasound) and simultaneously transmitting energy needed for liquefaction of the anchoring element (abstract and at least ¶s 10, 12, 15, 18, 24, 26, 52, 54, 71, and 94, in particular, ¶12 discloses “impinged with ultrasound energy and at the same time is pressed” and ¶94 discloses pressing the liquefiable material against the implant under the effect of ultrasound); wherein the liquefiable material (liquefiable material of ¶s 65, 71, and 95, Figs. 8 and 26, ¶s 65, and 71, and 95) is strengthened by admixed fibers or whiskers (¶65) and the fibers or whiskers comprise calcium phosphate ceramics or glasses or are made of calcium phosphate ceramics or glasses (¶65).
One of ordinary skill in the art at the time of the invention would have been motivated to specify that the fibers or whiskers as disclosed by Aeschlimann’276 are calcium phosphate ceramics or glasses as taught by Aeschlimann’341 in order to provide a known mechanically strengthened liquefiable material (Aeschlimann’341 ¶65) for anchoring in bone (Aeschlimann’276 page 24 line 21-26 – page 25 line 7; Aeschlimann’341 abstract).
As to claim 5, Aeschlimann’276 discloses the invention of claim 1 as well as that the fastener is strengthened by admixed fibers or whiskers (page 11 lines 14-24 disclose that liquifiable materials are thermoplastic polymers or composites and fillers such as fibers and whiskers).
Aeschlimann’276 is silent to the fibers or whiskers comprise calcium phosphate ceramics or glasses or are made of calcium phosphate ceramics or glasses.
Aeschlimann’341 teaches a similar set (Figs. 1, 8, 23, and 26, ¶s 65 and 95, where ¶65 discloses that the liquefiable material is mechanically strengthened by admixture of fibers or whiskers, e.g. calcium phosphate ceramics or glasses, and ¶95 discloses use of Fig. 26 in the application shown in Fig. 23 and the end of the implant being designed as in Fig. 8) capable of use in an opening provided in a human or animal bone (abstract), the set comprises: a fastener (7, liquefiable material as shown in Figs. 8 and 26 per ¶s 95 and 71, Figs. 8, 23, and 26, ¶95) capable of fixing in an opening provided in a human or animal bone (Figs. 23 and 26, ¶s 93-95; where ¶95 discloses use of Fig. 26 in the application shown in Fig. 23, ¶93 discloses use on a tubular bone of a human arm having cortical bone and marrow space, and ¶94 discloses drilling a threaded opening through the tubular bone and into the marrow space with a bore diameter corresponding to the diameter of the implant 7), the fastener comprising a proximal face (upper facing face as shown in Figs. 8 and 26), a distal end (lower end as shown in Figs. 8 and 26), a fastener axis (vertical central axis as shown in Figs. 8 and 26) extending between the proximal face and the distal end (as defined, Figs. 8 and 26) and a circumferential surface (radially outward facing surface as shown in Figs. 8 and 26, Figs. 8 and 26, ¶94 discloses that the implant has a diameter) extending around the fastener axis (as defined), and the fastener further comprising at least one first portion of the circumferential surface (left portion as shown in Figs. 8 and 26, Figs. 8 and 26) and at least one second portion (right portion as shown in Figs. 8 and 26, Figs. 8 and 26) different from the first portion of the circumferential surface (at least in position as shown in Figs. 8 and 26, Figs. 8 and 26), the fastener forming at least one anchoring element (liquefiable material as shown in Figs. 8 and 26 per ¶s 95 and 71, Figs. 8 and 26, ¶s 65, 71, and 95) comprising a liquefiable material (liquefiable material of ¶s 65, 71, and 95, Figs. 8 and 26, ¶s 65, and 71, and 95), and a sonotrode (6, Figs. 1 and 26, ¶s 18, 52, 71, 94, and 95) capable of use to advance relative to the fastener (Figs. 1 and 26, abstract and at least ¶26 discloses mechanical oscillation, ¶54 discloses use of sonotrode/resonator to press against the implant held in tissue, ¶71 discloses that the sonotrode/resonator is applied only on the liquefiable material, ¶94 discloses pressing the liquefiable material against the implant under the effect of ultrasound) and simultaneously transmitting energy needed for liquefaction of the anchoring element (abstract and at least ¶s 10, 12, 15, 18, 24, 26, 52, 54, 71, and 94, in particular, ¶12 discloses “impinged with ultrasound energy and at the same time is pressed” and ¶94 discloses pressing the liquefiable material against the implant under the effect of ultrasound); wherein the liquefiable material (liquefiable material of ¶s 65, 71, and 95, Figs. 8 and 26, ¶s 65, and 71, and 95) is strengthened by admixed fibers or whiskers (¶65) and the fibers or whiskers comprise calcium phosphate ceramics or glasses or are made of calcium phosphate ceramics or glasses (¶65).
One of ordinary skill in the art at the time of the invention would have been motivated to specify that the fibers or whiskers of the liquefiable material of the fastener as disclosed by Aeschlimann’276 are calcium phosphate ceramics or glasses as taught by Aeschlimann’341 in order to provide a known mechanically strengthened liquefiable material (Aeschlimann’341 ¶65) for anchoring in bone (Aeschlimann’276 page 24 line 21-26 – page 25 line 7; Aeschlimann’341 abstract).
Claim(s) 15-17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Beck et al. (US 5,632,748, hereinafter “Beck”) in view of Aeschlimann’341.
As to claim 15, Beck discloses a set (Figs. 1 and 2) capable of use for fastening a ligament, a tendon, or a graft (14, Fig. 1) capable of replacing a tendon or ligament in an opening provided in a human or animal bone (Fig. 1), the set comprises: a fastener (23) capable of use for fixing a tendon, a ligament, or a graft (14, Fig. 1) capable of replacing a tendon or ligament in an opening provided in a human or animal bone (Fig. 1), the fastener comprising a proximal face (lower left face as shown in Figs. 1 and 2, Figs. 1 and 2), a distal end (right end as shown in Figs. 1 and 2, Figs. 1 and 2), a fastener axis (along the longest dimension of 23 as shown in Fig. 2, Figs. 1 and 2) extending between the proximal face and the distal end (as defined, Figs. 1 and 2), and a circumferential surface (Fig. 1) extending around the fastener axis (Fig. 1), the fastener further comprising at least one first portion of the circumferential surface (portion above 14 as shown in Fig. 1, Fig. 1) and at least one second portion of the circumferential surface (portion shown holding 14 and below as shown in Fig. 1, Fig. 1), the at least one second portion of the circumferential surface being different from the at least one first portion of the circumferential surface (as defined, Fig. 1), at least one anchoring element (28), and wherein the fastener comprises at least one groove (defined by surface 17 as shown in Fig. 2, Figs. 1 and 2) along the at least one first portion of the circumferential surface extending from the proximal fastener face towards the distal end of the fastener (Figs. 1 and 2) and into which the anchoring element is capable of fitting (Fig. 1). Beck further discloses that the set is formed of plastic, bone, stainless steel or any other suitable material (col. 6 lines 30-34).
Beck silent to a sonotrode as an anchoring tool suitable to simultaneously advance the anchoring element relative to the fastener and transmit energy needed for liquefaction of the anchoring element. As to claim 16, Beck silent to the at least one anchoring element includes fibers or whiskers, and wherein the fibers or whiskers comprise calcium phosphate ceramics or glasses or are made of calcium phosphate ceramics or glasses. As to claim 17, Beck silent to the anchoring element comprises a composite material or is made from a composite material.
Aeschlimann’341 teaches a set (Fig. 8, ¶65) capable of use in an opening provided in a human or animal bone (abstract), the set comprises: at least one anchoring element (13, core/liquefiable material of ¶s 65 and 71, Fig. 8) comprising openings (Fig. 8, ¶71) and a liquefiable material (core/liquefiable material of ¶s 65 and 71, Fig. 8, ¶s 65 and 71) strengthened by admixed fibers or whiskers (¶65), and a sonotrode (6, Fig. 1, ¶s 18 and 52) as an anchoring tool (Fig. 1, ¶s 18 and 52) capable of use to simultaneously advance the anchoring element relative to a fastener (the core/liquefiable material relative to a fastener, Fig. 1, abstract and at least ¶26 discloses mechanical oscillation, ¶54 discloses use of sonotrode/resonator to press against the implant held in tissue) and transmit energy needed for liquefaction of the anchoring element (abstract and at least ¶s 10, 12, 15, 18, 24, 26, and 52, in particular, ¶12 discloses “impinged with ultrasound energy and at the same time is pressed”). As to claim 16, Aeschlimann’341 teaches that the at least one anchoring element includes fibers or whiskers (¶65), and wherein the fibers or whiskers comprise calcium phosphate ceramics or glasses or are made of calcium phosphate ceramics or glasses (¶65). As to claim 17, Aeschlimann’341 teaches that the anchoring element comprises a composite material or is made from a composite material (¶65).
One of ordinary skill in the art at the time of the invention would have been motivated to modify the at least one anchoring element as disclosed by Beck to comprise openings and a liquefiable material as taught by Aeschlimann’341 in order to form a positive connection with bone (Aeschlimann’341 abstract) by pressing liquified material into pores or other openings of the bone by the effect of external pressure to form positive-fit connections when re-solidified (Aeschlimann’341 ¶10) and using mechanical energy to keep the thermal burden to the surrounding tissue low to liquify the material while pressing the material into pores or openings of the surrounding bone by way of hydrostatic pressure, thereby permeating the surrounding tissue and enforcing it (Aeschlimann’341 ¶13), i.e. to strengthen the connection with the bone and prevent backout by increasing interdigitation with the bone. In forming the combination, one of ordinary skill in the art at the time of the invention would have been motivated to modify the set as disclosed by Beck by adding the sonotrode and corresponding structure and methods as taught by Aeschlimann’341 in order to provide a known tool for use with the liquefiable material to liquify the material while pressing the material into pores or openings of the surrounding bone by way of hydrostatic pressure, thereby permeating the surrounding tissue and enforcing it (Aeschlimann’341 ¶13) by a suitable design of the implant and by a suitable metering of the energy to ensure that only a required minimum amount of the liquefiable material is liquefied in a locally targeted manner (Aeschlimann’341 ¶12) to form a positive connection with bone (Aeschlimann’341 abstract), i.e. to strengthen the connection with the bone and prevent backout by increasing interdigitation with the bone.
Claim(s) 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Beck and Aeschlimann’341 in view of Jarvinen (US 2002/0040241).
As to claim 18, the combination of Beck and Aeschlimann’341 discloses the invention of claim 15.
The combination of Beck and Aeschlimann’341 is silent to the fastener is made of a calcium phosphate.
Jarvinen teaches a similar set (Figs. 2A-6C) capable of use for fastening tissue or a prosthetic element in an opening provided in a human or animal bone (Figs. 5-6C), the set comprises: a fastener (1, Figs. 2A-2C) comprising a proximal face (Figs. 2A-6C), a distal end (Figs. 2A-6C), a fastener axis (Figs. 2A-6C) extending between the proximal face and the distal end (Figs. 2A-6C), and a circumferential surface extending around the fastener axis (Figs. 2A-6C), at least one anchoring element (22, Fig. 6A-6C), wherein the fastener is made of a calcium phosphate (¶99).
One of ordinary skill in the art at the time of the invention would have been motivated to modify the fastener as disclosed by the combination of Beck and Aeschlimann’341 to comprise fibers of calcium phosphate as taught by Jarvinen in order to reinforce the material (Jarvinen ¶99).
Claim(s) 19-21 and 23-25 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bolton (US 5,906,632) in view of Aeschlimann’341.
As to claim 19, Bolton discloses a set (Figs. 1-6G) capable of use for fastening a ligament, a tendon, or a graft (80, 82, Fig. 6F, col. 3 lines 30-40) capable of replacing a tendon or ligament in an opening provided in a human or animal bone (Fig. 6F, col. 3 lines 30-40), the set comprises: a fastener (20) capable of use for fixing a tendon, a ligament, or a graft (80, 82, Fig. 6F, col. 3 lines 30-40) capable of replacing a tendon or ligament in an opening provided in a human or animal bone (Fig. 6F, col. 3 lines 30-40), the fastener comprising a proximal face (lower face(s) as shown in Figs. 6E and 6F, Figs. 6E and 6F), an open distal end (upper end as shown in Figs. 6E and 6F, Figs. 1, 6E, and 6F; where Fig. 1 shows that the distal end is open at 220), a fastener axis (vertical as shown in Figs. 6E and 6F, Figs. 6E and 6F) extending between the proximal face and the distal end (as defined, Figs. 6E and 6F), and a circumferential surface (208, Fig. 1, col. 3 lines 57-60 discloses that 208 is the outer surface of deformable ring 20) extending around the fastener axis (Fig. 1), the circumferential surface comprising at least one first portion (upper portion of 208 as shown in Fig. 1, Fig. 1) and at least one second portion (lower portion of 208 as shown in Fig. 1, Fig. 1), said at least one second portion of the circumferential surface being different from said at least one first portion of the circumferential surface (as defined, Fig. 1), at least one anchoring element (40), wherein the fastener comprises an inner cavity (208) that is open at the proximal fastener face (via 221, Fig. 1) and extends to the open distal end (via 220, Fig. 1); wherein the fastener is capable of fixation of the ligament, the tendon, or the graft in the opening by threading a first suture end of the ligament, the tendon, or the graft through the inner cavity of the fastener and further through the open distal end (as demonstrated with suture 60 in Fig. 6E and due to the continuous passage as shown used by pin 36 in Fig. 6E, Fig. 1), while a second suture end of the ligament, the tendon, or the graft extends along the circumferential surface of the fastener (Fig. 6F), and wherein the at least one anchoring element is capable of fitting into said inner cavity of the fastener Fig. 6F). Bolton further discloses that the fastener comprises a compliant material, such as a polymer, or additional materials (col. 4 lines 21-27) and the anchoring element may be made of metal or of a bioabsorbable material as non-limiting examples (col. 4 lines 40-44). As to claim 23, Bolton discloses that the first suture end and the second suture end are connected to one another by a suture retainer at the proximal fastener face (Fig. 6E). As to claim 24, Bolton discloses that the fastener is capable of press-fitting the ligament, the tendon, or the graft (Fig. 6F) capable of replacing a tendon or ligament in the opening provided in the human or animal bone (Fig. 6F). As to claim 25, Bolton discloses that the fastener is capable of being positioned in the opening such that the fastener axis extends generally parallel to a longitudinal axis of the opening (Fig. 6F).
Bolton is silent to the at least one anchoring element comprising a liquefiable material strengthened by admixed fibers or whiskers, and a sonotrode as an anchoring tool suitable to simultaneously advance the anchoring element relative to the fastener and transmit energy needed for liquefaction of the anchoring element. As to claim 20, Bolton silent to the fibers or whiskers comprise calcium phosphate ceramics or glasses or are made of calcium phosphate ceramics or glasses. As to claim 21, Bolton silent to the anchoring element comprises a composite material or is made from a composite material.
Aeschlimann’341 teaches a set (Fig. 8, ¶65) capable of use in an opening provided in a human or animal bone (abstract), the set comprises: at least one anchoring element (13, core/liquefiable material of ¶s 65 and 71, Fig. 8) comprising openings (Fig. 8, ¶71) and a liquefiable material (core/liquefiable material of ¶s 65 and 71, Fig. 8, ¶s 65 and 71) strengthened by admixed fibers or whiskers (¶65), and a sonotrode (6, Fig. 1, ¶s 18 and 52) as an anchoring tool (Fig. 1, ¶s 18 and 52) capable of use to simultaneously advance the anchoring element relative to a fastener (the core/liquefiable material relative to a fastener, Fig. 1, abstract and at least ¶26 discloses mechanical oscillation, ¶54 discloses use of sonotrode/resonator to press against the implant held in tissue) and transmit energy needed for liquefaction of the anchoring element (abstract and at least ¶s 10, 12, 15, 18, 24, 26, and 52, in particular, ¶12 discloses “impinged with ultrasound energy and at the same time is pressed”). As to claim 20, Aeschlimann’341 teaches that the fibers or whiskers comprise calcium phosphate ceramics or glasses or are made of calcium phosphate ceramics or glasses (¶65). As to claim 21, Aeschlimann’341 teaches that the anchoring element comprises a composite material or is made from a composite material (¶65).
One of ordinary skill in the art at the time of the invention would have been motivated to modify the at least one anchoring element as disclosed by Bolton to comprise openings and a liquefiable material as taught by Aeschlimann’341 in order to form a positive connection with bone (Aeschlimann’341 abstract) by pressing liquified material into pores or other openings of the bone by the effect of external pressure to form positive-fit connections when re-solidified (Aeschlimann’341 ¶10) and using mechanical energy to keep the thermal burden to the surrounding tissue low to liquify the material while pressing the material into pores or openings of the surrounding bone by way of hydrostatic pressure, thereby permeating the surrounding tissue and enforcing it (Aeschlimann’341 ¶13), i.e. to strengthen the connection with the bone and prevent backout by increasing interdigitation with the bone. In forming the combination, one of ordinary skill in the art at the time of the invention would have been motivated to modify the set as disclosed by Bolton by adding the sonotrode and corresponding structure and methods as taught by Aeschlimann’341 in order to provide a known tool for use with the liquefiable material to liquify the material while pressing the material into pores or openings of the surrounding bone by way of hydrostatic pressure, thereby permeating the surrounding tissue and enforcing it (Aeschlimann’341 ¶13) by a suitable design of the implant and by a suitable metering of the energy to ensure that only a required minimum amount of the liquefiable material is liquefied in a locally targeted manner (Aeschlimann’341 ¶12) to form a positive connection with bone (Aeschlimann’341 abstract), i.e. to strengthen the connection with the bone and prevent backout by increasing interdigitation with the bone.
Claim(s) 22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bolton and Aeschlimann’341 in view of Jarvinen (US 2002/0040241).
As to claim 22, the combination of Bolton and Aeschlimann’341 discloses the invention of claim 19.
The combination of Bolton and Aeschlimann’341 is silent to the fastener is made of a calcium phosphate.
Jarvinen teaches a similar set (Figs. 2A-6C) capable of use for fastening tissue or a prosthetic element in an opening provided in a human or animal bone (Figs. 5-6C), the set comprises: a fastener (1, Figs. 2A-2C) comprising a proximal face (Figs. 2A-6C), a distal end (Figs. 2A-6C), a fastener axis (Figs. 2A-6C) extending between the proximal face and the distal end (Figs. 2A-6C), and a circumferential surface extending around the fastener axis (Figs. 2A-6C), at least one anchoring element (22, Fig. 6A-6C), wherein the fastener is made of a calcium phosphate (¶99).
One of ordinary skill in the art at the time of the invention would have been motivated to modify the fastener as disclosed by the combination of Bolton and Aeschlimann’341 to comprise fibers of calcium phosphate as taught by Jarvinen in order to reinforce the material (Jarvinen ¶99).
Conclusion
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/AMY R SIPP/Primary Examiner, Art Unit 3775
