Detailed Action
This is the final office action for US application number 18/170,703. Claims are evaluated as filed on March 24, 2026.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre- AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed March 24, 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 teaches all the newly-amended limitations and is 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 the axially extending groove of claim 10 is described in page 26 line 9 and a new Fig. 4B has been added that conforms to the disclosure with corresponding specification amendments thus now new matter has been added (Remarks p. 12), Examiner agrees that original specification page 26 lines 9-16 disclose that the fastener 3 of Fig. 4 has a circumferential surface and/or an inner cavity that may comprise and axially extending groove for accommodation of the suture ends. However, there appears to be no description of the position, length, or depth of the disclosed axially extending groove relative to any disclosed feature or the fastener. Further, the added Fig. 4B shows a dashed line in a particular region of the fastener that is not shown to accommodate the suture ends. Thus, the entirety of the specification and drawing amendment dated March 24, 2026 constitutes new matter and should be cancelled.
Applicant' s arguments with respect to Re have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection.
With regards to Applicant’s argument that the sonotrode of Aeschlimann acts upon the implant as a whole to press it against or into the tissue during liquification and is therefore not suitable to advance the anchoring element relative to the fastener while simultaneously liquifying the polymer which is a critical element/a substantial feature of the claimed invention (Remarks p. 14-16), Examiner notes that the assertion that the sonotrode of Aeschlimann acts upon the implant as a whole is contrary to the express disclosure of Aeschlimann. For example, “For implantation, the implant according to the invention is brought into contact with the tissue part (on the surface or in an opening, which as the case may be, has been created specially for the implant), and is then impinged with ultrasound energy and at the same time is pressed against the tissue part” (¶12), implant 13 “is to be positioned in a tissue opening and the resonator is applied only on the liquefiable material, i.e. has a cross section adapted to the inner cross section of the sleeve” (¶71), “The implant is introduced into the opening 56 and is held at a predefined depth with suitable means to be applied externally. Then the liquefiable material 57 around the support 52 is pressed against the base plate 55 under the effect of ultrasound” (¶94, where base plate 55 is the bottom of the implant as shown in Fig. 26). Thus, the sonotrode of Aeschlimann is not only suitable for performing the function as claimed but is also disclosed to perform the argued method step.
With regards to Applicant’s argument that the claimed invention of claim 1 lines 25-32 would not have been obvious from the cited prior art (Remarks p. 16), Examiner notes that such has not been asserted and is therefore moot. Examiner further notes that such is not required of the invention of claim 1 as these limitations are claimed in the alternative to those of claim 1 lines 20-22, claim 1 lines 33-35, and claims 1 lines 36 and 37.
With regards to Applicant’s argument that Aeschlimann provides no specific guidance on the complex surgical problem of anchoring and tensioning soft tissue graft with sutures in the confines of a blind bore (Remarks p. 17-19), Examiner notes that such has not been asserted and is therefore moot. Further, anchoring and tensioning soft tissue graft with sutures in the confines of a blind bore has not been claimed nor has a system comprising a soft tissue graft, suture, or a structure capable of securing such in a blind bore as argued.
With regards to Applicant’s argument that the combination of features and the associated surgical method is entirely absent from the prior art (Remarks p. 17), Examiner suggests review of the claimed invention as such is not drawn to a method and the claimed features are so broad as to be anticipated by the prior art as detailed in the rejections below.
With regards to Applicant’s arguments regarding the fastener of the present invention having a dedicated inner cavity and open distal end that provide a smooth, protected, stable channel specifically designed for suture management in a blind bore that allows for suture tensioning without the risk of shearing from a pin and without the instability and wear associated with wrapping a suture around a tapered external surface (Remarks p. 19), Examiner suggests review of the claimed invention as such is not claimed. Examiner suggests that, if such is supported by the original disclosure, then Applicant should identify such support and claim such an invention if such is desired to be claimed.
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 applications, Application Nos. 61/298,746, 13/522,611, and 16/747,257, fail 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 Nos. 61/298,746, 13/522,611, and 16/747,257 fail to provide adequate support for the “fastener is equipped for anchoring by comprising an inner cavity of the fastener” of claim 8 line 2 that is in addition to the “inner cavity” of claim 1 line 23 or that of claim 1 line 33, the “fastener is equipped for anchoring by comprising an inner cavity of the fastener” of claim 9 line 2 that is in addition to the “inner cavity” of claim 1 line 23 or that of claim 1 line 33 and “the inner fastener cavity comprises an axially extending groove” of claim 10 that is in addition to “the circumferential fastener surface or the inner cavity of the fastener comprises an axially extending groove” of claim 9 lines 10-13 and “at least one groove along the at least one first portion” of claim 1 line 20 or “the anchoring element is provided as an integrated part” of claim 1 line 36.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claims 8 and 9, the specification appears to lack proper antecedent basis for the “fastener is equipped for anchoring by comprising an inner cavity of the fastener” of claims 8/9 line 2 that is in addition to the “inner cavity” of claim 1 line 23 or that of claim 1 line 33. That is, such was not originally claimed and does not appear to be described or shown in the original specification or drawings. Thus, the specification fails to provide proper antecedent basis for the “fastener is equipped for anchoring by comprising an inner cavity of the fastener” of claims 8/9 line 2 that is in addition to the “inner cavity” of claim 1 line 23 or that of claim 1 line 33. Examiner suggests amending to separate claim limitations drawn to different species to depend from independent claims that provide a supported species.
As to claim 10, the specification appears to lack proper antecedent basis for “the inner fastener cavity comprises an axially extending groove” of claim 10 that is in addition to “the circumferential fastener surface or the inner cavity of the fastener comprises an axially extending groove” of claim 9 lines 10-13 and “at least one groove along the at least one first portion” of claim 1 line 20 or “the anchoring element is provided as an integrated part” of claim 1 line 36. That is, such was not originally claimed and does not appear to be described or shown in the original specification or drawings. Thus, the specification fails to provide proper antecedent basis for “the inner fastener cavity comprises an axially extending groove” of claim 10 that is in addition to “the circumferential fastener surface or the inner cavity of the fastener comprises an axially extending groove” of claim 9 lines 10-13 and “at least one groove along the at least one first portion” of claim 1 line 20 or “the anchoring element is provided as an integrated part” of claim 1 line 36. Examiner suggests amending to separate claim limitations drawn to different species to depend from independent claims that provide a supported species.
The amendment filed March 24, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: all of the amendments to the specification to incorporate a new Fig. 4B and element 3a as the purported axially extending groove and new Fig. 4B showing a dashed line labeled 3a. As provided by original disclosure specification page 26 lines 9-16, the fastener 3 of Fig. 4 has a circumferential surface and/or an inner cavity that may comprise and axially extending groove for accommodation of the suture ends. However, there appear to be no description of the position, length, or depth of the disclosed axially extending groove relative to any disclosed feature or the fastener. Further, the added Fig. 4B shows a dashed line in a particular region of the fastener that is not shown to accommodate the suture ends. Thus, the entirety of the specification and drawing amendment dated March 24, 2026 constitutes new matter and should be cancelled.
Applicant is required to cancel the new matter in the reply to this Office Action
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “fastener is equipped for anchoring by comprising an inner cavity of the fastener” of claims 8/9 line 2 that is in addition to the “inner cavity” of claim 1 line 23 or that of claim 1 line 33 and “the inner fastener cavity comprises an axially extending groove” of claim 10 that is in addition to “the circumferential fastener surface or the inner cavity of the fastener comprises an axially extending groove” of claim 9 lines 10-13 and “at least one groove along the at least one first portion” of claim 1 line 20 or “the anchoring element is provided as an integrated part” of claim 1 line 36 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Examiner notes that there does not appear to be sufficient description in the original disclosure to support adding features to the drawings. Thus, Examiner suggests identifying if such was originally shown or amending to claim originally shown subject matter.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1 lines 5-7 should read “a fastener axis extending between the proximal face and the distal end, and a circumferential surface extending around the fastener axis, [[and]] the fastener further comprising”.
Appropriate correction is required.
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.
Claim(s) 8-10 is/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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claims 8 and 9, the “fastener is equipped for anchoring by comprising an inner cavity of the fastener” of claims 8/9 line 2 that is in addition to the “inner cavity” of claim 1 line 23 or that of claim 1 line 33 appears to be new matter. That is, such was not originally claimed and does not appear to be described or shown in the original specification or drawings. Thus, the “fastener is equipped for anchoring by comprising an inner cavity of the fastener” of claims 8/9 line 2 that is in addition to the “inner cavity” of claim 1 line 23 or that of claim 1 line 33 constitutes new matter. Examiner suggests amending to separate claim limitations drawn to different species to depend from independent claims that provide a supported species.
As to claim 10, “the inner fastener cavity comprises an axially extending groove” of claim 10 that is in addition to “the circumferential fastener surface or the inner cavity of the fastener comprises an axially extending groove” of claim 9 lines 10-13 and “at least one groove along the at least one first portion” of claim 1 line 20 or “the anchoring element is provided as an integrated part” of claim 1 line 36 appears to be new matter. That is, such was not originally claimed and does not appear to be described or shown in the original specification or drawings. Thus, “the inner fastener cavity comprises an axially extending groove” of claim 10 that is in addition to “the circumferential fastener surface or the inner cavity of the fastener comprises an axially extending groove” of claim 9 lines 10-13 and “at least one groove along the at least one first portion” of claim 1 line 20 or “the anchoring element is provided as an integrated part” of claim 1 line 36 constitutes new matter. Examiner suggests amending to separate claim limitations drawn to different species to depend from independent claims that provide a supported species.
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, 8-10, 13, and 14 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 unclear with regards to “the anchoring element is provided as an integrated part of the at least one first portion of the fastener” in lines 36-37 and how such can be supported by the disclosure to have the sonotrode be capable of advancing the anchoring element relative to the fastener (claim 1 lines 12-13), which Applicant has argued is critical, but yet Applicant’s anchoring element that is disclosed to be integrated into the fastener is disclosed as a feature of the embodiment of Fig. 8 where the fastener is fully made of the liquefiable material (page 30 lines 19-24). Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 1 is unclear with regards to “an inner cavity and the at least one anchoring element is adapted to fit into said inner cavity of the fastener,” in lines 23-24 and how it can reasonably be construed that the inner cavity is adapted to fit into itself or the intent of the amendment to this phrase. Examiner is interpreting this as referring to, and suggests amending as, “an inner cavity and the at least one anchoring element, wherein the at least one anchoring element is adapted to fit into said inner cavity of the fastener,”.
Claim(s) 1 is unclear with regards to “said inner cavity being open at the proximal fastener face and the fastener is suitable for fixation of a stitched graft end or a stitched tissue end in a bone opening being a blind bore” in lines 24-27 and the reasoning for including a general functional ability of the fastener with a specific limitation of the inner cavity as well as support for such capability in a bone opening that is a blind bore that is in addition to the opening of claim 1 line 4. Examiner is interpreting this broadly and suggests amending to clarify.
Regarding claim 1, the phrase "which for this purpose" in line 30 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). This is further unclear as to which structure is intended to be claimed as having an open distal end, e.g. the opening in the bone of line 4, the blind bore of line 27, or the inner cavity of line 23. Examiner is interpreting this broadly and suggests amending to clarify. Examiner suggests that it may be easiest to improve the clarity of lines 23-31 by reciting the positively recited features followed by the functional abilities of those features.
Claim(s) 1 is unclear with regards to “the fastener is equipped for anchoring by comprising:” (in lines 15-19) “- the anchoring element is provided as an integrated part” in line 36 and the missing words or phrase that connect the grammar from for anchoring by to is provided. Examiner is interpreting this as referring broadly and suggests amending to clarify.
Claim(s) 8 lines 1-10 and claim 9 lines 1-10 repeat the same language and thereby the same lack of clarity as claim 1 lines 24-32 as detailed above for claim 1 lines 24-32. Claim(s) 8 lines 1-10 and claim 9 lines 1-10 also have clarity issues with regards to their dependence on claim 1 and what unclear references to “an inner cavity” and “said inner cavity”. That is, claim(s) 8 line 2 and claim 9 line 2 are unclear with regards to “the fastener is equipped for anchoring by comprising an inner cavity of the fastener” relative to the recited “an inner cavity” of claim 1 lines 23 and 33 and where support can be found for a total of 2 recited inner cavities. Further, claim(s) 8 lines 3, 3-4, and 8-9 and claim 9 lines 3, 3-4, and 8-9 are unclear with regards to “said inner cavity” and if this is intended to refer to that of claim 1 line 23, claim 1 line 33, or claim 8/9 line 2. Examiner notes that this is due to the many alternatives in claim 1; thus, Examiner suggests amending to remove the alternatives from claim 1 or cancelling limitations that only apply to select alternatives of claim 1. That is, it appears that claim 1 is intended to read on 4 distinct species and thus Examiner suggests amending claim 1 to read on a single species and adding subsequent independent claims to read on each of the other species.
Claim(s) 10 is unclear with regards to “the inner fastener cavity” in line 3 and if such is intended to refer to that of claim 1 line 23, claim 1 line 33, or claim 9 line 2. Examiner is interpreting this broadly and suggests amending to clarify.
Claim(s) 13 is unclear with regards to “the opening provided in a human or animal bone” in line 3 and how an opening in a structure can have previously established antecedent basis support without the same being true for the structure. Instead, it appears that this is a reference to the “an opening provided in a human or animal bone” of claim 1 lines 3-4. 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 lines 5-6 and “the distal end of the opening" in line 6. There is insufficient antecedent basis for this limitation 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) 3-5 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, 3-5, 8-10, 13, and 14 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Aeschlimann et al. (US 2004/0030341, hereinafter “Aeschlimann”).
As to claims 1 and 8-10, Aeschlimann discloses a 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 a tissue or a prosthetic element 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) strengthened by admixed fibers or whiskers (¶65), and a sonotrode (6, Figs. 1 and 26, ¶s 18, 52, 71, 94, and 95) as an anchoring tool (Figs. 1 and 26, ¶s 18, 52, 71, 94, and 95) capable of use to advance the anchoring element 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), and wherein the fastener is capable of anchoring (Figs. 8, 23, and 26, ¶s93-95) by comprising: - an inner cavity of the fastener (central opening shown holding the liquifiable material in Figs. 8 and 26, Figs. 8 and 26) and at least one passage (58s, Fig. 26, ¶95) connects the inner fastener cavity with the at least one first portion of the circumferential surface (Fig. 26, ¶95).
As to claim 3, Aeschlimann discloses that the fibers or whiskers comprises calcium phosphate ceramics or glasses or are made of calcium phosphate ceramics or glasses (¶65).
As to claim 4, Aeschlimann discloses that the anchoring element comprises a composite material or is made from a composite material (¶65).
As to claim 13, Aeschlimann discloses that the fastener is adapted in cross section (¶94 discloses drilling the opening in bone so that the bore diameter corresponds to the implant diameter) capable of being press-fit into the tissue or the prosthetic element in the opening provided in the human or animal bone (Figs. 8, 23, and 26, ¶s 94 and 64, ¶64 discloses that the pin-like implants and bone openings are provided so that introducing the implant into the opening causes a friction fit).
As to claim 14, Aeschlimann discloses that the fastener is adapted to be 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 (Fig. 26) extending from a proximal end of the opening towards a distal end of the opening (Fig. 26).
As to claims 1 and 8-10, Aeschlimann discloses a set (Figs. 1-3, ¶s 65 and 58, where ¶65 discloses that the liquefiable material is mechanically strengthened by admixture of fibers or whiskers, e.g. calcium phosphate ceramics or glasses, and ¶58 discloses use of Fig. 3 in the application shown in Fig. 2) capable of use in an opening provided in a human or animal bone (abstract), the set comprises: a fastener (7, Figs. 1-3, ¶58) capable of fixing a tissue or a prosthetic element in an opening provided in a human or animal bone (Figs. 2 and 3, ¶s 57-59; where ¶58 discloses use of Fig. 3 in the application shown in Fig. 2, ¶57 discloses use to stabilize a bone fracture, and ¶59 discloses drilling a threaded opening), the fastener comprising a proximal face (upper facing face as shown in Figs. 2 and 3), a distal end (lower end as shown in Figs. 2 and ), a fastener axis (vertical central axis as shown in Fig. 3) extending between the proximal face and the distal end (as defined, Figs. 2 and 3) and a circumferential surface (radially outward facing surface as shown in Figs. 2 and 3, Figs. 2 and 3, ¶59 discloses drilling the opening and ¶64 discloses that the opening is slightly narrower than the opening, i.e. the implant has a circumferential) 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. 2 and 3, Figs. 2 and 3) and at least one second portion (right portion as shown in Figs. 2 and 3, Figs. 2 and 3) different from the first portion of the circumferential surface (at least in position as shown in Figs. 2 and 3, Figs. 2 and 3), at least one anchoring element (liquefiable material as shown in Figs. 2 and 3 per ¶36, Figs. 2 and 3, ¶36) comprising a liquefiable material (liquefiable material of ¶s 36 and 65, Figs. 2 and 3, ¶s 36 and 65) strengthened by admixed fibers or whiskers (¶65), and a sonotrode (6, Fig. 1, ¶s 18, 52, and 54) as an anchoring tool (Figs. 1 and 26, ¶s 18, 52, and 54) capable of use to advance the anchoring element relative to the fastener (in as much as Applicant’s, Figs. 1-3, abstract and at least ¶26 discloses mechanical oscillation, ¶54 discloses use of sonotrode/resonator to press against the implant held in tissue) 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), and wherein the fastener is capable of anchoring (Figs. 2 and 3, ¶s 57-59 and 64) by comprising: - the anchorinq element is provided as an integrated part of the at least one first portion of the fastener (in as much as Applicant’s, Figs. 2 and 3, ¶63).
As to claim 3, Aeschlimann discloses that the fibers or whiskers comprises calcium phosphate ceramics or glasses or are made of calcium phosphate ceramics or glasses (¶65).
As to claim 4, Aeschlimann discloses that the anchoring element comprises a composite material or is made from a composite material (¶65).
As to claim 5, Aeschlimann discloses that the fastener is made of a calcium phosphate (Figs. 2 and 3, ¶s 63 and 65).
As to claim 13, Aeschlimann discloses that the fastener is adapted in cross section (¶59 discloses drilling the opening and ¶64 discloses that the opening is slightly narrower than the opening, i.e. the implant has a circumferential) capable of being press-fit into the tissue or the prosthetic element in the opening provided in the human or animal bone (Figs. 2 and 3, ¶s 59 and 64, ¶64 discloses that the pin-like implants and bone openings are provided so that introducing the implant into the opening causes a friction fit).
As to claim 14, Aeschlimann discloses that the fastener is adapted to be 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 (Figs. 2 and 3) extending from a proximal end of the opening towards a distal end of the opening (Figs. 2 and 3).
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) 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Aeschlimann in view of Jarvinen (US 2002/0040241).
As to claim 5, Aeschlimann Fig. 26 discloses the invention of claim 1 as well as the fastener is made of a material (Fig. 26).
Aeschlimann 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 (Figs. 2A-6C) extending around the fastener axis (Figs. 2A-6C), at least one anchoring element (22, Fig. 6A-6C), and wherein the fastener is equipped for anchoring by comprising an inner cavity (opening shown in Figs. 6A and 6B for holding 22, Figs. 6A and 6B) of the fastener (Figs. 6A and 6B), wherein the anchoring element is capable of fitting into said inner cavity (Fig. 6B), said inner cavity open at the proximal fastener face (Fig. 6B), 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 material as disclosed by Aeschlimann by adding fibers of calcium phosphate as taught by Jarvinen in order to reinforce the implant material (Jarvinen ¶99).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775