DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/24/2025 has been entered.
Response to Arguments/ Amendments
The amendments/ arguments, dated 6/24/2025:
Applicant’s amendments have overcome the objection(s) to claim(s) 20, 27, 34;
Applicant’s amendments have overcome the rejection of claim(s) 39 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph;
Applicant’s amendments have overcome the rejection of claim(s) 21-22, 25, 27-33, 35, 39 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph;
Applicant’s amendments have overcome the rejection of claim(s) 34, 36-39, 41 under pre-AIA 35 U.S.C. 102(b) as being anticipated by Short et al. (US 2003/0204265 A1 – as previously cited);
Applicant’s amendments have overcome the rejection of claim(s) 20-33, 35, 40 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Short et al. (US 2003/0204265 A1 – as previously cited) in view of Perice et al. (US 6409767 B1 – as previously cited).
The aforementioned objections/ rejections have been withdrawn.
Claim Objections
Claim(s) 34 is/are objected to because of the following informalities:
Within claim 34, line 6: a semicolon is missing after “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) 20-26, 34-41 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Within claim 20, lines 11-12: Applicant claims, “the engagement between the tibial implant and the intermediate implant not comprising a fastener”; Examiner can not find support within the originally filed disclosure for the ALL the possibilities of connection “not comprising a fastener” – for example: an adhesive/ glue or a nail. Additionally, Applicant has failed to define “fastener”, as such, it is unclear what Applicant considers to be the scope of “fastener” does this include the dovetail shaped coupling means (10) also referred to as a “fastening means” by Applicant (within the specifications page 9, lines 23-26) or lip/ notch connection referred to as a “snap-fastening” by Applicant (within the specifications page 14, line 35-page 15, line 7). Claim(s) 21-26, which depend from claim 20, inherit all the problems associated with claim 20.
Within claim 34, lines 6-9: Applicant claims, “the intermediate implant comprising […] an interfitting connection between the top portion and the tibial implant”; Examiner can not find support within the originally filed disclosure for the INTERMEDIATE IMPLANT comprising an interfitting connection as required by the aforementioned claim requirement. Instead, Examiner can merely find support of the type of connection between the intermediate and tibial implants being an interfitting connection (see Applicant’s specifications page 14, line 23-page 15, line 7). In this “interfitting connection” however there appear to be two components which make the connection interfitting: the abutment element (21) which is part of the tibial implant NOT the intermediate implant; and the non-return means which is potentially a snap fit connection which is only partially made up of by a notch of the intermediate implant. As such, the “interfitting connection” seems to better describe the connection between the two components (the intermediate implant and the tibial implant) as opposed to a substructure of just the intermediate implant as currently claimed. Claim(s) 35-41, which depend from claim 34, inherit all the problems associated with claim 34.
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) 20-26, 39 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Within claim 20, lines 11-12: Applicant claims, “the engagement between the tibial implant and the intermediate implant not comprising a fastener”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of “fastener” as “fastener” is not defined by Applicant’s disclosure nor does it have a universally accepted definition in the art – does it include only screws? Nails? Does this include the dovetail shaped coupling means (10) also referred to as a “fastening means” by Applicant (within the specifications page 9, lines 23-26)? The lip/ notch connection referred to as a “snap-fastening” by Applicant (within the specifications page 14, line 35-page 15, line 7)? Claim(s) 21-26, which depend from claim 20, inherit all the problems associated with claim 20.
Within claim 24, liens 1-4: Applicant claims, “wherein the intermediate implant comprises a fastener configured to couple the intermediate implant with the tibial implant to lock the position of the intermediate implant relative to the tibial implant”; the aforementioned claim requirement directly conflicts with claim 20, lines 11-12 which requires an engagement (connection) without a fastener; as such, it is unclear, and therefore indefinite, if there is or is not a fastener.
Within claim 39, lines 1-3: Applicant claims, “wherein the anterior cortical buttress is configured to extend from the top portion and to be fixed to the tibia”; it is unclear, and therefore indefinite, how the anterior cortical buttress (which is a substructure of the tibial implant) can extend from the to portion of the intermediate implant (as the intermediate implant and the tibial implant are distinct structures). For the purposes of examination, Examiner is assuming the aforementioned claim requirement should read: --wherein the anterior cortical buttress is configured to extend from a top portion of the tibial implant and is configured to be fixed to the tibia--.
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, 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.
Claim(s) 34, 36-39, 41 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Short et al. (US 2003/0204265 A1 - as previously cited) in view of Hubach et al. (US 6485520 A1).
With respect to claim 34:
Short et al. discloses the invention substantially as claimed. Specifically, Short et al. discloses an ankle prosthesis component (ankle implant), as can be seen in fig. 6, for use with an ankle, comprising:
A tibial implant (tibial component 20) configured to be fixed to a tibia and comprising an anterior cortical buttress (anterior end wall 22), the tibial implant (tibial component 20) comprising a recess (recess 25) (paragraphs [0035-0036]);
A talar implant (talar component 30) configured to be fixed to a talus (paragraphs [0035, 0038]) and comprising a first contact surface (top surface 31a); and
An intermediate implant (bearing component 40) configured to be disposed between the tibial implant (tibial component 20) and the talar implant (talar component 30), the intermediate implant (bearing component 40) comprising:
a top portion (top segment 41) configured to be received in the recess (recess 25) to lock/ engage into (be affixed) with the tibial implant (tibial component 20),
a bottom portion (recess 47) comprising a second contact surface (recess 47) configured to engage with the talar implant (talar component 30) (paragraph [0037]).
However, Short et al. does not disclose the intermediate implant to comprise an interfitting connection between the top portion and the tibial implant configured to lock the intermediate implant with the tibial implant.
Hubach et al. teaches a prosthesis for a joint, as can be seen in fig. 1, including a carpal plate (35) and an intermediate element (bearing element 43), as can be seen in figs. 10-15 (column 3, lines 55-60, column 4, line 62-column 5, line 33). The plate (35) and the intermediate element (bearing element 43) are connected to each other via a dovetail connection (36, 47) which includes a lug (46) and elastic tongue (45) as part of the dovetail tenon (47) and a groove (49) in the dovetail groove (36) to securely lock the plate (35) and the intermediate element (bearing element 43) together (column 5, lines 21-33). The dovetail connection (36, 47) with the lug (46) and groove (49) allows for faster connection (than a screwed connection) between the plate (35) and the intermediate element (bearing element 43) without the need for steps requiring tools (column 2, lines 19-31).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the lug (46)/ elastic tongue (45) and groove (49), as taught by Hubach et al., on the top portion (top segment 41) of the intermediate implant (bearing component 40) and the recess (recess 25) of the tibial implant (tibial component 20) (respectively), as disclosed by Short et al., as the lug (46)/ elastic tongue (45) and groove (49) structures, as taught by Hubach et al., will securely anchor the intermediate implant (bearing component 40) and the tibial implant (tibial component 20), as disclosed by Short et al., together and the fastener/ screw connection will no longer be needed thereby reducing the time and tools needed to anchor the aforementioned components together, as taught by Hubach et al..
With respect to claim 36:
Wherein the top portion (top segment 41) with the lug (46)/ elastic tongue (45) of the intermediate implant (bearing component 40), as disclosed by Short et al. and modified by Hubach et al. (as discussed above), and the tibial implant (tibial component 20) with the groove (49), as disclosed by Short et al. and modified by Hubach et al. (as discussed above), are configured to be locked in vivo (via the lug 46 and groove 49) (Short et al. paragraphs [0037, 0041]/ Hubach et al. column 5, lines 21-33).
With respect to claim 37:
Wherein the tibial implant (tibial component 20) and the top portion (top segment 41) of the intermediate implant (bearing component 40), as disclosed by Short et al. and modified by Hubach et al. (as discussed above), are configured to be locked (via the lug 46 and groove 49) such that the tibial implant (tibial component 20) and the intermediate implant (bearing component 40) move together relative to the talar implant (talar component 30) (Short et al. paragraphs [0037, 0041]/ Hubach et al. column 5, lines 21-33).
With respect to claim 38:
Wherein the intermediate implant (bearing component 40), as disclosed by Short et al. and modified by Hubach et al. (as discussed above), is configured to occupy a predetermined position relative to the tibial implant (tibial component 20) by being received in the recess (recess 25) (Short paragraphs [0035-0037, 0041]).
With respect to claim 39:
Wherein the anterior cortical buttress (anterior end wall 22), as disclosed by Short et al. and modified by Hubach et al. (as discussed above), is configured to extend from a top portion of the tibial implant (tibial component 20) and is configured to be fixed to the tibia (Short et al. paragraph [0036]).
With respect to claim 41:
Wherein the top portion (top segment 41) of the intermediate implant (bearing component 40), as disclosed by Short et al. and modified by Hubach et al. (as discussed above), and the tibial implant (tibial component 20), as disclosed by Short et al. and modified by Hubach et al. (as discussed above), are configured to form a mechanical interface (via the dovetail with the lug 46 and groove 49) wherein the intermediate implant (bearing component 40) is configured to be fastened in a single position relative to the tibial implant (tibial component 20) (Short et al. paragraphs [0037, 0041]/ Hubach et al. column 5, lines 21-33).
Claim(s) 20-23, 25-33, 35, 40 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Short et al. (US 2003/0204265 A1 - as previously cited) in view of Hubach et al. (US 6485520 A1) as applied to claim(s) 34, 36-39, 41 above, and further in view of Perice et al. (US 6409767 B1 – as previously cited).
With respect to claim 40:
Short et al. as modified by Hubach et al. discloses the invention substantially as claimed, as discussed above. However, Short et al. as modified by Hubach et al., does not disclose the first contact surface (top surface 31a), Short et al. as modified by Hubach et al. (as discussed above), and the second contact surface (recess 47), Short et al. as modified by Hubach et al. (as discussed above), to each comprise a complementary frustoconical shapes.
Perice et al. teaches an ankle prosthesis component for use with an ankle including a first contact surface (frustoconical surface 7) of a talar implant (talus implant 1) and a second contact surface (bottom surface) of an intermediate implant (intermediate implant 5) which are complementary in shape at the contact interface (contact interface 4) and each comprises frustoconical shape (column 3, line 66, column 4, line 17). The frustoconical shape allows for the ankle prosthesis to faithfully reproduce the relative displacements within a natural ankle joint (column 5, lines 57-67).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the shape of the first contact surface (top surface 31a) and the second contact surface (recess 47), as disclosed by Short et al. as modified by Hubach et al. (as discussed above), to be frustoconical, as taught by Perice et al., as Perice et al. teaches the frustoconical shape allows for the ankle prosthesis to faithfully reproduce the relative displacements within a natural ankle joint.
With respect to claim 20:
Short et al. discloses the invention substantially as claimed. Specifically, Short et al. discloses an ankle prosthesis component (ankle implant), as can be seen in fig. 6, for use with an ankle, comprising:
A talar implant (talar component 30) configured to be fixed to a talus (paragraphs [0035, 0038]) and comprising a first contact surface (top surface 31a); and
A tibial implant (tibial component 20) configured to be fixed to a tibia and comprising an anterior cortical buttress (anterior end wall 22) (paragraphs [0035-0036]);
An intermediate implant (bearing component 40) configured to be disposed between the tibial implant (tibial component 20) and the talar implant (talar component 30), the intermediate implant (bearing component 40) comprising a top portion (top segment 41) configured to be received in the recess (recess 25) to lock/ engage into (be affixed) with the tibial implant (tibial component 20) and a bottom portion (recess 47), the bottom portion (recess 47) comprising a second contact surface (recess 47) (paragraph [0037]), the intermediate implant (bearing component 40) configured to freely slide with friction relative to the talar implant (talar component 30) at a contact interface comprising the first contact surface (top surface 31a) and the second contact surface (recess 47) (claim 1), the top portion (top segment 41) being configured to engage (via the recess 25) into the tibial implant (tibial component 20) (paragraphs [0035-0036]).
However, Short et al. does not disclose the engagement (created in part by the dovetail connection between the top segment 41 and the recess 25) between the tibial implant (tibial component 20) and the intermediate implant (bearing component 40) not comprising a fastener. Nor does Short et al. disclose the first contact surface (top surface 31a) and the second contact surface (recess 47) to each comprise a complementary frustoconical shape.
Hubach et al. teaches a prosthesis for a joint, as can be seen in fig. 1, including a carpal plate (35) and an intermediate element (bearing element 43), as can be seen in figs. 10-15 (column 3, lines 55-60, column 4, line 62-column 5, line 33). The plate (35) and the intermediate element (bearing element 43) are connected to each other via a dovetail connection (36, 47) which includes a lug (46) and elastic tongue (45) as part of the dovetail tenon (47) and a groove (49) in the dovetail groove (36) to securely lock the plate (35) and the intermediate element (bearing element 43) together (column 5, lines 21-33). The dovetail connection (36, 47) with the lug (46) and groove (49) allows for faster connection (than a screwed connection) between the plate (35) and the intermediate element (bearing element 43) without the need for steps requiring tools (column 2, lines 19-31).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the lug (46)/ elastic tongue (45) and groove (49), as taught by Hubach et al., on the top portion (top segment 41) of the intermediate implant (bearing component 40) and the recess (recess 25) of the tibial implant (tibial component 20) (respectively), as disclosed by Short et al., as the lug (46)/ elastic tongue (45) and groove (49) structures, as taught by Hubach et al., will securely anchor the intermediate implant (bearing component 40) and the tibial implant (tibial component 20), as disclosed by Short et al., together and the fastener/ screw connection will no longer be needed (thereby creating engagement between the tibial implant (tibial component 20) and the intermediate implant (bearing component 40) not comprising a fastener/ screw) thereby reducing the time and tools needed to anchor the aforementioned components together, as taught by Hubach et al..
Perice et al. teaches an ankle prosthesis component for use with an ankle. Which includes a first contact surface (frustoconical surface 7) of a talar implant (talus implant 1) and a second contact surface (bottom surface) of an intermediate implant (intermediate implant 5) which are complementary in shape at the contact interface (contact interface 4) and each comprises frustoconical shape (column 3, line 66, column 4, line 17). The frustoconical shape allows for the ankle prosthesis to faithfully reproduce the relative displacements within a natural ankle joint (column 5, lines 57-67).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the shape of the first contact surface (top surface 31a) and the second contact surface (recess 47), as disclosed by Short et al. as modified by Hubach et al. (as discussed above), to be frustoconical, as taught by Perice et al., as Perice et al. teaches the frustoconical shape allows for the ankle prosthesis to faithfully reproduce the relative displacements within a natural ankle joint.
With respect to claim 23:
Wherein the top portion (top segment 41) of the intermediate implant (bearing component 40), as disclosed by Short et al. and as modified by Hubach et al. and Perice et al. (as discussed above), is configured to be received in the recess (recess 25) proximate to the intermediate implant (bearing component 40) to engage into the tibial implant (tibial component 20) (Short et al. paragraphs [0035-0037, 0041]).
With respect to claim 26:
Wherein the top portion (top segment 41) of the intermediate implant (bearing component 40), as disclosed by Short et al. and as modified by Hubach et al. and Perice et al. (as discussed above), and the tibial implant (tibial component 20) are configured to form a mechanical interface (via the dovetail with the lug 46 and groove 49), and wherein the intermediate implant (bearing component 40) is configured to be fastened in a single position relative to the tibial implant (tibial component 20) (Short et al. paragraphs [0037, 0041]/ Hubach et al. column 5, lines 21-33).
With respect to claim(s) 21-22, 25, 27-33, 35:
Short et al. discloses the invention substantially as claimed. Specifically, Short et al. discloses an ankle prosthesis component (ankle implant), as can be seen in fig. 6, for use with an ankle, comprising:
A talar implant (talar component 30) configured to be fixed to a talus (paragraphs [0035, 0038]) and comprising a first contact surface (top surface 31a); and
A tibial implant (tibial component 20) configured to be fixed to a tibia and comprising an anterior cortical buttress (anterior end wall 22) (paragraphs [0035-0036]);
An intermediate implant (bearing component 40) configured to be disposed between the tibial implant (tibial component 20) and the talar implant (talar component 30), the intermediate implant (bearing component 40) comprising a top portion (top segment 41) and a bottom portion (recess 47), the bottom portion (recess 47) comprising a second contact surface (recess 47) (paragraph [0037]), the intermediate implant (bearing component 40) configured to move relative to the talar implant (talar component 30) at a contact interface comprising the first contact surface (top surface 31a) and the second contact surface (recess 47) (claim 1), the intermediate implant (bearing component 40) comprising a connection (via the recess 25 and the top segment 41 and screws) between the top portion (top segment 41) and the tibial implant (tibial component 20) configured to lock the intermediate implant (bearing component 40) with the tibial implant (tibial component 20) (paragraphs [0035-0036]).
However, Short et al. does not disclose the connection (via the recess 25 and the top segment 41 and screws) between the tibial implant (tibial component 20) and the intermediate implant (bearing component 40) to be an interfitting connection. Nor does Short et al. disclose the talar implant (talar component 30) to comprise first and second rails/ guide element along the sides of the talar implant (talar component 30) extending from the first contact surface (top surface 31a) beyond the contact interface such that the intermediate implant (bearing component 40) is configured to be constrained from moving medially and laterally beyond the rails/ guide element.
Hubach et al. teaches a prosthesis for a joint, as can be seen in fig. 1, including a carpal plate (35) and an intermediate element (bearing element 43), as can be seen in figs. 10-15 (column 3, lines 55-60, column 4, line 62-column 5, line 33). The plate (35) and the intermediate element (bearing element 43) are connected to each other via a dovetail connection (36, 47) which includes a lug (46) and elastic tongue (45) as part of the dovetail tenon (47) and a groove (49) in the dovetail groove (36) to securely lock the plate (35) and the intermediate element (bearing element 43) together (column 5, lines 21-33). The dovetail connection (36, 47) with the lug (46) and groove (49) allows for faster connection (than a screwed connection) between the plate (35) and the intermediate element (bearing element 43) without the need for steps requiring tools (column 2, lines 19-31).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the lug (46)/ elastic tongue (45) and groove (49), as taught by Hubach et al., on the top portion (top segment 41) of the intermediate implant (bearing component 40) and the recess (recess 25) of the tibial implant (tibial component 20) (respectively), as disclosed by Short et al., as the lug (46)/ elastic tongue (45) and groove (49) structures, as taught by Hubach et al., will securely anchor the intermediate implant (bearing component 40) and the tibial implant (tibial component 20), as disclosed by Short et al., together and the fastener/ screw connection will no longer be needed (thereby creating engagement between the tibial implant (tibial component 20) and the intermediate implant (bearing component 40) not comprising a fastener/ screw) thereby reducing the time and tools needed to anchor the aforementioned components together, as taught by Hubach et al..
Perice et al. teaches an ankle prosthesis component for use with an ankle. Which includes a first contact surface (frustoconical surface 7) of a talar implant (talus implant 1) and a second contact surface (bottom surface) of an intermediate implant (intermediate implant 5) which are complementary in shape at the contact interface (contact interface 4) and each comprises frustoconical shape (column 3, line 66, column 4, line 17). The frustoconical shape allows for the ankle prosthesis to faithfully reproduce the relative displacements within a natural ankle joint (column 5, lines 57-67). Perice et al. additionally teaches a talar implant (talus implant 1) comprising first and second rails/ a guide element (ribs 11) configured to extend along sides of the intermediate implant (intermediate implant 5) (column 4, lines 27-39), the first and second rails/ guide element (ribs 11) configured to constrain the intermediate implant (intermediate implant 5) from moving laterally and medially beyond the contact interface (contact interface 4) (column 4, lines 27-43).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the shape of the first contact surface (top surface 31a) and the second contact surface (recess 47), as disclosed by Short et al. as modified by Hubach et al. (as discussed above), to be frustoconical, as taught by Perice et al., as Perice et al. teaches the frustoconical shape allows for the ankle prosthesis to faithfully reproduce the relative displacements within a natural ankle joint. It would have additionally been obvious to one having ordinary skill in the art at the time the invention was made to further modify the talar implant (talar component 30) around the first contact surface (top surface 31a), as disclosed by Short et al. and as modified by Hubach et al. and Perice et al. (as discussed above), to include the first and second rails/ a guide element (ribs 11), as additionally taught by Perice et al., in order to prevent medial-lateral displacement of the implant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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/REBECCA S PRESTON/Examiner, Art Unit 3774