DETAILED ACTION
Notice of Pre-AIA or AIA Status
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-5, 8, 9, 11, 15-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 1, line 4 is objected to because of the following informalities: the word: --- bone ---, should be added between “navicular” and “when” in order to clarify that the applicant’s representative is referring to the patient’s bone. Appropriate correction is required.
Regarding the word: “configured”, this phrase has been identified as an intended use limitation because is typical of claim limitations which may not distinguish over prior art according to the principle. It has been held that the recitation that an element is “configured to” performing a function is not a positive limitation but only requires the ability to so perform.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-5, 8, 9, 11, 15-17 and 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over CN106618807A.
Regarding claims 1 and 26, the reference discloses a talus implant comprising: a body section, a neck portion that extends from a front end of the body section and defines a head of the talus implant. A crown portion at a top portion of the body section and a pair of wing sections that flare out from a back end of the body section. Wherein said neck portion, said crown portion and said pair of wing portions are made from two pieces and form a continuous single top articulation surface of the talus implant, and wherein the neck portion comprises a coupling hole (See figure below) that extend from a portion of the articulation surface defined by the neck portion to a bottom side of the body section. See figure below.
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However, the reference does not disclose an implant made of a single piece of material and two coupling holes.
It would be an obvious matter of design choice that integrating parts into a single piece instead of separate pieces is obvious, since, the function of the implant remains that same and there are no unexpected result. At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the two pieces of the reference with a single piece, since, the function of the implant remains that same and there is no unexpected result. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with two pieces because it would perform equally as well.
Therefore, it would have been an obvious matter of design choice to modify the ‘807A reference to obtain the invention as specified in claim 1.
Regarding the two holes, ‘807A disclose the claimed invention except for the addition hole. It would have been obvious to one having ordinary skill in the art at the time the invention was made to add an extra hole to the talus implant, since it has been held that finding an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 3, see post in figure above and Fig. 2.
Regarding claims 4 and 15, see page 2, line 31 disclosing a smooth surface and see Fig. 2 and page 2, lines 29-30 disclosing a porous coating. The Examiner interpreted the coating as a mesh structure because it is porous.
Regarding claim 5, see Fig. 2 showing two post extending from the porous structure (mesh structure). It is well known in the art to fully cover posts that are going to be inserted into the patient’s bone. These porous coatings are used to promote the growth of bone tissue around the implant to enhance the connection between the bone and the implant.
Regarding claim 8, it is inherent to have two separate domes if the intention of the invention is to replace the talar bone. See Figure 4, showing distinct surfaces, the surface to the left is different than the surface to the right.
Regarding claim 9, see Fig. 6 showing a dome having a semi-circular section.
Regarding claim 11, a comparison of the recited process with the prior art processes does NOT serve to resolve the issue concerning patentability of the product. In re Fessman, 489 F2d 742, 180 U.S.P.Q. 324 (CCPA 1974). Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. In re Klug, 333 F2d 905, 142 U.S.P.Q. 161 (CCPA 1964). In an ex parte case, product-by-process claims are not construed as being limited to the product formed by the specific process recited. In re Hirao et al., 535 F2d 67, 190 U.S.P.Q. 15, see footnote 3 (CCPA 1976).
Regarding claims 16 and 17, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the porous surface of the ‘807 reference by using a honeycomb configuration and varying porosity because Applicant has not disclosed that by having this specific configuration provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the regular porosity of the ‘807 reference because it would perform equally as well.
Therefore, it would have been an obvious matter of design choice to modify the ‘807 reference to obtain the invention as specified in claims 16 and 17.
Regarding claim 21, it is inherent to have a polished metal for the purpose of having a smooth articulation.
Regarding claims 22 and 25, ‘807A disclose the claimed invention except for the addition hole at the bottom side of the neck portion. It would have been obvious to one having ordinary skill in the art at the time the invention was made to add an extra hole to the talus implant, since it has been held that finding an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 23, see figure below for the Examiner’s interpretation of the outer solid frame portion and inherently the mesh has to extends beyond the frame portion so it can be in direct contact with bone for the purpose of promoting the growth of bone tissue.
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Regarding claim 24, if the neck portion is in contact with the navicular bone, it will be inherent to have a smooth surface in order to avoid premature wear and tear of the natural occurring bone of the patient.
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 12/12/25