DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 69 is 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.
Regarding Claim 69, it is unclear how a “point” can have a thickness. As a point is defined as “a geometric element that has zero dimensions and a location determinable by an ordered set of coordinates” (Merriam-Webster at merriam-webster.com), it is not possible for a point by definition to have a thickness, and therefore this limitation will be interpreted broadly.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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 –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9, 13-19, 21, and 69-71 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Spahn (US 2014/0004481 A1).
Regarding Claim 1, Spahn discloses an implant for use in joint or bone repair (abstract) comprising a stem (2 as seen in Figures 1-3) having a proximal end, a distal end, and an external surface (see Figures 1-4), in which a portion of the stem comprises two or more non-overlapping lamellas (“ribs” 6) around part or all of the circumference of the stem (as seen in Figures 1-4) where each lamella comprises an outer surface (see annotated figure 4 below), an inner surface (see annotated figure 4 below), and a thickness therebetween (as seen in Figure 4), where the inner surface of the lamella faces the external surface of the stem (as seen in Figures 1-4). Each lamella is connected to the external surface of the stem via a bending joint (see annotated figure 3 below) on the inner surface of the lamella at one edge of the lamella or adjacent thereto, where the rest of the inner surface of the lamella and the external surface of the stem is separated by a space (see annotated Figure 4 below). The bending joint permits the space between the rest of the inner surface of the lamella and the external surface of the stem to decrease upon application of a force to the outer surface of the lamella (as seen in Figure 9 and described in [0004-0005]). The lamellas are arranged in two or more columns of lamellas in a direction of the proximal end to the distal end (see Figure 1) of the stem, and two or more rows of lamellas around the circumference of the stem (see Figure 1). When implanted in a body, the space between the inner surface of the lamella and the external surface of the stem can decrease but cannot increase (as seen in Figure 9 and described in [0004-0005]).
Additionally, Spahn discloses that each of the lamellas comprises a proximal edge, a distal edge, a left edge, and a right edge (see annotated Figure 6 below, where the proximal edge is the proximal half of the inner surface of the lamella, the distal edge is the distal half of the inner surface of the lamella, the right and left edges are the lateral edges as indicated on the annotated Figure – Please note: as “left” and “right” have not been relatively defined, they would depend on orientation of the implant). Spahn further discloses that the bending joint is on the distal edge of the lamella (see annotated Figures 4 and 6 below) and that the bending joint is on adjacent both the right edge and the left edge of the lamella (as seen in the Figures below).
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Regarding Claim 2, Spahn discloses that the stem is substantially the shape of a cylinder (Figure 2).
Regarding Claim 3, Spahn discloses that the cylinder is a circular cylinder (Figure 2).
Regarding Claim 4, Spahn discloses that the stem comprises a taper between the proximal end and the distal end (Figure 1).
Regarding Claim 5, Spahn discloses that the stem comprises substantially a shape of a rounded cone (Figure 3).
Regarding Claim 6, Spahn discloses that the rounded cone is a rounded circular cone (Figure 2).
Regarding Claim 7, Spahn discloses that the number of lamellas in each column and each row is the same (Figure 3).
Regarding Claim 9, Spahn discloses that the lamellas comprise substantially the shape of a quadrilateral (as best seen in Figure 1).
Regarding Claim 13, Spahn discloses that the bending joint provides on the edge of the lamella a single continuous connection point between the inner surface of the lamella and the external surface of the stem (see annotated Figures 4 and 6 above).
Regarding Claim 14, Spahn discloses that the bending joint provides on the edge of the lamella two or more connection points between the inner surface of the lamella and the external surface of the stem (see Figures 4 and 6 – please note: as no structure has been claimed for the “connection points” the connection points can be interpreted broadly as any point along the inner surface of the lamella and external surface of the stem up to and including two adjacent points that would form a single continuous connection point).
Regarding Claim 15, Spahn discloses that the lamellas can be porous and further be coated ([0014]).
Regarding Claim 16, Spahn discloses a method of treating a subject in need of joint replacement or bone repair, the method comprising implanting into the subject the implant of claim 1 (([0017]).
Regarding Claim 17, Spahn discloses a method of reducing risk and incidence of bone damage caused by implantation of an implant in a subject, the method comprising implanting into the subject the implant of claim 1 ([0004] describes the advantages of the implant to decrease metallurgic problems such as corrosion).
Regarding Claim 18, Spahn discloses a method of reducing incidence of aseptic implant loosening in a subject, the method comprising implanting into the subject the implant of claim 1 ([0004], where the ribs are disclosed to prevent disengagement of the implant).
Regarding Claim 19, Spahn discloses that the implant is a dental implant (abstract).
Regarding Claim 21, Spahn discloses a method of treating a subject in need of dental repair, the method comprising implanting into the subject the dental implant of claim 19 ([0017]).
Regarding Claim 69, Spahn discloses that the two or more connection points extend into a thickness of the lamella (as the parameters for the connections points are not defined, they can be considered to extend into a thickness of the lamella inasmuch as any point of the present application can have a thickness). Please note: by definition a point does not have dimension as described above.
Regarding Claim 70, Spahn discloses that the portion of the stem comprises two or more non-overlapping lamellas around all of the circumference of the stem (as seen in Figure 2).
Regarding Claim 71, Spahn discloses that each of the lamellas comprises substantially a shape of a trapezoid or parallelogram (as seen in Figure 1, the lamella have 4 sides that are substantially parallel).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Spahn in view of Chung et al. (US 2011/0251697 A1, hereinafter “Chung”).
Regarding Claim 8, Spahn discloses the invention of Claim 1 substantially as described above, but does not specifically disclose that the number of lamellas in each column and each row is not the same. In the same art of implants, Chung discloses an implant (Figure 2, 100) with rows of lamella that do not have the same number of lamellas in each column. As seen in Figure 2, the number of lamella (“teeth” 110 as seen in Figure 3) are not the same on the medial face (Figure 2, 105) as the lateral face (Figure 2, 106). As one of the objectives of the implant of Spahn is to provide for customization (Spahn, [0004]), it would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide an unequal number of lamella when the dimensions of the implant are not symmetrical, as taught by Chung, based on differing anatomical conditions such as jawbone size and width in order to best accommodate the needs of the patient.
Response to Arguments
Applicant’s amendments have overcome the previous claim and drawing objections.
Regarding applicant’s argument that Spahn does not disclose the features of the newly amended claim 1, specifically that the bending joint “is on the right edge of the lamella or adjacent thereto or on the left edge of the lamella or adjacent thereto,” the examiner disagrees. As seen in the annotated Figures of Spahn above, both the right and left edge of the lamella of Spahn would be adjacent the bending joint. Therefore, the rejection of independent Claim 1 in view of Spahn is maintained.
Newly added claims 69 – 71 are disclosed by Spahn, as described above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE L NELSON whose telephone number is (571)270-5368. The examiner can normally be reached M - F 7:30-4:30 PT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached at 571-270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINE L NELSON/Examiner, Art Unit 3772
/EDWARD MORAN/Primary Examiner, Art Unit 3772