DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
3. Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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 Rejections - 35 USC § 101
4. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
a. Claims 2-4 and 6-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
(i) In claim 2 the Applicant positively recites part of a human, i.e., “having pores which induce bone ingrowth” (see line 2). Thus claim 2 includes a human or living tissue within their scope and are non-statutory. Claims 3 and 4 depend from claim 2. See M.P.E.P. 2105.
(ii) In claim 6 the Applicant positively recites part of a human, i.e., “which is a surface in contact with a bond” (see lines 3-4). Thus claim 6 includes a human or living tissue within their scope and are non-statutory. Claims 7-9 depend from claim 6. See M.P.E.P. 2105.
A claim directed to or including within its scope a human or living tissue is not considered to be patentable subject matter under 35. U.S.C. 101. The living matter of the present invention is not the result of human intervention; it is of nature, which has been held not patentable. The grant of a limited, but exclusively property right in a human being is prohibited by the Constitution. In re Wakefield, 422 Fed.Cir.2d 897, 164 USPQ 636 (CCPA 1970).
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 5-9 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.
a. Regarding claim 5, the recitation “which is a boundary between a surfaces and a surface of the body part” (line 2) is vague and confusing, rendering claim 5 indefinite as to the scope of the invention. What exactly are the “a surfaces”? Claims 6-9 depend from claim 5. This will be interpreted “as best understood”.
Claim Rejections - 35 USC § 102
7. 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
8. Claims 1-10, 13, and 14 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Kim et al. (KR 10-2019-0077787; cited in Applicant’s IDS).
Kim et al. ‘787 discloses an augment implant comprising:
a body part (Figures 4-6, 9, and 10 – part 10) having a shape complementary to a shape of a bone (Abstract; and page 5, paragraph 4 of English translation provided in Applicant’s IDS); and
a frame part (Figures 4-6, 9, and 10 – part 30) which has a shape to prevent damage to the body part and is combined with the body part (Abstract).
Regarding claim 2, Kim et al. ‘787 discloses wherein the body part is a porous structure having pores (Figure 6 - voids or pores 11) which induce bone ingrowth (page 5, paragraph 9 and paragraph 12 of the English translation provided in Applicant’s IDS).
Regarding claim 3, Kim et al. ‘787 discloses wherein the frame part is a non-porous (e.g., solid) structure having strength higher than the porous structure (Abstract).
Regarding claim 4, Kim et al. ‘787 discloses wherein the frame part does not close any one surface of the body part so that the body part is able to be inserted in various directions (the particular shape, particular spatial orientation, and/or particular metes and bounds of the recited “any one surface of the body part” is not recited in the claim language, and could be broadly interpreted to include any of the surface 103 and/or surface 101, which surfaces are clearly shown in Figures 9 and 18 as capable of allowing the body part to be inserted in various directions).
Regarding claim 5, as best understood, Kim et al. ‘787 discloses wherein the body part comprises an edge which is a boundary between a surfaces and a surface of the body part (see below for annotated Figure 18).
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Regarding claim 6, Kim et al. ‘787 discloses wherein the edge comprises a contact edge which is a boundary between an implant contact surface (103) of the body part which is a surface in contact with an implant and a bone contact surface (101) of the body part which is a surface in contact with a bone (see above for annotated Figure 18).
Regarding claim 7, Kim et al. ‘787 discloses wherein the contact edge is formed as a sharp edge which minimizes empty space between the implant and the implant contact surface (see “a sharp edge” depicted above in annotated Figure 18).
Regarding claim 8, Kim et al. ‘787 discloses wherein the frame part comprises an edge frame part formed on the contact edge (said “an edge frame part” is clearly shown in at least Figures 4, 10, and 15).
Regarding claim 9, Kim et al. ‘787 discloses wherein the implant contact surface has a shape complementary to a shape of an outer circumferential surface of the implant (Figures 9 and 18).
Regarding claim 10, Kim et al. ‘787 discloses wherein the body part (10) comprises a through hole (13) formed through a second surface of the body part from a first surface of the body part (Figures 8, 14, 16, and 17), and the frame part comprises a hole frame part (50) formed inside the through hole (Figures 16 and 17).
Regarding claim 13, Kim et al. ‘787 discloses wherein the augment implant is integrally manufactured by 3D printing (see page 5, paragraph 9 of the English translation provided in Applicant’s IDS).
Regarding claim 14, Kim et al. ‘787 discloses wherein a support generated during 3D printing is connected to the frame part (Figure 15 – support “S”).
Claim Rejections - 35 USC § 103
9. 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.
10. Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (KR 10-2019-0077787; cited in Applicant’s IDS), as applied to claim 10 above, in view of Grady, JR. et al. (US PG Pub No. 2005/0261688 A1).
Regarding claim 11, Kim et al. ‘787 discloses the invention as claimed, except for particularly disclosing wherein the through hole comprises a first tapered hole which has a truncated cone-shaped space by having a diameter decreasing gradually toward a second side from a first side, a second tapered hole which faces the first tapered hole and has a truncated cone-shaped space by having a diameter decreasing gradually toward the first side from the second side, and a connection hole which allows the first tapered hole and the second tapered hole to communicate with each other. However, this is already known in the art. For example, Grady, JR. et al. ‘688 teaches (Figures 1A, 1B, and 4A) a through hole (90) comprising a first tapered hole (92) which has a truncated cone-shaped space by having a diameter decreasing gradually toward a second side from a first side (clearly shown in Figure 4A), a second tapered hole (96) which faces the first tapered hole and has a truncated cone-shaped space by having a diameter decreasing gradually toward the first side from the second side (clearly shown in Figure 4A), and a connection hole (94) which allows the first tapered hole and the second tapered hole to communicate with each other (clearly shown in Figure 4A) in order to allow introduction of fixing means (i.e., screws or bolts) at different angles, that will reduce need to manufacture many different augment implants having varying hole arrangement patterns, and to provide desired flexibility for the surgeon without unduly compromising the strength, size, or integrity of the augment implants ([0048]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the through hole comprises a first tapered hole which has a truncated cone-shaped space by having a diameter decreasing gradually toward a second side from a first side, a second tapered hole which faces the first tapered hole and has a truncated cone-shaped space by having a diameter decreasing gradually toward the first side from the second side, and a connection hole which allows the first tapered hole and the second tapered hole to communicate with each other, as taught by Grady, JR. et al. ‘688, with the invention of Kim et al. ‘787, in order to allow introduction of fixing means (i.e., screws or bolts) at different angles, that will reduce need to manufacture many different augment implants having varying hole arrangement patterns, and to provide desired flexibility for the surgeon without unduly compromising the strength, size, or integrity of the augment implants.
Regarding claim 12, Kim et al. ‘787 discloses wherein the hole frame part (50) is formed in a tubular shape having open first and second surfaces to cover an inner surface of the through hole 13 (see inner surface 51 of hole frame part 50), and an outer surface (53) of the hole frame part has a shape complementary to a shape of the inner surface of the through hole (Figures 16 and 17). See page 6, paragraphs 9-13 of the English translation provided in Applicant’s IDS.
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Figures 2-4 of WO 9911188 A1
Figures 7, 7A, 7B, 8, and 9 of US PG Pub No. 2006/0241781 A1
Figures 6-8 of US PG Pub No. 2018/0193152 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774