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. Figure 1B (i.e., details of the “mouth”, “end”, and “sidewall” of recesses 140) and Figures 1C-19B of the instant application were first introduced in Provisional Application 63506050, filed 02 June 2023. Therefore, the effective filing date of the subject matter of Figure 1B (i.e., details of the “mouth”, “end”, and “sidewall” of recesses 140) and Figures 1C-19B is 02 June 2023.
Response to Amendment
3. Applicant’s amendment of claim 14 in the reply filed on 18 August 2026 is acknowledged.
4. Applicant’s cancellation of claims 1-13 in the reply filed on 18 August 2026 is acknowledged.
5. Applicant’s addition of claim 21 in the reply filed on 18 August 2026 is acknowledged.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 19 and 21 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 19, the recitation “wherein the one or more surfaces of the implant device comprise surface deformations” (lines 3-4) is vague and unclear, rendering it indefinite as to the scope of the invention. Independent claim 14 has been amended to include “wherein the one or more surfaces of the implant device comprise surface deformations”. Are the “wherein the one or more surfaces of the implant device comprise surface deformations” of claim 19 the same as, or different from, the “wherein the one or more surfaces of the implant device comprise surface deformations” of claim 1? It seems, from the specification, that they are the same “surface deformations”. If that is the case, then claim 19 is NOT further limiting claim 1. Claim 21 depends from claim 19.
Claim Rejections - 35 USC § 103
8. 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.
9. Claims 14, 15, and 19-21 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Dinkelacker (EP 1 013 236 A1; cited in Applicant’s IDS) or, in the alternative, under 35 U.S.C. 103 as obvious over Dinkelacker (EP 1 013 236 A1; cited in Applicant’s IDS) in view of Ricci et al. (US PG Pub No. 2001/0039454 A1; cited in Applicant’s IDS) and Ogawa (US PG Pub No. 2020/0113700 A1; previously cited by the Examiner).
Regarding independent claim 14, and referring to Figures 1, 2-6, and 7A-7C, Dinkelacker ‘236 disclose an implant device configured having at least one osteoinductive feature (18) to enhance new bone formation after implantation (Abstract), the implant device comprising:
one or more surfaces of the implant device having a plurality of recesses (Figures 1, 2, 5, 6, 7A, and 7B – recesses 20; Figure 7C – recesses 28) extending into the implant device;
wherein each recess has a mouth (rim or edge or main opening of each recess), an end (bottom of each recess) opposite from the mouth, and a sidewall extending between the mouth and the end;
wherein the sidewall extends inwardly from the mouth to the end and has a mid- depth halfway between the mouth and the end (Figure 6 – sidewalls of each recess 20;
wherein each recess has a depth as measured from its mouth to its end, and at least a majority of the recesses have a depth within a range from about 10 microns to about 500 microns (paragraphs [0015]-[0017], paragraphs [0028]-[0030], claims 1, 5, and 6).
Figure 6 of Dinkelacker ‘236 seems to show wherein at least a majority of the plurality of recesses are structured to taper inward based on the sidewall of each of the plurality of recesses being configured to incline from its mouth to its mid-depth.
Further, this is already known in the art. For example, Ricci et al. ‘454 teaches (Figures 7-14, 14A, and 19) an implant device comprising a plurality of recesses, wherein at least a majority of the plurality of recesses are structured to taper inward based on a sidewall of each of the plurality of recesses being configured to incline from its mouth to an end or at least to a mid-depth (paragraph [0064] and Figure 10). 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 at least a majority of the plurality of recesses are structured to taper inward based on a sidewall of each of the plurality of recesses being configured to incline from its mouth to an end or at least to a mid-depth, as taught by Ricci et al. ‘454, with the invention of Dinkelacker ‘236, in order to provide a guide for preferential promotion of the rate, orientation and direction of growth colonies of cells of the bone which are in contact with the surface pattern (Abstract).
Dinkelacker ‘236 discloses the one or more surfaces as comprising surface deformations (23). Further, Dinkelacker ‘236 recites the dimensions of the recesses (Figures 1, 2, 5, 6, 7A, and 7B – recesses 20; Figure 7C – recesses 28) in microns. Notice, surface deformations (23) are clearly shown as significantly smaller than the recesses. Therefore, Dinkelacker ‘236 disclose said surface deformation (23) as comprising nanoscale surface structures.
Further, this is already known in the art. For example, Ogawa ‘700 teaches (Figures 10 and 11) an implant (100) comprising one or more surfaces having a plurality of recesses (104) extending into the implant device, wherein each recess has a depth within a range from about 10 microns to about 500 microns ([0039]). Ogawa ‘700 further teaches the one or more surfaces comprise surface deformations comprising nanoscale surface structures (106). 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 one or more surfaces comprising surface deformations comprising nanoscale surface structures, as taught by Ogawa ‘700, with the invention of Dinkelacker ‘236, in order to promote the function of bone-forming cells ([0038]-0039]).
Regarding claim 15, Dinkelacker ‘236 teaches wherein the implant is made of a metal (titanium - [0002], [0020], [0022]).
Regarding claim 19, Dinkelacker ‘236 teaches:
wherein the recesses are arranged in a non-random, engineered pattern (Figures 1, 5, and 6 – recesses 20 are clearly shown as arranged in in a non-random, engineered pattern, e.g., parallel to longitudinal axis of implant device; Figures 7A and 7B - recesses 20 are clearly shown as arranged in in a non-random, engineered pattern, e.g., diagonal to longitudinal axis of implant device; Figure 7C – recesses 28 are clearly shown as arranged in in a non-random, engineered pattern 27); and
wherein the one or more surfaces of the implant device comprise surface deformations (23) that are random in comparison to the pattern of the recesses and are significantly smaller than the depth of the recesses (Figures 1, 5, 6, and 7A-7C, paragraphs [0015]-[0017], paragraphs [0028]-[0030], claims 1, 5, and 6).
Regarding claim 20, Dinkelacker ‘236 discloses the invention as claimed, except for particularly disclosing wherein the recesses have varying depths such that not all of the recesses have essentially the same depth. However, this is already known in the art. For example, Ricci et al. ‘454 teaches (Figures 7-14, 14A, and 19) an implant device comprising recesses having varying depths in order for the implant device to have different degrees of effect on individual cell orientation and tissue growth in vivo ([0013]). 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 recesses have varying depths such that not all of the recesses have essentially the same depth, as taught by Ricci et al. ‘454, with the invention of Dinkelacker ‘236, in order for the implant device to have different degrees of effect on individual cell orientation and tissue growth in vivo.
Regarding claim 21, Dinkelacker ‘236 in view of Ogawa ‘700 teaches wherein the surface deformation have a diameter or width of less than about 200 nanometers (Ogawa ‘700- [0039]).
10. Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dinkelacker (EP 1 013 236 A1; cited in Applicant’s IDS) in view of Ricci et al. (US PG Pub No. 2001/0039454 A1; cited in Applicant’s IDS) and Ogawa (US PG Pub No. 2020/0113700 A1; previously cited by the Examiner), as applied to claim 15 above, and further in view of Soboyejo et al. (US PG Pub No. 2004/0000540 A1)
Regarding claim 16, Dinkelacker ‘236, as modified by Ricci et al. ‘454 and Ogawa ‘700, discloses the invention as claimed, except for particularly disclosing wherein the metal is a titanium alloy. However, this is already known in the art. For example, Soboyejo et al. ‘540 teaches the use of a titanium alloy (Ti-6Al-4V) with an implant device due to their balance of biocompatibility, corrosion resistance, wear resistance and fatigue resistance ([0006]). 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 metal is a titanium alloy, as taught by Soboyejo et al. ‘540, with the invention of Dinkelacker ‘236, in order to improve balance of biocompatibility, corrosion resistance, wear resistance and fatigue resistance of the implant device.
Notice, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 17, Dinkelacker ‘236 in view of Soboyejo et al. ‘540 teaches wherein the titanium alloy is 90 percent titanium, 6 percent aluminum and 4 percent vanadium (Soboyejo et al. ‘540 - Ti-6Al-4V – [0006]).
Regarding claim 18, Dinkelacker ‘236 in view of Soboyejo et al. ‘540 teaches wherein the implant device has at least one surface that comprises titanium oxide (the Ti-6Al-4V disclosed by Soboyejo et al. ‘540 will oxide when the implant device is exposed to air or physiological fluids, thereby forming titanium oxide on the exposed surface). Notice, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Response to Arguments
11. Applicant's arguments filed 04 August 2026 have been fully considered but they are not persuasive. The Applicant argues Dinkelacker ‘236 does not disclose newly-added recitation “wherein at least a majority of the plurality of recesses are structured to taper inward based on the sidewall of each of the plurality of recesses being configured to incline from its mouth to the end or at least to its mid-depth; further wherein the one or more surfaces of the implant device comprise surface deformations comprising nanoscale surface structures”.
The Examiner respectfully disagrees. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action, which new ground(s) of rejection is explained in the 103(a) rejection above.
Conclusion
12. 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 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
