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 .
Response to Amendment
Claims 1-6, 8, 10-15, and 17-20 are pending. Claim 7 is canceled. Claims 17-20 are new.
In view of the amendment, filed 11/25/2025, the following objections and rejections are withdrawn from the previous Office Action mailed 08/07/2025:
Specification and claim objections
Claim rejections under 35 U.S.C. 112(b)
Prior art rejections are updated in response to claim amendments. Any new grounds of rejection are made in response to claim amendments.
Claim Objections
Claim(s) 2-3 is/are objected to because of the following informalities: claims 2-3 should still include “the” prior to “increasing” for proper reference to the recited limitations of claim 1.
Appropriate correction is required.
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(s) 8 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.
Claim 8 depends from canceled claim 7, rendering the claim scope indefinite. For further examination, the claim is interpreted as depending from claim 1.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 8, and 17-18 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Akash, US 20070116734 A1.
Regarding claim 1, Akash discloses a method for manufacturing a silicon nitride implant (creating a ceramic implant, Abstract, from ceramic powder including silicon nitride, [0045]; see, e.g., implant structure 44 of Fig. 4E), the method comprising:
Providing a silicon nitride green body (providing green tape structure made from ceramic powder including silicon nitride, [0045], Fig. 5 steps 52, 64);
Increasing the surface roughness of the silicon nitride green body (cutting apertures 32 in the tape, [0051], Fig. 5 step 66, some of which are open depressions at the outer surface and thereby increase the surface roughness, see Fig. 4E);
Increasing the porosity of the silicon nitride green body (cutting apertures 32 in the tape, [0051], Fig. 5 step 66, which are “pores,” [0026], [0044], and thereby increase the porosity, Fig. 4E);
Sintering the silicon nitride green body to obtain the silicon nitride implant (sintering, [0053], Fig. 5, step 74), and
Applying an osteogenic coating to a surface of the sintered silicon nitride implant (infiltrating the implant structure with one or more beneficial agents including agents to promote osteoconduction, [0055], Fig. 5 step 76 after firing/sintering).
Regarding claim 2, Akash discloses the method of claim 1, wherein the increasing the surface roughness of the silicon nitride green body is performed by laser etching (apertures 32 are cut by laser cutting, etching, [0051], Fig. 4E; note that laser cutting as disclosed by Akash that involves the selective removal of material by laser without complete severing of the part is considered to meet laser etching).
Regarding claim 3, Akash discloses the method of claim 1, wherein the increasing the porosity of the silicon nitride green body is performed by laser etching (apertures 32 are cut by laser cutting, etching, [0051], Fig. 4E; note that laser cutting as disclosed by Akash is considered to meet laser etching as set forth above; note that Akash also discloses drilling, [0051]).
Regarding claim 8, Akash discloses the method of [claim 1], wherein the osteogenic coating is hydroxyapatite ([0055]).
Regarding new claim 17, Akash discloses the method of claim 1, wherein the surface roughness or porosity is formed in a pattern (Fig. 4E, see top surface and apertures 32).
Regarding new claim 18, Akash discloses the method of claim 1, wherein the surface roughness is in a pattern that is dimpled (Fig. 4E, see top surface and apertures 32, where the round depressions are considered to meet at least dimpled).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 4-6 and is/are rejected under 35 U.S.C. 103 as being unpatentable over Akash, US 20070116734 A1, as applied to claim 1 above, in view of Jennissen, US 20180296345 A1 (of record).
Regarding claim 4, Akash discloses the method of claim 1. Akash is silent as to the silicon nitride implant having a Sa value of less than about 100 µm. In view of the specification, Sa is interpreted as the average surface roughness Sa or Ra ([0029]).
In the analogous art, Jennissen discloses production of an implant with a structured surface to promote ingrowth at the implantation location (Abstract, [0002]), the implant formed from a ceramic material ([0042]-[0043]), wherein the surface is structured by a laser ([0036]-[0038]). Jennissen teaches providing the structured surface to have a Ra value in the range of 1 to 80 µm ([0050], within the claimed range), wherein the structured surface provides advantages including a beneficially large surface area and surface capacity ([0072]-[0079]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to specify in Akash that the structured surface had a Sa value of less than about 100 µm in order to provide a suitable surface roughness for increasing the surface area and surface capacity to promote ingrowth, as desired by Akash (Abstract) and taught by Jennissen.
Regarding claim 5, modified Akash discloses the method of claim 4. The combination did not specifically address the silicon nitride implant having a Sa value of about 50 µm to about 100 µm. The upper end of the range being to “about 100 µm” is interpreted as still being less than about 100 µm as required by claim 4. As set forth above, Jennissen teaches providing the structured surface to have a Ra value in the range of 1 to 80 µm ([0050]), overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05(I). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further specify at least the overlapping portion of the range in order to achieve the benefits associated with the surface roughness taught by Jennissen as set forth above.
Regarding claim 6, modified Akash discloses the method of claim 4. The combination did not specifically address the silicon nitride implant having a Sa value of about 60 µm to about 90 µm. As set forth above, Jennissen teaches providing the structured surface to have a Ra value in the range of 1 to 80 µm ([0050]), overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05(I). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further specify at least the overlapping portion of the range in order to achieve the benefits associated with the surface roughness taught by Jennissen as set forth above.
Claim(s) 10 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akash, US 20070116734 A1, in view of Suganthi et al., A review of accuracy enhancement in microdrilling operations (2015).
Regarding claim 10, Akash discloses a method for manufacturing a silicon nitride implant (creating a ceramic implant, Abstract, from ceramic powder including silicon nitride, [0045]; see, e.g., implant structure 44 of Fig. 4E), the method comprising:
Providing a silicon nitride green body (providing green tape structure made from ceramic powder including silicon nitride, [0045], Fig. 5 steps 52, 64);
Laser etching an outer surface of the silicon nitride green body to increase the surface roughness of the silicon nitride green body (cutting apertures 32 in the tape by laser cutting, etching, [0051], Fig. 5 step 66, some of which are open depressions at the outer surface and thereby increase the surface roughness, Fig. 4E; as set forth above, note that laser cutting as disclosed by Akash is considered to meet laser etching);
Laser etching the silicon nitride green body to create porosity in the silicon nitride green body (cutting apertures 32 in the tape by laser cutting, etching, [0051], Fig. 5 step 66, which are “pores,” [0026], [0044], and thereby increase the porosity, Fig. 4E; note that Akash also discloses drilling, [0051]); and
Sintering the silicon nitride green body to obtain the silicon nitride implant (sintering, [0053], Fig. 5, step 74).
Akash discloses that forming the apertures, i.e., increasing the surface roughness and creating porosity, can be performed using techniques such as laser etching and mechanical cutting via a drill ([0051]). Akash does not specifically disclose the apertures are formed by both laser etching and peck drilling.
Given that Akash discloses performing laser etching and drilling for forming apertures, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform both techniques with a reasonable expectation of success in forming the apertures and thereby increasing the surface roughness and creating porosity. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. MPEP 2143(I)(A).
Akash as set forth above discloses the drilling but does not disclose peck drilling specifically.
In the analogous art directed to machining of micro-structures for medical/biomedical applications (Introduction, first paragraph; p. 204, Section 8, second paragraph; p. 214, Section 22, first paragraph), Suganthi discloses that peck drilling facilitates easy chip removal and tool cooling, improves tool life, and produces better shaped holes (p. 210, Section 15.1, second paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mechanical drilling of Akash to perform peck drilling in order to utilize a drilling technique that facilitates chip removal and tool cooling, as well as improves the tool life and hole shapes, as taught by Suganthi.
Regarding claims 14-15, modified Akash discloses the method of claim 10, and Akash discloses applying an osteogenic coating to the silicon nitride implant (infiltrating the implant structure with one or more beneficial agents including agents to promote osteoconduction, [0055], Fig. 5 step 76) after the sintering step (Fig. 5 step 76, after firing/sintering step 74), the osteogenic coating being hydroxyapatite ([0055]).
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akash, US 20070116734 A1, in view of Suganthi et al., A review of accuracy enhancement in microdrilling operations (2015), as applied to claim 10 above, in view of Jennissen, US 20180296345 A1 (of record).
Regarding claims 11-13, modified Akash discloses the method of claim 10. Akash is silent as to the claimed Sa values. Jennissen renders obvious the claimed ranges as set forth above for claims 4-6, respectively.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Akash, US 20070116734 A1, in view of Suganthi et al., A review of accuracy enhancement in microdrilling operations (2015), as applied to claim 10 above, and further in view of Tenney et al., US 20100233238 A1.
Regarding new claim 19, modified Akash discloses the method of claim 10. Akash discloses the pores/apertures have a diameter between about 0.1 and about 600 µm ([0026]). The combination does not specifically disclose the peck drilling forms pores with a depth of about 0.050 to about 0.500 mm (or about 50 to 500 µm).
In the analogous art, Tenney discloses forming medical implants (Abstract) with depressions having a diameter of 1 mm or less ([0027]), or 1000 µm or less, and a depth of 1 to 25 times the diameter ([0028]). Tenney teaches the depressions may be formed by microdrilling ([0031]) and may ultimately contain a therapeutic agent and/or coating ([0025]). Since Akash is silent as to a depth, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the depth teaching from Tenney in implementing a suitable depth dimension for the depressions.
The combination therefore discloses the pores have a depth of 1 to 25 times the diameter of 0.1 to 600 µm (diameter of Akash, [0026]), or a depth of about 0.0001 to 15 mm, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05(I). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further specify at least the overlapping portion of the range in selecting an appropriate pore depth in view of modified Akash and Tenney.
Regarding new claim 20, modified Akash discloses the method of claim 19. Akash does not explicitly disclose the pores have a diameter of about 300 to about 600 µm but does disclose the pores have a diameter between about 0.1 and about 600 µm ([0026]), overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05(I). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further specify at least the overlapping portion of the range in selecting an appropriate pore diameter in view of Akash.
Response to Arguments
Applicant's arguments filed 11/07/2025 have been fully considered but they are not persuasive.
Applicant argues (p. 7) that Akash does not expressly disclose any post-sintering coating applied onto the implant’s surface. Applicant argues that Akash’s infiltration of material into internal pores is different than forming a coating layer on the exterior surface of the implant, which one of ordinary skill in the art would recognize to mean depositing a layer on the implant’s surface, e.g., by dipping, spraying, or vapor deposition.
This argument is not found persuasive. Akash’s infiltration of the pore structure ([0055]) with the same material as the claimed coating necessarily involves the material being applied to a surface of the part. Note also that at least some of the apertures of Akash are on outer surfaces (e.g., Fig. 4E). The applied material must be supported by a surface of the part. The claim does not recite or require forming a coating layer on the exterior surface of the implant or using one of the argued deposition techniques. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding claim 10, Applicant argues (p. 7) that Akash does not disclose an embodiment combining both laser etching and peck drilling in one process and therefore amended claim 10 is not anticipated by Akash. This argument is persuasive with respect to anticipation and thus the 102 rejection is withdrawn in view of the amendment.
Applicant argues (p. 8) that Jennissen fails to overcome the previously argued deficiencies of Akash. This argument is not pertinent as Jennissen was not relied upon for the argued features.
Applicant argues (p. 8) that one of ordinary skill in the art would not have been motivated to combine Akash and Jennissen except by hindsight reasoning. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Akash discloses forming micro-scale features (e.g., [0026]) on a surface of the part by a number of suitable techniques ([0051]). Jennissen discloses that a micro-structured surface with roughness values in the claimed range provides advantages including a beneficially large surface area and surface capacity ([0072]-[0079]), contributing to good ingrowth (Abstract, [0002]), relevant to the goal of Akash (Abstract).
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 JENNIFER L GROUX whose telephone number is (571)272-7938. The examiner can normally be reached Monday - Friday: 9am - 5pm ET.
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/J.L.G./Examiner, Art Unit 1754 /SUSAN D LEONG/ Supervisory Patent Examiner, Art Unit 1754