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.
Election/Restrictions
3. Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-13, drawn to a method of manufacturing an implant device, classified in A61C 8/0006.
II. Claims 14-20, drawn to an implant device, classified in A61L 2400/18.
The inventions are distinct, each from the other because of the following reasons:
4. Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)).
In the instant case, the product as claimed can be made by another and materially different process such as, e.g., sandblasting, 3D printing, placing the material in a mold having a half comprising desired recess pattern, etc.
Alternatively, the process as claimed can be used to make another and materially different product such as, e.g., substrate for an ant farm.
5. Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior art applicable to one invention would not likely be applicable to another invention;
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
6. This application contains claims directed to the following patentably distinct species:
IMPLANT
Species A - embodied in Figure 1A
Species B - embodied in Figures 16A, 16B (cubed shaped spinal implant fusion device; body structure 212 of the device 210 may have a solid central area or region and an external region with ratio of void volume to mass volume that is relatively high and replicates trabecular bone, more particularly cancellous trabecular bone wherein the high porosity creates open pathways for fluid to move in and out similar to what happens in natural bone. The body structure 212 of the implant device 210 is formed by 3D or additive printing yielding exterior portions made with a plurality of interconnected struts 226. The struts 226 are curved or arched and spaced between connections with openings 228 forming a porous wall having a porosity that replicates that of an adult male or female depending on the implant being produced)
7. The species are independent or distinct because claims to the different species recite the mutually exclusive characteristics of such species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable.
There is an examination and search burden for these patentably distinct species due to their mutually exclusive characteristics. The species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species; and/or the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
8. During a telephone conversation with Richard Shoop on 26 February 2026 a provisional election was made WITHOUT traverse to prosecute the invention of Invention/Group II, claims 14-20 (drawn to an implant device). Affirmation of this election must be made by applicant in replying to this Office action.
9. Claims 1-13 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Specification
10. The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “wherein at least a majority of the recesses are structured to narrow progressively inward” (claim 14, lines 11-12).
Claim Objections
11. Claim 14 is objected to because of the following informalities:
a. Regarding claim 14, the recitation “majority of the recesses have a depth within a range from about 10 to about 500 microns” (line 10) lacks an unit of depth right after the number “10”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
12. 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.
13. Claims 14-20 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 14, the recitation “wherein at least a majority of the recesses are structured to narrow progressively inward because the sidewall of the recess that is structured to narrow progressively inward, is inclined from its mouth to its end or at least to its mid-depth” (last wherein clause) is vague and unclear, rendering it indefinite as to the scope of the invention. It seems that recitation needs to be rephrased. Claims 15-20 depend from claim 14.
b. Claim 14 recites the limitation "the sidewall of the recess that is structured to narrow progressively inward" in line 12. There is insufficient antecedent basis for this limitation in the claim. Claims 15-20 depend from claim 14.
Claim Rejections - 35 USC § 102
14. 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.
15. Claims 14, 15, and 19 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Dinkelacker (EP 1 013 236 A1; cited in Applicant’s IDS).
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 to about 500 microns (paragraphs [0015]-[0017], paragraphs [0028]-[0030], claims 1, 5, and 6); and
wherein at least a majority of the recesses are structured to narrow progressively inward because the sidewall of the recess that is structured to narrow progressively inward, is inclined from its mouth to its end or at least to its mid-depth (clearly shown in Figure 2 and Figure 6).
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).
Claim Rejections - 35 USC § 103
16. 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.
17. 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), as applied to claim 15 above, in view of Soboyejo et al. (US PG Pub No. 2004/0000540 A1)
Regarding claim 16, Dinkelacker ‘236 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.
18. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Dinkelacker (EP 1 013 236 A1; cited in Applicant’s IDS), as applied to claim 14 above, in view of Ricci et al. (US PG Pub No. 2001/0039454 A1; cited in Applicant’s IDS)
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.
Conclusion
19. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US PG Pub No. 2020/0038199 A1
US PG Pub No. 2020/0113700 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