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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-19, drawn to a sacroiliac fusion implant, classified in A61F 2002/30995.
II. Claim 20, drawn to a method implanting a sacroiliac implant with a guide, classified in A61F 2002/4677.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the sacroiliac implant of Group I does not have to be implanted using a guide or have a drill to bore in the iliac bone, but a surgeon could invasively place the implant in the site by cutting and positioning without a guide pin.
Restriction for examination purposes as indicated is proper because all the 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:
the inventions have acquired a separate status in the art in view of their different classification.
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.
During a telephone conversation with David Simmons on 1/12/2026 a provisional election was made without traverse to prosecute the invention of Group I (sacroiliac fusion implant), claims 1-19. Affirmation of this election must be made by applicant in replying to this Office action. Claim 20 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 7 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.
Claim 7 recites the limitation "the tube body" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5,7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahn (2021/0244548). Fig. 1 shows a sacroiliac fusion implant device 100 comprises: a unitarily formed implant extending along a longitudinal axis, the implant having a central core 170, a first latticed volume 200 and a second latticed volume 300; and wherein the central core has a proximal end 160, a distal end 150 and a body disposed between the proximal end and the distal end. Regarding claim 2, it can be seen (Fig. 4) show a unitarily formed implant 100 as a single piece construction that is fully capable of being made by additive manufacturing (note it is a product-by-process limitation which is only distinguished by features not how it’s made). Ahn does disclose (paragraph 48) an additive manufacturing process to make the implant. Regarding claim 3, it can be construed that the first latticed volume and second latticed volume are combined to a single latticed volume circumscribing the perimeter of the core or hollow implant body. With respect to claim 4, it can be seen (Fig. 5) the central core has a lumen extending along the longitudinal axis (paragraph 90) from a proximal end opening 163 to a distal end opening 152 configured to pass over a guide wire W or pin. Regarding claim 5, Fig. 1 shows the distal end 150 is tapered 151 extending to the distal end opening 152. With respect to claim 7 as best understood Fig. 4 shows the tube body has one or more transverse elongated longitudinal slots 170 or openings that extend across the lumen. Regarding claim 8, it can be seen (Fig. 5) the first latticed volume 200 is a repeating pattern as the pores are shown to be the same shape. With respect to claim 9 as best understood it can be construed that the pores that are circular or oval form a cylinder through a thickness of the material and thus the pattern of pores have some cylindrical volume or unit construction.
Claim Rejections - 35 USC § 103
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.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ahn (2021/0244548) in view of Predick et al. (2021/0353428). Ahn is explained supra. However, Ahn did not explicitly disclose the proximal end has external threads configured for instrument engagement. Predick et al. teach an implant with its proximal end , (see Figs. 1-4) with external threads 202 configured for instrument engagement, paragraph 57. It would have been obvious to one of ordinary skill in the art to utilize an external threaded connector alternatively on the spinal implant as taught by Predick et al. incorporated on the implant of Ahn such that it provides the surgeon the ability to move the implant to other positions while the implant is stabilized, see paragraph 88.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ahn (2021/0244548) in view of Harris et al. (2023/0114676). Ahn is explained supra. However, Ahn did not explicitly disclose the unit cell pattern is a Gyroid Triply Periodic Minimal Surface (TPMS) pattern. Harris et al. teach (paragraph 63) that a surface of a body implant can be provided with a unit cell pattern such as a Gyroid Triply Periodic Minimal Surface (TPMS) pattern. It would have been obvious to one of ordinary skill in the art to utilize a unit cell pattern which is a Gyroid Triply Periodic Minimal Surface (TPMS) pattern as taught by Harris et al. on the implant body of Ahn such that it improves the surface area (paragraph 165), advantageous for ingrowth or integration with bone.
Claim(s) 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ahn (2021/0244548) in view of Cain et al. (2021/0085481). Ahn is explained supra. However, Ahn did not explicitly disclose the second latticed volume is stochastic. Cain et al. teach (paragraph 224) that an implant be provided with stochastic lattice structure. It would have been obvious to one of ordinary skill in the art to utilize a stochastic lattice structure in the fusion implant ass taught by Cain et al. with the implant body of Ahn such that it improves the surface properties, see Table 2 of Cain. Regarding claims 13, 14 Cain also teaches (paragraph 225) the second latticed volume is formed via continuous interconnected beams between seed points such that the seed points are generated by a Voronoi diagram.
Claim(s) 11,15 are rejected under 35 U.S.C. 103 as being unpatentable over Ahn (2021/0244548) in view of Hayes et al. (5296180). Ahn is explained supra. However, Ahn did not explicitly disclose the first latticed volume encompasses 60-72 percent of a total implant volume or the second latticed volume encompasses 11-13 percent of a total implant volume. Hayes et al. teach (col. 6, lines 39,40) a percent volume of an implant can be within the range of 11-13 percent. Hayes et al. also teach (col. 8, lines 5-7) the first latticed volume encompasses 60-72 percent of a total implant volume. Hayes also teaches (abstract) the use of such porosity is for hollow ceramics which is a common material used in bone implants. It would have been obvious to one of ordinary skill in the art to utilize a first latticed volume encompasses 60-72 percent of a total implant volume or provide an 11-13 percent of a total implant volume for the second latticed volume as taught by Hayes et al. in the implant body of Ahn such that it appropriately provides the structural configuration analogous to bone, see Hayes col. 14, lines 49-52. It is also noted Hayes teaches (col. 12, lines 48-68) layers or what could be encompass the lattice formation of different porosity volumes. Finding the optimal porosity only involves routine skill in the art.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ahn (2021/0244548) in view of Miller et al. (11484413). Ahn is explained supra. However, Ahn did not explicitly disclose the implant has 30 - 50 percent porosity. Miller et al. teach (col. 30, claim 1 of doc.) that the implant can have a porosity with 50 percent. It would have been obvious to one of ordinary skill in the art to utilize a 50 percent porosity for the body of the fusion implant as taught by Miller et al. for the implant body of Ahn such that it appropriately permits bone integration in the site of implantation. Finding the optimal porosity only involves routine skill in the art.
Claim(s) 16,17 are rejected under 35 U.S.C. 103 as being unpatentable over Ahn (2021/0244548) in view of Schneider et al. (11071573). Ahn is explained supra. However, Ahn did not explicitly disclose the implant has 30 - 50 percent porosity or even in the range of 40-46 percent porosity. Schneider et al. teach (col. 8, lines 5-7) that the implant can have a porosity within 30-50 percent and even within 40-46 percent porosity. It would have been obvious to one of ordinary skill in the art to utilize a porosity within 30-50 percent or even 40-46 percent porosity for the body of the fusion implant as taught by Schneider et al. for the implant body of Ahn such that it appropriately permits bone integration in the site of implantation. Finding the optimal porosity only involves routine skill in the art.
Claim(s) 18 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Ahn (2021/0244548) or, in the alternative, under 35 U.S.C. 103 as obvious over Doehring et al. (10585420). Ahn is already explained above with respect to claim 1 and it must be noted that with respect to the limitation of "additive manufacturing is Direct Metal Laser Sintering (DMLS) on a powder bed fusion machine” it is considered to be a product-by- process limitation and even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process, (In re Thorpe, 227 964, 966). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference exists between the claimed product and the prior art product (In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir, 1983), MPEP 2113). Ahn does disclose (paragraph 48) the implant can be prepared by laser, thus it is fully capable of being an additive manufacturing process such as DMLS. However, in the alternative Ahn did not explicitly state there is additive manufacturing process using a powder bed fusion machine to form an implant body with direct metal laser sintering. Doehring et al. teach a bone implant (col. 10, lines 20-23) can be formed using the process of Direct Metal Laser Sintering (col. 9, lines 31,32,38,40,41). It would have been obvious to one of ordinary skill in the art to utilize the process of Direct Metal Laser Sintering as taught by Doehring et al. in the produced implant of Ahn such that the mechanical properties are improved, see Doehring et al.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ahn (2021/0244548) in view of Ali (2016/0374822). Ahn is explained supra. However, Ahn did not explicitly disclose the specific length of the implant body. Ali teaches (paragraph 80) that a length of the body for a fusion implant can be within the range of 30- 70 mm. It would have been obvious to one of ordinary skill in the art to utilize a length between 30-70 mm for the body of the fusion implant as taught by Ali for the implant body of Ahn such that it appropriately supports the dimensions of the vertebrae in which it is placed. Finding the optimal dimension only involves routine skill in the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799