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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the clamping feature and/or mounting point in claim 5, the fixation feature in claim 8, and the screw hole in claim 8 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Also, the drawings contain gray/black shading in Fig. 1 rendering Fig. 1 ineligible and of insufficient quality so that all details in the drawings are reproducible in the printed patent.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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 Objections
Claim 3 is objected to because of the following informalities: In line 3,"the material of the semi-finished part" should be amended this to be “a material of the semi-finished part”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: In line 4, "the shape of the at least one medical device" should be amended to be “a shape of the at least one medical device”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: The range for pore size “between 0,05 mm and 5,0 mm”. This is assumed to be a typo and the examiner suggests amending this to be “between 0.05 mm and 5.0 mm”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: “surfaces of the implant”. The examiner suggests amending this to be “surfaces of the medical implant”. Appropriate correction is required.
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)(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) 1-4, 6-7, 9-11, 13-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roeder et al. (US PG Pub No. 2008/0206297 A1).
Regarding claim 1, Roeder discloses a 3D-printed semi-finished part (Paragraph [0040], Fig. 6, porous matrix 604) for manufacturing at least one medical device (Paragraph [0040], “interbody spinal fusion cage” 600), the semi-finished part including: at least one functional feature (Paragraph [0040] 606 calcium phosphate reinforcements and pores) provided at a predefined location of the semi-finished part (the locations of the calcium phosphate reinforcements and pores are considered predefined locations).
Regarding claim 2, Roeder discloses wherein the at least one functional feature (606 and pores) includes a porous structure (due to the pores).
Regarding claim 3, Roeder discloses wherein the at least one functional feature (606 and pores) is made of a material that is different than the material of the semi-finished part (Fig. 6, 604 is formed from polymer and 606 is formed of calcium phosphate).
Regarding claim 4, Roeder discloses wherein the semi-finished part is manufactured through fused filament fabrication (FFF) (Paragraph [0045], fused deposition modeling).
Regarding claim 6, Roeder discloses wherein said 3D-printed semi-finished part has a shape that is configured to at least partially adapt to the shape of the at least one medical device to be manufactured (Fig. 6).
Regarding claim 7, Roeder discloses wherein said at least one medical device includes at least one surgical implant (spinal fusion cage 600).
Regarding claim 9, Roeder discloses wherein said at least one medical device includes at least one surgical instrument (spinal fusion cage 600).
Regarding claim 10, Roeder discloses A 3D-printed medical implant (Fig. 6, spinal fusion cage 600) obtained by using a 3D-printed semi-finished part according to claim 1 (Paragraph [0040], Fig. 6, porous matrix 604).
Regarding claim 11, Roeder discloses wherein the medical implant includes at least one porous structure (Paragraph [0040], Fig. 6, 604 porous polymer matrix).
Regarding claim 13, Roeder discloses wherein pores of the at least one porous structure (604) have a pore shape selected among: circular; rectangular; gyroid; diamond, or Schwarz triangle (see pore structure illustrated for similar matrix 102 in Fig. 1B, wherein the pores are circular).
Regarding claim 14, Roeder discloses wherein pores of the at least one porous structure are interconnected (pore structure illustrated for similar matrix 102 in Fig. 1B).
Regarding claim 15, Roeder discloses wherein the at least one porous structure (604) includes one or more among: at least one portion acting as a spring; at least one portion having non-linear mechanical properties (Paragraph [0018], bone tissue has non-linear mechanical properties and the scaffold matches the properties of bone tissue), and/or at least one portion having elastic properties that allow for elastic deformation of the implant after implantation (Paragraph [0028], calcium phosphate reinforcement particles 606).
Regarding claim 16, Roeder discloses wherein the at least one porous structure is provided on one or more surfaces of the implant (Fig. 6, porous polymer matrix 604).
Regarding claim 17, Roeder discloses wherein the medical implant includes a plurality of different materials (Paragraph [0040], porous polymer matrix 604, anisometric calcium phosphate reinforcements 606).
Regarding claim 19, Roeder discloses wherein the medical implant is one among: a spinal fusion device, an osteotomy wedge; a total endoprosthesis; a bone fixation plate; a Cranio Maxillo Facial (CMF) implant, and/or an augmentation or bone replacement implant (Paragraph [0040], spinal fusion cage).
Regarding claim 20, Roeder discloses A 3D-printed medical instrument (Paragraph [0040], “interbody spinal fusion cage” 600) obtained by using a 3D-printed semi-finished part according to claim 1 (Paragraph [0040], Fig. 6, porous matrix 604).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Roeder et al. (US PG Pub No. 2008/0206297 A1) as applied to claim 1 above, and further in view of Rodriguez Santiago et al. (US PG Pub No. 2021/0114298 A1).
Regarding claim 5, Roeder discloses the 3D-printed semi-finished part according to claim 1. Roeder fails to disclose wherein the at least one functional feature includes at least one clamping feature and/or mounting point, configured and adapted to connect the 3D-printed semi-finished part to a computer numerical control (CNC) machine.
Rodriguez Santiago also discloses a semi-finished part (Figs. 1, 3, and 5, spinal implant constructs 14), a functional feature (Figs. 1-3, and 5, build plate 10), and a medical implant (Fig. 4, spinal implant S). Rodriguez Santiago teaches wherein the at least one functional feature (10) includes at least one clamping feature and/or mounting point (Figs. 1-3, and 5, first recess 26, first protrusion 28, recess 62, protrusion 56, clamping arms 50, 52) configured and adapted to connect the 3D-printed semi-finished part to a computer numerical control (CNC) machine (Paragraphs [0017] and [0018]). Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Roeder’s semi-finished part wherein the at least one functional feature includes at least one clamping feature and/or mounting point, configured and adapted to connect the 3D-printed semi-finished part to a computer numerical control (CNC) machine, as taught by Rodriguez Santiago, in order to manufacture the semi-finished part into the medical implant (Paragraphs [0017] and [0018]).
Claim(s) 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Roeder et al. (US PG Pub No. 2008/0206297 A1) as applied to claim 1 above, and further in view of Greyf et al. (US PG Pub No. 2015/0054195 A1).
Regarding claim 8, Roeder fails to disclose wherein the at least one functional feature includes at least one fixation feature for connecting the at least one medical implant, manufactured by using the 3D-printed semi-finished part, to a target portion within the body of a patient, and wherein said at least one fixation feature includes at least one screw hole.
Greyf also discloses a semi-finished part (Fig. 12, negative mold 405), a medical implant (custom bone graft 120), and at least one functional feature (Fig. 12, porous biocompatible material 445). Greyf teaches wherein the at least one functional feature (445) includes at least one fixation feature (Fig. 12, place holders 450) for connecting the at least one medical implant (Fig. 13, custom bone implant 120), manufactured by using the 3D-printed semi-finished part (405), to a target portion within the body of a patient (Fig. 13, graft location 370), and wherein said at least one fixation feature includes at least one screw hole (Fig. 13, for locating screws 380).
Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Roeder’s semi-finished part wherein the at least one functional feature includes at least one fixation feature for connecting the at least one medical implant, manufactured by using the 3D-printed semi-finished part, to a target portion within the body of a patient, and wherein said at least one fixation feature includes at least one screw hole, as taught by Greyf, in order to ensure the medical implant is secured in the graft location (Paragraph [0107], Fig. 13, graft location 370).
Regarding claim 18, Roeder discloses wherein said plurality of different materials is selected from: at least one high-performance polymer, wherein said high-performance polymer is selected from (Paragraphs [0027] and [0040], matrix 604): Polyether ether ketone (PEEK); Polyetherketoneketone (PEKK) (Paragraph [0019] and [0027]); Polyphenylsulfone (PPSU); Polyaryletherketone (PAEK) (Paragraph [0027]); Polyetherketone (PEK) (Paragraph [0027]); Polyamide-imide (PAI), or Polyethylenimine (PEI); at least one high-performance polymer comprising one or more ceramic fillers (Paragraph [0032]), wherein the one or more ceramic fillers include biphasic calcium phosphate (BCP) or bioactive glasses (Paragraph [0032], BCP); at least one high-performance polymer comprising one or more fiber reinforcement materials (Paragraph [0017]). Roeder fails to disclose at least one high-performance polymer filled with a radio opaque filler, and/or at least one drug-loaded material, wherein said drug includes an anti-inflammatory agent and/or an antibiotic agent.
Greyf teaches at least one high-performance polymer filled with a radio opaque filler (Paragraph [0018]), and/or at least one drug-loaded material, wherein said drug includes an anti-inflammatory agent and/or an antibiotic agent (Paragraph [0018]). Therefore, it would have been obvious to someone of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Roeder’s semi-finished part wherein at least one high-performance polymer filled with a radio opaque filler, and/or at least one drug-loaded material, wherein said drug includes an anti-inflammatory agent and/or an antibiotic agent, as taught by Greyf, in order to make the porous structure more visible in an x-ray (Paragraph [0018]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Roeder et al.
Roeder discloses wherein pores of the at least one porous structure have a pore size between 20 nm and 2 mm (Paragraph [0031]), which overlaps the claimed range of between 0.05 nm and 5.0 mm. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Roeder’s porous structure to have a pore size between 0.05 mm and 5.0 mm as claimed, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/KARI L COCHRAN/Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774