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
Applicant’s election without traverse of invention I in the reply filed on 12/15/2025 is acknowledged. Claims 1-14 are pending.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show:
In Fig. 3B, facet features 20 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 5 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because applicant positively recites part of a human, i.e. "inferior surfaces in contact with bone on implantation as well as surfaces where new bone growth occurs on the internal surfaces and side surfaces.” Thus claim 14 includes a human within its scope and is non-statutory.
A claim directed to or including a human within its scope is not considered patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970).
For purposes of examination claim 5 will be interpreted as reciting “wherein the laser modified network includes the superior and inferior surfaces configured to contact bone on implantation as well as the interior side surfaces and exterior side surfaces of the device that help secure the device in place after bone fusion occurs.” 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.
Claims 1-14 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 1 recites the limitation "the internal" in line 8. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination “internal” is being interpretated as “interior.”
Claim 5 recites the limitation “the internal surfaces” and “side surfaces” in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination “internal” is being interpreted as “interior.”
Claim 7 recites the limitation “the internal or central bone graft space” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “the one or more bone growth surfaces” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation “the one or more bone growth surfaces” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites “nano scale features or prominences” in line 1. Claim 9 depends from claim 8 which defines the nano scale features as “prominences projecting less than 200 nano meters.” Correction is required.
Claim 9 recites the limitation "the non-laser modified surfaces" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. Claim 9 attempts to differentiate between surfaces of the implant comprising nano-scale features and surfaces of the implant without nano-scale features. The claim lacks clarity on the exact structures that include the nano-scale features, and the reference to volume is unclear.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-8 and 10 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McLean et al. (U.S. 12,161,565 B2).
Concerning claim 1, McLean discloses an implant device configured to be at least partially in contact with bone on implantation having an improved osteoinductive feature to enhance new bone formation (see Figs. 14-17), the implant device comprising: an implant body structure having a superior or first surface (116) and an inferior or second surface (118), both surfaces configured to be load bearing upon implantation and one or more exterior side surfaces (120) and one or more interior side surfaces (see Fig. 15 below) extending between the superior and inferior surfaces; and one or more facet features (see below) extending from the interior side surfaces, each of the facet features being inclined off parallel relative to the exterior side surface or off perpendicular relative to the superior and inferior surfaces at an angle which provides a surface to facilitate laser modification of the facet feature when a laser beam is oriented at an angle perpendicular to the load bearing inferior or superior surface.
[AltContent: arrow][AltContent: textbox (Exterior Side surface)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Interior Side surface)][AltContent: arrow][AltContent: connector][AltContent: connector][AltContent: textbox (Facet Features)][AltContent: arrow]
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Concerning claim 2, wherein the facet features are configured to facilitate laser modification to enhance osteoinductivity and promote bone ingrowth located in an internal or central bone graft space (124 and see col. 8, lines 36-65).
Concerning claim 3, wherein at least a portion of the implant body structure (126 and 128) is exposed to subtractive laser modification which creates a laser modified network having a random or non-random network of trenches, grooves or recesses having nano scale features or prominences for new bone growth formation to attach (see col. 8, lines 36-65).
Concerning claim 4, wherein the facet features (see Fig. 15, 116a, 118a; col. 7, lines 55-63) are exposed to subtractive laser engraving which creates a laser modified network having a random or non-
random network of trenches, grooves or recesses having nano scale features (see col. 8, lines 36-48) or prominences for new bone growth formation to attach.
Concerning claim 6, wherein the facet features (see Fig. 15 above) are inclined at an angle greater than zero off from parallel relative to the interior side surface or off perpendicular relative to the superior and inferior surfaces.
Concerning claim 7, wherein the implant body structure has one or more apertures (see Fig. 14, element 127) in the side surface extending through to an internal or central bone graft space (124) that allow for laser modification of interior surfaces across from the apertures.
Concerning claim 8, wherein the nano scale features are prominences projecting less than 200 nano meters (see col. 8, line 55) only visible through magnification of sub micron resolution exhibiting large surface areas relative to the size of the nano scale prominences configured to enhance and receive new bone growth providing the improved osteoinductive feature and variations of surface features resulting from the manufacturing process and the material composition of the implant device.
Concerning claim 10, wherein the inferior and superior surfaces are exposed to subtractive laser modification which creates a laser modified network having a random or non-random network of trenches, grooves or recesses having nano scale features or prominences for new bone growth formation to attach (see col. 7, lines 55-63 and col. 8, lines 49-65).
Claim Rejections - 35 USC § 103
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.
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, 9, 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean et al. (U.S. 12,161,565 B2) as applied to claims 1 and 3 above, in view of Keller et al. (U.S. 2024/0148514 A1).
McLean disclose the invention substantially as described above. However, McLean does not explicitly disclose that the interior side surfaces of the device are laser modified. McLean does disclose that the superior and inferior surfaces (116 and 118) are laser modified.
Keller et al. teach an implant device comprising interior side surfaces that are laser modified (see Figs. 1-7A and par. 0032) in the same field of endeavor for the purpose of stabilizing the spine and promoting bone ingrowth.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to laser modify the interior side surfaces of McLean’s implant, the concept of which is disclosed by Keller et al., in order to create surface textures and porous structures the encourage bone cells to grow into the implant thereby enhancing fusion between vertebrae, improving the patient outcome and reducing revision surgery rates.
Concerning claim 9, as best understood, more of the implant surface area has nano scale features than not (see Figs. 1-7B of Keller et al.).
Concerning claim 11, wherein the laser modified network when having a non-random network is an organized pattern (see col. 8, lines 34-35 of McLean).
Concerning claim 12, wherein the laser modified network is formed by emitting laser beams unobstructed to surfaces within the path of the laser beams (see col. 8, lines 49-65 of McLean).
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean et al. (U.S. 12,161,565 B2) as applied to claim 1 above, in view of Robinson (U.S. 2024/0423804 A1).
McLean et al. disclose the invention substantially as described above. However, McLean et al. do not explicitly disclose that the laser modifications are made by laser engraving or laser etching.
Robinson teaches laser modifications by laser engraving or laser etching (see par. 0009) in the same field of endeavor for the purpose of making a spinal implant fusion device.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify McLean’s implant by using laser engraving or laser etching to modify the surface, as taught by Robinson, in order to remove very shallow amounts of material. It is noted that engraving or etching are types of laser ablation – using laser energy to remove material from a surface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Orthopedic implants with surfaces that are modified by lasers to promote osteointegration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLEN C HAMMOND/ Primary Examiner, Art Unit 3773