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 .
Priority
This application claims priority from provisional application 62/480,383, filed 04/01/2017
Status of Claims
Claims 21-28 are pending.
Claims 1-20 have been cancelled.
Election/Restrictions
Applicant's election with traverse of Species 1 (Figures 1A-F) and Species B (Figures 4-6) in the reply filed on 03/17/2026 is acknowledged. The traversal is on the ground(s) that the claims and specification have been amended such that the third group of species is moot. The applicant’s arguments are persuasive and election from the third group species has been withdrawn.
The requirement for the first two groups is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The Information Disclosure Statements filed on 07/14/2025 and 03/17/2026 have been considered by the examiner.
Applicant should note that the large number of references (10 pages) in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). It appears that not all of the cited references are relevant to the patentability of the claims. For example cited reference 2013/0026492 is directed at a diamond semiconductor. Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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.
Claim(s) 21-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Additively Manufactured Open Cell Porous Biomaterials Made from Six Different Space-Filling Unit Cells: The Mechanical and Morphological Properties, Published 2015, Cited in the applicant’s IDS Filed on 07/14/2025 (Ahmadi).
21. Ahmadi discloses the invention substantially as claimed being an interbody implant (p. 1873 (e)) comprising: a three-dimensionally printed lattice structure (every implant is inherently 3D, printed is considered to be a product by process limitation and given limited weight, 3D printing is old and extremely well known as evidenced by Reference 1 of p. 1892, the implants of Ahmadi are fully capable of being 3D printed because of their simple structure) configured to define a space between two areas of tissue upon implantation between the two areas of tissue, and provide sole mechanical spacing between the two areas of tissue along at least one plane that intersects a loading axis of the implant (the positioning and spacing language are considered to be intended use limitations and given limited weight, the implants of Ahmadi are fully capable of being the sole device placed between two areas of tissue because they are biocompatible and formed from durable materials capable of supporting at least soft tissue), the lattice structure comprising:
a plurality of fluidly interconnected openings (p. 1873 (e)), wherein at least one opening comprises a diameter of between 300 pm to 900 pm (Ahmadi discloses multiple shapes with pores having openings within the range such as RCO p. 1874);
an elastic modulus configured to provide a scaffold for bone growth (p. 1890 first sentence second paragraph under 4.5); and a biocompatible material (p. 1890 first sentence first paragraph under 4.5).
Ahmadi discloses a plurality of volumetric densities for the including 28% and 33% for the Rhombic dodecahedron (Table 2 p. 1877). However, Ahmadi does not disclose the exact claimed values.
The applicant has not disclosed that having this specific volumetric density solves any stated problem or is for any particular purpose. The applicant has failed to provide evidence for unexpected result. Moreover, the only recitation addressing this claimed value for volumetric density [0045] isn’t even specifically identifying this value as being used with the current invention. The 30/70% is simply disclosed as an example for explaining how volumetric density applies to the material compared to the voids. It appears that the 28% and 33% densities of Ahmadi would perform equally as well at promoting ingrowth and supporting the adjacent tissues. The refinement of the density of Ahmadi to 30/70% would amount to an obvious optimization achievable through routine experimentation.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the implant of Ahmadi with a volumetric density comprising 30% primary material by volume and 70% voids by volume, in order to optimize the balance between material strength and ingrowth promotion.
22. Ahmadi discloses the biocompatible material comprises titanium (paragraph 2.1 p. 1873).
23. Ahmadi discloses three-dimensionally printed lattice structure is formed of titanium (paragraph 2.1 p. 1873).
24. Ahmadi discloses the least one opening from among the plurality of interconnected openings comprises a diameter of about 600 pm (Table 1 p. 1874 discloses multiple pores with diameters of about 600 and D-4 is 600).
25. Ahmadi discloses the least one opening from among the plurality of interconnected openings comprises an area ranging between 0.07 square millimeters and 145 square millimeters along its cross-sectional area (Table 2 p. 1874 discloses the openings can have diameters ranging from 600 to 1452 micrometers, which if squared to find the area of the window will both fit well within the range of 0.07-145 millimeters squared).
26. Ahmadi discloses the elastic modulus of the interbody implant along the loading axis of the implant comprises a range between and including 0.3 GPa and 12 GPa (Ahmadi discloses a variety of shapes and densities for the implants made from the same titanium material as the applicant, which are intended to replace the same tissues as the applicant’s invention, additionally, Ahmadi discloses the elastic modulus as the elastic gradient with values ranging from 0.93 to 2.34 in the first paragraph of p. 1882. Furthermore, the applicant has not disclosed that having this specific value solves any stated problem or is for any particular purpose. The recitations addressing this claimed value for elastic modulus, Table 2, is identified as an approximation and just listed as one of a plurality of options. The refinement elastic modulus of Ahmadi would amount to an obvious optimization achievable through routine experimentation with the desire to match the natural structures of the implant site).
27. Ahmadi discloses three-dimensionally printed lattice structure (p. 1873 (e)) comprises a plurality of repeating unit cells (2.1 p. 1873 discloses the repeating unit cells), each unit cell comprising a plurality of sub-unit cells (groups of windows within (e) are considered sub unit cells) each comprising a node located within a volume of the sub-unit cell (the node is at an intersection of struts of a group of windows), a plurality of struts extending radially from the node and defining boundaries of the sub-unit cell ((e) clearly shows the struts extending away from their intersecting points), and the plurality of interconnected openings ((e) clearly shows the windows that are considered openings).
28. Ahmadi discloses at least one unit cell from among the plurality of unit cells comprises a rhombic dodecahedron geometric shape (p. 1873 (e)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
Prosecution Insights