DETAILED ACTION
Response to Amendment
The Amendment filed 10/10/2025 has been entered. Claims 20-36 and 38-40 remain pending in the application. Claims 1-19 and 37 have been canceled. No new claims have been added. Applicant's amendments to the claims have overcome the objections previously set forth in the Non-Final Rejection mailed 07/10/2025. Applicant's amendments to the claims have overcome the 112(b) rejections previously set forth in the Non-Final Rejection mailed 07/10/2025.
The Examiner notes that the amended claims filed 10/10/2025 have an incorrect status identifier label in claim 36. See Claim Objections below.
As a courtesy, the Examiner has examined the improperly labelled claim set, rather than returning it to Applicant for correction.
Claim Objections
Claim 36 is objected to because of the following informalities: the claim is incorrectly labeled “(Previously Presented)” since the claim has been amended with the markings shown in the claims filed on 10/10/2025 and therefore should be labelled “(Currently Amended)” instead.
Applicant is reminded of 37 C.F.R. 1.121 and MPEP § 714 II C which states that: (A) Status Identifiers: The current status of all of the claims in the application, including any previously canceled or withdrawn claims, must be given. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers: (original), (currently amended), (previously presented), (canceled), (withdrawn), (new), or (not entered). (B) Markings to Show the Changes: All claims being currently amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version. The changes in any amended claim must be shown by strike-through (for deleted matter) or underlining (for added matter) with 2 exceptions: (1) for deletion of five or fewer consecutive characters, double brackets may be used (e.g., [[eroor]]); (2) if strike-through cannot be easily perceived (e.g., deletion of number "4" or certain punctuation marks), double brackets must be used (e.g., [[4]]). As an alternative to using double brackets, however, extra portions of text may be included before and after text being deleted, all in strike-through, followed by including and underlining the extra text with the desired change (e.g., number 4 as number 14 as ).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 20, 22-25, 28-29, and 32 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by US 2012/0321878 A1 of Landon (as cited in prior Office action).
Regarding claims 20 and 29, Landon teaches methods for fabricating porous structures suitable for medical implants that have improved combinations of strength, porosity and connectivity ([0002], reads on the claimed method of producing a porous three-dimensional structure). Landon teaches these porous structures form a complete orthopedic implant structure ([0074], methods of Landon therefore read on the claimed method of producing an orthopaedic prosthetic component). Landon teaches the fabrication methods produce porous structures with the desired porosity, pore size, strength and connectivity by controlling the randomization of the scaffold of a porous structure and resulting in improved scaffold structures more aesthetically pleasing to physician and patient ([0074], since the implants are built for patients, the structures of Landon read on the claimed porous three-dimensional structure shaped to be implanted in a patient's body).
Landon therefore reads on the limitations a method of producing a porous three-dimensional structure of claim 20, and a method of producing an orthopaedic prosthetic component of claim 29.
Landon teaches the improved porous structures are formed by using a free-from fabrication method, including rapid manufacturing techniques (RMT) such as direct metal fabrication (DMF) that use an energy source such as a laser beam to melt or sinter metal powder to build the structure one layer at a time according to the provided model ([0070]-[0073], free-form manufacturing reads on the claimed depositing and scanning successive layers of metal powder with a beam to form a porous three-dimensional structure).
Landon therefore reads on the limitation the method comprising: depositing and scanning successive layers of metal powder with a beam to form a porous three-dimensional structure of claim 20, and the method comprising: depositing and scanning successive layers of metal powder with a beam to form a porous three-dimensional structure shaped to be implanted in a patient's body of claim 29.
Landon teaches a method for fabricating a porous structure comprising defining a three dimensional space having an outer boundary and an inner volume, placing a plurality of outer spatial coordinates along the boundary, placing a plurality of inner spatial coordinates in the inner volume, moving one or more inner spatial coordinates a finite distance in a random direction, moving one or more outer spatial coordinates a finite distance in a random direction, and further dividing the volume of the three dimensional space evenly among the randomized outer and inner spatial coordinates, defining the boundary of one or more divided volume with one or more struts and one or more nodes, where each strut has a first end, a second end, and a continuous elongated body between the first and second ends for each strut, and each node is an intersection of at least two struts, and selecting a thickness and a shape for one or more struts to fabricate the porous structure according to the model by exposing fusible material to an energy source ([0023]-[0024]).
Landon teaches the base volume of randomized seed points may then be multiplied and tiled together with other identical base volumes to form a three dimensional scaffold for a porous structure, where the scaffold has a controlled randomness ([0093], multiplied and tiled base volumes reads on the claimed the porous three- dimensional structure comprising a plurality of unit cells, wherein each unit cell of the plurality of unit cells comprises a first structure having a first geometry and comprising a plurality of first struts, and a second structure having a second geometry and comprising a plurality of second struts connected to a number of the plurality of first struts to form the second structure, as further evidenced by Fig. 4, 9, 10, 11, 14, 15, and 17-19 which shows a plurality of unit cells with a first and second structure).
The resulting structures, as seen in the figures of Landon, have openings defined by the struts with each opening having a window size and respective pore size, and with a corresponding internal volume within the unit cells formed in the structures of Landon.. Landon further teaches the average diameter of openings or windows may be measured ([0110]).
Landon therefore reads on the limitation wherein: the depositing and scanning steps create respective pluralities of openings in the porous three-dimensional structure, the openings defined by the respective number of the lattice struts and the respective plurality of internal struts, each opening of the plurality of pluralities of openings having a window size, and the depositing and scanning steps define a respective pore size of each second structure of claim 20, and wherein each unit cell of the plurality of unit cells comprises a first structure having a first geometry and comprising a plurality of first struts, and a second structure having a second geometry and comprising a plurality of second struts connected to a number of the plurality of first struts to form the second structure, wherein: the second structure has a pore size, the number of the plurality of first struts and the plurality of second struts define a plurality of openings in the porous three-dimensional structure, each opening of the plurality of openings having a window size, and the pore size and the window size of each opening of the plurality of openings defines a ratio of pore size to window size of claim 29.
Landon teaches while the figures illustrate the disclosed methods using a cubical space or cubical spatial coordinates, it will be noted here that this disclosure is not limited to six-sided base structures or six-sided outer geometries and the disclosed methods apply to any space filling polyhedra (sometimes referred to as plesiohedra), space-filling convex polyhedra with regular faces including the triangular prism, hexagonal prism, cube, truncated octahedron and gyrobifastigium, space-filling convex polyhedra with irregular faces including the rhombic dodecahedron, elongated dodecahedron, and squashed dodecahedron, and any non-self-intersecting quadrilateral prism ([0092], rhombic dodecahedron reads on the claimed first structure is a rhombic dodecahedron of claims 20 and 32, and the truncated octahedron reads on the claimed each of the plurality of second structures is an octahedron of claim 28).
Landon therefore reads on the limitations wherein each of the connected unit cells includes,a first structure comprising a plurality of lattice struts arranged such that the first structure is a rhombic dodecahedron, and a plurality of second structures each formed out of a respective plurality of internal struts within the first structure and a respective number of the lattice struts of claim 20, wherein each of the plurality of second structures is an octahedron of claim 28, wherein the first structure is a rhombic dodecahedron of claim 32.
Regarding the ratio of pore size to window size of claims 20, 24-25, and 29, since Landon teaches a plurality of unit cells and the same claimed geometries, as described above, the structures of Landon necessarily have the claimed ratios of pore size to window size (see Fig. 18 as an example, which shows a plurality of unit cells as claimed).
Landon therefore reads on the limitation a ratio of the respective pore size to each window size is in a range of 1.00 to 2.90 of claim 20, wherein the ratio is in a range from 1.50 to 1.60 of claim 24, wherein the ratio is in a range from 1.00 to 1.10 of claim 25, and a ratio of pore size to window size that is in a range of 1.50 to 1.60 of claim 29.
Regarding claims 22 and 23, Landon teaches a substrate (2606, Fig. 26A-26C, reads on the claimed solid base) which is a tibial tray is attached to a coating or porous material (2602 and 2610 respectively, reads on the claimed porous structure) ([0066], [0113]). Landon teaches the shaping of the solid and porous material can be modified for rapid manufacturing ([0113]) and customized to provide a porous structure with desired strength, porosity, pore distribution, etc. ([0116]) for tibial components ([0113]) suitable for tissue in-growth ([0014]).
Landon therefore reads on the limitation further comprising the step of attaching the porous three-dimensional structure to a solid base of claim 22, and wherein the solid base includes a platform and a stem extending away from the platform, the stem extending through the porous three-dimensional structure of claim 23.
Landon therefore reads on all the limitations of claims 22-23.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 21, 26-27, 30-31, 33-36, and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0321878 A1 of Landon (as cited in prior Office action).
Regarding the porosity of claims 21 and 30-31, Landon teaches the method of claims 20 and 29 as described above.
Landon teaches porous structures with 60-85% porosity ([0110]). In 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); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). See MPEP § 2144.05 I.
Landon therefore reads on the limitation wherein the porous three- dimensional structure has a porosity between about 50% and about 75% of claims 21 and 31, and wherein the porous three- dimensional structure has a porosity that is between about 20% and about 95% of claim 30.
Landon therefore reads on all the limitations of claims 21 and 30-31.
Regarding the trigonal trapezohedron of claims 26-27 and 33-34, Landon teaches the method of claims 20 and 29 as described above.
Landon teaches while the figures illustrate the disclosed methods using a cubical space or cubical spatial coordinates, it will be noted here that this disclosure is not limited to six-sided base structures or six-sided outer geometries and the disclosed methods apply to any space filling polyhedra (sometimes referred to as plesiohedra), space-filling convex polyhedra with regular faces including the triangular prism, hexagonal prism, cube, truncated octahedron and gyrobifastigium, space-filling convex polyhedra with irregular faces including the rhombic dodecahedron, elongated dodecahedron, and squashed dodecahedron, and any non-self-intersecting quadrilateral prism ([0092], any space-filling polyhedral reads on the claimed second structure is trigonal trapezohedron of claims 26-27 and 33-34).
Landon therefore reads on all the limitations of claims 26-27 and 33-34.
Regarding claim 36, Landon teaches methods for fabricating porous structures suitable for medical implants that have improved combinations of strength, porosity and connectivity ([0002]). Landon teaches these porous structures form a complete orthopedic implant structure ([0074], methods of Landon therefore read on the claimed method of producing an orthopaedic prosthetic component). Landon teaches the fabrication methods produce porous structures with the desired porosity, pore size, strength and connectivity by controlling the randomization of the scaffold of a porous structure and resulting in improved scaffold structures more aesthetically pleasing to physician and patient ([0074], since the implants are built for patients, the structures of Landon read on the claimed porous three-dimensional structure shaped to be implanted in a patient's body).
Landon therefore reads on the limitation a method of producing an orthopaedic prosthetic component of claim 36.
Landon teaches the improved porous structures are formed by using a free-from fabrication method, including rapid manufacturing techniques (RMT) such as direct metal fabrication (DMF) that use an energy source such as a laser beam to melt or sinter metal powder to build the structure one layer at a time according to the provided model ([0070]-[0073], free-form manufacturing reads on the claimed depositing and scanning successive layers of metal powder with a beam to form a porous three-dimensional structure).
Landon therefore reads on the limitation the method comprising: depositing and scanning successive layers of metal powder with a beam to form a porous three-dimensional structure shaped to be implanted in a patient's body of claim 36.
Landon teaches a method for fabricating a porous structure comprising defining a three dimensional space having an outer boundary and an inner volume, placing a plurality of outer spatial coordinates along the boundary, placing a plurality of inner spatial coordinates in the inner volume, moving one or more inner spatial coordinates a finite distance in a random direction, moving one or more outer spatial coordinates a finite distance in a random direction, and further dividing the volume of the three dimensional space evenly among the randomized outer and inner spatial coordinates, defining the boundary of one or more divided volume with one or more struts and one or more nodes, where each strut has a first end, a second end, and a continuous elongated body between the first and second ends for each strut, and each node is an intersection of at least two struts, and selecting a thickness and a shape for one or more struts to fabricate the porous structure according to the model by exposing fusible material to an energy source ([0023]-[0024]).
Landon teaches the base volume of randomized seed points may then be multiplied and tiled together with other identical base volumes to form a three dimensional scaffold for a porous structure, where the scaffold has a controlled randomness ([0093], multiplied and tiled base volumes reads on the claimed the porous three- dimensional structure comprising a plurality of unit cells, wherein each unit cell of the plurality of unit cells comprises a first structure having a first geometry and comprising a plurality of first struts, and a second structure having a second geometry and comprising a plurality of second struts connected to a number of the plurality of first struts to form the second structure, as further evidenced by Fig. 4, 9, 10, 11, 14, 15, and 17-19 which shows a plurality of unit cells with a first and second structure).
The resulting structures, as seen in the figures of Landon, have openings defined by the struts with each opening having a window size and respective pore size, and with a corresponding internal volume within the unit cells formed in the structures of Landon. Landon further teaches the average diameter of openings or windows may be measured ([0110]).
Landon therefore reads on the limitation the porous three- dimensional structure comprising a plurality of connected unit cells, wherein at least one unit cell of the plurality of unit cells includes: a first structure comprising a plurality of lattice struts, and a plurality of second structures formed out of a respective plurality of internal struts within the first structure and a respective number of the lattice struts, wherein the lattice struts define an average lattice strut length of claim 36, and wherein the respective number of the lattice struts and the respective plurality of internal struts of the second structures define respective pluralities of openings in the porous three-dimensional structure, each opening of the plurality of openings having a window size defined as a diameter of a circle positioned in the opening such that each strut that defines the opening is positioned on a tangent of the circle, wherein each second structure has a respective internal volume that is bounded within the unit cell, and the pore size being is measured as an equivalent diameter of a sphere within the internal volume of claim 36.
Regarding the ratio of pore size to window size of claim 36, since Landon teaches a plurality of unit cells and the same claimed geometries, as described above, the structures of Landon necessarily have the claimed ratios of pore size to window size (see Fig. 18 as an example, which shows a plurality of unit cells as claimed).
Landon therefore reads on the limitation a ratio of the respective pore size to each window size is in a range of 1.00 to 2.90 of claim 36.
Regarding the strut lengths of claims 35-36 and 40, Landon teaches using space-filling convex polyhedra with irregular faces including the rhombic dodecahedron, elongated dodecahedron, and squashed dodecahedron ([0092], one of ordinary skill in the art understands elongated and squashed structures have some of the struts with a different length than the average strut length). Landon teaches structures with irregular faces where there are strut lengths that are shorter than the average strut length and others that are larger than the average strut length and the difference in length is within an order of magnitude ([0106]-[0107], Fig. 19-20, see Figure 1 below).
PNG
media_image1.png
398
514
media_image1.png
Greyscale
Figure 1. Reproduction of Figure 20 from Landon showing a structure where some of the struts (ex. strut marked 2002) are larger than the average strut length and other struts are shorter (ex. strut marked 2004) than the average strut length.
Landon therefore reads on the limitation at least some of the first struts have respective lengths that are different than the average first strut length and within 50% to 150% of the average first strut length of claims 35-36 and some of the lattice struts are within 75% to 125% of the average lattice strut length of claim 40.
Landon therefore reads on all the limitations of claims 35-36 and 40.
Regarding claim 38, Landon teaches the method of claim 36 as described above. Landon teaches porous structures with 60-85% porosity ([0110]). In 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); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). See MPEP § 2144.05 I.
Landon therefore reads on the limitation wherein the porous three- dimensional structure has a porosity between about 50% and about 75% of claim 38.
Regarding claim 39, Landon teaches the method of claim 36 as described above. Landon teaches a substrate (2606, Fig. 26A-26C, reads on the claimed solid base) which is a tibial tray is attached to a coating or porous material (2602 and 2610 respectively, reads on the claimed porous structure) ([0066], [0113]). Landon teaches the shaping of the solid and porous material can be modified for rapid manufacturing ([0113]) and customized to provide a porous structure with desired strength, porosity, pore distribution, etc. ([0116]) for tibial components ([0113]) suitable for tissue in-growth ([0014]).
Landon therefore reads on the limitation further comprising a solid base, wherein the porous three-dimensional structure is attached to the solid base of claim 39.
Landon therefore reads on all the limitations of claim 39.
Response to Arguments
Applicant's arguments filed 10/10/2025 have been fully considered but they are not persuasive.
Applicant argues that the Office Action fails to identify a teaching in Landon of the ratio of pore size to window size as recited in claims 20 and 29 (remarks, page 9). Applicant argues that the Office Action has failed to identify in Landon a teaching of internal struts that, in combination with lattice struts, define a window size (remarks, page 10).
In response, Landon teaches methods for fabricating porous structures suitable for medical implants that have improved combinations of strength, porosity and connectivity ([0002]) and teaches that the structures may include a variety of polyhedra including rhombic dodecahedron ([0092]), as outlined in the 102 and 103 rejections in the Non-Final Rejection mailed 07/10/2025 and in this Office action. Using a rhombic dodecahedron structure for the method of Landon, as taught by Landon, would necessarily result in the ratio of window size to pore size as claimed since the geometries are the same. Two of the figures from the instant invention and Landon are reproduced below for the sake of discussion (Fig. 10 of the instant invention showing the rhombic dodecahedron and its window size and Fig. 18 of Landon showing a structure with four volumes of randomized struts ([0060]). In general, the overall porous structure of Landon and the instant invention are formed by a plurality of lattice struts and second structures formed out of a plurality of internal struts within the first structure, as claimed and seen in the figures below. Landon teaches a rhombic dodecahedron may be used as the structure (not shown in the figures although one rhombic face is highlighted as comparison and an internal strut is highlighted as well). As an example, the rhombic face shown in the embodiment of Fig. 18 of Landon would have a window size comparable to that of the instant invention despite Landon not explicitly disclosing the measurements or ratios. Therefore, using the method of Landon to print a porous rhombic dodecahedron structure would necessarily result in ratios overlapping with the claimed ratios despite the ratios not being explicitly taught by Landon.
PNG
media_image2.png
1506
1430
media_image2.png
Greyscale
Applicant argues that it is the present invention, and not Landon, that recognizes the benefit of the claimed ratio of pore size to window size (remarks, page 10).
In response to applicant's argument that Landon does not recognize the benefit of the claimed ratio of pore size to window size, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In this case, Landon recognizes the improved complexity of the porous structures of the present disclosure provides for resemblance of trabecular features and improved porosity, and the methods of the present disclosure allow for simple and efficient customization of a porous structures with the desired strength, pore distribution, average pore sizes, porosity, etc. ([0116], the porous structures have ratios overlapping with the claimed ratios despite not being explicitly disclosed as argued above).
Applicant argues that not only has the Office Action failed to establish that the claimed ratio necessarily flows from the Landon's disclosure to the extent that it would apply to cubical space or spatial coordinates of Landon, the Office Action further fails to establish that the allegedly inherent ratios would remain inherent when Landon is modified to produce a rhombic dodecahedron (claim 20) (remarks, page 11). Applicant further argues that with respect to the pore size and window size defined in claim 36, the Office Action cite Landon in the same manner as applied to independent claims 20 and 29 (remarks, page 12).
In response, the porous structures of Landon, as those of the present invention, will necessarily change when using different geometric structures for printing the porous three-dimensional structures. One of ordinary skill in the art understands that using a cubic structure will have a ratio of pore size to each window size of 1.0 since the diameter of a sphere is equal to the side length of the cube and that the ratio will change when using different geometric structures. A mere conclusion that Landon’s method does not teach the claimed ratio of the instant invention is not enough to show distinction from the prior art. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). See MPEP 716.01(c). Evidence may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). See MPEP 716.02.
In this case, since the method and geometries of Landon overlap, the Applicant may demonstrate why the method of Landon does not possess the claimed ratio despite teaching the same method steps and geometric structures of the instant invention.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAYELA ALDAZ whose telephone number is (571)270-0309. The examiner can normally be reached Monday -Thursday: 10 am - 7 pm and alternate Friday: 10 am - 6 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Hendricks can be reached at (571) 272-1401. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.A./Examiner, Art Unit 1733
/REBECCA JANSSEN/Primary Examiner, Art Unit 1733