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 .
The examiner acknowledges receipt of amendment and remarks filed 04/15/2026
Claims 1 and 9 are amended.
Claims 1-5, 8-19 and 21-23 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, 1-5 and 8-13, in the reply filed on 11/20/2025 was acknowledged.
Claims 14-19 and 21-23 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/20/2025.
Claims 1-5 and 8-13 are under consideration.
Priority
This application claims benefit of 63/342,092 filed 05/12/2022.
Response to Arguments
Claim Rejections - 35 USC § 112
The rejection of claim 9 for reciting “CAD” without an initial description of what “CAD” stand for is withdrawn because of the amendment to claim 9.
For the rejection under 35 USC 102: applicant argues that Dong fails to disclose or suggest physical radii acting as an interface attachment because a) claim 1 explicitly requires an interface region comprising “a plurality of radii, each of the radii being directly attached only to a respective strut of the plurality of struts of the porous structure and to the solid structure,” and that Dong, in contrast, merely discloses adjusting the spatial placement of nodes using a “different radius from the origin of a polar coordinate system” and the action erring by equating Dong’s mathematical coordinate parameter (a spatial distance from the origin) with the physical, structural features, for example fillets or blend recited in claim 1; and b) that a mathematical coordinate used to define a nodes location in space is fundamentally distinct from a tangible radius feature that structurally bridges and attaches a strut to a solid structure.
Response: The examiner respectfully disagrees. Claim 1 does not recite fillets or blends. A spatial distance using mathematical coordinate, which is a point’s distance from a reference point, is not an imaginary distance but is a representation through mathematical coordinates for physical parameter/distance. With respect to interface region, Dong specifically teaches “fixation elements 790 extend from nodes 791 formed at the interface of the solid CAD volume 795 and a porous CAD volume 780 (paragraph [0099]). b) mathematical coordinate used to define a nodes location in space is not distinct from a tangible radius feature that structurally bridges and attaches a strut to a solid structure because in Dong, there are nodes at each end of struts (see at least claim 1). Thus Dong teaches the elements of the claims.
Applicant further argues that, to expedite prosecution, claim 1 has been amended to say that “each of the radii including a curved transition extending between a respective strut of the plurality of the struts of the porous structure and the solid structure, each of the radii being directly attached only to the respective strut of the plurality of struts of the porous structure and to the solid structure such that the porous structure and the solid structure are directly attached only to each other and by the plurality of radii." Applicant has pointed to paragraphs [0006], [0007], [0068], [0075] and FIGS 2B and 5B as providing support for the amendment. Applicant request withdrawal of the rejections.
Response: With respect to the amendment, the cited sections and other sections of the as filed specification do not support the amendment. Furthermore, the recitation, “each of the radii including a curved transition extending between a respective strut of the plurality of the struts of the porous structure and the solid structure” is confusing and for examination purposes the new limitation is examined as each radius includes curved extension between the struts of the plurality of the struts of the porous structure and solid structure. The predetermined boundary 100 in Figures 7, 8, 9, 10, 11 and 12 of Dong (paragraphs [0070], [0071]) is the curved extension overlapping the struts 8-21 of Fig 7. The rejection is being modified below to point out the boundary and the curved extensions.
New Rejections
Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5 and 8-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is new Matter rejection.
Claim 1 is amended to say that “each of the radii including a curved transition extending between a respective strut of the plurality of the struts of the porous structure and the solid structure.” The as filed specification does not envision radii including curved transition extending between respective struts of the plurality of the struts of the porous structure and the solid structure. Paragraphs [0006], [0007], [0068], [0075] and FIGS 2B and 5B and other section of the as filed specification do not provide support for this limitation.
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 1-5 and 8-13 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.
The recitation in claim 1 by amendment that “each of the radii including a curved transition extending between a respective strut of the plurality of the struts of the porous structure and the solid structure” is confusing. It is unclear what “curved transition extending between ,,, solid structure” means. In an attempt to understand and promote prosecution, the new recitation is examined as the radius/radii including curved extension between the struts of the plurality of the struts of the porous structure and solid structure.
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)(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.
(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) 1-5, 8-9 and 13 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Dong et al. (US 20130268085 A1) for reasons of record and with modification to address the amendment.
At the onset, the examiner acknowledges the amendment to claim 9 does not change the scope of claim 9.
Dong et al. (US 20130268085 A1) discloses medical implants (see the whole document with emphasis on the abstract, paragraphs [0051]-[0053], [0090], [0100]-[0101], [0103], [0116], [0119]-[0120], and claim 20). The medical implant comprises plurality of porous sections having plurality of struts with nodes at each end, the porous sections or geometries include porous CAD volume (paragraphs [0008]-[0013], [0015], [0016], [0018]-[0026], [0034], [0035], [0043], [0051], [0052], [0067], [0069]-[0079], [0083], [0095]-[0101], [0106], [0110], [0114], [[0117]-[0119], claims 1, 5, 15 and 21). The plurality of struts have nodes at each end (see at least the abstract and paragraph [0008]) and the nodes may be placed at different radius from the origin of polar coordinate (paragraph [0080]) and in another embodiment the radius component as well as the nodes along the boundary may be modified in the same or opposite directions and the struts may correspondingly be lengthened or shortened (paragraph [0084]). Because there are many nodes and struts, there will correspondingly be many radii. Fixation elements extend from nodes formed at the interface of the solid CAD volume (paragraph [0099], [0100]).
Therefore, for claims 1-5 and 13, Dong teaches the implant of claims 1-5 by teaching an implant comprising plurality of porous geometries having plurality of struts having nodes at each end and the nodes placed at different radii from the polar coordinate, and the implant comprises solid and porous materials/solid and porous CAD volumes (paragraphs [0065], [0066], [0081], [0099]-[0101]). The predetermined boundary 100 in Figures 7, 8, 9, 10, 11 and 12 of Dong (paragraphs [0070], [0071]) is the curved extension overlapping the struts 8-21 of Fig 7 meeting the curved extension between the struts of the plurality of the struts of the porous structure and solid structure.
For claim 8, the porous structure, the solid structure and the interface region are inseparable in Dong such that the porous structure, the solid structure and the interface region of the implant of Dong form an integral structure.
Claim 9 is a product by process claim. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. “[E]ven 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, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009), see also Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016).
Thus, Dong teaches the elements of claims 1-5, 8-9 and 13.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dong et al. (US 20130268085 A1), as applied to claim 1, in view of Wei Xu et al., “Design and performance evaluation of additively manufactured composite lattice structures of commercially pure T. (CP-Ti)” in Bioactive Materials, 6 (2021) 1215-1222.
Claims 10-12 depend on claim 1. Dong has been described above to teach claim 1. Dong differs from claims 10-12 by not teaching the radius of the strut in millimeters and required by claims 10-12. Dong teaches surface modified unit cell lattice (title). Wei Xu teaches lattice structures having strut radius (see the abstract) and the different radius are 0.2, 0.25. 0.5, 0.35 and 0.4 mm (right column of page 1217, Tables 1 and 2). Wei Xu teaches that pore features are directly related to strut radius and that porosity and pore size significantly influence biological properties (second full paragraph, right column of page 1220). Therefore, before the effective date of the invention, the artisan guided by the teachings of Wei Xu would be motivated to have the radius of the strut to be any one or combination of the strut radius disclosed in Wei Xu with the expectation of predictably influencing biological property of the implant having desired pore size.
Thus Dong in combination with Wei Xu renders claims 10-12 prima facie obvious.
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Prior art of Interest: Moore et al. (US 10098746 B2): This art discloses an implant that anchors into bone having bone facing regions that comprise plurality of interconnected struts; the interconnected struts may define local features that may help resist translation or rotation of the implant (abstract). The implant or implantable device comprises a first region that is substantially solid; a second region that is adjacent to the first region, the second region comprising plurality of interconnected struts. Some of the struts are joining the first region and the struts have average strut lengths; the struts define openings between the struts through which bone can grow and where the second region comprises struts that are connected at both of their ends to other struts. There is a bone facing enveloping surface that has at least one concavity and at least one convexity and these concave and convex surfaces have radii varying from fairly large to small (column 1, line 33 to column 5, line 3; FIG. 5D, column 5, lines 48-50; column 9, lines 7-10, 15-20, 54-65; column 10, lines 14-18, 21-32; column 12, lines 29-32, 57-61; column 13, lines 3-20, 57-67;column 14, lines 1-16; column 15, lines 32-48; claim 1). The concavity and convexity are curvatures that read on curved surfaces of amended claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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