DETAILED ACTION
This office action is responsive to the amendment of May 19, 2026, and Request for Continued Examination of June 10, 2026. Claims 1, 3, 4, 14 and 15 were amended; and claims 35-41 were newly presented. Claims 1-6 and 9-41 are pending, though claims 23-34 were previously withdrawn from consideration.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 10, 2026, has been entered.
Response to Arguments
The outstanding rejection of claims 14 and 15 under 35 USC 112(b) was overcome by the amendments to the claims.
Applicant’s arguments with respect to the rejection of claim(s) 14 and 15 under 35 USC 102(a)(1) in view of Rise et al. (US 2014/0316472 A1) have been considered. There is no particular argument, except to state that the rejection of record is overcome by the amendment at p. 9. Examiner has carefully considered the amendment, and disagrees that the rejection of record is overcome. The rejection is maintained, as below, modified only to correlate to the amended claim language.
Applicant’s arguments with respect to the rejection of claim(s) 1-6, 9-13, and 16-22 under 35 USC 103 in view of Heino et al. (US 2005/0261780 A1) and Ringeisen (US 2005/0015088 A1) have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The newly presented rejections are necessitated by the amendments to the claims of May 19, 2026.
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 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.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rise et al. (US 2014/0316472 A1).
Regarding claim 14, Rise teaches an implant capable of covering a thorax bone defect, comprising:
at least one lattice structure of fig. 1 of a plurality of individual lattice cells (each square of ring elements 112 is considered a cell, e.g. demonstrated in fig. 2), each lattice cell comprising one or more ring elements 112, each ring element comprising a through-hole configured for receiving a fixation device (112 is referred to as a screw hole [0029]),
at least one bar unit 151/152;
wherein the at least one lattice structure (unit of fig. 2) and the at least one bar unit are arranged in a regular pattern as arranged in fig. 1,
wherein at least some of the ring elements 112 of each lattice structure are connected via non-linear bridge elements 118 to one another,
wherein the implant is made of fig.1, at least predominantly, from a plastic material [0042], and
wherein lattice cells 160/164 of the at least one lattice structure that are immediately adjacent to a bar unit 151/152 of at least one bar unit are connected to the bar unit by linear bridge elements 150/153.
Examiner notes that as presently claimed, there is no structural distinction between a bar unit and a bridge unit.
Regarding claim 15, Rise teaches an implant as at fig. 1 capable of covering a thorax bone defect, comprising:
at least one lattice structure of a plurality of individual lattice cells (each square of ring elements 112 is considered a cell, see e.g. fig. 2), each lattice cell comprising one or more ring elements 112, each ring element 112 comprising a through-hole configured for receiving a fixation device [0029],
at least one bar unit 150/151/152/153,
wherein the at least one lattice structure and the at least one bar unit are arranged in a regular pattern as arranged in fig. 1,
wherein at least some of the ring elements 112 of each lattice structure are connected via non-linear bridge elements 118 to one another,
wherein the implant is made, at least predominantly, from a plastic material [0042], and
wherein the bridge elements connecting ring elements in a direction in parallel to the longitudinal direction of at least one bar unit (150/151/152/153) are linear bridge elements (see the column next to the indicated bar unit).
Examiner notes that as presently claimed, there is no structural distinction between a bar unit and a bridge unit.
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.
Claim(s) 1, 2, 4-6, 9-13, 16-22 and 35-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heino et al. (US 2005/0261780 A1) in view of Clifford et al. (US 2008/0275562 A1).
Regarding claim 1, Heino teaches an implant as at fig. 3C for covering a thorax bone defect, comprising:
at least one lattice structure of a plurality of individual lattice cells (cells being considered to be structures with sidewalls and open centers in the Heino structure), each lattice cell comprising one or more ring elements (throughholes seen in fig. 3C), each ring element comprising a through-hole configured for receiving a fixation device [0030],
wherein at least some of the ring elements (throughholes) of each lattice structure are connected via non-linear bridge elements to one another (various non-linear bridges are seen in fig. 3C),
wherein the implant is made, at least predominantly, from a plastic material [0027]; and
the implant is taught being planar (see the figures).
It is further noted that the Heino plate is taught being a bendable polymeric mesh shapeable to match an injury [0038].
Heino fails to teach the plastic material comprising PEEK, and fails to teach one of the planar surfaces of the lattice structure being roughly textured such that the one of the planar surfaces assists integration of living cells thereto, and the other of the planar surfaces of the lattice structure is not roughly textured.
Clifford teaches a bone plate-like structure, referred to as a base component 10. The base component 10 is taught being formed of a plastic material, being PEEK [0012], [0103]. The base 10 is then taught to include a porous coating in the form of titanium plasma spray in an osteointegration surface [0015], that coating being applied to an inner surface 28 [0084] as seen in fig. 7. (Examiner takes official notice of titanium plasma spray forming a porous surface upon application thereof). Alternatively, rather than use of a coating, it is also taught that the surface can simply be ‘roughened or etched’. [0084]
It would have been obvious to one with ordinary skill in the art at the invention to form the Heino plate of the Clifford material(s) in order to increase ability of the Heino plate to be osteointegrated into the bone to which it is implanted and to induce bone growth (Clifford, [0084]) by either, for example, coating one surface of the Heino plate with a titanium plasma spray, or by etching or roughening one surface of the Heino plate. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 2, the combination suggests the limitations of claim 1, as above, including use of polymer material (PEEK), but is silent as to the methods of production of the device.
Examiner takes the position that the limitations of claim 2 are ‘product-by-process’ and are directed by MPEP 2113. Once a single alternative is met, other alternatives in the claim need not be considered. Therefore, examiner addresses only additive techniques for purposes of making this rejection – though examiner is of the position that the same issues and rationales would equally apply to injection molding techniques.
The MPEP states: PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS
Examiner takes the position that all claimed structures appear to be read on by Heino such that Heino appears to be substantially identical to what is claimed. Examiner fails to see that the structure being formed by additive manufacturing techniques materially imparts structural differences to the structure.
The MPEP states: ONCE A PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS FOUND AND A PRIOR ART REJECTION IS MADE, THE BURDEN SHIFTS TO THE APPLICANT TO SHOW AN NONOBVIOUS DIFFERENCE
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Heino claim by any known method. Additive manufacturing techniques are known to be relatively inexpensive and easily modified. Therefore, a selection of an additive technique would have been made order to reduce ultimate cost of the device being produced.
Regarding claim 4, the claim is considered met once a single one of the alternatives is shown in the prior art. No further consideration is given to the additional alternatives. Heino teaches the material comprises tricalcium phosphate [0028]. Clifford alternatively suggests use of a hydroxyapatite plasma spray [0015].
Regarding claim 5, at least the at least one lattice structure has anti-bacterial properties. Heino, [0029]
Regarding claim 6, the at least one lattice structure has a thickness of from about 0.1 mm to about 5 mm. (0.8 mm Heino [0032])
Regarding claim 9, at least some of the plurality of lattice cells consist of a single ring element, together with at least a portion of at least one bridge element. (Examiner notes that the term “cell” is not particularly defined in the claim, such that examiner can select any portion he wishes to be considered the cell. To read on this claim, Examiner chooses the central hole and a portion of the bridges radiating therefrom as one of the cells, which cell includes a single ring element and at least one bridge element).
Regarding claim 10, all connections between all ring elements are non-linear as seen in fig. 3C.
Regarding claim 11, examiner now turns to fig. 3D. The implant comprises at least one lower-density lattice cell and at least one higher-density lattice cell having the same size and contour as the at least one lower-density lattice cell but comprising a higher number of ring elements. Compare, for example a square at the center of 3D having 8 ring elements as compared to a square at the edge of 3D having only 6 ring elements.
Regarding claim 12, turning back to the fig. 3C embodiment, the implant further comprises at least one bar unit, wherein the at least one the lattice structure and the at least one bar unit are arranged in a regular pattern. As claimed, any of the bridges can be considered a bar unit; or alternatively, any portion of the device can be considered a bar unit. Examiner proposes the outer edge being designated a hexagonal bar unit, while the central portion continues to be a lattice (a regular pattern).
Regarding claims 13, and 16-20, the at least one lattice structure and the at least one bar unit are arranged alternatingly. Examiner takes the position that in his proposed structure, there is one lattice at the center, which alternates to a bar at the edge. Alternatively, the edge can be considered to be six bar units. Alternatively, each side of the structure can be designated as a bar, or a lattice structure. Alternatively, two outer rows can be called a bar unit. As claimed, there is no reason the bar structure must be distinct from the lattice in structure. The hexagonal structure is considered to be ‘staggered’ (Google Define: arranged so as to alternate on either side of a center.) Opposite sides of the structure are exactly parallel with one another. Each bar unit includes at least one line of through holes as in fig. 3C, arranged in pairs. In the selection of two rows as the bar unit, the holes are arranged in two parallel rows, as claimed, the pairs not being parallel or perpendicular to a long axis of the bar unit.
Regarding claim 21, the device is taught with a plurality of plurality of fixation devices [0030].
Regarding claim 22. the plurality of fixation devices comprise bio-degradable screws. [0030]
Regarding claims 35-39 and 41, the combination suggests the limitations of claim 1, above, but fails to teach the claimed hexagonal shape or S-shaped bridges, number of ring elements, or particular angles of alignment of structures. A variety of shaped lattices (quadrilateral, pentagonal, etc.) and bridge elements (straight, curved) and number of ring elements and alignments are demonstrated in various embodiments.
The instant specification has been studied. The lattice is provided in a variety of shapes ([00155] etc.). The shape of the lattice, the particular bridge curvatures, the number of ring elements, and alignments between claimed elements, do not appear to be disclosed as providing any particular advantages, as disclosed.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Heino device to have hexagonal lattices and S-shaped bridges and a particular number of ring elements and alignments between components as a matter of design choice and as a matter of making the device correlate to particular patient anatomies for use thereon.
Regarding claim 40, the outer edges of the lattice structure are considered to have “different shapes” (e.g. from other lattice structures) in that the outer edges do not couple to further lattice portions.
Claim(s) 1 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Clifford in view of Heino.
Regarding claim 1, Clifford teaches a bone plate-like structure, referred to as a base component 10. The base component 10 is taught being formed of a plastic material, being PEEK [0012], [0103]. The base 10 is then taught to include a porous coating in the form of titanium plasma spray in an osteointegration surface [0015], that coating being applied to an inner surface 28 [0084] as seen in fig. 7. (Examiner takes official notice of titanium plasma spray forming a porous surface upon application thereof). Alternatively, rather than use of a coating, it is also taught that the surface can simply be ‘roughened or etched’. [0084] Another alternative material – plasma sprayed hydroxyapatite is taught [0015].
Clifford fails to teach the structural requirements of the plate required by claim 1.
All of those structures are taught in Heino, as noted above, in rejecting claim 1.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Clifford device in the configuration of Heino in order that the Clifford device would be usable in a different portion of patient anatomy.
Claim(s) 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Clifford in view of Heino and Morris (US 2024/0065843 A1).
Regarding claim 3 (and an alternative rejection of claim 4), the limitations of claim 1 are suggested by the combination of Clifford and Heino, as above. However, in the case of claim 3, the combination does not suggest use of any of the claimed materials, and in the case of claim 4, examiner provides an alternate rejection to show obviousness of the claim. Once a single one of the listed materials are identified as having been rendered obvious in the prior art, the remaining materials are not further considered. Examiner attacks the “magnesium” limitation found in both claims 3 and 4.
Morris teaches application of a bioresorbable magnesium-based coating material on orthopedic implants (abstract). [0026] teaches that the coating can be applied only to certain areas such that certain areas of the PEEK implant are not coated.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the Clifford device such that the coated area 28 is coated with porous magnesium rather than the materials suggested by Clifford. The fact that Clifford contemplates various materials makes clear that Clifford could function equally well with other materials. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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