DETAILED ACTION
This office action is responsive to the amendment filed December 23, 2025. By that amendment, claims 1-4, 11, 14, and 15 were amended; and claims 7 and 8 were canceled. Claims 1-6 and 9-34 are pending, though claims 23-34 were previously withdrawn from consideration.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 .
Response to Arguments
Examiner notes and appreciates applicant’s identification of bridge elements 732 found in fig. 7 as providing drawing support for the claims limitations of claim 14. The drawing objection is withdrawn.
The amendments to the claims have overcome the outstanding objections to claims 2-4 and 11.
Claims 7 and 8 were cancelled obviating examiner’s request for assistance.
The outstanding rejections under 35 USC 102(a)(1) of claims 1, 4-13 and 16-22 in view of Heino (US 2005/0261780); under 35 USC 102(a)(1) or alternatively 35 USC 103 of claim 2 in view of Heino; and under 35 USC 103 of claim 3 in view of Heino have overcome the rejections of record.
The newly presented rejections were necessitated by either amendments to the claims.
Claims 14 and 15 were previously indicated as having allowable subject matter. The claims were amended such that scope of the claims was changed. A prior art rejection of these claims is now proper in view of the changed scope of the claims.
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 14 and 15 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.
Each claims 14 and 15 include the limitation “the at least one bar unit”, which limitation lacks antecedent basis in the claims. Correction is required.
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), 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]),
wherein at least some of the ring elements 112 of each lattice structure are connected via non-linear 118 bridge elements 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), 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],
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 an 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) 1-6, 9-13, and 16-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heino et al. (US 2005/0261780 A1) in view of Ringeisen (US 2005/0015088 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 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.
Ringeisen teaches a bone plate implant as [0001]. The implant is made of a polymer material [0054] including a smooth surface and a porous surface (porous structures known to be rough) on the other side. (fig. 2C, 2D; [0047]). Porous materials are known to assist in integration of living cells into the plate (resorbable [0054]). Ringeisen further teaches that the porosity of the plate functions to assist in bending the plate.
It would have been obvious to one with ordinary skill in the art at the invention to form the Heino plate of the Ringeisen material in order to increase ability of the Heino plate to be bent and assume a new shape which it maintains without need for special tools or equipment to permit the device to match unique contours of the patient’s anatomy [0054]. 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.
Alternatively, it would have been obvious to form the material of Heino to include the porosity of Ringeisen in order to improve the flexibility of the plate. One would have done so in order to achieve a plate with desired material characteristics.
Regarding claim 2, the combination suggests the limitations of claim 1, as above, including use of polymer material, but does not 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 3, the combination suggests the implant of claim 1, above. Heino further specifies the device formed of a polymer, in general. Heino goes on to provide a list of potential polymers, and further states that “other polymers” may be used ([0027], claim 31). Ringeisen also provides a substantial list of “representative” materials at table 1, which implies he considered other materials.
However, the particular types of claimed polymers are not specifically taught being used by Heino.
It would have been obvious to one with ordinary skill in the art at the time of the invention to select one of the claimed polymers. 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 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].
Regarding claim 5, at least the at least one lattice structure has anti-bacterial properties. [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]
Conclusion
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.
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
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, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BATES/Primary Examiner, Art Unit 3799