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 .
Election/Restrictions
Applicant’s election without traverse of Group III, a set of tibial prostheses with different configurations represented by claims 16-20 and new claims 21-35 in the reply filed on 3/19/26 is acknowledged.
Claim Objections
Claims 16,29, 30 are objected to because of the following informalities: the recitation of “the at least pocket” in line 7 of claim 16 should read “at least one pocket” and is a typo.
In claim 29, lines 1-3 recite “further comprises a baseplate comprising a distal surface sized and shaped to substantially cover a proximal resected surface of a tibia” which can be interpreted as another element. However, this same intended functioning element was already recited in claim 16, but had no “placeholder” to define the element so it is understood that the clause of claim 29, just meant to define the feature of the tibial prosthesis as a baseplate that covers the resected tibia that was previously recited in claim 16 and Applicant is advised to possibly reword the limitation in the claim since the specification and drawings illustrate a single, integral baseplate to define the recited feature, not two surfaces of distinct elements that seem to be implied by the clause introduced in claim 29. The same issue is present in claim 30 with the limitation “further comprising a plurality of additional tibial prostheses each having a baseplate comprising a distal surface sized and shaped to substantially cover a proximal resected surface of a tibia” that implies another distinct or separate element, but the same function or use or placement of the surface was recited in claim 16. As mentioned already for claim 16, the feature used no “placeholder” to define the element so it is understood that the clause of claim 30, just meant to define the feature of the tibial prosthesis for each baseplate that covers the resected tibia that was previously recited in claim 16 and Applicant is advised to possibly reword the limitation in the claim since the specification and drawings illustrate a single, integral baseplate to define the recited feature, not two surfaces of distinct elements that seem to be implied by the clause introduced in claim 30.
Appropriate correction is required.
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) 16-20,22,23,25,29 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (2016/0278929) in view of Wang et al. (2018/0200066). Fig. 2 shows a tibial prosthesis 10 comprising: a first proximal surface 16; a first distal surface 18 opposite the first proximal surface, the first distal surface sized and shaped to substantially cover a proximal resected surface of a tibia (paragraph 36); at least one pocket 28 formed in the first tibial prosthesis and recessed from the first distal surface (defined with compartment structures 26,27,29), wherein the at least one pocket is configured to receive a bone cement therein (paragraph 36); a first keel 14 extending distally from the first distal surface; and a first plurality of fins 38,40 spanning a junction between the first keel and the first distal surface. It is also noted that Harris et al. also disclose (paragraph 55) a system to provide multiple prostheses. Harris et al. further disclose (paragraph 36) there can be coating material on at least the majority of the second distal surface or a second tibial prosthesis. However, Harris et al. did not explicitly state the coating material is porous. Wang et al. teach (Fig. 11) that a tibial prosthesis is provided with a layer of porous material 314 forming at least a majority of the second distal surface, see paragraph 68. It would have been obvious to one of ordinary skill in the art to use a porous coating on at least a majority of the second distal surface of a tibial prosthesis as taught by Wang et al. for the coating of a second tibial prosthesis of Harris et al. such that it can enhance integration with the bone. Harris et al. also teach (paragraph 54) that there can be different materials for at least a portion of the second tibial prosthesis. However, Harris et al. is silent that there is a layer of nonporous material forming at least a portion of the second prosthesis. Wang et al. also teach (paragraph 91) there is a layer of nonporous material forming at least a portion of the second prosthesis. It would have been obvious to one of ordinary skill in the art to select a layer of material to be nonporous as taught by Wang et al. with the second prosthesis of Harris et al. since such a modification only involves routine skill in the art and further Harris suggested a plurality of materials are capable of being selected for the desired properties needed in the prosthesis. Thus, it would have been obvious to one of ordinary skill in the art to create or provide a system with the two prostheses as taught by Harris and Wang such that it allows an orthopedic doctor/surgeon to select the appropriate prosthesis that meets the needs of the patient. Regarding claim 17, both Harris (figure 2) and Wang (figure 12) teach tibial prostheses with substantially the same geometry including an elongate length as measured proximal-distal, a distal end profile, and a medial-lateral width. Since both Harris and Wang relate to tibial implants, it would have been obvious to a person skilled in the art to design two tibial implants of substantially the same geometry for an elongate length as measured proximal-distal and medial-lateral width as seen in Harris and Wang. Regarding claim 18, Harris discloses (Fig. 5) there are a first plurality of fins angled that can be a first tibial prosthesis and can provide a second tibial prosthesis that could have similar geometry. However, Harris did not explicitly disclose a system with the first plurality of fins are angled anterior- posterior and medial-lateral to form a first flute on a posterior of the first tibial keel, wherein the second plurality of fins are angled anterior-posterior and medial-lateral to form a first flute on a posterior of the second tibial keel, and wherein the first flute of the first tibial prosthesis and the first flute of the second tibial prosthesis have substantially a same angle. Wang et al. teach (Fig. 11) that a plurality of fins are angled anterior- posterior and medial-lateral to form a first flute on a posterior of a tibial keel. Since both Harris and Wang disclose a plurality of fins on tibial implants angled, it would have been obvious to one of ordinary skill in the art to select the appropriate angle for the plurality of fins and use angled anterior-posterior and medial-lateral to form a flute on a posterior of the tibial keel as taught by Wang such that in view of the disclosed multiple prostheses suggestion Harris states one can provide both a first and second tibial prostheses with the angled fins to be substantially the same such that the selected prosthesis will appropriately stabilize within bone as desired by the surgeon using such an angle. Regarding claim 19, it is noted that Harris et al. disclose (paragraph 39) that the thickness of fins may vary. Thus, per the modification with Wang one of ordinary skill in the art would have been able to select a first prosthesis with a first plurality of fins being relatively thinner than a second plurality of fins for a second prosthesis absent any unexpected results one is highly educated and trained such that if needing thinner fins due to fragile bone conditions one can select a thinner profile whereas if the bone is more durable one might use thicker fins. Regarding claim 20, Harris et al. show (Fig. 5) a tibial keel 14 that can be considered to include a second flute and a third flute each extending to a distal tip of the tibial keel, whereas Wang also shows (Fig. 11) a tibial keel 316 which includes a second flute and a third flute each extending to a distal tip of the tibial keel. Thus, per the combined teachings with both including the tibial keel along with second and third flutes, it would have been obvious to one of ordinary skill in the art to provide the system of Harris as modified with Wang with the first tibial keel includes a second flute and a third flute each extending to a distal tip of the first tibial keel, wherein the second tibial keel includes a second flute and a third flute each extending to a distal tip of the tibial keel, wherein the second flute and the third flute of the first tibial keel share substantially a same geometry as the second flute and the third flute of the second tibial keel in order to give a surgeon both options to enable use in securing. Regarding claim 22, it can be seen (Fig. 5) of Harris the first plurality of fins are angled anterior- posterior and medial-lateral to form a flute on a posterior of the first keel. With respect to claim 23, Fig. 5 of Harris shows the first keel includes a second flute and a third flute each extending to a distal tip of the first keel, wherein the second flute and the third flute are connected by an anterior fin on an anterior of the first keel. Regarding claim 25, since the structure of the keel of Harris is constructed the same as claimed, it inherently is configured to form a press-fit with the tibia such that a cement mantle extends around only a portion of the first keel. With respect to claim 29, Fig. 1 shows a baseplate in which its distal surface 18 is sized and shaped to substantially cover a proximal resected surface of a tibia and a proximal surface 16 opposite the distal surface, the proximal surface having a lateral compartment and a medial compartment opposite the lateral compartment (seen by the middle line separating the two regions), and a periphery 20 extending between the distal surface and the proximal surface.
Claim(s) 21,26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (2016/0278929) in view of Wang et al. (2018/0200066) as applied to claim 16 above, and further in view of Shaw (4938769). Harris is explained supra. However, Harris et al. did not disclose a second pocket formed in the first tibial prosthesis and recessed from the first pocket, wherein the second pocket is configured to receive a portion of the bone cement. Shaw teaches (Fig. 4) that there is a tibial prosthesis 10 with a first pocket 55 formed in the first tibial prosthesis and recessed from the first distal surface, wherein the first pocket is configured to receive a bone cement therein, and a second pocket 57 formed in the first tibial prosthesis and recessed from the first pocket, wherein the second pocket is configured to receive a portion of the bone cement, col. 6, lines 2-14. It is obvious to one of ordinary skill in the art to utilize a second pocket formed in the first tibial prosthesis and recessed from the first pocket, wherein the second pocket is configured to receive a portion of the bone as taught by Shaw with the tibial prosthesis system of Harris et al. as modified by Wang et al. such that it provides an enhanced fixation using the stepped formation. Regarding claim 26, Shaw also teaches the second pocket of the first tibial prosthesis includes an undercut defined from walls 58 (see Fig. 5) so that an opening to the second pocket is smaller than a proximal surface that forms a bottom of the second pocket. Regarding claim 27, Shaw teaches (Fig. 4) the second pocket of the first tibial prosthesis comprises four pockets 57 located at, respectively, a posterior-medial corner, a posterior-lateral corner, an anterior-lateral corner, and an anterior-medial corner. Regarding claim 28, Shaw additionally shows (Fig. 4) each of the four pockets has a curvature along at least an exterior facing side that substantially matches a curvature of a periphery of the first tibial prosthesis at a corresponding location with the anterior side being greater in length than the curves on the posterior side corners.
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (2016/0278929) in view of Wang et al. (2018/0200066) as applied to claim 23 above, and further in view of Harmon et al. (WO 2019/084363) . Harris et al. in view of Wang et al. is explained supra. However, Harris et al. as modified by Wang et al. did not explicitly disclose the first plurality of fins form an angle of substantially 126 degrees for the flute, and wherein the second flute and the third flute each have an angle of substantially less than 126 degrees. Harmon et al. teach (Fig. 29) a tibial prosthesis 1000 along with flutes 1025. Harmon et al. further teach that a keel with fins form an angle of substantially 126 degrees (page 10 paragraph 77) for the flute, see Fig. 2. It would have been obvious to one of ordinary skill in the art to alternatively provide the first plurality of fins form an angle of substantially 126 degrees for the flute, and wherein the second flute and the third flute each have an angle of substantially less than 126 degrees per the teaching of Harmon et al. with the tibial prosthesis system of Harris et al. as modified with Wang et al. such that the flutes are appropriately angled for securement and stabilization in the bone such that it does not comprise its integrity.
Claim(s) 30-34 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (2016/0278929) in view of Wang et al. (2018/0200066) as applied to claim 16 above, and further in view of Yoo et al. (10172713) . Harris et al. in view of Wang et al. is explained supra. It is noted that Harris et al. stated (paragraphs 54,55) there can be different size prosthetics and kits or systems are within the scope of the invention. However, Harris et al. as modified by Wang et al. did not explicitly disclose a plurality of additional tibial prostheses each having a baseplate comprising a distal surface sized and shaped to substantially cover a proximal resected surface of a tibia, a proximal surface opposite the distal surface, and a periphery extending between the distal surface and the proximal surface, wherein a size of each of the plurality of additional tibial prostheses differs with respect to the distal surface, the proximal surface, and the periphery. Yoo et al. teach (Fig. 5) that a plurality of additional tibial prostheses each having a baseplate comprising a distal surface sized and shaped to substantially cover a proximal resected surface of a tibia, wherein a size of each of the plurality of additional tibial prostheses differs with respect to the distal surface and the periphery. Yoo et al. further teach that one can further provide a plurality of additional tibial prostheses each having a baseplate comprising a distal surface sized and shaped to substantially cover a proximal resected surface of a tibia, a proximal surface opposite the distal surface, and a periphery extending between the distal surface and the proximal surface, wherein a size of each of the plurality of additional tibial prostheses differs with respect to the distal surface, the proximal surface, and the periphery. It would have been obvious to one of ordinary skill in the art to utilize a plurality of additional tibial prostheses each having a baseplate comprising a distal surface sized and shaped to substantially cover a proximal resected surface of a tibia, a proximal surface opposite the distal surface, and a periphery extending between the distal surface and the proximal surface, wherein a size of each of the plurality of additional tibial prostheses differs with respect to the distal surface, the proximal surface, and the periphery as taught by Yoo et al. with the system of Harris et al as modified by Wang et al. such that it enables the orthopedic surgeon to be able to select the best matching structure for the patient anatomy or site condition and its preparation. Regarding claim 31, Yoo et al. further teach (Figs. 3A,3C, 3D) each of the plurality of additional tibial prostheses further comprises a tibial keel 50 extending distally from the distal surface to a dome shaped distal tip and also illustrate (Fig. 5) the tibial keel has an elongate length as measured proximal-distal and defines a longitudinal tibial keel axis extending along the elongate length, wherein the elongate length increases in a step- wise manner with an increase in the size of the plurality of additional tibial prostheses with respect to the distal surface, the proximal surface, and the periphery. It would have been obvious to one of ordinary skill in the art to provide each of the plurality each of the plurality of additional tibial prostheses further comprises a tibial keel extending distally from the distal surface to a dome shaped distal tip, wherein the tibial keel has an elongate length as measured proximal-distal and defines a longitudinal tibial keel axis extending along the elongate length, wherein the elongate length increases in a step- wise manner with an increase in the size of the plurality of additional tibial prostheses with respect to the distal surface, the proximal surface, and the periphery per the teaching of Yoo et al. with the system of Harris et al. as modified by Wang et al. since such a construction of elements only involves routine skill in the art and provides the orthopedic surgeon to adjust to different size patients as there are taller, shorter individuals along with larger bone anatomies in addition to fragile or diseased bone patients. Thus providing an assortment of size lengths is an obvious expedient. Regarding claim 32, it is noted that Harris et al. (Fig. 5) disclose a plurality of fins 36,38,40,42 spanning a junction between the tibial keel 14 and the distal surface 18. Thus per the modification with Wang and Yoo, the system would be provided such that each of the plurality of additional tibial prostheses further comprises a plurality of fins spanning a junction between the tibial keel and the distal surface. Regarding claim 33, it is noted that Harris et al. show (Figs. 2,4,5) the plurality of fins are angled anterior-posterior and medial-lateral to form flutes on a posterior of the tibial keel. Thus per the teaching with Wang and Yoo there is a system or kit having each of the plurality of additional tibial prostheses having the flutes on a posterior side. Regarding claim 34, it is noted that Harris et al. show (Figs. 2,4,5) the tibial keel 14 for a tibial prosthesis 10 has a second flute and a third flute each extending to a distal tip of the tibial keel, wherein the second flute and the third flute are connected by an anterior fin 36 on an anterior of the tibial keel. Thus per the teaching with Wang and Yoo there is a system or kit having each of the plurality of additional tibial prostheses include the second and third flutes being connected by the anterior fin.
Claim(s) 35 is rejected under 35 U.S.C. 103 as being unpatentable over Harris et al. (2016/0278929) in view of Wang et al. (2018/0200066) and Yoo et al. (10172713) as applied to claim 30 above, and further in view of Shaw (4938769). Harris et al. as modified by Wang et al. and Yoo et al. is explained supra. However, Harris in view of Wang and Yoo did not disclose a second pocket formed in the first tibial prosthesis and recessed from the first pocket, wherein the second pocket is configured to receive a portion of the bone cement or that the second pocket includes an undercut so that an opening to the second pocket is smaller than a proximal surface that forms a bottom of the second pocket. Shaw teaches (Fig. 4) that there is a tibial prosthesis 10 with a first pocket 55 formed in the first tibial prosthesis and recessed from the first distal surface, wherein the first pocket is configured to receive a bone cement therein, and a second pocket 57 formed in the first tibial prosthesis and recessed from the first pocket, wherein the second pocket is configured to receive a portion of the bone cement, col. 6, lines 2-14. It is obvious to one of ordinary skill in the art to utilize a second pocket formed in the first tibial prosthesis and recessed from the first pocket, wherein the second pocket is configured to receive a portion of the bone as taught by Shaw with the tibial prosthesis system of Harris et al. as modified by Wang et al. and Yoo et al. such that it provides an enhanced fixation using the stepped formation. Shaw also teaches the second pocket of the first tibial prosthesis includes an undercut defined from walls 58 (see Fig. 5) so that an opening to the second pocket is smaller than a proximal surface that forms a bottom of the second pocket.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-20 of copending Application No. 18/233861 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the current application claim (16) is merely broader in scope as the copending claim 16 of US ‘861 recites all the limitations of the current application claim 16 and additional features not claimed. Narrower claims anticipate the broader, see In re Goodman. Regarding claim 17, see claim 17 of US application ‘861 reciting the same limitation. Regarding claim 18, see claim 18 of US application ‘861 reciting the same limitation. Regarding claim 19, see claim 19 of US application ‘861 reciting the same limitation. Regarding claim 20, see claim 20 of US application ‘861 reciting the same limitation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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