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 .
Response to Arguments
Applicant's arguments filed 8/12/26 have been fully considered but they are not persuasive. In regard to the double patenting rejection, the claims were not amended and thus the rejection is still applicable such that it is maintained.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the assessed evaluation of claimed features are not commensurate in scope with the claims. First the main point, which must be made is that the claim (16) uses the clause “substantially same geometry” which is a relative phrase which renders the claim unlimited in scope. The recitation “substantially same geometry” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Applicant is reminded that the use of “substantially” broadens the scope of a term in which it precedes some other limitation. In this instance, more importantly it is not evident if the surfaces, thickness and even how much of a deviation is permitted in shape or configuration for a keel along with fins. However, what needs to be pointed out is that Harris does disclose a kit of prostheses, see paragraph 55, thus even with the combined teaching of Wang used with tibial prostheses of Harris, there is no requirement or suggestion that a keel structure and fins of Wang are to incorporated with that of Harris or a tibial prosthesis of Wang, what the combined teachings was clearly suggesting in the rejection was that if one of ordinary skill in the art (an orthopedic surgeon) can select surface characteristics to improve integration with the body, there was no suggestion that any geometry for a keel or plurality of fins was necessary to make a modification. Harris further suggests any modification, equivalents and alternatives are within ordinary skill in the art and within the scope of the disclosed prostheses and kit components.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant argues individual features of the combined teachings, for example starting with Harris alleging the reference does not teach a pocket recessed from the first distal surface. However, the examiner respectfully disagrees as Fig. 2 shows pockets 28 within distal surface structure which clearly establishes a “recessed” structure or pocket as claimed since there is surrounding structure about a pocket and can be said to below the distal most surface of the bottom of the baseplate which thus is a recess. In addition Applicant argues that one of ordinary skill in the art would not try to place the porous material taught by Wang on the distal surface of the tibial prosthesis of Harris because there is sometimes revision surgery needed. While that may be true, possibilities are not a controlling factor if it is not always the circumstances and if a patient does not have any issues with the prosthesis implanted, then a revision surgery is not necessary. Thus, it is not unreasonable to modify the tibial prosthesis of Harris and incorporate the porous material as taught by Wang because it clearly can enhance its stabilization when implanted and does not nothing to change the function of the prosthesis for use in the patient. The claims are not to any method of performing a revision surgery and whether the implant can be removed. The argument is a moot point. Applicant then focuses on Harris and that a coating cannot be on a “majority” of the second distal surface. However, the examiner would first like to note that again the assessed evaluation of claimed features are not commensurate in scope with the claims. First an important point, which must be made is that the claim (16) uses the clause “a majority of the second distal surface” which is a relative phrase which renders the claim unlimited in scope. The recitation “a majority of the second distal surface” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Applicant is reminded that the use of “majority” broadens the scope of a term in which it precedes some other limitation. In this instance, it does not mean that the entire surface requires a coating and in this instance the modified coating being the porous material taught by Wang. Wang clearly teaches the entire distal surface (bottom of baseplate is covered) see for example Fig. 11. Please note if Applicant is considering any structure such as the keel or plurality of fins to be within the scope of the distal surface, the claims should be amended to recite these elements require the material, but according to the scope of the claim, the prior art teachings of Harris and Wang meet the scope of providing the distal surface of the baseplate to be covered by a majority with the porous material. Applicant continues the argument against Wang alleging the porous area is not a layer. The examiner totally disagrees because the difference in cross-hatching or sketch of materials clearly shows a difference in structure which can be said to define a distinct layer of material. It must be noted that Figs. 11,12 of Wang illustrates area 314 to define a distinct layer of material construction, that being porous. If Applicant is attempting to suggest it has to be applied in some special way, that is irrelevant since the claim(s) are not methods of making, which thus the prior art is not distinguishable from the current claim(s).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Applicant continues on with seven points in an attempt to argue the combined teachings of Harris and Wang The arguments are as follow and have remarks/rebuttal following each:
reinterpret Harris's planar inferior surface 28 as a recessed cement pocket;
The Examiner is entitled to give terms in a claim its plain meaning as interpreted by one of ordinary skill in the art. It is noted that the specification must clearly set forth the definition explicitly and with reasonable clarity, deliberateness, and precision. Exemplification is not an explicit definition. Even explicit definitions can be subject to varying interpretations. See Teleflex, Inc. v. Ficosa North America Corp., 63 USPQ2d 1374, 1381 (Fed. Cir. 2002), Rexnord Corp. v. Laitram Corp., 60 USPQ2d 1851,1854 (Fed. Cir. 2001) and MPEP 2111.01. In this application the term “recessed” is not explicitly define with any clear meaning and since a lower extending structure can be said to define walls or a boundary on the distal surface of the baseplate, the regions 28 are within a broadest reasonable interpretation one of ordinary skill in the art would understand as “recessed poskets” on the distal surface.
2. create a second Harris prosthesis not disclosed by Harris; as already mentioned Harris states a “system” or what one in the art would understand as a kit or set which is clearly stated by Harris in paragraph 55, thus first of all it is inherent then that a second prosthesis is present, second the same paragraph states alterations or modifications can be made, which is within ordinary skill in the art to incorporate surface features (coating or layer of material) which as taught by Wang does not change the geometry, but only adds potentially a thickness, which is not exclusionary by the scope of the limitation “substantially same geometry” that is only a shape and not a size, thickness or dimensional aspect
3. select Wang's optional porous baseplate area from one embodiment; this appears to allege someone of ordinary skill in the art is incapable of using the porous structure taught by Wang. The examiner totally disagrees because first of all the level of ordinary skill in the art in this case is high. A person of ordinary skill in the art is an orthopedic surgeon, who is familiar with the risks and complications involved with any invasive orthopedic procedure and with the techniques used in such surgeries along with understanding the advantages and disadvantages for use during the a surgery. A person of ordinary skill is also a person of ordinary creativity, thus it would have been obvious to one of ordinary skill (an orthopedic surgeon) in the art to use a system, set or kit including at least first and second prostheses to be prepared for any specific circumstance or condition the patient might be in such that the appropriate prosthesis can be selected as taught by Harris and use the teachings of Wang so that the surgeon can use the known techniques to implant such prostheses in the body accordingly. It is common sense that a patient receiving an implantable device as disclosed by Harris, should use a prosthesis that can be cemented if it would be more advantageous to secure permanently to prevent any future movement, however, if the surgeon encounters a need of the patient such that would potentially require revision to change a size or potentially its orientation this problem would be addressed during the procedure by having an alternative prosthesis available. Such a surgeon would therefore have recognized that combinations of prosthesis in a kit are common practice going into surgery to have readily available.
4. characterize that unquantified area as a layer covering at least a majority of the distal surface; the distal surface is interpreted as the bottom of the baseplate of which as mentioned Wang clearly teaches covering the majority of the area, but more importantly the distal surface is not understood to be the keel, but only the bottom, therefore, the combination of Wang with Harris meets the scope of the claim.
5. combine it with a nonporous structure cited from another Wang embodiment or manufacturing example; First Applicant has no special definition for a nonporous structure and has shown no evidence Harris provides a porous structure, which one of ordinary skill in the art would understand such a structure to be clearly defined and stated, thus since Harris is silent, it can be concluded it is a solid material. However, in the alternative Wang clearly discloses combinations of using porous layer material and the remaining structure of the prosthesis is defined as solid or non-porous, thus there is no combining and mixing embodiments as Applicant is totally misconstruing the documents and what they actually can be said to disclose.
6. provide the second prosthesis with fins not identified in Wang; Applicant here is proposing a rejection that is not what was presented by the examiner. First it must be noted that the keel structure of the first and second prosthesis was said to be ‘substantially same geometry” and as mentioned in the rejection and above arguments Wang was used to teach the material characteristics not any keel structure as asserted by Applicant and is misconstruing the examiner’s rejection.
7. preserve substantially the same keel-and-fin geometry between the two prostheses despite the different structures disclosed by Harris and Wang. Again the rejection was not substituting any keel structure but to incorporate material construction taught by Wang which was using solid and porous portions to define the configuration. Also of note Harris disclosed as even acknowledged by Applicant (paragraph 55 of reference) that kits, set or system to provide a plurality of prostheses of which all alterations or modifications are within ordinary skill in the art and suggested by Harris.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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. Please note the claim uses generic and broad language, for example the clause “majority” of the second distal surface is relative terminology which has vague or essentially unlimited boundaries. The term is not defined and thus one of ordinary skill could consider a majority in the broadest sense, at a minimum of 51% but even more importantly the distal surface is undefined such that it could be some area at the bottom of the baseplate, such that it does not encompass the keel but is just the surface of the plate. 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 (bottom of plate), 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. It also must be noted the clause “substantially same geometry” which is a relative phrase which renders the claim unlimited in scope. The recitation “substantially same geometry” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Applicant is reminded that the use of “substantially” broadens the scope of a term in which it precedes some other limitation. In this instance, more importantly it is not evident if the surfaces, thickness and even how much of a deviation is permitted in shape or configuration for a keel along with fins. The geometry does not require exact or specifically the same, thus some deviation is permitted. However, it is also noteworthy Harris discloses kits and thus “substantially same geometry” prostheses are within the scope of the claim only requiring at a minimum two, but the size can differ or even the surface such that the proposed change or modification with Wang is essentially a material alteration, nothing more. 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, the first 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 first distal surface and the first 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, 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, 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, where 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bauchu et al. (FR 2793675) discloses set of femoral stems identical in shape and dimensions to be used/implanted with or without cement depending on the case of arthroplasty to treat.
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 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 BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
