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 Amendment
Claims 1-4,7-10 and 14-15 are pending. Claims 1, 14, and 15 are currently amended. Claims 5, 6, 11-13, and 16-20 are canceled. Claims 14 and 15 are indicated as withdrawn by the applicant.
Election/Restrictions
Applicant’s election without traverse of Group I, Species A in the reply filed on 07/20/2026 is acknowledged.
The office issued a requirement for unity of invention on 05/18/2026. While the applicant responded with an election without traverse on 07/20/2026, the applicant noted several points of disagreement. MPEP 821.02 provides that “Where the initial requirement is not traversed (either expressly or by virtue of an incomplete reply), the examiner should take appropriate action on the elected claims including determining whether the restriction requirement should be withdrawn in whole or in part.” The examiner has determined that the requirement for unity of invention is withdrawn in its entirety. All of the pending claims 1-4,7-10 and 14-15 are examined in this action.
Claim Objections
In claim 1, consider --wherein the polishing element comprises a different polymer material to [[the]] a polymer material of the body-- or --wherein the polishing element comprises a different polymer material to the PEEK of the body--.
In claim 3, consider --wherein [[the]] a difference in Ra value of [[the]] a polished portion of the body and an unpolished portion of the body is less than 0.8 micrometres--
In claim 4, consider --wherein [[the]] a Ra value of [[the]] a polished portion of the body is between 0.2 micrometres and 1.0 micrometres.--
In claim 7, consider -- wherein the method further comprises [[the]] a step of machining the body to form a machined edge--.
In claim 14, consider --wherein the polishing element comprises a different polymer material to [[the]] a polymer material of the body-- or --wherein the polishing element comprises a different polymer material to the PEEK of the body--.
In claim 15, consider --wherein [[the]] a difference in Ra value of [[the]] a polished portion of the body and an unpolished portion of the body is less than 0.8 micrometres--
The examiner notes that claim(s) 4 is/are not grouped together with claim(s) 2 as required by PCT Rule 6, which recites: “All dependent claims referring back to a single previous claim, and all dependent claims referring back to several previous claims, shall be grouped together to the extent and in the most practical way possible”, and MPEP 608.01(m), which recites “All dependent claims should be grouped together with the claim or claims to which they refer to the extent practicable”. The claim(s) should not be renumbered, the examiner will renumber the claim(s) should the application be allowed.
Applicant may also wish to consider whether the intention is for claim 4 to be dependent on claim 3 above, in which case, the applicant should ensure the use of “a/an” and “the” is consistent, with previously recited terms.
Claim Interpretation
The term “polishing element” does in claims 1, 2, 8, 14 does not invoke a section 112(f) interpretation despite reciting a nonce term “element” because the independent claims 1 and 14 define the composition of the polishing element.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kasinath (US 20210401583 A1) in view of Reo (US 20190336339 A1), Kim (KR 101987807 B1), Nakamura (JP S5993264 A), Tregub (US 20030207661 A1), and Rosesner (US 20020186370 A1).
With respect to claim 1, Kasinath discloses: A method of manufacturing a femoral knee component (abstract; femoral component for a prosthetic knee joint), wherein the method comprises: forming a body comprising polyetheretherketone (PEEK) (body 10, fig. 1; made of a PEEK material as in [0032]); however does not explicitly disclose polishing a portion of the body with a polishing element to smooth at least one imperfection; wherein the polishing element comprises a different polymer material to the polymer material of the body; and wherein the different polymer material of the polishing element comprises an annealed PEEK or barium sulphate filled annealed PEEK, and comprises a higher hardness than the PEEK of the body.
Kasinath, however describes that the body made of PEEK is formed of an injection molding process ([0032]).
Reo, in the same field of endeavor, related to medical implantable devices, teaches that implantable devices made through molding have flash [imperfection] at parts of the mold at the location of joints (flash 874, fig. 11; [0149]) and that the presence of flash “may contribute to a patient experiencing a foreign body sensation when implanted”, and that removal of the flash to smooth the surface would reduce foreign body sensation as well as biofilm formation ([0149]). Reo teaches that this removal could occur though any technique ([0149])
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath to have included smoothing of at least one imperfection (of a portion of a body), as taught by Reo, to reduce foreign body sensation as well as biofilm formation.
As for using a polishing element to smooth at least one imperfection, Kim, in the same field of endeavor, related to polishing techniques, and pertinent to the problem being solved of removing injection molding imperfections, teaches that injection molding causes flashes and burrs ([0005-0006]), and teaches of removal of the imperfections using a rotating polishing [abrasive] wheel (20, fig. 1; [0035], connected to either a polishing portion 3 or 4, fig .1, [through a spindle]), contacting the workpiece (1, fig. 1; [0035]). Kim teaches that using an abrasive wheel provides for high surface quality compared to other methods ([0041]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath to use a polishing element to smooth at least one imperfection, as taught by Kim, for the purpose of high surface quality.
Nakamura, in the same field of endeavor, related to polishing techniques, and pertinent to the problem being solved of a choice of material for an abrasive tool, teaches of wherein the polishing element comprises a polymer material that is PEEK (page 3, lines 16-18, “polyether ether ketone resin as described below, and have completed the invention relating to the resin bonded superabrasive grinding wheel by devising a way to use it as a resin bonding material for superabrasive grinding wheels”). Nakamura teaches that using this as part of the wheel makes for excellent heat resistance, and provides for a tough, high strength resin layer (page 2 line 17 to page 3 line 6).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath to use a polishing element made of a PEEK polymer resin material, for toughness and high strength.
Tregub, in the same field of endeavor, related to polishing techniques, and pertinent to the problem being solved of a choice of material for an abrasive tool, teaches of annealing a polymer of an abrasive tool ([0018, 0021], referring to abrasive pad 120, fig. 1). Tregub teaches that annealing the polymer allows for full curing of the pad and optimum performance characteristics ([0016]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath to anneal the polymer material of the polishing element, as taught by Tregub, for the purpose of providing for optimum performance characteristics. This arrangement would have resulted in wherein the polishing element comprises a different polymer material to the polymer material of the body (as the annealing of PEEK is understood to result in a different material, in a manner that is also abrasive; and also given that Kasinath does not discuss that the body is made of annealed PEEK); and wherein the different polymer material of the polishing element comprises an annealed PEEK or barium sulphate filled annealed PEEK (annealing of PEEK pad of Nakamura using the teachings of Tregub, for optimum performance characteristics).
Rosesner, in the same field of endeavor, related to polishing techniques, and pertinent to the problem being solved of a choice of material for an abrasive tool, teaches that typically “work layer of the tool is of a harder material than the workpiece, but nevertheless it degrades over its lifetime” ([0002], demonstrating that a softer tool would degrade faster).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath such that the polishing element comprises a higher hardness than the PEEK of the body, applying the teachings of Rosesner to minimize wear.
With respect to claim 2, Kasinath, as modified, teaches the limitations of claim 1 above, and further teaches wherein polishing the portion of the body comprises: spinning the polishing element (Kim, 20, fig. 1; [0035], the polishing element rotates); and bearing the spinning polishing element against a surface of the body such that the polishing element polishes the at least one imperfection (Kim generally describes that the workpiece 1 is machined in [0035], and therefore, the polishing wheel, which is abrasive, contacts the workpiece at the location of the imperfection [the flash] to remove and finish/polish that part of the surface).
With respect to claim 14, Kasinath discloses: A femoral knee component (abstract; femoral component for a prosthetic knee joint), manufactured by: forming a body comprising polyetheretherketone (PEEK) (body 10, fig. 1; made of a PEEK material as in [0032])
As for the following limitations, polishing a portion of the body with a polishing element to smooth at least one imperfection; wherein the polishing element comprises a different polymer material to the polymer material of the body; and wherein the different polymer material of the polishing element comprises an annealed PEEK or barium sulphate filled annealed PEEK, and comprises a higher hardness than the PEEK of the body, these limitations relate to a product by process limitation (see MPEP 2113), where the patentability of a product does not depend on its method of production. Kasinath, as shown by the body (10, in fig. 1), appears to have disclosed a product that would have been the result (consistent with the structure of the instant product) of “polishing a portion of the body with a polishing element to smooth at least one imperfection; wherein the polishing element comprises a different polymer material to the polymer material of the body; and wherein the different polymer material of the polishing element comprises an annealed PEEK or barium sulphate filled annealed PEEK, and comprises a higher hardness than the PEEK of the body”, and therefore the limitations of the claim are met (another process that imparts in the same structure as implied by the instant steps would also meet the claim, and 10, fig. 1 of Kasinath appears to have a smooth body with portions without imperfections on certain surfaces that polishing would have resulted in). Although “forming a body comprising polyetheretherketone (PEEK)” is also part of the process, this imparts structure of a body made by PEEK, which is met by the prior art. Therefore, the examiner submits that Kasinath anticipates this claim. The examiner notes that even if claim 1 is amended to be allowable, claim 14 would not necessarily be allowable, even if it recites the same method steps, because the patentability of a product does not depend on its method of production.
Alternatively, to address the product by process limitations, and further prosecution: Kasinath, describes that the body made of PEEK is formed of an injection molding process ([0032]).
Reo, in the same field of endeavor, related to medical implantable devices, teaches that implantable devices made through molding have flash [imperfection] at parts of the mold at the location of joints (flash 874, fig. 11; [0149]) and that the presence of flash “may contribute to a patient experiencing a foreign body sensation when implanted”, and that removal of the flash to smooth the surface would reduce foreign body sensation as well as biofilm formation ([0149]). Reo teaches that this removal could occur though any technique ([0149])
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath to have included smoothing of at least one imperfection (of a portion of the body), as taught by Reo, to reduce foreign body sensation as well as biofilm formation.
As for using a polishing element to smooth at least one imperfection, Kim, in the same field of endeavor, related to polishing techniques, and pertinent to the problem being solved of removing injection molding imperfections, teaches that injection molding causes flashes and burrs ([0005-0006]), and teaches of removal of the imperfections using a rotating polishing [abrasive] wheel (20, fig. 1; [0035], connected to either a polishing portion 3 or 4, fig .1, [through a spindle]), contacting the workpiece (1, fig. 1; [0035]). Kim teaches that using an abrasive wheel provides for high surface quality compared to other methods ([0041]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath to use a polishing element to smooth at least one imperfection, as taught by Kim, for the purpose of high surface quality.
Nakamura, in the same field of endeavor, related to polishing techniques, and pertinent to the problem being solved of a choice of material for an abrasive tool, teaches of wherein the polishing element comprises a polymer material that is PEEK (page 3, lines 16-18, “polyether ether ketone resin as described below, and have completed the invention relating to the resin bonded superabrasive grinding wheel by devising a way to use it as a resin bonding material for superabrasive grinding wheels”). Nakamura teaches that using this as part of the wheel makes for excellent heat resistance, and provides for a tough, high strength resin layer (page 2 line 17 to page 3 line 6).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath to use a polishing element made of a PEEK polymer resin material, for toughness and high strength.
Tregub, in the same field of endeavor, related to polishing techniques, and pertinent to the problem being solved of a choice of material for an abrasive tool, teaches of annealing a polymer of an abrasive tool ([0018, 0021], referring to abrasive pad 120, fig. 1). Tregub teaches that annealing the polymer allows for full curing of the pad and optimum performance characteristics ([0016]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath to anneal the polymer material of the polishing element, as taught by Tregub, for the purpose of providing for optimum performance characteristics. This arrangement would have resulted in wherein the polishing element comprises a different polymer material to the polymer material of the body (as the annealing of PEEK is understood to result in a different material, in a manner that is also abrasive; and also given that Kasinath does not discuss that the body is made of annealed PEEK); and wherein the different polymer material of the polishing element comprises an annealed PEEK or barium sulphate filled annealed PEEK (annealing of PEEK pad of Nakamura using the teachings of Tregub, for optimum performance characteristics).
Rosesner, in the same field of endeavor, related to polishing techniques, and pertinent to the problem being solved of a choice of material for an abrasive tool, teaches that typically “work layer of the tool is of a harder material than the workpiece, but nevertheless it degrades over its lifetime” ([0002], demonstrating that a softer tool would degrade faster).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath such that the polishing element comprises a higher hardness than the PEEK of the body, applying the teachings of Rosesner to minimize wear.
Claim(s) 3 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kasinath (US 20210401583 A1) in view of Reo (US 20190336339 A1), Kim (KR 101987807 B1), Nakamura (JP S5993264 A), Tregub (US 20030207661 A1), and Rosesner (US 20020186370 A1), and further in view of Beaty (US 20040148031 A1)
With respect to claim 3, Kasinath, as modified, teaches the limitations of claim 1 above, however does not explicitly teach wherein the difference in Ra value of the polished portion of the body and an unpolished portion of the body is less than 0.8 micrometres.
Lazzara, in the same field of endeavor, related to medical implantable devices, teaches that implantable devices should have a roughness that is substantially uniform ([0043]), which would promote osseointegration with adjacent bone.
MPEP 2144.05 provides that discovering workable ranges would have been obvious to a person of ordinary skill in the art, if the range has been shown to be a result effective variable, and if it has not been demonstrated that the range is critical.
As Lazarra demonstrates that the uniformity of the roughness affects osseointegration with adjacent bone, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath such that the difference in Ra value of the polished portion of the body and an unpolished portion of the body is less than 0.8 micrometres, given the lack of criticality of the claimed range of 0.8 um or less, and given the demonstration that the uniformity of roughness across a surface is result effective. The modification would have been predictable to a person of ordinary skill in the art.
With respect to claim 15, Kasinath, as modified, teaches the limitations of claim 14 above, however does not explicitly teach wherein the difference in Ra value of the polished portion of the body and an unpolished portion of the body is less than 0.8 micrometres.
Lazzara, in the same field of endeavor, related to medical implantable devices, teaches that implantable devices should have a roughness that is substantially uniform ([0043]), which would promote osseointegration with adjacent bone.
MPEP 2144.05 provides that discovering workable ranges would have been obvious to a person of ordinary skill in the art, if the range has been shown to be a result effective variable, and if it has not been demonstrated that the range is critical.
As Lazarra demonstrates that the uniformity of the roughness affects osseointegration with adjacent bone, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath such that the difference in Ra value of the polished portion of the body and an unpolished portion of the body is less than 0.8 micrometres, given the lack of criticality of the claimed range of 0.8 um or less, and given the demonstration that the uniformity of roughness across a surface is result effective. The modification would have been predictable to a person of ordinary skill in the art.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kasinath (US 20210401583 A1) in view of Reo (US 20190336339 A1), Kim (KR 101987807 B1), Nakamura (JP S5993264 A), Tregub (US 20030207661 A1), and Rosesner (US 20020186370 A1), and further in view of Grestner (US 7473160 B1) and Langhorn (US 20180085221 A1).
With respect to claim 4, Kasinath, as modified, teaches the limitations of claim 2 above, however does not explicitly teach wherein spinning the polishing element comprises spinning the polishing element at a spindle speed of between 1000 rpm and 20,000 rpm and a feed rate of between 100mm/min and 5000mm/min; and wherein the Ra value of the polished portion of the body is between 0.2 micrometres and 1.0 micrometres.
Grestner, in the same field of endeavor, related to abrasive techniques, and pertinent to the problem being solved of choosing speed of the abrasive tool and feed rate, teaches that both the spindle speed and feed rate of the tool can affect the amount of material removal (col 4 lines 51-57), and the material removal rate in turn affects the potential to damage the workpiece by burning (col 6 line 64-col 7 line 5).
MPEP 2144.05 provides that discovering workable ranges would have been obvious to a person of ordinary skill in the art, if the range has been shown to be a result effective variable, and if it has not been demonstrated that the range is critical.
As Grestner demonstrates that spindle speed and feed rate of the tool can cause damage, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath so that spinning the polishing element comprises spinning the polishing element at a spindle speed of between 1000 rpm and 20,000 rpm and a feed rate of between 100mm/min and 5000mm/min, given the demonstration both variables are result effect in the potential to damage the workpiece. The modification would have been predictable to a person of ordinary skill in the art.
Langhorn, in the same field of endeavor, related to medical implantable devices, teaches that the average surface roughness ([0020]) could impact the wear performance of the implant ([0012]).
MPEP 2144.05 provides that discovering workable ranges would have been obvious to a person of ordinary skill in the art, if the range has been shown to be a result effective variable, and if it has not been demonstrated that the range is critical.
As Langhorn demonstrates that the average surface roughness (Ra) can impact the wear performance of the implant, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath so that the Ra value of the polished portion of the body is between 0.2 micrometres and 1.0 micrometres given the demonstration that it can impact the wear performance of the implant. The modification would have been predictable to a person of ordinary skill in the art.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kasinath (US 20210401583 A1) in view of Reo (US 20190336339 A1), Kim (KR 101987807 B1), Nakamura (JP S5993264 A), Tregub (US 20030207661 A1), and Rosesner (US 20020186370 A1), and further in view of Stephens (US 5560096 A).
With respect to claim 7, Kasinath, as modified, teaches the limitations of claim 1 above, however does not explicitly teach wherein the method further comprises the step of machining the body to form a machined edge, and wherein the polishing step comprises smoothing the machined edge. Kasinath, however discloses of machining to remove coring features of the implant (removal of 32, fig. 1; [0036], result in fig. 2).
Stephens, in the same field of endeavor, related to medical implantable devices, teaches a step of machining the body to form a machined edge (grinding to form parallel grooves as in col 1 line 60-col 2 line 5, grooves shown on surface 23, fig. 3 with edges as in col 3 lines 23-35; done with a grinding wheel 12, fig. 2, as in col 3 lines 5-11; see also fig. 4) , and wherein the polishing step comprises smoothing the machined edge (a following polishing step to polish the peaks between grooves as in col 1 line 60-col 2 line 5). Stephens teaches that this arrangement enables proper size and shaping to interfacing surface within a femoral knee implant while reducing variation (col 1 lines 26-45).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath such that the method further comprises the step of machining the body to form a machined edge before polishing, using the arrangement in Stephens and wherein the polishing step comprises smoothing the machined edge [integrating with Kim, which, as noted above, is directed to removing edges/flash to form a smooth surface], so that the implant can be the correct size while reducing variation.
With respect to claim 8, Kasinath, as modified, teaches the limitations of claim 7 above, and further teaches wherein machining the body comprises cutting a path with a cutter to remove a section of the body (the cutter is the grinding tool which cuts and removes materials in the groove as in Stephens, col 1 line 60-col 2 line 5) and wherein the polishing element follows the path of the cutter (the polishing element in Kim, a wheel that rotates, would follow the path of the cutter because in Stephens the grooves formed by the cutter have edges that need to be removed, and to do so the wheel would need to follow or pass though said edges [formed by the cutting path] to remove the edges and form a smooth surface).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kasinath (US 20210401583 A1) in view of Reo (US 20190336339 A1), Kim (KR 101987807 B1), Nakamura (JP S5993264 A), Tregub (US 20030207661 A1), and Rosesner (US 20020186370 A1), and further in view of Langhorn (US 20180085221 A1).
With respect to claim 9, Kasinath, as modified, teaches the limitations of claim 1 above, and further teaches wherein prior to polishing the body, the method further comprises at least one of: abrading the portion of the body with an abrasive media; or smoothing the portion of the body with an etched glass rod.
Langhorn, in the same field of endeavor, related to medical implantable devices, teaches of prior to polishing the body, the method further comprises at least one of: abrading the portion of the body with an abrasive media; or smoothing the portion of the body with an etched glass rod (before a final step of polishing, blasting to abrade as in [0013,0015]). Langhorn teaches that this improves the wear resistance of the implant ([0010,0012]), applicable to femoral knee components ([0022]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kasinath, such that prior to polishing the body, the method further comprises at least one of: abrading the portion of the body with an abrasive media, as taught by longhorn, to improve the wear resistance of the article.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kasinath (US 20210401583 A1) in view of Reo (US 20190336339 A1), Kim (KR 101987807 B1), Nakamura (JP S5993264 A), Tregub (US 20030207661 A1), and Rosesner (US 20020186370 A1), and further in view of Hong (US 20030191524 A1).
With respect to claim 10, Kasinath, as modified, teaches the limitations of claim 1 above, and further teaches wherein the body is formed via injection moulding (Kasinath, [0032]), however does not explicitly teach at least one imperfection is a moulding gate.
Hong, in the same field of endeavor, related to implantable medical devices, teaches that injection molding causes a flashing [imperfection] at a gate during injection molding that can be removed by any means ([0053-0054]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would thus have understood the injection molding of Kasinath would have a gate imperfection at which flashing is present, and would therefore apply the removal technique addressed in the rejection of claim 1 to said gate, for the reasons in gate 1 (to smooth out the surface to reduce biofilm and foreign body sensation).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Steven Huang whose telephone number is (571)272-6750. The examiner can normally be reached Monday to Thursday 6:30 am to 2:30 pm, Friday 6:30 am to 11:00 am (Eastern Time).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Posigian can be reached at 313-446-6546. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Steven Huang/Examiner, Art Unit 3723
Prosecution Insights