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 .
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.
Response to Amendment
The amendment filed April 10, 2026 has been entered. Claims 9, and 19 have been amended.
Applicant’s arguments filed April 10, 2026 were fully considered but they were not persuasive. Maintained rejections and response to arguments are addressed below.
Claims 9-10, 16-20, 23-25, and 27-30 are pending in this application.
Priority
This application is a 371 of PCT/US2019/060904 filed November 12, 2019 which claims benefit of 62/760,405 filed November 13, 2018.
Specification
The disclosure is objected to because of the following informalities:
Many of the structures/legends shown in table 1 on pages 34-37 are blurry rendering them illegible. This issue has not been fully corrected with the corrected specification filed April 10, 2026. For example
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156
409
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Greyscale
has an illegible sulfur atom. Also many of the subscripts are blurry and difficult to read. For Example
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179
440
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Greyscale
,
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156
433
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Greyscale
.
Appropriate correction is required.
Maintained 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.
Claims 9-10, 16-20, 23-25, and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Oral (WO 2017/083476, IDS filed November 16, 2021) as evidenced by Technical Textiles (Textile Today, 2013, cited in previous action).
Regarding claims 9-10: Oral teaches methods of making therapeutic medical implants with optimum properties for clinical performance. For example, in total joint replacement bearing surfaces made out of UHMWPE as polymeric material, the addition of additives such as therapeutic agents can increase the wear rate of the bearing surfaces and/or decrease the mechanical strength of the implants (pg. 3, lines 2-6). In several embodiments the method comprises:
providing a UHMWPE polymeric material
blending the polymeric material with therapeutic agents
consolidating the polymeric material
machining the consolidated blended material into a medical implant (pg. 3, lines 3-5, pg. 3, lines 20-32, pg. 4, lines 1-32, pg. 5, lines 25-30).
Oral teaches the incorporation of additives happens during the blending step (i.e. in step a the UHMWPE has no additives, pg. 3, lines 3-5, pg. 38, lines 28-31). Oral teaches generally that the blending can be done using a liquid in which the liquid is removed by evaporating under vacuum (i.e. wet blending and vacuum dehydrating, pg. 27, lines 4-18, pg. 38, lines 20-27). Oral teaches that liquid blending (i.e. wet-blending) results in improved uniformity of the additive in the polymeric material (pg. 27, lines 14-16). Oral teaches the additive can be a therapeutic agent (pg. 23, lines 23-27). Oral teaches in an embodiment wherein the therapeutic agent is dissolved in a solvent and blended with UHMWPE (pg. 38, lines 20-27). Oral teaches in an embodiment that following blending with a therapeutic agent, the polymeric material is dried in a convection oven under vacuum at 60 °C for 7 days (i.e. dehydration, pg. 27, lines 4-10, pg. 38, lines 20-27). Oral also teaches the blending of dry reagents prior to consolidation (pgs. 38-39, bridging para.). It would have been prima facie obvious to one of ordinary skill in the art to implement a step of drying prior to consolidation as taught by Oral. One of ordinary skill in the art would have the motivation to do so as drying after blending and the blending of dry materials is an established practice expressly taught by Oral. The therapeutic agent is preferably in a concentration between 0.001 wt% to 50 wt %, 6 wt% to 10 wt%, or about 8 wt% (pg. 5, lines 1-11). Oral teaches the blending of vancomycin, an antibiotic, with the polymeric material (pg. 39, lines 28-31). Although Oral does not explicitly teach a blend with gentamicin, Oral lists gentamicin as a possible therapeutic agent (pg. 24-25, bridging para. pg. 25, line 2) and teaches that gentamicin is commonly used in the art of drug-eluting polymeric materials (pg. 2, lines 7-20). Wherein both vancomycin and gentamicin are known antibiotics used in antibiotic eluting polymeric materials, it is prima facie obvious to substitute equivalents known for the same purpose (See MPEP 2144.06 (II)). Oral teaches the consolidation can be done by “direct compression molding” to obtain a near-net shape solid form that can be used directly as an implant or with small amounts of manipulation such as machining (pg. 7, lines 30-32). Oral teaches that the medical device/implant, such as a tibial knee insert or acetabular liner, can be for short term use (i.e. temporary, pg. 20, lines 13-20, pg. 21, lines 1-13, pg. 55, lines 13-24). For example, in the case of acetabular liner, the polymeric bearing surface can be replaced (pg. 55, lines 13-24).
Although Oral does not specifically state wherein the blend is dried in two separate steps, a mere duplication of steps to arrive at the same goal of a blend that is free of liquid has no patentable significance unless a new and unexpected result is produced. A person of ordinary skill upon reading Oral, would understand that the purpose of oven drying under vacuum at 60 °C for 7 days is to remove liquid from the blend, absent evidence to the contrary.
Oral does not disclose the method comprising decreasing discoloration and caramelization of the dehydrated polymer. However, on page 16 of the instant specification, the specification states discoloration of GS/UHMWPE samples prepared by compression molding, may arise from the Maillard reactions or caramelization of the additives (para. 1). In some embodiments, discoloration during consolidation of the polymeric material blend, for example GS/UHMWPE, can be minimized by dehydration methods described herein (para. 1). Oral teaches a vacuum drying method comprising drying the blend in a convection oven under vacuum at 60 °C for 7 days (pg. 38, para. 5, example 1). Although Oral does not specifically use the phrase “dehydration”, or discuss the removal of water during this process, wherein the conditions of Oral are encompassed by the phrase “vacuum dehydration” as defined in the instant specification, the vacuum drying method of Oral constitutes “vacuum dehydration” as instantly claimed. Wherein the sole purpose of the drying method of Oral is to remove liquids used in the wet-blending process, a person of ordinary skill would recognize this method to include the removal of residual amounts of water, such as due to moisture. Additionally, wherein the method of vacuum dehydration in the instant specification includes vacuum at 45 C for 16 hours, the method of Oral under vacuum at higher temperatures for a longer period time, would similarly be capable of removing water from the blend, absent evidence to the contrary. Given that the specification attributes this to dehydration of the material, and as discussed above, the method of Oral accomplishes this feature, thus these results are inherent in a wet-blending process that includes removal/evaporation of liquid components.
Regarding claims 16-18 and 30: Oral teaches a method wherein the consolidation comprises compression molding, the compression molding comprising:
heating the polymeric material to be molded,
pressurizing the polymeric material while heated
keeping at temperature and pressure, and
cooling down and
releasing pressure. (pg. 29, lines 22-28, pg. 42, lines 7-10).
Oral teaches the pressure can range from 0.1 MPa to 1000 MPa (pg. 30, lines 9-12). The dwell temperature and dwell time for consolidation can be changed to control the amount of integration (pg. 30, lines 19-20). The dwell temperature can be within the range of 135-350 °C. In a specific embodiment the consolidation occurs at 170 °C at 20 MPa (pg. 42, lines 7-10).
Regarding claims 19, 23, and 25: As discussed above Oral renders obvious the method of claim 9. Oral teaches wherein the polymeric material is blended with multiple therapeutic agents, such as 3.3 wt% rifampin and 6.7 wt% vancomycin, which are antibiotics (pg. 16, lines 26-28, pg. 41, lines 22-31). The therapeutic agent is preferably in a concentration between 0.001 wt% to 50 wt %, 6 wt% to 10 wt%, or about 8 wt% (pg. 5, lines 1-11). The use of multiple therapeutic agents can be synergistic against infectious agents (pg. 5, lines 1-11).
Oral does not teach wherein the polymeric material comprises both vancomycin and gentamicin, which is how claim 19 differs from claim 9.
However, Oral teaches the blend can comprise multiple antibiotics agents and antioxidant, such as a composition comprising vancomycin, rifampin, and vitamin E (pg. 4, lines 16-21, pg. 15, lines 14-17). Although Oral does not explicitly teach a blend with gentamicin, Oral lists gentamicin as a possible therapeutic agent (pg. 24-25, bridging para. pg. 25, line 2) and teaches that gentamicin is commonly used in the art of drug-eluting polymeric materials (pg. 2, lines 7-20).
Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to incorporate gentamicin into the blend of Oral in the preferred concentrations of Oral (i.e. 8 wt%). A person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success given that Oral establishes multiple therapeutic agents can be utilized and the art recognizes the use of gentamicin as an antibiotic commonly used in antibiotic-eluting polymeric materials.
Regarding claim 20 and 24: Oral teaches that prior to blending with the antibiotics, the polymeric material can be pre-mixed with Vitamin E (i.e. after step a, before step b, pg. 15, lines 16-17). Oral teaches the vitamin E in the UHMPWPE is present at a concentration of 0.2 wt % (pg. 10, lines 12-13).
Regarding claims 27-28: Oral further teaches wherein the medical implant can be sterilized by gas sterilization or ionizing radiation (pg. 34, lines 19-28).
Regarding claim 29: As discussed above, Oral renders obvious the method of claim 9. Oral does not explicitly teach wherein the device is an articulating spacer.
However, Oral teaches the polymeric materials can be machined into the articulating surface of a tibial knee insert or acetabular liner (pg. 35, lines 10-22, pg. 51, lines 12-15). For example, a tibial insert, which is the polymeric bearing surface used in a total knee replacement, and is made with small indentations on its backside (which is typically in direct contact with the tibial base tray or cemented into the tibial plateau) into which the small plug fits. The bearing surface is then fits with the antibiotic-eluting plug(s) and placed into a tibial base tray (which comes into contact with the bony surfaces on the tibial side of the implant with or without bone cement as a fixation aid) (pg. 55, lines 6-12). According to Technical Textiles, this type of insert acts as a spacer in total knee replacements between the femur and tibia (pg. 1, section 3.3., pg. 3, section 3.5.1). Thus whereas Oral teaches the polymeric material can be machined into a tibial knee insert, claim 29 is rendered obvious as tibial knee inserts are encompassed by the phrase “articulating spacer”.
Maintained 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 9-10, 16-20, 23-25, and 27-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over the patented claims of U.S. Patent No. 8,933,145 (cited in previous action) in view of Oral (WO 2017/083476, IDS filed November 16, 2021) as evidenced by Technical Textiles (Textile Today, 2013, cited in previous action).
Regarding claims 9-10: The patented claims teach a method of making a polymeric material, the method comprises:
providing a polymeric material that can be UHMPWE (claims 1, 6, 9)
blending the polymeric material with therapeutic agents, such as vitamin E (claims 1 and 3)
consolidating the polymeric material by compression molding (claims 1 and 5).
The patented claims do not require additives in step a.
The patented claims do not explicitly teach a method comprising the steps of wet blending the polymeric material with gentamicin of dehydrating the blended UHMWPE polymeric material to form a dehydrated UHMPE polymeric material or wherein the gentamicin is in the claimed ranges. The patented claims do not teach a step of machining the blended material into a temporary device.
However, Oral teaches the incorporation of additives happens during the blending step (i.e. in step a the UHMWPE has no additives, pg. 3, lines 3-5, pg. 38, lines 28-31). Oral teaches generally that the blending can be done using a liquid in which the liquid is removed by evaporating under vacuum (i.e. wet blending and vacuum dehydrating, pg. 38, lines 20-27). Oral teaches in an embodiment that following blending with a therapeutic agent, the polymeric material is dried in a convection oven under vacuum (i.e. dehydration, pg. 27, lines 4-10, pg. 38, lines 20-27). Oral also teaches the blending of dry reagents prior to consolidation (pgs. 38-39, bridging para.). It would have been prima facie obvious to one of ordinary skill in the art to implement a step of drying prior to consolidation as taught by Oral. One of ordinary skill in the art would have the motivation to do so as drying after blending and the blending of dry materials is an established practice expressly taught by Oral. The therapeutic agent is preferably in a concentration between 0.001 wt% to 50 wt %, 6 wt% to 10 wt%, or about 8 wt% (pg. 5, lines 1-11). Oral teaches the blending of vancomycin, an antibiotic, with the polymeric material (pg. 39, lines 28-31). Although Oral does not explicitly teach a blend with gentamicin, Oral lists gentamicin as a possible therapeutic agent (pg. 24-25, bridging para. pg. 25, line 2) and teaches that gentamicin is commonly used in the art of drug-eluting polymeric materials (pg. 2, lines 7-20). Wherein both vancomycin and gentamicin are known antibiotics used in antibiotic eluting polymeric materials, it is prima facie obvious to substitute equivalents known for the same purpose (See MPEP 2144.06 (II)). Oral teaches the consolidation can be done by “direct compression molding” to obtain a near-net shape solid form that can be used directly as an implant or with small amounts of manipulation such as machining (pg. 7, lines 30-32). Oral teaches that the medical device/implant, such as a tibial knee insert or acetabular liner, can be for short term use (i.e. temporary, pg. 20, lines 13-20, pg. 21, lines 1-13, pg. 55, lines 13-24). For example, in the case of acetabular liner, the polymeric bearing surface can be replaced (pg. 55, lines 13-24).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to modify the patented claims by incorporating gentamicin at the suggested concentrations, implementing wet blending and dehydration, and machining the polymeric material into a temporary medical implant as taught by Oral. A person of ordinary skill in the art would have the motivation to do so as Oral teaches that incorporation of gentamicin, wet blending, and dehydration are known techniques in the art of blending a polymeric material for therapeutic purposes. A person of ordinary skill would have the motivation to machine the material into a temporary medical implant given that Oral recognizes this a common use for therapeutic containing UHMWPE polymeric materials.
Regarding claims 16-18 and 30: As discussed above, the patented claims and Oral render obvious the method of claim 9.
The patented claims do not teach a method wherein the compression molding comprises the steps and conditions as recited by instant claims 16-18.
However, Oral teaches a method wherein the consolidation comprises compression molding, the compression molding comprising:
heating the polymeric material to be molded,
pressurizing the polymeric material while heated
keeping at temperature and pressure, and
cooling down and releasing pressure. (pg. 29, lines 22-28).
Oral teaches the pressure can range from 0.1 MPA to 1000 MPa (pg. 30, lines 9-12). The dwell temperature and dwell time for consolidation can be changed to control the amount of integration (pg. 30, lines 19-20). In a specific embodiment the consolidation occurs at 170 °C at 20 MPa (pg. 42, lines 7-10). It would have been prima facie obvious to modify the method of the patented claims by incorporating the compression molding conditions as taught by Oral. One of ordinary skill in the art would have had the motivation to do so as Oral demonstrates these conditions are routine practices in the art in the process of making a blended polymeric material.
Regarding claims 19, 23, and 25: As discussed above the patented claims and Oral renders obvious the method of claim 9. The patented claims teach a method wherein the blending comprises blending with vitamin E and one or more therapeutic agents (antioxidant, claim 3).
The patented claims do not teach wherein the polymeric material comprises both vancomycin and gentamicin, which is how claim 19 differs from claim 9.
However, Oral teaches the blend can comprise multiple antibiotics agents and antioxidant, such as a composition comprising vancomycin, rifampin, and vitamin E (pg. 4, lines 16-21, pg. 15, lines 14-17). Oral teaches wherein the polymeric material is blended with multiple therapeutic agents, such as 3.3 wt% rifampin and 6.7 wt% vancomycin, which are antibiotics (pg. 16, lines 26-28, pg. 41, lines 22-31). The therapeutic agent is preferably in a concentration between 0.001 wt% to 50 wt %, 6 wt% to 10 wt%, or about 8 wt% (pg. 5, lines 1-11). The use of multiple therapeutic agents can be synergistic against infectious agents (pg. 5, lines 1-11). Although Oral does not explicitly teach a blend with gentamicin, Oral lists gentamicin as a possible therapeutic agent (pg. 24-25, bridging para. pg. 25, line 2) and teaches that gentamicin is commonly used in the art of drug-eluting polymeric materials (pg. 2, lines 7-20).
Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to incorporate gentamicin and vancomycin into the blend of the patented claims as taught by and in the preferred concentrations of Oral (i.e. 8 wt%). A person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success given that Oral establishes multiple therapeutic agents can be utilized and the art recognizes the use of gentamicin and vancomycin as an antibiotic commonly used in antibiotic-eluting polymeric materials.
Regarding claim 20 and 24: As discussed above, the patented claims and Oral render obvious the method of claims 19-20.
The patented claims do not teach a method wherein vitamin is blended after step a) and before step b). The patented claims do not specify the concentration of vitamin E.
However, Oral teaches that prior to blending with the antibiotics, the polymeric material can be pre-mixed with Vitamin E (i.e. after step a, before step b, pg. 15, lines 16-17). Oral teaches the vitamin E in the UHMPWPE is present at a concentration of 0.2 wt % (pg. 10, lines 12-13).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to further modify the patented claims by premixing the vitamin E in the concentration taught by Oral into the polymeric material. A person of ordinary skill person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success given that the patented claims include vitamin E into the polymeric materials, and oral teaches that this a known technique in the process of forming a polymeric material for the purpose of forming a medical implant.
Regarding claims 27-28: As discussed above, the patented claims and Oral render obvious the method of claims 19-20.
The patented claims do not teach wherein the medical implant can be sterilized by gas sterilization or ionizing radiation.
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to further modify the patented claims wherein the medical implant can be sterilized by gas sterilization or ionizing radiation. A person of ordinary skill person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success as Oral establishes this technique as routine practice in the art of forming a polymeric material for the purpose of forming a medical implant.
However, Oral further teaches wherein the medical implant can be sterilized by gas sterilization or ionizing radiation (pg. 34, lines 19-28).
Regarding claim 29: As discussed above, the patented claims and Oral render obvious the method of claim 9.
The patented claims do not explicitly teach wherein the device is an articulating spacer.
However, Oral teaches the polymeric materials can be machined into the articulating surface of a tibial knee insert or acetabular liner (pg. 35, lines 10-22, pg. 51, lines 12-15). For example, a tibial insert, which is the polymeric bearing surface used in a total knee replacement, and is made with small indentations on its backside (which is typically in direct contact with the tibial base tray or cemented into the tibial plateau) into which the small plug fits. The bearing surface is then fits with the antibiotic-eluting plug(s) and placed into a tibial base tray (which comes into contact with the bony surfaces on the tibial side of the implant with or without bone cement as a fixation aid) (pg. 55, lines 6-12). According to Technical Textiles, this type of insert acts as a spacer in total knee replacements between the femur and tibia (pg. 1, section 3.3., pg. 3, section 3.5.1).
Taken together, it would have been prima facie obvious to modify the patented claims such that the polymeric material is machined into an articulating space, such as a tibial insert or acetabular liner. A person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success as Oral establishes these materials are known in the art to be capable of serving this purpose.
Claims 9-10, 16-20, 23-25, and 27-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over patented claims of US 11,850,329 (previously copending Application No. 17/222398, US 2021/0228775, Patent issuance as US 11,850,329 on December 26, 2023, cited in previous action) in view of Oral (WO 2017/083476, IDS filed November 16, 2021) as evidenced by Technical Textiles (Textile Today, 2013 cited in previous action).
Regarding claims 9-10: The patented claims teach a method of making a consolidated UHMWPE polymeric material for use as a medical implant, such as for an acetabular liner (claims 1 and 8) comprising the steps of:
blending a first ultrahigh molecular weight polyethylene (UHMWPE) powder, flakes or particles with at least one pharmaceutical agent excluding vitamin-E in a solvent that comprises water and ethanol to provide a first UHMWPE blend;
drying the first UHMWPE blend under vacuum (i.e. vacuum dehydration or environmentally treating, claim 1 and 7);
consolidating as layers the UHMWPE blend from drying step with a second UHMWPE without blending to a pharmaceutical agent to yield layered consolidated UHMWPE comprising at least one pharmaceutical agent excluding vitamin-E in one layer; and
machining the layered consolidated UHMWPE into a medical implant (claim 1).
The medical implant is selected from a tibial insert or acetabular liner (claim 8). The consolidating step is by direct compression molding (claim 2).
The patented claims do not explicitly teach a method comprising the steps of wet blending the polymeric material with gentamicin of dehydrating the blended UHMWPE polymeric material to form a dehydrated UHMPE polymeric material or wherein the gentamicin is in the claimed ranges. The patented claims do not teach a step of machining the blended material into a temporary device.
However, Oral teaches the incorporation of additives happens during the blending step (i.e. in step a the UHMWPE has no additives, pg. 3, lines 3-5, pg. 38, lines 28-31). Oral teaches generally that the blending can be done using a liquid in which the liquid is removed by evaporating under vacuum (i.e. wet blending and vacuum dehydrating, pg. 38, lines 20-27). Oral teaches in an embodiment that following blending with a therapeutic agent, the polymeric material is dried in a convection oven under vacuum (i.e. dehydration, pg. 27, lines 4-10, pg. 38, lines 20-27). Oral also teaches the blending of dry reagents prior to consolidation (pgs. 38-39, bridging para.). It would have been prima facie obvious to one of ordinary skill in the art to implement a step of drying prior to consolidation as taught by Oral. One of ordinary skill in the art would have the motivation to do so as drying after blending and the blending of dry materials is an established practice expressly taught by Oral. The therapeutic agent is preferably in a concentration between 0.001 wt% to 50 wt %, 6 wt% to 10 wt%, or about 8 wt% (pg. 5, lines 1-11). Oral teaches the blending of vancomycin, an antibiotic, with the polymeric material (pg. 39, lines 28-31). Although Oral does not explicitly teach a blend with gentamicin, Oral lists gentamicin as a possible therapeutic agent (pg. 24-25, bridging para. pg. 25, line 2) and teaches that gentamicin is commonly used in the art of drug-eluting polymeric materials (pg. 2, lines 7-20). Wherein both vancomycin and gentamicin are known antibiotics used in antibiotic eluting polymeric materials, it is prima facie obvious to substitute equivalents known for the same purpose (See MPEP 2144.06 (II)). Oral teaches the consolidation can be done by “direct compression molding” to obtain a near-net shape solid form that can be used directly as an implant or with small amounts of manipulation such as machining (pg. 7, lines 30-32). Oral teaches that the medical device/implant, such as a tibial knee insert or acetabular liner, can be for short term use (i.e. temporary, pg. 20, lines 13-20, pg. 21, lines 1-13, pg. 55, lines 13-24). For example, in the case of acetabular liner, the polymeric bearing surface can be replaced (pg. 55, lines 13-24).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to modify the patented claims by incorporating gentamicin at the suggested concentrations, implementing wet blending and dehydration, and machining the polymeric material into a temporary medical implant as taught by Oral. A person of ordinary skill in the art would have the motivation to do so as Oral teaches that incorporation of gentamicin, wet blending, and dehydration are known techniques in the art of blending a polymeric material for therapeutic purposes. A person of ordinary skill would have the motivation to machine the material into a temporary medical implant given that Oral recognizes this a common use for therapeutic containing UHMWPE polymeric materials.
Regarding claims 16-18 and 30: As discussed above, the patented claims and Oral render obvious the method of claim 9.
The patented claims do not teach a method wherein the compression molding comprises the steps and conditions as recited by instant claims 16-18.
However, Oral teaches a method wherein the consolidation comprises compression molding, the compression molding comprising:
heating the polymeric material to be molded,
pressurizing the polymeric material while heated
keeping at temperature and pressure, and
cooling down and releasing pressure. (pg. 29, lines 22-28).
Oral teaches the pressure can range from 0.1 MPA to 1000 MPa (pg. 30, lines 9-12). The dwell temperature and dwell time for consolidation can be changed to control the amount of integration (pg. 30, lines 19-20). In a specific embodiment the consolidation occurs at 170 °C at 20 MPa (pg. 42, lines 7-10). It would have been prima facie obvious to modify the method of the patented claims by incorporating the compression molding conditions as taught by Oral. One of ordinary skill in the art would have had the motivation to do so as Oral demonstrates these conditions are routine practices in the art in the process of making a blended polymeric material.
Regarding claims 19, 23, and 25: As discussed above the patented claims and Oral renders obvious the method of claim 9. The patented claims teach a method wherein the blending comprises blending with vitamin E and one or more therapeutic agents (antioxidant, claim 3).
The patented claims do not teach wherein the polymeric material comprises both vancomycin and gentamicin, which is how claim 19 differs from claim 9.
However, Oral teaches the blend can comprise multiple antibiotics agents and antioxidant, such as a composition comprising vancomycin, rifampin, and vitamin E (pg. 4, lines 16-21, pg. 15, lines 14-17). Oral teaches wherein the polymeric material is blended with multiple therapeutic agents, such as 3.3 wt% rifampin and 6.7 wt% vancomycin, which are antibiotics (pg. 16, lines 26-28, pg. 41, lines 22-31). The therapeutic agent is preferably in a concentration between 0.001 wt% to 50 wt %, 6 wt% to 10 wt%, or about 8 wt% (pg. 5, lines 1-11). The use of multiple therapeutic agents can be synergistic against infectious agents (pg. 5, lines 1-11). Although Oral does not explicitly teach a blend with gentamicin, Oral lists gentamicin as a possible therapeutic agent (pg. 24-25, bridging para. pg. 25, line 2) and teaches that gentamicin is commonly used in the art of drug-eluting polymeric materials (pg. 2, lines 7-20).
Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to incorporate gentamicin and vancomycin into the blend of the patented claims as taught by and in the preferred concentrations of Oral (i.e. 8 wt%). A person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success given that Oral establishes multiple therapeutic agents can be utilized and the art recognizes the use of gentamicin and vancomycin as an antibiotic commonly used in antibiotic-eluting polymeric materials.
Regarding claim 20 and 24: As discussed above, the patented claims and Oral render obvious the method of claims 19-20.
The patented claims do not teach a method wherein vitamin is blended after step a) and before step b). The patented claims do not specify the concentration of vitamin E.
However, Oral teaches that prior to blending with the antibiotics, the polymeric material can be pre-mixed with Vitamin E (i.e. after step a, before step b, pg. 15, lines 16-17). Oral teaches the vitamin E in the UHMPWPE is present at a concentration of 0.2 wt % (pg. 10, lines 12-13).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to further modify the patented claims by premixing the vitamin E in the concentration taught by Oral into the polymeric material. A person of ordinary skill person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success given that the patented claims include vitamin E into the polymeric materials, and oral teaches that this a known technique in the process of forming a polymeric material for the purpose of forming a medical implant.
Regarding claims 27-28: The patented claims do not teach wherein the medical implant can be sterilized by gas sterilization or ionizing radiation.
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to further modify the patented claims wherein the medical implant can be sterilized by gas sterilization or ionizing radiation. A person of ordinary skill person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success as Oral establishes this technique as routine practice in the art of forming a polymeric material for the purpose of forming a medical implant.
However, Oral further teaches wherein the medical implant can be sterilized by gas sterilization or ionizing radiation (pg. 34, lines 19-28).
Regarding claim 29: As discussed above, the patented claims and Oral render obvious the method of claim 9.
The patented claims do not explicitly teach wherein the device is an articulating spacer.
However, Oral teaches the polymeric materials can be machined into the articulating surface of a tibial knee insert or acetabular liner (pg. 35, lines 10-22, pg. 51, lines 12-15). For example, a tibial insert, which is the polymeric bearing surface used in a total knee replacement, and is made with small indentations on its backside (which is typically in direct contact with the tibial base tray or cemented into the tibial plateau) into which the small plug fits. The bearing surface is then fits with the antibiotic-eluting plug(s) and placed into a tibial base tray (which comes into contact with the bony surfaces on the tibial side of the implant with or without bone cement as a fixation aid) (pg. 55, lines 6-12). According to Technical Textiles, this type of insert acts as a spacer in total knee replacements between the femur and tibia (pg. 1, section 3.3., pg. 3, section 3.5.1).
Taken together, it would have been prima facie obvious to modify the patented claims such that the polymeric material is machined into an articulating space, such as a tibial insert or acetabular liner. A person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success as Oral establishes these materials are known in the art to be capable of serving this purpose.
Claims 9-10, 16-20, 23-25, and 27-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/138588 (US 2023/0256139, cited in previous action) in view of Oral (WO 2017/083476, IDS filed November 16, 2021) as evidenced by Technical Textiles (Textile Today, 2013, cited in previous action).
Regarding claims 9-10: The copending claims teach a method of making a polymeric material, the method comprises:
providing a polymeric material that can be UHMPWE (claims 45-48)
blending the polymeric material with therapeutic agents, such as vitamin E or bupivacaine (claims 53-54)
consolidating the polymeric material by compression molding (claims 45-48)
machining the polymeric material into a medical implant, such as an acetabular liner or tibial knee insert (claims 48 and 50)
The copending claims do not explicitly teach a method comprising the steps of wet blending the polymeric material with gentamicin of dehydrating the blended UHMWPE polymeric material to form a dehydrated UHMPE polymeric material or wherein the therapeutic agent is gentamicin in the claimed ranges. The copending claims do not explicitly state that the device is temporary.
However, Oral teaches the incorporation of additives happens during the blending step (i.e. in step a the UHMWPE has no additives, pg. 3, lines 3-5, pg. 38, lines 28-31). Oral teaches generally that the blending can be done using a liquid in which the liquid is removed by evaporating under vacuum (i.e. wet blending and vacuum dehydrating, pg. 38, lines 20-27). Oral teaches in an embodiment that following blending with a therapeutic agent, the polymeric material is dried in a convection oven under vacuum (i.e. dehydration, pg. 27, lines 4-10, pg. 38, lines 20-27). Oral also teaches the blending of dry reagents prior to consolidation (pgs. 38-39, bridging para.). It would have been prima facie obvious to one of ordinary skill in the art to implement a step of drying prior to consolidation as taught by Oral. One of ordinary skill in the art would have the motivation to do so as drying after blending and the blending of dry materials is an established practice expressly taught by Oral. The therapeutic agent is preferably in a concentration between 0.001 wt% to 50 wt %, 6 wt% to 10 wt%, or about 8 wt% (pg. 5, lines 1-11). Oral teaches the blending of vancomycin, an antibiotic, with the polymeric material (pg. 39, lines 28-31). Although Oral does not explicitly teach a blend with gentamicin, Oral lists gentamicin as a possible therapeutic agent (pg. 24-25, bridging para. pg. 25, line 2) and teaches that gentamicin is commonly used in the art of drug-eluting polymeric materials (pg. 2, lines 7-20). Wherein both vancomycin and gentamicin are known antibiotics used in antibiotic eluting polymeric materials, it is prima facie obvious to substitute equivalents known for the same purpose (See MPEP 2144.06 (II)). Oral teaches the consolidation can be done by “direct compression molding” to obtain a near-net shape solid form that can be used directly as an implant or with small amounts of manipulation such as machining (pg. 7, lines 30-32). Oral teaches that the medical device/implant, such as a tibial knee insert or acetabular liner, can be for short term use (i.e. temporary, pg. 20, lines 13-20, pg. 21, lines 1-13, pg. 55, lines 13-24). For example, in the case of acetabular liner, the polymeric bearing surface can be replaced (pg. 55, lines 13-24).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to modify the copending claims by incorporating gentamicin at the suggested concentrations, implementing wet blending and dehydration, and machining the polymeric material into a temporary medical implant as taught by Oral. A person of ordinary skill in the art would have the motivation to do so as Oral teaches that incorporation of gentamicin, wet blending, and dehydration are known techniques in the art of blending a polymeric material for therapeutic purposes. A person of ordinary skill would have the motivation to machine the material into a temporary medical implant given that Oral recognizes this a common use for therapeutic containing UHMWPE polymeric materials.
Regarding claims 16-18 and 30: As discussed above, the copending claims and Oral render obvious the method of claim 9.
The copending claims do not teach a method wherein the compression molding comprises the steps and conditions as recited by instant claims 16-18.
However, Oral teaches a method wherein the consolidation comprises compression molding, the compression molding comprising:
heating the polymeric material to be molded,
pressurizing the polymeric material while heated
keeping at temperature and pressure, and
cooling down and releasing pressure. (pg. 29, lines 22-28).
Oral teaches the pressure can range from 0.1 MPA to 1000 MPa (pg. 30, lines 9-12). The dwell temperature and dwell time for consolidation can be changed to control the amount of integration (pg. 30, lines 19-20). In a specific embodiment the consolidation occurs at 170 °C at 20 MPa (pg. 42, lines 7-10). It would have been prima facie obvious to modify the method of the copending claims by incorporating the compression molding conditions as taught by Oral. One of ordinary skill in the art would have had the motivation to do so as Oral demonstrates these conditions are routine practices in the art in the process of making a blended polymeric material.
Regarding claims 19, 23, and 25: As discussed above the copending claims and Oral renders obvious the method of claim 9. The copending claims teach a method wherein the blending comprises blending with vitamin E and one or more therapeutic agents (bupivacaine, claims 45 and 53).
The copending claims do not teach wherein the polymeric material comprises both vancomycin and gentamicin, which is how claim 19 differs from claim 9.
However, Oral teaches the blend can comprise multiple antibiotics agents and antioxidant, such as a composition comprising vancomycin, rifampin, and vitamin E (pg. 4, lines 16-21, pg. 15, lines 14-17). Oral teaches wherein the polymeric material is blended with multiple therapeutic agents, such as 3.3 wt% rifampin and 6.7 wt% vancomycin, which are antibiotics (pg. 16, lines 26-28, pg. 41, lines 22-31). The therapeutic agent is preferably in a concentration between 0.001 wt% to 50 wt %, 6 wt% to 10 wt%, or about 8 wt% (pg. 5, lines 1-11). The use of multiple therapeutic agents can be synergistic against infectious agents (pg. 5, lines 1-11). Although Oral does not explicitly teach a blend with gentamicin, Oral lists gentamicin as a possible therapeutic agent (pg. 24-25, bridging para. pg. 25, line 2) and teaches that gentamicin is commonly used in the art of drug-eluting polymeric materials (pg. 2, lines 7-20).
Taken together, it would have been prima facie obvious to a person of ordinary skill in the art to incorporate gentamicin and vancomycin into the blend of the copending claims as taught by and in the preferred concentrations of Oral (i.e. 8 wt%). A person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success given that Oral establishes multiple therapeutic agents can be utilized and the art recognizes the use of gentamicin and vancomycin as an antibiotic commonly used in antibiotic-eluting polymeric materials.
Regarding claim 20 and 24: As discussed above, the copending claims and Oral render obvious the method of claims 19. The copending claims teach wherein vitamin E is pre-mixed with the polymeric material before blending with the therapeutic agent (claim 53).
The patented claims do not specify the concentration of vitamin E.
However, Oral teaches the vitamin E in the UHMPWPE is present at a concentration of 0.2 wt % (pg. 10, lines 12-13).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to further modify the copending claims by premixing the vitamin E in the concentration taught by Oral into the polymeric material. A person of ordinary skill person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success given that the patented claims include vitamin E into the polymeric materials, and Oral teaches that this concentration is effective in antibiotic-eluting materials for medical implants.
Regarding claims 27-28: As discussed above, the copending claims and Oral render obvious the methods of claim 9 and 19. The copending claims teach that the medical implant can be sterilized (claim 51).
The copending claims do not teach wherein the medical implant can be sterilized by gas sterilization or ionizing radiation.
However, Oral further teaches wherein the medical implant can be sterilized by gas sterilization or ionizing radiation (pg. 34, lines 19-28).
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to further modify the copending claims wherein the medical implant can be sterilized by gas sterilization or ionizing radiation. A person of ordinary skill person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success as Oral establishes this technique as routine practice in the art of forming a polymeric material for the purpose of forming a medical implant.
Regarding claim 29: As discussed above, the copending claims and Oral render obvious the method of claim 9. The copending claims teach a method wherein the polymer can be machined into a medical implant, such as an acetabular liner or tibial knee insert (claim 50).
The patented claims do not explicitly teach wherein the device is an articulating spacer.
However, Oral teaches the polymeric materials can be machined into the articulating surface of a tibial knee insert or acetabular liner (pg. 35, lines 10-22, pg. 51, lines 12-15). For example, a tibial insert, which is the polymeric bearing surface used in a total knee replacement, and is made with small indentations on its backside (which is typically in direct contact with the tibial base tray or cemented into the tibial plateau) into which the small plug fits. The bearing surface is then fits with the antibiotic-eluting plug(s) and placed into a tibial base tray (which comes into contact with the bony surfaces on the tibial side of the implant with or without bone cement as a fixation aid) (pg. 55, lines 6-12). According to Technical Textiles, this type of insert acts as a spacer in total knee replacements between the femur and tibia (pg. 1, section 3.3., pg. 3, section 3.5.1). Thus whereas the copending claims teach the polymeric material can be machined into a tibial knee insert, claim 29 is rendered obvious as tibial knee inserts are encompassed by the phrase “articulating spacer”.
Response to Arguments
Applicant’s arguments filed April 10, 2026 have been fully considered but they are not persuasive.
On pages 6-7 of Applicant’s response, Applicant argues that Oral does not disclose the method comprises decreasing discoloration and caramelization of the dehydrated polymer (bridging para.). Applicant argues that Oral does not provide a method for dehydrating antibiotic-blended material (bridging para.). On page 7 of Applicant’s response, Applicant argues the Maillard reaction occurs between the carbonyl and amine groups in the antibiotics and results in discoloration and caramelization of the dehydrated antibiotic-blended UHMWPE polymeric material (para. 2). Applicant argues Oral does not address the issue because the drying process of Oral would not yield a superior product by decreasing the discoloration and caramelization of the dehydrated antibiotic-blended UHMPWPE polymeric material (para. 2). On page 7 of Applicant’s response, Applicant argues that the Examiner referred to the specification that states discoloration/caramelization occurs during the consolidation/compression step, and the Examiner misinterpreted that if the material is dry prior to consolidation, then discoloration does not occur (para. 3). Applicant argues that Oral does not teach vacuum dehydration of antibiotic-blended material or even identify the discoloration/caramelization phenomenon since antibiotic-blended materials were not subject to vacuum drying prior to consolidation. On pages 7-8 of Applicant’s response, Applicant argues the newly amended claims further distinguish from the method of oral by reciting the discoloration and caramelization occurs as a result of step (b). On page 8 of Applicant’s response, Applicant submits that method using simultaneous steps of wet-blending and drying prior to vacuum dehydration yielded unexpectedly superior product by decreasing the discoloration of the antibiotic blended UHMWPE polymeric material (pg. 8, para. 2). Applicant further argues on page 8 that Oral does not teach wet-blending the material and gentamicin dissolved in a solvent and simultaneously drying the wet blended UHMWPE to remove the solvent in order to decrease discoloration and caramelization (para. 3).
However, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention (See MPEP 2145 (II)). The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. It is clear from the teachings of Oral that upon utilizing a liquid to blend the components, the liquid is to be removed by evaporation (pg. 27, para. 2). Although Oral does not specifically teach vacuum dehydrating an antibiotic blended material, Oral teaches a vacuum drying method comprising drying a blend containing an additive (i.e. vitamin E) in a convection oven under vacuum at 60 °C for 7 days, establishing this as a known technique in the art when adding additives to the material and wet-blending them (pg. 38, para. 5, example 1). Oral then teaches further including dry therapeutic agents in the bled via mechanically mixing, which would necessarily be dry (pgs. 38-39, example 2). Oral teaches liquid blending improves uniformity within the polymeric material (pg. 27, para. 2). With respect to Applicants argument regarding decreasing discoloration and caramelization of the dehydrated polymer as unexpected results, given that Applicant attributes this to dehydration of the material, and as discussed above, the method of Oral accomplishes this feature, thus these results are latent properties in a wet-blending process that includes removal/evaporation of liquid components. According to the instant specification, discoloration may be caused by the caramelization of one of the additives. For instance, caramelization of gentamicin sulfate in GS/UHMWPE blend results in darker colors, mostly caused by water retained in the polymeric material blend (pg. 19, para. 1). The instant specification discloses that discoloration/caramelization occurs during the consolidation/compression step (pg. 16, para. 1). The instant specification assesses discoloration following discoloration (pgs. 46-47, bridging para.). So long as the blended material is dry prior to consolidation, this does not occur. Thus, since Oral teaches vacuum dehydration (removal of liquids) prior to consolidation, this (discoloration) does not occur in the method of Oral either. In short, the art recognizes wet-blending as a known technique in the art, wherein, as part of the technique, the liquid is to be removed following blending, prior to consolidation. Wet-blending has the added benefit of uniformly distributing the additive through the material. Wherein it is prima facie obvious to utilize the wet-blending technique, it is similarly obvious to dry prior to consolidation, absent a teaching that following wet-blending it is typical to not remove the solvent or that wet-blending with antibiotics specifically is not favorable. Given that drying is a part of the method, the properties necessarily flow from the method. Although Oral does not specifically state wherein the blend is dried in two separate steps, a mere duplication of steps to arrive at the same goal of a blend that is free of liquid has no patentable significance unless a new and unexpected result is produced. Wherein Oral teaches completely drying, including vacuum dehydration as discussed in the 103 rejections, prior to consolidation, the decrease in caramelization and discoloration naturally flows from the method of Oral. Applicant has not demonstrated that it is specifically wet-blending and simultaneous drying that decreases discoloration and caramelization, compared to solely vacuum dehydration of Oral, and would lead to a superior product than that which is produced by the methods of Oral.
On page 9 of Applicant’s response, Applicant argues that the double patenting rejections are similarly overcome for failing to teach newly amended step b in claims 9 and 19.
However, see response to arguments above, wherein Oral teaches vacuum dehydration prior to consolidating, the decreasing of discoloration and caramelization necessarily flows from the suggestion in the prior art.
Applicant’s reply is considered to be a bona fide attempt at a response and is being accepted as a complete response. The 35 USC § 103 and double patenting rejections are maintained for reason of record and foregoing discussion.
Conclusion
No claims are allowed in this action.
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.
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/S.L.G./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
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