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 .
Status of Claims
This office action is responsive to the amendment filed on 04/27/2026. As directed by the amendment: new claims 19-21 have been added. Thus, claims 1-8, 11 and 13-21 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to claims 1, 8-12 and 16 rejected under 35 U.S.C. 103 as being unpatentable over Cao et al. (2011/0117170) in view of Bagga et al. (2011/0125265) “Bagga”; claims 2-7 and 17 rejected under 35 U.S.C. 103 as being unpatentable over Cao et al. (2011/0117170) in view of Bagga et al. (2011/0125265) “Bagga” further in view of Morris et al. (2020/0353123) “Morris”; claims 13-15 rejected under 35 U.S.C. 103 as being unpatentable over Cao et al. (2011/0117170) in view of Bagga et al. (2011/0125265) “Bagga” further in view of Lv et al. (2020/0268930) “Lv” and claim 18 rejected under 35 U.S.C. 103 as being unpatentable over Cao et al. (2011/0117170) in view of Bagga et al. (2011/0125265) “Bagga” further in view of Howell (6254605) have been fully considered but they are not persuasive.
On pages 8-9 of the response, the applicant argues that Bagga et al. fails to disclose the newly amended claim limitations of claim 1 including one or more through holes connecting the first channel to the second channel. This is not found to be persuasive since claim 1 broadly requires “a first channel positioned on a first side of the elongated member” and “a second channel positioned on a second side of the elongated member” and “one or more through holes connecting the first channel to the second channel”. Claim 1 is silent regarding the second channel positioned on a second side where the second side is located opposite the first channel side. As pointed out by the applicant on page 8, Bagga discloses one or more channels 50 in fluid communication with the central canal 60 via pores 54 (Fig. 2B). The first and second channels or recessed flutes 50 are located on a first and second side of the elongated member. Each channel comprises through holes 54 which fluidly connect the first and second channels. When a flowable material 70 is introduced into the canal 60, the material can flow from the pores 54 in the first channel to the pores 54 in the second channel. Therefore, Cao et al. in view of Bagga et al., discloses the claimed invention of amended claim 1 including “one or more through holes connecting the first channel to the second channel”.
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 1, 8, 11, 16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cao et al. (2011/0117170) in view of Bagga et al. (2011/0125265) “Bagga”.
Regarding claims 1, 8 and 11, Cao discloses an orthopedic implant (par. 0040 discloses a bone scaffold par. 0020 discloses surgical implant and par. 0128 discloses bone implants), comprising: a member having a first end and a second end opposite the first end (pars. 0020 and 0040 disclose a scaffold to repair bone which would obviously comprise a member body having opposing ends); and a porous coating secured to an exterior surface of the member (par. 0036 disclose the scaffold comprises a porous composition), wherein the porous coating includes magnesium phosphate (par. 0036 discloses the scaffold comprises a composition to induce pores where the pore forming composition is a coating comprising magnesium phosphate).
Cao is silent regarding an elongated member is tapered at the second end such that a width of the second end is less than a width of the first end; a first channel positioned on a first side of the elongated member and extending from the first end to the second end; a second channel positioned on a second side of the elongated member and extending from the first end to the second end; wherein the first channel is recessed in the first side of the elongated member, and wherein the second channel is recessed in the second side of the elongated member; and one or more through holes connecting the first channel to the second channel; wherein the one or more through holes comprises a plurality of through holes and an elongated member having a first end and a second end opposite the first end and wherein the elongated member comprises titanium, polyetheretherketone (PEEK), polyurethane, bone, or a cured osteostimulative material.
However, Bagga discloses a similar porous orthopedic implant 40 (Fig. 2A and par. 0132 disclose a porous implant) comprising an elongated member 46 is tapered at the second end such that a width of the second end is less than a width of the first end (tapered tip 48); a first channel 50 positioned on a first side of the elongated member and extending from the first end to the second end; a second channel 50 positioned on a second side of the elongated member and extending from the first end to the second end (Fig. 2A discloses flutes 50 on two sides); and one or more through holes 54 connecting the first channel to the second channel (the first and second channels comprise through holes 54 which fluidly connect the first and second channels; when a flowable material 70 is introduced into the canal 60, the material can flow from the pores 54 in the first channel to the pores 54 in the second channel; Fig. 2B); wherein the one or more through holes comprises a plurality of through holes 54 (as shown in Fig. 2A) and wherein the first channel is recessed in the first side of the elongated member, and wherein the second channel is recessed in the second side of the elongated member (flutes 50 are recessed; Fig. 2A and par. 0079) and an elongated member having a first end and a second end opposite the first end (opposing ends of implant 40; Fig. 2A); and wherein the elongated member comprises titanium, polyetheretherketone (PEEK), polyurethane, bone, or a cured osteostimulative material (par. 0076 discloses titanium and PEEK).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orthopedic implant in Cao to include an elongated member is tapered at the second end such that a width of the second end is less than a width of the first end; a first channel positioned on a first side of the elongated member and extending from the first end to the second end; a second channel positioned on a second side of the elongated member and extending from the first end to the second end; wherein the first channel is recessed in the first side of the elongated member, and wherein the second channel is recessed in the second side of the elongated member; and one or more through holes connecting the first channel to the second channel; wherein the one or more through holes comprises a plurality of through holes and an elongated member having a first end and a second end opposite the first end and wherein the elongated member comprises titanium, polyetheretherketone (PEEK), polyurethane, bone, or a cured osteostimulative material, as taught and suggested by Bagga, for providing a biocompatible implant for treatment of damaged bone tissue near a joint allowing bone ingrowth (pars. 0003 and 0117 of Bagga).
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the materials as required since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.04.
Regarding claim 16, Cao discloses the claimed invention of claim 1; except for a method for securing an orthopedic implant to a bone, the method comprising: providing the orthopedic implant; removing a portion of the bone to create a cavity; and inserting the second end of the elongated member of the orthopedic implant into the cavity in the bone. However, Bagga teaches a similar orthopedic implant 40 (Fig. 2A and par. 0132 disclose a porous implant) and a method for securing an orthopedic implant to a bone (Figs. 7B-7F), the method comprising: providing the orthopedic implant (Fig. 2A); removing a portion of the bone to create a cavity (par. 0102); and inserting the second end of the elongated member of the orthopedic implant into the cavity in the bone (par. 0103 discloses employing the orthopedic implant in the bone 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orthopedic implant in Cao to include a method for securing an orthopedic implant to a bone, the method comprising: providing the orthopedic implant; removing a portion of the bone to create a cavity; and inserting the second end of the elongated member of the orthopedic implant into the cavity in the bone, as taught and suggested by Bagga, for providing a biocompatible implant for treatment of damaged bone tissue near a joint allowing bone ingrowth (pars. 0003 and 0117 of Bagga).
Regarding claims 19-20, Cao in view of Bagga discloses the claimed invention of claim 1; except for wherein the elongated member is substantially flat and wherein the one or more through holes connect the first channel to the second channel through the elongated member. However, Bagga teaches a similar orthopedic implant 100 (Fig. 3C) having an elongated member that is substantially flat (par. 0074 discloses the elongated body can be rectangular shape) and wherein the one or more through holes connect the first channel to the second channel through the elongated member (the through holes 54 fluidly connect channels 50 and extend through the walls of the elongated member; Fig. 2B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orthopedic implant in Cao to include wherein the elongated member is substantially flat and wherein the one or more through holes connect the first channel to the second channel through the elongated member, as taught and suggested by Bagga, for providing a biocompatible implant for treatment of damaged bone tissue near a joint allowing bone ingrowth (pars. 0003 and 0117 of Bagga).
Claims 2-7, 17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Cao et al. (2011/0117170) in view of Bagga et al. (2011/0125265) “Bagga” further in view of Morris et al. (2020/0353123) “Morris”.
Regarding claims 2-7 and 17, Cao in view of Bagga discloses the claimed invention of claim 1; except for the porous coating further includes KH2PO4 in an amount between about 20-70 dry weight percent, MgO in an amount between 10-50 dry weight percent, a calcium containing compound, and a poly-lactic acid; wherein the poly-lactic acid comprises one of Poly(L-lactic acid) PLA, poly(L, DL-lactide) PLDLA, and poly(L-lactide-co- glycolide) PLGA; wherein the porous coating further includes a bioactive therapeutic agent; wherein the bioactive therapeutic agent comprises one of amikacin, butirosin, dideoxykanamycin, fortimycin, gentamycin, kanamycin, lividomycin, neomycin, netilmicin, ribostamycin, sagamycin, seldomycin and epimers thereof, sisomycin, sorbistin, spectinomycin and tobramycin; wherein the porous coating further comprises a sugar, and wherein the sugar comprises one of sugar alcohols, sugar acids, amino sugars, sugar polymers glycosaminoglycans, glycolipds, sugar substitutes and combinations thereof; wherein a thickness of the porous coating on the exterior surface of the elongated member ranges from 200 um to 50 mm; applying an uncured osteostimulative material to an exterior surface of the elongated member; and applying an uncured osteostimulative material to an exterior surface of the elongated member .
However, Morris teaches a similar porous coated elongated orthopedic implant (Fig. 1 and par. 0030 discloses exterior surface 104 comprises a coating 106) comprising the porous coating further includes KH2PO4 in an amount between about 20-70 dry weight percent, MgO in an amount between 10-50 dry weight percent, a calcium containing compound, and a poly-lactic acid (par. 0030 discloses the coating 106 comprises KH2PO4 in an amount between about 20-70 dry weight percent, MgO in an amount between 10-50 dry weight percent, a calcium containing compound, and a poly-lactic acid); wherein the poly-lactic acid comprises one of Poly(L-lactic acid) PLA, poly(L, DL-lactide) PLDLA, and poly(L-lactide-co- glycolide) PLGA (par. 0031); wherein the porous coating further includes a bioactive therapeutic agent (par. 0037 discloses the bone screw 100 comprises a therapeutic agent); wherein the bioactive therapeutic agent comprises one of amikacin, butirosin, dideoxykanamycin, fortimycin, gentamycin, kanamycin, lividomycin, neomycin, netilmicin, ribostamycin, sagamycin, seldomycin and epimers thereof, sisomycin, sorbistin, spectinomycin and tobramycin (par. 0037); wherein the porous coating further comprises a sugar, and wherein the sugar comprises one of sugar alcohols, sugar acids, amino sugars, sugar polymers glycosaminoglycans, glycolipds, sugar substitutes and combinations thereof (par. 0057); wherein a thickness of the porous coating on the exterior surface of the elongated member ranges from 200 um to 50 um (par. 0032) and applying an uncured osteostimulative material to an exterior surface of the elongated member (par. 0030).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orthopedic implant in Cao to include the porous coating further includes KH2PO4 in an amount between about 20-70 dry weight percent, MgO in an amount between 10-50 dry weight percent, a calcium containing compound, and a poly-lactic acid; wherein the poly-lactic acid comprises one of Poly(L-lactic acid) PLA, poly(L, DL-lactide) PLDLA, and poly(L-lactide-co- glycolide) PLGA; wherein the porous coating further includes a bioactive therapeutic agent; wherein the bioactive therapeutic agent comprises one of amikacin, butirosin, dideoxykanamycin, fortimycin, gentamycin, kanamycin, lividomycin, neomycin, netilmicin, ribostamycin, sagamycin, seldomycin and epimers thereof, sisomycin, sorbistin, spectinomycin and tobramycin; wherein the porous coating further comprises a sugar, and wherein the sugar comprises one of sugar alcohols, sugar acids, amino sugars, sugar polymers glycosaminoglycans, glycolipds, sugar substitutes and combinations thereof and wherein a thickness of the porous coating on the exterior surface of the elongated member ranges from 200 um to 50 mm and and applying an uncured osteostimulative material to an exterior surface of the elongated member, as taught and suggested by Morris, for providing the implant with a cured osteostimulative material that allows for a secured attachment of the implant to the surrounding bone (par. 0011 of Morris) and to allow for biocompatibility.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the materials as required since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.04.
Regarding claim 21, Cao discloses an orthopedic implant (par. 0040 discloses a bone scaffold par. 0020 discloses surgical implant and par. 0128 discloses bone implants), comprising: a member having a first end and a second end opposite the first end (pars. 0020 and 0040 disclose a scaffold to repair bone which would obviously comprise a member body having opposing ends); and a porous coating secured to an exterior surface of the member (par. 0036 disclose the scaffold comprises a porous composition), wherein the porous coating includes magnesium phosphate (par. 0036 discloses the scaffold comprises a composition to induce pores where the pore forming composition is a coating comprising magnesium phosphate).
Cao is silent regarding an elongated member is substantially flat and is tapered at the second end such that a width of the second end is less than a width of the first end; a first channel positioned on a first side of the elongated member and extending from the first end to the second end; a second channel positioned on a second side of the elongated member and extending from the first end to the second end; wherein the first channel is recessed in the first side of the elongated member, and wherein the second channel is recessed in the second side of the elongated member; and one or more through holes connecting the first channel to the second channel through the elongated member; a porous coating secured to an exterior surface of the elongated member, wherein the porous coating includes H2PO4 in an amount between about 20-70 dry weight percent, MgO in an amount between 10-50 dry weight percent, a calcium containing compound, and a poly-lactic acid.
However, Bagga discloses a similar porous orthopedic implant 40 (Fig. 2A and par. 0132 disclose a porous implant) comprising an elongated member 46 is substantially flat (par. 0074 discloses rectangular shape) and is tapered at the second end such that a width of the second end is less than a width of the first end (tapered tip 48); a first channel 50 positioned on a first side of the elongated member and extending from the first end to the second end; a second channel 50 positioned on a second side of the elongated member and extending from the first end to the second end (Fig. 2A discloses flutes 50 on two sides); wherein the first channel is recessed in the first side of the elongated member, and wherein the second channel is recessed in the second side of the elongated member (flutes 50 are recessed; Fig. 2A and par. 0079) and one or more through holes 54 connecting the first channel to the second channel (the first and second channels comprise through holes 54 which fluidly connect the first and second channels; when a flowable material 70 is introduced into the canal 60, the material can flow from the pores 54 in the first channel to the pores 54 in the second channel; Fig. 2B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orthopedic implant in Cao to include an elongated member is substantially flat and is tapered at the second end such that a width of the second end is less than a width of the first end; a first channel positioned on a first side of the elongated member and extending from the first end to the second end; a second channel positioned on a second side of the elongated member and extending from the first end to the second end; wherein the first channel is recessed in the first side of the elongated member, and wherein the second channel is recessed in the second side of the elongated member; and one or more through holes connecting the first channel to the second channel through the elongated member; a porous coating secured to an exterior surface of the elongated member, as taught and suggested by Bagga, for providing a biocompatible implant for treatment of damaged bone tissue near a joint allowing bone ingrowth (pars. 0003 and 0117 of Bagga).
Furthermore, Morris teaches a similar porous coated elongated orthopedic implant (Fig. 1 and par. 0030 discloses exterior surface 104 comprises a coating 106) comprising the porous coating further includes KH2PO4 in an amount between about 20-70 dry weight percent, MgO in an amount between 10-50 dry weight percent, a calcium containing compound, and a poly-lactic acid (par. 0030 discloses the coating 106 comprises KH2PO4 in an amount between about 20-70 dry weight percent, MgO in an amount between 10-50 dry weight percent, a calcium containing compound, and a poly-lactic acid). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orthopedic implant in Cao in view of Bagga to include wherein the porous coating includes H2PO4 in an amount between about 20-70 dry weight percent, MgO in an amount between 10-50 dry weight percent, a calcium containing compound, and a poly-lactic acid, as taught and suggested by Morris, for providing the implant with a cured osteostimulative material that allows for a secured attachment of the implant to the surrounding bone (par. 0011 of Morris) and to allow for biocompatibility.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the materials as required since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.04.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Cao et al. (2011/0117170) in view of Bagga et al. (2011/0125265) “Bagga” further in view of Lv et al. (2020/0268930) “Lv”.
Cao in view of Bagga discloses the claimed invention of claim 1 including porous coating is formed of sintered layers that create a three-dimensional porous coating (par. 0124 discloses three-dimensional patterns and laser sintering to form the scaffold comprising the coating) and wherein the porous coating is formed via a chemical vapor deposition process (par. 0124 discloses vapor based bonding); except for wherein the porous coating comprises a powder with a particle size between 10 um and 200 um. However, Lv teaches a similar magnesium phosphate powder (abstract) comprising powder with a particle size between 10 um and 200 um (par. 0031 discloses particles in the powder having a size of 1-75 um and greater than 100 um). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orthopedic implant in Cao in view of Bagga to include wherein the porous coating comprises a powder with a particle size between 10 um and 200 um, as taught and suggested by Bagga, for enhancing the cell adhering and osteoinduction (par. 0011 of Lv).
Furthermore, Regarding claim 15, the claimed phrase “wherein the porous coating is formed via a chemical vapor deposition process” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Cao et al. (2011/0117170) in view of Bagga et al. (2011/0125265) “Bagga” further in view of Howell (6254605).
Cao in view of Bagga discloses the claimed invention of claim 1; except for further comprising: inserting a ligament in the cavity in the bone; and inserting the second end of the elongated member of the orthopedic implant into the cavity in the bone such that the elongated member fills a substantial portion of the cavity, wherein the ligament is securely fixed between the elongated member and an inner surface of the cavity in the bone. However, Howell teaches a similar method of inserting an orthopedic implant (Fig. 22) comprising inserting a ligament 52 in the cavity in the bone (Fig. 22); and inserting the second end of the elongated member of the orthopedic implant into the cavity 218 in the bone such that the elongated member fills a substantial portion of the cavity (Fig. 22 discloses inserting elongated member 280 into bone), wherein the ligament 52 is securely fixed between the elongated member 280 and an inner surface of the cavity 218 in the bone (Fig. 22).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orthopedic implant in Cao in view of Bagga to include inserting a ligament in the cavity in the bone; and inserting the second end of the elongated member of the orthopedic implant into the cavity in the bone such that the elongated member fills a substantial portion of the cavity, wherein the ligament is securely fixed between the elongated member and an inner surface of the cavity in the bone, as taught and suggested by Howell, for securely attaching a ligament into a joint cavity (abstract).
Conclusion
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 extension fee 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 comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri. If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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