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
Claims 1-22 are pending and examined below.
Response to Arguments
The remarks of 06/26/2025 have been fully considered but they are not persuasive.
Applicant argues that the prior art doesn't explicitly teach or disclose all of the elements of claim 1, in particular applicant argues the following claim language:
“a non-biodegradable implant for the replacement and regeneration of biological tissue in the shape of a plug comprising, in part, a base section configured for anchoring gin bone tissue and a top section configured for growing cartilage tissue onto and into”
Applicant argues that the prior art combination of Liljensten in view of Wiley is a biodegradeable implant because Liljensten is formed of a biodegradeable polycaprolactone-based polyurethaneurea.
However, the prior art implant of Liljensten in view of Wiley corresponds to a non-biodegradeable implant, as a whole, because the core base material disclosed in Wiley corresponds to a non-biodegradeable implant (¶0069, wherein “the triple network hydrogel may resist degradation and retain these mechanical and tribological properties over many cycles of deformation” corresponds to non-biodegradeable, see also Table 9, wherein the triple network hydrogel contains 2M – 6M of acrylamide, which is non-biodegradeable)
Therefore, claim 1 remains rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0164014 (Liljensten) in view of US 2021/0369915 A1 (Wiley).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 7-9, 11, 12, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0164014 (Liljensten) in view of US 2021/0369915 A1 (Wiley)
Regarding claim 1, Liljensten discloses a non-biodegradable implant for the replacement and regeneration of biological tissue in the shape of a plug (Fig. 1), comprising:
a base section (Fig. 1, bottom 3) configured for anchoring in bone tissue (see Fig. 4, wherein bottom 3 is anchored in bone),
a middle section (Fig. 1, barrier 4) configured for replacing cartilage tissue of an intermediate and deep zone of a cartilage layer (¶0043, wherein barrier 4 is configured for this intended use) and having a thickness of at least 0.2 mm (see claims 17, wherein the thickness of the barrier is 50µm -300µm which converts to 0.05mm – 0.3mm which overlaps the claimed range) and
a top section (Fig. 1, top 2) configured for growing cartilage tissue onto and into (¶0043, wherein 2 is configured for this intended use because it is porous), thus regenerating a superficial zone of the cartilage layer (¶0043, wherein 2 is configured for this intended use because it is porous),
wherein the middle (Fig. 1, 4) and top section (Fig. 1, 2) comprise the same non-biodegradable thermoplastic elastomeric material (¶0043 wherein polyurethane urea corresponds to a thermoplastic elastomeric material), which is porous in the top section (¶0043, wherein 90% porosity corresponds to porous),
wherein the thermoplastic elastomeric material comprises a linear block copolymer comprising urethane and urea groups (¶0043, wherein polyurethane urea corresponds to a linear block copolymer comprising urethane and urea groups), and wherein the base section material comprises one of a biocompatible metal, mineral, and a non-biodegradable polymer, and combinations thereof (¶0025, wherein titanium corresponds to a biocompatible metal), and is substantially free of an added peptide compound having cartilage regenerative properties (¶0043, wherein the polyurethane urea doesn’t require an added peptide compound).
Liljensten doesn't explicitly teach or disclose a non-porous middle section or a circumferential shell of porous base section material.
Wiley discloses an implant (Figs. 11 – 12) wherein the base section comprises a core of non-porous base section material (¶0076, wherein “solid gel core” corresponds to non-porous base section material) and a circumferential shell of porous base section material (¶0076, wherein the “porous shell of gel” corresponds to the shell of porous base section material), wherein a cross-sectional area of the circumferential shell covers at most 35% of a largest cross-sectional area of the base section (¶0077, wherein the 0.4mm thick corresponds to at most 35% of a largest cross-sectional area of the base section).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the base section of Liljensten with a core of non-porous material and a thin porous shell, as taught by Wiley, in order to improve integration into surrounding bone and cartilage (Wiley, ¶0076)
Regarding claim 2, Liljensten discloses wherein the thermoplastic elastomeric material (¶0043 wherein polyurethane urea corresponds to a thermoplastic elastomeric material) further comprises carbonate groups (¶0019, wherein poly(glycolide-co-trimethylene carbonate) corresponds to a carbonate group).
Regarding claim 7, Liljensten discloses a base section (see rejection of claim 1) with a largest diameter of 20mm (see ¶0023). Liljensten doesn't explicitly teach or disclose a non-porous core and a porous circumferential shell with a thickness less than 10% of the largest diameter of the base section.
Wiley discloses an implant (Figs. 11-12) wherein the base section comprising the core of non-porous base section material (¶0076, wherein “solid gel core” corresponds to non-porous base section material) and the circumferential shell of porous base section material, is characterized in that the shell has a thickness that is less than 10% of a largest diameter of the base section (¶0077, wherein the shell can be as thin as 0.4mm thick – which corresponds to less than 10% of the largest diameter of 20mm taught by Liljensten)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the base section of Liljensten with a thin porous shell, as taught by Wiley, in order to maintain the majority of the strength of elastic modulus of the implant (Wiley, ¶0077).
Regarding claim 8, Liljensten discloses a base section (Fig. 1, base section 3) comprising a biocompatible elastomeric material (¶0043, “resilient biocompatible polyurethane urea”) which extends between a top surface and a bottom surface (see Fig. 1) with a largest height of 20mm (¶0016). Liljensten but doesn't explicitly teach or disclose that the base section comprises a porous layer that has a thickness that is less than 10% of a largest height of the base section.
Wiley discloses an implant which comprises a layer of porous base section material (¶0076, wherein the “porous shell of gel” corresponds to the shell of porous base section material), wherein the layer is adjacent to the top surface (See Fig. 11D, wherein the coating is adjacent to top layer) and has a thickness that is less than 10% of a largest height of the base section (¶0077, wherein the shell can be as thin as 0.4mm thick – which corresponds to less than 10% of the largest height of 20mm taught by Liljensten),
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the biocompatible elastomeric base section of Liljensten with a porous layer that is less than 10% of the largest height of the base section, as taught by Wiley, in order to maintain the majority of the strength of elastic modulus of the implant (Wiley, ¶0077).
Regarding claim 9, Liljensten discloses wherein the base section (Fig. 1, 3) material comprises a metal, selected from titanium, zirconium, chromium, aluminum, stainless steel, hafnium, tantalum or molybdenum, and their alloys, or any combination thereof (¶0025, “titanium)
Regarding claim 11, Liljensten discloses wherein the base section (Fig.1 , 3) material comprises a (hydrogel) polymer, selected from collagen, poly(lactic-co- glycolic acid) (PLGA), polylactic acid (PLA), polycaprolactone (PCL), polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), polyacrylamide, polyurethane, polyethylene glycol (PEG), chitin, poly(hydroxyalkyl methacrylate), water- swellable N-vinyl lactams, starch graft copolymers, and derivatives and combinations thereof (¶0019, wherein “poly(L-lactic acid) and its co-polymers and D-lactic acid and/or glycolic acid” corresponds to PLGA).
Regarding claim 12, Liljensten discloses wherein the base section material comprises a non-hydrogel polymer (¶0043, wherein polyurethane urea material corresponds to a non-hydrogel polymer).
Regarding claim 22, Liljensten discloses a base section (Fig. 1, 3) wherein the base section material comprises a reinforcing material (Fig. 6, 705, ¶0046) selected from the group consisting of fibrous or particulate polymers and/or metals (¶0024, “particulate and/or fibrous stiffening agent).
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0164014 (Liljensten) in view of US 2021/0369915 A1 (Wiley), as applied to claims above, and further in view of US 2005/0013793 (Beckman)
Regarding claim 3, Liljensten discloses a thermoplastic elastomeric material (see rejection of Claim 1) but doesn’t explicitly teach or disclose poly-urethane-bisurea- alkylenecarbonate. Wiley but doesn't explicitly teach or disclose poly-urethane-bisurea- alkylenecarbonate.
Beckman discloses wherein the thermoplastic elastomeric material comprises a poly-urethane-bisurea- alkylenecarbonate (¶0174, wherein the polyurethane has soft segments connected by urea linkages, see also 0174, “urea linkages”, see also ¶0044, wherein the poyol compound can be a polycarbonate)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the thermoplastic elastomeric material of Liljensten in view of Wiley to be poly-urethane-bisurea- alkylenecarbonate, as taught by Beckman, in order to match the properties of natural tissue (¶Beckman, ¶0005).
Regarding claim 4, Liljensten discloses a thermoplastic elastomeric material (¶0043, “polyurethane urea”) but doesn't explicitly teach or disclose that the material is aliphatic. Wiley doesn't explicitly teach or disclose that the material is aliphatic.
Beckman discloses a thermoplastic elastomeric material (¶0128, “polyurethane”) is aliphatic (¶0128, wherein the polyurethane is formed of aliphatic polyisocyanates and is therefore an aliphatic material).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the thermoplastic elastomeric material of Liljensten in view of Wiley to be aliphatic, as taught by Beckman, in order to form a material with mechanical integrity for a sufficient period of time to allow the ingrowth of tissue necessary for bone formation (Backman, ¶0006).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0164014 (Liljensten) in view of US 2021/0369915 A1 (Wiley), as applied to claims above, and further in view of US 2014/0222149 (Amis)
Regarding claim 5, Liljensten discloses a middle section formed of an elastomeric material (see rejection of claim 1) but doesn’t explicitly teach or disclose a specific modulus of elasticity at room temperature. Wiley but doesn't explicitly teach or disclose a specific modulus of elasticity at room temperature
Amis discloses an implant device (Fig. 1, 10) wherein the elastomeric material (¶0134, “silicone/polyurethane elastomer”) has an elastic modulus at room temperature of less than 10 MPa (¶0134, wherein elastic modulus below around 10Mpa corresponds to an elastic modulus at room temperature of less than 10MPa).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the middle layer of Liljensten in view of Wiley to have a modulus of elasticity of less than 10 MPa at room temperature, as taught by Amis, in order to replace the mechanical properties of human tissue.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0164014 (Liljensten) in view of US 2021/0369915 A1 (Wiley), as applied to claims above, and further in view of US 2001/0051833 (Walter)
Regarding claim 6, Liljensten discloses a porous elastomeric top section and a middle section that are formed of polyurethane urea (see rejection of claim 1). Liljensten doesn't explicitly teach or disclose the top section has an elastic modulus at room temperature of less than 80% of the elastic modulus of the elastomeric material of the middle section. Wiley doesn't explicitly teach or disclose a top section that has an elastic modulus at room temperature of less than 80% of the elastic modulus of the elastomeric material of the middle section.
Walter discloses wherein the porous elastomeric material of the top section has an elastic modulus at room temperature of less than 80% of the elastic (¶wherein “the elastic modulus of the top section is less than 1Mpa” corresponds to less than 80% of the middle section”) modulus of the elastomeric material of the middle section.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the top section of Liljensten in view of Wiley to be less than 80% of the middle section as taught by Walter, in order to provide an implant with mechanical properties similar to those of the tissue into which it is placed (Walter, ¶0009).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0164014 (Liljensten) in view of US 2021/0369915 A1 (Wiley), as applied to claims above, and further in view of US 2014/0324169 (Maher)
Regarding claim 10, Liljensten a base section (see rejection of claim 1) but doesn’t explicitly teach or disclose a ceramic or mineral, selected from oxides, nitrides, carbides and borides, or any combination thereof. Wiley doesn't explicitly teach or disclose a ceramic or mineral, selected from oxides, nitrides, carbides and borides, or any combination thereof.
Maher discloses an implant (Fig. 1) comprising a base section (¶0110, “rigid base”) material further comprising a ceramic or mineral, selected from oxides, nitrides, carbides and borides, or any combination thereof (¶0110, wherein sodium oxide corresponds to a ceramic from the claimed group)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the base section of Liljensten in view of Wiley with sodium oxide, as taught by Maher, in order to strength the implant to carry load in the site of the injury of defect (Maher, ¶0124)
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0164014 (Liljensten) in view of US 2021/0369915 A1 (Wiley), as applied to claims above, and further in view of US 2009/0228106 (Strzepa)
Regarding 13, Liljensten disclose a base section (see rejection of claim 1) but doesn't explicitly teach or disclose a substantially non-porous polyaryletherketone polymer with a porosity of less than 20 %, relative to the total volume of the polyaryletherketone polymer. Wiley doesn't explicitly teach or disclose a substantially non-porous polyaryletherketone polymer with a porosity of less than 20 %, relative to the total volume of the polyaryletherketone polymer.
Strzepa discloses comprising a substantially non-porous polyaryletherketone polymer with a porosity of less than 20 %, relative to the total volume of the polyaryletherketone polymer (¶0051, wherein PEKK corresponds to a non-porous polyaryletherketone polymer).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the base section of Liljensten in view of Wiley with a substantially non-porous polyaryletherketone polymer, as taught by Strzepa, in order to produce an implant with high strength, chemical resistance, and dimensional stability.
Regarding claim 14, Liljensten discloses a base section (see rejection of claim 1) but doesn't explicitly teach or disclose a non-porous polyaryletherketone polymer. Wiley but doesn't explicitly teach or disclose a non-porous polyaryletherketone polymer.
Strzepa discloses an implant (Fig. 1, 100) wherein the base section comprises a non-porous polyaryletherketone polymer (¶0051, wherein PEKK corresponds to a non-porous polyaryletherketone polymer)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the base section of Liljensten in view of Wiley with a non-porous polyaryletherketone polymer, as taught by Strzepa, in order to produce an implant with high strength, chemical resistance, and dimensional stability.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0164014 (Liljensten) in view of US 2021/0369915 A1 (Wiley), as applied to claims above, and further in view of US 2011/0093073 (Gatt)
Regarding claim 15, Liljensten discloses an implant (see rejection of claim 1) but doesn't explicitly teach or disclose a contrast or radiopharmaceutical agent. Wiley but doesn't explicitly teach or disclose a contrast or radiopharmaceutical agent.
Gatt discloses an implant (Fig. 1) further comprising a contrast or radiopharmaceutical agent (¶0067, “MRI contrast agents”) or body for medical imaging (¶0067, wherein the agent is configured for this intended use because it can aid in visualization under ultrasound, fluoroscopy and/or MRI)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Liljensten in view of Wiley with a contrast agent, as taught by Gatt, in order to aid in visualization under medical imaging such as ultrasound, fluoroscopy, or MRI (Gatt, ¶0067)
Claim(s) 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0164014 (Liljensten) in view of US 2021/0369915 A1 (Wiley), as applied to claims above, and further in view of US 2004/0266000 (Offermann)
Regarding claim 16, Liljensten discloses a base section (see rejection of claim 1) but doesn't explicitly teach or disclose that the top surface has irregularities or undulations. Wiley doesn't explicitly teach or disclose irregularities or undulations.
Offermann discloses a plug shaped scaffold (Fig. 7) wherein the base section (¶0018, “base material”) comprises a top surface having irregularities or undulations (¶0018, wherein a wavy form corresponds to undulations)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the base section of Liljensten in view of Wiley to have undulations on the top surface, as taught by Offermann, in order to increase surface area and promote adhesion after implantation.
Regarding claim 18, Liljensten discloses a base section (see rejection of claim 1) but doesn't explicitly teach or disclose that the outer surface has irregularities or undulations. Wiley doesn't explicitly teach or disclose an outer surface with irregularities or undulations
Offermann discloses a plug shaped scaffold (Fig. 7) wherein the base section (¶0018, “base material”) comprises an outer surface having irregularities or undulations (¶0018, wherein a wavy form corresponds to undulations)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the base section of Liljensten in view of Wiley to have undulations on the outer surface, as taught by Offermann, in order to increase surface area and promote adhesion after implantation.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0164014 (Liljensten) in view of US 2021/0369915 A1 (Wiley), as applied to claims above, and further in view of US 2021/0361435 (Zhang)
Regarding claim 17, Liljensten disclose a base section and a thermoplastic elastomeric material (see rejection of claim 1) but doesn't explicitly teach or disclose a centrally located cavity. Wiley doesn't explicitly teach or disclose a centrally located cavity.
Zhang discloses a base section (Fig. 1, base 10) with a centrally located cavity (Fig. 2, 20) that comprises elastomeric material (¶0034, wherein polyurethane corresponds to an elastomeric material).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the base section of Liljensten in view of Wiley with a cavity comprised of elastomeric material, as taught by Zhang, in order to create space for tissue and bone integration.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0164014 (Liljensten) in view of US 2021/0369915 A1 (Wiley), as applied to claims above, and further in view of US 2019/0290440 (Karl)
Regarding claim 19, Liljensten discloses a base section, a middle section, and a top section (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the implant is configured to be implanted in an osteochondral structure such that a top surface of the implant comes to lie below a top surface of cartilage present on a osteochondral structure when implanted.
Wiley discloses wherein the implant is configured to be implanted in an osteochondral structure (¶0067, wherein “to fill osteochondral defects” corresponds to configured to be implanted in an osteochondral structure)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the implant of Liljensten to be implanted in an osteochondral structure, as taught by Wiley, in order to prevent degenerative joint changes (¶0067)
Liljensten doesn't explicitly teach or disclose the top surface of the implant comes to lie below a top surface of cartilage. Wiley doesn't explicitly teach or disclose doesn't explicitly teach or disclose the top surface of the implant comes to lie below a top surface of cartilage.
Karl discloses an implant (Fig. 1, 1, ¶0037) wherein the top surface of the implant comes to lie below a top surface of cartilage present on a osteochondral structure when implanted (¶0037, wherein “the top surface of the joint implant lies below the surface of the bone or cartilage” corresponds to the top surface of the implant comes to lie below a top surface of cartilage present on a osteochondral structure when implanted)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the implant of Liljensten in view of Wiley to lie below a top surface of cartilage when implanted, as taught by Karl, in order to promote new tissue formation (Karl, ¶0037).
Regarding claim 20, Liljensten discloses an implant with a middle section (see rejection of claim 1) but doesn't explicitly teach or disclose that the implant is configured to be implanted in an osteochondral structure.
Wiley discloses wherein the implant is configured to be implanted in an osteochondral structure (¶0067, wherein “to fill osteochondral defects” corresponds to configured to be implanted in an osteochondral structure)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the implant of Liljensten to be implanted in an osteochondral structure, as taught by Wiley, in order to prevent degenerative joint changes (¶0067)
Liljensten discloses an implant (see rejection of claim 1) but doesn’t explicitly teach or disclose the bottom surface of the middle section comes to lie about level with a bottom surface of cartilage present on a osteochondral structure when implanted. Wiley doesn’t explicitly teach or disclose a bottom surface of the middle section comes to lie about level with a bottom surface of cartilage present on a osteochondral structure when implanted.
Karl discloses wherein a height of the base section, a height of the non-porous middle section, and a height of the porous top section are selected such that a bottom surface of the middle section comes to lie about level with a bottom surface of cartilage present on an osteochondral structure when implanted (see Fig. 4 provided below, wherein the bottom surface of the cartilage section of a femoral head is annotated with a broken line and comes to lie about level with the middle section of the cavities for the implant)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to align the middle section of Liljensten in view of Wiley with the cartilage layer, as taught by Karl, in order to promote new tissue formation (Karl, ¶0037)
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0164014 (Liljensten) in view of US 2021/0369915 A1 (Wiley), as applied to claims above, and further in view of US 2007/0185585 (Bracy)
Regarding claim 21, Liljensten discloses a top section (Fig. 1, top 2) but doesn’t explicitly teach or disclose that it has a slightly curved top surface, having a radius of curvature in a sagittal and/or medial-lateral plane ranging from 15 mm to 150 mm. Wiley doesn't explicitly teach or disclose a radius of curvature in a sagittal and/or medial-lateral plane ranging from 15 mm to 150 mm.
Bracy discloses an implant for biological tissue (Fig. 10, 200) comprising a top section (Fig. 10, 210) with a slightly curved top surface, having a radius of curvature in a sagittal and/or medial-lateral plane ranging from 15 mm to 150 mm (¶0086, wherein the radius of curvature of 210 is about 0.973 inches or about 25mm, which falls within the claimed range)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the top section of Liljensten in view of Wiley to have a slightly curved top, as taught by Bracy, in order to provide better bonding to the recipient site.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774