DETAILED ACTION
RESPONSE TO AMENDMENT
1. Receipt of Applicants’ amendments and arguments/remarks filed 3/23/2026 are acknowledged.
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 3/23/2026 has been entered.
INFORMATION DISCLOSURE STATEMENT
2. No new Information Disclosure Statement has been submitted for review.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections- 35 USC § 103
4. 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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 is rejected under 35 U.S.C. 103 as being unpatentable over Guire (US Patent 4,973,493) in view of Morra et al. “Surface engineering of titanium by collagen immobilization. Surface characterization and in vitro and in vivo studies”, Guilak et al. (US 2007/0041952), Gronowitz et al. “A Comparative Study of Osteoblast Response to PEEK or Titanium used in Dental Implants”, Becker et al. “Covalent Grafting of the RGD-Peptide onto Polyetherketone Surfaces via Schiff Base Formation”, Chen et al. “Comparison of titanium and polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical spondylotic myelopathy: a prospective, randomized, control study with over 7-year follow-up” Lo et al. “Mineralization of osteoblasts with electrospun collagen/hydroxyapatite nanofibers”, Dubrow et al. (US 20060204738), and Safronova et al. “Ceramics Based on Hydroxyapatite Synthesized from Calcium Chloride and Potassium Hydrophopshate”.
Guire (US Patent 4,973,493) (hereinafter Guire) disclose a method of modifying the solid surface to improve its biocompatibility where the solid surface has a covalently linked biocompatible agent (abstract). A biocompatible agent is covalently linked to the solid surface of a biomaterial to provide that surface with substantially the same biocompatible characteristics that are possessed by the biocompatible agent (col. lines 60-65). The surface may be any suitable metal such as titanium and the devices include those such as soft or hard tissues prosthesis (e.g., bone) (col. 4, lines 27-29 and col. 4, lines 44-45). The biocompatible agent can include collagen (col. 4, line 67). Morra et al. “Surface engineering of titanium by collagen immobilization. Surface characterization and in vitro and in vivo studies” (hereinafter Morra et al.) disclose bone implants and collagen covalently bound to the surface of titanium (abstract). This kind of surface modification could accelerate the time to loading of load bearing, bone contacting devices (conclusion). Thus, one of ordinary skill in the art would clearly envisage using the implants of Guire for bone implants (soft and hard tissue prosthesis). The reactive groups include maleimides. Example 4 artificial “hip joints” thus the compositions are clearly contemplated for bone implants.
Guilak et al. (US 2007/0041952) (hereinafter Guilak et al.) discloses implants that can have materials such as collagen or gelatin immobilized to surfaces that include PEEK, titanium, and combinations (para 0107 and 0144).
As shown by Gronowitz et al. “A Comparative Study of Osteoblast Response to PEEK or Titanium used in Dental Implants” discloses PEEK as an alternative to metals such as titanium. PEEK confers many beneficial properties such as X-ray compatibility and versatility. The reference also states “PEEK is often used in spinal fusion cages and orthopedic applications” (background). PEEK is comparable to that of titanium commonly used in dental implants. Furthermore, Becker et al. “Covalent Grafting of the RGD-Peptide onto Polyetherketone Surfaces via Schiff Base Formation” discloses as a possible substitute for titanium, PEEK matches more closely the mechanical properties of bone. Chen et al. “Comparison of titanium and polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical spondylotic myelopathy: a prospective, randomized, control study with over 7-year follow-up” disclose in surgical treatment of multilevel CSM, PEEK cage is superior to titanium cage in maintenance of intervertebral height and vertical lordosis, resulting in better clinical outcomes in the long-term-follow up. Thus, PEEK is cervical sponoylic myelopathy (CSM) has been shown to be advantages. It would have been prima facie obvious to one of ordinary skill before the effective filing date to further include PEEK as such materials are non-absorbable for use in the bone implants promoting tissue restoration. One would have had a reasonable expectation of success because both Guire, Morra and Guilak are drawn to collagen containing metal implants and Guilak disclose PEEK or titanium may be used where and Gronowitz, Becker and Chen et al. all recognize PEEK as being a suitable substitute for titanium not just for the fact that it matches more closely the mechanical.
Guire does not disclose calcium phosphate however, Lo et al. “Mineralization of osteoblasts with electrospun collagen/hydroxyapatite nanofibers” (hereinafter Low et al.) disclose a composite matrix with collagen containing hydroxyapatite (e.g., calcium phosphate). Such composite matrix, when including osteoblast cells, showed better osteoconductive properties in comparison to monolithic hydroxyapatite (HA). The crystalline HA was loaded into the collagen nanofibers and embedded within the nanofibrous matrix of the scaffolds (see results). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include hydroxyapatite (calcium phosphate) embedded within the collagen matrix. One would have been motivated do so for the purpose of providing better osteoconductive properties and promoting osteogenesis and mineralization of bone.
The modified Guire et al. has been disclosed supra and the combination discloses linkages such as carbodiimide but does not disclose a linker selected from the group consisting of dicarboxylic acid linker, a maleimide linker, and a hexamethylene diisocyanate linker.
Dubrow et al. (US 20060204738) (hereinafter Dubrow et al.) disclose coatings can be coupled via linker binding groups with linking agents such as maleimides or propylcarbodiimides (para 0117). Bone implants are disclosed (para 0021). Furthermore, the crosslinkers are disclose in the context of other devices (para 0185, 0192, 0204 and 0221). Paragraph 0221 disclose implants with these crosslinkers which include orthopedic. Thus it is clear from the teachings that the crosslinkers are applicable to all the implants disclosed which are inclusive of bone implants (orthopedic). Absent any evidence of unexpected results or criticality, one of ordinary skill in the art would know to use the suitable crosslinker which are inclusive of maleimides and carbodiimides.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute one known linker the carbodiimide for another with a reasonable expectation of success of directly linking the coating composition. Absent, any evidence of criticality, it is prima facie obvious to substitute one linker for another to achieve crosslinking.
Safronova et al. “Ceramics Based on Hydroxyapatite Synthesized from Calcium Chloride and Potassium Hydrophopshate” discloses ceramics based on hydroxyapatite synthesized from calcium chloride and potassium hydrophosphate and the formation of HAP-based ceramic with a uniform microstructure and grain size of less than 1 µm is possible because of the low formation temperature and surface activity of the melt whose main component is KCl. Various chemical and physical processes occur in the powder material consisting of HAP and secondary product of the reaction predominantly containing KCl. The bulk density is 0.4 g/cm3 and the maximum particle aggregate did not exceed 100 µm. Therefore, the reference discloses this is a process that obtains HAP. Absent any evidence of criticality, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the known process to create hydroxyapatite.
6. Claim 1 is are rejected under 35 U.S.C. 103 as being unpatentable over S. Munisamy et al. “A Bone-like Strategy for Implants: Collagen Immobilization and its Mineralization on Pure Titanium Implant Surface” Guilak et al. (US 2007/0041952), Gronowitz et al. “A Comparative Study of Osteoblast Response to PEEK or Titanium used in Dental Implants”, Becker et al. “Covalent Grafting of the RGD-Peptide onto Polyetherketone Surfaces via Schiff Base Formation”, Chen et al. “Comparison of titanium and polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical spondylotic myelopathy: a prospective, randomized, control study with over 7-year follow-up”, Vanderleyden et al. “Comparative Study of Collagen and Gelatin coatings on Titanium Surfaces”, Ao et al. “Improved hMSC functions on titanium coatings by type I collagen immobilization” and Dubrow et al. (US 20060204738) and Safronova et al. “Ceramics Based on Hydroxyapatite Synthesized from Calcium Chloride and Potassium Hydrophopshate” .
S. Munisamy et al. “A Bone-like Strategy for Implants: Collagen Immobilization and its Mineralization on Pure Titanium Implant Surface” (hereinafter Munisamy et al.) disclose bone implants comprising a titanium surface where an immobilized collagen layer is applied (abstract). A mineralization of the collagen layer with a calcium chloride solution containing polyvinyl phosphoric acid and polyaspartic acid leads to the precipitation of calcium phosphate (abstract). Calcium phosphate is deposited on the collagen scaffold and the X-ray diffraction peaks closely resemble hydroxyapatite. Munisamy et al. does not disclose the surface is polyetheretherketone (PEEK).
Guilak et al. (US 2007/0041952) (hereinafter Guilak et al.) discloses implants that can have materials such as collagen or gelatin immobilized to surfaces that include PEEK, titanium, and combinations (para 0107 and 0144).
As shown by Gronowitz et al. “A Comparative Study of Osteoblast Response to PEEK or Titanium used in Dental Implants” discloses PEEK as an alternative to metals such as titanium. PEEK confers many beneficial properties such as X-ray compatibility and versatility. The reference also states “PEEK is often used in spinal fusion cages and orthopedic applications” (background). PEEK is comparable to that of titanium commonly used in dental implants. Furthermore, Becker et al. “Covalent Grafting of the RGD-Peptide onto Polyetherketone Surfaces via Schiff Base Formation” discloses as a possible substitute for titanium, PEEK matches more closely the mechanical properties of bone. Chen et al. “Comparison of titanium and polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical spondylotic myelopathy: a prospective, randomized, control study with over 7-year follow-up” disclose in surgical treatment of multilevel CSM, PEEK cage is superior to titanium cage in maintenance of intervertebral height and vertical lordosis, resulting in better clinical outcomes in the long-term-follow up. Thus, PEEK is cervical sponoylic myelopathy (CSM) has been shown to be advantages. It would have been prima facie obvious to one of ordinary skill before the effective filing date to further include PEEK as such materials are non-absorbable for use in bone implants for promoting tissue restoration. One would have had a reasonable expectation of success because both Guilak and Munisamy et al. are drawn to collagen containing metal implants and Guilak disclose PEEK or titanium may be used where and Gronowitz, Becker and Chen et al. all recognize PEEK as being a suitable substitute for titanium not just for the fact that it matches more closely the mechanical properties of bone but also because it has been shown to be superior for CSM.
It is believed that “chemical” modification such that it is immobilized meets the limitation of reading on having a covalent linkage however, Ao et al. “Improved hMSC functions on titanium coatings by type I collagen immobilization” (hereinafter Ao et al.) discloses collagen fixed onto plasma-sprayed porous titanium coatings by either absorptive immobilization of covalent immobilization and it was found that type I immobilized on titanium coating led to enhance cell-material interactions and improved human mesenchymal stem cells (hMSCs) functions, such as attachment, proliferation, and differentiation. Covalently immobilized collagen on titanium coating showed a greater capacity to regulate osteogenic activity of hMSCs than did absorbed collagen, which was explained in terms of the increased amount and higher stability of the covalently linked collagen (see abstract). Vanderleyden et al. “Comparative Study of Collagen and Gelatin coatings on Titanium Surfaces” discloses that covalent immobilization of collagen and gelatin is required to obtain stable surface coatings. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to covalently immobilize the biomolecule (collagen or gelatin) onto the metal (PEEK). One would have been motivated to do so for the purpose of regulating osteogenic activity.
The modified Munisamy et al. has been disclosed supra and the combination discloses linkages via carbodiimide but does not disclose a linker selected from the group consisting of dicarboxylic acid linker, a maleimide linker, and a hexamethylene diisocyanate linker.
Dubrow et al. (US 20060204738) (hereinafter Dubrow et al.) disclose coatings can be coupled via linker binding groups with linking agents such as maleimides or propylcarbodiimides (para 0117). Dubrow et al. disclose bone implants (para 0021). Furthermore, the crosslinkers are disclose in the context of other devices (para 0185, 0192, 0204 and 0221). Paragraph 0221 disclose implants with these crosslinkers which include orthopedic. Thus it is clear from the teachings that the crosslinkers are applicable to all the implants disclosed which are inclusive of bone implants (orthopedic). Absent any evidence of unexpected results or criticality, one of ordinary skill in the art would know to use the suitable crosslinker which are inclusive of maleimides and carbodiimides.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute one known linker the carbodiimide for another with a reasonable expectation of success of directly linking the coating composition. Absent, any evidence of criticality, it is prima facie obvious to substitute one linker for another to achieve crosslinking.
Safronova et al. “Ceramics Based on Hydroxyapatite Synthesized from Calcium Chloride and Potassium Hydrophopshate” discloses ceramics based on hydroxyapatite synthesized from calcium chloride and potassium hydrophosphate and the formation of HAP-based ceramic with a uniform microstructure and grain size of less than 1 µm is possible because of the low formation temperature and surface activity of the melt whose main component is KCl. Various chemical and physical processes occur in the powder material consisting of HAP and secondary product of the reaction predominantly containing KCl. The bulk density is 0.4 g/cm3 and the maximum particle aggregate did not exceed 100 µm. Therefore, the reference discloses this is a process that obtains HAP. Absent any evidence of criticality, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the known process to create hydroxyapatite.
7. Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Guire (US Patent 4,973,493) in view of Morra et al. “Surface engineering of titanium by collagen immobilization. Surface characterization and in vitro and in vivo studies”, Guilak et al. (US 2007/0041952), Gronowitz et al. “A Comparative Study of Osteoblast Response to PEEK or Titanium used in Dental Implants”, Becker et al. “Covalent Grafting of the RGD-Peptide onto Polyetherketone Surfaces via Schiff Base Formation”, Chen et al. “Comparison of titanium and polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical spondylotic myelopathy: a prospective, randomized, control study with over 7-year follow-up” Lo et al. “Mineralization of osteoblasts with electrospun collagen/hydroxyapatite nanofibers” and Dubrow et al. (US 20060204738), Safronova et al. “Ceramics Based on Hydroxyapatite Synthesized from Calcium Chloride and Potassium Hydrophopshate” as applied to claim 1 above, and further in view of Khoury et al. (US 2010/0227523).
The modified Guire et al. has been discussed supra and does not disclose oxidic ceramic. Khoury et al. (US 2010/0227523) (hereinafter Khoury et al.) disclose medical objects intended for implant into the body may be fabricated from a variety of materials including various metals, metal alloys, plastic or polymer or co-polymer materials, solid resin materials, glass and glassy materials, biological materials, silk and other natural fibers and other materials that may be suitable for the application and that are appropriately biocompatible. As example, certain stainless steel alloys, titanium and titanium alloys, zirconium, zirconium alloys, and various ceramics including alumina (e.g. aluminum oxide) and zirconia (zirconium dioxide) ceramics are employed. (para 0007). The implants may be for example dental implants or joint prosthesis (i.e., a bone implants). Khoury et al. disclose titania which includes oxides and ceramic forms (para 0005).
It would have been prima facie obvious to one of ordinary skill in the art to have the body structure of the device be formed of ceramic materials such as oxides (e.g., zirconia or alumina, titania) in view of Khoury et al. that discloses that medical devices may be formed of these in order to have a surface that has increased ability to attract and host the growth, attachment and proliferation of living biological cells (para 0004). One would have a reasonable expectation of success because both Guire and Khoury et al. are directed to body structures of medical devices that may contain materials that may be metal or ceramics and Khoury et al. disclose that such ceramics may be oxides (e.g., alumina).
8. Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over
Munisamy et al. “A Bone-like Strategy for Implants: Collagen Immobilization and its Mineralization on Pure Titanium Implant Surface” Guilak et al. (US 2007/0041952), Gronowitz et al. “A Comparative Study of Osteoblast Response to PEEK or Titanium used in Dental Implants”, Becker et al. “Covalent Grafting of the RGD-Peptide onto Polyetherketone Surfaces via Schiff Base Formation”, Chen et al. “Comparison of titanium and polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical spondylotic myelopathy: a prospective, randomized, control study with over 7-year follow-up”, Vanderleyden et al. “Comparative Study of Collagen and Gelatin coatings on Titanium Surfaces”, Ao et al. “Improved hMSC functions on titanium coatings by type I collagen immobilization”, Dubrow et al. (US 20060204738) and Safronova et al. “Ceramics Based on Hydroxyapatite Synthesized from Calcium Chloride and Potassium Hydrophopshate”, as applied to claim 1 above, and further in view of Khoury et al. (US 2010/0227523).
as applied to claim 1 above, and further in view of Khoury et al. (US 2010/0227523).
The modified Munisamy et al. has been discussed supra and does not disclose oxidic ceramic. Khoury et al. (US 2010/0227523) (hereinafter Khoury et al.) disclose medical objects intended for implant into the body may be fabricated from a variety of materials including various metals, metal alloys, plastic or polymer or co-polymer materials, solid resin materials, glass and glassy materials, biological materials, silk and other natural fibers and other materials that may be suitable for the application and that are appropriately biocompatible. As example, certain stainless steel alloys, titanium and titanium alloys, zirconium, zirconium alloys, and various ceramics including alumina (e.g. aluminum oxide) and zirconia (zirconium dioxide) ceramics are employed. (para 0007). The implants may be for example dental implants or joint prosthesis (i.e., a bone implants). Khoury et al. disclose titania which includes oxides and ceramic forms (para 0005).
It would have been prima facie obvious to one of ordinary skill in the art to have the body structure of the device be formed of ceramic materials such as oxides (e.g., zirconia or alumina or titania) in view of Khoury et al. that discloses that medical devices may be formed of these in order to have a surface that has increased ability to attract and host the growth, attachment and proliferation of living biological cells (para 0004). One would have a reasonable expectation of success because both Munisamy and Khoury et al. are directed to body structures of medical devices that may contain materials that may be metal or ceramic and Khoury et al. disclose that such ceramics may be oxides (e.g., alumina).
RESPONSE TO ARGUMENTS
9. The Examiner maintains the previous arguments of record. With regards to the new claim limitations, this is addressed by the Safronova et al. reference as discussed supra.
CORRESPONDENCE
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am- 6:00 pm; M-F (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR.
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/DANAH AL-AWADI/Primary Examiner, Art Unit 1615
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