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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 21 May 2026 lists US Patent Application Publication #1 as 2009130169 to Bernstein and should be 20090130169. The entry from said IDS is struck as it lists the wrong document identifier. US 2009/0130169 to Bernstein is concurrently listed on a PTO-892 to be property documented. No further action by applicant is needed if this is the intended reference.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 21-35 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (US 2018/0228613) and claim 37 is further rejected over Jones in view of Banin et al. (WO2013/001433).
Considering claim 21, Jones teaches biocompatible structures for use in an implant (abstract). The implant is a three dimensional material in whole or in part of a lattice (Paragraph 49) formed by 3D printing of a range of materials including metals by processes including selective laser sintering, etc. (Paragraph 63) (e.g. a monolithic body). The lattice is coated with a bioactive coating including anti-microbial, calcium phosphate, hydroxyapatite, hydrophobic, hydrophilic, etc. (Paragraph 64) (e.g. non-plasma coatings).
While not expressly teaching a singular example of the claimed medical device this would have been obvious to one of ordinary skill in the art before the effective filing date in view of the teachings of Jones as this is considered a combination of a three-dimensional printed structure and bioactive coating known to afford implants and one would have had a reasonable expectation of success. The recitation of “formed by a non-plasma deposition process” is considered a product-by-process limitation and is not considered to render a patentable distinction over the prior art absent a showing as to how the claimed process affects the final structure of the claimed medical device. See MPEP 2113.
Considering claims 22 and 25, Jones teaches where the implant is biocompatible (Paragraph 7) and capable of bone attachment or osteointegration over time (Paragraph 47) and is considered ‘configured for implantation into a mammal’ as no particular configuration is recited. See MPEP 2111.01.
Considering claim 23, Jones teaches where the implant may be temporary (Paragraph 113).
Considering claim 24, Jones teaches where the device may be used outside of the body (Paragraph 5) (e.g. external use on a mammal).
Considering claims 26-27, Jones teaches where the lattice is the whole or part of the device (Paragraph 49).
Considering claims 28-29, Jones teaches where the device is an implant (i.e. an artificial implant) for bones (i.e. a bone prosthetic) (Paragraph 47).
Considering claim 30, Jones teaches examples of where the lattice structure having a height twice that of the width (Fig.4) as well as where the struts of the lattice are 0.5 mm in diameter and lengths of 2.00 mm (Paragraph 124) overlapping the instantly claimed aspect ratio and the courts have held that where claimed ranges overlap or lie inside of those disclosed in the prior art a prima facie case of obviousness exists. See MPEP 2144.05.
Considering claims 31-34, Jones teaches where the article is formed by 3D printing including selective laser sintering, etc. (Paragraph 63) and where the body is of unitary construction without seams, braze joints, or weld joints (e.g. Figs. 1-2).
Considering claim 35, the recitations of the coating being an ALD, CVD, or solution deposition coating are considered product-by-process limitations and are not considered to render a patentable distinction over the prior art absent a showing as to how the claimed process affects the final structure of the medical device.
Considering claim 37, Jones teaches where the coating may be an anti-microbial, etc. (Paragraph 64) but does not teach the claimed materials.
In a related field of endeavor, Banin teaches antibacterial and antibiofilms coatings of nanoparticles of fluoride salts (abstract) for use with biomedical devices, etc. (Paragraph 5) including joint implants, etc. (Paragraph 3). The coating of nanoparticles comprises YF3, etc. (Paragraph 7) which have enhanced biological and physical properties (Paragraph 8).
As both Jones and Banin teach medical devices with antimicrobial films they are considered analogous. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Jones with the YF3 antibacterial material taught by Banin as this is known to have enhanced biological and physical properties and one would have had a reasonable expectation of success.
Claims 21-23, 25-26, 28-29, 31-36, and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Kopp (WO2020/104653).
Considering claim 21, Kopp teaches biodegradable implants (i.e. a medical device) coated with oxides and/or phosphates (abstract). The implant is formed by additive manufacturing, such as laser powder bed fusion or selective laser sintering (p.13 lines 26-28) (i.e. a monolithic body) and the coating is optionally formed by anodization (Claim 3).
While not expressly teaching a singular example of the claimed medical device this would have been obvious to one of ordinary skill in the art before the effective filing date in view of the teachings of Kopp as this is considered a combination of a conventionally known implant with coating known to afford alloy implants that are non-toxic and non-immunogenic (p.3 lines 23-30) and one would have had a reasonable expectation of success. The recitation of “formed by a non-plasma deposition process” is considered a product-by-process limitation and is not considered to render a patentable distinction over the prior art absent a showing as to how the claimed process affects the final structure of the claimed medical device. See MPEP 2113.
Considering claim 22, Kopp teaches where the implants are used with humans (p.1, lines 11-17) as an orthopedic bone repairing material (p.1 lines 28-33) and is therefore considered configured for implantation into a mammal.
Considering claim 23, Kopp teaches where the device biodegrades in situ (i.e. temporary insertion) (p.2 lines 1-7).
Considering claims 25-26, Kopp teaches where the implant is the formed product (i.e. a 3D body) (p.13 lines 26-28) for use in humans (i.e. biocompatible) (p.1 lines 28-33).
Considering claims 28-29, Kopp teaches where the article is an implant (e.g. an artificial implant) and is for bone repair or replacement (i.e. a bone prosthetic) (p.1 lines 28-33).
Considering claims 31-34, Kopp teaches where the implant is formed by additive manufacturing including laser powder bed fusion or selective laser sintering (p.13 lines 26-28) which forms a unitary body without seams, braze joints, or weld joints.
Considering claim 35, the recitations of the coating being an ALD, CVD, or solution deposition coating are considered product-by-process limitations and are not considered to render a patentable distinction over the prior art absent a showing as to how the claimed process affects the final structure of the medical device. See MPEP 2113. Kopp teaches where the coating is optionally formed by anodization (Claim 3) and is considered to meet these limitations.
Considering claims 36 and 38-39, Kopp teaches where the coating is an oxide of Zr (e.g. zirconia; a transitional metal oxide), Mg (e.g. MgO), etc. (p.12 lines 15-19).
Response to Arguments
Applicant's arguments filed 20 July 2026 have been fully considered but they are not persuasive. Applicant argues that Jones does not teach a deposition process to form the coatings disclosed within Jones and therefore does not teach a non-plasma deposition process as required (remarks p.5) and that Kopp teaches where the coatings are formed by plasma electrolytic oxidation (PEO) and does not teach a non-plasma deposition as recited (remarks p.6).
This is not persuasive as "[E]ven 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. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) and the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983). See MPEP 2113 (II).
As of the writing of this Office action no objective evidence or technical reasoning has been presented to demonstrate indicia of non-obviousness over the products disclosed by the prior art of Jones and/or Kopp. Further, the instant claims do not positively recite any particular deposition technique or specific process steps and merely only recite “formed by a non-plasma deposition process” and this phrase is generic and is not considered to render any particular structure to the claimed medical device. Absent any particular distinction over the teachings of Jones and Kopp, applicant’s argument alone is insufficient to rebut the prima facie case. See MPEP 2145(I). Last, it is noted that Kopp teaches where the layer is formed “preferably” by PEO and is therefore not limited to that embodiment alone. See MPEP 2123.
In response to the instant Office action it is suggested that applicant provide objective evidence demonstrating structural distinctions over the prior art or amend the claims to recite a specific process with steps and materials which would distinguish the structure of the medical device over the prior art.
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 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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SETH DUMBRIS
Primary Examiner
Art Unit 1784
/SETH DUMBRIS/Primary Examiner, Art Unit 1784
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