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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
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.
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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Karazivan et al. (US 2015/0182321), Fonte et al. (US 2016/0158417), Antoni et al. (US 2017/0014553), and Ryd et al. (US 2018/0243096) teach coated medical devices similar to that which is claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH DUMBRIS whose telephone number is (571)272-5105. The examiner can normally be reached M-F 6:00 AM - 3:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Humera Sheikh can be reached at 571-272-0604. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
SETH DUMBRIS
Primary Examiner
Art Unit 1784
/SETH DUMBRIS/Primary Examiner, Art Unit 1784
Prosecution Insights