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27/10/2018 IP REPORT

ORTHOPAEDIC COATINGS

LEIF SHARKEY

43171091
PAGE INTENTIONALLY LEFT BLANK
TABLE OF CONTENTS

LIST OF TABLES .......................................................................................................................................... II

LIST OF FIGURES ........................................................................................................................................ II

1. FREEDOM TO OPERATE ..................................................................................................................... 1

1.1. EXPLORING OF HA COATINGS & DERIVATIVES OF, IN THE FIELD OF ORTHOPAEDICS ................... 1
1.2. AVAILABLE INNOVATION SPACE ........................................................................................................... 1
1.3. CURRENT STATE OF IP DEVELOPMENT................................................................................................. 1

2. SUMMARY OF PROPOSED INNOVATION ...................................................................................... 2

2.1. MOTIVATION ........................................................................................................................................... 2


2.2. INNOVATIVE IDEA ................................................................................................................................... 2
2.3. END GOAL ............................................................................................................................................... 2

3. PLANNING AND WORK PACKAGES ................................................................................................ 3

3.1. SUMMARISED PATENT PROCESS............................................................................................................ 3


3.2. KEY ENABLERS ....................................................................................................................................... 3
3.3. LONG-TERM DEVELOPMENT & COMMERCIALISATION ...................................................................... 3
3.4. CONTINGENCY PLAN .............................................................................................................................. 4
3.5. ADDITIONAL RESOURCE PLANNING & RECOMMENDED ACTIVITIES ................................................ 4

4. RESOURCE ALLOCATIONS ................................................................................................................ 5

4.1. WORK FLOW, MEASURABLE PERFORMANCE INDICATORS & RESOURCE STRATEGIES (MICHIGAN
TECH) ................................................................................................................................................................. 5
4.2. CONCLUSION ........................................................................................................................................... 5

5. REFERENCES .......................................................................................................................................... 6

APPENDIX A ................................................................................................................................................... 7

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APPENDIX B.................................................................................................................................................... 8

APPENDIX C ................................................................................................................................................... 9

APPENDIX D ................................................................................................................................................. 10

LIST OF TABLES
Table 1: Itemised checklist for sustaining a commercial presence ......................................................................................3

Table 2: Key organisations to assist in commercialising products ......................................................................................4

Table 3: Patent Details .........................................................................................................................................................7

LIST OF FIGURES
Figure 1: Summarises medium-long term goals ..................................................................................................................2

Figure 2: Typical timeline for dental implant (Dental Implants Dublin, 2018) .................................................................10

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1. FREEDOM TO OPERATE
1.1. Exploring of HA Coatings & Derivatives of, in the Field of Orthopaedics
Patents under review of their respective claims, validity and evidenced with supporting data are

summarised in Table 3 of APPENDIX A. Both patents #1 and #2 identified in Table 3 represent

similar work developed through advancing applications by the inventors. Followed by Malshe et al.

(2008) publishing an electrostatic spray to deposit nanostructured hydroxyapatite (HA) coating for

biomedical applications. Malshe et al. verifies early works by Gitzhofer et al. (1994) which patented

plasma spraying technologies, but was further developed through published work in 2018. Main

disparity between Patent #1 and #2 is a “registered” viable method of creating a porous HA surface

using a premixed suspension of a HA composition and Malshe et al. (2012) using the electrostatic

application to now adhere HA-ZnO composite. Patent #3 seems to be an attempt to secure a piece of

IP landscape in HA coatings and orthopaedic treatments. This is evident in APPENDIX B where the

yellow highlighted text derived from Patent #3 is vague in regards to application, composition and

topography of the HA coating, merely attempts to publish the idea of HA being applied to dental

implants with little evidence of HA supporting literature (US Patent No. US5873725A, 1999).

1.2. Available Innovation Space


Similar to how Malshe and Wenping (2008) patented an invention of HA deposition via electrostatic

spray and in 2012 patented an innovation through the addition of ZnO, shows there is room to move

with other ‘body-excepting elements’ (i.e. MgO, CuO). Xia et al. (2018) has published extensive

literature on optimising the plasma spray technique (alternate application method) and recent work

by Hidalgo-Robatto, et al. (2018) incorporates copper and zinc with highlighted text taking from

Patent #2 seen in APPENDIX C shows this scenario being eluded to.

1.3. Current state of IP development


Since the published article of 2012 (Malshe et al.) there has been developments in literature, but lack

of defining in patents. Possible cause is still testing for optimal HA adhesion and composition. There

is much reported literature on when deciding the optimal technique of applying a HA composite to

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the surface, much of which was discussed in the individual literature review. Understood that a

defined method must be established in-order to fully commit to patenting and commercialisation.

2. SUMMARY OF PROPOSED INNOVATION


2.1. Motivation
The basis of motivation is a two-fold split between financial benefit and lifting the societal standard

of living. Despite the many improvements to social living standards, APPENDIX D shows the 180

days associated with a dental implant and often reworking of implants several times throughout the

patient lifespan. Producing a high-strength coating for orthopaedic implants via a HA composite is

foreseen to benefit both tiers of mentioned motivation.

2.2. Innovative Idea


Basis is engrained with producing a bio-ceramic material that incorporates HA composites which can

endure a robust environment, applying this to the field of dentistry. A field resistant to rivalry and

competitive nature of artificial intelligence, at least in the medium-long term. Applied using the

advances in plasma-spraying, optimised by Xia et al. (2018) via thermal conditioning to form rod like

nano-crystals. Composite would aim at incorporating silver (Ag) for the antibacterial properties

which could reduce teeth decay when implemented in a highly bio-active environment.

2.3. End Goal


Error! Reference source not found. below summarises the three phases, goals of each phase has a

specific task checklist to fulfil. Once the final process goals have been reached, the ideal end-point is

envisioned as a technology buy-out of the orthopaedic application so as to alleviate pressures of

generating revenue and refocus on research and development.

ASSESSMENT 1 yr PROTECTION 4-6 yr COMMERCIALISE

•Market opportunity •Copyrights •Cross-licensing


•Prior art & literature •Trademarks & secrets •Spin-off phases
•Public readiness •Patents •Proof of concept
•Licensing • Marketing

Figure 1: Summarises medium-long term goals

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3. PLANNING AND WORK PACKAGES
3.1. Summarised Patent Process
File Disclosure Document: establish date of conception idea (granted a two-year grace period) > File

Provisional Patent Application: protect the ideas whilst engaging potential funders, assuring to

include “patent pending” on the invention (only good for twelve months) > File Non-Provisional

Patent Application: complete description will be filed to the Patent and Trademark Office (PTO).

3.2. Key Enablers


Broader scope on the current technological and engineering approaches to material science and the

developmental pathway generated by nanoscience. This enables the strict control over processes to

continue generating advanced synthetic materials. New insight re-scoped to further characterise

biological systems to integrate the performance and functionality. Therefore, advanced materials

engineer and biological scientist to achieve HA composites.

3.3. Long-term Development & Commercialisation


The following checklist (Table 1) is to be fulfilled through maintaining “academic progression”

within the field, creating a cycle of public awareness, knowledge and presence. This becomes an

intangible form of marketing with an overall commercialisation goal to be a product considered and

evaluated through the three traditional approaches being: the income approach, the market approach

and the cost approach (Ecosphere Technologies, 2014).

Table 1: Itemised checklist for sustaining a commercial presence

Item Description/Reasoning
Being productive in industry shows interaction that will lead to funding
Productivity
opportunities and additional resources for greater outputs

Ongoing engagement with industry and commercialisation will result in


Publications
published papers being ranked higher

Often measured by universities and industry on publications, profile, output


Progression
and impact, contributing to commercialisation outcomes

Allocating time and space during Stage 2 (Resource Allocation) for creating
Profile
and maintain public presence, attract quality staff and enhance reputation

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3.4. Contingency Plan
Basis of the contingency plan consists two protocols: Table 2 defines two organisations to assist in

patent formation and commercialisation, pre-allocate time and space in Stage 2 planning (Resource

Allocation) to manage the possibility of PTO denial (could require additional financial and technical

resources, possibly engaging industry and/or academic expertise).

Table 2: Key organisations to assist in commercialising products

Identifier Description/Reasoning
Specialists in commercialising IP and distinguished technology transferor
Uniquest
from research and development phase to the commercial market place

Pre-submission patent process to address issues of invalidity prior to


IP Australia
examination using the Pre-Examination Process (PEP)

However, engaging Uniquest or similar organisation is a last result, although highly regarded and

recommended within the field, percentage dividend contracted with Uniquest is 30% of earnings

without guaranteed commercial success and viability.

Secondary strategy if dental implants denied, follows the mindset of continuing with a HA composite,

but applying it to a less pronounced field. Such as jewellery or manicures, both fields encounter

customers who cannot engage with the trends and services due to adverse reactions. Further analysis

would address the financial return of such venture, marketability holds in this suggested field.

3.5. Additional Resource Planning & Recommended Activities


Important to note that the work flow in Section 4 (Resource Allocation) combines measurable

outcomes, cohesive activities in addition to Table 1 that will boost collaboration and expected to raise

funding. Each of the five stages listed below are named across the top with each stage flowing into

objectives and/or expectations of that stage followed with a flow into activities and milestones

associated with the respective stage.

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4. RESOURCE ALLOCATIONS
4.1. Work Flow, Measurable Performance Indicators & Resource Strategies (Michigan Tech)
ASSESSMENT DEVELOP PROPRIETARY IMPLEMENT
PHASE COMMERCIAL PROTECTION COMMERCIAL LICENSING
(COMMENCED) STRATEGY & PLANNING PLAN

Stage 1 Stage 2 Stage 3 Stage 4 Stage 5


0-3 mths 3-6 mths 6 mth-1yr 1-2 yrs Ongoing
•Preliminary • Pre-commercial • Collect necessary •Commercial •Negotiate license
milestone based technical experimental data
assessment & develop-ment plan to de- • Detailed assessment of milestone based terms
value proposition risk business prior art development plan •Build strategic
• Engage in early stage
•Proprietary & funding sources for
• Patent filing for technical & partner relations
• Develop alternate business de-risk
current researh university based proprietary strategies & •Follow-on
•Commercial accomplishment implement •Recruitment of milestones &
landscape & FTO funding for review the patent
•Market (social) commercial, process cycle
opportunity technical & •Strength market
business de-risk presence

• Identify • Coordinate • Follow-on with • Business model • Continue on

LICENSING & REVENUE


FIND, IMPROVE, INNOVATE

NEGOTIATE WITH PARTNER


CULTIVATE PARTNERS

EXECUTE BUSINESS PLAN


opportunies activities (i.e. proprietary developments development
• Initiate project setting calls, protection • Negotiate term • Realign with
assessment market strategies (i.e. sheet, start-up market trends
• Investment materials) how to protect commercial & expectations
decision • Inventors & trade secrets, implementation • Assessment
technicians to copyrights, of license
• Customer commitments
support trademark, • Company for- to further R&D
discovery &
discussions & patent filing)
identification mation/ partner • Identify
activities • Identify goals, identification
• Resource opportunities to
allocation, • Decisions for expectations & • License & improve the
appropriate performance implement performance of
work-flow, key
proprietary indicators of methods to the firm
enablers
strategies prospective
• Literature generate metric • Create
• Generate busi- partners reports
review & IP customised
ness models • Set criteria & • Allocate time plan to address
report
that canvas: a standards of & space for opportunities
• Innovation operation
product road- continued • Work with
strategies agreed on by
map, verify research partners &
• Improve technology & all parties towards company to
operation mgt. plan • Initiate, engage strengthening review, modify
efficiency: • Develop patent monitoring of value, prop- & implement
combining contractual
valuation rietors competi- customised
experi-mental milestones with
methods to est. tive advantage strategies
design & flexible rework
royalties & & overcome • Leverage tech.
statistical options
claims technology risk via widespread
analysis
• Demo. proof of partnering
concept
4.2. Conclusion
Engaging this research plan and innovation strategy being aimed at translating current scientific and

engineering developments into tangible IP will be a significant in-road to commercialisation of a

viable and marketable product that will meet the expectations and goals of Section 2.0, where

commercial sustainability rests in continued research and development with industry presents.

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5. REFERENCES
Ecosphere Technologies. (2014). Independent Appraisal Report. Boston: IPV.

Hidalgo-Robatto, B., López-Álvarez, M., Azevedo, A., Dorado, J., Serra, J., Azevedo, F., &

González, P. (2018). Pulsed laser deposition of copper and zinc doped hydroxyapatite

coatings for biomedical applications. Surface and Coatings Technology, 168-177.

Jiang, W., Sun, l., Nyandoto, G., & Malshe, A. (2008). Electrostatic Spray Deposition of

Nanostructured Hydroxyapatite Coating for Biomedical Applications. Journal of

Manufacturing Science and Engineering, 2001-7.

Malshe, A., & Jiang, W. (2012). US Patent No. US20120276336A1.

Perler, R., & Wager, W. (1999). US Patent No. US5873725A.

Xia, L., Xie, Y., Fang, B., Wang, X., & Lin, K. (2018). In situ modulation of crystallinity and nano-

structures to enhance the T stability and osseointegration of hydroxyapatite coatings on Ti-

6Al-4V implants. Chemical Engineering Journal, 711-720.

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APPENDIX A
Table 3 highlights patents #1 and #2 as being a the current IP landscape around HA coatings for

orthopaedic applications. Patent #3 provided as an example paper seeking to own the landscape

before existing state-of-the-art advancements.

Table 3: Patent Details

Filed Date of Patent Pub No. Type

Patent #1

July, 2009 2014 8877283 Granted

Inventors

Fang Wu, Yi Huang, Lei Song, Xiaoguang Liu, Yanfeng Xiao, Jiamin Feng, Jiyong Chen

Title

Method for preparing porous hydroxyapatite coatings by suspension plasma spraying

Patent #2

2009 2012 US2012/0276336A1 Granted

Inventors

Ajay P. Malshe, Wenping Ji

Title

Nanostructured hydroxyapatite coating for dental and orthopaedic implants

Patent #3

1996 1999 US5873725A Granted

Inventors

Robert Perler, William Wager

Title

Support post and method for coronal prosthesis

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APPENDIX B
The following text is a direct quote by Perler and Wager (1996) from Patent #3 found in Table 3 of

that will meet the expectations and goals of Section 2.0, where commercial sustainability rests in

continued research and development with industry presents.

6. REFERENCES
Ecosphere Technologies. (2014). Independent Appraisal Report. Boston: IPV.

Hidalgo-Robatto, B., López-Álvarez, M., Azevedo, A., Dorado, J., Serra, J., Azevedo, F., &

González, P. (2018). Pulsed laser deposition of copper and zinc doped hydroxyapatite

coatings for biomedical applications. Surface and Coatings Technology, 168-177.

Jiang, W., Sun, l., Nyandoto, G., & Malshe, A. (2008). Electrostatic Spray Deposition of

Nanostructured Hydroxyapatite Coating for Biomedical Applications. Journal of

Manufacturing Science and Engineering, 2001-7.

Malshe, A., & Jiang, W. (2012). US Patent No. US20120276336A1.

Perler, R., & Wager, W. (1999). US Patent No. US5873725A.

Xia, L., Xie, Y., Fang, B., Wang, X., & Lin, K. (2018). In situ modulation of crystallinity and nano-

structures to enhance the T stability and osseointegration of hydroxyapatite coatings on Ti-

6Al-4V implants. Chemical Engineering Journal, 711-720.

Leif Sharkey_43171091_CHEE4305_Literature Review Page 2 of 2


APPENDIX A. Full citation in found in the above list of that will meet the expectations and goals of

Section 2.0, where commercial sustainability rests in continued research and development with

industry presents.

REFERENCES.

“The next step in the fabrication of the inventive dental post is the application of

an thin layer of hydroxyapatite or other suitable ceramic materials. In accordance

with the invention, it is necessary that a strong bond be formed between the dental

post and the layer of hydroxyapatite. The same is insured by first putting the

substrate post through a cleaning regimen not unlike that used to clean metals

before the deposition of hydroxyapatite in, for example, the manufacture of a dental

implant. Generally, the techniques for the deposition of the ceramic hydroxyapatite

to metallic posts are the same as the techniques employed in the manufacture of

metallic dental implants. These techniques are well known in the art and form no

part of the invention except as may be specifically detailed herein. Alternatively,

other coating methods, demonstrated to result in a strong coating substrate bond,

may be employed.”

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APPENDIX C
The following text is a screenshot from Malshe and Wenping 2012 patent as shown in Table 3 of that

will meet the expectations and goals of Section 2.0, where commercial sustainability rests in

continued research and development with industry presents.

7. REFERENCES
Ecosphere Technologies. (2014). Independent Appraisal Report. Boston: IPV.

Hidalgo-Robatto, B., López-Álvarez, M., Azevedo, A., Dorado, J., Serra, J., Azevedo, F., &

González, P. (2018). Pulsed laser deposition of copper and zinc doped hydroxyapatite

coatings for biomedical applications. Surface and Coatings Technology, 168-177.

Jiang, W., Sun, l., Nyandoto, G., & Malshe, A. (2008). Electrostatic Spray Deposition of

Nanostructured Hydroxyapatite Coating for Biomedical Applications. Journal of

Manufacturing Science and Engineering, 2001-7.

Malshe, A., & Jiang, W. (2012). US Patent No. US20120276336A1.

Perler, R., & Wager, W. (1999). US Patent No. US5873725A.

Xia, L., Xie, Y., Fang, B., Wang, X., & Lin, K. (2018). In situ modulation of crystallinity and nano-

structures to enhance the T stability and osseointegration of hydroxyapatite coatings on Ti-

6Al-4V implants. Chemical Engineering Journal, 711-720.

Leif Sharkey_43171091_CHEE4305_Literature Review Page 2 of 2


APPENDIX A as Patent #2. Full citation in found in the above list of that will meet the expectations

and goals of Section 2.0, where commercial sustainability rests in continued research and

development with industry presents.

REFERENCES.

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APPENDIX D
Figure 2 summarises the average timeline required to implant a dental crown, this is not including

healing after the crown placement.

Figure 2: Typical timeline for dental implant (Dental Implants Dublin, 2018)

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