`
`Ignon et al.
`In re Patent of:
`11,865,287
`U.S. Patent No.:
`January 9, 2024
`Issue Date:
`Appl. Serial No.: 18/094,884
`January 9, 2023
`Filing Date:
`Title:
`DEVICES AND METHODS FOR TREATING SKIN
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` Attorney Docket No.: 58484-0001IP1
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`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`DECLARATION OF ERIC SIMON IN SUPPORT OF PETITION FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 11,865,287
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`1
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`Sinclair Pharma et al.
`EUNSUNG-1003
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`Attorney Docket No. 58484-0001IP1
`IPR of U.S. Patent No. 11,865,287
`TABLE OF CONTENTS
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`ASSIGNMENT ................................................................................................ 5
`QUALIFICATIONS ........................................................................................ 5
`SUMMARY OF CONCLUSIONS FORMED ................................................ 9
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` BACKGROUND KNOWLEDGE PRIOR TO THE PRIORITY DATE OF
`THE ’287 PATENT ....................................................................................... 10
`LEGAL PRINCIPLES ................................................................................... 10
`A. Claim construction .................................................................................. 11
`B. Priority .................................................................................................... 11
`C. Anticipation ............................................................................................. 12
`D. Obviousness ............................................................................................ 12
` MATERIALS CONSIDERED ...................................................................... 14
` TECHNOLOGY OVERVIEW ...................................................................... 16
`A. Microdermabrasion ................................................................................. 16
` OVERVIEW OF THE ’287 PATENT .......................................................... 22
` OVERVIEW OF THE PROSECUTION HISTORY .................................... 26
`SUMMARY OF THE PRIOR ART .............................................................. 27
`1. Karasiuk Overview ........................................................................ 27
`2.
`Palmer Overview ........................................................................... 32
`3.
`Trueba Overview ........................................................................... 35
`4. Greenberg Overview ..................................................................... 38
`[GROUND 1A] – Karasiuk And Palmer ....................................................... 43
`1.
`The Karasiuk-Palmer Combination ............................................... 43
`2.
`Claim 1 .......................................................................................... 61
`3.
`Claim 2 .......................................................................................... 97
`4.
`Claim 3 .......................................................................................... 99
`5.
`Claim 8 ........................................................................................101
`6.
`Claim 9 ........................................................................................106
`7.
`Claim 10 ......................................................................................109
`8.
`Claim 11 ......................................................................................113
`9.
`Claim 12 ......................................................................................127
`10. Claim 14 ......................................................................................129
`11. Claim 15 ......................................................................................129
`12. Claim 16 ......................................................................................131
`13. Claim 22 ......................................................................................131
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`14. Claim 23 ......................................................................................150
`15. Claim 26 ......................................................................................152
`16. Claim 28 ......................................................................................156
`17. Claim 29 ......................................................................................157
`18. Claim 34 ......................................................................................157
`19. Claim 35 ......................................................................................158
`20. Claim 36 ......................................................................................158
`21. Claim 37 ......................................................................................159
`22. Claim 39 ......................................................................................162
`23. Claim 40 ......................................................................................163
`24. Claim 45 ......................................................................................163
`[GROUND 1B] – Karasiuk, Palmer, And Trueba .......................................164
`1.
`The Karasiuk-Palmer-Trueba Combination ................................164
`2.
`Claim 1 and its Dependent Claims ..............................................171
`3.
`Claims 12, 22, 23, 29, 40 and their Dependent Claims ...............174
`4.
`Claims 3, 26 and their Dependent Claims ...................................175
`5.
`Claim 4 ........................................................................................175
`6.
`Claim 5 ........................................................................................176
`7.
`Claim 6 ........................................................................................176
`8.
`Claim 7 ........................................................................................177
`9.
`Claim 17 ......................................................................................177
`10. Claim 18 ......................................................................................177
`11. Claim 19 ......................................................................................178
`12. Claim 20 ......................................................................................178
`13. Claim 24 ......................................................................................178
`14. Claim 25 ......................................................................................179
`15. Claim 30 ......................................................................................179
`16. Claim 31 ......................................................................................179
`17. Claim 32 ......................................................................................179
`18. Claim 33 ......................................................................................180
`19. Claim 41 ......................................................................................180
`20. Claim 42 ......................................................................................180
`21. Claim 43 ......................................................................................180
`22. Claim 44 ......................................................................................181
` [GROUND 2A] – Greenberg .......................................................................181
`1.
`Claim 1 ........................................................................................181
`2.
`Claim 2 ........................................................................................210
`3.
`Claim 3 ........................................................................................212
`4.
`Claim 8 ........................................................................................214
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`Claim 9 ........................................................................................216
`5.
`Claim 10 ......................................................................................218
`6.
`Claim 11 ......................................................................................222
`7.
`Claim 12 ......................................................................................236
`8.
`Claim 14 ......................................................................................237
`9.
`10. Claim 15 ......................................................................................237
`11. Claim 16 ......................................................................................238
`12. Claim 22 ......................................................................................239
`13. Claim 23 ......................................................................................250
`14. Claim 26 ......................................................................................253
`15. Claim 28 ......................................................................................256
`16. Claim 29 ......................................................................................256
`17. Claim 34 ......................................................................................257
`18. Claim 35 ......................................................................................257
`19. Claim 36 ......................................................................................257
`20. Claim 37 ......................................................................................258
`21. Claim 39 ......................................................................................260
`22. Claim 40 ......................................................................................261
`23. Claim 45 ......................................................................................261
`[GROUND 2B] – Greenberg And Trueba ...................................................262
`1.
`The Greenberg-Trueba Combination ..........................................262
`1.
`Claim 1 and its Dependent Claims ..............................................267
`Claims 12, 22, 23, 29, 40 and their Dependent Claims ...............271
`2.
`3.
`Claims 3, 26 and their Dependent Claims ...................................271
`4.
`Claim 4 ........................................................................................272
`5.
`Claim 5 ........................................................................................272
`6.
`Claim 6 ........................................................................................273
`7.
`Claim 7 ........................................................................................273
`8.
`Claim 17 ......................................................................................274
`9.
`Claim 18 ......................................................................................274
`10. Claim 19 ......................................................................................274
`11. Claim 20 ......................................................................................274
`12. Claim 24 ......................................................................................275
`13. Claim 25 ......................................................................................275
`14. Claim 30 ......................................................................................275
`15. Claim 31 ......................................................................................275
`16. Claim 32 ......................................................................................276
`17. Claim 33 ......................................................................................276
`18. Claim 41 ......................................................................................276
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`19. Claim 42 ......................................................................................277
`20. Claim 43 ......................................................................................277
`21. Claim 44 ......................................................................................277
` CONCLUSION ............................................................................................277
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`Attorney Docket No. 58484-0001IP1
`IPR of U.S. Patent No. 11,865,287
`I, Eric Simon, of Salt Lake City, Utah, declare that:
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`1.
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`ASSIGNMENT
`I have been retained on behalf of Eunsung Global Corp (“Eunsung”)
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`to offer technical opinions related to U.S. Patent No. 11,865,287 (“The ’287
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`patent”) (EUNSUNG-1001). I understand that Eunsung is requesting that the
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`Patent Trial and Appeal Board (“PTAB” or “Board”) to institute an inter partes
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`review (“IPR”) proceeding of the ’287 patent.
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`2.
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`I have been asked to provide my independent analysis of the ’287
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`patent in light of the prior art publications cited in this declaration.
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`3.
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`I am not and never have been, an employee of Eunsung. I received no
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`compensation for this declaration beyond my normal hourly compensation based
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`on my time actually spent analyzing the ’287 patent, the prior art publications cited
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`below, and issues related thereto, and I will not receive any added compensation
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`based on the outcome of any IPR or other proceeding involving the ’287 patent.
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` QUALIFICATIONS
`A detailed description of my professional qualifications, including a
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`4.
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`list of publications, patents, awards, and professional activities, is contained in my
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`curriculum vitae, a copy of which is attached as Appendix A.
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`5.
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`I received a Master of Engineering (M.Eng.) in Bioengineering and a
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`Bachelor of Science (B.S.) in Materials Science and Engineering, both degrees
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`from the University of Utah. My focus during my master’s degree was on device
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`design, mechanical engineering, and manufacturing processes; my focus during my
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`bachelor’s degree was on biomaterials and materials processing. In addition to
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`various traditional engineering disciplines, my studies included physics, chemistry,
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`ergonomics, optics, and applied biomaterials, I also had extensive coursework in
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`the biological sciences including neurobiology, cell biology, and medical-school
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`level anatomy and physiology,
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`6.
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`I have been designing biomedical products since 1981. I am the
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`President, Principal Design Engineer, and Founder of Dexterity Design, a product
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`design, development, and engineering firm specializing in the design and
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`development of biomedical and biotechnical products, including dermatology and
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`cosmetology devices. The product scope of Dexterity Design is primarily
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`biomedical and biotechnical devices and instrumentation, both for therapeutics and
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`diagnostics. I have also designed and developed consumer, industrial, and
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`recreational products.
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`7.
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`I have experience designing and implementing a wide range of
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`medical therapeutic and diagnostic devices including those used in orthopedics,
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`dermatology, cosmetology, ophthalmology, and cardiovascular medicine. These
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`encompass implantables, procedural tools, and extra-corporeals, both durable and
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`disposable. I also have experience in designing biotechnical instruments used in
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`proteomics, genomics, and other areas of molecular analysis, as well as cell culture
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`systems. I am often called upon to develop mechanical components and enclosures
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`for these products and am very familiar with the design and the materials,
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`prototyping, and manufacturing thereof. I have expertise in fluidics and
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`microfluidics, both liquid and gaseous, utilized in these products. Furthermore, I
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`work closely with electronic designers/engineers and programmers and have solid
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`working knowledge of the use of microcontrollers and other circuitry for device
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`control, and the programming requirements they encumber.
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`8. My experience with the development of cosmetology/dermatology
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`devices includes the design, prototyping, testing, and manufacturing of various
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`products for dermal and subdermal conditions. These conditions include various
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`disease-based skin disorders, as well as dermal rejuvenation for aging and sun
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`damage. I have also designed and developed products to reduce tissue pain and
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`damage to near-surface structures such as tendons, ligaments, and muscles such as
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`ultrasonic and photonic therapeutic devices.
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`9.
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`Pertaining to the case herein, I have designed and developed
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`microdermabrasion devices which utilize abrasive particles fluidized into an air
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`stream which is directed onto the skin of the patient/customer for purposes of
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`removing epidermal cells. Typically, these devices are used for cosmetology to
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`induce skin regeneration within the dermis and lower epidermis which in turn
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`gives the recipient the appearance of more youthful skin. In some cases, the device
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`may be powerful enough to abrade deeper into the skin tissue, making it useful for
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`remediating scars and tattoo removal. The devices I designed all used vacuum
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`(negative pressure) to draw the abrasive grit from a supply vessel, fluidize the grit
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`in a separate chamber, carburate it into an air stream, and deliver it into a
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`handpiece where it is then directed onto the skin. Concurrently, impacted abrasive
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`grit, debrided skin cells, and body fluids are withdrawn from the site of impact and
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`then returned to the device and deposited into a waste containment vessel for later
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`disposal. During the course of this development, I was required to read and
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`understand numerous prior art patents relating to dermabrasion,
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`microdermabrasion, and other forms of fluidized-stream surface abrasion (e.g.,
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`those sued for industrial sand-blasting and bead-blasting). I also studied various
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`microdermabrasion apparatuses offered from competitive manufacturers. A
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`product based on this design and development efforts was offered for sale and
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`generated good sales and user reviews for many years; I was listed as an inventor
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`on two utility patents and two design patents relating to this product.
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`10. To date, I am a listed inventor on 22 U.S. patents, issued and pending.
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`As mentioned, several of these include microdermabrasion apparatuses, and others
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`relating to dermal and subdermal therapeutics.
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`11. Please see my CV, attached hereto as Appendix A, for further
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`Attorney Docket No. 58484-0001IP1
`IPR of U.S. Patent No. 11,865,287
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`information.
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` SUMMARY OF CONCLUSIONS FORMED
`12. This Declaration explains the conclusions that I have formed based on
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`my analysis. To summarize those conclusions:
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`Ground 1A: Based upon my knowledge and experience and my review of
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`the prior art publications in this declaration, I believe that claims 1-3, 8-12,
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`14-16, 22-23, 26, 28-29, 34-37, 39-40, and 45 of the ’287 patent are
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`rendered obvious by Karasiuk and Palmer.
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`Ground 1B: Based upon my knowledge and experience and my review of
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`the prior art publications in this declaration, I believe that claims 1-10, 12,
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`17-20, 22-26, 28-36, and 40-44 of the ’287 patent are rendered obvious by
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`Karasiuk, Palmer, and Trueba.
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`Ground 2A: Based upon my knowledge and experience and my review of
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`the prior art publications in this declaration, I believe that claims 1-3, 8-12,
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`14-16, 22-23, 26, 28-29, 34-37, 39-40, and 45 of the ’287 patent are
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`rendered obvious by Greenberg.
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`Ground 2B: Based upon my knowledge and experience and my review of
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`the prior art publications in this declaration, I believe that claims 1-10, 12,
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`17-20, 22-26, 28-36, and 40-44 of the ’287 patent are rendered obvious by
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`Greenberg and Trueba.
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`Attorney Docket No. 58484-0001IP1
`IPR of U.S. Patent No. 11,865,287
` BACKGROUND KNOWLEDGE PRIOR TO THE PRIORITY
`DATE OF THE ’287 PATENT
`I have been informed that a person of ordinary skill in the art is a
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`13.
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`hypothetical person who is presumed to have the skill and experience of an
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`ordinary worker in the field at the time of the alleged invention. Based on my
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`knowledge and experience in the field and my review of the ’287 patent and file
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`history, I believe that a person having ordinary skill in the art (POSITA) at the time
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`of the alleged invention would have had an undergraduate degree (B.S.) in
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`Mechanical Engineering or equivalent knowledge, training, or experience, with
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`two years of work experience in the design of mechanical products, design of
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`fluidic systems, and/or the design of devices intended for medical or
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`cosmetological applications. Additional education or industry experience may
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`compensate for a deficit in one of the other aspects of the requirements stated
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`above
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`14. My analysis and conclusions set forth in this declaration are based on
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`the perspective of a person of ordinary skill in the art having this level of
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`knowledge and skill as of the date of the alleged invention of the ’287 patent.
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`Based on instruction from Counsel, I have applied December 30, 2005 (“Critical
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`Date”), as the date of the alleged invention of the ’287 patent.
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` LEGAL PRINCIPLES
`15.
`I am not a lawyer and I will not provide any legal opinions in this IPR.
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`Although I am not a lawyer, I have been advised that certain legal standards are to
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`be applied by technical experts in forming opinions regarding the meaning and
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`validity of patent claims.
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`A. Claim construction
`I understand that claim terms are generally given their plain and
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`16.
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`ordinary meaning in light of the patent’s specification and file history as
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`understood by a POSITA at the time of the purported invention. In that regard, I
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`understand that the best indicator of claim meaning is its usage in the context of the
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`patent specification as understood by a POSITA. I further understand that the
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`words of the claims should be given their plain meaning unless that meaning is
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`inconsistent with the patent specification or the patent’s history of examination
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`before the Patent Office. I also understand that the words of the claims should be
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`interpreted as they would have been interpreted by a POSITA at the time of the
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`invention was made (not today).
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`B.
`Priority
`I understand that a continuation application is a later-filed application
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`17.
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`that has the same disclosure (specification and figures) as an earlier-filed
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`application to which the later-filed application claims priority. A continuation is
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`generally entitled to the same priority date as the earlier-filed application to which
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`it claims priority.
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`C. Anticipation
`I understand that a patent claim is invalid as anticipated if each and
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`18.
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`every element as set forth in the claim is found, either expressly or inherently
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`described, in a single prior art reference. I also understand that, to anticipate, the
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`reference must teach all of the limitations arranged or combined in the same way
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`as recited in the claim.
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`19. With respect to inherency, I understand that the fact that a certain
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`result or characteristic may occur or be present in the prior art is not sufficient to
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`establish the inherency of that result or characteristic. Instead, the inherent
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`characteristic must necessarily flow from the teaching of the prior art.
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`D. Obviousness
`I understand that a patent claim is invalid if the claimed invention
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`20.
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`would have been obvious to a person of ordinary skill in the field at the time of the
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`purported invention, which is often considered the time the application was filed.
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`Thus, even if all of the claim limitations are not found in a single prior art
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`reference that anticipates the claim, the claim can still be invalid.
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`21. To obtain a patent, a claimed invention must have, as of the priority
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`date, been nonobvious in view of the prior art in the field. I understand that an
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`invention is obvious when the differences between the subject matter sought to be
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`patented and the prior art are such that the subject matter as a whole would have
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`been obvious at the time the invention was made to a person having ordinary skill
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`in the art.
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`22.
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`I understand that, to prove that prior art or a combination of prior art
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`renders a patent obvious it is necessary to: (1) identify the particular references
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`that, singly or in combination, make the patent obvious; (2) specifically identify
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`which elements of the patent claim appear in each of the asserted references; and
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`(3) explain a motivation, teaching, need, market pressure or other legitimate reason
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`that would have inspired a person of ordinary skill in the art to combine prior art
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`references to solve a problem.
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`23.
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`I also understand that certain objective indicia can be important
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`evidence regarding whether a patent is obvious or nonobvious. Such indicia
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`include:
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`Commercial success of products covered by the patent claims;
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`A long-felt need for the invention;
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`Failed attempts by others to make the invention;
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`Copying of the invention by others in the field;
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`Unexpected results achieved by the invention as compared to the closest
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`prior art;
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`Praise of the invention by the infringer or others in the field;
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`The taking of licenses under the patent by others;
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`Expressions of surprise by experts and those skilled in the art at the making
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`of the invention; and
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`The patentee proceeded contrary to the accepted wisdom of the prior art.
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`24. To the extent these factors have been brought to my attention, if at all,
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`I have taken them into consideration in rendering my opinions and conclusions.
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` MATERIALS CONSIDERED
`25. Based on my above-described experience, I believe that I am
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`considered to be an expert in the field. Also, based on my experiences, I
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`understand and know of the capabilities of persons of ordinary skill in the field
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`during the early 1990s–2010s, and I have worked closely with persons in the field
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`during that time frame.
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`26. As part of my independent analysis for this declaration, I have
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`considered the following: the background knowledge/technologies that were
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`commonly known to persons of ordinary skill in this art during the time before the
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`Critical Date; my own knowledge and experiences gained from my work
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`experience in the field of the ’287 patent and related disciplines; and my
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`experience in working with others involved in this field and related disciplines.
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`27.
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`In addition, I have analyzed the following publications and materials:
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`EUNSUNG-1001 U.S. Pat. No. 11,865,287 to Ignon (“the ’287 patent”)
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`IPR of U.S. Patent No. 11,865,287
`EUNSUNG-1002 Excerpts from the Prosecution History of the ’287 patent
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`(“the Prosecution History”)
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`EUNSUNG-1004 U.S. Patent Publication No. 2003/0212415 (“Karasiuk”)
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`EUNSUNG-1005 U.S. Patent No. 5,199,604 (“Palmer”)
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`EUNSUNG-1006 U.S. Patent Publication No. 2003/0093089 (“Greenberg”)
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`EUNSUNG-1007 U.S. Patent No. 6,390,815 (“Pond”)
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`EUNSUNG-1008 U.S. Patent No. 6,684,880 (“Trueba”)
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`EUNSUNG-1009 U.S. Patent No. 4,512,764 (“Wunsch 1982”)
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`EUNSUNG-1010 U.S. Patent Publication No. 2003/0018252 (“Duchon”)
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`EUNSUNG-1011 U.S. Patent No. 4,215,476 (“Armstrong”)
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`EUNSUNG-1012 Friedman, et al., Chemical peels, dermabrasion, and laser
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`therapy, Disease-a-Month 55.4 (2009): 223-235 (“Friedman”)
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`EUNSUNG-1013 Burgess, Cheryl M., Cosmetic dermatology, Heidelberg,
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`Germany: Springer, 2005 (“Burgess”)
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`EUNSUNG-1014 Pickering, J. A., Touch-sensitive screens: the
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`technologies and their application, International Journal of Man-Machine
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`Studies 25.3 (1986): 249-269 (“Pickering”)
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`EUNSUNG-1015 Friedman, Mark J. et al., The AMSA injection: A new
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`concept for local anesthesia of maxillary teeth using a computer-controlled
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`injection system. Quintessence Int 29 (1998): 297-3 (“Friedman 1998”)
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`Attorney Docket No. 58484-0001IP1
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`EUNSUNG-1016 Lee, Woan-Ruoh, et al., Lasers and microdermabrasion
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`enhance and control topical delivery of vitamin C, Journal of investigative
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`dermatology 121.5 (2003): 1118-1125 (“Lee”)
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`EUNSUNG-1017 U.S. Patent No. 9,550,052 (“the ’052 patent”)
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`EUNSUNG-1018 U.S. Patent No. 11,446,477 (“the ’477 patent”)
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`EUNSUNG-1019 U.S. Patent No. 6,428,518 (“Brengle”)
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`EUNSUNG-1020 U.S. Patent No. 4,559,036 (“Wunsch”)
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`EUNSUNG-1021 U.S. Patent No. 6,099,511 (“Devos”)
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`EUNSUNG-1022 U.S. Patent No. 5,163,902 (“Lynn”)
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`EUNSUNG-1023 U.S. Patent No. 5,190,525 (“Oswald”)
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`EUNSUNG-1024 U.S. Patent No. 6,673,082 (“Mallett”)
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`EUNSUNG-1025 Rajan, Poonam, et al., Skin barrier changes induced by
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`aluminum oxide and sodium chloride microdermabrasion, Dermatologic
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`surgery 28.5 (2002): 390-393 (“Rajan”)
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`EUNSUNG-1026 Karimipour, Darius J., et al., Molecular analysis of
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`aggressive microdermabrasion in photoaged skin, Archives of dermatology
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`145.10 (2009): 1114-1122 (“Karimipour”)
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`EUNSUNG-1027 U.S. Patent No. 6,241,739 (“Waldron”)
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` TECHNOLOGY OVERVIEW
`A. Microdermabrasion
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`Attorney Docket No. 58484-0001IP1
`IPR of U.S. Patent No. 11,865,287
`28. Dermabrasion mechanically removes the upper layer of skin to treat
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`various skin conditions including wrinkles, acne scars, uneven skin surfaces, and
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`pigmentary disorders of photoaging. EUNSUNG-1012, 6; EUNSUNG-1013, 57.
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`Microdermabrasion, a variation of dermabrasion, typically relies on two basic
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`functions: “(1) superficially abrading the skin with fine, sharp particles or
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`“crystals” (aluminum oxide, salt, or sodium bicarbonate) suspended in an airstream
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`and actuated via positive- or negative-flowing pressure, and (2) a vacuum closed-
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`loop suction device to remove the crystals, along with dead skin, oil, and surface
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`debris.” EUNSUNG-1013, 84. “The intensity of the treatment, as determined by
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`the number of passes and level of suction, is chosen based on the condition being
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`treated.” EUNSUNG-1013, 86. After treatment, the skin can be rinsed with tepid
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`water and a moisturizer with adequate sunscreen applied. EUNSUNG-1013, 86.
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`29. As an alternative to laser resurfacing, chemical peels, and
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`dermabrasion, microdermabrasion is indicated for similar skin issues but with the
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`limitation of having relatively superficial results. EUNSUNG-1013, 85.
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`Microdermabrasion, described as a “skin polishing,” is used for atrophic acne
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`scars, mild facial rhytids, clogged pores, traumatic scars, enlarged pores, brown
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`spots, stretch marks, melasma, keratosis pilaris, and to improve skin texture. Id.
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`Microdermabrasion has also been used to prime the skin for superficial chemical
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`peels by stripping the stratum corneum to ensure more even absorption. Id. When
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`Attorney Docket No. 58484-0001IP1
`IPR of U.S. Patent No. 11,865,287
`used in conjunction with microdermabrasion, traditional superficial chemical
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`peeling agents. Id.
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`30. Prior to treatment, the area is cleansed and allowed to dry completely.
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`EUNSUNG-1013, 85. Vacuum level and crystal pressure may be determined by
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`testing an area of nonfacial skin, but patient tolerance can also dictate an
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`adjustment in the power setting. EUNSUNG-1013, 85-86. The first pass is
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`performed by allowing gentle suction of the skin into the hand piece as it is made
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`to glide along the skin surface. EUNSUNG-1013, 86. The surface area being
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`treated is stretched taut by the clinician’s free hand to avoid excessive suction in
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`any one area, which can cause an abrasion or pinpoint bleeding. Id. A second pass
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`is made at a right angle to the first, and if more passes are required, they should
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`continue to follow this alternating pat