This heat induces treatment by delivering the thermal of the PW settings, highly conductive tissues such as the basement wound jealing and collagen effect of radiofrequency into the skin with and=microvasculatureneedles.

production Unlike lasers, RF does not depend on the absorption coefficient selectively react, resulting in structural developed and manufactured by ot chromophores such as melanin

pigmentation, especially melasma long-pulsed laser CW RF produces strong heat in the tissue resulting in Skin types Hl arrive with vascular usec coagulated collagen and is lesions, especially rosacea.

| can personally attest to the Na effect of tear dropped thermal energy dispersion as | had a treatment with 1000 pulses on my face using the 25 needle cartridge, which equals 25,000 needie insertions with no pinpoint bleeding!

We now use the Sylfirm X as afirst line treatrment of melasma, and only employ Picosecond lasers to clean up any remaining melanosames after repairing the basement membrane anc underlying hypervascular pathology.

Access to confidential information is limited to the following individuals who have executed the acknowledgment appended to this order:

Such employees and representatives shall include the Director, members of the Board and their clerical staff, other support personnel, court reporters, and other persons acting on behalf of the Office.

The documents or information shall remain under seal unless the Board determines that some or all of it does not qualify for confidential treatment.

Within 60 days after the final disposition of this action, including the exhaustion of all appeals and motions, each party receiving confidential information must return, or certify the destruction of, all copies of the confidential information to the producing party.

disclosure to such support staff I informed or will inform them of the requirements of the Protective Order; that I am personally responsible for the requirements of the terms of the Protective Order and I agree to submit to the jurisdiction of the Office and the United States District Court for the Eastern District of Virginia for purposes of enforcing the terms of the Protective Order and providing remedies for its breach Dated:

Jordana Herschthal, MD: We chose VirtueRF Microneedling for our practice because it is well tolerated and yields great results with essentially no downtime.

In my experience,this is the only procedurein this industry where husbands/boyfriends/partners not only notice their other half's skin is improving and comment onit, but they then comein to have VirtueRF treatments themselves.

There are manypatients that have had every treatmentin our office and forthefirst time, they comein and say they are seeing a difference.| also love this treatment for my patientsin their 40's who are just starting to see changes in their skin.

Cartessa has helped my team with social media strategies, email marketing, patient acquisition and in general, has been there to support us when we needanything.

When | have voiced my suggestions for improvement and feedback as they grow at an unprecedented rate, | am met with warmth, understanding, and receptivity, whichis not often the case.

Viol global website is only for international users.

Viol Patent list This product is protected by the following patents.

No. Device for acupuncture Electric Skin Treatment Device Method, system, and apparatus for dermatological treatment Method, system, and apparatus for dermatological treatment Method, system, and apparatus for dermatological treatment Method, system, and apparatus for dermatological treatment Method, system, and apparatus for dermatological treatment Method, system, and apparatus for dermatological treatment Method, system, and apparatus for dermatological treatment Skin treatment apparatus and method

Viol global website is only for international users.

2722072 Apparatus for Surgical Procedure in the Body, and Endoscope Equipped therewith Medical Device Treating Vascular Tissue in Dermatological Tissue

This invention relates to improvements in devices for delivery of Substances Such as drugs, vaccines, fluorescent or magnetic material, and dyes into a Surface, Such as the skin of a human being, animal or other organic matter.

A problem with this type of System is that their use can cause considerable pain to the perSon or animal to which they are being applied and can, in extreme circumstances, Such as that of a Standard tattooing machine, damage the skin to Such an extent that recovery takes Several days.

This last point has prevented tattooing machines being used for drug delivery U.S. Pat. No. 5,681,283 discloses the use of a system in which needles are injected into the skin using elastic bands at a higher Velocity with the intention of making the injec tion “painless”.

Also these devices are prone to permit significant levels of lateral or transaxial movement of the needle during penetration of the skin casing extra damage and trauma.

If a rapid Series of injections are required e.g. in which the needle penetrates only a Small distance into the Skin, a motorised means can be used to generate the pulse of air and Subsequent reversal of pressure.

06/12) Summonsin a Civil Action (Page 2) Civil Action No. 1:23-cv-00224-UNA (This section should not be filed with the court unless required by Fed. R. Civ.

This summonsfor (name of individual andtitle, ifany) ENDYMED MEDICAL,INC.

1 I left the summonsatthe individual’s residence or usual place of abode with (name) , a person of suitable age and discretion whoresides there, on (date) , and mailed a copy to the individual’s last known address; or @ 1 servedthe summons on(name ofindividual) Nadia Bellamy - Authorized to Accept , whois designated by law to accept service of process on behalf of (name oforganization) corp, Services, LLC 108 W. 13th S. Suite 100, Wilmington, DE 19801 @2:52 pm on (date) 03/14/2023 > or 1 I returned the summons unexecuted because 3; or O Other (specify): Myfees are $ for travel and $ I declare under penalty of perjury that this information is true.

arber - Process Server Printed nameandtitle

Additional information regarding attempted service,etc: Server's address 230 North Market Street Wilmington, DE 19801 Ex. 2001-002

This cosmetically beneficial effect can be achieved in facial and neck areas of the body in a minimally intrusive manner, without requiring the Surgical removal of the outer layers of skin and the atten dant problems just listed.

In one example, fabrication of an elec trode array may cause undesired cross-current paths forming between adjacent electrodes resulting in an increase in the amount of energy applied to tissue.

Saline can be delivered to provide a diffuse path for radio frequency current delivery or to add or remove thermal energy from the target tissue.

In additional variations of 20 the system 200, the stabilization plate 214 can be fabricated to be transparent and the feature 216 can comprise a marking to outline the tissue region in which the probes will be inserted.

The electrodes of the probe array can also include any number of visually distinguishing features (e.g., depth mark ings, colors, shades, etc.) that enable a physician to observe proper placement.

This coS metically beneficial effect can be achieved in facial and neck areas of the body in a minimally intrusive manner, without requiring the Surgical removal of the outer layers of skin and the attendant problems just listed.

According to this aspect of the invention, a microporous pad on the carrier overlays the array of electrodes, forming an interior chamber to contain an electrically conductive mate rial.

Like the pad 66, the carrier 80 can also be specially shaped and contoured to provide different geometries, Selected to match the topography of the targeted facial or neck region, as shown in FIG. 5.

The cooling effect places the tissue region where maximum temperature conditions exist at a location (designated TMAX in FIG. 9) spaced from the distal ends of the electrodes 90, which includes the reticular dermis 22.

Like the pad 66, the carrier 88 can also be specially shaped and contoured to provide different geometries, Selected to match the topog raphy of the targeted facial or neck region, as shown in FIG.

Again, after these -- combining this technology 3 with the microneedle gave birth to many devices, some of the 4 first ones described here is a Miratone, which is shown on 5 the right, figure A, B, C, D, INTRAcel product made by 6 Jeisys, talked about earlier today, and as well as the DeAge 7 from Dashin Enterprise.

This is basic mechanical 2 engineering, so the relevant art is very predictable, and 3 the implementation is obvious and doesn't require much 4 experimentation, you can do some CAD drawing, and routine 5 optimization for manufacturing, production, and so on.

What does Mehta disclose about the highlighted 17 limitation, placing a user holdable device releasably 18 couplable deployable needle module end surface on or near 19 dermatological tissue to be treated?

What does Mehta disclose about the highlighted 11 releasably couplable deployable needle module mechanically 12 separatably from the user holdable device proximal end 13 limitation?

We can see on the Fig. 2D the needle module that is 16 separated from the handle, and he mentions in column 15, 17 line 31-33, any number of structures can be incorporated 18 into the device to permit removable coupling of the 19 cartridge body.

The inspection was conducted on June 26th 2023 at the law offices of Latham & Watkins LLP, 650 Town Center Drive, 20th Floor, Costa Mesa, CA.

The end of the handpiece has four electrical contacts, an aperture for the drive shaft, and a bayonet latching mechanism to allow connection and removal of the consumable tip, as shown below.

Each consumable tip has a protective cap to prevent exposure of the extendable needles, as shown in the left hand picture below.

Product Inspection Report – Sylfirm X Connection to drive shaft Needles retracted Extendible deformable pins Needles extended Attaching the Consumable Tip to the Handpiece The consumable tip is attached to the handpiece with a latching bayonet mechanism.

(Note, this is shown without the protective cap, which should always stay in place when attaching the needle tip assembly to the handpiece.)

Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul Hamburg Shanghai Hong Kong Silicon Valley Houston Singapore London Tel Aviv Los Angeles Tokyo Madrid Washington, D.C. Re: Certain Dermatological Treatment Devices and Components Thereof Dear Acting Secretary Hiner: Enclosed for filing on behalf of Complainant Serendia, LLC (“Serendia” or “Complainant”) are documents in support of Serendia’s request that the Commission commence an investigation pursuant to Section 337 of the Tariff Act of 1930, as amended.

Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul Hamburg Shanghai Hong Kong Silicon Valley Houston Singapore London Tel Aviv Los Angeles Tokyo Madrid Washington, D.C. Re: Certain Dermatological Treatment Devices and Components Thereof Dear Acting Secretary Hiner: I am counsel to Complainant Serendia, LLC (“Serendia” or “Complainant”).

The Accused Products reduce facial wrinkles to promote youthful-looking skin, which is purely cosmetic and a non-life-threatening concern that does not raise the type of health, safety, or welfare issues that the Commission has found may implicate the public interest.

Third parties, including Candela, Goldskin, Sano-Laser, MicroDerma, Benev, Hironic, Lumenis, and more, make like and directly competitive articles that can replace the Accused Products if they are excluded from the United States.

Instead, they are sold to dermatologists or cosmetic dermatology clinics, and any price increase that may result from the elimination of infringing competition would be spread widely across the clinic’s clientele for this optional and purely aesthetic procedure.

I have worked on the clinical trials and regulatory submission for multiple products, starting in 1984 when I was the primary author of the Pre- Market Approval Application (PMAA) for Cochlear (a multi-channel implantable hearing prosthesis).

It is my opinion that a person of ordinary skill in the art (“POSITA”) for the ’774 Patent would have (1) 7-10 years of experience with developing and/or using treatment systems for delivery of electromagnetic radiation energy to skin or other tissues, and (2) a related graduate engineering degree or M.D.

Relevant to the meaning and scope of “desired distance” the Examiner relied on column 10, lines 11-20 in asserting that Crocker disclosed that “[a] motor is energized to extend the needles a desired distance.” Ex. 2114 (’536 Patent File History), 278.

Mehta also discloses preventing probes from delivering energyat “an unintended shallower location”other than “a specific depth in the target tissue that corresponds to the length of the extended electrode” by only coupling the probesto the power supply when“fully extended.” Id., 15:62-16:8.

In fact, a user selecting a cartridge with a different array configuration would be akin to manual adjustment to reach a target tissue, which is outside the scope of claims 13 and 14 as they require a motor/mechanism to extend the needles.

se welsal, 2H wale Bey aac aqed eq] BRAY HP ANG Sal] BA 4} Po) vplaz SS Byer, Wl By] Sy AAAS 2 FEFHS Avo Se] Av) Bg] AMSA AA ASS ASE Fel AHN alg,

24mme] Aol] Beast], Seal BAIS ABS 0.8m Ho] BESS Blelt, B VSS ANB sei, sel 4) BACSDS) BeAe](Q) 2 ara) PACD) FS ASEH BASSEMEE Css WA BAe | Thee Alt.

Soe gz, E wee eS a7] AF 87100) BARS A4}F3 Ges da ged, 2 WS ye] S Chole) (159)e] BAleoy Qh, Beas set R14, BIPISO)S| Bee Ae, MSS, 2B, Baa 39 e274) Bd TS se Vas S4, S49 7S PABsa HAS BY SLE VrAa - he AeA BEF (150)q GIF BUSH) WEYELE lie] Be che} Sele 7 Hee salsa glow, aero ee lol} BS Us} elt wale Pasa Ia.

(9041) [0042] 10043] 10044) 10045] 10045] (0047] UE aAoll oe a9H Yao ASgase Sta, ade a ye 130)BBY, FE] Gupa VAASS Pts] ASH] Ua WPS 7, o] 2 $s] Bd SP Mos FHS) GO AIA, yolaw fb Ala Sz, oleae & & vis] Sela) VAS) BOS AES Fakea] UAE PS oeRAOR desl, olal oh wo] IPAS] LES SRAala GE ass et BS Loria ach.

sal dg, al WE ATS Sep, | , AL Sol Bry] ooas} oO BMPS HIE AS) QW Sea] cise] mls Aysdayd, B Wye Bea s aid 8 Sa) G84se, aves] ache Bae axe dole) Wel ga

In my role of providing technical leadership, training, and education both internally as well as externally, I was able to develop and maintain over 65% market share for this plasma mediated radio-frequency surgical system for over 16 years which created a $250 million revenue stream.

", International Federation of Automatic Control, Human Gait Analysis and Applications, pp. 273-299, 1983 J. Woloszko, J. Graille; "Etude informatisée de la cinématique du mouvement articulaire: une nouvelle approche clinique de la spasticité".- Innov.

North American congress on Biomechanics, Chicago, IL., August 24-28, 1992 J. Woloszko, R.J. Jaeger.- "Muscle activity at the ankle in response to center of mass shifts".- 14th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Paris, October 29- November 1, 1450-1451, 1992.

Kaula, N. F.; Mihran, R.; Woloszko, J.; Huber, K. M.; Schmidt, R. A. .-“Charge and impedance analysis of 4500/plus hours of electrical stimulation of sacral roots with a foramen electrode implant” - Proceedings of the 18th Annual International Conference of the IEEE Engineering in Medicine and Biology Society.

Rajitha Aluru; (Austin, TX), Doug Evans, David Cox, Jean Woloszko, Johnson Goode, Philip Tetzlaff, Gerardo Molina “Systems and methods for turbinate reduction [9,254,166] February 9, 2016 ENDYMED Ex. 1025 Page 21 of 27

I have over 25 years of experience translating thousands of technical, legal, and business documents from Korean to English submitted to, among others, various U.S. federal courts and the U.S. International Trade Commission

(57) Abstract The present invention relates to a skin regeneration apparatus used for performing multi-hole procedures to remove or treat stretch marks, calluses, wrinkles, hair loss, scars, etc.

The present invention works with a mechanism that enables hundreds to tens of thousands of holes created on the human skin, as the needle assembly repeats this linear motion.

<62> After the preparation step is completed as described above, the end of the guide cap 21 mounted to the gunpoint of the gun 13 is placed on the skin area to be treated, the switch 22 is pressed to drive the motor 14.

<63> As described above, the process of reciprocating operation of the microneedles is repeated multiple times by repetitively driving the motor back and forth, allowing creation of hundreds to tens of thousands of holes on the human skin.