`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`17.0. Box 1450
`Alexandria, Virginia 22313-1450
`www.usplo.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`90/009,625
`
`10/28/2009
`
`‘
`
`'6482 I 99
`
`7590
`
`‘
`
`03/12/2010
`
`Joseph Neev c/o
`Y-BEAM TECHNOLOGIES, INC.
`20321 Lake Forest Drive
`Suite D-6
`Lake Forest, CA 92630
`
`'
`
`4434
`
`EXAMINER
`
`,
`
`'
`
`DATE MAILED: 03/12/2010
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
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`f-‘EQQICQ, SLAKHMQ <1 LAG: BEQMAAIJ LLC
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`CLXTKQ ATWA N (90 NStg
`
`PTO-90C (Rev. 10/03)
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 1
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 1
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Commissioner for Patents
`United States Patents and Trademark Office
`P.O.Box 1450
`Alexandria, VA 22313-1450
`"
`www.uspto. gov
`
`THIRD PARTY REQUESTER'S CORRESPONDENCE ADDRESS
`
`Date:
`
`Scott Catlin
`
`ABBOTT MEDICAL OPTICS INC.
`
`1700 East St. Andrew Place
`
`Santa Ana, CA 92705
`
`EX PARTE REEXAMINATION COMMUNICATION TRANSMITTAL FORM
`
`REEXAMINATION CONTROL NO. : 90009625
`
`PATENT NO. : 6482199
`
`ART UNIT : 3993
`
`Enclosed is a copy of the latest communication from the United States Patent and Trademark
`Office in the above identified ex parte reexamination proceeding (37 CFR 1.550(f)).
`
`Where this copy is supplied after the reply by requester, 37 CFR 1.535, or the time for filing a
`reply has passed, no submission on behalf of the ex parte reexamination requester will be
`acknowledged or considered (37 CFR 1.550(9)).
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 2
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 2
`
`
`
`
`
`Control No.
`90/009,625
`
`Patent Under Reexamination
`6482199
`
`Art Unit
`3993
`
`
`
`Office Action in Ex Parte Reexamination
`Examiner
`BEVERLY M. FLANAGAN
`
`
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`
`
`
`
`bl] This action is made FINAL.
`.
`alj Responsive to the communication(s) filed on
`CIXI A statement under 37 CFR 1.530 has not been received from the patent owner.
`
`
`A shortened statutory period for response to this action is set to expire g month(s) from the mailing date of this letter.
`Failure to respond within the period for response will result in termination of the proceeding and issuance of an ex parte reexamination »
`
`certificate in accordance with this action. 37 CFR 1.550(d). EXTENSIONS OF TIME ARE GOVERNED BY 37 CFR 1.550(c).
`
`If the period for response specified above is less than thirty (30) days, a response within the statutory minimum of thirty (30) days
`will be considered timely.
`
`
`
`
`
`
`THE FOLLOWING ATTACHMENT(S) ARE PART OF THIS ACTION:
` 1. El Notice of References Cited by Examiner, PTO—892.
`3. E]
`Interview Summary, PTO-474.
`
`
`2. E]
`Information Disclosure Statement, PTO/88708.
`'4.
`[:1
`
`
`Part II
`SUMMARY OF ACTION
`
`
`
`Claims 1 and 2 are subject to reexamination.
`
`
`IZI
`Claims 3-16 are not subject to reexamination.
`
`
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`
`
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`
`
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`
`
`
`
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`
`
`
`
`
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`
`
`Part I
`
`D E
`
`Claims
`
`have been canceled in the present reexamination proceeding.
`
`] Claims __ are patentable and/or confirmed.
`
`has been (7a)l:| approved (7b)I:I disapproved.
`
`Claims 1 and 2 are rejected.
`
`Claims
`
`are objected to.
`
`E I
`
`II
`
`[:I The drawings, filed on
`are acceptable.
`E] The proposed drawing correction, filed on
`
`[:1 Acknowledgment is made of the priority claim under 35 U.S.C. § 119(a)-(d)‘or (f).
`
`a)[:l All b)l:I Some* c)EI None
`
`of the certified copies have
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`1:] been received.
`
`2E] . not been received.
`
`3D been filed in Application No.
`
`4:] been filed in reexamination Control No.
`
`5|:I been received by the International Bureau in PCT application No.
`* See the attached detailed Office action for a list of the certified copies not received.
`
`9. I] Since the proceeding appears to beIn condition forIssuance of an ex parte reexamination certificate except for formal
`matters, prosecution as to the merits Is closedIn accordance with the practice under Ex parte Quayle, 1935 C. D.
`
`11, 453 O G. 213
` 10. C] Other:
`
`US. Patent and Trademark Office
`
`PTOL-466 (Rev. 08-06)
`
`V
`
`'
`
`Office Action in Ex Parte Reexamination
`
`Part of Paper No. --
`Alcon Research, Ltd.
`Exhibit 1007-Page 3
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 3
`
`
`
`
`
`Application/Control Number: 90/009,625
`
`‘
`
`Page 2
`
`Art Unit: 3993
`
`DETAILEO ACTION
`
`Reexamination Procedures
`
`In order to ensure full consideration of any amendments, affidavits or
`
`declarations, or other documents as evidence of patentability, such documents must be
`
`submitted in response to this Office action. Submissions after the next Office action,
`
`which is intended to be a final action, will be governed by the requirements of 37 C.F.R.
`
`1.116, after final rejection and 37 C.F.R. 41.33 after appeal, which will be strictly
`
`enforced.
`
`Extensions of time under 37 C.F.R. 1.136(a) will not be permitted in these
`
`proceedings because the provisions of 37 C.F.R. 1.136 apply only to “an applicant" and
`
`not to parties in a reexamination proceeding. Additionally, 35 U.S.C. § 305 requires that
`
`reexamination proceedings “will be conducted with special dispatch” (37 C.F.R.
`
`1.550(a)). Extension of time in ex parte reexamination proceedings are provided for in
`
`‘
`37 C.F.R. 1.550(0).
`The patent owner is reminded‘of the continuing responsibility under 37 C.F.R.
`
`1.565(a) to apprise the Office of any litigation activity, or other prior or concurrent
`
`proceeding, involving Patent No. 6,482,199 throughout the course of this reexamination
`
`proceeding. The third party requester is also reminded of the ability of similarly apprise
`
`the Office of any such activity or proceeding throughout the course of this reexamination
`
`proceeding. See MPEP §§ 2207, 2282 and 2286.
`
`Patent owner is notified that any proposed amendment to the specification and/or
`
`claims in this reexamination proceeding must comply with 37 C.F.R. 1.530(d)-(j), must
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 4
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 4
`
`
`
`Application/Control Number: 90/009,625
`Art Unit: 3993
`
`Page 3
`
`be formally presented pursuant to 37 C.F.R. 1.52(a) and (b), and must contain any fees
`
`required by 37 C.F.R. 1.20(c).
`
`After the filing of a request for reexamination by a third party requester, any
`
`document filed by either the patent owner or the third party requested must be served
`
`on the other party (or parties where two or more third party requested proceedings are
`
`merged) in the reexamination proceeding in the manner provided in 37 C.F.R. 1.248.
`
`See 37 C.F.R. 1.550(r).
`
`Patent Owner’s Statement
`
`No timely patent owner’s statement has been filed.
`
`Claim Rejections - 35 USC § 102
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
`
`' A person shall be entitled to a patent unless -
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in public
`use or on sale in this country, more than one year prior to the date of application for patent in the United
`States.
`
`Claims 1 and 2 are rejected under 35 U.S.C. 102(b) as being anticipated by Bille.
`
`In regard to claims 1 and 2, Bille teaches a method for varying the volumetric
`
`power density of the laser to vary the rate of material modification from zero, through a
`transition range of tissue modification, to complete ablation (see col. 3, lines 50-54 and
`
`col. 7, lines 28-46). Bille also teaches, through the recitation of a “quasi-continuous
`
`laser beam” a pulsed laser that emits a continuous stream of discrete pulses. For
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 5
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 5
`
`
`
`Application/Control Number: 90/009,625
`
`'
`
`Page 4
`
`Art Unit: 3993
`
`example, Fig. 1A shows two “emissions” (pulses) in a string of more that 10,000
`
`emissions per second where each emission has a peak energy intensity of 10
`
`megawatts and a duration 14 as short as 1 picosecond (see col. 4, lines 49-64).
`
`Between the emissions-is a quiescent period 17, which is substantially and significantly
`
`larger than duration 14 (see col. 4, lines 49-64). Bille also teaches that, by adjusting the
`
`laser parameters, one can very the volumetric power density of each pulse from a very
`
`low level up to the point where the volumetric power density exceeds a threshold at
`
`which the tissue is modified and beyond, to a threshold at which the tissue is ablated
`
`(see col. 7,» lines 28-46). Bille teaches that the volumetric power density may be varied
`
`by changing the beam intensity, by altering the focus and therefore, the spot size, or by
`
`changing the pulse duration (see col. 5, line 62 through col. 6, line 5). Bille also teaches
`
`that the beam intensity can be changed during the operation of the pulse source in
`
`internal ablation procedures (see col. 6, lines 5-8). Bille also teaches material
`modification in the form of water evaporated from the tissue and intermolecular bonds
`
`are broken to change the visco-elastic properties of the material (photoablation) (see
`
`col. 8, lines 35-37), which equates to at least two different forms of material
`
`modification: ablation and alteration of viscoelastic properties (see also col. 6, lines 31-
`
`43). Bille also teaches an interval between pulses that is long enough .to allow
`
`interaction energy transients caused by the electromagnetic radiation pulse to
`
`substantially decay so that material modification is effected (see page 31 of the request,
`
`detailing the disclosure of Bille and pointing out that the down time between pulses is
`
`about 100 times longer than that taught by US. Patent No. 6,482,199). Bille also
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 6
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 6
`
`
`
`Application/Control Number: 90/009,625
`
`Page 5
`
`Art Unit: 3993
`
`’
`
`teaches a repetition rate of 10,000 repetitions per second (see col. 5, lines 8-10). Bille
`
`also teaches focusing the beam at a particular depth below the surface, so as to
`
`achieve the desired volumetric power density at that point (see col. 6, lines 5-8).
`
`In
`
`order for the light to reach that depth, the wavelength of the incident light must be
`
`matched to the material such that the material is substantially transparent to the linear
`
`propagation of light. Near-infra red light applied to biological tissue, Such as the cornea,
`
`--is an example (see col. 10, lines 30-45).
`
`Claim 1 is rejected under 35 U.S.C. 102(b) as being anticipated by Niemz.
`
`Niemz teaches ablating the cornea in a controlled manner with a pulsed laser, by
`
`placing 50 lines, one of top of the other, in order to ablate for depth and working with a
`
`spot size that allowed two spots to be situated only 15 microns apart (see page 428).
`
`The depth of ablation resulting is a direct function of the radiation energy, allowing
`
`controlled an predictable ablation (material modification) (see page 430). The
`
`operational parameters of the laser are such that the power absorbed by the cornea
`exceeds the "plasma threshold" (see page 426). Niemz teaches a pulsed laser that
`
`generated an output of pulses having a width or duration of about 60 picoseconds (see
`
`page 427). Niemz teaches that, to obtain the desired plasma-mediated interation, one
`must increase the energy density until visible sparking, indicating formation of a plasma,
`
`occurs (see pages 426-428). Niemz teaches that the combination of low pulse energy,
`
`picosecond pulse widths and small minimum spot size provides an extremely high peak
`
`power density of 10 12W/cm2, and fluence of 100 J/cmz, which exceeds the
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 7
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 7
`
`
`
`Application/Control Number: 90/009,625
`
`Page6
`
`Art Unit: 3993
`
`'
`
`requirements to achieve plasma-mediated ablation (see pages 426—428). Niemz
`
`teaches that the rapid expansion of the plasma causes a shock wave (see page 430).
`
`Niemz provides several photographs of the modified material. Niemz also teaches a
`
`pulse repetition rate of 1kHz or 1000 pulses per second (see page 427).
`
`Claims 1 and 2 are rejected under 35 U.S.C. 102(b) as being anticipated by
`
`Juhasz.
`
`In regard to claims 1 and 2, Juhasz teaches ablating the cornea in a controlled
`
`manner with a laser where the beam is focused down to a 5 uM spot, the energy per
`
`pulse is variable and the pulse repetition rate is controlled within a range (see pages 24—
`
`25). The operational parameters of the laser are such that the power absorbed by the
`
`cornea exceeds a threshold at which cavitation bubbles are observed, which are
`
`associated with plasma formation and photodisruption forms (see page 25). Juhasz
`
`teaches working with a pulse laser that generated an output of pulses having a width or
`
`duration of about 150 femtoseconds (see page 24). Juhasz also teaches that the
`
`interaction energy transients that take the form of a shock wave with decay as it loses
`energy, until it becomes harmless (see page 27). Juhasz teaches that to ensure decay,
`
`avoiding overlaying two pulses is avoided (see page 30). Juhasz also teaches a pulse
`
`repetition rate of between 25 Hz and 1 kHz. Furthermore, since cavitation bubbles area
`
`below some layers or portion of the cornea, the corneal tissue must at least be in part
`
`transparent to linear beam propagation (see page 29).
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 8
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 8
`
`
`
`Application/Control Number: 90/009,625
`
`Page 7
`
`Art Unit: 3993
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`Claims 1 and 2 are rejected under 35 U.S.C. 103(a) as being unpatentable over
`
`Jacques in view of Bille.
`
`Inregard to claims 1 and 2, Jacques teaches several different types of material
`
`modification, including photochemical ablation, photothermal ablation and
`
`photomechanical ablation, as well as non-ablative modifications of tissue such as
`
`coagulation, using pulsed lasers having pulse durations ranging between the low
`
`picoseconds and ten milliseconds (see Fig. 13 and page 555). Jacques also teaches
`
`laser having an output beam made up of a series of pulses of laser light, the pulse
`
`widths varying from 100 femtoseconds to 500 milliseconds (see page 536). Jacques
`
`also teaches that, to obtain a desired laser-tissue effect, one must turn up the laser
`
`power (intensity) until, at some “threshold laser exposure", the effect is achieved (see
`
`page 531). Jacques also discloses the importance of the combination of fluence
`
`(energy over a particular surface area) and depth of penetration in determining ablation
`
`(see page 541). Jacques also teaches that at a certain energy level, photochemical
`ablation will occur (see page 543). Jacques also teaches the photomechanical effects
`of laser-tissue interaction, such as ablation at the surface or cellular damage within the
`
`tissue and photochemical effects , such as cross-linking and oxidative injury (see page
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 9
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 9
`
`
`
`Application/Control Number: 90/009,625
`
`Page 8
`
`Art Unit: 3993
`
`'
`
`‘
`
`550).
`
`Jacques is not directed at operating specifics of the laser. However, Bille
`
`discloses that, by adjusting the laser parameters, one can very the volumetric power
`
`density of each pulse from a very low level up to the point where the volumetric power
`
`density exceeds a threshold at which the tissue is modified and beyond, to a threshold
`
`at which the tissue is ablated (see col. 7, lines 28-46). Bille teaches that the volumetric
`
`power density may be varied by changing the beam intensity, by altering the focus and
`
`therefore, the spot size, or by changing the pulse duration (see col. 5, line 62 through
`
`col. 6, line 5). Bille also teaches that the beam intensity can be changed during the
`
`operation of the pulse source in internal ablation procedures (see col. 6, lines 5-8). Bille
`
`also teaches material modification in the form of water evaporated from the tissue and
`
`intermolecular bonds are broken to change the visco-elastic properties of the material
`
`(photoablation) (see col. 8, lines 35-37), which equates to at least two different forms of
`
`material modification: ablation and alteration of viscoelastic properties (see also col. 6,
`
`lines 31-43). Bille also teaches an interval between pulses that is long enough to allow
`interaction energy transients caused by the electromagnetic radiation pulse to
`
`I
`
`substantially decay so that material modification is effected (see page 31 of the request,
`
`detailing the disclosure of Bille and pointing out that the down time between pUlses is
`
`about 100 times longer than that taught by US. Patent No. 6,482,199). Bille also
`
`teaches a repetition rate of 10,000 repetitions per second (see col. 5, lines 8-10). Bille
`
`also teaches focusing the beam at a particular depth below the surface, so as to
`
`achieve the desired volumetric power density at that point (see col. 6, lines 5-8).
`
`In
`
`order for the light to reach that depth, the wavelength of the incident light must be
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 10
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 10
`
`
`
`Application/Control Number: 90/009,625
`
`Art Unit: 3993
`
`Page 9
`
`‘ matched to the material such that the material is substantially transparent to the linear
`
`propagation of light. Near-infra red light applied to biological tissue, such as the cornea,
`
`is an example (see col. 10, lines 30-45). As Bille teaches a similar device and method
`
`and, as such, one of ordinary skill in the art would be motivated to turn to Bille to teach
`
`the operating parameters of the laser and to apply'these applications to Jacques.
`
`Scope of Reexamination
`
`Since requester did not request reexamination of claims 3-16 and did not assert
`
`the existence of a substantial new question of patentability (SNQP) for such claims
`
`(see 35 U.S.C. § 311(b)(2); see also 37 CFR 1.915b and 1.923), such claims will not be
`
`reexamined. This matter was squarely addressed in Sony Computer Entertainment
`
`America Inc., et al. v. Jon W Dudas, Civil Action No. 1:050V1447.(E.D.Va. May 22,
`
`2006), Slip Copy, 2006 WL 1472462.
`
`(Not Reported in F.Supp.2d.) The District Court
`
`upheld the Office's discretion to not reexamine claims in an inter partes reexamination
`
`proceeding other than those claims for which reexamination had specifically been
`
`requested. The Court stated:
`
`To be sure, a party may seek, and the PTO may grant, inter
`partes review of each and every claim of a patent. Moreover,
`while the PTO in its discretion may review claims fOr which inter
`partesreview was not requested, nothing in the statute compels
`it to do so. To ensure that the PTO considers a claim for inter
`partes review, § 311(b)(2)
`requires that
`the party seeking
`reexamination demonstrate why the PTO should reexamine
`each and every claim for which it seeks review. Here,
`it
`is
`undisputed that Sony did not seek review of every claim under
`the '213 and '333 patents. Accordingly, Sony cannot now claim
`that the PTO wrongly failed to reexamine claims for which Sony
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 11
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 11
`
`
`
`Application/Control Number: 90/009,625
`
`Page 10
`
`Art Unit: 3993
`
`never requested review, and its argument that AIPA compels a
`contrary result is unpersuasive.
`
`(Slip copy at page 9.)
`
`The Sony decision’s reasoning and statutory interpretation apply analogously to
`
`ex parte reexamination, as the same relevant statutory language applies to both inter
`
`partes and ex parte reexamination. 35 U.S.C. § 302 provides that the ex parte
`
`reexamination “request must set forth the pertinency and manner of applying cited prior
`
`art to evem claim for which reexamination is regueste " (emphasis: added), and 35
`U.S.C. § 303 provides that “the Director will determine whether a substantial new I
`
`question of patentability affecting any claim of the patent concerned is raised by the
`
`Lem...” (Emphasis added). These provisions are analogous to the language of 35
`
`U.S.C. § 311(b)(2) and 35 U.S.C. § 312 applied and construed in Sony, and would be
`
`. construed in the same manner. As the Director can decline to reexamine nbn-
`
`requested claims in an inter partes reexamination proceeding, the Director can likewise
`
`do so in ex parte reexamination proceeding. S_e§ Notice of Clarification of Office Policy
`
`To Exercise'Discretion in Reexamining Fewer Than All the Patent Claims (signed Oct.
`
`5, 2006) 1311 0G 197 (Oct. 31, 2006). fiaisg MPEP § 2240, Rev. 5, Aug. 2006.
`
`4
`
`Therefore, claims 3-16 will not be reexamined in this inter partes reexamination
`
`proceeding.
`
`' Alcon Research, Ltd.
`Exhibit 1007 - Page 12
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 12
`
`
`
`Application/Control Number: 90/009,625
`Art Unit: 3993
`
`Page 11
`
`Please mail any communications to:
`
`Conclusion
`
`Attn: Mail Stop “Ex Parte Reexam"
`Central Reexamination Unit
`
`Commissioner for Patents
`P.O. Box1450 ‘
`
`Alexandria, VA 22313-1450
`
`Please FAX any communications to:
`
`(571) 273-9900
`Central Reexamination Unit
`
`Please hand-deliver any communications to:
`
`Customer Service Window
`
`Attn: Central Reexamination Unit
`
`Randolph Building, Lobby Level
`401 Dulaney Street
`Alexandria, VA 22314
`
`Any inquiry concerning this communication or earlier communications from the
`Examiner, or as to the status of this proceeding, should be directed to the Central.
`Reexamination Unit at'telephone number (571) 272-7705.
`
`Signed:
`
`IBeverly M. Flanagan/
`
`Beverly M. Flanagan
`CRU Examiner
`
`GAU 3993
`
`(571) 272-4766
`
`Conferee:/J RJ/
`
`Conferee:
`
`fl
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 13
`
`Alcon Research, Ltd.
`Exhibit 1007 - Page 13
`
`