DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
1. Claim(s) 1, 4, and 6-9 is/are rejected under 35 U.S.C. 103 as being obvious over Morley (US 20160302971 A1) in view of Skerl (US 20150313756 A1).
In regards to claim 1, Morley discloses a method of changing a refractive power of a cornea (Par. 0002 discloses refractive correction), the method comprising:
flattening the cornea by applying pressure through a transparent plate to the cornea (Par. 0051 discloses applanating the eye with a transparent plate to provide pressure);
during the flattening of the cornea by the transparent plate, controlling a light source to apply light energy pulses and focus the light energy pulses to a posterior corneal layer that begins at a posterior surface of the cornea and extends up to 200 pm from the posterior corneal layer toward an anterior surface of the cornea (Par. 0051 discloses a light/laser source and Par. 0070 discloses applying pulses to the eye. Par. 0102 discloses moving the pulses from the posterior surface towards the anterior surface);
and after the controlling of the light source, removing the transparent plate from contact with the anterior surface of the cornea (It is understood that the plate would have to be removed after the laser pulses were applied),
wherein the light energy pulses ionize water molecules within the posterior corneal layer to generate reactive oxygen species that cross-link collagen within the posterior corneal layer in the absence of a photosensitizer (Applicant discloses on Page 6 of their specification that the ionization of water molecules that lead to cross-linking is achieved by using a wavelength of 600 nm and 1600 nm and Par. 0047 of Morley discloses using a wavelength of 300-2500 nm. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency [Ex parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993)].).
Morley does not disclose wherein the applied pulses are below an optical breakdown threshold for the cornea. However, in the same field of endeavor, Skerl discloses a method for refractive surgery for corneal crosslinking (Abstract) wherein it is noted that pulses should be delivered with a reduced radiation (Par. 0058) in order to prevent photodisruption, i.e. below the optical breakdown threshold.
Therefore, it would have been obvious to one having ordinary skill in the art to have taken the teachings of Morley and modified them by applying the pulses with less radiation, as taught and suggested by Skerl, in order to prevent photodisruption, i.e. below the optical breakdown threshold.
In regards to claim 2, the combined teachings of Morley and Skerl discloses the method of claim 1, wherein the light source is a femtosecond laser (Morley: Par. 0047 discloses using a femtosecond laser).
In regards to claim 4, the combined teachings of Morley and Skerl discloses the method of claim 1, wherein the light energy pulses have a pulse energy between 0.1 nJ and 10 nJ (Morley: Par. 0047 discloses using a n energy of 1 nJ).
In regards to claim 5, the combined teachings of Morley and Skerl discloses the method of claim 1, wherein the light energy pulses have a wavelength between 600 nm and 1600 nm (Morley: Par. 0047 discloses using a wavelength of 300-2500 nm).
In regards to claim 6, the combined teachings of Morley and Skerl discloses the method of claim 1, wherein the light energy pulses have a wavelength that is not absorbed by amino acids in collagen (Applicant states this is laser wavelength can be in the range from about 250 nm to about 1600 nm to not absorb amino acids. Morley in Par. 0047 discloses using a wavelength of 300-2500 nm).
In regards to claim 7, the combined teachings of Morley and Skerl discloses the method of claim 1, wherein the light energy pulses are applied in a pattern (Morley: Abstract discloses application in a pattern).
2. Claim 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morley and Skerl in view of Spooner (US 20120078240 A1).
In regards to claim 3, the combined teachings of Morley and Skerl discloses method of claim 1, wherein the light energy pulses have an average power output between 10 mW and 100 mW (Morley: Par. 0044 discloses the power can be varied to the users liking but doesn’t disclose this exact power).
However, Morley does not disclose explicitly wherein the power output is between 10mW and 100 mW. On the other hand, in the same field of endeavor Spooner discloses a method for performing refractive surgery wherein the power is between 100 milliWatts and 1 Watt (Par. 0253) for the purpose of more accurately incising the cornea.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Morley and Skerl and modified them by having the power between 10-100mW, as taught and suggested by Spooner, for the purpose of more accurately incising the cornea.
3. Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morley and Skerl in view of Kurtz (US 20090171327 A1).
In regards to claim 8, the combined teachings of Morley and Skerl discloses the method of claim 9, except for wherein the pattern extends across a center of an iris posterior to the cornea. However, in the same field of endeavor, Kurtz discloses a device for applanating the eye and using a laser for refractive changes wherein the laser treatment can generate a pattern that extends across the center of an iris (Par. 0240) for the purpose of further concurrently provide lens treatment
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Morley and Skerl and modified them by having the pattern extend across the center of the iris, as taught and suggested by Kurtz for the purpose of further concurrently provide lens treatment.
4. Claim 9 and 11-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morley and Skerl and in view of Brady (US 20110077624 A1).
In regards to claim 9, the combined teachings of Morley and Skerl discloses the method of claim 9, except for wherein the pattern surrounds, but does not extend across a center of an iris posterior to the cornea. However, in the same field of endeavor, Brady discloses a method for treating the cornea wherein the pattern surrounds but does not extend across the center of the iris (Par.0062 discloses wherein the pattern surrounds but does not extend across the iris) for the purpose of providing lens accommodation.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings Morley and Skerland modified them by having the pattern surround but not extend across the iris, as taught and suggested by Brady, for the purpose of providing lens accommodation.
In regards to claim 11, Morley discloses a method of steepening a curvature of a cornea (Par. 0007 discloses modifying the curvatures of a cornea), the method comprising:
temporarily flattening the cornea by applying a transparent plate to an anterior surface of the cornea (Par. 0051 discloses applanating the eye with a transparent plate to provide pressure);
during the temporarily flattening, controlling a light source to apply light energy pulses and focus the light energy pulses to at least a corneal stroma layer of the cornea in a pattern (Par. 0051 discloses a light/laser source and Par. 0070 discloses applying pulses to the eye. Abstract discloses applying laser pulses in a pattern);
and after the controlling of the light source, removing the transparent plate (It is understood that the plate would have to be removed after the laser pulses were applied),
wherein the light energy pulses ionize water molecules within the corneal stroma layer to generate reactive oxygen species that cross-link collagen within the cornea in the absence of a photosensitizer (Applicant discloses on Page 6 of their specification that the ionization of water molecules that lead to cross-linking is achieved by using a wavelength of 600 nm and 1600 nm and Par. 0047 of Morley discloses using a wavelength of 300-2500 nm. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency [Ex parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993)].).
Morley does not disclose wherein the applied pulses are below an optical breakdown threshold for the cornea. However, in the same field of endeavor, Skerl discloses a method for refractive surgery for corneal crosslinking (Abstract) wherein it is noted that pulses should eb delivered with a reduced radiation (Par. 0058) in order to prevent photodisruption, i.e. below the optical breakdown threshold.
Therefore, it would have been obvious to one having ordinary skill in the art to have taken the teachings of Morley and modified them by applying the pulses with less radiation, as taught and suggested by Skerl, in order to prevent photodisruption, i.e. below the optical breakdown threshold.
The combined teachings of Morley and Skerl do not disclose wherein the pattern surrounds, but does not extend across a center of an iris posterior to the cornea. However, in the same field of endeavor, Brady discloses a method for treating the cornea wherein the pattern surrounds but does not extend across the center of the iris (Par.0062 discloses wherein the pattern surrounds but does not extend across the iris) for the purpose of providing lens accommodation.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings Morley and Skerl and modified them by having the pattern surround but not extend across the iris, as taught and suggested by Brady, for the purpose of providing lens accommodation.
In regards to claim 12, the combined teachings of Morley, Skerl, and Brady discloses wherein the light source is a femtosecond laser (Par. 0047 of Morley discloses using a femtosecond laser).
In regards to claim 14, the combined teachings of Morley, Skerl, and Brady discloses the method of claim 12, wherein the light energy pulses have a pulse energy between 0.1 nJ and 10 nJ (Par. 0047 of Morley discloses using a n energy of 1 nJ).
In regards to claim 15, the combined teachings of Morley, Skerl, and Brady discloses the method of claim 12, wherein the light energy pulses have a wavelength between 600 nm and 1600 nm (Par. 0047 of Morley discloses using a wavelength of 300-2500 nm).
In regards to claim 16, the combined teachings of Morley, Skerl, and Brady discloses the method of claim 12, wherein the light energy pulses have a wavelength that is not absorbed by amino acids in collagen (Applicant states this is laser wavelength can be in the range from about 250 nm to about 1600 nm to not absorb amino acids. Morley in Par. 0047 discloses using a wavelength of 300-2500 nm).
5. Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morley, Skerl, and Brady as applied to claim 12 and in view of Spooner (US 20120078240 A1).
In regards to claim 13, Morley, Skerl, and Brady as applied to claim 12 discloses method of claim 12, wherein the light energy pulses have an average power output between 10 mW and 100 mW (Par. 0044 of Morley discloses the power can be varied to the users liking but doesn’t disclose this exact power).
However, Morley, Skerl, and Brady does not disclose explicitly wherein the power output is between 10mW and 100 mW. On the other hand, in the same field of endeavor Spooner discloses a method for performing refractive surgery wherein the power is between 100 milliWatts and 1 Watt (Par. 0253) for the purpose of more accurately incising the cornea.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Morley, Skerl, and Brady and modified them by having the power between 10-100mW, as taught and suggested by Spooner, for the purpose of more accurately incising the cornea.
6. Claims 10 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morley and Skerl (or Morley, Skerl, and Brady) in view of Yavitz (US 6161546 A).
Regarding claims 10 and 17, Morley and Skerl (or Morley, Skerl, and Brady) discloses the method of claim 1 (or claim 12) except for further comprising: introducing deuterium oxide onto the cornea.
However, in the same field of endeavor, Yavitz discloses a system for treating an eye wherein deuterium oxide is introduced (col 4, lines 52-60) to aid in crosslinking. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Morley and Skerl (or Morley, Skerl, and Brady) and modified them by introducing deuterium oxide onto the cornea, as taught and suggested by Yavitz, to aid in crosslinking.
Conclusion
This is a continuation of applicant's earlier Application No. 16/936,768. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SKYLAR LINDSEY CHRISTIANSON whose telephone number is (571)272-0533. The examiner can normally be reached on Monday-Friday, 7:30-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796