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 .
Response to Arguments
Applicant's arguments filed 12/04/2025 have been fully considered and are not fully persuasive.
Applicant argues that the previously cited prior art does not teach the beam stimulation parameters as limited in the amended independent claim. Applicant states that the prior art does not teach a pulsed laser radiation, wherein the laser is pulsed with a pulse duration that is less than 1 us and an energy that is less than 5 mJ per pulse.
The alleged discrepancy between the prior art and the claimed invention hinges on the assertion that there would be no motivation to combine the stem-cell stimulating laser radiation of Tedford with the femtosecond laser source taught by Wang. Applicant argues that the prior art of Wang is directed to a laser which damages tissue in the form of liquefying the vitreous humor of an eye whereas the prior art of Tedford specifies that tissue remains undamaged.
Examiner can appreciate Applicant’s arguments, however, Examiner asserts that the prior art of Wang is introduced to show support for the modulation of radiation pulse parameters in which a pulse duration is shortened while maintaining a desired pulse energy in order to account for the safety of tissues surrounding the site of interest. Examiner thereby offers a rejection of the claims detailed below in view of Tedford and optionally in view of Wang, wherein the radiation parameters as taught by Wang are relied upon to establish that reducing the pulse time does not prevent the applied pulsed laser radiation from achieving the desired energy.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 05/24/2022, 08/04/2022, 11/03/2022, 02/02/2023, 05/06/2023, 08/22/2023, 12/27/2023, 04/08/2024, 04/18/2024, 07/18/2024, 11/21/2024, and 03/30/2025 have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 86-89 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 86-89, which depend upon amended claim 73, recite a broader or unincluded range than presented in the parent claim, and therefore fail to further limit the claim.
Claim 73 recites the limitation of a laser configured to emit laser radiation, wherein the laser radiation is pulsed, with a pulse duration that is less than 1 us and an energy that is less than 5 mJ per pulse.
Claim 86, which depends from claim 73, limits the pulsed laser radiation with a pulse duration that is between 1ms and 500ms and an energy that is less than 100mJ per pulse. The claimed pulse energy presents a broader range than the parent claim, and the claimed pulse duration presents a range that is separate from the range of the parent claim and has no overlap.
Claim 87, which depends from claim 86, limits the pulse duration to less than 50ms. Claim 88, which depends from claim 86, limits the energy per pulse to less than 50mJ. Both of these limitations present a broader range than the range presented in claim 73.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 73, 75, and 83-89 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tedford et al (US 20190142636) in view of Smith (US 5537164 A) and Luttrull et al (US 20150157498 A1) and optionally in view of Wang et al (US 20200038241 A1).
Regarding claim 73, Tedford teaches an apparatus for treating an eye of a patient (see [0002]; ophthalmic phototherapy device), the apparatus comprising:
an optical unit (see Fig. 1; device 100), comprising:
a laser (see Fig. 4; light engine 420, light sources 422a, 422b, 422c), which is configured to emit laser radiation (see [0063]; light emitted from the light sources 422a, 422b, 422c forms light beams 430a, 430b, 430c, [0064]; in some embodiments laser diodes are used);
wherein the laser radiation is pulsed (see [0115]; pulsed light beam), with an energy that is less than 5 mJ per pulse (see [0108]; the pulsed light beam has an energy or fluence per pulse between 0.001 uJ/cm2 to 150 J/cm2);
one or more mirrors positioned around an optical axis of the eye (see Fig. 5, [0069]; one or more mirrors 534); and
beam conditioning and scanning optics, which are configured to focus and direct the laser radiation to reflect from the one or more mirrors to impinge on an anterior surface of the eye (see [0086]; Spatial Light Modulator (SLM) to precisely shape and control the exposed area on the retina. The SLM may be an LCOS panel, scanning mirror, deformable mirror array, or other modulation device, [0138]);
and a controller (see [0088]; programmable controller includes a logic circuit, a clock coupled to the logic circuit, and an interface coupled to the logic circuit), which is configured to control the optical unit so that the laser radiation impinges on the eye at the oblique angle in a set of one or more locations in a vicinity of the limbus (see [0077]; the programmable controller can be used to transmit light to specific target regions of the eye according to a therapeutic regimen) with a fluence selected so as to stimulate stem cells at the one or more locations (see [0048]; to promote the proliferation, migration and regenerative cellular properties of endogenous progenitor retinal stem cells for use in retinal or ocular diseases).
Tedford is silent regarding wherein the laser radiation is pulsed, with a pulse duration that is less than 1 us;
wherein the laser radiation reflects from the one or more mirrors so as to impinge on an anterior surface of the eye at an oblique angle relative to the optical axis with a beam diameter no greater than 1mm.
Tedford teaches wherein the pulsed laser radiation has an energy that is less than 5mJ per pulse (Tedford [0108]) and may have a pulse duration between 0.001 milliseconds and 150 seconds (Tedford [0129]). The pulse duration taught by Tedford of 0.001 millisecond is equivalent to 1 microsecond (us). It can be appreciated that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse duration from 1 microsecond to a pulse duration of less than 1 microsecond, for the purpose of ensuring that the temperature of any portion of the tissue does not increase more than 1 degree Celsius above the baseline (Tedford [0121]). It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05(II), In re Aller, 105 USPQ 233.
Optionally, Examiner additionally offers the prior art of Wang which teaches an apparatus for treating the eye of a patient using pulsed laser radiation (Wang [0004]) with a pulse duration that is less than 1 us and an energy that is less than 5 mJ per pulse (see Wang [0008]; a pulse width 100-1000 fs, a pulse energy of 2-20 uJ).
It can be appreciated that the pulsed laser as disclosed by Wang demonstrates that shortening the pulse duration by orders of magnitude does not preclude the radiation from achieving the desired pulse energy.
One of ordinary skill in the art would have been motivated to shorten the pulse duration as taught by Tedford with support from the teaching of Wang that a desired pulse energy may still be achieved with a short pulse width. Both teachings may demonstrate a desire to modulate the radiation parameters to most advantageously operate on a patient with regard for safety to the tissue surrounding the treatment area (Wang [0023], Tedford [0121]).
Smith (US 5537164 A) teaches wherein the laser radiation reflects from the one or more mirrors so as to impinge on an anterior surface of the eye at an oblique angle relative to the optical axis (see Smith Abstract; the portion of the beam reflected from the gonioprism anterior surface back toward the observer again undergoes partial reflection oblique to the visual axis and slight lateral displacement before reaching the observer).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the apparatus for treating an eye of a patient as taught by Tedford with the oblique reflection angle of Smith. One of ordinary skill in the art would have been motivated to make this modification in order to reduce the intensity of light reflected from the gonioprism anterior surface back toward the observer (Smith, Abstract).
Luttrull teaches a process for photostimulation of the eye tissue via subthreshold diode micropulse laser treatment (SDM), which is a clinically harmless form of photostimulation, not causing any laser induced retinal damage (Luttrull [0039]), wherein the beam diameter is no greater than 1mm (see Luttrull [0047]; small laser spots are used having a diameter of less than 1mm).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the apparatus for treating an eye as taught by Tedford and Smith with the beam diameter less than 1mm as taught by Luttrull. One of ordinary skill in the art would have been motivated to make this modification in order to avoid tissue damage by maximizing heat distribution and heat dissipation when the laser is in contact with the eye (Luttrull [0047]).
Regarding claim 75, Tedford in view of Smith, Luttrull, and optionally Wang teach the apparatus according to claim 73. Tedford also teaches wherein the controller is configured to control the optical unit (see [0077]; the programmable controller can be used to transmit light to specific target regions of the eye according to a therapeutic regimen) so that the laser radiation impinges on and stimulates the stem cells in an epithelium of the eye (see [0050]; can be used to treat one or more disease or disorders including limbal epithelial cell deficiency).
Regarding claim 83, Tedford in view of Smith, Luttrull, and optionally Wang teach the apparatus according to claim 73. Tedford teaches where the pulse duration may be between 0.001 ms and 150 seconds (Tedford [0129]). The pulse duration taught by Tedford of 0.001 millisecond is equivalent to 1 microsecond (us). It can be appreciated that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pulse duration from 1 microsecond to a pulse duration of 100ns, or 0.1us, for the purpose of ensuring that the temperature of any portion of the tissue does not increase more than 1 degree Celsius above the baseline (Tedford [0121]). It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP 2144.05(II), In re Aller, 105 USPQ 233.
Optionally, Examiner additionally offers the prior art of Wang which teaches an apparatus for treating the eye of a patient using pulsed laser radiation (Wang [0004]) with a pulse duration that is less than 100ns (see Wang [0008]; a pulse width 100-1000 fs).
It can be appreciated that the pulsed laser as disclosed by Wang demonstrates that shortening the pulse duration by orders of magnitude does not preclude the radiation from achieving a desired pulse energy.
One of ordinary skill in the art would have been motivated to shorten the pulse duration as taught by Tedford with support from the teaching of Wang that a desired pulse energy may still be achieved with a short pulse width. Both teachings may demonstrate a desire to modulate the radiation parameters to most advantageously operate on a patient with regard for safety to the tissue surrounding the treatment area (Wang [0023], Tedford [0121]).
Regarding claim 84, Tedford in view of Smith, Luttrull, and optionally Wang teach the apparatus according to claim 73. Tedford further teaches wherein the energy per pulse is less than 3mJ (see Tedford [0108]; the pulsed light beam has an energy per pulse between 0.001uJ/cm2 to 150J/cm2).
Regarding claim 85, Tedford, Smith, Luttrull, and optionally Wang teach the apparatus according to claim 73. Tedford further teaches wherein the laser radiation is focused to impinge on each of the one or more locations with a fluence less than 0.4 J/cm2 (see Tedford [0108]; the pulsed beam has a fluence per pulse between 0.01 mJ/cm2 to 100 mJ/cm2).
Regarding claim 86, Tedford, Smith, Luttrull, and optionally Wang teach the apparatus according to claim 73. Tedford further teaches wherein the laser radiation is pulsed, with a pulse duration that is between 1 ms and 500 ms (see Tedford [0129]; the pulses have a temporal pulse width between 0.5ms and 100ms) and an energy that is less than 100 mJ per pulse (see Tedford [0108]; the pulsed light beam has an energy per pulse between 0.001uJ/cm2 to 150J/cm2).
Regarding claim 87, Tedford, Smith, Luttrull, and optionally Wang teach the apparatus according to claim 86. Tedford further teaches wherein the pulse duration is less than 50 ms (see Tedford [0129]; the pulses have a temporal pulse width between 2 ms and 20 ms).
Regarding claim 88 Tedford, Smith, Luttrull, and optionally Wang teach the apparatus according to claim 86. Tedford further teaches wherein the energy per pulse is less than 50 mJ (see Tedford [0108]; the pulsed light beam has an energy per pulse between 0.001uJ/cm2 to 150J/cm2)
Regarding claim 89, Tedford, Smith, and Luttrull teach the apparatus according to claim 86. Tedford further teaches wherein the laser radiation is focused to impinge on each of the one or more locations with a fluence less than 30 J/cm2 (see Tedford [0108]; the pulsed beam has a fluence per pulse between 0.01 mJ/cm2 to 100 mJ/cm2).
Claim(s) 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tedford et al (US 20190142636) in view of Smith (US 5537164 A), Luttrull et al (US 20150157498 A1), and Belkin et al (US 20130123761), and optionally in view of Wang et al (US 20200038241 A1).
Regarding claim 74, Tedford, Smith, Luttrull, and optionally Wang teach the apparatus according to claim 73. They are silent regarding wherein the one or more mirrors comprise a ring mirror, which surrounds the optical axis.
However, Belkin teaches wherein the one or more mirrors comprise a ring mirror, which surrounds the optical axis (see Belkin [0064]; an ellipsoidal or parabolic mirror can be used that when illuminated by a large spat of light scanning along a large circle generate a small ring at its focal plane).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the apparatus as taught by Tedford, Smith, and Luttrull with a ring mirror that surrounds the optical axis as taught by Belkin. One of ordinary skill in the art would have been motivated to make this modification in order to effectively focus and direct a beam having an annular cross section in order to treat the target tissue (Belkin [0043]).
Claim(s) 76 and 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tedford et al (US 20190142636) in view of Smith (US 5537164 A) and Luttrull et al (US 20150157498 A1) with evidentiary support from Sridhar (MS. Anatomy of cornea and ocular surface. Indian J Ophthalmol. 2018 Feb;66(2):190-194. doi: 10.4103/ijo.IJO_646_17. PMID: 29380756; PMCID: PMC5819093), and optionally in view of Wang et al (US 20200038241 A1).
Regarding claims 76 and 77, Tedford, Smith, Luttrull, and optionally Wang teach the apparatus according to claim 73, wherein the controller is configured to control the optical unit (see Tedford [0077]; the programmable controller can be used to transmit light to specific target regions of the eye according to a therapeutic regimen) so that the laser radiation impinges on and stimulates the stem cells in a stroma or in an endothelium of the eye (see Tedford [0047]; the irradiated portion of the eye is a targeted region of the eye such as the cornea).
Tedford teaches targeting the cornea but does not explicitly mention the stroma or an endothelium of the eye. However, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention, that by targeting the cornea with laser light, the different layers of the cornea would also be targeted. This is evidenced by Sridhar, which discloses the well-known and well-established anatomy of the cornea, namely that the cornea consists of layers including the stroma and endothelium, see table 1.
Tedford also teaches wherein the power output of the light source can be tailored depending on the thickness of the cornea between the light source and the target tissue (Tedford [0072), which may include the cornea (Tedford [0047]). Therefore, the apparatus as taught by Tedford can transmit light to specific target regions of the eye to stimulate stem cells at various layers of the cornea, including the stroma and endothelium.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Farberov (US 20040196431 A1) teaches an optical device for intraocular observation.
Anderson et al (US 20050288745 A1) teaches a method and device for optical ophthalmic therapy.
Angeley et al (US 20110202046 A1) teaches a method and apparatus for automated placement of scanned laser capsulorhexis incisions.
Schuele et al (US 20170000647 A1) teaches a sub-nanosecond laser surgery system utilizing multiple pulsed laser beams.
THIS ACTION IS MADE FINAL. 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 ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached on 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792