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 and amendments, see pages 11-13, filed 7/21/2025, with respect to the rejection(s) of claim(s) 1, 4-17, and 20-32 under USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Homer (US 11278452 B1) in view of Holland (US 2021/0220176 A1).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-17, 20-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1, 17, and 29, there is insufficient description as to explain the interaction between the photodisruptive energy to disrupt an ocular tissue at the focus to an elemental gas. The only mention of elemental gas disrupted are Para. 7 and 35, but do not give sufficient detail as to how it works.
The respective dependent claims do not remedy the 112 issues, therefore are also rejected.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-17, 20-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1, 4-17, 20-32, the language “energy sufficient to disrupt the ocular tissue at the focus to an elemental gas” is unclear about the interaction of the energy with regards to the focus and the elemental gas. For example, it is not clear what the role the elemental gas has with regards to the ocular tissue disruption at a focus. Further clarification is needed.
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) 1-7, 10-23, and 26-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Homer (US 11278452 B1) in view of Holland (US 2021/0220176 A1).
Regarding claim 1, 17, and 29, Homer discloses a method of photodisrupting a target volume of ocular tissue of an eye with a laser (eg. Abstract, Col. 10, Ln. 40- Col. 14, Ln. 30, Col. 17, Ln. 17, Fig. 1-9), the method comprising: determining an energy parameter based on pigmentation of the target volume of ocular tissue (eg. Fig. 3, Col. 2, Ln. 20-54, Col. 16, Ln. 40 – Col. 18, Ln. 10,); placing a focus of a laser at an initial location within the target volume of ocular tissue (eg. Col. 14, Ln. 43-Col. 15, Ln. 17 and another embodiment, Fig. 7, Col. 25, Ln. 1-61); and applying photodisruptive energy by the laser at the initial location based on the energy parameter (eg. Abstract, Fig. 2, Col. 5, Ln. 15-Col. 6, Ln. 67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the embodiments of the laser mapping and the tilt/rangefinder (eg. Fig. 2-3 and 7) to provide the predictable result of reducing inefficacious treatment or injury (eg. Col. 25, Ln. 1-26). Homer does not disclose photodisruptive energy sufficient to disrupt the ocular tissue at the focus to an elemental gas and repeating the placing and applying at one or more subsequent locations within the target volume of the ocular tissue until the focus of the laser has scanned through the target volume of ocular tissue to form the aperture.
Holland teaches an ocular laser device that produces openings by repeatedly scanning and repeating firings to disrupt gas bubbles at a focus and create openings (eg. 138-152, 176-179, 182, 224-229 Fig. 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Homer with the repeated air bubble photodisruption as taught by Holland as a known method in the art for forming openings in the ocular tissue.
Regarding claims 4 and 20, the combined invention of Homer and Holland discloses the energy parameter corresponds to a minimum energy level that ensures photodisruption at the initial location and the one or more subsequent locations (eg. Col. 2, Ln. 53- Col. 3, LN. 31, Coil. 9, Ln. 1- Col.10, Ln. 1, Claim 1, determining MRE values).
Regarding claims 5, 21, and 30, the combined invention of Homer and Holland discloses determining an energy parameter based on pigmentation of the target volume of ocular tissue comprises: obtaining, with an image sensor, a color image of the target volume of ocular tissue; determining a composite pigmentation metric for the target volume of ocular tissue based on comparisons of colors present in the color image and a reference color; and determining the energy parameter based on the composite pigmentation metric (eg. Fig. 1-9, Col. 16-Ln. 40-Col. 20, Ln. 55).
Regarding claims 6, 22, and 31, the combined invention of Homer and Holland discloses the color image comprises an array of pixels and each of the colors present in the color image corresponds to a color of a pixel, and determining a composite pigmentation metric for the target volume of ocular tissue comprises: for each of a plurality of pixels, determining an individual pigmentation metric based on the color of the pixel and the reference color; and determining the composite pigmentation metric based on the plurality of individual pigmentation metrics (eg. Fig. 1-9, Col. 16-Ln. 40-Col. 20, Ln. 55).
Regarding claims 7 and 23, the combined invention of Homer and Holland discloses determining the composite pigmentation metric based on the plurality of individual pigmentation metrics comprises calculating an average of the plurality of individual pigmentation metrics. (eg. Col. 17, Ln. 65- Col. 18, Ln. 9).
Regarding claim 10, the combined invention of Homer and Holland discloses the reference color corresponds to the darkest color in the target volume (eg. Fig. 1-9, Col. 16-Ln. 40-Col. 20, Ln. 55).
Regarding claims 11 and 26, Homer discloses determining the composite pigmentation metric based on the plurality of individual pigmentation metrics comprises calculating an average of the plurality of individual pigmentation metrics based on the claimed equation (eg. Fig. 1-9, Col. 16-Ln. 40-Col. 20, Ln. 55). The Examiner notes that this is just the well-known average formula applied to a series of however many pixels are designated.
Regarding claims 12 and 27, the combined invention of Homer and Holland discloses determining the energy parameter based on pigmentation comprises: comparing the composite pigmentation metric to a plurality of different pigmentation metrics, each having an associated energy parameter: and identifying which of the plurality of different pigmentation metrics the composite pigmentation metric is closest to and selecting the associated energy parameter of identified pigmentation metric as the energy parameter (eg. Fig. 1-9, Col. 16-Ln. 40-Col. 20, Ln. 55).
Regarding claims 13, the combined invention of Homer and Holland discloses the target volume of ocular tissue is at a first location around a circumferential angle of the eye, and the method further comprises: repeating the determining, the placing, and the applying for a second volume of ocular tissue at a second location around the circumferential angle of the eye different from the first location (Eg. Col. 9, Ln. 1-11, Fig. 1-9, Col. 16-Ln. 40-Col. 20, Ln. 55).
Regarding claim 14, the combined invention of Homer and Holland discloses the target volume of ocular tissue is in one of an irido-corneal angle, a cornea, a crystalline lens, a posterior capsule of the lens, an anterior capsule of the lens. a vitreous humor, and a retina (Eg. Col. 9, Ln. 1-11, Fig. 1-9, Col. 16-Ln. 40-Col. 20, Ln. 55).
Regarding claim 15, the combined invention of Homer and Holland discloses the target volume of ocular tissue is in a trabecular meshwork of the eye (eg. Col. 12, Ln. 20-45).
Regarding claims 16, 28, and 32, the combined invention of Homer and Holland discloses determining an energy parameter based on pigmentation of the target volume of ocular tissue comprises: obtaining, with an image sensor, a color image of the target volume of ocular tissue; applying the color image to a clustering algorithm configured to partition the color image into a plurality of clusters of pixels, wherein each pixel in a cluster has a similar color profile; and determining the energy parameter based on the cluster that includes a pixel associated with the initial location (eg. Fig. 1-9, Col. 16-Ln. 40-Col. 20, Ln. 55).
Allowable Subject Matter
Claims 8-9, and 24-25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J LAU/Examiner, Art Unit 3796
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