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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Election/Restrictions
Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on June 9, 2025.
Applicant argues without rationale or support that no search burden is present.
Applicant’s opinion is insufficient and unpersuasive to traverse the present election requirement.
Claim Objections
Claims 6, 12, and 18 are objected to because of the following informalities: claims 6, 12, and 18 note a “ciliary boy” instead of ciliary body. Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 7, 8, 13, and 14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by U.S. PG Pub. 2019/0105519 A1 to Herekar et al. or, in the alternative, under 35 U.S.C. 103 as obvious over Herekar in view of U.S. PG Pub. No. 2018/0104514 A1 to Gertner et al.
Regarding claims 1, 7, and 13, Herekar discloses a system, method, and CRM for imaging and treating an eye of a patient, comprising: one or more ultrasound transducers; a positioning mechanism that displaces the one or more ultrasound transducers into a desired location relative to an eye of the patient; wherein: in a first mode, the one or more ultrasound transducers emits ultrasound energy at a first range of frequencies to acquire an image of at least a portion of the eye of the patient; and in a second mode, the one or more ultrasound transducers emits ultrasound energy at a second range of frequencies to alter a physical characteristic of the eye, wherein the first range of frequencies is different than the second range of frequencies (see Figs. 1D, 2, 14A, 36, and 38 and para 4-22, 193-198, 201-203, 210-212 and 240).
It appears a skilled artisan would know that imaging and treatment frequencies are different. However, in the alternative Gertner discloses a similar ultrasound imaging and treatment scheme of the eye, wherein different frequencies are used for imaging and treatment (see para 76, 77, 469, 480, 489, 502,509, and 510).
It would have been obvious and predictable to have used different frequencies for the imaging and treatment of the eye because doing so would optimize the imaging frequency and would optimize different treatment effects based on frequency.
Regarding claims 2, 8, and 14, Herekar discloses a device, method, and CRM, wherein in the first and second modes the positioning mechanism is in a common spatial location, wherein the at least a portion of the eye comprises a ciliary body and/or trabecular meshwork, wherein the image of the at least a portion of the eye comprises an image of the ciliary body and trabecular meshwork, and wherein the physical characteristic of the eye is one or more of an intraocular pressure, radius of a cornea, radius of a lens, cornea thickness, lens thickness, angle between peripheral edges of the lens and cornea, angle between peripheral edges of the iris and cornea, on-axis distance between an anterior surface of the cornea and the anterior surface of the lens, on axis distance between a posterior surface of the cornea and the posterior surface of the lens, on axis distance between the posterior surface of the lens and the anterior surface of the retina, sclera parameter, and iris/pupil ratio (see Figs. 1D, 2, 14A, 36, and 38 and para 4-22, 193-198, 201-203, 210-212 and 240, noting that imaging and treatment elements are combined in Herekar and that imaging and treatment occurs simultaneously, which reads on the first element of the wherein clause).
Claims 3, 9, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Herekar or Herekar and Gertner as applied to claims 2, 8, and 14 above, and further in view of U.S. PG Pub. No. 2014/0009741 A1 to Levien et al.
Regarding claims 3, 9, and 15, Herekar discloses a device, method, and CRM wherein in a first mode images of the ciliary body and trabecular meshwork are created, and wherein, in the second mode, the one or more transducers ablates at least a portion of the ciliary body and/or vibrates the trabecular mesh (see Figs. 1D, 2, 14A, 36, and 38 and para 4-22, 193-198, 201-203, 210-212 and 240).
Herekar however does not indicate if A or B mode scanning is used.
Levien discloses a similar eye imaging scheme, comprising a plurality of A-scan images of the at least a portion of an eye of a patient, and further comprising a processor that converts the plurality of A-scans to a plurality of B-scans (see para 97).
It would have been obvious and predictable to have used and substituted A mode to B mode scanning as taught in Levien because doing so would predictably provide the images already taught in Herekar so that treatment of the eye could be targeted to specific portions of the eye and so that treatment could be monitored over time.
Claims 4, 10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Herekar and Levien or Herekar, Gertner, and Levien as applied to claims 3, 9, and 15 above, and further in view of U.S. PG Pub. No. 2002/0055736 A1 to Horn et al.
Regarding claims 4, 10, and 16 Herekar and Gertner discloses a device, method, and CRM, wherein a mode frequency of the first range of frequencies is different than a mode frequency of the second range of frequencies (see citations and reasons to combine for claim 1).
Further, Horn discloses a similar eye imaging scheme, comprising a processor; and
a computer readable medium comprising a set of instructions that, when executed by the processor, cause the processor to: determine, from a first image of the at least a portion of the eye, a first set of measurements, the first image being acquired before second mode and from a second image of the at least a portion of the eye, a second set of measurements, the second image being acquired after the second mode; and compare the first and second sets of measurements to determine a degree of alteration of the physical characteristic of the eye (see para 116-118).
It would have been obvious and predictable to add monitoring of the treatments already taught in Herekar and Gertner because doing so would assist the suer in determining if the treatment was effective, complete, and/or incomplete.
Claims 5, 11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Herekar or Herekar and Gertner as applied to claims 1, 8, and 14 above, or also further in view of the skill in the art.
Regarding claims 5, 11, and 17, Herekar discloses a device, method, and CRM, wherein the physical characteristic of the eye comprises an angle between peripheral edges of the lens and cornea, an angle between a back of the sclera and/or cornea and the front of the iris, and/or a dimension or angle of the sclera, wherein in the first and second modes the one or more transducers have a commonly positioned focal point, wherein a median frequency of the first range of frequencies is different than a median frequency of the second range of frequencies and wherein a mean frequency of the first range of frequencies is different than a mean frequency of the second range of frequencies (see Figs. 1D, 2, 14A, 36, and 38 and para 4-22, 193-198, 201-203, 210-212 and 240, noting that a skilled artisan would recognize that the different first and second frequencies in Herekar and Gertner would have different means and medians). Alternatively, optimizing frequencies for a given purpose is predictable and common place in the art and would have been obvious.
Examiner also notes that closed angle glaucomatous eye opening in Herekar paragraph 274 opens the same angle as Applicant claims and is directly analogous to the angles disclosed in paragraph 72 of the published application.
Examiner also takes Official Notice that changing an angle between a back of the sclera and/or cornea and the front of the iris, and/or a dimension or angle of the sclera is a well-known and obvious treatment for closed angle glaucomatous eye disease.
Claims 6, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Herekar or Herekar and Gertner as applied to claims 1, 8, and 14 above, and further in view of U.S. Patent No. 5,025,811 A to Dobrogowski et al. and the skill in the art.
Regarding claims 6, 12, and 18, Herekar and Gertner discloses a device, method, and CRM, wherein the one or more ultrasound transducers emit ultrasound energy at a second range of frequencies to treat the ciliary body and the one or more ultrasound transducers vibrating a trabecular meshwork of the eye, wherein the second range of frequencies is different than the third range of frequencies (see citations and reasons to combine for claim 1).
Further, Dobrogowski discloses a similar treatment for reducing intraocular pressure, wherein the second mode comprises: ablating a ciliary body of the eye (see col 2 ln 1-8).
Lastly, Examiner takes Official Notice that ultrasound ablation is a known and predictable substitute for laser ablation.
It would have been obvious and predictable to have combined the teachings of Herekar, Dobrogowski, and the skill in the art because doing so would predictably provide a lasting treatment for high intraocular pressure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJEEV P SIRIPURAPU whose telephone number is (571)270-3085. The examiner can normally be reached 9-5 M-F.
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/RAJEEV P SIRIPURAPU/Primary Examiner, Art Unit 3798