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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/5/2026 has been entered.
Claim Objections
Claim 47 is objected to because of the following informalities: “for the deliver a therapeutic laser beam to the eye” should read --for the delivery of a therapeutic laser beam to the eye--, or the like. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 44 and 45 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ootsuki (US 2023/0320899, hereinafter “Ootsuki”).
In regards to claim 44, Ootsuki discloses a system comprising: a. an ophthalmic device (e.g., Figs. 1 and 3); and, b. deep learning means for providing a determined characteristic of a structure of an eye (pars. 0094, 0098-0102, 0113, 0169-0172).
In regards to claim 45, the determined characteristic is the structure of the lens (pars. 0098-0102; residual amount of the nucleus of the lens).
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.
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, 6-8, 11-14, 17, 19, 23, 24, 36-42, 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Ootsuki in view of Teuma et al. (US 2021/0378864, hereinafter “Teuma”).
In regards to claims 1 and 11, Ootsuki discloses the essential features of the claimed invention including an ophthalmic therapeutic laser system, comprising: a. an assembly, the assembly comprising: a therapeutic laser for providing a therapeutic laser beam in some arbitrary beam pattern along a laser beam path (pars. 0152-0157, 0165-0172, 0183-0184, 0191-0195); and, a deep learning means for providing a determined characteristic of a structure of an eye (e.g., par. 0094, 0098-0102, 0169-0172). Although Ootsuki strongly implies an arm attached to the assembly; the arm having a distal end and a proximal end, wherein the distal end is attached to the assembly; wherein the proximal end has a laser delivery head; wherein the arm contains a portion of the laser beam delivery path (Fig. 1 showing the arm; par. 0211 indicating that the various modules (such as the laser therapy module) are housed in a single housing, and thus providing the claimed structure in combination with Figure 1), Ootsuki does not expressly and explicitly disclose an arm attached to the assembly; the arm having a distal end and a proximal end, wherein the distal end is attached to the assembly; wherein the proximal end has a laser delivery head; wherein the arm contains a portion of the laser beam delivery path. However, Teuma in the same field of endeavor of determining characteristics of the eye in a therapy system teaches providing an arm attached to the assembly; the arm having a distal end and a proximal end, wherein the distal end is attached to the assembly; wherein the proximal end has a laser delivery head; wherein the arm contains a portion of the laser beam delivery path (Figs. 3 and 4) to provide the predictable results of improving the size of systems in operating rooms for a variety of ophthalmic procedures to thereby improve ergonomics of the operating room, time required for procedures, and patient comfort (par. 0022). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ootsuki by providing an arm attached to the assembly; the arm having a distal end and a proximal end, wherein the distal end is attached to the assembly; wherein the proximal end has a laser delivery head; wherein the arm contains a portion of the laser beam delivery path to provide the predictable results of improving the size of systems in operating rooms for a variety of ophthalmic procedures to thereby improve ergonomics of the operating room, time required for procedures, and patient comfort.
In regards to claim 2, the deep learning means provides targeting information for the direction, placement or both of a therapeutic laser beam shot pattern (pars. 0090-0094, 0169-0172, 0227-0229).
In regards to claims 6-8 and 12-14, the deep learning means comprises a computer vision device (CVD), wherein the deep learning means comprises a computer vision device (CVD), wherein the CVD is based upon/trained by a convolutional neural network (pars. 0092-0094).
In regards to claim 17, the structure of the eye is the retina (pars. 0162-0172).
In regards to claim 19, the determined characteristic provides in part targeting information for the delivery of the laser beam pattern (pars. 0162-0172).
In regards to claim 23, the system further comprises a phacoemulsification system for providing therapeutic ultrasonic energy to the eye (e.g., Fig. 3, par. 0054).
In regards to claim 24, the system further comprises a phacoemulsification system for providing therapeutic ultrasonic energy to the eye (e.g., Fig. 3, par. 0054); wherein the phacoemulsification system in integrated with the laser system and shares, at least a part of, one or more of a common housing, a common control system, a common power source (par. 0211).
In regards to claims 36 and 37, Ootsuki discloses the essential features of the claimed invention except for wherein the system is configured to provide two therapeutic laser beams having different pulse durations, and wherein the therapeutic laser is a femto-second laser; and wherein the system is configured to provide two therapeutic laser beams having different pulse durations; wherein both therapeutic laser beams are configured to ablate tissue, cut tissue, or both. However, Teuma teaches providing two therapeutic laser beams having different pulse durations, and wherein the therapeutic laser is a femto-second laser; and wherein the system is configured to provide two therapeutic laser beams having different pulse durations; wherein both therapeutic laser beams are configured to ablate tissue, cut tissue, or both (pars. 0161, 0357, 0358, 0380) to provide the predictable results of effectively allowing cutting of either lens or corneal tissue (par. 0380). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ootsuki by providing two therapeutic laser beams having different pulse durations, and wherein the therapeutic laser is a femto-second laser; and wherein the system is configured to provide two therapeutic laser beams having different pulse durations; wherein both therapeutic laser beams are configured to ablate tissue, cut tissue, or both to provide the predictable results of effectively allowing cutting of either lens or corneal tissue.
In regards to claim 38, the system comprises a surgical microscope (Fig. 1, par. 0033); and the surgical microscope is integral with the system and configured to receive one or more of images, data, information from the laser system (par. 0033, 0211); wherein the surgical microscope is configured to display the received images, data or information, including images, data and information from the deep learning means during a laser procedure, a phacoemulsification producer, or both (pars. 0039, 0069, 0083, 0121-0124).
In regards to claim 39, the system comprises a 3D viewing system; and the 3D viewing system is integral with the system and configured to receive one or more of images, data, information from the laser system; wherein the 3D viewing system is configured to display the received images, data or information during a laser procedure, a phacoemulsification producer, or both (pars. 0046, 0048 – the front and tomographic images depicts the eye in all three dimensions, so the examiner is considering this to fairly read on a “3D viewing system”).
In regards to claim 40, the system comprises a foot switch in control communication with one or more of the integration control system, the therapeutic laser control system, and the phacoemulsification control system (Fig. 3, element 93, pars. 0068, 0072).
In regards to claim 41, Ootsuki discloses the essential features of the claimed invention including providing a laser control system (pars. 0191-0196), a phacoemulsification control system (par. 0054), and a deep-learning means that determines information about a cataract in the eye (pars. 0089-0094). Ootsuki does not expressly and explicitly disclose that that the laser control system has a plurality of predetermined laser delivery patterns; the phacoemulsification control system has a plurality of predetermined phacoemulsification procedures; or the system is configured based upon determined information to recommend, at least in part, a laser-phaco combined therapy based upon the determined information about the cataract; wherein the laser-phaco combined therapy comprises: at least one of the plurality of predetermined laser delivery patterns; and at least one of the plurality of predetermined phacoemulsification producers. However, Teuma teaches a laser control system that has a plurality of predetermined laser delivery patterns (par. 0141); the phacoemulsification control system has a plurality of predetermined phacoemulsification procedures (par. 0160); and the system is configured based upon determined information to recommend, at least in part, a laser-phaco combined therapy based upon the determined information about the cataract; wherein the laser-phaco combined therapy comprises: at least one of the plurality of predetermined laser delivery patterns; and at least one of the plurality of predetermined phacoemulsification producers (pars. 0160-0161) to provide the predictable results of optimizing control variables based on the nature of the cataract and the interrelation between the laser and phacoemulsification therapies (par. 0160) with the need for the surgeon or the patient to move (pars. 0172, 0185).
In regards to claims 42 and 46, Ootsuki discloses the essential features of the claimed invention including general eye position registration using deep learning, but does not expressly disclose the deep learning means provides iris registration information. However, Teuma teaches providing iris registration (par. 0357) to provide the predictable results of more accurately registering the laser with respect to the eye (par. 0145). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Ootsuki by providing iris registration to provide the predictable results of more accurately registering the laser with respect to the eye.
In regards to claim 47, the determined characteristic of the structure of the eye comprises targeting information for the delivery of a therapeutic laser beam to the eye (pars. 0169-0172; laser emission is prohibited if the aiming beam overlaps the macula or optic disc).
Claims 3-5, 18 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ootsuki and Teuma, as applied to claim 1 above, and further in view of Rill et al. (US 2017/0007446, hereinafter “Rill”). Ootsuki discloses the essential features of the claimed invention, including providing a phacoemulsification system for providing therapeutic ultrasonic energy to the eye (e.g., Fig. 3) integrated with the laser system and shares, at least a part of, one or more of a common housing, a common control system, a common power source (par. 0211), but does not expressly disclose that the targeting information comprises a cyclotorsion of the eye based solely upon a retina of the eye; wherein the determined characteristics are not based upon an individual markers or specific reference points on the iris; wherein the determined characteristic is the cyclotorsion of an un-dilated pre-treatment eye and a dilated treatment eye; or wherein the determined characteristic is the cyclotorsion of an eye having different amounts of dilation between pre-treatment and treatment. However, Rill in the same field of endeavor of acquiring characteristic of the eye for therapy teaches determining targeting information comprising a cyclotorsion of the eye based solely upon a retina of the eye (par. 0010); wherein the determined characteristics are not based upon an individual markers or specific reference points on the iris (par. 0010, the retina); wherein the determined characteristic is the cyclotorsion of an un-dilated pre-treatment eye and a dilated treatment eye (par. 0008); and wherein the determined characteristic is the cyclotorsion of an eye having different amounts of dilation between pre-treatment and treatment (par. 0008) to provide the predictable results of registering the location of the eye in cases where the pupil might be dilated by medication that makes pattern recognition of the iris difficult or impossible (par. 0007). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Ootsuki by determining targeting information comprising a cyclotorsion of the eye based solely upon a retina of the eye; wherein the determined characteristics are not based upon an individual markers or specific reference points on the iris; wherein the determined characteristic is the cyclotorsion of an un-dilated pre-treatment eye and a dilated treatment eye; and wherein the determined characteristic is the cyclotorsion of an eye having different amounts of dilation between pre-treatment and treatment to provide the predictable results of registering the location of the eye in cases where the pupil might be dilated by medication that makes pattern recognition of the iris difficult or impossible.
Claims 9, 10, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ootsuki and Teuma, as applied to claims 6 and 12 above, and further in view of Leiderman et al. (US 2022/0104884, hereinafter “Leiderman”). Ootsuki’s modified invention discloses the essential features of the claimed invention including a computer vision device (see above), but does not expressly disclose that the deep learning means is based upon/trained by a U-Net approach to information. However, Leiderman in the same field of endeavor of determining tissue characteristics for microsurgery, such as in the eye (pars. 0005-0006), teaches a deep learning means based upon/trained by a U-Net approach to information (par. 0093) to provide the predictable results of more accurately registering image data with small datasets that have been appropriately augmented (par. 0093). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify Ootsuki by providing a deep learning means based upon/trained by a U-Net approach to information to provide the predictable results of more accurately registering image data with small datasets that have been appropriately augmented.
Response to Arguments
Applicant's arguments filed 6/5/2026 have been fully considered but they are not persuasive. In regards to claim 44, Applicant argued that Ootsuki fails to disclose a deep learning means for providing a determined characteristic of a structure of an eye, but instead uses the machine learning algorithm only to identify the type and position of surgical instruments. As understood by the examiner, Ootsuki discloses a control system for an ophthalmic surgical system (abstract). This system uses a front image and tomographic image of the patient’s eye (par. 0055) to control the surgical system based on situation information automatically acquired by a deep learning means that has been trained to recognize various parameters including the phase of the surgical procedure (par. 0056, 0084) and dangerous conditions (pars. 0084, 0086). Applicant’s disclosure at paragraph 0012 defines a “characteristic” as referring to “information and data about the shape, location, composition, physical properties or position of a structure. Characteristics would include, for example, the location of a structure with respect to a fixed point, the location of a structure with respect to a coordinate system, the location of a structure with respect to a fix point in a coordinate system, the orientation of the structure (e.g., vertical axis, horizontal axis, equatorial axis, astigmatic axis, tilt, cyclotorsion), topography, optical properties (e.g., opacity, reflectivity, transmissivity), boundary layers, boundaries, cavities within the structure, roughness, compositional changes within the structure, and combinations and variations of these.” Applicant’s arguments appear to take the position that Ootsuki merely provides the algorithm only to identify a type and position of a surgical instrument without regard to any “characteristic of a structure of an eye.” Not only do all embodiments of Ootsuki provide the location of a surgical instrument in relation to the eye (e.g., pars. 0057-0059 describing phases defined by various instruments and their relationship to the eye and determined by the deep learning means that recognizes these phases via artificial vision), but Ootsuki further describes various specific embodiments of drawn to identifying anatomical properties of the eye itself. Again though, Applicant’s own definition of “characteristics” in the original disclosure include location of a structure (for instance presumably including within its scope the position of a structure of an eye with respect to a surgical instrument). Regardless of this broad scope of “characteristics,” Ootsuki further discloses specific embodiments drawn to determining anatomical properties of eye structures themselves. For instance, paragraphs 0098 describe the deep learning means configured to determine the residual amount of the nucleus of the lens. The examiner respectfully maintains that determining the residual amount of a patient’s lens nucleus is a “characteristic of a structure of an eye.” Further, Ootsuki discloses at paragraphs 0163-0172 performing a retinal procedure with the deep learning means wherein “a distance between the surgical instrument and the retina is estimated from the captured image” (par. 0165) and controls the instrument in a ”first mode [that] is a mode of prohibiting the laser emission in a case where it is detected from the captured image that the aiming beam overlaps the site (macula or optic disc) of the eyeball” (par. 0172). The examiner respectfully maintains that determining the distance of the retina from a surgical tool and determining that the macula or optic disc is overlapping with an aiming beam fairly reads on determining a “characteristic of a structure of an eye” because these determinations necessarily require determining those structures of the eye in relationship to the instrument and aiming beam.
In regards to claims 1 and 11, Applicant argued that it would be non-obvious to provide the laser probe with an arm because the motivation provided in the rejection is not related to claim terms because the claims do not discuss size, ergonomics, or timing. However, this motivation was provided by Teuma at paragraph 0022. Further, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Although Ootsuki clearly discloses a system that includes imaging in combination with phacoemulsiphication (par. 0056) and laser therapy (par. 0152), Ootsuki does not specifically detail the form factor of the system. The examiner respectfully maintains that Teuma is in the same field of endeavor, teaches the feature, and provides motivation for doing so in the text of the document, and therefore maintains the basis of rejection under section 103.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Monkeberg et al. (US 2023/0260122) is another example of utilizing machine learning to determine a characteristic of a structure of an eye in a laser system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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 at (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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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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