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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-24, 36-42 and 44-46 in the reply filed on 11/2/2025 is acknowledged.
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 an eye (pars. 0090-0094).
In regards to claim 45, the determined characteristic is one or more of an image, data, targeting information for a structure of an eye (e.g., par. 0094).
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 and 46 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, 0183-0184, 0191-0195); and, a deep learning means for providing one or more of an image, data and information for a structure of an eye (e.g., par. 0094). 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, 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.
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 11/2/2025 have been fully considered but they are not persuasive. Applicant’s amendments and arguments with respect to the rejections under section 112(b) are moving. These rejections are withdrawn. In regards to the prior art rejections, Applicant argued that Ootsuki, including paragraph 0089, merely discloses the use of deep learning to develop a relationship between ultrasound power, fragmentation and aspiration in an attempt to have a better control system for the ultrasound unit and does not “determine a characteristic of an eye,” as claimed. However, referring back to paragraph 0089, these parameters of ultrasonic output, fragmentation and aspiration are associated with the phase of the particular surgical procedure based on the “learned model” derived per paragraphs 0090-0094, which is “used for the purpose of identifying objects in a captured image.” Ootsuki discloses determining the phase of the surgical procedure using by “recogniz[ing] the situation information relating to the surgery on the basis of the captured image relating to the patient eyeball. In the present embodiment, a currently performed phase of the surgery is recognized on the basis of the front image and the tomographic image. The phase of the surgery is recognized for example on the basis of a surgical instrument in the front image, such as a scalpel and a fragmentation unit (e.g., on the basis of the type of surgical instrument used). Moreover, whether or not a situation where the surgical instrument can damage the posterior capsule or the retina (dangerous situation) is recognized for example on the basis of the tomographic image” (par. 0084). In other words, Ootsuki is using the eye image-derived machine-learned model described at paragraphs 0089-0094 (i.e., an image, data or information about an eye) to determine the particular current phase of the surgical procedure and takes particular actions accordingly (see also, abstract). For instance, previously cited paragraphs 0191-0195 describe an embodiment utilizing laser eye surgery wherein “[a]s shown in FIG. 10B, the image acquisition unit 81 acquires a captured image 150 obtained by capturing an image of a laser probe 143, an aiming beam 145, a macula 151, and an optic disc 152. The recognition unit 82 recognizes that the current phase is the “laser irradiation” on the basis of the surgical instrument (laser probe 143) in the captured image. The control unit 83 prohibits the laser emission of the laser probe 143 in a case where the aiming beam 145 comes within a predetermined distance (dotted line 155) from the macula 151.”
Applicant further argued that Ootsuki does not disclose the arm of claim 1, element b, but instead appears to utilize a handheld surgical device. Although Ootsuki does not appear to specifically indicate whether the laser surgical system is a handheld or arm-mounted surgical device, this rejection was made under section 103 in view of Teuma, which is one of many teachings of arm-mounted laser eye surgery devices. Although Applicant notes that Ootsuki does not provide motivation for an arm-mounted laser device, Teuma in the same field of endeavor does so. Applicant further argued that the Office action provides no objective basis for the combination of Ootsuki with Teuma because 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” are not claim terms and have no relation to the pending claims. This motivation for providing an arm-mounted combination of e.g., laser, phacoemulsification, and microscope devices is provided explicitly by Teuma. Teuma provides an arm-mounted combination of multiple devices (e.g., par. 0245) and provides the motivation at the cited passage at paragraph 0022, “[t]here has existed a long standing and unfulfilled need to address and improve, alone or in combination, the size of systems in operating rooms and medical offices, the ergonomics of the operating theater, surgical systems and equipment, the time required to efficaciously perform a procedure, and patient comfort, among other things.” Teuma proceeds to describe how this motivation is met by providing a combined laser, phacoemulsification device and microscope in an arm-mounted system (e.g., par. 0109). The examiner respectfully maintains the basis for combining Ootsuki and Teuma for the reasons set forth in the previous rejection and provided by Teuma’s own disclosure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Homer (US 11,278,452) is another example of an arm-based laser system.
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 MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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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