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 group I in the reply filed on 6/1/2026 is acknowledged.
Claims 11-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/1/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/18/2023, 7/15/2024, 12/23/2025, and 4/29/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The abstract of the disclosure is objected to because:
The abstract is one long sentence written similar to claim 1. The abstract should be in narrative form. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts. Examiner suggests restructuring the abstract into several sentences to put the abstract in clearer form.
The abstract uses legal phraseology “means” when stating “an image capturing means”. The abstract should avoid the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 8 objected to because of the following informalities:
Line 2 recites “and vibration.” Examiner suggests replacing “and vibration” with “and a vibration” to put the claim in clearer form and clearer introduce the vibration of the piezoelectric element.
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. The claim limitation being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is: image capturing means for acquiring images in claim 1.
Claim Rejections - 35 USC § 112
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 1-10 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.
In regard to claim 1,
Line 9 recites “the captured images”. There is insufficient antecedent basis for the limitation in this claim. Line 7 recites “image capturing means for acquiring images”. It is unclear if the captured images are the same images that the image capturing means are configured for acquiring. For examination purposes Examiner construes them to be the same. Examiner suggests replacing “the captured images” with “the acquired images from the image capturing means”. Examiner notes line 11 of claim 1, line 3 of claim 2, line 3 of claim 3, line 2 of claim 5, line 1 of claim 10 also recite “the captured images” and should be amended accordingly.
Examiner notes claims 2-10 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 7,
Line 5 recites “the image”. There is insufficient antecedent basis for the limitation in this claim. It is unclear which image “the image” refers to. Claim 1, which claim 7 depends on, introduces multiple images. For examination purposes Examiner construes “the image” to be “the acquired images”. Examiner suggests replacing “the image” in line 5 of claim 7 with “the acquired images”. Examiner notes line 3 of claim 8 also recites “the image” and should be amended accordingly.
Line 5 recites “irrigation is stopped”. An irrigation has not previously been introduced. It is unclear if the irrigation refers to the irrigation module configured to supply a flow of irrigation fluid or if irrigation refers to the flow of irrigation fluid. For examination purposes Examiner construes “irrigation” to be “the flow of irrigation fluid”. Examiner suggests replacing “irrigation” in line 5 of claim 7 with “the flow of irrigation fluid”.
Examiner notes claim 8 is similarly rejected by virtue of its dependency on claim 7.
In regard to claim 8,
Line 2 recites “aspiration and vibration of the piezoelectric element”. An aspiration has not previously been introduced. It is unclear if the aspiration is the same as the removal of the material from the eye by the aspiration module. It is also unclear if “aspiration” should be “the aspiration module”. For examination purposes Examiner construes “aspiration” to be “the aspiration module”. Examiner suggests replacing “aspiration” in line 2 with “the aspiration module”.
In regard to claim 9,
Line 3 recites “the continuous mode”. There is insufficient antecedent basis for the limitation in this claim. Examiner construes the continuous mode to be a mode when the irrigation module continuously moistens a cornea of the eye. Examiner suggests replacing “is configured to operate the irrigation module continuously to moisten a cornea of the eye” in claim 9 with “is configured to operate the irrigation module in a continuous mode in which the irrigation module continuously moistens a cornea of the eye”.
Line 4 recites “irrigation is stopped”. An irrigation has not previously been introduced. It is unclear if the irrigation refers to the irrigation module configured to supply a flow of irrigation fluid or if irrigation refers to the flow of irrigation fluid. For examination purposes Examiner construes “irrigation” to be “the flow of irrigation fluid”. Examiner suggests replacing “irrigation” in line 4 of claim 9 with “the flow of irrigation fluid”.
In regard to claim 10,
Line 1-2 recites “wherein the captured images are streamed as video output and projected on a display”. It is unclear if a method step is being claimed due to the phrase “are streamed as video output and projected”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). For examination purposes Examiner construes “wherein the captured images are streamed as video output and projected on a display” to be “wherein the captured images are configured to be streamed as video output and configured to be projected on a display”. Examiner suggests replacing “wherein the captured images are streamed as video output and projected on a display” in line 1-2 of claim 10 with “wherein the captured images are configured to be streamed as video output and configured to be projected on a display”.
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.
Claims 1, 4-5, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Albrecht (U.S. PG publication 20210085522).
In regard to claim 1,
Albrecht discloses a phacoemulsification system (figure 1, item 1; paragraph [0121]), comprising:
a handpiece (figure 1, item 9) comprising a piezoelectric element (figure 1, item 11) and a needle (figure 1, item 12), wherein the needle is configured to be inserted into an eye and to be vibrated by the piezoelectric element to emulsify a lens of the eye (Examiner notes “configured to be inserted into an eye and to be vibrated by the piezoelectric element to emulsify a lens of the eye” is a functional limitation. The needle is fully capable of the recited functions due to its structure as supported by paragraph [0119] and [0121]);
an irrigation module (figure 1, item 6) configured to supply a flow of irrigation fluid into the eye (Examiner notes “configured to supply a flow of irrigation fluid into the eye” is a functional limitation. The irrigation module is fully capable of the recited function due to its structure as supported by paragraph [0119] and [0157]);
an aspiration module (figure 1, item 7) configured for removing material from the eye (Examiner notes “configured for removing material from the eye” is a functional limitation. The aspiration module is fully capable of the recited function as supported by paragraph [0119] and [0157]);
image capturing means (figure 1, item 19; paragraph [0066]-[0067] and paragraph [0125]-[0126]) for acquiring images which include the eye (Examiner notes “for acquiring images which include the eye” is a functional limitation. The image capturing means is fully capable of the recited function due to its structure as supported by paragraph [0125]-[0126]);
an image analysis module (figure 1, item 20; paragraph [0052], [0057], [0129] and [0152], and [0167]) configured to determine whether at least a distal tip of the needle is present in the captured images (Examiner notes “configured to determine whether at least a distal tip of the needle is present in the captured images” is a functional limitation. The image analysis module is fully capable of the recited function as supported by paragraph [0029]-[0030], [0125], [0128]-[0129], [0152], and [0156]-[0157] in which item 20 can recognize a normal state in which the needle is outside the eye and no fluid is supplied and can also recognize the state in which the distal tip of the needle has entered the eye and fluid is supplied as supported by paragraph [0029]-[0030], [0125], [0128]-[0129], [0152], and [0156]-[0157]; see figure 2A and 2B); and
a processor (controller 21 shown in figure 1; paragraph [0018], [0029]-[0039], [0059], [0131]), which is configured to receive a determination from the image analysis module as to whether the distal tip of the needle is present in the captured images, and to control operation of at least the irrigation module according to the determination (Examiner notes “configured to receive a determination from the image analysis module as to whether the distal tip of the needle is present in the captured images, and to control operation of at least the irrigation module according to the determination” is a functional limitation. The processor is fully capable of the recited function as the processor receives a determination via receiver 18a of the pupil size/position of the needle from the image analysis module (see paragraph [0128] and [0152]; see figure 2A), and operation of at least the irrigation module is controlled according to the determination (see paragraph [0131] and [0059])).
In regard to claim 4,
Albrecht discloses the system according to claim 1, further comprising a surgical microscope (paragraph [0138]), wherein the image capturing means include a camera integrated in the surgical microscope (paragraph [0138]).
In regard to claim 5,
Albrecht discloses the system according to claim 1, wherein the image analysis module is further configured to identify the eye in the captured images and to determine a relative position of the distal tip of the needle with respect to the eye (Examiner notes “configured to identify the eye in the captured images and to determine a relative position of the distal tip of the needle with respect to the eye” is a functional limitation. The image analysis module is fully capable of the recited function as supported by paragraph [0029]-[0030], [0125], [0128]-[0129], [0152], and [0156]-[0157]. Examiner notes the image analysis module can determine whether the needle is within or outside the eye i.e. the relative position of the distal tip of the needle with respect to the eye).
In regard to claim 10,
Albrecht discloses the system according to claim 1, wherein the captured images are streamed as video output and projected on a display (figure 1, item 4A; paragraph [0119] and [0150]).
Claim Rejections - 35 USC § 103
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.
Claims 2-3, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Albrecht (U.S. PG publication 20210085522) further in view of Claus (U.S. PG publication 20090306581) further in view of Hedgeland (U.S. PG publication 20230140303).
In regard to claim 2,
Albrecht discloses the system according to claim 1.
Albrecht is silent as to wherein the processor is configured for stopping the flow of irrigation fluid when the image analysis module determines that the distal tip of the needle is not present in the captured images.
Claus teaches wherein the processor is configured for stopping the flow of irrigation fluid when the image analysis module determines an event has occurred in the captured images (Examiner notes “configured for stopping the flow of irrigation fluid when the image analysis module determines an event has occurred in the captured images” is a functional limitation. The processor is fully capable of the recited function as supported by paragraph [0010]-[0011], [0021]-[0022], [0035], [0037]-[0038], [0040] and [0043]; see also paragraph [0043] in which fluid flow can be shut down and paragraph [0035] wherein the detected surgical event can be a change in system, commencements of procedures, or termination of procedures; Examiner notes the system can control parameters of the surgical instrument based on an analysis of captured images as supported by paragraph [0010]-[0011], [0021]-[0022], [0035], [0037]-[0038], [0040] and [0043]. Irrigation is one of the parameters which can be controlled as supported by paragraph [0029] and [0043]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Albrecht to include wherein the processor is configured for stopping the flow of irrigation fluid when the image analysis module determines an event has occurred in the captured images, as taught by Claus, for the purpose of enabling a quick response to a surgical event (paragraph [0008]-[0009] of Claus).
Albrecht in view of Claus is silent as to wherein the processor is configured for stopping the flow of irrigation fluid when the image analysis module determines that the distal tip of the needle is not present in the captured images.
Hedgeland teaches wherein the processor is configured for stopping the flow of irrigation fluid when the distal tip of the needle is not in the eye (paragraph [0074]-[0077]: wherein the position of the needle is determined and when the needle is in contact with the eye a response module is activated and paragraph [0053]-[0056] and [0077]: wherein the response module includes a valve that is closed until the correct position of the needle is detected; Examiner notes a valve can be closed to stop irrigation depending on the position of the needle relative to the eye).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Albrecht in view of Claus to include wherein the processor is configured for stopping the flow of irrigation fluid when the distal tip of the needle is not in the eye, as taught by Hedgeland, for the purpose of ensuring fluid is only delivered when the needle is in a desired position (paragraph [0056] of Hedgeland). Examiner notes modifying the processor of Albrecht in view of Claus, which controls the system based on the image analysis module analyzing captured images of the eye and which is configured to stop the flow of irrigation fluid based on the captured images, would result in wherein the processor is configured for stopping the flow of irrigation fluid when the image analysis module determines that the distal tip of the needle is not present in the captured images since when the distal tip of the needle is not in the eye, it would not be in the captured images.
In regard to claim 3,
Albrecht discloses the system according to claim 1.
Albrecht is silent as to wherein the processor is configured for enabling the flow of irrigation fluid only when the image analysis module determines that the distal tip of the needle is present in the captured images.
Claus teaches wherein the processor is configured for enabling the flow of irrigation fluid when the image analysis module determines an event has occurred in the captured images (Examiner notes “configured for enabling the flow of irrigation fluid when the image analysis module determines an event has occurred in the captured images” is a functional limitation. The processor is fully capable of the recited function as supported by paragraph [0010]-[0011], [0021]-[0022], [0035], [0037]-[0038], [0040] and [0043]; see also paragraph [0035] wherein the detected surgical event can be a change in system, commencements of procedures, or termination of procedures; Examiner notes the system can control parameters of the surgical instrument based on an analysis of captured images as supported by paragraph [0010]-[0011], [0021]-[0022], [0035], [0037]-[0038], [0040] and [0043]. Irrigation is one of the parameters which can be controlled as supported by paragraph [0029] and [0043]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Albrecht to include wherein the processor is configured for enabling the flow of irrigation fluid when the image analysis module determines an event has occurred in the captured images, as taught by Claus, for the purpose of enabling a quick response to a surgical event (paragraph [0008]-[0009] of Claus).
Albrecht in view of Claus is silent as to wherein the processor is configured for enabling the flow of irrigation fluid only when the image analysis module determines that the distal tip of the needle is present in the captured images.
Hedgeland teaches wherein the processor is configured for enabling the flow of irrigation fluid only when the distal tip of the needle is present in the eye (paragraph [0074]-[0077]: wherein the position of the needle is determined and when the needle is in contact with the eye a response module is activated and paragraph [0053]-[0056] and [0077]: wherein the response module includes a valve that is closed until the correct position of the needle is detected; Examiner notes the processor is configured for enabling the flow of irrigation fluid only when the distal tip of the needle is present in the eye as the valve remains closed until the sensor detects the needle is in a certain position within the eye).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Albrecht in view of Claus to include wherein the processor is configured for enabling the flow of irrigation fluid only when the distal tip of the needle is present in the eye, as taught by Hedgeland, for the purpose of ensuring fluid is only delivered when the needle is in a desired position (paragraph [0056] of Hedgeland). Examiner notes modifying the processor of Albrecht in view of Claus, which controls the system based on the image analysis module analyzing captured images of the eye and which is configured to enable the flow of irrigation fluid based on the captured images, would result in wherein the processor is configured for enabling the flow of irrigation fluid only when the image analysis module determines that the distal tip of the needle is present in the captured images since when the distal tip of the needle is in the eye, it would be in the captured images.
In regard to claim 6,
Albrecht discloses the system according to claim 5.
Albrecht is silent as to wherein the processor is configured for stopping the flow of irrigation fluid if the image analysis module determines that the distal tip of the needle is outside the eye or is at a position which exceeds a threshold distance from the eye.
Claus teaches wherein the processor is configured for stopping the flow of irrigation fluid if the image analysis module determines an event has occurred in the captured images (Examiner notes “configured for stopping the flow of irrigation fluid when the image analysis module determines an event has occurred in the captured images” is a functional limitation. The processor is fully capable of the recited function as supported by paragraph [0010]-[0011], [0021]-[0022], [0035], [0037]-[0038], [0040] and [0043]; see also paragraph [0043] in which fluid flow can be shut down and paragraph [0035] wherein the detected surgical event can be a change in system, commencements of procedures, or termination of procedures; Examiner notes the system can control parameters of the surgical instrument based on an analysis of captured images as supported by paragraph [0010]-[0011], [0021]-[0022], [0035], [0037]-[0038], [0040] and [0043]. Irrigation is one of the parameters which can be controlled as supported by paragraph [0029] and [0043]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Albrecht to include wherein the processor is configured for stopping the flow of irrigation fluid if the image analysis module determines an event has occurred in the captured images, as taught by Claus, for the purpose of enabling a quick response to a surgical event (paragraph [0008]-[0009] of Claus).
Albrecht in view of Claus is silent as to wherein the processor is configured for stopping the flow of irrigation fluid if the image analysis module determines that the distal tip of the needle is outside the eye or is at a position which exceeds a threshold distance from the eye.
Hedgeland teaches wherein the processor is configured for stopping the flow of irrigation fluid if the distal tip of the needle is outside the eye (paragraph [0074]-[0077]: wherein the position of the needle is determined and when the needle is in contact with the eye a response module is activated and paragraph [0053]-[0056] and [0077]: wherein the response module includes a valve that is closed until the correct position of the needle is detected; Examiner notes a valve can be closed to stop irrigation depending on the position of the needle relative to the eye).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Albrecht in view of Claus to include wherein the processor is configured for stopping the flow of irrigation fluid if the distal tip of the needle is outside the eye, as taught by Hedgeland, for the purpose of ensuring fluid is only delivered when the needle is in a desired position (paragraph [0056] of Hedgeland). Examiner notes modifying the processor of Albrecht in view of Claus, which controls the system based on the image analysis module analyzing captured images of the eye and which is configured to stop the flow of irrigation fluid based on the captured images, would result in wherein the processor is configured for stopping the flow of irrigation fluid if the image analysis module determines that the distal tip of the needle is outside the eye or is at a position which exceeds a threshold distance from the eye since when the distal tip of the needle is outside the eye, it would not be in the captured images.
In regard to claim 9,
Albrecht discloses the system according to 1, wherein the processor is configured to operate the irrigation module continuously to moisten a cornea of the eye (Examiner notes “wherein the processor is configured to operate the irrigation module continuously to moisten a cornea of the eye” is a functional limitation. The processor is fully capable of the recited function as supported by paragraph [0016], [0026] and [0145]),
Albrecht is silent as to and wherein the processor is further configured so that even in the continuous mode, if the image analysis module determines that the distal tip of the needle is not present in the image, irrigation is stopped.
Claus teaches wherein the processor is further configured so that even in the continuous mode, if the image analysis module determines an event has occurred in the captured image, irrigation is stopped (Examiner notes “configured so that if the image analysis module determines an event has occurred in the captured image, irrigation is stopped” is a functional limitation. The processor is fully capable of the recited function as supported by paragraph [0010]-[0011], [0021]-[0022], [0035], [0037]-[0038], [0040] and [0043]; see also paragraph [0043] in which fluid flow can be shut down and paragraph [0035] wherein the detected surgical event can be a change in system, commencements of procedures, or termination of procedures; Examiner notes the system can control parameters of the surgical instrument based on an analysis of captured images as supported by paragraph [0010]-[0011], [0021]-[0022], [0035], [0037]-[0038], [0040] and [0043]. Irrigation is one of the parameters which can be controlled as supported by paragraph [0029] and [0043]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Albrecht to include wherein the processor is further configured so that even in the continuous mode, if the image analysis module determines an event has occurred in the captured image, irrigation is stopped, as taught by Claus, for the purpose of enabling a quick response to a surgical event (paragraph [0008]-[0009] of Claus).
Albrecht in view of Claus is silent as to wherein the processor is further configured so that even in the continuous mode, if the image analysis module determines that the distal tip of the needle is not present in the image, irrigation is stopped.
Hedgeland teaches wherein the processor is further configured so that even in the continuous mode (mode when fluid is delivered), if a determination that the distal tip of the needle is not present in the eye, irrigation is stopped (paragraph [0053]-[0056]) and [0074]-[0077]; Examiner notes “configured so that even in the continuous mode, if a determination that the distal tip of the needle is not present in the eye, irrigation is stopped” is a functional limitation. The processor is fully capable of the recited function as a valve can be closed to stop irrigation depending on the position of the needle relative to the eye).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Albrecht in view of Claus to include wherein the processor is further configured so that even in the continuous mode, if a determination that the distal tip of the needle is not present in the eye, irrigation is stopped, as taught by Hedgeland, for the purpose of ensuring fluid is only delivered when the needle is in a desired position (paragraph [0056] of Hedgeland). Examiner notes modifying the processor of Albrecht in view of Claus, which controls the system based on the image analysis module analyzing captured images of the eye and which is configured to stop the flow of irrigation fluid based on the captured images, would result in wherein the processor is further configured so that even in the continuous mode, if the image analysis module determines that the distal tip of the needle is not present in the image, irrigation is stopped since when the distal tip of the needle is not present in the eye, it would not be in the captured images.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Albrecht (U.S. PG publication 20210085522) further in view of Heeren (U.S. Patent no 11432961) further in view of Claus (U.S. PG publication 20090306581) further in view of Hedgeland (U.S. PG publication 20230140303).
In regard to claim 7,
Albrecht discloses the system according to claim 1.
Albrecht is silent as to wherein the processor is configured to operate the irrigation module and the aspiration module according to a stabilizing mode in which intraocular pressure (IOP) levels are maintained within prespecified safe limits; and wherein the processor is further configured so that even in the stabilizing mode, if the image analysis module determines that the distal tip of the needle is not present in the image, irrigation is stopped.
Heeren teaches wherein the processor is configured to operate the irrigation module and the aspiration module according to a stabilizing mode in which intraocular pressure (IOP) levels are maintained within prespecified safe limits (column 11, line 20-column 12, line 10; Examiner notes “configured to operate the irrigation module and the aspiration module according to a stabilizing mode in which intraocular pressure (IOP) levels are maintained within prespecified safe limits” is a functional limitation. The processor is fully capable of recited function due to its structure as supported by column 11, line 20-column 12, line 10).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Albrecht to include wherein the processor is configured to operate the irrigation module and the aspiration module according to a stabilizing mode in which IOP levels are maintained within prespecified safe limits, as taught by Heeren, for the purpose of avoiding over pressurization of the eye (column 12, line 3-10 of Heeren).
Albrecht in view of Heeren is silent as to wherein the processor is further configured so that even in the stabilizing mode, if the image analysis module determines that the distal tip of the needle is not present in the image, irrigation is stopped.
Claus teaches wherein the processor is configured for stopping the flow of irrigation fluid if the image analysis module determines an event has occurred in the captured images (Examiner notes “configured for stopping the flow of irrigation fluid when the image analysis module determines an event has occurred in the captured images” is a functional limitation. The processor is fully capable of the recited function as supported by paragraph [0010]-[0011], [0021]-[0022], [0035], [0037]-[0038], [0040] and [0043]; see also paragraph [0043] in which fluid flow can be shut down and paragraph [0035] wherein the detected surgical event can be a change in system, commencements of procedures, or termination of procedures; Examiner notes the system can control parameters of the surgical instrument based on an analysis of captured images as supported by paragraph [0010]-[0011], [0021]-[0022], [0035], [0037]-[0038], [0040] and [0043]. Irrigation is one of the parameters which can be controlled as supported by paragraph [0029] and [0043]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Albrecht in view of Heeren to include wherein the processor is configured for stopping the flow of irrigation fluid if the image analysis module determines an event has occurred in the captured images, as taught by Claus, for the purpose of enabling a quick response to a surgical event (paragraph [0008]-[0009] of Claus).
Albrecht in view of Heeren in view of Claus is silent as to wherein the processor is further configured so that even in the stabilizing mode, if the image analysis module determines that the distal tip of the needle is not present in the image, irrigation is stopped.
Hedgeland teaches wherein the processor is further configured so that even in the stabilizing mode (mode when fluid is delivered), if a determination that the distal tip of the needle is not present in the eye, irrigation is stopped (paragraph [0053]-[0056]) and [0074]-[0077]; Examiner notes “configured so that even in said stabilizing mode, if a determination that the distal tip of the needle is not present in the eye, irrigation is stopped” is a functional limitation. The processor is fully capable of the recited function as a valve can be closed to stop irrigation depending on the position of the needle relative to the eye).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Albrecht in view of Heeren in view of Claus to include wherein the processor is further configured so that even in the stabilizing mode, if a determination that the distal tip of the needle is not present in the eye, irrigation is stopped, as taught by Hedgeland, for the purpose of ensuring fluid is only delivered when the needle is in a desired position (paragraph [0056] of Hedgeland). Examiner notes modifying the processor of Albrecht in view of Heeren in view of Claus, which controls the system based on the image analysis module analyzing captured images of the eye and which is configured to stop the flow of irrigation fluid based on the captured images, would result in wherein the processor is further configured so that even in the stabilizing mode, if the image analysis module determines that the distal tip of the needle is not present in the image, irrigation is stopped since when the distal tip of the needle is not present in the eye, it would not be in the captured images.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Albrecht (U.S. PG publication 20210085522) in view of Heeren (U.S. Patent no 11432961) in view of Claus (U.S. PG publication 20090306581) in view of Hedgeland (U.S. PG publication 20230140303) further in view of Kraemer (U.S. PG publication 20170246036).
In regard to claim 8,
Albrecht in view of Heeren in view of Claus in view of Hedgeland teaches the system according to claim 7, wherein the processor is further configured to stop one or both of aspiration and vibration of the piezoelectric element, if the image analysis module determines that an event has occurred in the captured images (Examiner notes “configured to stop one or both of aspiration and vibration of the piezoelectric element, if the image analysis module determines that an event has occurred in the captured images” is a functional limitation. The processor is fully capable of the recited function as supported by paragraph [0043] of Claus in which the system can be shut down which would shut down aspiration and vibration and paragraph [0035] of Claus wherein the detected surgical event can be a change in system, commencements of procedures, or termination of procedures; Examiner notes the system can control parameters of the surgical instrument based on an analysis of captured images as supported by paragraph [0010]-[0011] of Claus, [0021]-[0022] of Claus, [0035] of Claus, [0037]-[0038] of Claus, [0040] of Claus and [0043] of Claus. Aspiration and vibration of the piezoelectric element are parameters which can be controlled as supported by paragraph [0029] of Claus).
Albrecht in view of Heeren in view of Claus in view of Hedgeland is silent as to wherein the processor is further configured to stop one or both of aspiration and vibration of the piezoelectric element, if the image analysis module determines that the distal tip of the needle is not present in the image.
Kraemer teaches wherein the processor is further configured to stop the element used to break up a cataract when it is determined that the distal tip of the needle is not present in the eye (paragraph [0047]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the processor and piezoelectric element of Albrecht in view of Heeren in view of Claus in view of Hedgeland, which is vibrated/used to break up a cataract, to include wherein the processor is further configured to stop the element used to break up a cataract when it is determined that the distal tip of the needle is not present in the eye, as taught by Kraemer, for the purpose of avoiding tissue damage (paragraph [0047] of Kraemer). Examiner notes modifying the processor of Albrecht in view of Heeren in view of Claus in view of Hedgeland, which controls the system based on the image analysis module analyzing captured images of the eye and which is configured to stop one or both of aspiration and vibration of the piezoelectric element based on the captured images, would result in wherein the processor is further configured to stop one or both of aspiration and vibration of the piezoelectric element, if the image analysis module determines that the distal tip of the needle is not present in the image since when the distal tip of the needle is not present in the eye, it would not be in the captured images.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hauger (U.S. PG publication 20130218168) discloses a phacoemulsification system, comprising an image analysis module (figure 1, item 7) configured to determine whether at least a distal tip of the needle (item 13) is present in the captured images (see figure 2-6; paragraph [0007], and [0030]-[0031]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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