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 .
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1 recites “first imaging sensor for capable of generating image data using the first light source”, the phrase for capable of does not make grammatical sense and should be corrected by removing the word for “first imaging sensor
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 2 recites “a controller for controlling”, controller being a term uses as a substitute for “means” and controlling being the function. Para. [0102] of the instant specification reads “The controller of the base device 602 may comprise a central processing unit (CPU) 610 or other type of controller such as an FPGA or ASIC, along with memory 612, possibly non-volatile storage 614 and one or more input/output connections for coupling one or more devices, such as display 608, to the processor. The input/output devices may include one or more wireless radios such as Wi-Fi® and/or Bluetooth® radios, wired Ethernet adapters, graphical displays and various input components including touch screens, keyboards, mice, vocal interfaces, gesture based interfaces, etc. The memory 612 may store instructions which when executed by the processor configure the base device to provide various functionality including for example, module enrollment and verification functionality 618, calibration functionality 620, ophthalmology functionality 622, remote operation functionality 624, and patient management functionality 626.” Additionally see Para. [0104]-[0109] and Figs. 6-10 and related text.
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.
Claim 19 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 19:
Claim 19 is amended to read “wherein the first optical module comprises an input module and an output module” however it’s not clear how the first optical module can be two separate modules. The instant specification is silent on how an optical module can be both an input module and an output module. The specification states in para. [0024] “In a further embodiment of the kit, the first optical module comprises an input module, and the kit further comprises an output module.” For the purposes of compact prosecution claim 19 will be interpreted as the kit comprises an input module and an output module.
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.
Claim(s) 1-2, 7, and 10-17 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 20040174495 A1 (Levine).
Regarding claim 1:
Levine discloses an ophthalmology device (See abstract) comprising:
a first optical device (Fig. 2A, optical subsystem [201]) comprising a first light source (Fig. 2A, Observation light source [225]) and first imaging sensor (Fig. 2A, Imaging array [231]) for capable of generating image data using the first light source (Para. [0085], light source [225] is used to generate an image using imaging device [231] to display on display [229] using light from observation light source [225]);
a first input coupling (Fig. 2A, detachable connectors [232]) comprising:
a physical interface connection for aligning and securing an input optical module (Para. [0086], connectors [232] are used for interfacing optical subsystem [201] with optical subsystems [203] or [205]); and
an optical interface connection (Fig. 2A showing light travelling between optical subsystems [201] and [203] through the connection at connectors [232]);
a first optical output (Fig. 2A, optical output at connectors [232] connecting optical subsystems [203] and [201]);
an optical pathway coupling the first optical device and the optical interface connection of the first input coupling to the first optical output (Fig. 2A showing light travelling between optical subsystems [201] and [203] through the connection at connectors [232])); and
an output coupling providing a physical interface connection for aligning and securing a third optical device (Fig. 2A, Optical subsystem [205] physically aligned and secured to optical subsystem [203] by connectors [232]).
Regarding claim 2:
Levine discloses the ophthalmology device of claim 1, further comprising a controller for controlling (Fig. 2A, Control driver [215]) operation of the ophthalmology device (Para. [0060], the controller [215] controls optical element [211]) and providing one or more of:
image registration functionality; and
retina tracking functionality. (Para. [0132]-[0133] describing the system being used to identify the retina of the subject eye by image registration.)
Regarding claim 7:
Levine discloses the ophthalmology device of claim 1, further comprising a second input coupling (See para. [0088] and Fig. [2A], Relay lens [250] may instead be in a relay lens adapter that is detachably interfaced to optical subsystem [201] creating a second input coupling.) comprising:
a physical interface connection for aligning and securing a fourth optical device (The relay lens adapter of Para. [0088], the relay lens adapter along with optical subsystems [201], [203], and [205] is a total of four optical devices each requiring physical interface connections.); and
an optical interface connection. (As described in Para. [0088], the relay lens adapter comprises relay lens [250] and forms an optical interface with the optical subsystem [201])
Regarding claim 10:
Levine discloses the ophthalmology device of claim 1, wherein the optical pathway comprises one or more of:
an optical splitter/combiner; (Fig. 2A, Beam Splitter [249])
a filter; (Para. [0073], Filters may be inserted into the optical path.)
a lens (Fig. 2A, lens [250]); and
Regarding claim 11:
Levine discloses an ophthalmology system (See abstract) comprising:
a first optical device (Fig. 2A, optical subsystem [201]) comprising a first light source (Fig. 2A, Observation light source [225]) and first imaging sensor (Fig. 2A, Imaging array [231]) capable of generating image data using the first light source (Para. [0085], light source [225] is used to generate an image using imaging device [231] to display on display [229] using light from observation light source [225]);
a first input coupling (Fig. 2A, detachable connectors [232]) comprising:
a physical interface connection for aligning and securing an input optical module (Para. [0086], connectors [232] are used for interfacing optical subsystem [201] with optical subsystems [203] or [205]); and
an optical interface connection (Fig. 2A showing light travelling between optical subsystems [201] and [203] through the connection at connectors [232]);
a first optical output (Fig. 2A, optical output at connectors [232] connecting optical subsystems [203] and [201]);
an optical pathway coupling the first optical device and the optical interface connection of the first input coupling to the first optical output (Fig. 2A showing light travelling between optical subsystems [201] and [203] through the connection at connectors [232])); and
an output coupling providing a physical interface connection for aligning and securing a third optical device (Fig. 2A, Optical subsystem [205] physically aligned and secured to optical subsystem [203] by connectors [232]); and
an input optical module (Fig. 2A, optical subsystem [203]) secured to the first input coupling (Fig. 2A, Optical subsystem [203] secured via connectors [232]).
Regarding claim 12:
Levine discloses the ophthalmology system of claim 11, wherein the input optical module [232] comprises at least one of:
an imaging device including a light source and sensor (Fig. 2A, WaveFront sensor [213] and light [207]), optically coupled to the optical interface connection of the first input coupling (Fig. 2A, optical subsystem [203] is optically coupled to [232]); and
Regarding claim 13:
Levine discloses the ophthalmology system of claim 12, wherein the input optical module [232] further comprises one or more of:
an optical device; (Fig. 2A, optical subsystem [203] has multiple optical devices such as lens [251], beam splitter [257], and Wavefront Sensor [213])
a pilot laser; (Para. [0058], a light source may be a laser light source.)
an additional input coupling. (Fig. 2A, optical subsystem [203] has an additional input coupling [232])
Regarding claim 14:
Levine discloses the ophthalmology system of claim 13, wherein the input optical module provides one or more of:
a 2D imaging system (Fig. 2A, high resolution imaging array [217] and image storage and output [221]);
Regarding claim 15:
Levine discloses the ophthalmology system of claim 11, further comprising an additional input optical module. (Fig. 2A and Para. [0088], relay lens [250] may be in a relay lens adapter forming an additional input optical module.)
Regarding claim 16:
Levine discloses the ophthalmology system of claim 11,
further comprising an output optical module. (Fig. 2A, optical subsystem [205])
Regarding claim 17:
Levine discloses the ophthalmology system of claim 16, wherein the output optical module [205] comprises one or more of:
an optical device; (Fig. 2A, optical subsystem [205] comprises many optical devices such as lenses beam splitters and an imaging array.)
an additional input coupling;
an additional output coupling (Fig. 2A, optical subsystem [205] has an additional couplings [232] for input and output.); or
a sensor. (Fig. 2A, High resolution imaging array [217] is a sensor.)
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.
Claim(s) 3-4,and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20040174495 A1 (Levine) in view of US 20020097379 A1 (Goldfain et al.).
Regarding claim 3:
Levine discloses the ophthalmology device of claim 2,
Levine fails to disclose
wherein the first input coupling further comprises an electrical interface connection. (Levine is silent on how electrical connections arranged through the ophthalmology device.)
Goldfain teaches an ophthalmology device (See abstract) wherein
the first input coupling (Fig. 6I showing an input module [77] with an input coupling [66]) further comprises an electrical interface connection (Fig. 6I, electrical interface connection [85]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have “the first input coupling further comprises an electrical interface connection” as taught by Goldfain in the ophthalmology device of Levine for the purpose of transferring an electrical connection across the first input coupling.
Regarding claim 4:
Levine in combination with Goldfain teaches the ophthalmology device of claim 3,
Goldfain additionally teaches
wherein the electrical interface connection [85] provides a communication channel to the controller (Fig. 6I, processor [54]) of the ophthalmology device. (Fig. 6I and Paras. [0097] and [0099], Processor and image sensor [52] are connected to display [77] by mating connection leads [55A] and [55B] mounted on [85] that provide a communication channel.)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have “the electrical interface connection provides a communication channel to the controller of the ophthalmology device” as taught by Goldfain in the ophthalmology device of Levine in view of Goldfain for the purpose of transferring a communication connection across the first input coupling.
Regarding claim 7:
Levine discloses the ophthalmology device of claim 7,
wherein the second input coupling further comprising an electrical interface connection. (Levine is silent on how electrical connections arranged through the ophthalmology device.)
Goldfain teaches an ophthalmology device (See abstract) wherein
wherein an input coupling(Fig. 6I showing an input module [77] with an input coupling [66]) further comprising an electrical interface connection (Fig. 6I, electrical interface connection [85]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have “the second input coupling further comprising an electrical interface connection” as taught by Goldfain in the ophthalmology device of Levine for the purpose of transferring an electrical connection across the second input coupling.
Regarding claim 8:
Levine discloses the ophthalmology device of claim 1,
wherein the output coupling further comprises an electrical interface connection. (Levine is silent on how electrical connections arranged through the ophthalmology device.)
Goldfain teaches an ophthalmology device (See abstract) wherein
wherein a coupling(Fig. 6I showing a module [77] with a coupling [66]) further comprising an electrical interface connection (Fig. 6I, electrical interface connection [85]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have “the output coupling further comprises an electrical interface connection” as taught by Goldfain in the ophthalmology device of Levine for the purpose of transferring an electrical connection across the output coupling.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20040174495 A1 (Levine) in view of US 20240225442 A1 (Dave et al.).
Regarding claim 5:
Levine discloses the ophthalmology device of claim 1,
Levine fails to disclose the ophthalmology device further comprising:
a first tunable lens for the first optical device within the optical pathway; and
a second tunable lens for the first input coupling within the optical pathway. (Levine discloses relay lenses [250] and [251] but does not disclose that they are tunable lenses.)
However the properties of tunable lenses would have been well known to one of ordinary skill in the art ophthalmic optics, see for example Dave:
Dave teaches an ophthalmology device (See abstract) comprising
Tunable lenses (Fig. 20, tunable lenses [2072]) within the optical pathway configured to be mounted to the ophthalmology device (Para. [0069]) for the purpose of optically coupling light along an optical path (See Para. [0170])
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use tunable lenses in place of the relay lenses as taught by the Dave in the ophthalmology device of Levine for the purpose of providing lenses for the relay lenses to couple the optical pathways of the first input coupling and the first optical device.
Regarding claim 6:
Levine in combination with Dave teaches the ophthalmology device of claim 5,
Dave additionally teaches
wherein the first tunable lens and second tunable lens are controlled by a controller in order to co-align light from the first optical device and the optical interface connection of the first input coupling. (Para. [0120], teaches the use of lens driver [232a] and control module [220] to control a tunable lens)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have “the first tunable lens and second tunable lens are controlled by a controller in order to co-align light from the first optical device and the optical interface connection of the first input coupling” as taught by the Dave in the ophthalmology device of Levine for the purpose of providing control for the tunable lenses to couple the optical pathways of the first input coupling and the first optical device.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20040174495 A1 (Levine) in view of US 20220409911 A1 (DeShazo et al.).
Regarding claim 18:
Levine discloses a kit for an ophthalmology device (Para. [0086] describing the optical subsystems being separable into kits.) comprising:
a first optical module (Para. [0086], “For example, a user might purchase only the optical subsystem 201 and imaging subsystem 205” imaging subsystem [205] is the first optical module.) comprising:
one or more optical components for providing ophthalmology functionality to the ophthalmology device (Para. [0086] and Abstract and Fig. [2A]. The kit is provided is for ophthalmology purposes and may include imaging subsystem [205] for providing high resolution imaging);
a physical interface connection for mechanically securing the first optical module to the ophthalmology device (Fig. 2A, connectors [232] for securing imaging module [205] to the ophthalmology device);
an optical interface connection for optically coupling at least a portion of the one or more optical components to the ophthalmology device (Fig. 2A showing the optical components of imaging subsystem [205] are optically coupled to the ophthalmology device.);
Levine fails to disclose
The first optical module comprising: a module identifier for uniquely identifying the first optical module; and
an authorization for use of one or more software components by the ophthalmology device to provide the ophthalmology functionality using the first optical module identified by the module identifier.
DeShazo teaches a medical device (See abstract) with
a module identifier for uniquely identifying the Para. [0040], the device has a device identifier for identifying the unique device.) and
an authorization for use of one or more software components by thePara. [0039]-[0040], Authorization is required for the use of software for medical application with the device associated with the device identifier.)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a module identifier for uniquely identifying the module and have authorization for use of one or more software components by the device to provide the functionality using the module identified by the module identifier” as taught by DeShazo in the kit for an ophthalmology device of Levine for the purpose of preventing unauthorized access to the software associated with the module.
Claim(s) 19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20040174495 A1 (Levine) in view of US 20220409911 A1 (DeShazo et al.) as applied to claim 18 above, and further in view of US 20170156588 A1 (Ren et al.).
Regarding claim 19:
Levine in combination with DeShazo teaches the kit of claim 18,
Neither Levine nor DeShazo teaches
wherein the kit
Ren teaches a modular ophthalmic device (See Para. [0048]) comprising at least one input module and output module (Fig. 2 shows multiple input and output modules, [170], [150], [180], and [190])
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have at least one input module and output module as taught by Ren in the kit of Levine in combination with DeShazo for the purpose of providing both input and output modules to the ophthalmic device.
Regarding claim 21:
Levine in combination with DeShazo teaches the kit of claim 18,
Neither Levine nor DeShazo teaches
wherein the kit comprises at least one input module and output module suitable for performing one or more of:
central photocoagulation;
peripheral photocoagulation;
vitreous treatment with femtosecond laser;
vitreous treatment with YAG laser; or
glaucoma treatment with femtosecond laser.
Ren teaches a modular ophthalmic device (See Para. [0048]) comprising at least one input module and output module (Fig. 2 shows multiple input and output modules, [170], [150], [180], and [190]) suitable for performing one or more of:
vitreous treatment with femtosecond laser;
vitreous treatment with YAG laser; or (Para. [0032] the ophthalmic device is suitable for preforming vitreous treatment with a surgical device [140] which can be a laser.)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the kit comprises at least one input module and output module suitable for performing one or more of: vitreous treatment with femtosecond laser; vitreous treatment with YAG laser as taught by Ren in the ophthalmic kit of Levine in combination with DeShazo for the purpose of providing modules that can be used in vitreous treatment of the eye.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH D MOSER whose telephone number is (703)756-5803. The examiner can normally be reached Mon-Fri, 10am-6pm.
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, Bumsuk Won can be reached at (571)270-1782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SETH D MOSER/Examiner, Art Unit 2872
/BUMSUK WON/Supervisory Patent Examiner, Art Unit 2872
Prosecution Insights