DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/05/2024 was filed and is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-15 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being disclosed by Scheibler (US 2018/0271363).
Regarding claim 1, Scheibler discloses a method of monitoring a medical condition of an eye of a patient (see Fig 20D), comprising: collecting, by an optical coherence tomography (OCT) system, an OCT scan of the eye (see Fig 20D; Para [0237]; an OCT system scans an eye of a user); designating, by a processor, a macular region of interest (ROI) within the OCT scan (see Fig 20D; Para [0268]; process may be configured to determine a macular region of a fundus); determining, by the processor, a representative macular thickness measure that is characteristic of the overall thickness of the macular ROI (see Fig 25; Para[0248-0254]; discloses the method of determining a macular/retinal thickness of the user); determining, by the processor, a patient-personalized baseline thickness for the macular ROI (see Fig 20D; Para [0186]; a OCT device containing a processor unit may gather a baseline thickness determined from multiple measurements of a user’s eye); defining, by the processor, an upper specification limit based on the patient-personalized baseline thickness; defining, by the processor, a lower specification limit based on the patient-personalized baseline thickness (see Fig 20D; Para [0186]; a OCT device containing a processor unit may gather a baseline thickness determined from multiple measurements of a user’s eye including an upper and lower limits); in response to the representative macular thickness measure being higher than or equal to the upper specification limit, issuing, by the processor, an electronic signal indicating a need for medical attention (see Fig 20D; Para [0078, 0083]; an alert may be caused by a calculated RT value beyond the healthy limit); and in response to the representative macular thickness measure being lower than or equal to the lower specification limit, adjusting, by the processor, at least one of the patient-personalized baseline thickness, the upper specification limit, or the lower specification limit based on the representative macular thickness measure (see Fig 20D; Para [0186]; OCT reading during the prescribed interval may be used to calculate change baseline thickness).
Regarding claim 2, Scheibler discloses the method of claim 1.
Scheibler further discloses wherein the representative macular thickness measure is based on a plurality of individual macular thickness measures within the macular ROI, and the representative macular thickness measure is determined as the average of all the individual macular thickness measures within the macular ROI, the highest individual macular thickness measure within the ROI, or the average of two or more of the highest individual macular thickness measures within the ROI (see Fig 25; Para [0251-0255]; the RT is determined from an estimated average value of the read signal frequency).
Regarding claim 3, Scheibler discloses the method of claim 1.
Scheibler further discloses wherein the patient- personalized baseline thickness is based on an average of a predefined number of lowest, previous representative macular thickness measures of the macular ROI determined according to caregiver-scheduled, macular thickness check-up times (see Fig 20D; Para [0186]; a baseline thickness profile for a user is determined from RT reading by an ophthalmologist during the course of a determined period of time).
Regarding claim 4, Scheibler discloses the method of claim 3.
Scheibler further discloses wherein the lowest, previous representative macular thickness measures are extracted only from stable periods, wherein the medical condition is age- related macular degeneration (AMD) in the eye and a stable period is defined as one or more of a dry AMD period, which is a period where individual macular thickness measures of the macular ROI did not vary by more than 5%, or a period wherein no injection of medication was administered to the eye (see Fig 2; Para [0079]; reference for thickness may be taken on an onset of a disease to track progression, to track progress of pharmaceutical before the effect of said pharmaceutical).
Regarding claim 5, Scheibler discloses the method of claim 1.
Scheibler further discloses wherein at least one of the upper specification limit or the lower specification limit is defined as an offset from the patient-personalized baseline thickness, and the offset is based on a statistical analysis of a population of macular thickness measures from corresponding macular ROIs in a general population of test eyes taken during stable periods, wherein the medical condition is age-related macular degeneration (AMD) in in the eye and a stable period is defined as a dry AMD period, which is a period wherein a test eye's individual macular thickness measures do not vary by more than 5%, or a period wherein no injection of medication was administered to a test eye (see Fig 2 and 10B; Para [0168-0173]; determination of change of thickness of Scheibler depends on a 95% confidence interval of a set of multiple short readings compared to another set of multiple short readings; examiner is interpreting the offset as the region within the 95% confidence interval as seen in Fig 10B; Para [0079] discloses measuring before and after disease/drug to view progression/effect).
Regarding claim 6, Scheibler discloses the method of claim 5.
Scheibler further discloses wherein the statistical analysis provides a statistical deviation among the population of macular thickness measures, and the offset is based on a maximum statistical deviation (see Fig 10B; Para [0168-0173]; examiner is interpreting the statistical deviation to be the same as the measured deviation from repeatability of measurements at a specific time period as seen in said Fig 10B).
Regarding claim 7, Scheibler discloses the method of claim 1.
Scheibler further discloses wherein the patient- personalized baseline thickness is user adjustable in intervals of fixed size within a predefined range, the user adjusted patient-personalized baseline overriding any previous determined of the patient-personalized baseline thickness (see Fig 10D; Para [0172]; examiner is interpreting this to be similar how a value of the repeatability may be adjusted to different confidence intervals).
Regarding claim 8, Scheibler discloses the method of claim 1.
Scheibler further discloses wherein in response to the representative macular thickness measure being lower than or equal to the lower specification limit, the patient-personalized baseline thickness is adjusted to an average of the current representative macular thickness measure and one or more previous macular thickness measures of the eye that are also lower than or equal the lower specification limit (see Fig 10D; Para [0173]; examiner is interpreting this to be similar to how the average repeatability value is an average of the repeatability measurements).
Regarding claim 9, Scheibler discloses the method of claim 1.
Scheibler further discloses wherein the patient- personalized baseline thickness is adjusted if the current representative macular thickness measure that is lower than or equal to the lower specification limit is the third, or more, consecutive representative macular thickness measure of the eye that is lower than or equal to the lower specification limit (see Fig 10D; Para [0173]; examiner is interpreting this to be similar to how multiple repeatable measurement may be taken to show a difference in reproducibility).
Regarding claim 10, Scheibler disclose the method of claim 1.
Scheibler further discloses wherein the at least one of the upper specification limit or the lower specification limit is adjusted independent of the patient-personalized baseline thickness (see Fig 10D; Para [0173]; examiner is interpreting this to be similar to how the repeatability is independent of the baseline thickness but rather on the confidence interval).
Regarding claim 11, Scheibler discloses the method of claim 1.
Scheibler further discloses wherein the at least one of the patient-personalized baseline thickness, the upper specification limit, or the lower specification limit is automatically adjusted by a preset incremental amount within a predefined range (see Fig 10D; Para [0186]; examiner is interpreting this to be similar to how repeatability of signal may be adjusted by confidence interval automatically).
Regarding claim 12, Scheibler discloses the method of claim 1.
Scheibler further discloses wherein the at least one of the upper specification limit or the lower specification limit, is automatically adjusted by incorporating the value of the representative macular thickness measure into a recalculation of the at least one of the upper specification limit or the lower specification limit (see Fig 10D; Para [0186]; examiner is interpreting this to be similar to how repeatability measurements of a new signal may be used to determine reproducibility as seen in Fig 10B).
Regarding claim 13, Scheibler discloses the method of claim 1.
Scheibler further discloses wherein a plurality of the macular ROIs are designated, each having a respective of the patient-personalized baseline thickness independent of each other (see Fig 5; Para [0117 and 0173]; the measured patient reference of RT or RLT may constitute a plurality of ROI such as a nerve fiber layer, the ganglion cell layer, etc.. as disclosed in Para [0117]).
Regarding claim 14, Scheibler discloses the method of claim 13. Scheibler further discloses wherein the plurality of the macular ROIs have different respective upper specification limits and lower specification limits (see Fig 3A; Para [0098]; an alert may be provided based on results of test falling outside of a normal range; as example see Para [0078] range is 175 to 225 microns).
Regarding claim 15, Scheibler discloses the method of claim 13.
Scheibler further discloses wherein the upper offset and lower offset of a select one of the plurality of the macular ROIs is set as the upper offset and lower offset of all of the plurality of macular ROIs (see Fig 10A-D; Para [0174, 0186]; examiner is interpreting this to be that the confidence interval offset of the signal is set as the confidence interval for any measured RT or RLT values).
Regarding claim 18, Scheibler discloses the method of claim 1.
Scheibler further discloses wherein the at least one of the upper specification limit, the lower specification limit, or the patient-personalized baseline thickness is remotely adjustable by an authorized user in response to receiving an electronic message over a telecommunication network (see Fig 20D; Para [0173]; a reference measurement of a user may be stored on a cloud based storage in order to communicate with the handheld device).
Regarding claim 19, Scheibler discloses the method of claim 1.
Scheibler further discloses wherein the OCT scan of the eye is collected using a self-applied optical coherence tomography system (see Fig 20D; Para [0008]; the compact OCT system may be a system of the user to measure themselves).
Regarding claim 20, Scheibler discloses an optical coherence tomography (OCT) system (see Fig 6A) comprising: a light source for generating a beam of light (see Fig 6A; Para [0133]; a light source 600); a beam splitter having a beam-splitting surface for directing a first portion of the light into a reference arm and a second portion of the light into a sample arm (see Fig 6A; Para [0133]; a beam splitter 610 having a reference arm towards the processing unit 640 and a second arm towards the sample 650); optics for directing the light in the sample arm to one or more locations on a sample (see Fig 6A; Para [0133]; front end optics 620 for directing light into the sample arm to locations on the sample 650); a detector for receiving light returning from the sample and reference arms and generating signals in response thereto (see Fig 6A; Para [0133]; photodetector 642 receives light from reference arm and sample as seen in Fig 6A); and the OCT system being characterized by a processor configured to implement the method of claim 1 (see Fig 6A; Para [0133]; a processing unit 640 with a signal processing module 644 configured to determine a thickness).
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.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Scheibler (US 2018/0271363) in view of Hogen (US 2021/0059518).
Regarding claim 16, Scheibler discloses the method of claim 13.
Scheibler does not disclose wherein the plurality of the macular ROIs are concentric to each other. Scheibler and Hogan are related because both disclose methods using OCT.
Hogen discloses a method using OCT (see Fig 1) wherein the plurality of the macular ROIs are concentric to each other (see Fig 18; Para [0134]; macular ROI’s may be concentric to each other as seen in Fig 18)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Scheibler with wherein the plurality of the macular ROIs are concentric to each other of Hogen for the purpose of improving testing capabilities through flexible fixation (Para [0039-0041])
Regarding claim 17, Scheibler in view of Hogen discloses the method of claim 16.
Scheibler further discloses wherein: each of the plurality of the macular ROIs has a respective of the upper specification limit and the lower specification limit based on a corresponding upper offset and lower offset from its respective patient-personalized baseline thickness (see Fig 3A; Para [0098]; an alert may be provided based on results of test falling outside of a normal range; as example see Para [0078] range is 175 to 225 microns); and the upper offset and lower offset of the center-most ROI is set as the upper offset and lower offset of all of the plurality of macular ROIs (see Fig 10A-D; Para [0174, 0186]; examiner is interpreting this to be that the confidence interval offset of the signal is set as the confidence interval for any measured RT or RLT values).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Walsh (US 11,839,430) discloses an OCT system which includes measuring the thickness of elements of the eye.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL ANDRES SANZ whose telephone number is (571)272-3844. The examiner can normally be reached Monday-Friday 8:30 am -5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pinping Sun can be reached at (571) 270-1284. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.A.S./Examiner, Art Unit 2872
/WILLIAM R ALEXANDER/Primary Examiner, Art Unit 2872
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