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 .
Response to Amendment
The amendment was filed on 12/5/2025.
Claims 1-20 are pending.
Response to Arguments
Applicants’ arguments filed under Remarks on pages 10-12 on 12/5/205 have been fully considered but they are not persuasive. However, please note that the previous rejection in view of Munk is withdrawn and now the claims are rejected under 35 USC 103 over Wartak et al. in combination with Munk.
Applicants state on page 11 that:
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The Examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “a flattening of the cross-section”) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). No where in the claims flattening of the cross-section is recited. Munk discloses change in vein diameter as the pressure changes, as also illustrated in Figures 3a and 3b. Pending claim 1 recites “determined, based on the first plurality of characteristic vein diameters, whether the at least one vein has experienced a vein collapse during the first time period”. Munk on page 12 discloses Fig. 3a shows the vein diameters for the two test subjects, respectively when normal intracranial pressure exists, and when high intracranial pressure due to exists due to the test subjects performing of the Valsalva maneuvers. As can be seen, the vein diameter increases with increased pressure for both test subjects. Therefore, from this page and at least from the illustration of Fig. 3a, it is clear that as the pressure changes the vein diameter decreases – therefore the vein collapse. It is this in combination with other citation in the non-final rejection that Munk meets the limitations recited in at least claim 1.
On page 12 of the Remarks, the Applicants argue that:
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The Examiner respectfully disagrees. On page 2 lines 21-30 Munk discloses that “a data processing device adapted to calculate an arteriovenous ratio based on said first and second characteristic diameter values, and comparing said arteriovenous ratio with a predetermined threshold value, and an output device for outputting information, based on which it can determined whether said predetermined threshold is exceeded or not. Thereby an apparatus allowing non-invasive assessment of potential intracranial overpressure to be readily performed is provided”. This is interpreted as “pressure is determined to exceed” in view of said predetermined threshold. At top of page 3, Munk discloses that “According to a preferred embodiment of the first aspect of the invention, said retina part comprises an optic disc. Scanning the optic disc yields valuable information as to dimensions of the eye and may serve as a reference for determining locations of interest on the veins and arteries”. Therefore, as stated in the previous office action, in combination with these citation, Munk meets the limitations of pending claims in combination with Wartak et al.
Drawings
The drawings are objected to because the unlabeled rectangular box(es) shown in the drawings (boxes, 3, 4, 5 in Fig. 2, boxes 63, 65 in Fig. 3, boxes in Fig. 8) should be provided with descriptive text labels. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “cardiac monitoring component” and “respiratory monitoring component”, in claims 12-13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., abstract idea – mental process) without significantly more. Claim 1 is used as an example. Claim 11 recites a system having a processing unit (i.e., a processor). The two-part test to identify claims that are directed to a judicial exception (Step 2A) and to then evaluate if additional elements of the claim provide an inventive concept (Step 2B) are:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Are the claims directed to a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims are directed to a judicial exception under Prong One, then is the judicial exception integrated into a practical application;
(2B) If the claims are directed to a judicial exception and do not integrate the judicial exception, do the claims provide an inventive concept.
Claim 1. (Previously Presented) A method for a non-invasive assessment of a relation between an intracranial pressure and an intraocular pressure using an image recording device, comprising: (a) recording, over a first time period, a plurality of images of a retina part of an eye of a person using the image recording device, (b) identifying, in the plurality of images, at least one vein, (c) determining, in a first set of images from the plurality of images recorded over the first time period, a first plurality of characteristic vein diameters for the at least one vein at a first vein location, (d) determining, based on the first plurality of characteristic vein diameters, whether the at least one vein has experienced a vein collapse during the first time period, and (e) determining the relation between the intraocular pressure and the intracranial pressure during the first time period, wherein if the at least one vein has experienced a vein collapse the intraocular pressure is determined to exceed the intracranial pressure. [emphasis added].
With regard to (1), the instant claims recite an apparatus and a method, therefore the answer is "yes".
With regard to (2A), Prong One: Yes. When viewed under the broadest most reasonable interpretation, the instant claims are directed to a Judicial Exception – an abstract idea belonging to the group of mental process – concepts that are practicably performed in the human mind (including an observation, evaluation, judgement, opinion). The steps of (b), (c), (d) and (e) (above in emphasized claim 1) are generically recited and nothing in these steps precludes the steps from practically being performed by a human equipped with an appropriate apparatus. It can be interpreted as merely looking at the data and determining a shape of a section in the image – whether the diameter/size/shape of the vein has changed. There is nothing in the claim that requires more than an operation that a human, armed with the appropriate apparatus, pen and a paper, can not perform. The identifying and determining, under its broadest reasonable interpretation, covers performance of the limitation in the mind. The claim encompasses the user looking at image of a retina part of an eye and determining shape or size of it once a vein is identified, characteristic such as a shape or a size of a section of the image can be determined. This way, essentially one can present/output information about the section of an image that represents that shape/size. Thus, these limitations are a mental process.
With regard to (2A), Prong Two: No. The instant claims do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception of (a) “recording”, and therefore does not integrate the judicial exception into a practical application.
The use of a system/processor to record an image (i.e., “data”) at a high level of generality such that said “data” can be used in the operation of the recited judicial exception (the mental step of “recording”). Supplying “data” does not provide for “integration” of the abstract idea into a practical application, as said data do not change the way in which said system operates. There are no specifics on how the data is recorded – it is just that multiple images are obtained at a different time period. This can be interpreted as “visualization”. Even if this step is by a “image recording device”/ “processor” that may be, for example, a camera. A camera/sensor is well known in the field, and receiving data from a camera/sensor is also well known.
This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. In conclusion, the claim as a whole does not provide for “integration” of the abstract idea into a practical application.
The claim is directed to the abstract idea.
With regard to (2B), as discussed with respect to Step 2A Prong Two, the additional element in the claim amounts to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. The pending claims do not show what is more than a routine in the art presented in the claims, i.e., the additional elements are nothing more than routine and well-known steps. There is no improvement to technology here. There is only steps of (b), (c), (d) and (e). with additional elements of (a), and it has not been shown that the mental process allows the “technology” to do something that it previously was not able to do.
Therefore, the claims 1 and 11 are ineligible under 35 USC 101.
With regard to dependent claims 2-10 and 12-20, similar analysis is applied and therefore does not integrate the judicial exception into a practical application – does not provide significant more than the judicial exception. These claims are similarly rejected for the same reasons discussed in view of steps recited in claim 1 and not repeated herewith. Pease note, these claims further “determines”, “calculates”, and “compares” data that are part of an abstract idea presented above, and therefore not repeated herewith.
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.
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.
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 1-3 and 5-20 are rejected under 35 U.S.C. 103 as being unpatentable over by Wartak et al. (“Investigating spontaneous retinal venous pulsation using Doppler optical coherence tomography”, Scientific Reports, 2019), (hereafter Wartak) in combination with Munk et al. (WO2016/116370 A1, (hereafter, “Munk”).
Regarding claim 1, Wartak teaches a method for a non-invasive assessment of a relation between an intracranial pressure and an intraocular pressure using an image recording device, comprising: (Abstract, page 9, 2nd paragraph, “A method to non-invasively assess ICP would denote a milestone for monitoring and management of numerous neurological disorder and conditions 7,15,16. The introduction of time-resolved DOCT for investigation of SRVP might assist the proposed optical methods for potential future non-invasive ICP assessment.”) recording, over a first time period, a plurality of images of a retina part of an eye of a person using the image recording device (page 4 first three lines “Figure 4 is arranged similarly to Fig. 2 and depicts image data of a partial collapse in an inferior hemivein of a second eye. Supplementary Video S4 presents the corresponding movie (intensity tomograms – top; Doppler tomograms – bottom; 24 fps). Fig. 6 and 7, supplementary video S5”), identifying, in the plurality of images, at least one vein, (Fig. 6, Quantitative SRVP evaluation of DOCT image data over three full cardiac cycles of subject 2 by the expert reader. (a,b) DOCT tomograms at time points of t1 and t2) determining, in a first set of images from the plurality of images recorded over the first time period, a first plurality of characteristic vein diameters for the at least one vein at a first vein location, (Fig. 6, Graph of normalized change of transversal vessel diameter and normalized change of perfused cross-sectional vessel area with indicated t1 and t2. Fig. 7, (a) Fundus photography with indications of measurement locations (A and B) and respective DOCT tomograms) determining, based on the first plurality of characteristic vein diameters, whether the at least one vein has experienced a vein collapse during the first time period, and (page 4 3rd paragraph, quantitatively evaluated Supplementary Video S4 of the second eye showing a partial collapse -cf. Fig. 6. Again, three cardiac cycles were manually evaluated, this time only in terms of the DOCT data. Page 5 3rd paragraph, Figure 7(d) plots the normalized mean phase-difference × the normalized area (this product is proportional to the flow through the respective cross-section) of the collapsing vein at locations A and B).
Wartak discloses determining the relation between the intraocular pressure and the intracranial pressure during the first time period (page 1 second paragraph “the intraocular pressure (IOP) is commonly equated with the external venous pressure, while the internal venous pressure is equated with the intracranial pressure (ICP)1,8”; page 2 last paragraph of Methods section where “For comparison with previous SRVP reports, image data of standard ophthalmic imaging procedures (fundus photography and SLO) of the same eyes were recorded”; page 4 second paragraph where “To compare SRVP quantification between SLO and DOCT, the image sequences of Supplementary Videos S1 and S2 were manually evaluated by an expert reader regarding changes of image features. For this purpose, data acquired over three consecutive cardiac cycles were analyzed. For both sequences the transversal vessel diameter was determined at the site of highest collapse amplitude via marking the vessel’s laterally outmost areas at the borderline between static and dynamic tissue components at both sides),
wherein [if the at least one vein has experienced] a vein collapse the intraocular pressure is determined [to exceed the intracranial pressure]. (page 1 second paragraph “the intraocular pressure (IOP) is commonly equated with the external venous pressure, while the internal venous pressure is equated with the intracranial pressure (ICP)1,8”; page 2 last paragraph of Methods section where “For comparison with previous SRVP reports, image data of standard ophthalmic imaging procedures (fundus photography and SLO) of the same eyes were recorded”).
However, Wartak does not expressly teach wherein if the at least one vein has experienced [a vein collapse the intraocular pressure is determined] to exceed the intracranial pressure.
Munk teaches wherein if the at least one vein has experienced [a vein collapse the intraocular pressure is determined] to exceed the intracranial pressure (Page 2, lines 3-8 “in said image, a first characteristic diameter value for said identified artery, determining, in said image, a second characteristic diameter value for said identified vein, calculating an arteriovenous ratio (A/V ratio) based on said first and second characteristic diameter values, comparing said arteriovenous ratio with a predetermined threshold value to estimate (109) intercranial pressure.”; Page 12, lines 8-12 “Fig. 3a shows the vein diameters for the two test subjects, respectively when normal intracranial pressure exists, and when high intracranial pressure due to exists due to the test subjects performing of the Valsalva maneuvers. As can be seen, the vein diameter increases with increased pressure for both test subjects.”).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Wartak’s reference to have intraocular pressure exceeding the intracranial pressure of Munk’s reference. The suggestion/motivation for doing so would have been to show changes in vein and artery diameters, as suggested by Munk on page 12.
Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Munk with Wartak to obtain the invention as specified in claim 1.
Regarding claim 2, Wartak in combination with Munk teaches the method of claim 1. Wartak discloses determining, based on the comparison between the vein diameter behaviour and the artery diameter behaviour, whether the at least one vein has experienced a vein collapse during the first time period. (Figure 7 “Time-resolved investigation of venous caliber pulsations and venous and arterial flow pulsations using the double-channel imaging mode over five cardiac cycles.”).
However, Munk teaches wherein determining whether the at least one vein has experienced a vein collapse comprises (Page 2, lines 3-8 “in said image, a first characteristic diameter value for said identified artery, determining, in said image, a second characteristic diameter value for said identified vein, calculating an arteriovenous ratio (A/V ratio) based on said first and second characteristic diameter values, comparing said arteriovenous ratio with a predetermined threshold value to estimate (109) intercranial pressure.”): identifying, in the plurality of images, at least one artery associated with the at least one vein, (Page 2, lines 17-18 “in said at least one image, at least one artery and at least one vein associated with said artery”), determining, in the first set of images from the plurality of images recorded over the first time period, a first plurality of characteristic artery diameters for the at least one artery at a first artery location, (Page 2, lines 19-20 “in said image, a first characteristic diameter value for said identified artery”; Fig 1, Step 104, 106, 108) determining, based on the first plurality of characteristic artery diameters, an artery diameter behaviour, (Page 3, lines 10-12 “Identifying the time of occurrence of heart beats, where the arteries are subject to increased pressure that is likely to increase the diameter of the arteries, will allow this to be suppressed as a potential error source.”; Fig 3b) determining, based on the first plurality of characteristic vein diameters, a vein diameter behaviour, (Page 5, lines 23-29 “More specifically the images should be of the fundus 2 of the eye 8 with the optic disc 3 in the middle of which the arteries 4 and veins 5 enter and exit, respectively, along the optic nerve, and from which they branch out in all directions across the fundus 2. As will be explained later it may be advantageous to record a plurality of sequential images 1 over a certain time interval, in order to minimize error sources, but in principle a single image 1 of good quality, mainly a sharp image 1 , suffices.”).
Wartak and Munk and are considered analogous to the claimed invention because both are in the same field of using noninvasive methods of determining intracranial pressure via intraocular pressure. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Munk to incorporate the teachings of Wartak to determine if a vein has collapsed based on vein and artery behaviour. Doing so would make it easier and more reliably determine the intracranial pressure within a patient.
Regarding claim 3, Wartak in combination with Munk teaches the method of claim 1. Wartak teaches determining, in the first set of images from the plurality of images recorded over the first time period, a second plurality of characteristic vein diameters for the at least one vein at a second vein location, wherein the second vein location is farther away from the optic disc than the first vein location, (Figure 7, (a); Page 4, Paragraph 4 “Besides caliber pulsations, we also found flow pulsations in the same retinal veins that exhibit SRVP, as illustrated in Fig. 7. Here, the double-channel mode of our instrument (at 50 kHz A-scan rate) was used to simultaneously study the collapsing vein at the site of collapse (A) and at a location inferior (B). Due to individual vasculature arrangement of the imaged eye, the same data set also enabled investigation of an artery at the two referred locations. Figure 7(a) depicts the same fundus photography already presented in Fig. 2(a). The bold white horizontal lines indicate the retinal locations of the two linear B-scans – A and B. The dashed white lines indicate a slight vertical drift towards inferior throughout the 5.0 s acquisition time.”) determining, based on the first plurality of characteristic vein diameters, a first vein diameter behaviour, determining, based on the second plurality of characteristic vein diameters, a second vein diameter behaviour, comparing the first vein diameter behaviour to the second vein diameter behaviour, and (Figure 7, (a-d)) determining based on the comparison between the first vein diameter behaviour and the second vein diameter behaviour, whether the at least one vein has experienced a vein collapse during the first time period. (Page 5, Paragraph 2 “Figure 7(c) depicts the quantitative results of the collapsing venous segment at location A. The red curve tracks the cross-sectional area changes over time (as previously in Figs 5 and 6), while the green curve tracks changes of flow velocity. Interestingly, an opposing pulsatile behavior was observed among the two curves. As the measurement location is slowly drifting inferiorly, the mean flow velocity change seems to increase as the amplitude of caliber change decreases. The maximum mean flow velocity seems to be in phase with the collapse.”).
However, Munk teaches wherein the plurality of images of the retina part of the eye are also of an optic disc of the eye, and wherein determining whether the at least one vein has experienced a vein collapse comprises: (page 1 line 32 - Page 2, lines 1-2 “recording at least one image of a retina part of an eye of a person using said image recording device”; Page 3, lines 2-5 “According to a preferred embodiment of the first aspect of the invention, said retina part comprises an optic disc. Scanning the optic disc yields valuable information as to dimensions of the eye and may serve as a reference for determining locations of interest on the veins and arteries.”) determining, in the first set of images from the plurality of images recorded over the first time period, a location of the optic disc, (Page 5, lines 21-30 “Having prepared the patient, the next step is to record, in box 101 , one or more images 1 of an eye 8 of the patient. In principle, a single image 1 of the eye 8 will suffice. More specifically the images should be of the fundus 2 of the eye 8 with the optic disc 3 in the middle of which the arteries 4 and veins 5 enter and exit, respectively, along the optic nerve, and from which they branch out in all directions across the fundus 2.”).
Munk and Wartak are considered analogous to the claimed invention because both are in the same field of using noninvasive methods of determining intracranial pressure via intraocular pressure. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Munk to incorporate the teachings of Wartak where a second vein location is farther away from an optic disc, comparing the second vein diameter and the first, and determining a vein collapse based on that. Doing so would make it easier and more reliably determine the intracranial pressure within a patient.
Regarding claim 5, Wartak in combination with Munk teaches the method of claim 1. Wartak teaches determining, based on the comparison between the change in the vein diameter and the threshold value, whether the at least one vein has experienced a vein collapse during the first time period. (Fig 5 and 6; Page 4, Paragraphs 2 and 3).
However, Munk teaches wherein determining whether the at least one vein has experienced a vein collapse comprises: (Page 12, lines 8-13 “Fig. 3a shows the vein diameters for the two test subjects, respectively when normal intracranial pressure exists, and when high intracranial pressure due to exists due to the test subjects performing of the Valsalva maneuvers. As can be seen, the vein diameter increases with increased pressure for both test subjects.”) determining, based on the first plurality of characteristic vein diameters, a change in vein diameter during the first time period, comparing the change in the vein diameter with a threshold value, and (Page 2, lines 5-8 “a second characteristic diameter value for said identified vein, calculating an arteriovenous ratio (A/V ratio) based on said first and second characteristic diameter values, comparing said arteriovenous ratio with a predetermined threshold value to estimate (109) intercranial pressure”).
Munk and Wartak are considered analogous to the claimed invention because both are in the same field of using noninvasive methods of determining intracranial pressure via intraocular pressure. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Munk to incorporate the teachings of Wartak where by comparing the vein diameter and threshold value to determine if a vein collapse. Doing so would make it easier and more reliably determine the intracranial pressure within a patient.
Regarding claim 6, Wartak in combination with Munk teaches the method of claim 1. Wartak also teaches these more explicitly over a second time period (Fig 5 and 6; Page 4, Paragraphs 2 and 3).
However, Munk teaches recording, over a second time period, a second plurality of images of the retina part of the eye of the person using the image recording device, (Page 13, lines 5-17 “The A/V ratio measurement according to the method described above is therefore preferably performed one or more times later, say after arrival in the hospital, and hours later during monitoring…Such patients may be monitored by recording and monitoring A/V ratio at regular intervals, such as once, twice or three times a day. In this way it can be determined whether the intracranial pressure is rising or not, and accordingly whether a potentially lethal intracranial pressure is likely to evolve.”) identifying, in the second plurality of images, the at least one vein, (Page 5, line 21-26 “Having prepared the patient, the next step is to record, in box 101 , one or more images 1 of an eye 8 of the patient. In principle, a single image 1 of the eye 8 will suffice. More specifically the images should be of the fundus 2 of the eye 8 with the optic disc 3 in the middle of which the arteries 4 and veins 5 enter and exit, respectively, along the optic nerve, and from which they branch out in all directions across the fundus 2.”; Fig 1, Step 106 and 108) determining, in a second set of images from the second plurality of images recorded over the second time period, a second plurality of characteristic vein diameters for the at least one vein at the first vein location, (Page 12, line 8 “Fig. 3a shows the vein diameters for the two test subjects, respectively when normal intracranial pressure exists, and when high intracranial pressure due to exists due to the test subjects performing of the Valsalva maneuvers. As can be seen, the vein diameter increases with increased pressure for both test subjects.”; Page 3, line 6 “According to another preferred embodiment of the first aspect of the invention, the method further comprises, recording information about at least one heart pulse cycle of the person, and performing said calculation based on an image recorded at a predetermined time during the pulse cycle of said person. Identifying the time of occurrence of heart beats, where the arteries are subject to increased pressure that is likely to increase the diameter of the arteries, will allow this to be suppressed as a potential error source.”) determining, based on the second plurality of characteristic vein diameters, whether the at least one vein has experienced a vein collapse during the second time period, and (Page 12, line 8 “Fig. 3a shows the vein diameters for the two test subjects, respectively when normal intracranial pressure exists, and when high intracranial pressure due to exists due to the test subjects performing of the Valsalva maneuvers. As can be seen, the vein diameter increases with increased pressure for both test subjects.”; Page 3, line 6 “According to another preferred embodiment of the first aspect of the invention, the method further comprises, recording information about at least one heart pulse cycle of the person, and performing said calculation based on an image recorded at a predetermined time during the pulse cycle of said person. Identifying the time of occurrence of heart beats, where the arteries are subject to increased pressure that is likely to increase the diameter of the arteries, will allow this to be suppressed as a potential error source.”) determining the relation between the intraocular pressure and the intracranial pressure during the second time period, wherein if the at least one vein has experienced a vein collapse the intraocular pressure is determined to exceed the intracranial pressure. (Page 1, line 30 “in said image, a first characteristic diameter value for said identified artery, determining, in said image, a second characteristic diameter value for said identified vein, calculating an arteriovenous ratio (A/V ratio) based on said first and second characteristic diameter values, comparing said arteriovenous ratio with a predetermined threshold value to estimate (109) intercranial pressure.”; Page 12, line 8 “Fig. 3a shows the vein diameters for the two test subjects, respectively when normal intracranial pressure exists, and when high intracranial pressure due to exists due to the test subjects performing of the Valsalva maneuvers. As can be seen, the vein diameter increases with increased pressure for both test subjects.”).
Munk and Wartak are considered analogous to the claimed invention because both are in the same field of using noninvasive methods of determining intracranial pressure via intraocular pressure. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Munk to incorporate the teachings of Wartak being over a second time period. Doing so would make it easier and more reliably determine the intracranial pressure within a patient.
Regarding claim 7, Wartak in combination with Munk teaches the method of claim 1. Munk teaches identifying, in the plurality of images, at least one artery associated with the at least one vein, (Page 2, line 13 “in said at least one image, at least one artery and at least one vein associated with said artery,”) determining, in the first set of images from the plurality of images recorded over the first time period, a first plurality of characteristic artery diameters for the at least one artery at a first artery location, (Page 2, line 13 “in said image, a first characteristic diameter value for said identified artery”; Fig 1, Step 104, 106, 108) calculating an arteriovenous ratio based on the first plurality of characteristic artery diameters and the first plurality of characteristic vein diameters, and (Page 2, line 13 “calculating an arteriovenous ratio (A/V ratio) based on said first and second characteristic diameter values”) comparing the arteriovenous ratio to the relation between the intraocular pressure and the intracranial pressure during the first time period. (Page 2, line 13 “comparing said arteriovenous ratio with a predetermined threshold value to estimate (109) intercranial pressure.”).
Regarding claim 8, Wartak in combination with Munk teaches the method of claim 6. Further, Munk teaches identifying, in the second plurality of images, at least one artery associated with the at least one vein; (Page 2, line 13 “in said at least one image, at least one artery and at least one vein associated with said artery,”) determining, in the second set of images from the plurality of images recorded over the second time period, a second plurality of characteristic artery diameters for the at least one artery at a first artery location, (Page 2, line 13 “in said image, a first characteristic diameter value for said identified artery”; Fig 1, Step 104, 106, 108) calculating an arteriovenous ratio based on the second plurality of characteristic artery diameters and the second plurality of characteristic vein diameters, (Page 2. line 13 “data processing device adapted to calculate an arteriovenous ratio based on said first and second characteristic diameter values, and comparing said arteriovenous ratio with a predetermined threshold value, and an output device for outputting information, based on which it can determined whether said predetermined threshold is exceeded or not.”) determining a change in the arteriovenous ratio between the first time period and the second time period, and comparing the change in the arteriovenous ratio to the relation between the intraocular pressure and the intracranial pressure during the first time period and to the relation between the intraocular pressure and the intracranial pressure during the second time period. (Page 13, lines 5-17).
Regarding claim 9, Wartak in combination with Munk teaches the method of claim 6. Further, Munk teaches wherein the first time period, the second time period, or both is at least equal to a duration of at least one heart pulse cycle of the person, a duration of at least one respiratory cycle for the person, or both. (Page 3, line 6 “recording information about at least one heart pulse cycle of the person, and performing said calculation based on an image recorded at a predetermined time during the pulse cycle of said person.”; Page 3, line 20 “According to yet a preferred embodiment of the first aspect of the invention, the method further comprises recording information about at least one respiratory cycle for said person”).
Regarding claim 10, Wartak in combination with Munk teaches the method of claim 9. Wartak further teaches based on the first plurality of characteristic vein diameters. (Figure 5).
However, Munk teaches The method of claim 9, further comprising: determining, the duration of at least one heart pulse cycle of the person, the duration of at least one respiratory cycle of the person, or both. (Page 3, line 6 “recording information about at least one heart pulse cycle of the person, and performing said calculation based on an image recorded at a predetermined time during the pulse cycle of said person.”; Page 3, line 20 “According to yet a preferred embodiment of the first aspect of the invention, the method further comprises recording information about at least one respiratory cycle for said person”).
Munk and Wartak are considered analogous to the claimed invention because both are in the same field of using noninvasive methods of determining intracranial pressure via intraocular pressure. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Munk to incorporate the teachings of Wartak determining, based on the first plurality of characteristic vein diameters, the duration of at least one heart pulse cycle of the person. Doing so would make it easier and more reliably determine the intracranial pressure within a patient.
With regard to claim 11, claim 11 is rejected same as claim 1 and the arguments similar to that presented above for claim 1 are equally applicable to claim 11. Both Wartak (last paragraph of Methods section on page 2) and Munk (Fig. 4) discloses a device, and all of the other limitations similar to claim 1 are not repeated herein, but incorporated by reference.
Regarding claim 12, Wartak in combination with Munk teaches the system of claim 11. Wartak teaches a cardiac monitoring component configured to determine a heart pulse cycle of the person, wherein the processing unit is further configured to determine the first plurality of characteristic vein diameters for the at least one vein at the first vein location based on temporal information about the heart pulse cycle (Figure 5 “Quantitative SRVP evaluation of DOCT vs. SLO image data over three full cardiac cycles of subject 1 by the expert reader.”; Page 5, Paragraph 2 “The red curve tracks the cross-sectional area changes over time (as previously in Figs 5 and 6), while the green curve tracks changes of flow velocity. Interestingly, an opposing pulsatile behavior was observed among the two curves. As the measurement location is slowly drifting inferiorly, the mean flow velocity change seems to increase as the amplitude of caliber change decreases. The maximum mean flow velocity seems to be in phase with the collapse.”)
Wartak and Munk are considered analogous to the claimed invention because both are in the same field of using noninvasive methods of determining intracranial pressure via intraocular pressure. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Munk to incorporate the teachings of Wartak of the addition of a cardiac monitor. Doing so would make it easier and more reliably determine the intracranial pressure within a patient.
Regarding claim 13, Wartak in combination with Munk teaches the system of claim 11. Munk teaches a respiratory monitoring component configured to determine a respiratory cycle of the person, wherein the processing unit is further configured to determine the first plurality of characteristic vein diameters for the at least one vein at the first vein location based on temporal information about the respiratory cycle. (Page 4, lines 10-20).
With regard to claim 14, claim 14 is rejected same as claim 2 and the arguments similar to that presented above for claim 2 are equally applicable to claim 14, and all of the other limitations similar to claim 2 are not repeated herein, but incorporated by reference.
With regard to claim 15, claim 15 is rejected same as claim 3 and the arguments similar to that presented above for claim 3 are equally applicable to claim 15, and all of the other limitations similar to claim 3 are not repeated herein, but incorporated by reference.
With regard to claim 16, claim 16 is rejected same as claim 5 and the arguments similar to that presented above for claim 5 are equally applicable to claim 16, and all of the other limitations similar to claim 5 are not repeated herein, but incorporated by reference.
With regard to claim 17, claim 17 is rejected same as claim 6 and the arguments similar to that presented above for claim 6 are equally applicable to claim 17, and all of the other limitations similar to claim 6 are not repeated herein, but incorporated by reference.
Regarding claim 18, Wartak in combination with Munk teaches the system of claim 17. Munk teaches wherein the processing unit is further configured to: identify, in the second plurality of images, at least one artery associated with the at least one vein; (Page 2, lines 17-18 “in said at least one image, at least one artery and at least one vein associated with said artery,”) determine, in the second set of images from the plurality of images recorded over the second time period, a second plurality of characteristic artery diameters for the at least one artery at a first artery location, (Page 2, lines 19-20 “in said image, a first characteristic diameter value for said identified artery”; Fig 1, Step 104, 106, 108) calculate an arteriovenous ratio based on the second plurality of characteristic artery diameters and the second plurality of characteristic vein diameters, (Page 2. line 13 “data processing device adapted to calculate an arteriovenous ratio based on said first and second characteristic diameter values, and comparing said arteriovenous ratio with a predetermined threshold value, and an output device for outputting information, based on which it can determined whether said predetermined threshold is exceeded or not.”) determining a change in the arteriovenous ratio between the first time period and the second time period, and compare the change in the arteriovenous ratio to the relation between the intraocular pressure and the intracranial pressure during the first time period and to the relation between the intraocular pressure and the intracranial pressure during the second time period (Page 13, lines 5-17).
With regard to claim 19, claim 19 is rejected same as claim 7 and the arguments similar to that presented above for claim 7 are equally applicable to claim 19, and all of the other limitations similar to claim 7 are not repeated herein, but incorporated by reference.
With regard to claim 20, claim 20 is rejected same as claim 10 and the arguments similar to that presented above for claim 10 are equally applicable to claim 20, and all of the other limitations similar to claim 10 are not repeated herein, but incorporated by reference.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wartak et al. (“Investigating spontaneous retinal venous pulsation using Doppler optical coherence tomography”, Scientific Reports, 2019), (hereafter Wartak) in combination with Munk et al. (WO2016/116370 A1, (hereafter, “Munk”), and further in view of Abramoff et al (US 9,924,867 B2 (hereafter, “Abramoff”).
Regarding claim 4, Munk and Wartak discloses the method of claim 3. Wartak discloses the second vein location (Figure 7, (a); Page 4, Paragraph 4 “Besides caliber pulsations, we also found flow pulsations in the same retinal veins that exhibit SRVP, as illustrated in Fig. 7. Here, the double-channel mode of our instrument (at 50 kHz A-scan rate) was used to simultaneously study the collapsing vein at the site of collapse (A) and at a location inferior (B). Due to individual vasculature arrangement of the imaged eye, the same data set also enabled investigation of an artery at the two referred locations. Figure 7(a) depicts the same fundus photography already presented in Fig. 2(a). The bold white horizontal lines indicate the retinal locations of the two linear B-scans – A and B. The dashed white lines indicate a slight vertical drift towards inferior throughout the 5.0 s acquisition time.”). Neither Wartak nor Munk disclose a distance corresponding to a diameter of the optic disc away from the optic disc.
However, Abramoff teaches a distance corresponding to a diameter of the optic disc away from the optic disc. (Fig 1; Fig 8, Step 802 – 805).
Munk, Wartak, and Abramoff are considered analogous to the claimed invention because all are in the same field of using AVR in images to determine vein diameter. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Munk or Wartak to incorporate the teachings of Abramoff of a second vein location at least a distance corresponding to a diameter of the optic disc away from the optic disc. Doing so would make it easier and more reliably determine the intracranial pressure within a patient.
Further, one skilled in the art could have combined the elements as described above by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, it would have been obvious to combine Abramoff with Wartak and Munk to obtain the invention as specified in claim 4.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10,149,624 discloses a method for measuring the intracranial pressure, ICP, in a subject, the method comprising detecting whether spontaneous retinal venous pulsations, SRVPs, are occurring in an eye of the subject as the orientation of the head of the subject changes; identifying the orientation of the head of the subject at which SRVPs start to occur or stop occurring; and using the identified orientation of the head of the subject at which SRVPs start to occur or stop occurring to determine the ICP in the subject.
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SHEFALI D. GORADIA
Primary Patent Examiner
Art Unit 2676
/SHEFALI D GORADIA/Primary Patent Examiner, Art Unit 2676
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