DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 1 August 2025 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-17 and 19-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 calls for finding “an IOP reading” without providing the terms this abbreviates; the first recitation should define “an intraocular pressure (IOP) reading”. Correction is required.
Claim 8 also calls for “recording images” and later refers to “one or more cornea topography images” – are these the images obtained via recording? Or is “recording images” some other images and the cornea topography images are obtained via some other source? For the purposes of examination the claim will be treated as though calling for recording cornea topography images, where one or more of the cornea topography images are used to determine deformation; correction is required.
Claim 10 recites that “the cornea topography images further comprises a distortion of an image”; in addition to the grammatical issue where the plural images should further comprise, how can the plural images comprise a single image? Is “a distortion” some sort of graphical processing or manipulation that can transform the single image into the plurality of topography images? If so, what is “a distortion”, as this is not a term commonly used in the art for this purpose? It should be noted that the disclosure provides no clarification for this as the term “distortion” is not recited in the disclosure, only this claim. The claim is too indefinite in scope to allow further examination on the merits; clarification is required.
Claim 11 refers to “a plurality of cornea deformation images taken at a plurality of frequencies” – does “a plurality of frequencies” refer to the capturing of images? Is each image of the plurality of images taken at a plurality of frequencies? Is this intended to include a reference to a light source operating at one or more frequencies as in claim 10? Even if so, does each individual image of the plurality of images capture light at a plurality of frequencies or is it one light frequency per image a plurality of times? Or does this potentially refer to the excitation of the coil at at least one frequency of a periodic current as in claim 9? If not these, what aspect of the method is performed “at a plurality of frequencies”? The claim cannot be further treated on the merits as the scope is too indefinite to allow examination on the merits; clarification is required.
Claim 12 calls for using an algorithm “to revert a set of corneal frequency response data” – there is no antecedent basis for this limitation in the claim, as it is not clear what this set of data is, where it comes from, or how it might relate to any other data captured as part of the method. Further, it is entirely unclear what aspect might result in a “frequency response”, as no claim from which this depends involves a frequency, but two other unrelated dependent claims have wholly different aspects which involve frequencies (as in claim 11). The claim cannot be further treated on the merits as the scope is too indefinite to allow examination on the merits; clarification is required.
Claims 13 and 14 each call for performing measurements “at each frequency”; there is no antecedent basis for this limitation in the claim, nor is it clear what aspect of the method this might refer to as both claims 9 and 10 define different aspects of the method as being performed at various frequencies, such that the claims are too indefinite in scope to allow further examination on the merits. Clarification is required.
Claim 15 calls for “generating a frequency response curve for a cornea” - the only parameter sensed is “images”, and it does not appear possible to generate a “frequency response curve” for or from “images”. Further, is “a cornea” the same cornea whose deformation is determined? Or is this some other cornea? The claim is too indefinite in scope to allow further examination on the merits; clarification is required.
Claim 16 calls for “using a Fourier transform to convert a time domain response to a frequency domain response” – a time domain response of what? The only parameter sensed is “images” – are these images somehow in a time domain? Or does this refer to some other unidentified response that is also measured? The claim is too indefinite in scope to allow further examination on the merits; clarification is required.
Claim 17 further refers to “calculating a deformation of corneal topography” – is this the same step as “determining a cornea deformation based on the one or more cornea topography images”? Or is this an additional parameter to be found? Further, the claim refers to “at each frequency”; there is no antecedent basis for this limitation in the claim. The claim is too indefinite in scope to allow further examination on the merits; clarification is required.
Claim 24 calls for “determining a change in spot positions after exciting the excitation coil”; there is no antecedent basis for determining a change in spot positions as no initial spot position(s) exist within the method as claimed. Further, it is unclear what this “spot” or “spot positions” might even be. The claim is too indefinite in scope to allow further examination on the merits; clarification is required.
Where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. See MPEP 2173.06.
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 8-17 and 19-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) calculating a pressure from obtained images, which falls into the grouping of mental processes. This judicial exception is not integrated into a practical application because calculating the pressure
does not present any improvement to the functioning of a computer or to any other technology, as the judicial exception itself is entirely disembodied
does not apply or use a judicial exception to effect a particular treatment or as a prophylaxis for a disease or medical condition, as the determined pressure is not used or even output in any way
does not apply the judicial exception with, or by use of, a particular machine, as the judicial exception itself is entirely disembodied
does not effect a transformation or reduction of a particular article to a different state or thing, as the calculation of pressure is merely manipulation of gathered information
does not apply or use the judicial exception in some other meaningful way, as the judicial exception is not used or applied
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only elements are recited only in the preamble and not defined as being even related to the judicial exception, these elements being a non-specific “apparatus for reading a contact lens” which has “a controller”, where “reading a contact lens” is not recited as part of the claimed method, nor is the controller recited as performing any part of the judicial exception, such that these elements are unrelated to the judicial exception itself. As such, considered individually and as a whole, the claim elements do not amount to significantly more than the abstract idea itself.
The dependent claims also fail to provide anything significantly more, as claims 9, 10, 13, 14, 19-23, 26, and 27 are directed to the insignificant extrasolution activity of data gathering (See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional); claims 11, 12, 15-17, 24, and 25 are directed to the analysis performed as part of the abstract idea itself.
Claim Rejections - 35 USC § 102
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.
Claim(s) 8, 9, 25-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lipman (US 6083160).
Regarding claim 8, Lipman discloses a method of determining an intraocular pressure (IOP) reading using an apparatus having a controller (figure 1), the method comprising:
exciting an “excitation coil” (element 20) with an electric current pulse (column 4, lines 52-55; the coil is “excited” and thus an “excitation coil”);
recording images over a pre-established period of time (column 3, lines 46-48; column 4, lines 55-58);
determining a cornea deformation based on one or more cornea topography images (column 4, lines 59-63); and
calculating the IOP reading using the cornea deformation (column 4, lines 63-66).
When reading the preamble in the context of the entire claim, the recitation “using an apparatus for reading a contact lens with an embedded magnet, the apparatus having a controller” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Regarding claim 9, Lipman further discloses that the excitation of the coil is done with a periodic current pulse train with at least one frequency (column 4 line 50 to column 5 line 11 – the applied current is controlled to maintain a desired contact area while periodic physiological parameters change the amount of pressure needed, such that the control results in excitation of the coil with periodic pulsation; a periodic signal inherently has at least one frequency).
Regarding claim 25, Lipman further discloses processing, via the controller, a received program instruction and a received data from an external source (column 4, lines 26-32).
Regarding claim 26, Lipman further discloses that the excitation coil comprises a magnetic excitation coil (claim 6).
Regarding claim 27, Lipman further discloses that the controller is configured to synchronize excitation of the excitation coil and the recording of the images (column 4, lines 50-67).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 19, 20, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lipman in view of Que (US 2021/0311329).
Regarding claim 19, Lipman does not disclose the method further comprising illuminating, via a light source, a contact lens to produce a reflection of light or a refraction of light from the contact lens. Que teaches a method of monitoring intraocular pressure comprising illuminating, via a light source, a contact lens to produce a reflection of light or a refraction of light from the contact lens (paragraph [0010]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Lipman and included producing a reflection or refraction of light from a light source by a contact lens, as taught by Que, in order to provide an additional measurement for comparison. The Examiner notes that, as presented, the illumination of the lens has no relation to any other step in the claim.
Regarding claim 20, Que further teaches detecting, via an optical sensor, the reflected or refracted of light (paragraph [0055]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Lipman, as modified, and further detected the reflected or refracted light, as further taught by Que, in order to obtain the measurement.
Regarding claim 23, Que further teaches that the light source is structured in the form of a two-dimensional array or a matrix (paragraph [0065]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Lipman, as modified above, and further structured the light source as a two-dimensional array or matrix, as further taught by Que, in order to ensure illumination of the entire target area.
Claim(s) 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lipman and Que, as applied above, and further in view of Marsh (US 2017/0337706).
Que does not teach the optical sensor comprising a camera or the light source comprising a laser; Marsh teaches an optical monitoring method (figure 9) comprising illuminating a contact lens via a light source to produce a reflection or refraction of light from the contact lens and detecting the reflected or refracted light with an optical sensor (paragraph [0044]), where the light source comprises a laser (element 901, paragraph [0044]) and the optical sensor comprises a camera (paragraph [0028]). It would have been obvious to follow the method of Lipman and Que using a laser and camera for illumination and detection, as taught by Marsh, as Marsh teaches a number of equivalent light sources and detectors including these and also those used by Que, such that it would be a simple matter of substitution to use a laser and camera in the method.
Conclusion
No art has been applied against claims 10-17 and 24 at this time; however, as the claims are all rejected under 101 and 112 they are not presently allowable and the question of prior art will be revisited once the scope of the claims has been defined.
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/KAREN E TOTH/ Examiner, Art Unit 3791