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 . 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 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.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-9) in the reply filed on 04/09/2026 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Accordingly, claims 1-9 are currently under consideration.
Information Disclosure Statement
Applicant is reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this application.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 5 is objected to because of the following informalities: the recitation of “wherein eye tracking system” should instead read –wherein the eye tracking system--.
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.
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: “head-mounted device” in claim 6.
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 § 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 5 is 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 pre-AIA the applicant regards as the invention.
Regarding claim 5, it is unclear whether “an external illumination source” is the same as or different than the illumination source recited in claim 4. For purposes of examination, it will be interpreted as a different illumination source.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-9 are directed to an “apparatus,” which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 recites (“sets forth” or “describes”) the abstract idea of a mental process and a mathematical concept, substantially as follows:
identify conditions associated with a detection of the polarization state of the light reflected from the individual's eye; determine whether the identified conditions match certain conditions within predefined difference levels; and determine a variance in the detected polarization state of the light from a previously detected polarization state based on a determination that the identified conditions match the certain conditions within the predefined difference levels, wherein a change in a glucose level of the individual is to be determined based on the determined variance.
The identifying and determining steps can be practically performed in the human mind, with the aid of a pen and paper, but for performance on a generic computer, in a computer environment, or merely using the computer as a tool to perform the steps. If a person were to see a printout of the detected polarization state (and conditions), they would be able to identify conditions, determine whether they were a match, and determine a variance of the polarization state accordingly. There is nothing to suggest an undue level of complexity in the identification and determination. Therefore, a person would be able to perform the steps mentally or with pen and paper.
The identifying and determining steps also involve the mathematical concepts of data matching/classification and variance calculation. These steps correspond to “[w]ords used in a claim operating on data to solve a problem [that] can serve the same purpose as a formula.” See MPEP 2106.04(a)(2)(I).
Prong Two: Claim 1 does not include additional elements that integrate the mental process or mathematical concept into a practical application. Therefore, the claims are “directed to” the mental process and mathematical concept. The additional elements merely:
recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. a processor and a memory), and
add insignificant extra-solution activity (the pre-solution activity of: accessing a detected polarization state).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the determined variance is not outputted in any way such that a diagnostic benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 1 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the abstract idea (e.g. identifying features (claims 2 and 5), disregarding data based on no match (claims 3 and 8), repeating abstract idea steps (claim 7), determining a change in glucose level (claim 9), etc.),
further describe the pre-solution activity (or the structure used for such activity) (e.g. an eye tracking system that obtains the data for accessing (claim 4), etc.), and
describe field-of-use context (e.g. a head-mounted device (claim 6), etc.).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology or technical field, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 6-8 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 6, the recitation of “head-mounted device” can be interpreted as including the head within the scope of the claim. Applicant may consider referring to the device as “head-mountable.”
Claims 7 and 8 are rejected because they depend on rejected claims.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of US Patent Application Publication 2018/0160956 (“Robaina”).
Regarding claim 1, Robaina teaches [a]n apparatus, comprising: a processor (Fig. 2, local processing and data module 70 includes a hardware processor, ¶ 0152); and a memory on which is stored machine-readable instructions that when executed by the processor, cause the processor to (Fig. 2, local processing and data module 70 include non-volatile memory, ¶ 0152 – also see ¶ 0164, a controller 210 that is part of module 70 includes instructions in the non-transitory medium for performing functions, and ¶ 0243): access a detected polarization state of light reflected from an individual's eye (Fig. 13, ¶¶s 0241 and 0242); identify conditions associated with a detection of the polarization state of the light reflected from the individual's eye (¶ 0238, eye tracking to identify whether the polarized light transmitted to the eye); determine whether the identified conditions match certain conditions within predefined difference levels (¶ 0238, the identification being based on some boundary related to the eye or target area); and determine a variance in the detected polarization state of the light from a previously detected polarization state based on a determination that the identified conditions match the certain conditions within the predefined difference levels (¶ 0238, only determining glucose levels when the eye tracking sensor determines proper location), wherein a change in a glucose level of the individual is to be determined based on the determined variance (¶ 0242, determining a glucose level; ¶ 0149, comparing a contemporaneous glucose level with historical glucose levels. Although it is not explicit that the comparison is to determine a variance/change in glucose level, ¶ 0149 describes monitoring glucose over time, and ¶ 0150 describes providing real time feedback to help users maintain a target level, etc., which suggests the importance of tracking changes over time. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine a variance in polarization and therefore a variance/change in glucose level, for the purpose of helping the user maintain a target level (¶ 0150)).
Regarding claim 2, Robaina teaches all the features with respect to claim 1, as outlined above. Robaina further teaches wherein the conditions comprise one or more of, at a time when the polarization state of the light was detected: pupil dilation level of the individual's eye; accommodation distance of the individual's eye; gaze direction of the individual's eye (¶ 0238, eye tracking to identify whether the polarized light transmitted to the eye); and an illumination level at a detector of the polarization state of the light caused by an external illumination source.
Regarding claim 3, Robaina teaches all the features with respect to claim 1, as outlined above. Robaina further teaches wherein the instructions cause the processor to: disregard the detected polarization state of the light based on a determination that the identified conditions do not match the certain conditions within the predefined difference levels (¶ 0238, only determining glucose levels when the eye tracking sensor determines proper location. Thus, measurements are disregarded when conditions do not match).
Regarding claim 4, Robaina teaches all the features with respect to claim 1, as outlined above. Robaina further teaches an eye tracking system (¶ 0238, eye tracking) including: a polarization sensitive detector (¶¶s 0172, 0194, 0195, Fig. 10, etc. – also see Fig. 13, ¶¶s 0241 and 0242); and an illumination source to direct light at a known polarization state into the individual's eye, wherein the processor is to access the polarization state of light detected by the polarization sensitive detector in the eye tracking system (¶¶s 0172, 0194, 0195, Fig. 10, etc. – also see Fig. 13, ¶¶s 0241 and 0242).
Regarding claim 5, Robaina teaches all the features with respect to claim 4, as outlined above. Robaina further teaches wherein eye tracking system is to detect one or more of, at a time when the polarization state of the light is detected: a pupil dilation level of the individual's eye; an accommodation distance of the individual's eye; a gaze direction of the individual's eye (¶ 0238, eye tracking to identify whether the polarized light transmitted to the eye); and an illumination level at the polarization sensitive detector caused by an external illumination source.
Regarding claim 6, Robaina teaches all the features with respect to claim 4, as outlined above. Robaina further teaches wherein the apparatus comprises a head-mounted device and wherein the individual is a user of the head-mounted device (¶ 0146, Figs. 10 and 13).
Regarding claim 7, Robaina teaches all the features with respect to claim 6, as outlined above. Robaina further teaches wherein the eye tracking system is to detect a polarization state of light multiple times when the individual is using the apparatus (¶ 0147, continuous wear, ¶ 0143, multiple times a day) and wherein the instructions cause the processor to: access multiple detected polarization states of the light reflected from the individual's eye; and for each of the accessed multiple detected polarization states, identify conditions associated with the detection of the detected polarization state; determine whether the identified conditions match the certain conditions within the predefined difference levels; and determine a variance in the detected polarization state and a previously detected polarization state based on a determination that the identified conditions match the certain conditions with the predefined difference levels (performing the same method as above, but multiple times a day. I.e., monitoring over time, or continuously).
Regarding claim 8, Robaina teaches all the features with respect to claim 7, as outlined above. Robaina further teaches wherein the instructions cause the processor to: for the accessed multiple detected polarization states that were detected under conditions that do not match the certain conditions within the predefined difference levels, disregard the detected polarization states (¶ 0238, only determining glucose levels when the eye tracking sensor determines proper location. Thus, measurements are disregarded when conditions do not match).
Regarding claim 9, Robaina teaches all the features with respect to claim 1, as outlined above. Robaina further teaches wherein the instructions cause the processor to: determine the change in the glucose level of the individual based on the determined variance of the detected polarization state of the light from the previously detected polarization state (¶ 0242, determining a glucose level; ¶ 0149, comparing a contemporaneous glucose level with historical glucose levels. Although it is not explicit that the comparison is to determine a variance/change in glucose level, ¶ 0149 describes monitoring glucose over time, and ¶ 0150 describes providing real time feedback to help users maintain a target level, etc., which suggests the importance of tracking changes over time. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine a change in glucose level, based on the determined variance, for the purpose of helping the user maintain a target level (¶ 0150)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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