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
Receipt is acknowledged of the amendment filed 7/08/2026. Claims 1-18 and 22 are amended, claims 25-26 are new and claims 1-22 and 25-26 are currently pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-22 and 25-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a computer configured to: provide target display input to the display device … receive the patient input indicating that the patient sees the floater; record the patient input; calculate a plurality of intermediate scores based on the patient input, the plurality of intermediate scores corresponding to factors that contribute to a severity of the floater; calculate a severity score according to one or more of the intermediate scores, the severity score indicating the severity of the floater”, a computer-based algorithmic solution to determining a floater severity indicating “the severity of the floater”. In the Specifications, Applicant discloses various algorithmic sub-components of a floater severity algorithm in [0057]-[0074] in connection with Fig. 5 without specifying the details with sufficient precision to evidence possession of the claimed genus. The specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008). It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) Applicant separately discloses a possible algorithmic solution for each of the components 80a-80e. For the location score, Applicant discloses “a floater location closer to or at the eye axis (i.e., in the central field of vision) may yield a severity score indicating greater severity, and a floater location farther away from the eye axis may yield a severity score indicating lesser severity” while also noting “location of the floater may be determined in any suitable manner” – thus extending the algorithmic scope beyond the specific algorithmic step of locating the floater relative to the central field. For the occurrence score, Applicant discloses “the number of times the patient indicates seeing the floater” without details of the conditions (i.e. duration, field of view, etc.) of this test and “occurrence score may be calculated in any suitable manner” – thus extending the algorithmic scope beyond the specific algorithmic step of counting occurrences. For density score, Applicant discloses “a static perimetry approach could be used where the background intensity is progressively increased until the patient sees a floater … [i]f the patient sees the floater at a lower intensity, then the floater may have a higher density … [i]f the patient does not see the floater until a higher intensity, then the floater may have a lower density” while also noting “a density score indicating the density of the floater in any suitable manner” – thus extending the algorithmic scope beyond the specific algorithmic step of changing background intensity. For situational score, Applicant discloses “a situational score that indicates one or more factors relevant to the patient's situation, such as the living environment” – which is not clearly defined relative to a target display. For patient description score, Applicant discloses “may include a factor (e.g., occurrence, location, size, or other factor of the floater) that affects the severity of the floater” and leaves the algorithmic process open to any possible input from a patient. In sum, the scope of an algorithmic solution in which a severity score is calculated extends far beyond that which Applicant evidences as possessed.
In the 7/08/2026 Remarks, Applicant argues that the requirements for algorithmic specificity are met in the [0057] disclosure of various calculators (e.g. “score calculators 80 calculate intermediate scores for factors that can contribute to the severity of a floater, and severity score calculator 82 calculates a severity score according to one or more of the intermediate scores”). Examiner maintains that these calculators are black box modules that rely on an undisclosed computer implementation for transformation input data into output data useful in the disclosed floater severity determination. In [0058], Applicant explicitly states “scores may be calculated in any suitable manner”. In [0064], Applicant explicitly states “[s]everity score calculator 82 calculates the severity score using one or more of the intermediate scores in any suitable manner”. The disclosure amounts to there being an unknown input by the patient, an unknown conversion of that input to an intermediate score via an unknown calculation process, and then an unknown conversion of the intermediate score via an unknown calculation process for outputting a severity score. The mathematical summation in [0064] does not amount to algorithmic specificity in any of the conversion steps for meeting the requirements under 35 U.S.C. 112(a). Possession is not evidenced by stating the algorithm (i.e. a “calculator”) is possessed as it is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015)
Dependent claims 2-22 and 25-26 are rejected for failing to cure the deficiency of the base claim.
Claim 18 has been amended to recite “provide trial run display input to the display device to yield trial run instructions for conducting a trial run of a test, the trial run instructions comprising instructions that: a trial run will be conducted; results of the trial run will not be included in the report; the patient should fixate on the target; the patient should follow the target with the patient's gaze; and the patient should provide patient input when the patient sees the floater”. The amended renders moot the previous rejection as the language now clearly limits the computer-implemented “provide trial run display input … for conducting a trial run of a test” to merely displaying information and not a computer-implementation of conducting a trial run.
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 1-22 and 25-26 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 1 recites “a computer configured to: provide target display input to the display device … receive the patient input indicating that the patient sees the floater; record the patient input; calculate a severity score according to the patient input, the severity score indicating severity of the floater”, a computer-based algorithmic solution to determining floater severity. If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention a rejection under 35 U.S.C. 112(a) for lack of written description must be made (see above). A rejection under 35 U.S.C. 112(b) or the second paragraph of pre-AIA 35 U.S.C. 112 must be made in addition to the written description rejection. The metes and bounds of the claimed calculating a severity score step cannot be determined on account of the lack of algorithmic specificity. For the purpose of examination, calculating a severity score will include any quantitative or qualitative description of a floater or lack thereof.
Dependent claims 2-22 and 25-25 fail to remedy the deficiencies of the base claim.
Claim 1 recites the limitation "the severity of the floater" in Line 17. There is insufficient antecedent basis for this limitation in the claim. As there is no empirical data characterizing the recited floater, there is no antecedence for a severity of the floater. It can be said that there is antecedence for a severity score, but as recited “a severity of the floater” is in an adjective clause modifying “factors” to which intermediate scores “correspond”. From the Specifications, intermediate score correspond to factors such as location and density and from the disclosure it is understood that location and density contribute to a severity of the floater. There continues to be disagreement as to the correlation between objective severity of a floater and subjective severity of a floater, and the current claim language does not clearly define severity and provides an indefinite limitation via the recited antecedence.
Claim 6 recites “determining a location of the floater according to the patient input; determining a location score according to the location of the floater; and calculating the severity score in accordance with the location score, a location closer to the eye axis corresponding to a greater severity, a location farther away from the eye axis corresponding to a lesser severity”. As noted above, the algorithmic solution to determining a location and calculating a severity score accordingly are unclear for at least the reason that there is no clear methodology for this measure. Even assuming, en arguendo, that this may be a binary measure whereby a subjective determination is made as to whether the floater is located farther from the axis than a threshold distance, there is no clear process nor means for providing the diagnostic method. The metes and bounds of the claim cannot be determined.
Claim 7 recites “the computer configured to calculate the severity score by: determining a density score indicating a density of the floater; and calculating the severity score in accordance with the density score”. As noted above, the algorithmic solution to determining a density and calculating a severity score accordingly are unclear for at least the reason that there is no clear methodology for this measure. Even assuming, en arguendo, that this may be a binary measure whereby a subjective determination is made as to whether a floater exists within the field of view there is no clear process nor means for providing the diagnostic method (e.g. size determination, area determination, etc.). The metes and bounds of the claim cannot be determined.
Claim 8 and 9 recite “determine a density score”. As noted above, the algorithmic solution to determining a density and calculating a severity score accordingly are unclear for at least the reason that there is no clear methodology for this measure. Even assuming, en arguendo, that this may be a binary measure whereby a subjective determination is made as to whether a floater exists within the field of view there is no clear process nor means for providing the diagnostic method (e.g. size determination, area determination, etc.). The metes and bounds of the claim cannot be determined.
Claim 11 recites “determine an occurrence score” and “calculating the severity score in accordance with the occurrence score”. As noted above, the algorithmic solution to determining an occurrence score is unclear for at least the reason that there is no clear methodology for this measure. The metes and bounds of the claim cannot be determined. It is noted that detecting a reaction time between the moving target and receiving patient input provided when a floater is detected is clear and definite. Further, correlating a high severity score to a shorter reaction time and a low severity score to a longer reaction time could be definite in an algorithmic-sense.
Claim 12 recites “determining a situational score that indicates one or more factors relevant to a patient situation” and “calculating the severity score”. As noted above, the algorithmic solution to determining a situational score is unclear for at least the reason that there is no clear methodology for this measure. Further, there is no clear example defined of a factor relevant to a patient situation and an artisan would not understand the metes and bounds of such language.
Claim 18 recites “”provide trial run display unput to the display device to yield trial run instructions for conducting a trial run of a test”. If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention a rejection under 35 U.S.C. 112(a) for lack of written description must be made (see above). A rejection under 35 U.S.C. 112(b) or the second paragraph of pre-AIA 35 U.S.C. 112 must be made in addition to the written description rejection. The metes and bounds of the claimed calculating a severity score step cannot be determined on account of the lack of algorithmic specificity. For the purpose of examination, calculating a severity score will include any quantitative or qualitative description of a floater or lack thereof.
Claim 13 recites “calculating the severity score in accordance with the patient description”. As noted above, the algorithmic solution to calculating a severity score in accordance with a patient description is unclear for at least the reason that there is no clear methodology for this measure. The metes and bounds of such language cannot be determined by a person having ordinary skill in the art.
Response to Arguments
Applicant's arguments filed 7/8/2026 have been fully considered but they are not persuasive.
In the 7/08/2026 Remarks, Applicant argues that the requirements for algorithmic specificity are met in the [0057] disclosure of various calculators (e.g. “score calculators 80 calculate intermediate scores for factors that can contribute to the severity of a floater, and severity score calculator 82 calculates a severity score according to one or more of the intermediate scores”). Examiner maintains that these calculators are black box modules that rely on an undisclosed computer implementation for transformation input data into output data useful in the disclosed floater severity determination. In [0058], Applicant explicitly states “scores may be calculated in any suitable manner”. In [0064], Applicant explicitly states “[s]everity score calculator 82 calculates the severity score using one or more of the intermediate scores in any suitable manner”. The disclosure amounts to there being an unknown input by the patient, an unknown conversion of that input to an intermediate score via an unknown calculation process, and then an unknown conversion of the intermediate score via an unknown calculation process for outputting a severity score. The mathematical summation in [0064] does not amount to algorithmic specificity in any of the conversion steps for meeting the requirements under 35 U.S.C. 112(a). Possession is not evidenced by stating the algorithm (i.e. a “calculator”) is possessed as it is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015)
On page 11 of the Remarks, Applicant argues the merits of the claimed invention in view of a previous 35 U.S.C. 112(b) rejection. Claim 18 has been amended to recite “provide trial run display input to the display device to yield trial run instructions for conducting a trial run of a test, the trial run instructions comprising instructions that: a trial run will be conducted; results of the trial run will not be included in the report; the patient should fixate on the target; the patient should follow the target with the patient's gaze; and the patient should provide patient input when the patient sees the floater”. The amended renders moot the previous rejection as the language now clearly limits the computer-implemented “provide trial run display input … for conducting a trial run of a test” to merely displaying information and not a computer-implementation of conducting a trial run.
On pages 13-15, Applicant argues the merits of determining the various recited “score” determinations in Claims 6-9 and 11-13. As maintained in the rejection above, a recited “calculator” fails to sufficiently describe the algorithmic solution under 35 U.S.C. 112(a) and 112(b). For example, on page 13 Applicant states “describing location score calculator 80a, which determines a location score indicating the location of the floater, and explains that locations closer to or at the eye axis may yield greater severity while locations farther from the eye axis may yield lesser severity”. A person having ordinary skill in the art would understand that this methodology is inadequately described in the Specifications as a patient’s ability to determine location is notoriously unreliable and so the input of particular information would be of paramount importance in defining the algorithmic solution and subsequent use of the input information in forming a particular intermediate score and final severity determination. For example, a specific algorithmic solution to location determination may require the patient to merely input a binary indication of whether a floater is centrally located or peripherally located. Even assuming this most basic patient input, there is no clear and understood methodology for converting the binary input into an intermediate score. In claim 6, the step of “determining a location of the floater” is a genus that includes a binary determination of a floater’s appearance in the patient’s field of view and a specific, coordinate-based location within the field of view. Applicant has not described the algorithmic solution in sufficient specificity for a person having ordinary skill in the art to understand the determination of floater severity. Analogous reasoning is applicable to density score, occurrence score, situational score, and at least the description score.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J STANFORD whose telephone number is (571)270-3337. The examiner can normally be reached 8AM-4PM PST M-F.
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/CHRISTOPHER STANFORD/Primary Examiner, Art Unit 2872
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