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 Arguments
Applicant’s arguments with respect to claim(s) Claims 1-3, 5, 6, 8-11, 13-22, 24 and 25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-3, 5, 6, 8-11, 13-22, 24 and 25 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.
Exemplary Claim 1 is rejected is rejected under 35 U.S.C. § 112(a) because the specification does not provide adequate written description and fails to enable a person having ordinary skill in the art to make and use the full scope of the claimed subject matter without undue experimentation as presented. Claim 1states the following: A method for automatically focusing a microscope comprising: initial coarse focusing at a “best‑suited” lateral xy‑location of a lateral edge/corner of specified objects selected from a plurality of assessed lateral xy‑locations in an overview image based on “predetermined criteria” while disregarding other regions, followed by subsequent fine focusing at the sample using the coarse focus as a starting point. The specification must convey with reasonable clarity to a person having ordinary skill in the art that the inventor had possession of the claimed invention as of the filing date. Even though the specification provides some areas of support at a high-level for claim 1; detecting boundaries such as cover slip peripheries, slide peripheries, well peripheries using segmentation/detection or ML techniques and determining a coarse focus by capturing z‑stack images at a detected boundary and selecting a height corresponding to a maximum quality factor. The specification also expressly describes performing a subsequent fine focusing step about the coarse focus to improve image sharpness. However, there are certain are shortfalls that are associated with the claim limitations, despite the broad support, the specification does not sufficiently demonstrate possession of several specific claim limitations as broadly recited:
“Predetermined criteria” and “best‑suited” selection: The claim requires assessing a plurality of lateral xy‑locations of lateral edges/corners and selecting a single or at least one “best‑suited” lateral xy‑location based on “predetermined criteria.” The specification states only generally that “Using predetermined criteria, which may in particular have been taught using a machine learning algorithm, one or more of the boundaries can be selected” ([0016]) and that a learning mode may be used to teach typical boundaries ([0018]). The specification does not disclose any concrete or specific examples, definitions, or embodiments of this predetermined criteria, by which a person having ordinary skill in the art would understand how to determine which candidate boundary is the “best‑suited” for coarse focus and how then how to disregard other regions. This statement that selection can be based on unspecified “criteria” or that ML might be used does not demonstrate possession of the particular selection/disregard behavior recited in the claim.
“Disregarding other regions” of the overview image: Claim 1 requires disregarding other regions recorded in the overview image for the determining of the coarse focus setting. The specification describes selecting and using one or more boundary locations and also possibly using multiple locations to increase/improve accuracy ([0069]), but does not describe any specific selection procedure(s) that explicitly teaches the act of systematically disregarding all other regions in the overview image for coarse focus determination as a required behavior. Thus, the specification fails to show clear possession of the claimed exclusive disregard limitation.
Thus, since the specification lacks disclosure of a concrete suitability criteria, ranking/selection algorithms, or any specific examples that show selection of a unique “best‑suited” location and the explicit act of disregarding other regions, the specification does not reasonably convey possession of those claim aspects to a person having ordinary skill in the art. Accordingly, the written description requirement is not satisfied for those recited limitations of Claim 1.
The examiner would like to make several recommendations in order to expedite prosecution and to provide possible guidance in overcoming the 35 USC 112a written description recommendation. (1) Amend the claim to support the scope (Remove or narrow the “best‑suited” and “disregarding other regions” language, or recite specific criteria that are supported by the specification (e.g., alignment relative to illumination direction, contrast threshold, boundary orientation scoring) rather than an open‑ended “predetermined criteria.” Cite supporting paragraphs, (recite selection of “one or more” suitable boundary locations (rather than exclusive single best) consistent with the spec’s disclosure of using multiple locations to improve accuracy. (2) Provide evidence or declaration inventor/expert declaration under 37 CFR 1.132.
If Applicant elects to amend Claims 1, 21, 22 and 25 or present argumentation or evidence, submit the amendment or argument/evidence and the Examiner will consider whether the § 112(a) rejection should be withdrawn.
Claims 1-3, 5, 6, 8-11, 13-22, 24 and 25 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Exemplary claim 25 recites the following limitations which are not clearly defined in the present specification where it requires “determining for each ascertained lateral xy‑location “a suitability for determination of the coarse focus setting based on predetermined criteria” and selecting a “best‑suited” lateral xy‑location”. The specification provides no enabling detail as to how to define or compute such suitability criteria (no features, metrics, thresholds, scoring functions, or algorithmic examples). A person of ordinary skill in the art would have to develop, test and tune such criteria across different microscope optics, magnifications, illumination modes (brightfield, dark field, fluorescence), sample types, and boundary geometries. This would cause undue experimentation because the specification gives no real working examples, on how to choose or generalize criteria.
If Applicant elects to amend Claims 1, 21, 22 and 25 or present arguments or evidence, submit the amendment or argument/evidence and the Examiner will consider whether the § 112(a) rejection should be withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. 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 WILLIAM C VAUGHN JR whose telephone number is (571)272-3922. The examiner can normally be reached Monday-Friday, 8:30am-5:00pm.
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/WILLIAM C VAUGHN JR/Supervisory Patent Examiner, Art Unit 2481