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 .
Applicant’s preliminary amendment filed on January 13, 2025 has been entered and made of record.
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke § 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke § 112(f) except as otherwise indicated in an Office action.
Claim limitation “segmentator”, “acquirer”, and “determiner” has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “segmentator”, “acquirer”, and “determiner” coupled with functional language without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 13 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: a computer as described in paragraph [0024] is the corresponding structure that performs all claim functions.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see M.P.E.P. § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claims 1-11 are not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because they are all method claims.
Claim 12 is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it is an article of manufacture claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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) 1-2, 4, 6, 10 and 12-13 is/are rejected under 35 U.S.C. 102(a/b) as being anticipated by Guanzhen et al. (CN 112927188A1 (English translated copy provided by Applicant), Art of record IDS filed on 2/14/2025, referred as Guanzhen hereinafter).
Regarding claim 1 as a representative claim, Guanzhen teaches an analysis support method for supporting analysis of a stained image of a sample, the analysis support method comprising:
a) preparing a plurality of stained images by applying a plurality of types of staining methods on one sample, said plurality of stained images corresponding respectively to said plurality of types of staining methods (see para. [0023] (“…The quality control detection system includes region labeling, model building, region determination, and region removal. Region labeling involves labeling invalid regions in HE and IHC staining images. Model building relies on manual annotation to establish a corresponding identification model. Region determination relies on the identification model to determine invalid regions on HE and IHC staining images. Region removal involves removing the corresponding regions on the double-stained images”; where the “HE and IHC staining images” correspond to said plurality of stained images; where “removing the corresponding regions” implicitly discloses that said staining methods are applied on one sample as both as both images correspond to each other));
b) segmenting each stained image of said plurality of stained images into a plurality of segmented regions in a predetermined segmentation mode (see para. [0036] (“…The double stained images are divided into blocks for registration…and then the model obtained during the training phase is used to perform quality inspection on the double-stained image blocks”; where “dividing into blocks” corresponds to said segmentation into a plurality of segmented regions));
c) acquiring a uniformity level in said each stained image by using a trained model generated by machine learning, the uniformity level indicating uniformity of a stained condition of each of said plurality of segmented regions (see paras. [0036] (“…After manually labeling areas such as detachment, folding, contaminant areas, and areas with low clarity. the Random Forest (RF) algorithm is used to identify relevant regions on the double-stained images. The double-stained images are divided into blocks for registration...and then the model obtained during the training phase is used to perform quality inspection on the double-stained image blocks. The scoring system then scores the blocks, retaining high-scoring images and discarding low-scoring ones”) and [0023] (“The quality control detection system identifies problematic regions on the double-stained images and then removes these regions and the corresponding related regions of the staining image. Invalid regions include areas with detachment, roll-up, contaminants, and low clarity”); where the identification of “problematic regions” corresponds to said acquisition of a uniformity level; where “low clarity” strongly implies the existence of a nonuniform staining and, thus, inevitably corresponds to said uniformity of a stained condition); and
d) determining suitability of each segmented region of said plurality of segmented regions for a predetermined analysis method in accordance with said uniformity level in each of said plurality of stained images (see para. [0023] (“The quality control detection system identifies problematic regions on the double-stained images and then removes these regions and the corresponding related regions of the staining image”); where the identification of “problematic regions on the double-stained images” and the removal of these “regions” relates to said consideration of the uniformity level across the stained images; inherently, this step results in determining suitable regions).
Regarding claim 2, Guanzhen further teaches claim limitations “wherein an analysis matching region is displayed on said plurality of stained images in accordance with a result of the determination in said operation d), the analysis matching region being a segmented region that matches said analysis method” (see paras. [0032] – [0035]).
Regarding claim 4, Guanzhen further teaches claim limitations “wherein an analysis unmatching region is displayed on said plurality of stained images in accordance with a result of the determination in said operation d), the analysis unmatching region being a segmented region that does not match said analysis method” (see paras. [0032] – [0035]).
Regarding claim 6, Guanzhen further teaches claim limitations “wherein a middle region is displayed on said plurality of stained images in accordance with a result of the determination in said operation d), the middle region being a segmented region that may or may not match said analysis method” (see paras. [0032] – [0035]).
Regarding claim 10, Guanzhen further teaches claim limitations “wherein said trained model used to acquire said uniformity level in said operation c) is common among said plurality of stained images” (see para. [0036] (single machine learning mode (Random Forest algorithm) is used for all the images)).
Regarding claim 12, it is noted claim recites similar claim limitations called for in the counterpart claim 1. Thus, the advanced statements as applied to claim 1 above are incorporated hereinafter. Guanzhen further teaches medium storing program being executed by a computer (see para. [0036] (algorithms and GPU; medium is inherently included so GPU can execute these algorithms)).
Regarding claim 13, it is noted claim recites similar claim limitations called for in the counterpart claim 1. Thus, the advanced statements as applied to claim 1 above are incorporated hereinafter. Guanzhen further teaches an analysis support device (see para. [0007] (a quality control and detection system)).
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.
Claim(s) 3, 5 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guanzhen.
The advanced statements as applied to claims 1-2, 4, 6, 10 and 12-13 above are incorporated hereinafter.
Regarding claim 3, Guanzhen does not further teaches claim limitations “wherein a magnification of display of each of said plurality of stained images can be changed, and when the magnification of display of said each stained image is changed, a magnification of display of said analysis matching region on said each stained image is also changed together with the magnification of display of said each stained image”.
However, such claim limitations are well known in the art (Official Notice).
The motivation for doing so is to help/aid the viewer to see the images clearer.
Therefore, before the effective filing date of the instant claim invention, it would have been obvious to one of ordinary skill in the art to incorporate such claim limitations in combination with Guanzhen for that reasons. Also, it would have been obvious to incorporate such claim limitations into Guanzhen because doing so would merely combine prior art elements according known method to yield predictable results.
Regarding claim 5, Guanzhen does not further teaches claim limitations “wherein a magnification of display of each of said plurality of stained images can be changed, and when the magnification of display of said each stained image is changed, a magnification of display of said analysis unmatching region on said each stained image is also changed together with the magnification of display of said each stained image”.
However, such claim limitations are well known in the art (Official Notice).
The motivation for doing so is to help/aid the viewer to see the images clearer.
Therefore, before the effective filing date of the instant claim invention, it would have been obvious to one of ordinary skill in the art to incorporate such claim limitations in combination with Guanzhen for that reasons. Also, it would have been obvious to incorporate such claim limitations into Guanzhen because doing so would merely combine prior art elements according known method to yield predictable results.
Regarding claim 7, Guanzhen does not further teaches claim limitations “wherein a magnification of display of each of said plurality of stained images can be changed, and when the magnification of display of said each stained image is changed, a magnification of display of said middle region on said each stained image is also changed together with the magnification of display of said each stained image”.
However, such claim limitations are well known in the art (Official Notice).
The motivation for doing so is to help/aid the viewer to see the images clearer.
Therefore, before the effective filing date of the instant claim invention, it would have been obvious to one of ordinary skill in the art to incorporate such claim limitations in combination with Guanzhen for that reasons. Also, it would have been obvious to incorporate such claim limitations into Guanzhen because doing so would merely combine prior art elements according known method to yield predictable results.
Regarding claim 8, Guanzhen does not further teaches claim limitations “comprising: between said operations a) and c), performing resolution reduction processing on each of said plurality of stained images”.
However, such claim limitations are well known in the art (Official Notice).
The motivation for doing so is to reduce computation time and improve processing efficiency.
Therefore, before the effective filing date of the instant claim invention, it would have been obvious to one of ordinary skill in the art to incorporate such claim limitations in combination with Guanzhen for that reasons. Also, it would have been obvious to incorporate such claim limitations into Guanzhen because doing so would merely combine prior art elements according known method to yield predictable results.
Regarding claim 9, Guanzhen does not further teaches claim limitations “wherein in each of said plurality of stained images that have undergone said resolution reduction processing, cells in said sample have an average diameter of greater than or equal to a pixel size”.
However, such claim limitations are well known in the art (Official Notice).
The motivation for doing so is to reduce computation time and improve processing efficiency.
Therefore, before the effective filing date of the instant claim invention, it would have been obvious to one of ordinary skill in the art to incorporate such claim limitations in combination with Guanzhen for that reasons. Also, it would have been obvious to incorporate such claim limitations into Guanzhen because doing so would merely combine prior art elements according known method to yield predictable results.
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 11, the cited prior art does not teach or suggest claim limitations “wherein said uniformity level in a learning image that is used to generate said trained model is determined based on luminance values of a positive cell and a negative cell in said learning image”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gallagher et al. (U.S. Pat. No. 8,116,551 B2) teaches a method and system for image analysis comprising biological samples from subjects with various deceases (col. 2 lines 45-58), obtaining sufficient resolution image of the samples (col. 16 lines 20-30), magnifying cells (col. 2 line 1-13), segmenting stained cells into relevant and irrelevant groups, and removing irrelevant groups from analysis (col. 2 lines 59-67).
Madabhushi et al. ( U.S. Pat. App. Pub. No. 2012/0106821 A1) teaches a lymphocyte detection system and method (fig. 6) teaches obtaining image of sample and extracting lymphocyte from such image (paras. [0018] and [0047]), segmenting lymphocyte (paras. [0039] and [0048]), and magnifying images (para. [0069]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUY M DANG whose telephone number is (571)272-7389. The examiner can normally be reached Monday to Friday from 7:00AM to 3:00PM.
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DMD
8/2026
/DUY M DANG/Primary Examiner, Art Unit 2662
