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 .
Claim Objections
The claim 9 is objected to because they include reference characters which are not enclosed within parentheses.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
Claim 9 recites the abbreviation "ROI" and “IHC” without expanded text. The claim should be rewritten in such manner so as to recite "region of interest (ROI)" and “immunohistochemistry (IHC)” in order to introduce the abbreviation along with its corresponding expanded text. Note the order of abbreviation with respect to its corresponding expanded text. Additionally, it is the abbreviation that which should be enclosed by parentheses.
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: “a coordinate localization module configured to”, “a hierarchical clustering analysis module configured to”, “a Raman predictive imaging module configured to”, “a similarity analysis module configured to” in claim 9.
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.
Claims 3-4, 6 and 9-10 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 3 recites the limitation “the image” in line 21. It is unclear whether “the image” refers to the IHC image or the image of the ROI. For examination purpose, the limitation has been interpreted as the image of the ROI.
Claim 4 recites the limitation "the same angle" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the machine learning classification model" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation “the ROI” in line 21. It is unclear whether the limitation refers to ROI of an IHC image or ROI of a Raman white light image. If the limitation refers to ROI of the Raman white light image, ROI of the IHC is not associated with any claim limitation of the rest of the claim . For examination purpose, the limitation has been interpreted as ROI of the Raman white light image.
Claim 10 is also rejected under 35 U.S.C. 112(b) as being dependent upon a rejected base claim.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Aidi et al (US 20240029409 A1), hereinafter Aidt.
-Regarding claim 9, Aidt discloses a molecular imaging system of Raman spectra based on machine learning cascade, comprising (Abstract; [0034], “detecting multiple target molecules in a biological sample”; FIGS. 1-22
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; [1224]-[1226]): a coordinate localization module configured to obtain coordinates of ROIs (FIG. 4A; FIG. 7A, blocks 715-740; [0259], “patches”; [0574]; [0721]; [0781], “region of interest detection”) of an IHC image (FIG. 4A, 2nd image 410; FIG. 7A; [0242], “The second image may be stained …”; [0010], “… IHC staining …”) and a Raman white light image (FIG. 4A, 1st image 405; FIG. 7A; [0256], “The first image may be unstained … captured by applying a selected illumination … Raman spectroscopy … confocal … using a non-label process …”); a hierarchical clustering analysis module configured to conduct classification and purification on the Raman spectra in the ROI and obtain the Raman spectra of a target biomolecule in the ROI (FIGS. 4A-4C, 7A; [0722], “at least one first image patch …a first cell classifier net … generate first instance classification of features of interest …”; [0723]; [0717], “… misalignment introduces noise …”; [0756]); a Raman predictive imaging module configured to predict a molecular type of a sample to be detected and build a Raman image, and to obtain a Raman predictive image (FIGS 4A-4C, 7A, 9D-9E; [0709], “predict ..”) and a quantitative score of a target biomolecule of the Raman predictive image (FIG. 5N; [0383]; [0709], “… a clinical score”; [0766]; [0790]); and a similarity analysis module configured to evaluate similarity between the Raman predictive image of the Raman predictive imaging module and the IHC image, and to evaluate correlation between quantitative scores of target biomolecules of the Raman predictive image and the IHC image (FIG. 5N; [0731]; Note: correlation between predicted and actual labels such as Matthews Correlation Coefficient (MCC) can be derived from the confusion matrix shown in FIG. 5N. The similarity between predicted and actual labels are evaluated based on F1-score and the correlation based on confusion matrix).
Allowable Subject Matter
Claims 1-2, 5, and 7-8 are allowed. Claims 3-4 and 6 are allowed under the condition to overcome claim rejections in above section of “Claim Rejections - 35 USC § 112”. Regarding claim 1, Aidt, Venkatakrishnan et al (US 20250250637 A1), hereinafter Venkatakrishnan, Ali-Adeeb et al (PLOS One 2022), hereinafter Ali-Adeeb, and Kreiss et al (arXiv:2303.08140v 2023), hereinafter Kreiss appear to be the closest prior arts on record. Aidt discloses a method using tissue staining and sequential imaging of biological samples for deep learning analysis. Venkatakrishnan teaches a method for immunome profiling based on obtaining Raman spectra of biomarkers and performing training to obtain machine learning models (Venkatakrishnan: FIGS. 5A-5E). Venkatakrishnan further teaches selecting the optimal model from a number of classification models that have been generated (Venkatakrishnan: [0228]; [0239]) and performing hierarchical clustering analysis to locate different types of tumors (Venkatakrishnan: [0097]; [0106]). Ali-Adeeb teaches a method to measure and differentiate radiation induced toxicity in murine lungs using Raman spectroscopy and machine learning. Ali-Adeeb further teaches region matching between Raman bright field images and IHC images with region of interest (ROI) (Ali-Adeeb: FIG. 1). Kreiss provides a reviews for digital staining in optical microscopy using deep learning (Kreiss: Abstract; FIGS. 1-4). However, the closest prior arts, either alone or in combination do not teach or suggest the overall claim limitations as a whole.
Claim 10 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, and overcome claim rejections in above section of “Claim Rejections - 35 USC § 112”.
Conclusion
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/XIAO LIU/Primary Examiner, Art Unit 2664
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