Prosecution Insights
Last updated: October 25, 2026
Application No. 19/001,863

METHOD FOR OBSERVING BIOLOGICAL SAMPLE

Non-Final OA §101§112
Filed
Dec 26, 2024
Priority
Dec 28, 2023 — JP 2023-223642
Examiner
CHAN, CAROL WANG
Art Unit
2672
Tech Center
2600 — Communications
Assignee
Kanazawa Medical University
OA Round
1 (Non-Final)
84%
Grant Probability
Favorable
1-2
OA Rounds
7m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 84% — above average
84%
Career Allowance Rate
319 granted / 379 resolved
+22.2% vs TC avg
Strong +34% interview lift
Without
With
+33.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
17 currently pending
Career history
394
Total Applications
across all art units

Statute-Specific Performance

§101
11.9%
-28.1% vs TC avg
§103
40.4%
+0.4% vs TC avg
§102
16.6%
-23.4% vs TC avg
§112
25.5%
-14.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 379 resolved cases

Office Action

§101 §112
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 . Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statement (IDS) submitted on 12/26/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections Claim 5 is objected to because of the following informalities: Line 7 recites “an observation target region (region of interest)” which Examiner suggests amending to “a region of interest” (deleting “an observation target region”) in order to provide consistency and clarity in the claim since the rest of the dependent claims only recite the region of interest and not the observation target region. Appropriate correction is required. Claim 9 is objected to because of the following informalities: Line 1 recites “according to any one of claim 5” which Examiners suggests amending to “according to claim 5” (deleting “any one of”). Appropriate correction is required. Claim 10 is objected to because of the following informalities: Line 8 recites “an observation target region (region of interest)” which Examiner suggests amending to “a region of interest” (deleting “an observation target region”) in order to provide consistency and clarity in the claim since the rest of the limitations only recite the region of interest and not the observation target region. 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. 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 1-4, 7, and 8 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 the limitation "the image information" in Line 11. There is insufficient antecedent basis for this limitation in the claim as there is no earlier mention of image information of the light microscope and the x-ray microscope, an image captured by an x-ray microscope and an image captured by a light microscope. Examiner suggests amending the limitation to “image information” (deleting “the”) and has interpreted the limitation as such. Claim 2 recites the limitation "the volume or shape of the evaluation target region" in Line 2. There is insufficient antecedent basis for this limitation in the claim as there is no earlier mention of a volume or shape of the evaluation target region. Examiner suggests amending to “a volume or shape of the evaluation target region” and has interpreted the limitation as such. Claim 3 recites the limitations "the number of voxels" in Line 2, “the image of the binarized evaluation target region” in Line 2, and “the voxel volume” in Line 3. There is insufficient antecedent basis for these limitations in the claim as there is no earlier mention of a number of voxels, an image of the binarized evaluation target region, or a voxel volume. Examiner suggests amending the limitations to “a number of voxels”, “an image of the binarized evaluation target region”, and “a voxel volume”, respectively, and has interpreted the limitations as such. Claim 4 depends on claim 1 and thus is also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite. Claim 7 recites the limitation "the volume or shape of the extracted evaluation target region" in Line 2. There is insufficient antecedent basis for this limitation in the claim as there is no earlier mention of a volume or shape of the extracted evaluation target region. Examiner suggests amending to “a volume or shape of the extracted evaluation target region” and has interpreted the limitation as such. Claim 8 recites the limitations "the number of voxels" in Line 2, “the image of the binarized evaluation target region” in Line 2, and “the voxel volume” in Line 3. There is insufficient antecedent basis for these limitations in the claim as there is no earlier mention of a number of voxels, an image of the binarized evaluation target region, or a voxel volume. Examiner suggests amending the limitations to “a number of voxels”, “an image of the binarized evaluation target region”, and “a voxel volume”, respectively, and has interpreted the limitations as such. 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. Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter as follows. Claim 10 defines a “computer-readable recording medium” embodying functional descriptive material. "The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non- transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent." Subject Matter Eligibility of Computer Readable Media, 1351 Off. Gaz. Pat. Office 212 (Feb. 23, 2010), available at http://www.uspto.gov/web/offices/com/sol/og/2010/week08/TOC.htm#ref20. Paragraph [0091] of the Specification recites various implementations of the claimed storage medium, “[e]xamples of the recording medium or the storage means include, but are not limited to, a magnetic medium (flexible disk, hard disk, etc.), an optical medium (CD, DVD, etc.), a magneto-optical medium, and flash memory”. As the Specification merely lists examples of a computer-readable recording medium, the broadest reasonable interpretation of the computer-readable recording medium could be taken to encompass signals. Signals are nothing but the physical characteristics of a form of energy, and as such is non-statutory natural phenomena (See MPEP § 2106 I). Thus, claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Allowable Subject Matter The following is a statement of reasons for the indication of allowable subject matter: With regards to claim 5, Vinshtein et al. (US 2019/0323976) discloses obtaining a signal captured by an X-ray microscope using X-rays and a signal of a same measurement point of the same object captured by a light microscope and matching the signals to identify misalignment, however, there is no mention of extracting an evaluation target region of a biological sample in three dimensions based on two images that are matched: an image of the biological sample embedded in a wax block captured by an X-ray microscope using X-rays having an energy of 4-12 keV and an image of a same measurement point of the same biological sample captured by a light microscope after the X-ray microscopy imaging, extracting a region of interest from the images of the biological sample, which are captured by the X-ray microscope and the light microscope and matched, and binarizing the extracted region of interest to further extract the evaluation target region from the region of interest. Asano et al. (US 2007/0286467) discloses the concept of extracting a region of interest from an image by performing binarization, however, there is no mention of two images that are matched: an image of the biological sample embedded in a wax block captured by an X-ray microscope using X-rays having an energy of 4-12 keV and an image of a same measurement point of the same biological sample captured by a light microscope after the X-ray microscopy imaging nor is there any mention of binarizing the region of interest that was extracted to further extract the evaluation target region from the region of interest. Thus, while different prior arts disclose parts of the claim, none of the prior arts disclose or have reasonable motivation to combine to disclose all of the limitations of the claim as a whole. With regards to claims 6 and 9, they are dependent on claim 5. Claim 1 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. With regards to claim 1, Vinshtein et al. (US 2019/0323976) discloses obtaining a signal captured by an X-ray microscope using X-rays and a signal of a same measurement point of the same object captured by a light microscope and matching the signals to identify misalignment, however, there is no mention of extracting an evaluation target region of a biological sample in three dimensions based on two images that are matched: an image of the biological sample embedded in a wax block captured by an X-ray microscope using X-rays having an energy of 4-12 keV and an image of a same measurement point of the same biological sample captured by a light microscope after the X-ray microscopy imaging, the method comprising extracting a region of interest from the image of the X-ray microscope that has been matched with the image of the light microscope and binarizing the region of interest to further extract the evaluation target region from the region of interest by using the image information of the light microscope and the X-ray microscope in a complementary manner. Asano et al. (US 2007/0286467) discloses the concept of extracting a region of interest from an image by performing binarization, however, there is no mention of two images that are matched: an image of the biological sample embedded in a wax block captured by an X-ray microscope using X-rays having an energy of 4-12 keV and an image of a same measurement point of the same biological sample captured by a light microscope after the X-ray microscopy imaging nor is there any mention of binarizing the region of interest that was extracted to further extract the evaluation target region from the region of interest. Thus, while different prior arts disclose parts of the claim, none of the prior arts disclose or have reasonable motivation to combine to disclose all of the limitations of the claim as a whole. Claim 10 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action. With regards to claim 10, Vinshtein et al. (US 2019/0323976) discloses obtaining a signal captured by an X-ray microscope using X-rays and a signal of a same measurement point of the same object captured by a light microscope and matching the signals to identify misalignment, however, there is no mention of extracting an evaluation target region of a biological sample in three dimensions based on two images that are matched: an image of the biological sample embedded in a wax block captured by an X-ray microscope using X-rays having an energy of 4-12 keV and an image of a same measurement point of the same biological sample captured by a light microscope after the X-ray microscopy imaging, extracting a region of interest from the images of the biological sample, which are captured by the X-ray microscope and the light microscope and matched, and binarizing the extracted region of interest to further extract the evaluation target region from the region of interest. Asano et al. (US 2007/0286467) discloses the concept of extracting a region of interest from an image by performing binarization, however, there is no mention of two images that are matched: an image of the biological sample embedded in a wax block captured by an X-ray microscope using X-rays having an energy of 4-12 keV and an image of a same measurement point of the same biological sample captured by a light microscope after the X-ray microscopy imaging nor is there any mention of binarizing the region of interest that was extracted to further extract the evaluation target region from the region of interest. Thus, while different prior arts disclose parts of the claim, none of the prior arts disclose or have reasonable motivation to combine to disclose all of the limitations of the claim as a whole. Claims 2-4, 7, and 8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. With regards to claims 2-4, they are dependent on claim 1. With regards to claims 7 and 8, they are dependent on claim 5. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicants are directed to consider additional pertinent prior art included on the Notice of References Cited (PTOL 892) attached herewith. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROL W CHAN whose telephone number is (571)272-5766. The examiner can normally be reached 9:30-3:30 M-F. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sumati Lefkowitz can be reached at (571) 272-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CAROL W CHAN/Primary Examiner, Art Unit 2672
Read full office action

Prosecution Timeline

Dec 26, 2024
Application Filed
Oct 01, 2026
Non-Final Rejection mailed — §101, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
84%
Grant Probability
99%
With Interview (+33.6%)
2y 5m (~7m remaining)
Median Time to Grant
Low
PTA Risk
Based on 379 resolved cases by this examiner. Grant probability derived from career allowance rate.

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