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
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 12/27/2022. It is noted, however, that applicant has not filed a certified copy of the JP2022-209788 application as required by 37 CFR 1.55. The Examiner notes that the electronically filed version filed on 12/19/2024 is not an acceptable certified copy, nor does it meet the requirements for an acceptable interim copy. See MPEP 215 and 502.05(I)(B)(2) for guidance.
Claim Interpretation – 112(f)
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:
“an acquisition section that acquires…”, “a display processing section that displays…”, “a selection section that selects…”, and “a counting section that applies…and counts…” in claim 1;
“an image processing section that generates…”, “a detection section that detects…” in claim 5;
“a determining section that determines…” in claim 6; and
“a calculation section that calculates…” in claim 10;
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.
Regarding an “acquisition section” the corresponding structure described in the specification is a camera or MCU/processor/computer implementing the function of this “section” as a program/algorithm (Fig. 3, element 11; Fig. 4, element 30; paragraphs 15-17, 329). Therefore according to MPEP 2181(II)(B), the entire algorithm associated with the function of acquiring images as is disclosed throughout the specification, for example paragraphs 15-17 and 329, is also considered be included in the structure covered by the interpretation.
Regarding a “display processing section” the corresponding structure described in the specification is a MCU/processor/circuit/computer implementing the function of this “section” as a program/algorithm (Fig. 4, element 30; paragraphs 17, 329). Therefore according to MPEP 2181(II)(B), the entire algorithm associated with the function of displaying results as is disclosed throughout the specification, for example paragraphs 17 and 329-369, is also considered be included in the structure covered by the interpretation.
Regarding a “selection section” the corresponding structure described in the specification is a pointing device or MCU/processor/computer implementing the function of this “section” as a program/algorithm (Fig. 4, elements 30 or 33; paragraphs 17, 329). Therefore according to MPEP 2181(II)(B), the entire algorithm associated with the function of selecting a result as is disclosed throughout the specification, for example paragraphs 17 and 329-369, is also considered be included in the structure covered by the interpretation.
Regarding a “counting section” the corresponding structure described in the specification is a MCU/processor/computer implementing the function of this “section” as a program/algorithm (Fig. 4, elements 30; paragraphs 17, 329). Therefore according to MPEP 2181(II)(B), the entire algorithm associated with the function of apply the detection parameter and counting colonies as is disclosed throughout the specification, for example Fig. 39; paragraphs 17, 143-146, 193 and 329-369, is also considered be included in the structure covered by the interpretation.
Regarding an “image processing section” the corresponding structure described in the specification is MCU/processor/computer implementing the function of this “section” as a program/algorithm (Fig. 4, elements 30; paragraphs 17, 339). Therefore according to MPEP 2181(II)(B), the entire algorithm associated with the function of generating a binarized image as is disclosed throughout the specification, for example paragraphs 17 and 339, is also considered be included in the structure covered by the interpretation.
Regarding a “detection section” the corresponding structure described in the specification is MCU/processor/computer implementing the function of this “section” as a program/algorithm (Fig. 4, elements 30; paragraphs 17, 339). Therefore according to MPEP 2181(II)(B), the entire algorithm associated with the function of detecting colonies from the binarized image as is disclosed throughout the specification, for example paragraphs 17 and 339, is also considered be included in the structure covered by the interpretation.
Regarding a “determining section” the corresponding structure described in the specification is MCU/processor/computer implementing the function of this “section” as a program/algorithm (Fig. 4, elements 30; paragraphs 17, 341). Therefore according to MPEP 2181(II)(B), the entire algorithm associated with the function of determining a plurality of different detection parameters as is disclosed throughout the specification, for example paragraphs 17 and 341, is also considered be included in the structure covered by the interpretation.
Regarding a “calculation section” the corresponding structure described in the specification is MCU/processor/computer implementing the function of this “section” as a program/algorithm (Fig. 4, elements 30; paragraphs 17, 348). Therefore according to MPEP 2181(II)(B), the entire algorithm associated with the function of generating a binarized image as is disclosed throughout the specification, for example paragraphs 17 and 348, is also considered be included in the structure covered by the interpretation.
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(b)
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 11-13 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 11 recites the limitation "when a first type colony detection parameter is decided and stored in a saving section" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Specifically, it appears to reference a preexisting scenario in which a “first type colony detection parameter” has already been decided upon and stored. Parent claim 1 doesn’t disclose this scenario either.
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)(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.
Claims 1-5, 14-17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2021/240986 to Tominaga (please refer to the English translation provided with the official version herewith).
Regarding claim 1, Tominaga discloses a colony counting device comprising:
an acquisition section (Figs. 1-3 and paragraphs 19-25, which discloses a CPU implementing a program) that acquires an image of a test individual obtained by capturing the test individual (paragraph 05, wherein the processor acquires an image of fibroblast-like cells corresponding to the test individual);
a display processing section (Figs. 1-3 and paragraphs 19-25, which discloses a CPU implementing a program) that displays a plurality of colony detection results, obtained by applying different colony detection parameters to the image of the test individual acquired by the acquisition section, on a display section in a comparable manner (paragraph 09 and 46-52, wherein a plurality of estimated density distributions, mean-shift results for each and region detection, the combination of which corresponds to colony detection results, are obtained by applying kernel density estimation, mean-shift and region framing at a plurality of types of bandwidths (i.e. different colony detection parameters) and presented/displayed to a user);
a selection section (Figs. 1-3 and paragraphs 19-25, which discloses a CPU implementing a program) that selects one colony detection result from among the plurality of colony detection results displayed on the display section according to an operation of a user (paragraphs 09, 29 and 53, wherein the user selects one of the detection results presented/displayed and thereby also the associated bandwidth); and
a counting section (Figs. 1-3 and paragraphs 19-25, which discloses a CPU implementing a program) that applies the colony detection parameter used to obtain the one colony detection result selected by the selection section to the image of the test individual and counts a number of colonies included in the image of the test individual (paragraphs 10-13 and 54-59, wherein evaluation is performed based on the parameter used in association with the detection result selected which includes number and size of colonies in the image).
Regarding claim 2, Tominaga discloses the colony counting device according to claim 1, wherein each of the plurality of colony detection results is an image in which a marker indicating a colony detection position is superimposed on the image of the test individual (Figs. 13-16 and paragraphs 46-52, wherein the region framing obtained by applying a plurality of bandwidths is displayed along with colony regions marked with, for example, different colors).
Regarding claim 3, Tominaga discloses the colony counting device according to claim 1, wherein each of the plurality of colony detection results includes a numerical value indicating a number of detected colonies (Fig. 13 and paragraphs 47-49, wherein each of the kernel density estimated (i.e. associated with colony detection results) corresponds to a numerical value indicating a number of detected colonies).
Regarding claim 4, Tominaga discloses the colony counting device according to claim 1, wherein each of the plurality of colony detection results are displayed on the display section in association with the colony detection parameter used to detect colonies (Figs. 15 and 16; paragraphs 51-53, wherein marked regions (i.e. colony detection results) and associated bandwidth (i.e. colony detection parameter) are displayed for user designation).
Regarding claim 5, Tominaga discloses the colony counting device according to claim 1, further comprising:
an image processing section that generates a binarized image from the image of the test individual based on the colony detection parameter (Fig. 4 and paragraph 34); and
a detection section that detects colonies from the binarized image, wherein the counting section counts a number of the colonies detected by the detection section, and the plurality of colony detection results include the binarized image, detection positions of the colonies, and the number of the colonies (Figs. 5-10 an paragraphs 35-41, wherein kernel density estimation and mean-shift are performed on the binarized image from which position and number of colonies is detected).
Regarding claim 14, Tominaga disclose the colony counting device according to claim 1,
wherein the display processing section is configured to display a first screen and a second screen on the display section, the first screen is a screen that displays the plurality of colony detection results, and the second screen is a screen for adjusting another colony detection parameter different from the colony detection parameter corresponding to the one colony detection result selected by the operation of the user on the first screen (paragraphs 80-85, wherein a first screen is displayed with detection results determined in association with the initial bandwidth and when not appropriate, as selected/designated by a user operation, a second screen is displayed with detection results in association with an adjusted bandwidth (i.e. parameter)).
Regarding claim 15, Tominaga discloses the colony counting device according to claim 14, wherein the colony detection parameter adjusted through the first screen is adjusted by selecting the one colony detection result from among the plurality of colony detection results obtained by applying discretely adjusted image processing parameters (paragraphs 48, 80-85, wherein by selecting/designating that a bandwidth (e.g. BW_L) is not appropriate another bandwidth (e.g. BW_M) is applied and selected, corresponding to selecting a detection result from among the plurality).
Regarding claim 16, Tominaga discloses the colony counting device according to claim 14, wherein the second screen is a screen for receiving adjustment of colony detection parameters having consecutive values (paragraphs 48, 80-85, wherein if an initial bandwidth (e.g. BW_L) is displayed and selected as not appropriate in a first screen, then a consecutive bandwidth (e.g. BW_M) is subsequently displayed on the second screen).
Regarding claim 17, Tominaga discloses the colony counting device according to claim 1, wherein the display processing section is configured to cause the display section to display a result display screen including:
the one colony detection result selected by the selection section according to the operation of the user (Figs. 15 and 16; paragraphs 51-53, wherein one result is selected by the user and displayed);
identification information of the test individual corresponding to the one colony detection result (Figs. 15 and 16; paragraphs 51-53, wherein regions are framed (e.g. in different colors) corresponding to identification information);
a culture condition for the test individual (Fig. 20; paragraphs 73-77, wherein average size over a number of days displayed corresponds to the culture condition); and
the number of colonies (paragraphs 13, 39 and 75).
Regarding claim 19, Tominaga discloses a control method for a colony counting device, the control method comprising:
acquiring an image of a test individual obtained by capturing the test individual (paragraph 05, wherein the processor acquires an image of fibroblast-like cells corresponding to the test individual);
displaying a plurality of colony detection results obtained by applying different colony detection parameters to the acquired image of the test individual in a comparable manner on a display section (paragraph 09 and 46-52, wherein a plurality of estimated density distributions, mean-shift results for each and region detection, the combination of which corresponds to colony detection results, are obtained by applying kernel density estimation, mean-shift and region framing at a plurality of types of bandwidths (i.e. different colony detection parameters) and presented/displayed to a user);
selecting one colony detection result from among the plurality of colony detection results displayed on the display section according to an operation of a user (paragraphs 09, 29 and 53, wherein the user selects one of the detection results presented/displayed and thereby also the associated bandwidth); and
storing the colony detection parameter used to obtain the one selected colony detection result as an official colony detection parameter (paragraphs 28, 29, 53 and 66, wherein the selected bandwidth (i.e. detection parameter) is stored and used repeatedly for cultures obtained for that patient, thereby corresponding to the official parameter for that patient).
Allowable Subject Matter
Claim 20 is allowed.
Claims 6-10 and 18 are 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 an examiner’s statement of reasons for allowance:
Regarding claim 20, none of the prior art teach or fairly suggests the limitation of “a second step of displaying a plurality of colony detection results, obtained by applying the first type colony detection parameter applied to the one colony detection result and different second type colony detection parameters to the image of the test individual acquired by the acquisition section, on the display section in a comparable manner, selecting one colony detection result according to an operation of the user from among the plurality of colony detection results displayed on the display section, and storing the second type colony detection parameter used to obtain the selected one colony detection result in the storage device”, in combination with the other limitations of the claim. As noted above, the prior art of Tominaga (WO2021/240986) discloses a similar colony counting device that includes displaying colony detections results obtained by applying different first type colony detection parameters to an image, displaying those in a comparable manner, a user selecting one result and storing the result for further use. However, neither the prior art of Tominaga nor any other prior art found teach or fairly suggests the limitation above.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON W CARTER whose telephone number is (571)272-7445. The examiner can normally be reached 8am - 5pm (Mon - Fri).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, John Villecco can be reached at (571) 272-7319. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON W CARTER/Primary Examiner, Art Unit 2661
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