DETAILED ACTION
This office action is in response to the communication received on 11/20/2025 concerning application no. 18/306,966 filed on 04/25/2023.
Claims 1 and 3-5 are pending.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/20/2025 has been entered.
Claims 1 and 3-5 are pending.
Response to Arguments
Applicant’s arguments, see page 10, filed 11/20/2025, with respect to the lack of clarity between the ultrasound endoscope and the ultrasound imaging device have been fully considered and are persuasive. The 112(b) rejection of claims 1 and 4-5 with respect to that issue has been withdrawn.
Examiner notes that the amended language establishes the ultrasound imaging device to be part of the endoscope. Furthermore, Applicant explicitly acknowledges they are different elements.
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive.
Regarding the 112(b) rejection, Applicant argues that the three-dimensional image pick-up device is different from the radiation image pick-up device.
Examiner respectfully disagrees. The invocation of the 112(f) and the interpretation under paragraph 0031 establishes that the three-dimensional image pick-up device may be a CT device. Given that CT devices are radiation devices, it would be unclear to one with ordinary skill in the art if the system is using two radiation devices or using the same radiation device.
Applicant’s arguments, see pages 11-14, filed 11/20/2025, with respect to the 35 U.S.C. 101 rejection have been fully considered and are persuasive. The 35 U.S.C. 101 rejection of the claims has been withdrawn.
Applicant’s arguments, see pages 14-18, filed 11/20/2025, with respect to 35 U.S.C. 103 rejections have been fully considered and are persuasive. The 35 U.S.C. 103 rejections of the claims has been withdrawn.
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:
“extract the body cavity from a three-dimensional image of the subject acquired, by a three-dimensional image pick-up device, in advance” in claim 3: Paragraph 0031 teaches “The three-dimensional image pick-up device 2 is a device that generates a three-dimensional image representing a treatment target site of a subject H by imaging the site, and is specifically, a CT device, an MRI device, a positron emission tomography (PET) device, and the like.”
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 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 and 3-5 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.
Claim 1 recites “a predetermined number of pixels”. While the specification discusses the use of pixels in paragraphs 0022, 0050-52, and 0063, the specification does not disclose the selection and use of predetermined number of pixels. The specification, in paragraph 0051 teaches the use of exactly 5 pixels. However, the specification does not disclose that this is predetermined. There is no disclose in what manner the pixels are predetermined, how they are selected, or what are the considerations in predetermining a number of pixels. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim 4 recites “a predetermined number of pixels”. While the specification discusses the use of pixels in paragraphs 0022, 0050-52, and 0063, the specification does not disclose the selection and use of predetermined number of pixels. The specification, in paragraph 0051 teaches the use of exactly 5 pixels. However, the specification does not disclose that this is predetermined. There is no disclose in what manner the pixels are predetermined, how they are selected, or what are the considerations in predetermining a number of pixels. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim 5 recites “a predetermined number of pixels”. While the specification discusses the use of pixels in paragraphs 0022, 0050-52, and 0063, the specification does not disclose the selection and use of predetermined number of pixels. The specification, in paragraph 0051 teaches the use of exactly 5 pixels. However, the specification does not disclose that this is predetermined. There is no disclose in what manner the pixels are predetermined, how they are selected, or what are the considerations in predetermining a number of pixels. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(a) are also rejected because they inherit the deficiencies of the claims they respectively depend upon.
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 and 3-5 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 is indefinite for the following reasons:
Recites “sequentially acquire the plurality of two-dimensional ultrasound images corresponding to the plurality of radiation images, which are acquired by the ultrasonic imaging device”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the ultrasound images are acquired from the ultrasound imaging device or the endoscope of the imaging device as the preceding claim element establishes “an ultrasonic endoscope, comprising an ultrasonic imaging device and a marker which is radiation impermeable, capturing a plurality of two-dimensional ultrasound images corresponding to the plurality of radiation images”.
Applicant is encouraged to provide consistent and clear language.
Recites “wherein the at least one processor derives a vector representing a positional relationship between a predetermined number of pixels of the first two-dimensional ultrasound image and a predetermined number of pixels of the second two-dimensional ultrasound image based on the position and the posture of the ultrasonic endoscope, and interpolates corresponding pixels of the first two-dimensional ultrasound image and the second two-dimensional ultrasound image based on the vector representing the positional relationship to generate the three-dimensional ultrasound image”. This claim element is indefinite. The claim establishes a circular logic where the vector is according to the pixels in the two ultrasound images. However, the pixels are interpolated to be corresponding according to the vector itself. It is unclear which element defines the other.
Applicant is encouraged to provide consistent and clear language.
Claim 3 is indefinite for the following reasons:
Recites “a three-dimensional image pick-up device”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the “three-dimensional image pick-up device” is the same as the “radiation image pick-up device comprising an X-ray source and an X-ray collector” established in claim 1 or is a separate and distinct feature given that the paragraph 0031 establishes that the three-dimensional image pick-up device may be a CT device.
Applicant is encouraged to provide consistent and clear language.
Claim 4 is indefinite for the following reasons:
Recites “sequentially acquiring the plurality of two-dimensional ultrasound images corresponding to the plurality of radiation images, which are acquired by the ultrasonic imaging device”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the ultrasound images are acquired from the ultrasound imaging device or the endoscope of the imaging device as the preceding claim element establishes “wherein a plurality of two-dimensional ultrasound images corresponding to the plurality of radiation images are captured by the ultrasonic endoscope”.
Applicant is encouraged to provide consistent and clear language.
Recites “wherein a vector representing a positional relationship between a predetermined number of pixels of the first two-dimensional ultrasound image and a predetermined number of pixels of the second two-dimensional ultrasound image based on the position and the posture of the ultrasonic endoscope are derived, and corresponding pixels of the first two- dimensional ultrasound image and the second two-dimensional ultrasound image based on the vector representing the positional relationship are interpolated to generate the three- dimensional ultrasound image”. This claim element is indefinite. The claim establishes a circular logic where the vector is according to the pixels in the two ultrasound images. However, the pixels are interpolated to be corresponding according to the vector itself. It is unclear which element defines the other.
Applicant is encouraged to provide consistent and clear language.
Claim 5 is indefinite for the following reasons:
Recites “sequentially acquiring the plurality of two-dimensional ultrasound images corresponding to the plurality of radiation images, which are acquired by the ultrasonic imaging device”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the ultrasound images are acquired from the ultrasound imaging device or the endoscope of the imaging device as the preceding claim element establishes “wherein a plurality of two-dimensional ultrasound images corresponding to the plurality of radiation images are captured by the ultrasonic endoscope”.
Applicant is encouraged to provide consistent and clear language.
Recites “wherein a vector representing a positional relationship between a predetermined number of pixels of the first two-dimensional ultrasound image and a predetermined number of pixels of the second two-dimensional ultrasound image based on the position and the posture of the ultrasonic endoscope are derived, and corresponding pixels of the first two- dimensional ultrasound image and the second two-dimensional ultrasound image based on the vector representing the positional relationship are interpolated to generate the three- dimensional ultrasound image”. This claim element is indefinite. The claim establishes a circular logic where the vector is according to the pixels in the two ultrasound images. However, the pixels are interpolated to be corresponding according to the vector itself. It is unclear which element defines the other.
Applicant is encouraged to provide consistent and clear language.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tanaka et al. (PGPUB No. US 2016/0095573): Teaches image fusion between ultrasound and radiation modalities.
Atlmann et al. (PGPUB No. US 20060253024): Teaches image fusion between ultrasound and radiation modalities.
Camus et al. (PGPUB No. US 2007/0043292): Teaches that angiographic markers are used to indicate pose of the instruments on which they rest.
Boese et al. (PGPUB No. US 2009/0326373): Teaches image fusion between ultrasound and radiation modalities.
Liu et al. (PGPUB No. US 2020/0405397): Teaches image fusion between ultrasound and radiation modalities.
Sakaguchi (PGPUB No. US 2025/0221624): Teaches that angiographic markers are used to indicate pose of the instruments on which they rest.
Stampf et al. (PGPUB No. US 2010/0145197): Teaches that angiographic markers are used to indicate pose of the instruments on which they rest.
Yamaguchi et al. (PGPUB No. US 2005/0101870): Teaches that angiographic markers are used to indicate pose of the instruments on which they rest.
Maschke (PGPUB No. US 2006/0287595): Teaches that angiographic markers are used to indicate pose of the instruments on which they rest.
John et al. (PGPUB No. US 2015/0223773): Teaches overlay of ultrasound and CT image data.
Slager (US Patent No. 5,771,895): Teaches that angiographic markers are used to indicate pose of the instruments on which they rest.
Altmann et al. (US Patent No. 10,835,207): Teaches pixel based interpolation for 3D image generation.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798