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 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 2, 10, and 12 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.
In claim 2, line 3, it is unclear whether intravenous injection is a limitation of the claim due to “such as” language.
In claim 10, line 9, it appears ‘an’ should be ‘the’.
In claim 12, line 10, it appears ‘at least one’ should be ‘the’ for clarity due to prior and subsequent usage of the term.
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 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Otsu et al (US Pub 2020/0197720 -cited by applicant as JP2020138940).
Re claims 1, 2: Otsu discloses an energy radiation treatment method comprising:
administering a medicinal agent to an affected part [0084; see the administering of the photosensitive substance];
performing energy radiation with a predetermined energy on the affected part [0096; see the irradiating of the tumor]; and
confirming therapeutic effects by the energy radiation on the affected part [0050, 0080; see the tomographic ultrasound image that detects a change in the tumor], wherein
before administering the agent: determining a state of a lesion based on an ultrasound image based on ultrasound waves reflected from the affected part, and
based on a result of the determination, determining a method of administering the medicinal agent to the affected part [0102, 0144, 0154; see the acquiring and checking of an ultrasound image during the bringing of the endoscope to the vicinity of the tumor and during puncturing of the tumor which determines a lesion state and, subsequently, see that the administering of the anti-cancer agent is determined to be either administering at a particular location or, alternatively, “to the vein” or locally; the location and type of injection are methods of administering that are based on the imaged state of the tumor].
Re claim 3: The at least one ultrasound image includes an ultrasound image based on photoacoustic waves obtained by irradiating an inside of a living body with light and ultrasound waves [0050; see the ultrasound image obtained after irradiation with light such that the image is based on ultrasound light as a photoacoustic effect].
Re claim 4: The administering further includes observing injection of the medicinal agent in the ultrasound image based on the photoacoustic waves [0084; see the imaging as part of a checking which observes the administration/injection].
Re claim 5: The determining of a method of administering the medicinal agent is determined based on at least one of a positional state of a lesion part, a state of stroma, or a state of a blood vessel [0075, 0144, 0154; see the target tumor irradiated from a blood vessel, wherein the image yields its state; also see the ultrasound imaging that indicates at least a position of the tumor and surrounding structures].
Re claim 6: The confirming further includes monitoring consumption of the medicinal agent in the at least one ultrasound image based on the photoacoustic waves while performing the energy radiation, and determining an end of the energy radiation based on the medicinal agent not being confirmed [0050, 0091; see the image indicating dead tumor cells based on consumption of the agent and see the determination to end irradiation].
Re claim 7: The determination of the lesion state based on the at least one ultrasound image further includes: determining based on the image, at least a size of the affected part, properties of scatterers of the affected part, movement of blood in the affected part, increase/decrease of blood vessels in the affected part, expansion/contraction of the affected part, consumption of the medicinal agent, a reaching range of the medicinal agent and therapeutic light, or a healing state of the affected part and surrounding tissues [0080, 0084, 0144, 0154; see the imaging in real time which provides a checking of various states of the target tumor and blood vessel].
Re claim 8: An additional determination is performed through comparison of a plurality of images acquired at different timings [0084; see the continued ‘checking’ which allows the operator to compare over time].
Re claim 9: The predetermined energy is one of light, ultrasound vibration, or a neutron beam [0096; see the NIR].
Re claim 10: The administering and the performing are, or performing is, repeated based on a confirmation result in the confirming, in the confirming, comparison of the at least one ultrasound image acquired in a period before start of the administering or a period between the administering and the performing, with the at least one ultrasound image acquired in a first period after an end of the performing, comparison of the at least one ultrasound image acquired in the period before start of the administering or the period between the administering and the performing, with the at least one ultrasound image acquired in a second period after an end of the performing and after the first period, or comparison of the at least one ultrasound image acquired in the first period with the at least one ultrasound image acquired in the second period, is performed, and in the performing, a condition of the energy radiation is determined based on a comparison result in the confirming [0050, 0084; see the ultrasound imaging that confirms and see the checking from the ultrasound images acquired in at least a first period after the performing].
Re claim 11: The second period is a period on or after a next day of the first period [0050, 0084; the second period is after the first period, which is on the next day].
Re claim 12: Otsu discloses a supporting energy radiation treatment, the system comprising:
an ultrasound endoscope including a channel, the ultrasound endoscope being configured to acquire an ultrasound image of an affected part, the channel allowing insertion of an energy radiation probe to perform energy radiation with predetermined energy on the affected part and being used to administer a medicinal agent to the affected part [0043, 0079; see the endoscope to acquire an ultrasound image and the probe to irradiate energy to a target]; and
a processor comprising hardware, the processor being configured to: determine, before administering the agent, a state of a lesion based on an ultrasound image based on ultrasound waves reflected from the affected part, and based on a result of the determination, determine a method of administering the medicinal agent to the affected part [0102, 0144, 0154; see the acquiring and checking of an ultrasound image during the bringing of the endoscope to the vicinity of the tumor and during puncturing of the tumor which determines a lesion state and, subsequently, see that the administering of the anti-cancer agent is determined to be either administering at a particular location or, alternatively, “to the vein” or locally; the location and type of injection are methods of administering that are based on the imaged state of the tumor].
Re claim 13: The processor is configured to determine the method of administering the medicinal agent and the radiation condition of the energy radiation by determining at least one of a size of the affected part or properties of scatterers of the affected part, based on the ultrasound image [0050, 0084; see the ultrasound imaging that confirms and see the checking from the ultrasound images which indicates at least scatterer properties].
Re claim 14: the processor is configured to determine the method of administering the medicinal agent and the radiation condition of the energy radiation by determining at least one of movement of blood in the affected part, increase/decrease of blood vessels in the affected part, or expansion/contraction of the affected part, based on the ultrasound image [0080, 0084; see the imaging in real time which provides a checking of various states of the target tumor and blood vessel].
Re claim 15: The processor is configured to determine the method of administering the medicinal agent and the radiation condition of the energy radiation by determining at least one of consumption of the medicinal agent, reaching range of the medicinal agent and therapeutic light, or a healing state of the affected part and surrounding tissues, based on the ultrasound image [0080, 0084; see the imaging in real time which provides a checking of various states of the target tumor, including a consumption of the administered agent].
Response to Arguments
Applicant's arguments filed 9/16/25 have been fully considered but they are not persuasive. Regarding the 102 rejection, Applicant argues that Otsu discloses intravenous administration before endoscope placement or local administration after endoscope placement with imaging only during puncture. Respectfully, the Examiner disagrees. While Otsu does disclose administering the agent intravenously before imaging with the endoscope in some embodiments (i.e see the 3rd embodiment [0096]), other embodiments are not so limited. The 4th embodiment refers to ultrasound imaging via endoscope 70 for guidance to the tumor and using the image to puncture the tumor also provides for determining a state of the lesion at least in regard to its position [0102]. Similarly, the 8th and 9th embodiments refer to administration after ultrasound imaging [0144, 0154], wherein the imaging determines a state of the lesion. Furthermore, the imaging provides for determining of a method of administering as either a particular position to administer, or permits the determination to administer intravenously or locally depending on how quickly the agent is needed to act on the tumor cells [0145].
The prior 112 rejections are withdrawn except in regard to claim 10 that was not addressed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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, Christopher Koharski can be reached at 571-272-7230. 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.
/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797