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 .
DETAILED ACTION
This Office Action is in response to the application 18/871,049 filed on 12/02/2024.
Claims 1 – 6, 12 – 19 and 23 have been examined and are pending in this application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/02/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim limitation “observation device”, ”synthesis unit”, “inversion unit” has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “device/unit” coupled with functional language “that observes…”, “that generates…”, “” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1, 3, 5 and 18 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 – 6, 12 – 19 and 23 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 pre-AIA the applicant regards as the invention.
Claim elements “observation device that observes…”, “generation unit that generates…”, “inversion unit that generates…” are limitations that invoke 35 U.S.C. 112 Sixth, paragraph. However, the written description fails to disclose the corresponding structure, material or acts for the claimed function. The drawings and the corresponding description do not specifically state what structure performs the “observation device that observes…”, “generation unit that generates…”, “inversion unit that generates…”.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112, sixth paragraph; or
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the claimed function without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01 (o) and 2181.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1 – 4, 12, 18 – 19 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Sato et al. (JP 2017161730 A) in view of IKEHARA et al. (US 20200026316 A1) and further in view of Doi et al. (US 20240016460 A1).
Regarding claim 1, Sato discloses: “an observation device that observes a blood vessel model as an observation target into which a catheter is inserted [see para: 0004; a blood vessel visualization apparatus has been proposed in which a blood vessel image is taken using near infrared light and a radial artery can be punctured while watching the image. And para: 0002; In examination or treatment using a catheter, for example cardiac catheter examination, an artery is pierced, a guide wire is inserted, and a catheter is inserted], the blood vessel model including a substance disposed inside having near-infrared light absorption characteristics different from that of a constituent material of the blood vessel model [see para: 0015; As such a blood vessel visualization apparatus 30, for example, a blood vessel visualization apparatus (model PM - RAPN - D) manufactured by Plus Med Co., Ltd. can be used], and the catheter including a sheath and wires inserted into the sheath [see para: 0002; a guide wire is inserted], the observation device comprising:
a first light source that emits first near-infrared light [see para: 0004; a blood vessel visualization apparatus has been proposed in which a blood vessel image is taken using near infrared light];
a display that displays the first image [see para: 0033; the blood vessel image is displayed on the monitor 35 (FIG. 4)]
Sato does not explicitly disclose: “a first light reception unit that can receive the first near-infrared light;
a first image generation unit that generates a first image based on the first near-infrared light received by the first light reception unit; and
wherein the first near-infrared light can transmit through the blood vessel model, substance in the blood vessel model, and the sheath of the catheter”.
However, Ikehara, from the same or similar field of endeavor teaches: “a first light reception unit that can receive the first near-infrared light [see para: 0045; The first imager 21 includes an imaging optical system (detecting optical system) 23 and an imaging element (light-receiving elements) 24];
a first image generation unit that generates a first image based on the first near-infrared light received by the first light reception unit [see para: 0004; generate an image of the sample based on a detection result obtained by irradiating the sample with the first-wavelength infrared light and the second-wavelength infrared light simultaneously]; and
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/head mounted camera system disclosed by Sato to add the teachings of Ikehara as above, in order to improve the observing system for blood vessel image taken with near-infrared light, image processor or computer controller can generates images based on the near-infrared light that received and synthesized [Ikehara see para: 0045].
Sato and Ikehara does not explicitly disclose: “wherein the first near-infrared light can transmit through the blood vessel model, substance in the blood vessel model, and the sheath of the catheter”.
However, Doi, from the same or similar field of endeavor teaches: “wherein the first near-infrared light can transmit through the blood vessel model, substance in the blood vessel model, and the sheath of the catheter [see para: 0040; The catheter sheath 11a constitutes a tube portion that is continuous from a connection portion with the guide wire insertion portion 14 to a connection portion with the connector portion 15. And para: 0041; a. An ultrasound transmitter and receiver 12 a (hereinafter referred to as an IVUS sensor 12 a) that transmits ultrasound into the blood vessel and receives a reflected wave from the blood vessel, and an optical transmitter and receiver 12 b (hereinafter referred to as an OCT sensor 12 b) that transmits near-infrared light into the blood vessel and receives a reflected light from the blood vessel are disposed in the housing 12 d].
Therefore, It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system by Sato to add the teachings of Ikehara as above, to further incorporate the teachings of Doi to improve the observing system for blood vessel image taken with near-infrared light, these specific types of lights can transmit through the blood vessel, substance in the blood vessel, and the sheath of the catheter which is a great advantage [Doi see para: 0040].
Regarding claim 2, claim 2 is rejected under the same art and evidentiary limitations as determined for the method of claim 1.
However, Sato does not explicitly disclose: “adjusting a light amount of the first near-infrared light used for generating the first image as necessary to enable simultaneous visual recognition of the sheath of the catheter, the wires in the sheath, and the blood vessel model”.
However, Ikehara, from the same or similar field of endeavor teaches: “adjusting a light amount of the first near-infrared light used for generating the first image as necessary to enable simultaneous visual recognition of the sheath of the catheter, the wires in the sheath, and the blood vessel model [see para: 0023; FIG. 16 depicts a configuration example of a graphical user interface (GUI) 1600 which is used when setting and adjusting the wavelength values and optical intensity of infrared light for simultaneous irradiation according to the present embodiment].
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/head mounted camera system disclosed by Sato to add the teachings of Ikehara as above, in order to improve the observing system for blood vessel image taken with near-infrared light, using adjustable controller, adjusting light amount of the near-infrared for generating the image as necessary to visually recognize blood vessel model [Ikehara see para: 0023].
Regarding claim 3, Sato, Ikehara and Doi disclose all the limitation of claim 1 and are analyzed as previously discussed with respect to that claim.
Sato does not explicitly disclose: “further comprising: a second light source that emits second near-infrared light;
a second light reception unit that can receive the second near-infrared light;
a second image generation unit that generates a second image based on the second near-infrared light received
an image synthesis unit that superimposes the first image and the second image, wherein
However, Ikehara, from the same or similar field of endeavor teaches: “further comprising:
a second light source that emits second near-infrared light [see abstract: second-wavelength infrared light from a light source];
a second light reception unit that can receive the second near-infrared light [see para: 0053; As illustrated in FIG. 2C, a plurality of the illumination units 3 are disposed around the optical axis 21 a (for example, the optical axis of the light received by the light-receiving elements) of the imager (detector)];
a second image generation unit that generates a second image based on the second near-infrared light received [see para: 0004; generate an image of the sample based on a detection result obtained by irradiating the sample with the first-wavelength infrared light and the second-wavelength infrared light simultaneously]; and
an image synthesis unit that superimposes the first image and the second image, wherein [see para: 0234; The controller 7′ may generate display data for displaying on the display screen the image captured by the first imager 21 superimposed over the image captured by the second imager 22].
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/head mounted camera system disclosed by Sato to add the teachings of Ikehara as above, in order to improve the observing system for blood vessel image taken with near-infrared light, multiple light source unit will provide lighting to the targeted spot which are near infrared lights and plurality reception unit will received returned emitted lights and image processors will superimposes divided or synthesized image as overlaid which are common in the art [Ikehara see abstract, para: 0053; 0004; 0234].
Regarding claim 4, claim 4 is rejected under the same art and evidentiary limitations as determined for the method of claim 2.
Claims 7 – 11. Canceled.
Regarding claims 12, “wherein the first near-infrared light includes monochromatic light” is only a matter of design choice because it only requires mere selection of wavelength or specific type of light that required to achieve targeted output.
Claims 13 and 14. Canceled.
Regarding claim 18, claim 18 is rejected under the same art and evidentiary limitations as determined for the method of claim 1.
Regarding claim 19, Sato, Ikehara and Doi disclose all the limitation of claim 16 and are analyzed as previously discussed with respect to that claim.
Sato does not explicitly disclose: “wherein the first near-infrared light has a wavelength of 1300 nm to 1550 nm”.
However, Ikehara, from the same or similar field of endeavor teaches: “wherein the first near-infrared light has a wavelength of 1300 nm to 1550 nm [see para: 0104; The absorbance of water exhibits substantially no change between the wavelengths of around 1200 nm to around 1300 nm, and begins to increase sharply as the wavelength exceeds 1300 nm. And para: 0105; Further, for example, with respect to infrared light with wavelengths of around 1400 nm to around 1550 nm, water, heavy water, and oil have relatively large differences in absorbance].
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/head mounted camera system disclosed by Sato to add the teachings of Ikehara as above, in order to improve the observing system for blood vessel image taken with near-infrared light, various wavelength could be used to get expected results in range 1300 to 1550nm [Ikehara see para: 0104].
Regarding claim 23, Sato, Ikehara and Doi disclose all the limitation of claim 1 and are analyzed as previously discussed with respect to that claim.
Sato does not explicitly disclose: “further comprising:
a background image storage unit; and
an image synthesis unit, wherein the image synthesis unit synthesizes a background image stored in the background image storage unit with the first image generated by the first image generation unit, and
a synthesized image is displayed on the display”.
However, Ikehara, from the same or similar field of endeavor teaches: “further comprising:
a background image storage unit [see para: 0222; the imaging system 1 may be provided in advance with a table (stored in a storage device, such as a memory]; and
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/head mounted camera system disclosed by Sato to add the teachings of Ikehara as above, in order to improve the observing system for blood vessel image taken with near-infrared light, memory inside the computer will be allocated for background image storing and later processed [Ikehara see para: 0222].
Sato and Ikehara does not explicitly disclose: “an image synthesis unit, wherein the image synthesis unit synthesizes a background image stored in the background image storage unit with the first image generated by the first image generation unit, and
a synthesized image is displayed on the display”.
However, Doi, from the same or similar field of endeavor teaches: “an image synthesis unit, wherein the image synthesis unit synthesizes a background image stored in the background image storage unit with the first image generated by the first image generation unit [see para: 0060; Therefore, as shown in a lower row in FIG. 7B, the image processing device 3 of the present embodiment performs correction processing of eliminating the deviation between the observation position of the OCT image and the observation position of the IVUS image by synthesizing each area in the OCT images of a plurality of frames to construct an OCT image of one frame. In the following description, processing of correcting the OCT image to match the observation target in the OCT image with the observation target in the IVUS image is performed, but processing of correcting the IVUS image in the same manner to match the observation target in the IVUS image with the observation target in the OCT image may be performed], and
a synthesized image is displayed on the display [see para: 0051; In addition, the control unit 31 displays a medical image on the display apparatus 4 by outputting a medical image signal of the IVUS image, the OCT image, or the angiographic image to the display apparatus 4 via the input and output I/F 33. Furthermore, the control unit 31 receives information input to the input device 5 via the input and output I/F 33].
Therefore, It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system by Sato to add the teachings of Ikehara as above, to further incorporate the teachings of Doi to improve the observing system for blood vessel image taken with near-infrared light, images captured by the cameras will be synthesized for image processing and displayed to the user or doctor on the monitor [Doi see para: 0060; 0051].
Claim 15 – 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sato et al. (JP 2017161730 A) in view of IKEHARA et al. (US 20200026316 A1) in view of Doi et al. (US 20240016460 A1) and further in view of Ayvali et al. (US 2021/0298590 A1).
Regarding claim 15, Sato, Ikehara and Doi disclose all the limitation of claim 1 and are analyzed as previously discussed with respect to that claim.
The combination does not explicitly disclose: “wherein the substance having near-infrared light absorption characteristics different from that of the constituent material of the blood vessel model includes a material that receives the first near- infrared light and causes Rayleigh scattering”.
However, Ayvali, from the same or similar field of endeavor teaches: “wherein the substance having near-infrared light absorption characteristics different from that of the constituent material of the blood vessel model includes a material that receives the first near- infrared light and causes Rayleigh scattering [see para: 0138; Examples of types of position sensor devices that may be implemented in connection with embodiments of the present disclosure include, but are not limited to, accelerometers, gyroscopes, magnetometers, fiber optic shape sensing (e.g., via Bragg gratings, Rayleigh scattering, interferometry, or related techniques), etc. Depending on the implementation, registration to a separate form of patient imagery, such as a CT scan, may or may not be necessary to provide a frame of reference for locating a urinary stone within the patient].
Therefore, It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention was made to modify the combination to include the missing limitation as taught by Ayvali in order to improve the observing system for blood vessel image taken with near-infrared light, can generate Rayleigh pattern lighting effect. There are other various lighting technique can be used on the substance for absorption based on the requirement [Ayvali see para: 0138].
Regarding claim 16, claim 16 is rejected under the same art and evidentiary limitations as determined for the method of claim 15.
Regarding claim 17, Sato, Ikehara and Doi disclose all the limitation of claim 16 and are analyzed as previously discussed with respect to that claim.
Sato does not explicitly disclose: “wherein the first near-infrared light has a wavelength of 1300 nm to 1550 nm”.
However, Ikehara, from the same or similar field of endeavor teaches: “wherein the first near-infrared light has a wavelength of 1300 nm to 1550 nm [see para: 0104; The absorbance of water exhibits substantially no change between the wavelengths of around 1200 nm to around 1300 nm, and begins to increase sharply as the wavelength exceeds 1300 nm. And para: 0105; Further, for example, with respect to infrared light with wavelengths of around 1400 nm to around 1550 nm, water, heavy water, and oil have relatively large differences in absorbance].
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/head mounted camera system disclosed by Sato to add the teachings of Ikehara as above, in order to improve the observing system for blood vessel image taken with near-infrared light, various wavelength could be used to get expected results in range 1300 to 1550nm [Ikehara see para: 0104].
Claims 20 to 22. Canceled.
Allowable Subject Matter
Claims 5 and 6 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nerney et al (US 9,558,678 B1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Masum Billah whose telephone number is (571)270-0701. The examiner can normally be reached Mon - Friday 9 - 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jamie J. Atala can be reached at (571) 272-7384. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MASUM BILLAH/Primary Patent Examiner, Art Unit 2486