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 .
Amendment Entered
In response to the amendment filed on 10/16/2025, claims 10, 14, and 15 are cancelled, and amended claims 1, 2, 8, 9, 11-13 and 16 have been entered. Claims 1-9, 11-13, and 16 remain pending in the application.
Response to Amendment
Applicant' s remarks and amendments with respect to the specification and claims have been fully considered and overcome each and every objection and rejection under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed on 07/29/2025. The objections and rejections are withdrawn in view of amendments to independent claims 1, 13 and 16, and in view of amendments to dependent claims 9 and 11.
Acknowledgement is made of applicant’s claim to the application under examination as a continuation of PCT/JP2021/015576 and PCT/JP2020/016638 filed under 35 U.S.C. §111(a), claiming domestic benefit under 35 U.S.C. §120 (see page 8-9 of remarks). Therefore, the requirement for a certified priority document under 37 CFR §1.55 is withdrawn in view of applicant’s arguments regarding the Application Data Sheet dated 10/11/2022, acknowledging the status of the current application as a continuation of PCT/JP2021/015576 (with a priority date of 04/15/2021), and a continuation in part of PCT/JP2020/016638 (with a priority date of 04/15/2020).
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 5-6, 8, 11-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0131284 A1 to Kobayashi et al. (“Kobayashi”, cited by applicant in 10/11/2022 IDS) in view of US 2015/0173626 A1 to Irisawa et al. (“Irisawa”, cited by applicant in 10/16/2023 IDS), and further in view of US 2020/0121242 A1 to Mehrmohammadi et. al (“Mehrmohammadi”).
Regarding independent claims 1, 13, and 16, Kobayashi discloses a hemoglobin concentration measuring system (see [0033], “…diagnostic device and data acquisition method …”. see also [0077], “…determined by the method for determining the quantity of hemoglobin by near-infrared spectroscopy, since the heme iron concentration in the cystic fluid is approximate to the concentration of hemoglobin…”) comprising:
a transvaginal probe (see Fig. 6b and [0097], “…probe 1 for measuring…and the probe 3 of the image forming unit can be integrated in a single insertion member 2…so that both probes can be inserted simultaneously intravaginally …”, probes 1 and 3 of integrated insertion member 2, inserted vaginally), the transvaginal probe including:
an ultrasound transmitting/receiving part configured to transmit ultrasound to an ovarian cyst in living tissue and receive an ultrasound echo reflected from the living tissue (see Fig. 6b and [0096], “…probe of the image forming unit of the diagnostic device…arranged on an insertion member which can be inserted into the vagina of a subject, so that the probe can be inserted up to the vicinity of endometriosis ovarian cysts…image forming unit can be an ultrasonic diagnostic device used in transvaginal ultrasonography…”, image forming unit 3 of integrated insertion member 2, is a vaginal ultrasound diagnostic device (i.e., transmits/receives ultrasound reflected from ovarian cystic tissue)) ;
a light irradiation part configured to emit light (see Fig. 6 and [0074], “…“probe” may has at least a light emitting part that emits near-infrared light …”, ) wherein the light contains components of a plurality of specific wavelengths from a wavelength region of near- infrared light (see [0074], “…light emitting part that emits near-infrared light…near infrared light transmitted through the cystic fluid…measuring the near-infrared light of spectroscopy…”, light emitter of probe 1 emits near-infrared light. See also [0083], “…measuring the sensitivity (absorbance (ABS) or optical density (O.D)) of met-heme and oxy-heme at attributed wavelengths …”, attributed wavelengths, indicative of plurality of emitted wavelengths)) and
a light receiving part configured to receive reflected light or transmitted light, wherein the reflected light or the transmitted light is light emitted from the light irradiation part and reflected by or transmitted through the living tissue (see Fig. 6 and [0074], “…“probe” may has…a light receiving part for receiving a near infrared light reflected from the cystic fluid or a near infrared light transmitted through the cystic fluid…”, light receiving part of probe 1 receives reflected/transmitted light through cystic fluid (i.e., living tissue) from light emitting part of probe 1).
display an ultrasound image containing an image of an ovarian cyst based on the ultrasound echo received by the ultrasound transmitting/receiving part (see [0096], “…the probe can be inserted up to the vicinity of endometriosis ovarian cysts and the endometriosis ovarian cysts can be visualized… image forming unit can be an ultrasonic diagnostic device…”, visualization of ovarian cysts using diagnostic ultrasound imaging (i.e., display of an ultrasound image containing an ovarian cyst, based on ultrasound image formed by the image forming unit of integrated probes 1 and 3 of insertion member 2); and
a concentration calculation part configured to calculate hemoglobin concentration in a cystic fluid retained in the ovarian cyst based on an optical spectrum of the reflected light or the transmitted light from the ovarian cyst received by the light receiving part (see [0073], “…a data processing unit for calculating the concentration of iron in the cystic fluid from an absorption spectrum of near-infrared light obtained”, data processing unit (i.e., concentration calculation part) determines concentration in cystic fluid from a spectrum of absorbed light reflected or transmitted. see also [0077], “…heme iron concentration in the cystic fluid can be determined by the method for determining the quantity of hemoglobin by near-infrared spectroscopy, since the heme iron concentration in the cystic fluid is approximate to the concentration of hemoglobin”, iron concentration calculation is determined based on the determination of hemoglobin concentration using near infrared spectroscopy (i.e., hemoglobin concentration is determined)) .
wherein the concentration calculation part is configured to acquire absorbance measurement values at the plurality of specific wavelengths based on the optical spectrum (see [0065], “…the sensitivity of each wavelength (absorbance or optical density) in the cyst fluid samples are measured to obtain the sensitivity ratios…”, ). see also [0073], “…calculating the concentration of iron in the cystic fluid from an absorption spectrum…”, determine absorbance values at a plurality of specific wavelengths, and calculate concentration based on absorption spectra), and calculate the hemoglobin concentration by substituting the absorbance measurement values into a pre-acquired predetermined formula that represents a relationship between absorbance at the plurality of specific wavelengths and hemoglobin concentration (see [0081], “…As explained in “1. Data acquisition method”, the presence ratio of met-heme/oxy-heme in cyst fluid can be measured also by measuring the sensitivity (absorbance (ABS) or optical density (O.D)) of met-heme and oxy-heme at attributed wavelengths to calculate a ratio of their sensitivities…”, absorbance measurement values for attributed wavelengths are applied to a predetermined formula (i.e., a predetermined sensitivity relationship)); and
However, Kobayashi fails to disclose “…a light irradiation part configured to emit light in a direction parallel to a scanning plane of the ultrasound transmitted from the ultrasound transmitting/receiving part…”.
Irisawa teaches probe for photoacoustic measurements (see abstract) including light transmission components and ultrasound transducer components (see [0046 ], “…photoacoustic measurement apparatus is a photoacoustic imaging apparatus 10 as an example, and includes an ultrasonic unit 12, a laser light source unit 13, and image display means 14 in addition to an ultrasonic probe…”) where light is transmitted in a direction parallel to a scanning plane of the ultrasound transducer (see Fig. 3 and [0049], “…ultrasonic transducers are disposed so as to be arranged in a line in a plane parallel to the spread plane of a laser beam…”).
Although Kobayashi is silent regarding the direction of light emission relative to the scanning plane of the ultrasound transmitter/receiver, Kobayashi discloses the light emitter (i.e., of probe 1) and the image forming unit (i.e., of probe 3) are integrated on a single member (i.e., insertion member 2) (see Fig. 6b [0097]). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify Kobayashi to emit light in a direction parallel to a scanning plane (of an ultrasound transmitted from the ultrasound transmitting/receiving part), for the purpose of acquiring a photoacoustic image over a wide range of a subject, as evidence by Irisawa (see [0072]). Furthermore, one of ordinary skill in the art would have had predictable success combining Kobayashi and Irisawa, since both teachings relate to the same narrow field of endeavor, i.e., transvaginal probes utilizing photoacoustic measurements.
Additionally, Kobayashi fails to disclose “…wherein the light contains components of a plurality of specific wavelengths from a wavelength region ranging from visible light to near- infrared light, the plurality of specific wavelengths including at least one wavelength in a visible light region;…”.
Kobayashi further discloses a concentration measurement unit utilizing near infrared spectroscopy and visible spectroscopy measurements (see [0073], “…concentration measurement unit can be configured in such a manner that the method of measuring the concentration…(for example, by a well-known near-infrared spectroscopy, visible spectroscopy, etc.)…”), and further discloses determining cystic fluid heme concentration using visible light (see [0062], “…a sample of the cyst fluid is irradiated by ultraviolet or visible light and transmitted light (or reflected light) is observed in term of absorbance…”. See also [0065], “…a marker wavelength…can be selected in the vicinities of 400 nm, 490 nm and 620 nm respectively…”, wavelengths indicative of the visible spectrum of light).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Kobayashi/Irisawa combination to emit light containing a plurality of wavelengths ranging from visible light to near infrared light including at least components of a wavelength in a visible light region, for the purpose of comparing the spectral shapes of absorbance, as evidence by Kobayashi (see [0062]).
Additionally, Kobayashi fails to disclose “…wherein the reflected light or the transmitted light is light emitted from the light irradiation part and reflected by or transmitted through the living tissue to propagate in a direction parallel to the scanning plane…”.
Although Kobayashi is silent regarding the direction of light emission relative to the scanning plane of the ultrasound transmitter/receiver, Kobayashi discloses the light emitter (i.e., of probe 1) and the image forming unit (i.e., of probe 3) are integrated on a single member (i.e., insertion member 2) (see Fig. 6b [0097]). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify Kobayashi to emit light in a direction parallel to a scanning plane (of an ultrasound transmitted from the ultrasound transmitting/receiving part), for the purpose of acquiring a photoacoustic image over a wide range of a subject, as evidence by Irisawa (see [0072]).
Additionally, Kobayashi fails to disclose “…a display part configured to display an ultrasound image containing an image of an ovarian cyst based on the ultrasound echo received by the ultrasound transmitting/receiving part…”.
Irisawa further teaches a display for displaying an acquired photoacoustic image (see [0060], “…photoacoustic image of the cross-section is displayed on the image display means 14…”).
Kobayashi further discloses, in an alternate embodiment, an image presentation unit (see [0187], “…an image presentation part of the testing and diagnostic device…”). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Kobayashi/Irisawa combination to include a display part (to display an ultrasound image containing an image of an ovarian cyst) for the purpose of sensitive ovarian cyst visualization, as evidence by Kobayashi (see [0096]).
Additionally, the Kobayashi/Irisawa combination fails to explicitly disclose “wherein the pre-acquired predetermined formula is a multiple regression formula constructed based on measurements using simulated cysts.”
Mehrmohammadi teaches systems and methods using optical absorption measurements associated with hemoglobin concentration (see [0042], “...optical absorption through PA imaging is associated with physiological properties such as hemoglobin concentration and oxygen saturation”) and determining physiological parameters of cervical tissue based on a predetermined correlation between known absorption of hemoglobin and measured acoustic signals (see [0067]- [0069], “... PA signals may be analyzed to determine correlation maps and a blood oxygen saturation map...determined based on a correlation between a known absorption of oxy-hemoglobin (HbO) and a recorded PA signal... result may be normalized, and a 256 levels color map may be applied on the normalized result…utilizing values from two different wavelengths, may be estimated at least partially based on the obtained measurements of oxygen saturation of the cervix...”).
Irisawa further teaches using measurements taken from simulations to determine a light-use efficiency (see [0104]-[0106], “…light-use efficiency is calculated by simulations that are performed by a calculator… light-use efficiency…is a value that is standardized using the energy of light incident on the light diffusion member… the angular range (viewing angle) and the light-use efficiency of light emitted…are changed in accordance with the length…”).
The Kobayashi/Irisawa combination teaches a pre-acquired predetermined formula representing a relationship between absorbance at a plurality of wavelengths and hemoglobin concentrations (see Kobayashi [0081], predetermined sensitivity relationship), but fails to explicitly disclose a multiple regression formula. Mehrmohammadi teaches determining physiological parameters of cervical tissue using a pre-determined multiple regression formula (see [0067]-[0069]), but fails to explicitly disclose constructing the multiple regression formula based on simulated cyst measurements. Irisawa further teaches using simulated measurements to determine photoacoustic properties (see [0103]-[0106]).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the pre-acquired predetermined formula of the Kobayashi/Irisawa combination (to be a multiple regression formula), for the purpose of measuring cervical tissue hemoglobin content, as evidence by Mehrmohammadi (see [0065]). Furthermore, one of ordinary skill in the art would have had predictable success combining Kobayashi/Irisawa, and Mehrmohammadi since their teachings relate to the same narrow field of endeavor, i.e., transvaginal probes utilizing photoacoustic measurements. Additionally, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the multiple regression formula of the Kobayashi/Irisawa/Mehrmohammadi combination (to determined based on simulated cyst measurements), for the purpose of standardizing measured values, as evidence by Irisawa (see [0105]).
Regarding claim 2, the Kobayashi/Irisawa/Mehrmohammadi combination discloses the invention as claimed above in claims 1, 13, and 16 respectively. The Kobayashi/Irisawa/Mehrmohammadi combination further discloses wherein the plurality of specific wavelengths are wavelengths in the visible light region (visible light region of the Kobayashi/Irisawa combination, discussed above regarding claims 1, 13, and 16. see Kobayashi [0062], “…a sample of the cyst fluid is irradiated by ultraviolet or visible light and transmitted light (or reflected light) is observed in term of absorbance…”. See also [0065], “…a marker wavelength…can be selected in the vicinities of 400 nm, 490 nm and 620 nm respectively…”, wavelengths indicative of the visible spectrum of light).
Regarding claims 3 and 4, the Kobayashi/Irisawa/Mehrmohammadi combination discloses the invention as claimed above in claims 1, 13, and 16 respectively. The Kobayashi/Irisawa/Mehrmohammadi combination further discloses wherein the plurality of specific wavelengths includes, at least wavelengths selected from 580nm, 590nm, 640nm, 680nm, and 762nm (see Kobayashi [0064], “…, a wavelength of 580 nm is selected as a marker wavelength…and a wavelength of 620 nm is selected as a marker wavelengths…”, wavelength of 580nm selected).
However, the Kobayashi/Irisawa/Mehrmohammadi combination fails to disclose “…wherein the plurality of specific wavelengths includes, at least, two or more wavelengths selected from 580nm, 590nm, 640nm, 680nm, and 762nm”.
Additionally, the Kobayashi/Irisawa/Mehrmohammadi combination fails to disclose “…wherein the plurality of specific wavelengths includes two or more wavelengths selected from 580nm, 590nm, 640nm, 680nm, 762nm, 876nm, 900nm, 932nm, 958nm, 968nm, 978nm, and 1095nm”.
Mehrmohammadi further teaches vaginal photoacoustic probe devices and methods (see abstract) including a photoacoustic probe emitting light across a plurality of wavelengths, including wavelengths between 680nm and 2500nm (see [0046], “…tunable across a range of wavelengths between 680 nm to 2500 nm…”. See also [0056], “…Wide-spectrum range spectroscopic photoacoustic (sPA) imaging from imaging in a range of from about 1150 nm to about 1650 nm was performed, and the laser energies at different wavelengths…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the Kobayashi/Irisawa combination to emit light in a direction parallel to a scanning plane (of an ultrasound transmitted from the ultrasound transmitting/receiving part), for the purpose of normalizing photoacoustic signals with respect to energy variations, as evidence by Mehrmohammadi (see [0056]). Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include two or more wavelengths selected from the recited wavelengths, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 5, the Kobayashi/Irisawa/Mehrmohammadi combination discloses the invention as claimed above in claims 1, 13, and 16 respectively. The Kobayashi/Irisawa/Mehrmohammadi combination further discloses wherein the ultrasound transmitting/receiving part is configured to transmit the ultrasound so as to scan the living tissue (scanning direction of the Kobayashi/Irisawa/Mehrmohammadi combination, described above in relation to claims 1, 13, and 16).
However, the Kobayashi/Irisawa/Mehrmohammadi combination fails to disclose “…wherein the ultrasound transmitting/receiving part is configured to transmit the ultrasound so as to scan the living tissue in a convex manner…” and “…light irradiation part is capable of emitting the light in a direction parallel to an ultrasound transmission direction at the center of the convex-shaped scanning plane”.
Irisawa further teaches a convex shaped ultrasonic transducer array (see [0069], “…the ultrasonic transducer array 52 is formed of an array of which an outer end face is formed in a so-called convex shape”) arranged in parallel to a direction intersecting a scanning direction (see Figs. 3-4 and [0049], “…an ultrasonic transducer array including a plurality of ultrasonic transducers that are arranged in parallel in a direction intersecting with a scanning direction…”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Kobayashi/Irisawa/Mehrmohammadi combination to scan living tissue in a convex manner and emit light in a direction parallel to an ultrasound transmission direction at the center of the convex-shaped scanning plane, for the purpose of irradiating a wide range of an object to be measured with light, as evidence by Irisawa (see [0023]).
Regarding claim 6, the Kobayashi/Irisawa/Mehrmohammadi combination discloses the invention as claimed above in claims 1, 13, and 16 respectively. The Kobayashi/Irisawa/Mehrmohammadi combination further discloses wherein the light irradiation part and the light receiving part are arranged opposite each other with the ultrasound transmitting/receiving part sandwiched therebetween.
However, the Kobayashi/Irisawa/Mehrmohammadi combination is silent regarding the arrangement of the light irradiation/receiving part, in particular, “…wherein the light irradiation part and the light receiving part are arranged opposite each other with the ultrasound transmitting/receiving part sandwiched therebetween”.
Kobayashi further discloses a light emitting part and a light receiving part located at close proximity to each other in a measurement probe (see Fig. 6b and [0074], “…the light emitting part and the light receiving part can be located at close proximity in an iron concentration measurement unit…”), and a light emitting/receiving element positioned adjacent to an image forming unit (see Fig. 6b, integrated probe contains measurement probe 1 (i.e., light emitting/receiving element) positioned adjacent to image forming probe 3 (i.e., ultrasound transmitter/receiver) located on insertion member 2).
Irisawa further teaches a light guide (see [0015], “…in the probe for a photoacoustic measurement apparatus of the invention, it is preferable that the probe further include a light guide member, which uniformizes the distribution of the intensity of light emitted from the light propagation part, be disposed between the inner peripheral surface of the light transmission member and the light propagation part”).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Kobayashi/Irisawa/Mehrmohammadi combination to arrange a light emitting part and a light receiving part opposite each other, with an ultrasound transmitter/receiver sandwiched between, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 8, the Kobayashi/Irisawa/Mehrmohammadi combination discloses the invention as claimed above in claims 1, 13, and 16 respectively. The Kobayashi/Irisawa/Mehrmohammadi combination further discloses wherein the ultrasound transmitting/receiving part is provided on a transvaginal ultrasound probe (see Fig. 6b and [0096], “…probe of the image forming unit of the diagnostic device…arranged on an insertion member which can be inserted into the vagina of a subject, so that the probe can be inserted up to the vicinity of endometriosis ovarian cysts…image forming unit can be an ultrasonic diagnostic device used in transvaginal ultrasonography…”, image forming unit 3 of integrated insertion member 2, is a vaginal ultrasound diagnostic device, provided on member 2),
the light irradiation part and the light receiving part are attached to a holder on an insertion part, which is to be inserted into the vagina, of the ultrasound probe (see Kobayashi [0097]-[0098], “…probe 1 for measuring the iron concentration and the probe 3 of the image forming unit can be integrated in a single insertion member 2… Material, shape, size and structure of the “insertion member” are not particularly limited but can be any ones as long as the probe of the image forming unit can be inserted into the vagina of a subject”, light irradiation/receiving part (i.e., probe 1) attached to insertion member 2, and inserted into a vagina of a subject).
However, the Kobayashi/Irisawa/Mehrmohammadi combination fails to disclose “…the light irradiation part and the light receiving part are attached to a holder to be placed over an insertion part…” and “…the light irradiation part and the light receiving part, along with the holder, are detachable from the ultrasound probe”.
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Kobayashi/Irisawa/Mehrmohammadi combination to arrange a light emitting part and a light receiving part attached to a holder, (placed over an insertion part), since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Additionally, It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify Kobayashi/Irisawa/Mehrmohammadi combination to make the light irradiation part, light receiving part, and holder detachable from the ultrasound probe, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlicnrnan, 168 USPQ 177, 179.
Regarding claim 11, the Kobayashi/Irisawa/Mehrmohammadi combination discloses the invention as claimed above in claim 1 respectively. The Kobayashi/Irisawa/Mehrmohammadi combination further discloses wherein the predetermined formula is determined by a method including:
a step (a) of applying light in a wavelength region ranging from visible light to near-infrared light to a simulated living body sample, the simulated living body sample being a transparent container containing a fluid of a known hemoglobin concentration covered by living tissue (see Kobayashi [0111], “…cyst fluid was dispensed into wells and the electron absorption spectrum was measured by a microplate reader…”, samples (i.e., simulated living body samples) dispensed into wells (i.e., transparent container) measurement of absorption spectrum (i.e. measurement of transmitted wavelengths applied), to ;
a step (b) of receiving reflected light reflected by the simulated living body sample or transmitted light transmitted through the simulated living body sample (see Kobayashi [0111], “…electron absorption spectrum was measured by a microplate reader…”, applied light measured (i.e., received) by microplate reader).;
a step (c) of acquiring an optical spectrum of the reflected light or the transmitted light received in the step (b) (see Kobayashi [0112], “…The electronic absorption spectra for the cyst fluid…”, absorption spectra (i.e., of reflected or transmitted light) determined); and
a step (d) of acquiring, based on a plurality of optical spectra acquired by performing the steps (a) to (c) on a plurality of simulated living body samples, a plurality of absorbances at a plurality of predetermined wavelengths including at least a wavelength of a visible light region from among wavelength regions of the light applied in the step (a) (see Kobayashi [0112], “…The electronic absorption spectra for the cyst fluid…show the absorption maxima at 408 nm, 538 nm, at 575 nm and 625 nm”, absorption spectra (i.e., of reflected or transmitted light) determined at wavelengths within the visible light spectrum) and determining a relationship between the absorbances at the plurality of predetermined wavelengths and the hemoglobin concentration based on the plurality of absorbances and the concentration of the fluid of the known concentration (see Kobayashi [0062], “…possible to estimate the presence ratio of met-heme and oxy-heme (concentration ratio) from a difference because there is a typical difference in spectral shapes of the met-heme and of oxy-heme…”, determine a relationship (i.e., a ratio) based on spectral shapes (i.e., of absorbances and concentration)), and wherein
the plurality of specific wavelengths are the plurality of predetermined wavelengths (see Kobayashi [0112], “…The electronic absorption spectra for the cyst fluid…show the absorption maxima at 408 nm, 538 nm, at 575 nm and 625 nm”, absorption spectra, determined wavelengths).
Regarding claim 12, the Kobayashi/Irisawa/Mehrmohammadi combination discloses the invention as claimed above in claims 1, 13, and 16 respectively. The Kobayashi/Irisawa/Mehrmohammadi combination further discloses a determination part (see Kobayashi [0023], “…diagnostic device according to the present invention can include further a determination unit which can perform any of the following determinations …”, determination part) configured to determine under which classifications of degree of malignancy of an endometriotic ovarian cyst pre- associated with hemoglobin concentration the hemoglobin concentration calculated by the concentration calculation part falls (see [0044]-[0045], “…determine a likelihood of canceration of endometriosis ovarian cysts on the base of the data acquired by the data acquisition method of the present invention. In practice, the determination is made… likelihood of canceration of endometriosis ovarian cysts is determined when the heme iron concentration in the cyst fluid is not lower than 0 mg/L and equal to or less than 63 mg/L…”, see also Kobayashi [0188], “…concentration of cyst fluid of endometriosis ovarian cysts obtained from a subject in which malignant transformation is suspected, by a measuring unit…” , likelihood of cancerous tissue (i.e., degree of malignancy) determined from heme data calculated by concentration calculation part (i.e., of the Kobayashi/Irisawa combination)).
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi in view of Irisawa, further in view of Mehrmohammadi, and further in view of US 2020/0352487 A1 to Ray et al. (“Ray”).
Regarding claim 7, the Kobayashi/Irisawa/Mehrmohammadi combination discloses the invention as claimed above in claims 1, 13, and 16 respectively. The Kobayashi/Irisawa/Mehrmohammadi combination further discloses wherein light irradiation in an orthogonal direction (see Irisawa [0019], “…degree of light diffusion in a direction orthogonal to the one direction be applied as the light diffusion member”) and a scanning direction of the ultrasound transmitted from the ultrasound transmitting/receiving part (of the Kobayashi/Irisawa combination, as described above in reference to claims 1, 13, and 16).
However, the Kobayashi/Irisawa/Mehrmohammadi combination is silent regarding the arrangement of the light emitting and light receiving parts relative to the ultrasound scanning direction, particularly, “…wherein the light irradiation part and the light receiving part are arranged such that a line connecting an end surface of the light irradiation part and an end surface of the light receiving part is orthogonal to a scanning direction of the ultrasound transmitted from the ultrasound transmitting/receiving part”.
Ray teaches a system for determining fetal hemoglobin oxygen saturation level (see abstract) including a plurality of light sources emitting light at a plurality of wavelengths (see [0006], “…the light source may include a plurality of light producing elements. At times, the light producing elements may produce light of two or more different wavelengths or ranges of wavelengths…”) and a light detector (see [0006], “…detector configured to detect light…”). Additionally, Ray teaches a light source and light detector positioned perpendicularly relative to a housing (see Fig. 1D and [0115], “…light source 105 and detector 115 relative to housing 125 and shows light source 105 and detector 115 aligned so that reference line 140D is perpendicular to reference line 145…”).
The Kobayashi/Irisawa/Mehrmohammadi combination discloses a light irradiation part, a light receiving part, an ultrasound scanning direction, and an orthogonal direction of light emission, but fails to teach how the light irradiating part and light receiving part are arranged relative to the ultrasound scanning direction. Ray teaches a light emitting part and a light receiving part, arranged orthogonally. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the Kobayashi/Irisawa/Mehrmohammadi combination to connect an end surface of the light irradiation part and an end surface of a light receiving part (with a line orthogonal to an ultrasound scanning direction), since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 9, the Kobayashi/Irisawa/ Mehrmohammadi/Ray combination discloses the invention as claimed above in claim 7/1 respectively (see 35 U.S.C. 112(b) section above regarding dependency of claim 9). The Kobayashi/Irisawa/Mehrmohammadi/Ray combination further discloses wherein the center-to-center distance between the end surface of the light irradiation part and the end surface of the light receiving part is between 10 mm and 31 mm, inclusive (see Irisawa [0107], “…14 mm which is equal to the distance between both ends of the inner peripheral surface of the light transmission member…”, 14 mm distance between light members is 14mm, (i.e., between 10mm and 31mm, inclusive)).
Response to Arguments
Applicant’s arguments, filed 10/16/2025, with respect to the rejections of claims 1-2, 5-6, 8, 10-13, and 16 under 35 U.S.C. 103 have been fully considered but they are moot in view of the current combination of references that were necessitated by amendment. The new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ALYSSA P NOVAK whose telephone number is (703)756-1947. The examiner can normally be reached M-F: 8-5.
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, Jacqueline Cheng can be reached at (571) 272-5596. 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.
/ALYSSA PAIGE NOVAK/Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791