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 1-7, 9-10, and 14-16 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.
As to claims 1 and 16, recitation of “the object image is a basis for determining whether the patient has an infection disease relating to the oral cavity based on a determination algorithm” is either an indefinite method step (a single claim which claims both an apparatus and method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) (see MPEP 2173.05(p)(II))) and/or an unbounded functional limitation that is not tied to structure, making the boundaries of the claim scope unclear because it may cover any and all means for providing the function.
Dependent claims inherit those defects.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
“The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.”
Claim(s) 1-2, 7, 9-10, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamakita et al. (U.S. Pat. 6,293,910, hereinafter “Yamakita”) in view of Nakada et al. (U.S. 5,301,061, hereinafter “Nakada”).
As to claim 1, Yamakita discloses an imaging apparatus, comprising:
a main body (light directing member 1, Figs.1A,3) which has a proximal end (right side in Fig.3) and a distal end (left side in Fig.3), the main body being formed into a hollow columnar shape (cylindrical member, col.6, lines 48-50) having a predetermined length (inherent) between the proximal end and the distal end, at least the distal end being configured to be inserted into an oral cavity (inserted into a subject, col.3, lines 32-33), an accommodation space (space within inner wall of light directing member 1, Fig.3) being defined by an inner surface of a wall of the main body, the wall being made of a resin without having an optical fiber (transparent resin such as acrylic, col.7, lines 45-52), the wall being a light guiding member (transparent (to light), col.7, lines 24-28);
one or a plurality of light sources (one or a plurality of light guide fibers 9a,Figs.9A,9B) which are provided at or adjacent to the proximal end of the main body (collimated into a light directing ring 8A and dispose at or adjacent the proximal end of light directing member 1, Figs.1A,9B), the one or the plurality of light sources being configured to emit light having a predetermined frequency band toward the proximal end of the main body (light directing member 8A emits light (which inherently has a predetermined frequency band) into the proximal end of the light pipe 1, col.12, lines 24-34), the light being guided within the wall itself from the proximal end to the distal end of the main body (col.7, lines 23-28);
a diffuser plate (any of V groove surface 49, Fig.17a, tapered surface 53, Fig.18, V groove surface 54, Figs.19A,19B, or reflecting member 55, Fig.20A,20B) which is provided at or adjacent to the distal end of the main body (as shown in Figs.17a, 18, 19A and 20A), the diffuser plate being configured to diffuse the light guided by the wall itself of the main body toward the oral cavity (disperses light, col.14, lines 31-33, col.15, lines 35-38, col.15, lines 57-62, col.16, lines 28-37); and
a camera (solid state image sensing device 3, Figs.1,3) which is provided in the accommodation space of the main body at a location between the diffuser plate and the one or the plurality of light sources along a longitudinal direction of the main body (as shown in Figs.1,3), the camera being configured to image an object image based on reflected light which has been diffused by the diffuser plate and reflected from the oral cavity (col.7, lines 22-35). Although not further structurally limiting for the apparatus (see 112(b) rejection appearing above), an object image from any body cavity obtained by the camera of Yamakita is capable of being used by an image processing algorithm to detect a disease.
Yamakita fails to disclose an auxiliary member (sheath) having a tubular shape in the longitudinal direction, wherein the imaging apparatus is covered with the auxiliary member. Nakada teaches, in the imaging apparatus art, to provide a tubular sheath (auxiliary member) to cover the main body of the imaging apparatus (Nakada: any of sheaths 4, 6, 7, 8, 9, 10, 11, Fig.1 are configured to receive and cover the insertion part 12 (main body) of the endoscope 2 (imaging apparatus)). Nakada teaches that a sheath can act as a protective cover to the main body (col.4, lines 49-57) or provide additional auxiliary functions when combined with the main body for different uses (col.1, lines 60-64, col.10, lines 4-23). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a sheath (auxiliary member) to cover the main body of Yamakita as is known in the art, to provide the predictable result of protecting the main body or providing additional functionality, as taught by Nakada. One having ordinary skill in the art would do this knowing there would be a reasonable expectation of success.
As to claim 2, wherein the object image corresponds to an image of a pharynx (by nature of the inherent operation of an imaging apparatus, if the imaging apparatus of Yamakita is pointed at the pharynx, the images obtained will include images of the pharynx).
As to claim 7, Yamakita further discloses a handgrip (connector 8, Fig.2) which is provided on the proximal end of the main body (Fig.2), the handgrip being configured to be held by a user of the imaging apparatus (is capable of being held).
As to claim 9, Yamakita as modified by Nakada above, would further comprise at least one engagement protrusion configured to be engaged with an engagement protrusion of the auxiliary member. With modification to use the sheath of Nakada with the imaging apparatus of Yamakita, Nakada further teaches to provide an engagement protrusion (15, Fig.1, col.4, lines 24-26) on the imaging apparatus so as to engage with an engagement protrusioin on the auxiliary member (29, Figs.1,4B, col.5, lines 1-21) to secure each other together.
As to claim 10, Yamakia, as modified by Nakada above, would further comprise a positioning protrusion which is to be inserted into an insertion hole of the auxiliary member, the positioning protrusion being configured to fix a relative location between the imaging apparatus and the auxiliary member (With modification to use the sheath of Nakada with the imaging apparatus of Yamakita, Nakada further teaches to provide a postioning protrusion (15, Fig.1, col.4, lines 24-26) on the imaging apparatus so to be inserted into an insertion hole on the auxiliary member (29, Figs.1,4B, col.5, lines 1-21) to fix the relative location of the imaging apparatus and sheath.
As to claim 14, the resin is a thermoplastic resin (acrylic resin, col.7, lines 45-52).
As to claim 15, the thermoplastic resin is one of a polyolefin-based resin, a cellulosic ester- based resin, a polyester-based resin, a polycarbonate-based resin, an acrylic resin, and a polystyrene-based resin (acrylic resin, col.7, lines 45-52).
As to claim 16, Yamakita discloses an imaging apparatus, comprising:
a main body (light directing member 1, Figs.1A,3) which has a proximal end (right side in Fig.3) and a distal end (left side in Fig.3), the main body being formed into a hollow columnar shape (cylindrical member, col.6, lines 48-50) having a predetermined length (inherent) between the proximal end and the distal end, at least the distal end being configured to be inserted into an oral cavity (inserted into a subject, col.3, lines 32-33), an accommodation space (space within inner wall of light directing member 1, Fig.3) being defined by an inner surface of a wall of the main body, the wall being made of a resin (transparent resin such as acrylic, col.7, lines 45-52), the wall being a light guiding member (transparent (to light), col.7, lines 24-28);
one or a plurality of light sources (one or a plurality of light guide fibers 9a,Figs.9A,9B) which are provided at or adjacent to the proximal end of the main body (collimated into a light directing ring 8A and dispose at or adjacent the proximal end of light directing member 1, Figs.1A,9B), the one or the plurality of light sources being configured to emit light having a predetermined frequency band toward the proximal end of the main body (light directing member 8A emits light (which inherently has a predetermined frequency band) into the proximal end of the light pipe 1, col.12, lines 24-34), the light being guided within the wall itself from the proximal end to the distal end of the main body (col.7, lines 23-28);
a diffuser plate (any of V groove surface 49, Fig.17a, tapered surface 53, Fig.18, V groove surface 54, Figs.19A,19B, or reflecting member 55, Fig.20A,20B ) which is ring-shaped (all of 49, 53, 54 and 55 are ring-shaped) and provided at the distal end of the main body (as shown in Figs.17a, 18, 19A and 20A), the diffuser plate being configured to diffuse the light guided by the wall of the main body toward the oral cavity (disperses light, col.14, lines 31-33, col.15, lines 35-38, col.15, lines 57-62, col.16, lines 28-37); and
a camera (solid state image sensing device 3, Figs.1,3) which is provided in the accommodation space of the main body at a location between the diffuser plate and the one or the plurality of light sources along a longitudinal direction of the main body (as shown in Figs.1,3), the camera being configured to image an object image based on reflected light which has been diffused by the diffuser plate and reflected from the oral cavity (col.7, lines 22-35),
wherein the camera is aligned with an opening of the diffuser plate when viewed along an optical axis of the camera (all diffusers mentioned above are ring-shaped, providing an opening that corresponds to the accommodation space which includes the camera, as can be seen for example in a combination of Figs.13 and 19A). Although not further structurally limiting for the apparatus (see 112(b) rejection appearing above), an object image obtained by the camera of Yamakita is capable of being used by an image processing algorithm to detect a disease.
Yamakita fails to disclose an auxiliary member (sheath) having a tubular shape in the longitudinal direction, wherein the imaging apparatus is covered with the auxiliary member. Nakada teaches, in the imaging apparatus art, to provide a tubular sheath (auxiliary member) to cover the main body of the imaging apparatus (Nakada: any of sheaths 4, 6, 7, 8, 9, 10, 11, Fig.1 are configured to receive and cover the insertion part 12 (main body) of the endoscope 2 (imaging apparatus)). Nakada teaches that a sheath can act as a protective cover to the main body (col.4, lines 49-57) or provide additional auxiliary functions when combined with the main body for different uses (col.1, lines 60-64, col.10, lines 4-23). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a sheath (auxiliary member) to cover the main body of Yamakita as is known in the art, to provide the predictable result of protecting the main body or providing additional functionality, as taught by Nakada. One having ordinary skill in the art would do this knowing there would be a reasonable expectation of success.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamakita et al. (U.S. Pat. 6,293,910, hereinafter “Yamakita”) in view of Nakada et al. (U.S. 5,301,061, hereinafter “Nakada”), as set forth above with respect to claim 1, and further in view of Suzuki et al. (US 2002/0089586, hereinafter “Suzuki”).
As to claim 3, Yamakita, as set forth above with respect to claim 1, generally discloses a light source apparatus (12) for an endoscope but fails to provide the details of such light source, including the wavelengths provided by such. Typical endoscope light sources include high intensity lamps, such as a xenon lamp, which provides a wide range of wavelengths, including infrared and ultraviolet wavelengths, as well as visible light. Suzuki is just one of numerous references that teach this ([0062]). Since Yamakita does not disclose the particulars of the light source apparatus (12), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provide a light source known in the endoscope art, including a light source (e.g. xenon) with a wide range of wavelengths including the ultraviolet light band, as taught by Suzuki.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamakita et al. (U.S. Pat. 6,293,910, hereinafter “Yamakita”) in view of Nakada et al. (U.S. 5,301,061, hereinafter “Nakada”), as set forth above with respect to claim 1, and further in view of Huang et al. (US 2016/0007833, hereinafter “Huang”).
As to claim 4, Yamakita, as set forth above with respect to claim 1, fails to disclose camera characteristics and in particular, a depth of field of at least 20 mm. However, Huang teaches providing camera with a depth of field from about 20 mm to 110 mm ([0034]) in an endoscopic imaging device that is designed to observe internal features of a natural body orifice ([0002]). Huang teaches that such depth of field provides for a focus-free device that allows for sharp images at a relatively large distance without having to move the camera to a set focal distance ([0034]). Since Yamakita does not provide camera characteristics, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the camera of Yamakita with a relatively large depth of field (at least 20 mm) since Huang teaches such depth of field is known in the art to be suitable for clear imaging inside of the body while eliminating the need to adjust focus of the camera.
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamakita et al. (U.S. Pat. 6,293,910, hereinafter “Yamakita”) in view of Nakada et al. (U.S. 5,301,061, hereinafter “Nakada”), as set forth above with respect to claim 1, and further in view of Oota et al. (US 2010/0189341, hereinafter “Oota”).
As to claims 5 and 6, Yamakita, as set forth above with respect to claim 1, discloses a main body for insertion into a body cavity, but fails to disclose any particular body cavity, and thus fails to disclose any particular length or width of the main body associated with any particular use, and thus fails to disclose that the main body is equal to or smaller than 200 mm in length, and equal to or less than 3.2 cm in width. However, it would be obvious to one of ordinary skill to have made the length and width of the main body any length or width that is suitable for viewing a desired body cavity. Oota teaches that a endoscopic camera system designed to obtain measurement images of the oral cavity (Fig.1), and thus sized to be capable of being inserted into the oral cavity, can be 200 mm in length and 20 mm (2.0 cm) to 25 mm (2.5 cm) in width ([0054]). Since Yamakita fails to disclose any particular dimension for the main body, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have designed the main body of Yamakita for use in any body cavity, including the oral cavity, and thus designed the main body to have a length and width suitable for introduction into the oral cavity, including the length and width taught by Oota.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamakita et al. (U.S. Pat. 6,293,910, hereinafter “Yamakita”) in view of Nakada et al. (U.S. 5,301,061, hereinafter “Nakada”), as set forth above with respect to claim 1, and further in view of Tanaka et al. (US 2014/0334698, hereinafter “Tanaka”).
As to claim 13, Yamakita/Nakada discloses an imaging system, comprising:
the imaging apparatus of claim 1 (see description of claim 1 above); and
a processing device (camera control unit 11, Fig.2) which is connected to the imaging apparatus in a wired or wireless manner (at least wired, 9b, Fig.2) so as to be communicable with the imaging apparatus, the processing device being configured to process the object image imaged by the camera (processed for display on a monitor, col.7, lines 28-35).
Yamakita fails to disclose that the processing device includes a memory configured to store a processing function (algorithm) that determines whether a patient has an infection disease relating to the oral cavity based on the object image. Tanaka is just one of numerous references that teach to provide a processing device of an endoscope (in-vivo imaging apparatus) with an algorithm stored therein to diagnose whether a patient has an infection disease from an image obtained in a body cavity (Tanaka: endoscope images, obtained from any particular body cavity, [0324], can be analyzed in the processor 4, Fig.1, to diagnose/discriminate information concerning a disease condition, [0008],[0200],[0269],[0324]; it is noted that a “processor” for performing functions to manipulate data (e.g. image data) inherently includes, at the least, hardware (e.g. circuits, memory) arranged to memorize particular electronic functions/algorithms, and thus constitutes processor/memory storing that function/algorithm). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the Yamakita processor with the ability (algorithm) to determine the existence of an infection disease from the image of any desired body cavity to provide a “computer aided diagnosis” (CAD) to eliminate relatively different manually derived diagnoses and aid in diagnosis performed by more inexperienced doctors (Tanaka: [0008]).
Response to Arguments
Rejections and objections from the previous Office Action that have not been repeated in this Office Action should be considered as addressed or corrected, and thus hereby withdrawn.
Applicant's arguments filed March 6, 2026 have been fully considered but they are not persuasive. Applicant’s arguments are directed to the claims as amended in the amendment filed March 6, 2026. These amended claims are addressed above with respect to the newly added limitation of computer aided diagnosis from endoscope images.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited on PTO-892, all of which teach processing images to diagnose disease.
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 JOHN P LEUBECKER whose telephone number is (571)272-4769. The examiner can normally be reached Generally, M-F, 5:30-2:00.
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/JOHN P LEUBECKER/Primary Examiner, Art Unit 3795