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 .
Response to Amendment
The amendment filed on 02/26/2026 has been entered. Claims 1-2, 4-7, 9, 11, 13-15, 17-20, 22, 25, 27, 29-30 are pending. Claims 3, 8, 10, 12, 16, 21, 23-24, 26, 28 are cancelled. Applicant’s amendment to the claims have overcome 112 rejections and objections previously set forth in the Non-Final Office Action notified on 12/3/2025.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2, 4-6, 14-15, 17-19, 25, 27, 29-30, is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakai (US 20140296639) in view of Takeuchi (US 20190223706).
Regarding claim 1, Sakai discloses a scanning fiber endoscope probe (FIG. 1), comprising:
a scanning illumination optical path (FIG. 1, light passing through the fibers 16, 14 and lenses 13a, 13b) an inner-layer fiber collecting array (detection fibers 16; FIG. 3; para [0028]), wherein the scanning illumination optical path includes a lens set (lenses 13a, 13b), and the scanning illumination optical path is configured to scan laser emitted by a light source to form an optical spot (point position 43; FIGS. 3, 7; para [0060]) on a surface of a sample tissue and to form a field of view; and
the inner-layer fiber collecting array is configured to collect and transmit (FIG.1) a portion of detecting light scattered from or reflected by the sample tissue through the lens set to perform an imaging by a photoelectric detector (Detectors 37a-37c);
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wherein the inner-layer fiber collecting array is located on a side of the lens set that is away from the sample tissue along an axial direction of the lens set (As seen from FIG. 3, for the tissue positioned at X, the inner-layer fiber collecting array is located on a side of the lens set that is away from the sample tissue along an axial direction of the lens set. The specification discusses axial position but does not provide any specific definition of the axial direction of the lens set. Any direction that is parallel to an axis of the lens may be considered as axial direction because the position of the axial direction is not specified by the claim language.).
Sakai does not expressly disclose an outer-layer fiber collecting array, and
the outer-layer fiber collecting array is a tubular fiber array formed by disposing a plurality of collecting fibers at a periphery of a cavity of the scanning illumination optical path and is configured to collect and transmit a portion of the detecting light scattered from or reflected by the sample tissue back to an exterior of the scanning illumination optical path to perform an imaging on the photoelectric detector.
Takeuchi is directed to endoscopic probe extending from a proximal end to a distal end (abstract) and teaches an outer-layer fiber collecting array (Eight detection fibers 422 and eight detection fibers 421; FIGS. 4C, 4D), and
the outer-layer fiber collecting array is a tubular fiber array formed by disposing a plurality of collecting fibers at a periphery of a cavity of the scanning illumination optical path (Eight detection fibers 422 and eight detection fibers 421; FIGS. 4C, 4D, annotated below; para [0050]) and is configured to collect and transmit a portion of the detecting light scattered from or reflected by the sample tissue back to an exterior of the scanning illumination optical path to perform an imaging on the photoelectric detector (detector 1208; FIG. 12; para [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sakai to include a second array of the optical fibers with the first layer so that additional imaging signal could be detected and image quality could be enhanced.
Regarding claim 2, Sakai discloses the scanning illumination optical path further includes a sleeve (tube body of the endoscope 2; FIG. 3 annotated; para [0026]), the inner-layer fiber collecting array is fixed within a cavity of the sleeve (FIG. 3).
Regarding claim 4, Sakai discloses, wherein the scanning illumination optical path further includes: a vibrating component (Optical fiber 14, actuators 15, a piezoelectric element; FIG. 3; Para [0049]) and a fixture (fixing member 42);
the vibrating component is disposed within a cavity of a sleeve (FIG. 3) and at a proximal end of the lens set (The fiber 14 is located at a proximal end of the lens set. FIG. 3), wherein the proximal end of the lens set refers to a side closer to the lens set; and the fixture fixes the vibrating component within the sleeve (FIG. 3).
Regarding claim 5, Sakai discloses wherein the inner- layer fiber collecting array is located at the proximal end of the lens set (More than a majority of the inner- layer fiber collecting array is located at the proximal side of the lens set; FIG. 3) and is disposed on an outer side of the vibrating component (FIG. 3), and the fixture installs the inner-layer fiber collecting array between the sleeve and the vibrating component (The inner-layer fiber collecting array is between the sleeve and the vibrating component; FIG. 3).
Regarding claim 6, Sakai discloses, wherein the inner- layer fiber collecting array is located at the proximal end of the lens set (More than a majority of the inner-layer fiber collecting array is located at the proximal side of the lens set; FIG. 3) and is disposed on an outer side of the vibrating component (FIG. 3), and the inner-layer fiber collecting array is disposed on an outer side of the fixture (FIG. 3).
Regarding claim 14, Sakai discloses wherein an inner diameter of the inner-layer fiber collecting array and an axial position inside the sleeve are determined based on a spatial stereo angle formed by a fiber cantilever in the scanning illumination optical path during a vibrating process (In FIG. 3, the spiral diameter is spanning to the largest spatial angle of the fiber. Therefore, inner diameter is determined based on the stereo angle; Further, position of the fiber depends on the angle because, the cantilever fiber position shifts more towards radial and proximal side as the fiber spirals out. FIG. 3), thereby improving a collecting efficiency of the inner-layer fiber collecting array without interfering with the scanning illumination optical path (Since the collection fiber and scanning fiber do not intersect, there no interference.).
Regarding claim 15, Sakai discloses, wherein an inner diameter of the inner-layer fiber collecting array is greater than twice a maximum offset of the fiber cantilever (As seen from FIGF. 3) and less than an inner diameter of the sleeve (FIG. 3), or a distance between an illuminated surface of the inner-layer fiber collecting array and a principal surface of an object space of the lens set is less than a distance between a distal end of the fiber cantilever and the principal surface of the object space of the lens set.
Regarding claim 17, Sakai discloses wherein an axial position of the inner-layer fiber collecting array inside the sleeve satisfies a constraint relationship:
arctan (R/(u+L-l)) > a; where R refers to a radius of the inner-layer fiber collecting array, u refers to a distance between a distal end of the fiber cantilever and a principal surface of an object space of the lens set, L refers to a length of the fiber cantilever, l refers to a distance between an illuminated surface of the inner-layer fiber collecting array and the principal surface of the object space of the lens set,
the illuminated surface is a surface that receives the detecting light on the inner-layer fiber collecting array (The illuminated surface can be considered inside the fiber between the lenses and distal end of the cantilever.),
and a refers to a deflection angle of the fiber cantilever (Since the applicant has not defined the illuminated surface of the inner-layer fiber collecting array and its position regarding where it is located, any point in the fiber may be considered as the illuminated surface of the inner-layer fiber collecting array; Considering an illuminated surface inside the fiber between the lenses and distal end of the cantilever, and applying Tangent alpha = height divided by base, a mathematical truth, where the alpha is the angle formed by the cantilever when it bends to deflect radially towards the collecting fiber, provides an expression between the above reference letters. This expression provides the inequality relation, above when the base is substituted by u+L-l, in the relation Tangent alpha = height divided by base; Note that any suitable value of l may be chosen to meet the inequality relation because the applicant has not defined an illuminated surface of the inner-layer fiber collecting array; FIG. 3, reproduced below).
Regarding claim 18, Sakai discloses, wherein an axial position of an illuminated surface of the inner-layer fiber collecting array inside the sleeve is located at a focal point of the lens set (The light is exiting from the focal point of the half lenses. Note the position of the inner-layer fiber collecting array; FIG. 2).
Regarding claim 19, Sakai discloses wherein in the scanning illumination optical path, a diameter of a fiber cantilever of a single-mode fiber after a corrosion process is less than a standard diameter of the single-mode fiber (After a corrosion, which is a natural chemical process, the diameter of a fiber cantilever of a single-mode fiber would be less than a standard diameter of the single-mode fiber before corrosion. FIG.3).
Regarding claim 22, Sakai discloses wherein the inner-layer fiber collecting array includes one (One layer of inner- layer fiber collecting array; FIG. 3) or two layers, and/or, the outer-layer fiber collecting array includes one or two layers.
Regarding claim 25, Sakai discloses, a scanning fiber endoscope (FIG. 1), comprising a scanning fiber endoscope probe (FIG. 1) and a photoelectric detector (Detectors 37a-37c), the scanning fiber endoscope probe including:
a scanning illumination optical path (light passing through the fibers 16, 14 and lenses 13a, 13b; FIG. 1) and an inner-layer fiber collecting array (detection fibers 16; FIG. 3; para [0028]);
wherein the scanning illumination optical path is configured to scan laser emitted by a light source to form an optical spot (point position 43; FIGS. 3, 7; para [0060]) on a surface of a sample tissue and to form a field of view ;
the inner-layer fiber collecting array is configured to collect a detecting light scattered from or reflected by the sample tissue and collected through a lens set (lenses 30a, 30b); and
the photoelectric detector (Detectors 37a-37c) collects the detecting light collected by the inner-layer fiber collecting array and performs an imaging on the detecting light (FIG. 1),
wherein the inner-layer fiber collecting array is located on a side of the lens set that is away from the sample tissue along an axial direction of the lens set (As seen from FIG. 3, the inner-layer fiber collecting array is located on a side of the lens set that is away from the sample tissue along an axial direction of the lens set.).
Sakai does not expressly disclose an outer-layer fiber collecting array, and
the outer-layer fiber collecting array is a tubular fiber array formed by disposing a plurality of collecting fibers at a periphery of a cavity of the scanning illumination optical path and is configured to collect and transmit a portion of the detecting light scattered from or reflected by the sample tissue back to an exterior of the scanning illumination optical path to perform an imaging on the photoelectric detector.
Takeuchi is directed to endoscopic probe extending from a proximal end to a distal end (abstract) and teaches an outer-layer fiber collecting array (Eight detection fibers 422 and eight detection fibers 421; FIGS. 4C, 4D), and
the outer-layer fiber collecting array is a tubular fiber array formed by disposing a plurality of collecting fibers at a periphery of a cavity of the scanning illumination optical path (Eight detection fibers 422 and eight detection fibers 421; FIGS. 4C, 4D, annotated below; para [0050]) and is configured to collect and transmit a portion of the detecting light scattered from or reflected by the sample tissue back to an exterior of the scanning illumination optical path to perform an imaging on the photoelectric detector (detector 1208; FIG. 12; para [0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sakai to include a second array of the optical fibers with the first layer so that additional imaging signal could be detected and image quality could be enhanced.
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Regarding claim 27, Sakai discloses wherein the scanning illumination optical path includes: a vibrating component (actuators 15, a piezoelectric element; FIG. 3; Para [0049]), the lens set (lenses 30a, 30b), a sleeve and a fixture (tube body of the endoscope 2; FIG. 3 annotated; para [0026]);
wherein the vibrating component is located in an innermost portion of a cavity of the sleeve and is located at a proximal end of the lens set (FIG. 3, annotated);
the inner-layer fiber collecting array is located at a proximal end of the lens set (More than a majority of the inner- layer fiber collecting array is located at the proximal side of the lens set; FIG. 3) and is disposed at an outer side of the vibrating component (FIG. 3), and the inner-layer fiber collecting array is a tubular fiber array surrounded by a plurality of fibers (At least 2 fibers 16, surround the other fibers 16; FIG. 3);
the fixture fixes the vibrating component within the sleeve (FIG. 3) and fixes the inner-layer fiber collecting array between the sleeve and the vibrating component (FIG. 1B); and
the inner-layer fiber collecting array is configured to collect a portion of detecting light entering a cavity of the probe through the lens set (FIG. 3 annotated).
Regarding claim 29, Sakai as modified teaches wherein the outer- layer fiber collecting array (Takeuchi: Eight detection fibers 422 and eight detection fibers 421; FIGS. 4C, 4D) and the inner-layer fiber collecting array (detection fibers 16; FIG. 3; para [0028]) form an inner-outer collecting channel, one or more fibers of the inner-outer collecting channel are evenly distributed on an inner circumference and an outer circumference of the inner-outer collecting channel (FIG. 3 annotated), the inner-outer collecting channel is configured to collect the portion of the detecting light scattered from or reflected by the sample tissue (Sakai, Takeuchi ), and a field of view of the inner-outer collecting channel is greater than a field of view of the scanning illumination optical path (Sakai: FIG. 3).
Regarding claim 30, Sakai as modified teaches wherein the outer- layer fiber collecting array is located at a periphery of the lens set (Sakai: FIG. 3, annotated) along a radial direction of the lens set.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakai (US 20140296639) in view of Seibel (US 20150313503).
Regarding claim 20, Sakai discloses wherein a maximum outer diameter of the scanning fiber endoscope probe is less than or equal to 1.5 mm (As compared to the length L, which is 3.5 mm, in FIG. 6, the outer diameter of the scanning fiber endoscope probe is less than or equal to 1.5 mm), a length of a fiber cantilever is within a range of 2 mm to 4 mm (L is 3.5 mm. FIG. 6; Para [0061]), and a scanning amplitude of the fiber cantilever is within a range of 0.5 mm to 0.8 mm (Based on FIG. 3, the length of the fiber cantilever is 3.5 mm, thus, the amplitude of the displacement is about 3.5/4 or 0.87 mm).
Sakai does not expressly disclose an imaging frame rate of the photoelectric detector is within a range of 15 fps to 25 fps.
Seibel is directed to methods and systems for imaging internal tissues within a body (abstract) and teaches an imaging frame rate of the photoelectric detector is within a range of 15 fps to 25 fps (video frame rate of 15 Hz; para [0114]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sakai to include frame rate of 15 fps to 25 fps in accordance with the teaching of Seibel so that scanning can provide sufficient time to navigate to a peripheral region (para [0114] of Seibel).
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Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakai (US 20140296639) in view of Takeuchi (US 20190223706).
Regarding claim 11, Sakai discloses the fixture includes a fixture body (fixing member 42), and a fixture body includes: a vibrating component fixing hole (In FIG. 3, the vibrating component is inserted inside the fixture body.), wherein the vibrating component fixing hole is coaxial with a center axis of the fixture body (FIG. 3).
Sakai does not expressly disclose at least two inner-layer fiber fixing holes, wherein the at least two inner-layer fiber fixing holes are distributed evenly relative to a circumference of the center axis of the fixture body, and each collecting fiber of the inner-layer fiber array is disposed on the at least two inner-layer fiber fixing holes, respectively.
Takeuchi is directed to endoscopic probe (abstract) and teaches at least two inner-layer fiber fixing holes, wherein the at least two inner-layer fiber fixing holes (Holes 1002 and 1004; FIG. 10, reproduced below; para [0071]) are distributed evenly relative to a circumference of the center axis of the fixture body, and each collecting fiber of the inner-layer fiber array is disposed on the at least two inner-layer fiber fixing holes (Holes 1002 in 1014 and 1004; FIGS. 7, 10; para [0071]), respectively.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sakai to include holes in the fixture body so that layers of fibers could be inserted in the holes to secure the fibers in the fixture.
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Claim(s) 7, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakai (US 20140296639) in view of Zergiebel (US 20170056064).
Regarding claim 7, Sakai does not expressly disclose wherein the fixture is a circular ring with an opening, one end of the opening of the circular ring is provided with a first buckle, another end of the opening of the circular ring is provided with a first slot, the first buckle is inserted into the first slot, and then the first buckle and the first slot are fixed relative to each other by using a first fixing member.
Zergiebel is directed to an access device for surgical procedures (abstract) and teaches wherein the fixture is a circular ring with an opening (FIGS. 32-37, reproduced below), one end of the opening of the circular ring is provided with a first buckle, another end of the opening of the circular ring is provided with a first slot, the first buckle is inserted into the first slot, and then the first buckle and the first slot are fixed relative to each other by using a first fixing member (FIG. 34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sakai to include a ring in accordance with the teaching of Zergiebel for ease of manufacturing (manufacturing convenience). For example, the fixture body and fiber array could be secured with the ring provided by Zergiebel during manufacturing of the endoscope disclosed by Sakai so that fiber array could be secured by the ring.
Regarding claim 9, Sakai does not expressly disclose wherein the fixture is divided into a first half-circular ring and a second half-circular ring, each of two ends of the first half-circular ring is provided with a second buckle, respectively, each of two ends of the second half-circular ring is provided with a second slot, respectively, the first buckle is inserted into the second slot, and then the second buckle and the second slot are fixed relative to each other by using a second fixing member.
Zergiebel discloses having a ring fixture wherein the fixture is a circular ring with an opening (FIGS. 32-37), one end of the opening of the circular ring is provided with a first buckle, another end of the opening of the circular ring is provided with a first slot, the first buckle is inserted into the first slot, and then the first buckle and the first slot are fixed relative to each other by using a first fixing member (FIG. 34).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sakai to include a ring in accordance with the teaching of Zergiebel for ease of manufacturing. For example, the fixture body and fiber array could be secured with a ring provided by Zergiebel during manufacturing of the endoscope disclosed by Sakai so that fiber array could be secured by the ring. Further, another buckle and slot could be provided on the other side of the fixture so that manufacturing and assembly of the fixture could be convenient by way of having two attachment portions in the fixture.
Response to Arguments
Applicant’s arguments submitted on 02/26/2026 have been fully considered and are persuasive. Therefore, the rejection dated 02/26/2026 has been withdrawn. However, upon further consideration, a new rejection has been made in view of amendment.
As seen from FIG. 3 of Sakai below, for the tissue positioned at X, the inner-layer fiber collecting array is located on a side of the lens set that is away from the sample tissue along an axial direction of the lens set. The specification discusses axial position but does not provide any specific definition of the axial direction of the lens set. Any direction that is parallel to an axis of the lens may be considered as axial direction because the position of the axial direction is not specified by the claim language.
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See rejection set forth above.
Accordingly, the applicants’ arguments are not persuasive at this time.
Allowable Subject Matter
Claim 13
The following is an examiner’s statement of reasons for allowance:
The prior art of record fails to explicitly teach or fairly suggest, alone or in combination,
a scanning fiber endoscope probe wherein the vibrating component includes a piezoelectric ceramic tube and a single-mode fiber; wherein the single-mode fiber is fixedly disposed on the piezoelectric ceramic tube, and protrudes and extends a fiber of a preset length at a distal end of the piezoelectric ceramic tube to form a fiber cantilever; the piezoelectric ceramic tube is configured to drive the fiber cantilever to vibrate in a resonance mode for scanning under a drive of an alternating voltage of a preset frequency; a lens set disposed at a side close to a distal end of the fiber cantilever is configured to focus dispersed light emitted by the single-mode fiber and image on the sample tissue; a distance between an end of the fiber cantilever and a principal surface of an object space of the lens set matches an angle of field of view and a size of an optical spot of a circular field of view; and the piezoelectric ceramic tube and the lens set are fixedly disposed in the sleeve, wherein the piezoelectric ceramic tube is fixedly disposed in the sleeve, along with the remaining features of claims 13, 4 and 1,
The closest art Seibel (US 20150313503) teaches above features but could not be modified to have outer layer fiber collecting array as required by claim 1.
Another closet art Sakai (US 20140296639) could be not modified to include the features recited in claim 13.
Accordingly, claim 13 is allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
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, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 4/24/26
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