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 .
This Office Action is in response to the amendments dated October 21, 2025.
Claims 1-5 are pending.
Specification
The disclosure is objected to because of the following informalities: paragraph [0047] of US PGPUB 2024/0008716 includes the terms “grasping portion Ca”, which appear to be a typographical error for “grasping portion 6a”; paragraph [0067] of US PGPUB 2024/0008716 includes the term “opening Sib”, which appears to be a typographical error for “opening 51b”.
Appropriate correction by Applicant is required.
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.
Claims 1-2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Hino (US PGPUB 2004/0082836 – “Hino”) in view of Mitsuya (US PGPUB 2016/0051130 – “Mitsuya”) and Mulcahey et al. (US PGPUB 2017/0311789 – “Mulcahey”).
Regarding Claim 1, Hino discloses:
A distal end portion (Hino FIG. 1, end 10) of an endoscope (Hino FIG. 1 and paragraph [0019], “FIG. 1 is an assembly drawing showing structure of an end of a side-looking endoscope according to the present invention”) comprising:
a moving mechanism (Hino FIG. 6, stand 46) configured to change a protruding direction of a treatment instrument (Hino paragraph [0029], “The guided treatment devise is stood up by the stand 46 and is led upward”);
a base (Hino FIG. 1, end body 12) made of metal (Hino paragraph [0029], “end body 12 is made of a corrosion-resistant metal such as stainless steel”) and including a supporting portion (Hino FIG. 6, stand lever 44) configured to rotationally support the moving mechanism (Hino paragraph [0030], “stand lever 44…for swinging the stand 46”);
a cover member (Hino FIG. 1, cap 14), the cover member being fitted to the base (Hino paragraph [0028], “cap 14 is mounted on the end body 12”) so as to cover the moving mechanism and including an opening portion (Hino FIG. 1, opening 14A) formed at a position at which the moving mechanism is placed.
Hino does not explicitly disclose the cover member (cap) being made of resin.
Mitsuya teaches the cover member (Mitsuya FIG. 1B, cap 50) being made of resin (Mitsuya paragraph [0060], “cap 50 is formed of a soft material such as resin”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Mitsuya’s resin when manufacturing the cover member for the distal end portion of an endoscope disclosed by Hino. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a distal cap that prevents injury to a patient by being soft (see Mitsuya paragraph [0134]).
Hino in view of Mitsuya does not explicitly teach:
a wiring pattern formed on a surface of the cover member; and
an electronic component electrically connected to the wiring pattern formed on the surface of the cover member.
Mulcahey teaches:
a wiring pattern (Mulcahey FIG. 7, flexible heater/sensor circuit 702) formed on a surface of the cover member (Mulcahey FIG. 7, flag 706; Mulcahey paragraph [0092], “the flexible heater/sensor circuit 702 is attached to endoscope 712 by wrapping the distal “flag” 706 around the cylindrical insertion end of the endoscope 712”); and
an electronic component (Mulcahey FIG. 7, heater coil 716) electrically connected to the wiring pattern (Mulcahey FIG. 7, flexible heater/sensor circuit 702) formed on the surface of the cover member.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Mulcahey’s heater/flag with the distal end portion of the endoscope taught by Hino in view of Mitsuya. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a heated distal tip on the endoscope that defrosts distal lenses on the endoscope (see Mulcahey paragraph [0089]).
Regarding Claim 2, Hino in view of Mitsuya and Mulcahey teach the features of Claim 1, as described above.
Mitsuya further teaches wherein the electronic component (Mitsuya FIG. 8A, high-strength portion 57 of cap 50 and illumination window 110a) is integrated, by insert molding (Mitsuya paragraph [0135], “high-strength portion 57 may be integrally molded with the low-strength portion 55 by insert molding”), with a resin material that forms the cover member (Mitsuya paragraph [0077], “high-strength portion 57 is disposed so as to be adjacent to the illumination unit and the illumination window 110a in the axis circumferential direction of the cap 50 when the cap 50 is attached to the distal end hard portion 21”).
Regarding Claim 5, Hino discloses:
An endoscope (Hino FIG. 1 and paragraph [0019], “FIG. 1 is an assembly drawing showing structure of an end of a side-looking endoscope according to the present invention”) comprising:
an insertion body configured to be inserted into a subject (Hino paragraph [0010], “the present invention is directed to an end of a side-looking endoscope, comprising: an end body which is provided at an end of an endoscope insertion portion”);
a moving mechanism (Hino FIG. 6, stand 46) configured to change a protruding direction of a treatment instrument configured to be inserted through the insertion body (Hino paragraph [0029], “The guided treatment devise is stood up by the stand 46 and is led upward”);
a base (Hino FIG. 1, end body 12) made of metal (Hino paragraph [0029], “end body 12 is made of a corrosion-resistant metal such as stainless steel”) and including a supporting portion (Hino FIG. 6, stand lever 44) configured to rotationally support the moving mechanism (Hino paragraph [0030], “stand lever 44…for swinging the stand 46”);
a cover member (Hino FIG. 1, cap 14), the cover member being fitted to the base (Hino paragraph [0028], “cap 14 is mounted on the end body 12”) so as to cover the moving mechanism and including an opening portion (Hino FIG. 1, opening 14A) formed at a position at which the moving mechanism is placed.
Hino does not explicitly disclose the cover member (cap) being made of resin.
Mitsuya teaches the cover member (Mitsuya FIG. 1B, cap 50) being made of resin (Mitsuya paragraph [0060], “cap 50 is formed of a soft material such as resin”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Mitsuya’s resin when manufacturing the cover member for the distal end portion of an endoscope disclosed by Hino. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a distal cap that prevents injury to a patient by being soft (see Mitsuya paragraph [0134]).
Hino in view of Mitsuya does not explicitly teach:
a wiring pattern formed on a surface of the cover member; and
an electronic component electrically connected to the wiring pattern formed on the surface of the cover member.
Mulcahey teaches:
a wiring pattern (Mulcahey FIG. 7, flexible heater/sensor circuit 702) formed on a surface of the cover member (Mulcahey FIG. 7, flag 706; Mulcahey paragraph [0092], “the flexible heater/sensor circuit 702 is attached to endoscope 712 by wrapping the distal “flag” 706 around the cylindrical insertion end of the endoscope 712”); and
an electronic component (Mulcahey FIG. 7, heater coil 716) electrically connected to the wiring pattern (Mulcahey FIG. 7, flexible heater/sensor circuit 702) formed on the surface of the cover member.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Mulcahey’s heater/flag with the endoscope taught by Hino in view of Mitsuya. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a heated distal tip on the endoscope that defrosts distal lenses on the endoscope (see Mulcahey paragraph [0089]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hino (US PGPUB 2004/0082836 – “Hino”) in view of Mitsuya (US PGPUB 2016/0051130 – “Mitsuya”), Mulcahey et al. (US PGPUB 2017/0311789 – “Mulcahey”), and Kibayashi (US PGPUB 2013/0027534 – “Kibayashi”).
Regarding Claim 3, Hino in view of Mitsuya and Mulcahey teach the features of Claim 1, as described above.
Hino in view of Mitsuya and Mulcahey do not explicitly teach wherein the cover member is a molded interconnect device in which the wiring pattern is formed.
Kibayashi teaches wherein the cover member (Kibayashi FIG. 2, image pickup device package 40 at distal end of an endoscope – see Kibayashi paragraph [0031]) is a molded interconnect device (Kibayashi paragraph [0027], “image pickup device package 40 is one resulting from unitization by means of integral molding using an insulating sealing resin 44”) in which the wiring pattern (Kibayashi FIG. 2, electronic components 45a electrically connected to circuit substrate portion 43a – see Kibayashi paragraph [0027]) is formed.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Kibayashi’s image pickup device package with the distal end portion of an endoscope as taught by Hino in view of Mitsuya and Mulcahey. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope having in integrated image pickup unit that includes requisite circuitry, devices, and packaging (including sealing resin 44 shown in Kibayashi FIG. 2) that is protected from the environment (see Kibayashi paragraph [0029].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hino (US PGPUB 2004/0082836 – “Hino”) in view of Mitsuya (US PGPUB 2016/0051130 – “Mitsuya”), Mulcahey et al. (US PGPUB 2017/0311789 – “Mulcahey”), Kibayashi (US PGPUB 2013/0027534 – “Kibayashi”), and Lemelson (US Patent 4,803,992 – “Lemelson”).
Regarding Claim 4, Hino in view of Mitsuya and Mulcahey teach the features of Claim 1, as described above.
Hino and Mitsuya further teach a second resin member in which the opening portion is formed (Hino FIG. 1, half of cap 14 that has an opening 14A, made of resin as taught by Mitsuya paragraph [0060], “cap 50 is formed of a soft material such as resin”).
Hino in view of Mitsuya and Mulcahey does not explicitly teach a first resin member in which the wiring pattern is formed and the electronic component is mounted.
Kibayashi teaches a first resin member (Kibayashi FIG. 2, top half of package 40) in which the wiring pattern (Kibayashi FIG. 2, circuit substrate portion 43a) is formed and the electronic component (Kibayashi FIG. 2, electronic components 45a) is mounted.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Kibayashi’s image pickup device package with the distal end portion of an endoscope as taught by Hino in view of Mitsuya and Mulcahey. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope having in integrated image pickup unit that includes requisite circuitry, devices, and packaging (including sealing resin 44 shown in Kibayashi FIG. 2) that is protected from the environment (see Kibayashi paragraph [0029]).
Hino in view of Mitsuya, Mulcahey, and Kibayashi do not explicitly teach two molded bodies being bonded to each other.
Lemelson teaches two molded bodies being bonded to each other (Lemelson FIG. 8, operating head 80 of the catheter 10 shown in Lemelson FIG. 1; Lemelson col. 8, lines 58-62, “the operating head is molded of two half-sections, of substantially semi-cylindrical shape, which are aligned and joined together to form the cylindrical housing, preferably by adhesive bonding, ultrasonic or radio frequency welding”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Lemelson’s welding of two halves of the distal/operating end/cap in the endoscope taught by Hino in view of Mitsuya, Mulcahey, and Kibayashi. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope that is easier to construct by using modular components that are bonded together after other components are aligned therewithin.
Response to Arguments
Regarding Applicant’s arguments with respect to Claims 1-5 have been considered but are moot because 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.
With further regard to the rejection of Claims 1 and 5 under 35 U.S.C. 103, Applicant argues on pages 5-6 of the October 21, 2025 response that neither Hino nor Mitsuya disclose or contemplate a wiring pattern being formed on a surface of a "resin" distal end cover. However, as described in the rejection of independent Claims 1 and 5 above, the present final rejection incorporates not only the features of Hino and Mitsuya, but also Mulcahey when rejecting Claims 1 and 5. That is, Hino discloses a silicon cover member/cap (Hino FIG. 1, cap 14), and Mitsuya teaches a cover member (Mitsuya FIG. 1B, cap 50) being made of resin (Mitsuya paragraph [0060], “cap 50 is formed of a soft material such as resin”). It would be obvious to one skilled in the art before the effective filing date of the presently claimed invention to substitute Mitsuya’s resin cap for Hino’s silicon cap, since doing so would result in Mitsuya’s soft distal cap being less likely to injure a patient in situ (see Mitsuya paragraph [0134]). Once this substitution is made under 35 U.S.C. 103, it would be obvious to place/form Mulcahey’s wiring pattern (Mulcahey FIG. 7, flexible heater/sensor circuit 702) on the surface of Mitsuya’s resin cap, in order to defrost distal lenses in the endoscope taught by Hino in view of Mitsuya. Thus, the rejections of Claims 1 and 5, as well as Claims 2-4 under 35 U.S.C. 103 are maintained.
Regarding the objection to the specification made in the September 15, 2025 non-final rejection, this objection is not addressed in either the arguments or the amendments, and thus is maintained.
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 JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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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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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
01/07/26