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 .
Response to Amendment
The Amendment filed February 12th, 2026 has been entered. Claims 1, 4-5 and 15 have been amended. Claims 16-20 have been cancelled and Claims 21-25 have been newly added. Claims 1-15 and 21-25 are now pending in the application.
Response to Arguments
Applicant's arguments filed 03/16/26 have been fully considered but they are not persuasive.
In response to arguments that the specification clearly defines the meaning of the term “approximate,” the examiner respectfully disagrees, as detailed below, and therefore the 35 U.S.C. 112 (b) rejection is maintained.
In response to arguments that Yamaya (US 20030040657 A1) does not disclose that “a portion of the accessory medical device that is distal to the first surface extends (a) distally of a distalmost end of the housing and (b) approximately parallel to a longitudinal axis of the distal tip in a configuration in which the elevator is actuated so that it is at least partially raised.” As detailed below, the examiner has updated the claim mapping for the Yamaya rejection to provide more clarity and distinctly reference an embodiment of the prior art which meets the limitations of the claims as amended.
Therefore, the examiner is maintaining the rejection under 35 U.S.C. 102(a)(1) with the reference mentioned above.
Examiner’s Comments
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”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
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.
The term “approximately” in claims 1, 5 and 10 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Please amend the claim language to more definitively claim the intended structural and/or functional limitations.
Claim 1 recites the limitation “approximately parallel” which does not distinctly provide the intended meets and bounds of the limitation and is not further elaborated upon within the specification, therefore, the examiner will interpret this broadly and maintains that amendment should be made to more particularly claim the subject matter as intended
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-10, 21-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (US 20130190562 A1, hereinafter Smith).
Regarding Claim 1, Smith discloses
A distal tip (distal end 3, FIG. 1) of a medical device (endoscope 1, FIG. 1), comprising:
a housing (flexible tube 13, FIG. 2A); and
an elevator (pivoting member 218, FIGS. 2A-3B),
wherein the elevator includes an opening (open lumen 300, FIGS. 3A-3B) extending from a first surface of the elevator to a second surface of the elevator (FIGS. 3A-3B, par. 77 disclose lumen extends from proximal end, i.e. first surface, to distal end, i.e. second surface, of pivoting member);
wherein the opening is configured to receive an accessory medical device (distal tool 11, FIG. 3A) therethrough (depicted in FIG. 3A),
a portion of the accessory medical device that is distal to the first surface extends
(a) distally of a distalmost end of the housing (depicted in FIG. 3A) and
(b) approximately parallel to a longitudinal axis of the distal tip in a configuration in which the elevator is actuated so that it is at least partially raised (FIGS. 2B-2C, par. 66, 70 disclose the pivoting member can be actuated to varying degrees relative to the longitudinal axis, i.e. actuating the pivoting member to an angle of 1-5° from the longitudinal axis would be considered approximately parallel; par. 82 discloses pivoting member may be actuated to deflect distal tool to a position substantially aligned with the longitudinal axis).
Regarding Claim 4, Smith discloses
The distal tip of claim 1,
wherein the housing includes a boss (flexible delivery tube 14, FIGS. 3A-3B), and
wherein, in a lowered, non-actuated, configuration of the elevator, the boss is configured to be received within the opening (depicted in FIGS. 3A-3B).
Regarding Claim 5, Smith discloses
The distal tip of claim 4,
wherein the second surface of the elevator and the boss are configured to engage the accessory medical device in a configuration in which the accessory medical device is received through the opening (depicted in FIG. 3A) and
the elevator is actuated so that it is at least partially raised (depicted in FIGS. 2B-2C),
wherein engagement between the elevator and the boss retains the accessory medical device in a locked configuration (FIG. 3A, par. 78 disclose upon the delivery tube reaching the stop (303) of the pivoting member, distal advancement of the distal tool is prevented, i.e. locked),
in which the accessory medical device extends approximately parallel to a longitudinal axis of the distal tip (depicted in FIGS. 2A-3B).
Regarding Claim 6, Smith discloses
The distal tip of claim 5, wherein the boss includes a depression, wherein the depression is configured to receive the accessory medical device (par. 78 discloses suitable shoulder structure positioned between distal tool and delivery tube, i.e. receives distal tool).
Regarding Claim 7, Smith discloses
The distal tip of claim 5,
wherein the second surface of the elevator includes a recess (first portion 301, FIGS. 3A-3B),
wherein, in the locked configuration, the accessory medical device is received within a recess of the second surface (depicted in FIG. 3A).
Regarding Claim 8, Smith discloses
The distal tip of claim 7, wherein the recess is distal of the opening (FIGS.3A-3B disclose first portion is more distal than entrance of the opening).
Regarding Claim 9, Smith discloses
The distal tip of claim 1, wherein the opening has a fully enclosed perimeter (depicted in FIGS. 2A-5C).
Regarding Claim 10, Smith discloses
The distal tip of claim 8, wherein the opening is approximately circular (depicted in FIGS. 3A-3B).
Regarding Claim 21, Smith discloses
A distal tip (distal end 3, FIG. 1) of a medical device (endoscope 1, FIG. 1), comprising:
an elevator (pivoting member 218, FIGS. 2A-3B),
wherein the elevator includes an opening (open lumen 300, FIGS. 3A-3B) extending from a first surface of the elevator to a second surface of the elevator (FIGS. 3A-3B, par. 77 disclose lumen extends from proximal end, i.e. first surface, to distal end, i.e. second surface, of pivoting member),
wherein the opening is configured to receive an accessory medical device (distal tool 11, FIG. 3A) therethrough (depicted in FIG. 3A); and
a housing (flexible tube 13, FIG. 2A),
wherein the housing includes a boss (flexible delivery tube 14, FIGS. 3A-3B), and
wherein, in a lowered, non- actuated position of the elevator, the boss is received within the opening (depicted in FIGS. 3A-3B).
Regarding Claim 22, Smith discloses
The distal tip of claim 21,
wherein the housing includes a locking surface (stop 303, FIGS. 3A-3B), wherein the locking surface is configured to mate with the first surface of the elevator in an actuated, raised configuration of the elevator (par. 78 discloses meeting point of proximal and distal portions forms stop, i.e. stop mates with both portions in any/all configurations of the elevator).
Regarding Claim 23, Smith discloses
The distal tip of claim 21, wherein the second surface of the elevator and the boss are configured to engage the accessory medical device in a configuration in which the accessory medical device is received through the opening and the elevator is in an actuated, at least partially raised configuration (depicted in FIGS. 2B-3A).
Regarding Claim 24, Smith discloses
A distal tip (distal end 3, FIG. 1) of a medical device (endoscope 1, FIG. 1), comprising:
a housing (flexible tube 13, FIG. 2A); and
an elevator (pivoting member 218, FIGS. 2A-3B),
wherein the elevator includes an opening (open lumen 300, FIGS. 3A-3B) extending from a first surface of the elevator to a second surface of the elevator (FIGS. 3A-3B, par. 77 disclose lumen extends from proximal end, i.e. first surface, to distal end, i.e. second surface, of pivoting member),
wherein the opening is fully enclosed (depicted in FIGS. 2A-5C),
wherein the elevator is configured such that:
in a lowered configuration of the elevator, the elevator is configured to receive a first accessory medical device such that a distal portion of the accessory medical device extends along the first surface from a proximal end of the elevator to at least a distal end of the elevator (depicted in FIGS. 3A-3B),
in a first raised configuration of the elevator, the distal portion of the first accessory medical device extends along the first surface and is bent with respect to an adjacent portion of the first accessory medical device that is proximal of the elevator (depicted in FIG. 2B), and
in a second raised configuration of the elevator (depicted in FIGS. 6A-6C),
the opening is configured to receive a second accessory medical device (distal tool 601/ 701/ 801, FIGS. 6A-6C),
such that a distal portion of the second accessory device is unbent with respect to an adjacent portion of the second accessory medical device that is proximal of the elevator (depicted in FIGS. 6A-6C).
Regarding Claim 25, Smith discloses
The distal tip of claim 24,
wherein the housing includes a boss (flexible delivery tube 14, FIGS. 3A-3B) and a locking surface (stop 303, FIGS. 3A-3B),
wherein, in the lowered configuration, a boss of the housing is received within the opening (depicted in FIGS. 3A-3B), and
wherein, in the first raised configuration, the first accessory medical device is locked between the locking surface and the first surface of the elevator (depicted in FIGS. 2B-3A).
Claim(s) 1, 2-3, 9, 11-15, 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamaya et al. (US 20030040657 A1, hereinafter Yamaya).
Regarding Claim 1, Yamaya discloses
A distal tip (distal part 105, FIG. 52) of a medical device (endoscope 101B, FIG. 52), comprising:
a housing (housing of distal part 105, FIGS. 50-53); and
an elevator (first treatment instrument swing stand 114, FIG. 50),
wherein the elevator includes an opening (treatment instrument passage hole 145, FIG. 53) extending from a first surface of the elevator to a second surface of the elevator (FIGS. 5, 50-53 depicts passage hole extending from front of swing stand to back of swing stand);
wherein the opening is configured to receive an accessory medical device (first treatment instrument 153, FIG. 50) therethrough (depicted in FIGS. 50-55),
a portion of the accessory medical device that is distal to the first surface extends
(a) distally of a distalmost end of the housing (depicted in FIG. 50) and
(b) approximately parallel to a longitudinal axis of the distal tip in a configuration in which the elevator is actuated so that it is at least partially raised (depicted in FIG. 50).
Regarding Claim 2, Yamaya discloses
The distal tip of claim 1,
wherein the first surface of the elevator is on a first side of an axis of rotation of the elevator (FIG. 54, par. 372 disclose axis of rotation is about first rotation shaft 155a, i.e. back side of elevator where treatment instrument is received from is first surface on a first side of rotation axis),
wherein the second surface of the elevator is on a second side of the axis of rotation (FIG. 54, par. 372 disclose axis of rotation is about first rotation shaft 155a, i.e. front side of elevator where treatment instrument exits from is second surface on a second side of rotation axis), and
wherein the first side is opposite the second side (depicted in FIG. 54).
Regarding Claim 3, Yamaya discloses
The distal tip of claim 1,
wherein, in a raised configuration of the elevator, the opening is configured to receive the accessory medical device therethrough (depicted in FIGS. 50, 54), and
wherein, in the raised configuration of the elevator, the first surface is proximal of the second surface (depicted in FIGS. 50, 54).
Regarding Claim 9, Yamaya discloses
The distal tip of claim 1, wherein the opening has a fully enclosed perimeter (depicted in FIGS. 50-56).
Regarding Claim 11, Yamaya discloses
The distal tip of claim 1,
wherein the distal tip also includes a channel (treatment instrument swing stand storage member 113, FIG. 52),
wherein the elevator is received within the channel (depicted in FIG. 52).
Regarding Claim 12, Yamaya discloses
The distal tip of claim 11, wherein the channel has an open distal end (depicted in FIGS. 52-53).
Regarding Claim 13, Yamaya discloses
The distal tip of claim 11,
wherein the housing defines at least one surface of the channel (par. 337 discloses storage member formed in distal face of distal part, i.e. surface), and
wherein the at least one surface includes a notch at a distal end (FIG. 52, par. 337 discloses storage member shaped substantially as L-shaped notch).
Regarding Claim 14, Yamaya discloses
The distal tip of claim 11,
wherein the housing defines a locking surface (terminal ends of the angling wires 157, FIG. 50) at a proximal end of the channel (depicted in FIG. 50),
wherein the locking surface is configured to mate with the first surface of the elevator in a raised configuration of the elevator (FIG. 50, par. 372 disclose terminal ends of the angling wires are locked in both sides of the swing stand, i.e. including first surface).
Regarding Claim 15, Yamaya discloses
The distal tip of claim 1, wherein, in a lowered configuration of the elevator, the distal tip is configured to receive the accessory medical device such that the accessory medical device extends from a proximal end of the elevator to at least a distal end of the elevator (depicted in FIG. 50).
Regarding Claim 24, Yamaya discloses
A distal tip (distal part 105, FIG. 52) of a medical device (endoscope 101B, FIG. 52), comprising:
a housing (housing of distal part 105, FIGS. 50-56); and
an elevator (treatment instrument swing stand 114/ 115, FIGS. 50, 54),
wherein the elevator includes an opening (treatment instrument passage hole 145/ 146, FIG. 53, 54) extending from a first surface of the elevator to a second surface of the elevator (FIGS. 5, 50-55 depicts passage hole extending from front of swing stand to back of swing stand),
wherein the opening is fully enclosed (depicted in FIGS. 50-56),
wherein the elevator is configured such that:
in a lowered configuration of the elevator, the elevator is configured to receive a first accessory medical device (second treatment instrument 154, FIG. 54) such that a distal portion of the accessory medical device extends along the first surface from a proximal end of the elevator to at least a distal end of the elevator (depicted in FIG. 50, 55),
in a first raised configuration of the elevator (depicted in FIG. 54),
the distal portion of the first accessory medical device extends along the first surface and is bent with respect to an adjacent portion of the first accessory medical device that is proximal of the elevator (depicted in FIG. 54), and
in a second raised configuration of the elevator (depicted in FIG. 50),
the opening is configured to receive a second accessory medical device (first treatment instrument 153, FIG. 50),
such that a distal portion of the second accessory device is unbent with respect to an adjacent portion of the second accessory medical device that is proximal of the elevator (depicted in FIG. 50).
Claim(s) 1 & 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamaya (US 20200367732 A1).
Regarding Claim 1, Yamaya discloses
A distal tip (distal end portion 8, FIG. 1) of a medical device (endoscope 2, FIG. 1), comprising:
a housing (distal end cover 61, FIG. 2); and
an elevator (raising base 42, FIG. 25),
wherein the elevator includes an opening (recessed locking groove 44c, FIG. 27 + sloped opening of elevator depicted in FIGS. 25-26) extending from a first surface of the elevator to a second surface of the elevator (FIGS. 25-27 depicts passage hole extending from front of swing stand to back of swing stand);
wherein the opening is configured to receive an accessory medical device (flexible tube 51, FIG. 27) therethrough (depicted in FIGS. 25-28),
a portion (distal end pipe sleeve member 54, FIGS. 25-27) of the accessory medical device that is distal to the first surface (depicted in FIGS. 25-28) extends
(a) distally of a distalmost end of the housing (depicted in FIGS. 6, 25-27) and
(b) approximately parallel to a longitudinal axis of the distal tip in a configuration in which the elevator is actuated so that it is at least partially raised (depicted in FIGS. 25-27).
Regarding Claim 9, Yamaya discloses
The distal tip of claim 1, wherein the opening has a fully enclosed perimeter (depicted in FIG. 27).
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 ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 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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/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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