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 .
Election/Restrictions
Newly submitted claims 25-34 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The new inventions presented in the amendments of 5 February, 2026 are as following, compared to the originally elected Invention I as presented in the claims of 19 April, 2023:
I. Originally presented claims 1-10 of 4/19/2023, drawn to a medical device handle that actuates a wire in the medical device via an actuator with particular parts inside and outside a body of the handle, classified in A61B2017/00367.
II. Claims 25-29 of 2/5/2026, drawn to a medical device handle with a knob and elevator actuator aligned with a particular axis, classified A61B17/00234.
III. Claims 30-34 of 2/5/2026, drawn to a medical device handle with an elevator actuator, a knob, and a recess, classified in A61B17/00234.
The new inventions are distinct from the originally elected Invention because of the following reasons:
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because it does not require the actuator to be configured to move along a curved proximalmost end of a body of handle. The subcombination has separate utility such as a medical device handle that does not require the interior body and shaft of Invention I, classified in A61B17/00234.
Inventions I and III are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because it does not require the recess of the knob actuator between the knob actuator and actuator. The subcombination has separate utility such as a medical device handle that does not require the interior body and shaft of Invention I, classified in A61B17/00234.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 25-34 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
The cancellation of claims 2, 6, 8-9 and 11-20, addition of claims 21-34 and the amendments to claims 1, 5 and 10 in the response filed on 5 February, 2026 are acknowledged.
Claims 1, 3-5, 7, 10 and 21-34 remain pending in the application.
Claims 25-34 are withdrawn by original presentation hereinabove.
Claims 2, 6, 8-9 and 11-20 are cancelled.
Claims 1, 3-5, 7, 10 and 21-24 are examined.
Response to Arguments
Rejection under 35 USC 102 – Fukushima et al. (US 2015/0148598)
Argument:
In regards to the amended claim 1, the applicant argues that Fukushima does not disclose or suggest an umbilicus or a button [in the applicant's arguments dated 5 February, 2026, page 8].
Response:
The examiner respectfully disagrees.
Fukishima explicitly discusses an umbilicus [universal cable 16, Fig.1, para.37] and discloses buttons in Fig.1 in profile, near where “10” points. Note that the applicant has not set forth the function that the button is configured to control in the claims.
As such, this argument is found to be unconvincing.
The applicant provides further arguments in regards to claims 25 and 30, however these claims are presently withdrawn by original presentation and as such are moot.
Claim Objections
Claim 10 is objected to because of the following informalities:
In claim 10, the claim reads “at least one knob actuator [line 3] where it is clear this was instead intended to read “the at least one knob actuator”.
Appropriate correction is required.
Claim Interpretation
In regards to claim 4, the claim clearly recites only functional limitations: neither the actuation wire or elevator are positively claimed items.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3-5, 7, 10, 21-22 and 24 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Fukushima et al. (US 2015/0148598).
In regards to Claim 1, Fukushima discloses a handle assembly for a medical device comprising:
a handle body [15, Fig.1, para.40]; and
a wire actuator [40, Figs.4-6, para.50] for controlling movement of an actuation wire [32, Fig.7: note the actuation wire is not positively claimed here] within a medical device, the wire actuator comprising:
a contact portion [linear portion of 20, Figs.1, 4-6, para.40, 50-52, 59] including a first portion [exterior portion of 20, Figs.1, 4-6] positioned exterior to the handle body and a second portion [interior portion of linear portion of 20, Figs.4-6] positioned within an interior portion of the handle body; and
an interior body [ring part of 20, Fig.5] coupled to (i) the contact portion [Fig.5] and (ii) a shaft [51, Figs.4-6, para.51-52] within the handle body;
an umbilicus [16, Fig.1]; and
a button [buttons near where “10” is pointing, Fig.1], wherein the button is disposed between the umbilicus and the wire actuator [going the long way around the circumference of the handle when viewed from the proximal end of the handle],
wherein the wire actuator is configured to move across an exterior surface of the handle body between a first position [Figs.1, 7a] and a second position [Figs.1, 7c, para.66], and the actuator is configured to:
move the actuation wire to a third position [Fig.7a] when a user moves the actuator to the first position; and
move the actuation wire to a fourth position [Fig.7c] when the user moves the actuator to the second position.
In regards to Claim 3, Fukushima discloses the handle assembly of claim 1, wherein a ring [50, Fig.5] is rotatably coupled to the shaft via couplings [portions of 41, Figs.5-6, para.51] that extend radially outward from a central longitudinal axis of the shaft; and
wherein a rod [43, Figs.5-7] is rotatably coupled to the ring at a first end [Figs.5-7, via other items] and to the actuation wire [32, Fig.5] at a second end [Figs.5-7, via other items].
In regards to Claim 4, Fukushima discloses the handle assembly of claim 1, wherein the actuation wire is coupled to an elevator [30, Figs.1-3, 7, para.46; note the actuation wire and elevator are not positively set forth here] at a distal end of the medical device.
In regards to Claim 5, Fukushima discloses the handle assembly of claim 3, wherein the shaft is rotatable relative to the handle body [Figs.5-7] and longitudinally extends in a direction transverse to the central longitudinal axis of the medical device [Figs.1, 5-7: Top portion of 51 seen rotating relative to handle body in Figs.5-7. Note that lines may be transverse to each other without intersecting.].
In regards to Claim 7, Fukushima discloses the handle assembly of claim 1, wherein the contact portion is configured to move along a curved path [Fig.7].
In regards to Claim 10, Fukushima discloses the handle assembly of claim 1, further comprising at least one knob actuator [19, Fig.1] wherein the contact portion of the wire actuator is positioned between the button and at least one knob actuator [Fig.1: going the long way around the circumference of the handle when viewed from the proximal end of the handle].
In regards to claim 21, Fukushima discloses the handle assembly of claim 1, wherein the handle body includes a curved portion [Mount upon which the buttons are placed, Fig.1: note that the front end of this mount is curved. “Curved portion” is an unusually broad limitation] between the wire actuator and the umbilicus, wherein the button projects outward from the curved portion [Fig.1].
In regards to claim 22, Fukushima discloses the handle assembly of claim 1, wherein the button is spaced from a central longitudinal axis of the handle body [Fig.1].
In regards to claim 24, Fukushima discloses the handle assembly of claim 1, further comprising a tubular member disposed within the handle body [at minimum this is the tubular inner surface of the handle body 15, Fig.1], wherein the actuation wire is moveable within the tubular member [Figs.1, 7].
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.
Claim(s) 23 is rejected under 35 U.S.C. 103 as being unpatentable over Fukushima et al. (US 2015/0148598) in view of Sullivan et al. (US 2006/0069311)
In regards to claim 23, Fukushima discloses the handle assembly of claim 10, however does not positively disclose wherein the handle body includes a recess, and wherein the recess is configured to receive the at least one knob actuator,
or particularly detail the knob.
Fukushima further discloses wherein the knob is configured to move wires to steer distal parts of the medical device [para.40], and wherein the medical device is an endoscope [abstract].
Sullivan teaches an analogous endoscope handle comprising a handle body [24, Figs.1, 5] including a recess [hole thorough which shaft 240 penetrates, Fig.5, para.32], and wherein the recess is configured to receive the at least one knob actuator [204, 208, 240, Figs.1, 5, para.32] configured to move wires to steer distal parts of the endoscope.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the handle body and knob actuator of Fukushima to have the knob actuator and recess in accordance with the teaching of Sullivan. This would be done as Sullivan shows that this construction is known in the art, and to obtain a working knob actuator.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection (reinterpretation of art, new art) 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 AARON B FAIRCHILD whose telephone number is (571)270-5276. The examiner can normally be reached 8:30am-5pm Monday-Friday.
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, Michael Carey can be reached at (571) 270-7235. 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.
/AARON B FAIRCHILD/Primary Examiner, Art Unit 3795