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 .
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, 3-5, 13 and 15-17 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.
Claims 1, 3, 13, 15 and 17 recite multiple instances of “the working channel” however fail to clarify whether it’s the working channel of the endoscope or the working channel of the device / coupler device that’s being referred to which creates indefiniteness regarding the scope of the claims. Appropriate correction is required.
Claim 13 recites the limitation "the groove" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 3-5, 16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller (US Patent Application Publication No. 2018/0206708).
In regard to claim 1, Miller discloses a device (10) for use with an endoscope (40), the device comprising:
a main body (12) comprising a visualization section (24) for allowing viewing of tissue by the endoscope and a proximal end configured for attachment to a distal end portion of the endoscope (Fig. 1);
a working channel (34) within the main body, the working channel having an open distal end and a proximal end that is configured for attachment to the working channel of the endoscope when the proximal end of the main body is attached to the distal end portion of the endoscope(the proximal end (34a) of the instrument channel (34) sealable connects to the working channel (42) of the endoscope, Fig. 4, Par. 49),
a flexible membrane (38) at least partially surrounding the open distal end of the working channel (Fig. 1A); and
wherein the device is configured to constrain an instrument passing through the working channel between the flexible membrane and the working channel (Par. 61).
In regard to claim 3, Miller teaches wherein the device is configured to compress a portion of the working channel extension against the flexible membrane instrument to secure the instrument in place within the working channel extension (Par. 61).
In regard to claim 4, Miller teaches wherein the open distal end is oriented at an angle relative to a longitudinal axis of the endoscope working channel, the device being configured to secure the instrument in position at said angle (Par. 61).
In regard to claim 5, Miller teaches wherein the device is configured to allow movement of the instrument while the instrument is secured at said angle (Par. 61).
In regard to claim 16, Miller teaches further comprising a mechanism (50) for articulating an instrument passing through the endoscope (Figs. 5-7).
In regard to claim 17, Miller teaches wherein the working channel extension is flexible and capable of angular adjustment by actuation of the endoscope (Figs. 5-7).
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US Patent Application Publication No. 2018/0206708) in view of Crank (US Patent Application Publication No. 2008/0114203).
In regard to claim 13, Miller does not expressly teach further comprising one or more protrusions extending into the working instrument channel and an actuator for compressing the instrument channel to secure the instrument within the groove.
Crank teaches an analogous endoscope comprising an adaptor ring (102, i.e. protrusion) that can be press fit within a distal end of the working channel of the endoscope. The adaptor ring (102) is configured to stabilize a position of the instrument within the lumen as well as provide fluid pathways therethrough (Figs. 1-3, Par. 33).
It would’ve been obvious to one of ordinary skill in the art the effective filing date of the invention to provide the working channel (34,134) of Miller with the adaptor ring (102) of Crank enabling the surgical tool to be stably positioned centrally within the working channel while also providing for unobstructed fluid pathways surrounding the surgical instrument.
In regard to claim 15, Crank teaches wherein the protrusions are removably coupled to the working instrument channel (the adaptor ring (102) can be press fit with the working channel and therefore is removable).
Claims 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US Patent Application Publication No. 2018/0206708) in view of Maseda et al. (US Patent Application Publication No. 2007/0225554, hereinafter Maseda).
In regard to claim 24, Miller discloses a kit (10,40) or use in a procedure on a patient, the kit comprising:
an endoscope (40) having an optical element and a working channel for receiving an instrument (Par. 47, Fig. 1); and
a coupler device (10) comprising:
a main body (12) comprising a visualization section (24) for allowing viewing of tissue by the endoscope and a proximal end configured for attachment to a distal end portion of the endoscope (Fig. 1);
a passageway (34) within the main body having an open distal end and a proximal end in operational proximity to the working channel of the endoscope when the proximal end of the coupler device is attached to the distal end portion of the endoscope (the proximal end (34a) of the instrument channel (34) sealable connects to the working channel (42) of the endoscope, Fig. 4, Par. 49);
a flexible membrane (38) at least partially surrounding the open distal end of the passageway (Fig. 1A); and
wherein the coupler device is configured to constrain an instrument passing through the passageway between the flexible membrane and the passageway (Par. 61).
Miller does not expressly teach wherein the open distal end comprises a substantially V-shaped groove for receiving the instrument.
Maseda teaches an analogous endoscope (Fig. 1) comprising a plurality of working channel configurations. The working channel can have a non-circular cross-section, such as a pentagon (50) or hexagonal shape (52) illustrated in Fig. 2. The first working channel (50), the instrument (14) inserted within the channel can have a complementary shape to the working channel (50) thereby forming a lock and key relationship in order to maintain a desired orientation of the instrument and prevent rotation of the instrument within the channel (Par. 27). The second working channel (52) has a hexagonal shape for receiving a circular instrument (62) such that fluid can pass through gaps between the circular instrument and the hexagonal shape of the working channel (Par. 23).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the cross-sectional shape of the working channel and working channel extension of Miller to be a pentagon or hexagonal shape as taught by Maseda thereby enabling instruments having complimentary shapes to the pentagon or hexagonal shaped working channel to form a lock and key configuration enabling a surgeon to maintain an orientation of the instruments. Additionally, circular instruments can be inserted through the pentagon or hexagonal shaped working channel thereby forming gaps between the instrument and the working channel allowing fluids to pass therethrough. There being no unexpected results modifying the circular cross-sectional shape of the working channel and working channel extension of Miller for the pentagon or hexagonal working channel shapes as taught by Miller.
In regard to claim 25, Miller teaches further comprising the instrument (100).
In regard to claim 26, Miller teaches wherein the instrument comprises a guidewire (Par. 13).
In regard to claim 27, Miller teaches wherein the coupler device is configured to secure the instrument in place (Par. 61).
In regard to claim 28, Miller teaches wherein the open distal end is oriented at an angle relative to the endoscope working channel, the coupler device being configured to secure the instrument into position at said angle (Par. 61).
In regard to claim 29, Miller teaches wherein the coupler device is configured to allow translational movement of the instrument while the instrument is secured at said angle (Figs. 5-7).
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-5, 13, 15-17 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.
Applicant's arguments filed 9/15/2026 have been fully considered regarding claims 24-29 but they are not persuasive.
Applicant argues:
“Miller does disclose a flexible membrane. However, the flexible membrane of Miller serves primarily as a protective covering or hood for the working end of the coupler device. Miller describes the membrane as surrounding the working channel region and providing a seal to prevent the ingress of fluids, debris, bacteria, and other unwanted material. Miller does not disclose using the flexible membrane to cooperate with the working channel to constrain an instrument passing through the working channel. Rather, Miller's working channel extension itself provides the passage through which the instrument travels, and Miller's disclosed mechanisms for securing an instrument rely on other structures, including adjustment of the working channel extension and engagement with a lock.
Thus, the mere presence of a flexible membrane in Miller does not satisfy the presently claimed structural and functional relationship. The claims require that the instrument be constrained between the flexible membrane and the working channel. This limitation requires the flexible membrane and the working channel to cooperate to define a constraint on the instrument. The Examiner has not identified, and Applicants are unaware of, any disclosure in Miller of such an arrangement.
Maseda does not remedy this deficiency. Maseda is directed to non-circular cross-sectional configurations of a working channel and an endoscopic instrument. In particular, Maseda describes polygonal configurations, including pentagonal and hexagonal configurations, that can provide a lock-and-key relationship between a correspondingly shaped instrument and working channel. Maseda does not disclose a flexible membrane at least partially surrounding an open distal end of the working channel, nor does Maseda disclose constraining an instrument between such a flexible membrane and the working channel.
Moreover, the Examiner's proposed modification of Miller in view of Maseda does not result in the claimed structure. The Examiner proposes modifying the cross-sectional shape of Miller's working channel to have a pentagonal or hexagonal shape. Such a modification would merely change the cross-sectional geometry of the working channel. It would not provide the claimed flexible membrane or cause an instrument passing through the working channel to be constrained between the flexible membrane and the working channel. The rejection therefore relies on an impermissible reconstruction of the claimed invention using Applicants' disclosure as a roadmap.”
The examiner disagrees since Miller teaches the working channel (34,134) is constructed such that as an angle of exit of the working channel causes a compressive force within the working channel to lock an instrument in place (Par. 61). Therefore, an instrument will be locked in place within the working channel as the flexible membrane and working channel exit are moved to adjust the angle of exit of the instrument. The examiner would like to note that the claim does not have language specific enough requiring the flexible membrane to directly contribute to locking of an instrument as argued.
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 RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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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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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 September 28, 2026
