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 Arguments
Applicant’s arguments with respect to the claim(s) 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.
Election/Restrictions
Newly submitted claim 21 is directed to an invention that lacks unity with the invention originally claimed for the following reasons: Group I (claims 1-19) and Group II (claim 21) lack unity of invention because even though the inventions of these groups require the shared technical feature of an assembly having an endoscope, a tunneling shaft having an insertion pathway extending therethrough with an optical window disposed at a distal end, wherein the shaft is bendable, and a constriction mechanism configured to constrict the insertion pathway, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Ebersole (US 2020/0038048) as modified by Poll (US 2010/0168520). See the rejections below for a detailed explanation of how Ebersole as modified by Poll discloses the shared technical features.
Since applicant has received an action on the merits for the originally presented invention (Group I), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 21 is withdrawn from consideration as being directed to a nonelected invention.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.
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) 1-4, 7-11, and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ebersole et al. (US 2020/0038048) in view of Poll et al. (US 2010/0168520).
Ebersole discloses an assembly comprising: a handle (34); a tunneling shaft (32) coupled to the handle, the tunneling shaft extending from the handle to a distal end, wherein at least a portion of the tunneling shaft is sufficiently rigid to maintain its shape as it is inserted into and through tissue of a patient (see [0037] – “shaft 32 exhibits substantially no flex when greater than about 5 pounds of force is applied to the distal end 38 in direction 37 shown in fig. 3”; see also [0038]), an optical window (44; figs. 5a, 5b) disposed at the distal end of the tunneling shaft; an insertion pathway (46; [0040]) extending through the handle and the tunneling shaft to the optical window; and an endoscope configured to be inserted in the handle of the optical window along the insertion pathway ([0040]). Ebersole fails to disclose a constriction mechanism as claimed.
Poll discloses an assembly comprising: a handle (320; fig. 6); a tunneling shaft (210) coupled to the handle, the tunneling shaft extending from the handle to a distal end; an optical window ([0067]; the distal end forms an optical window) disposed at the distal end of the tunneling shaft; an insertion pathway extending through the handle and the tunneling shaft to the optical window (see fig. 2c); and a constriction mechanism (locking grommet 2250 and locking knob 2000; figs. 16, 17a-c, which is consistent with corresponding structure invoked by 35 USC 112f) coupled to the handle defining a portion of the insertion pathway, wherein the constriction mechanism is configured to selectively constrict the insertion pathway (via actuation of knob 2000; [0136]) about endoscope (100) (see fig. 2c and [0136]) in order to grip and stabilize the endoscope relative to the tunneling shaft. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Ebersole to include such a constriction mechanism coupled to the handle and defining a portion of the insertion pathway, the constriction mechanism configured to selectively constrict the insertion pathway as taught by Poll, in order to allow the endoscope to be secured in a desired relative position with respect to the tunneling shaft (see and claim 7-9 of Poll).
Regarding claim 2, as taught by Poll, the constriction mechanism comprises an inner diaphragm (rubber grommet 2250) defining the portion of the insertion pathway ([0138]).
Regarding claims 3 and 10, as taught by Poll, the constriction mechanism comprises a manually engageable knob (2000).
Regarding claims 4, 11, and 17, as taught by Poll, the constriction mechanism is configured for selective disengagement and reengagement of the endoscope (e.g., by inserting or withdrawing the endoscope through the insertion pathway, or by actuating knob 2000 to change size of insertion path into and out of engagement with outer surface of endoscope).
Regarding claims 7 and 14, the constriction mechanism of Poll has a pressure limiter (2410; fig. 17a-b of Poll) configured to limit compression of the insertion pathway ([0134] – tabs limit extent to which collet 2210 is compressed).
Regarding claims 8 and 15, as taught by Poll, the magnitude of constriction of the constriction mechanism is adjustable by a user (by actuating knob 2000 of Poll).
Regarding claims 9 and 16, as understood in view of par. [0059] of Ebersole, the tunneling shaft is bendable by a user’s hands without the use of additional tools and is configured to bend without collapse of the insertion pathway (see [0059] – shaft is malleable to retain curvature when bent by a user; bendable wires embedded in wall of shaft are 21-gauge stainless steel and thus considered configured to bend by a user’s hand without use of additional tools; note also [0037] – no “jam up”).
Claim(s) 5-6, 12-13, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ebersole in view of Poll as applied to claims 1-3 above and further in view of Vazales (US 2013/0023729)).
Regarding claims 5, 12, and 18, Ebersole in view of Poll discloses the invention substantially as stated above, but fails to disclose an optical material as claimed.
Vazales discloses another tunneling shaft (122; fig. 3b) through which an endoscope (128) is inserted, the tunneling shaft having an optical window (142) formed at the distal end.
Vazales teaches including an optical material (silicone oil) disposed in the insertion pathway and in contact with the optical window (142) formed at the distal end of the tunneling shaft (122) ([0103] – silicone oil placed on one or both sides of window; see also [0062]) in order to act as an optical coupling agent that creates an approximately equivalent refractive index between the window and the scope. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Ebersole to include an optical material disposed in the insertion pathway in contact with the optical window as taught by Vazales to reduce the difference in refractive index between the window and the scope, thereby reducing reflecting and improving contrast of the images ([0103]).
Regarding claims 6, 13, and 19, Ebersole in view of Poll discloses the invention substantially as stated above but fails to disclose an orientation indicator as claimed.
Vazales teaches including an orientation indicator (see [0097]) on an optical window (142) of a tunneling shaft (122) in order to orient the user to the patient anterior and/or posterior. It would have been obvious to one of ordinary skill in the art to have further modified the prior art of Ebersole to include an orientation indicator on the optical window of Ebersole as taught by Vazales in order to allow the user to more easily determine the orientation of the device with respect to the patient.
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 KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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, Elizabeth Houston can be reached at 571-272-7134. 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.
KSH 9/22/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
Prosecution Insights