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
Applicant’s election without traverse of Group I, readable on Claims 1-18 in the reply filed on 5/15/2026 is acknowledged.
Applicant's election with traverse of Species A of Group I, Species A, Sub-Species II of Group II in the reply filed on 9/3/2026 is acknowledged. The traversal is on the ground(s) that Species A-C of Group I are generic to Claim 1 and Species A, Sub-Species A of Group II as generic to claim 19. This is not found persuasive since whether the species are generic to an independent claim is not a valid reason for whether an election of species is proper. The species are directed towards separate constructions of a medical device including different embodiments of a guide catheter and dilation catheter that are distinct from each other and would require separate search and examination considerations.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Akbarian et al. (US Patent Application Publication No. 2020/0178775, hereinafter Akbarian).
In regard to claim 1, Akbarian discloses a catheter system (10, Fig. 1), comprising:
a shaft (14) dimensioned to be inserted transnasally to facilitate access to a Eustachian Tube of a pediatric patient (Par. 29, the catheter system is capable of being used for the intended function) and comprising a rigid proximal portion (42) defining an open proximal end, a deflectable distal portion (44) located distally from the proximal portion (Fig. 1), wherein the rigid proximal portion and the deflectable distal portion define a lumen (62), and a pull wire extending from the deflectable distal portion along the proximal portion and being configured to drive the deflectable distal portion between a straight configuration and a bent configuration (Par. 37); and
a visualizing distal tip (40) located distally from the deflectable distal portion and configured to actuate with the deflectable distal portion between the straight configuration and the bent configuration (Fig. 1), wherein the visualizing distal tip comprises a distally facing camera (72) and defines a portion of the lumen (Fig. 2A),
wherein the deflectable distal portion is configured to be inserted transnasally into a nasopharynx region of the pediatric patient when the deflectable distal portion is in the straight configuration (Par. 29, the catheter system is capable of performing the intended function),
the deflectable distal portion is configured to be deflected from the straight configuration into the bent configuration when the deflectable distal portion is located within the nasopharynx region of the pediatric patient, such that the visualizing distal tip is oriented toward the Eustachian Tube of the pediatric patient (Par. 29, the catheter system is capable of performing the intended function via actively bending the flex section (44)).
Claim 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwartz et al. (US Patent Application Publication No. Schwartz et al. (US Patent Application Publication No. 2012/0078050, hereinafter Schwartz).
In regard to claim 1, Schwartz discloses a catheter system (10, Fig. 1), comprising:
a shaft (12,13) dimensioned to be inserted transnasally to facilitate access to a Eustachian Tube of a pediatric patient (Par. 78, the catheter system is capable of being used for the intended function) and comprising a rigid proximal portion (12) defining an open proximal end, a deflectable distal portion (13) located distally from the proximal portion (Fig. 2), wherein the rigid proximal portion and the deflectable distal portion define a lumen (Par. 81), and a pull wire extending from the deflectable distal portion along the proximal portion and being configured to drive the deflectable distal portion between a straight configuration and a bent configuration (Par. 81, Fig. 4B); and
a visualizing distal tip (112) located distally from the deflectable distal portion and configured to actuate with the deflectable distal portion between the straight configuration and the bent configuration (Fig. 2), wherein the visualizing distal tip comprises a distally facing camera (28) and defines a portion of the lumen (Fig. 4E, Par. 90),
wherein the deflectable distal portion is configured to be inserted transnasally into a nasopharynx region of the pediatric patient when the deflectable distal portion is in the straight configuration (Par. 29, the catheter system is capable of performing the intended function),
the deflectable distal portion is configured to be deflected from the straight configuration into the bent configuration when the deflectable distal portion is located within the nasopharynx region of the pediatric patient, such that the visualizing distal tip is oriented toward the Eustachian Tube of the pediatric patient (Par. 29, the catheter system is capable of performing the intended function via actively bending the flex section (44)).
In regard to claim 2, Schwartz teaches further comprising a handle assembly (20, Fig. 1) configured to be grasped by a single hand and comprising a first handle section (22) fixed to the rigid proximal portion of the shaft, a second handle section (21) slidably coupled to the first handle section (Fig. 5), and a pull wire anchor fixed to both a proximal potion of the pull wire and the second handle section (Par. 97), such that the first handle section and the second handle section are configured to actuate relative to each other to drive the deflectable distal portion between the straight configuration and the bent configuration (Fig. 4B).
In regard to claim 3, Schwartz teaches wherein the handle assembly further comprises a resilient member (31) configured to bias the first handle section and the second handle section away from each other (Par. 105).
In regard to claim 4 Schwartz teaches further comprising a camera communication wire extending proximally from the camera, along the shaft, and into an interior defined by the handle assembly (Par. 115).
In regard to claim 5, Schwartz teaches wherein the second handle section defines an elongate slot (121), and the camera communication wire extends out of the interior defined by the handle assembly via the elongate slot (the camera communication wire extends from the handle assembly through an interior of the elongate slot (121) and into the shaft, Fig. 11).
In regard to claim 6, Schwartz teaches wherein the first handle section defines a chamber (via interior of the first handle section) dimensioned to slidably house a portion of the second handle section (via pivoting of the second handle section within the interior of the first handle assembly), and a proximal section of the elongate slot is dimensioned to slide within the chamber (via pivoting of the pivot member / elongate slot (121)) as the first handle section and the second handle section actuate toward each other (Fig. 11).
Allowable Subject Matter
Claims 7-18 are allowed.
Conclusion
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 October 9, 2026
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