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
This office action is responsive to the preliminary amendment filed on November 28, 2022. As directed by the amendment: claim 1 has been amended, no claims have been added, no claims have been canceled. Thus claim 1 is presently pending in this application. Applicant’s amendment to the Application Title has been entered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 28, 2022 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement (IDS) submitted on January 10, 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Utterberg (US 5951519), in view of Fantuzzi et al. (US 20170312492), hereinafter Fantuzzi, and Burkholz et al. (US 20170120040), hereinafter Burkholz.
Regarding claim 1, Utterberg discloses--- an endotracheal tube barrier kit with a sealing cap attached to a clamp with several stages for adjusting the degree of occlusion for use in advanced airway management procedures (Device of Figs. 1-4), the kit comprising: a sealing device (cap 32) with a circumferential shape (Fig. 1, cap has a circumferential shape) with a removal ear (tether 34, which made be used to remove cap 32) made of the same flexible material as the said sealing device (Figs. 1 and 4 and Col. 3:54-60, tether is formed integrally with cap 32 and is flexible, therefore it is made of the same flexible material); and an occluder clamp (pressure clamp 18), being a single-body structure (Fig. 4, pressure clamp 18 is a single-body structure) that has central holes through which the endotracheal tube passes (Figs. 2-4, pressure clamp 18 has central holes: bore 14 and aperture 24, which tubing 12 of the desired size extends through), a support for fitting of the sealing device (Fig. 3, connector 10 for fitting of cap 32 to pressure clamp 18), a finger attachment (pressure member 26), having a fin (projection 28)..
Utterberg fails to disclose the sealing device having a central virtual hole made of flexible material with the possibility of deformation of its internal walls. However, Fantuzzi discloses a central virtual hole made of flexible material with the possibility of deformation of its internal walls (Fig. 10 and [0076], capped end of device can comprise a hemostasis valve 712, which comprises a hemostasis valve slit membrane 721, comprising flexible material comprising slits for deformation to allow passage a solid device through).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Utterberg to incorporate the disclosures of Fantuzzi and modify the cap to comprise a hemostasis valve slit membrane, such that the cap has a central virtual hole made of flexible material with the possibility of deformation of its internal walls. Doing so would allow for ease in the introduction or removal of a medical device through the capped device, without the risk of fluid loss (Fantuzzi, [0066, 0076]).
Utterberg, in view of Fantuzzi, fails to disclose the occluder clamp structure composed of plastic material; wherein the fin has a cylindrical shape on one of its sides, so as to be fitted into a gap formed by two other fins, also cylindrical, on the opposite side. However, Burkholz discloses the occluder clamp structure composed of plastic material ([0002, 0050-0051,0061], clamp is formed of plastic material); wherein the fin has a cylindrical shape on one of its sides (Fig. 17, surface 1702b of clamping surface 26 is cylindrically formed), so as to be fitted into a gap formed by two other fins, also cylindrical, on the opposite side (Fig. 17 and [0093], surface 1702b is fitted into recess 1701c, formed by surfaces 1701a and 1701b, which also have a cylindrical shape).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Utterberg, in view of Fantuzzi, to incorporate the disclosures of Burkholz and modify the clamp to composed of plastic material; and modify the fin to have a cylindrical shape on one of its sides, so as to be fitted into a gap formed by two other fins, also cylindrical, on the opposite side. Doing so would provide a clamp made of a material which is resilient and capable of controlled flexion to enable engagement and disengagement of the clamping surfaces (Burkholz, [0002]). Additionally, the clamping surfaces configuration would ensure fluid contained within the tubing that is distal to the raised surfaces will be forced back distally when the surfaces are clamped, ensuring that the tubing is properly clamped (Burkholz, [0092-0094]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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, BHISMA MEHTA can be reached at (571) 272-3383. 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.
/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783