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 .
Priority
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(a-d) with reference to Application Number: IT102021000031256 filed on 12/14/2021.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
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(s) 1 – 2, 5 – 6, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holtz (US 20090165784).
Regarding claim 1, Holtz discloses an endotracheal tube [0035], comprising at least one main tubular body (10), configured for the at least partial insertion into the respiratory tract of a patient, through the mouth or the nose [0039], further comprising at least one tubular reinforcement skeleton for said body (30), at least one useful portion of said skeleton being constituted by at least one first filament which is wound in a helical manner around a longitudinal axis of said body (16, Figs. 1 and 2, [0019]) and being selectively disengageable from said body (double helix 16 contacts the inside surface of the tube 10, and may be selectively withdrawn/disengaged from the tube, see [0019]), for a removal thereof after completion of the step of insertion of said body into the respiratory tract of the patient [0003].
2. The tube according to claim 1, wherein said at least one first filament extends substantially over the entire longitudinal extension of said body, said skeleton being entirely disengageable from said body (see Figs. 1 and 2, [0018], ball passes port 22).
5. The tube according to claim 1, wherein said skeleton is accommodated within a thickness of said body, said at least one first filament being longitudinally extractable from said thickness (skeleton is accommodated within a thickness defined by an outer diameter of the body running from one outer surface to the diametrically opposed other outer surface).
6. The tube according to claim 1, wherein said skeleton is engaged with either an internal lateral surface or an external lateral surface of said body (see [0019]).
9. The tube according to claim 1, further comprising a grip element, which is kept protruding from a proximal segment of said body and is anchored to said at least one first filament, said grip element being grippable by an operator in order to remove said at least one first filament (element 18).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 - 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holtz in view of Virag (US 5546936).
Regarding claim 7, Holtz discloses the tube according to claim 1. Virag discloses wherein at least one second portion of said skeleton, which is separate from said at least one useful portion of the skeleton and is integral with said body (portions 30 and 130 of Virag, which would correspond to the separate tube 10 of Holtz, and are integral thereto), comprises at least one second filament which is wound in a helical manner around the longitudinal axis of said body (c. 7: 10 – 25). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the tube 10 of Holtz to include the second filament of Virag for the benefit of designing a tube allowing improved access to the tracheal tube once intubation is complete (see c. 7: 43 – 65).
8. The tube according to claim 1, wherein at least one second portion of said skeleton, which is separate from said at least one useful portion of the skeleton and is integral with said body, is substantially constituted by a mesh composed of a plurality of wires that are mutually interwoven and wound around the longitudinal axis of said body (see rejection above, Virag, c. 7: 10 – 25, a filament mesh is mutually interwoven wires).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holtz in view of Sheridan (US 4990143).
Regarding claim 10, Holtz discloses the tube according to claim 1. Sheridan discloses further comprising an inflatable enclosure, which is wrapped externally around a distal segment of said body and is associated with an inflation line, for stabilization of said body in the respiratory tract of the patient (see Fig. 4, 14, c. 4: 24 – 28). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the tube 10 of Holtz to include the inflatable enclosure 14 of Sheridan for the benefit of enclosing the lungs to allow appropriate delivery of respiratory gas to the lungs, without diffusion therefrom.
Allowable Subject Matter
Claims 3 and 4 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Holtz fails to disclose wherein said skeleton is constituted substantially by a proximal part and a distal part, which are arranged in sequence along the longitudinal extension of said body and are mutually disengaged, said useful portion being constituted by said distal part. Cheer (US 6130406) discloses a skeleton having a proximal part and distal part which are mutually disengaged (see Fig. 2b, c. 6: 47 – 49). However, it would not have been obvious to modify the skeleton of Holtz with Cheer so that mutual disengagement is made via the useful portion, since the useful portion of Holtz 16 constitutes a stylet entirely removable from its tubular body. Similarly, it would not have been obvious to modify Cheer on top of Berard (US 20240100278), who discloses a helically wound filament at the distal end of the stylet (see Fig, 1a, 1f), since the distal part of Berard constitutes a stylet entirely removable from its tubular body, rather than via mutual disengagement from the tubular reinforcement skeleton.
Examiner notes that Cheer does not anticipate claim 1, since the distal part of Cheer is not reasonably capable of removal from the tubular body after completion of insertion of said body in the respiratory tract of the patient. Notably, the distal part of Cheer is removed from the distal end of tubular body, rather than the proximal end, see Fig. 2b. Furthermore, it would not have been obvious to modify Cheer for removal of the distal part via the proximal end of the tube, since such modification would greatly complicate the method of manufacture. See Cheer, c. 6: 47 – 53.
The examiner lastly notes prior art to Layer (US 20100269830), Zeldman (US 3948274), and Phythyon (US 7918227).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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, Brian Casler can be reached at (571) 272-4956. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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