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 .
Priority
Acknowledgment is made of applicant’s claim for priority to Application No. (TW112131220) filed on the August 18, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 21, 2024 is being considered by the examiner. However, the information disclosure statement filed August 14, 2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because it is a duplicate copy of the IDS filed on April 21, 2024. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed April 21, 2024, and August 14, 2025, fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claims 5, and 8-9 are objected to because of the following informalities:
Regarding Claim 5 and 8, remove the “(30)” from the claims.
Regarding Claim 8, line 4, “ the blocking ribs” should read as “the plurality of blocking ribs”
Regarding Claim 9, lines 1 and 2, “ the blocking ribs” should read as “the plurality of blocking ribs”
Appropriate correction is required.
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.
Claim 11 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.
Claim 11 recites the limitation "the upper end of the suction pad" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting that claim to mean “the upper end of the cuff”.
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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schnell (WO 2019121645 A1) in view of Blom et al. (US 20070144526 A1), hereafter as Blom.
Regarding Claim 1, Schnell discloses a sputum suction structure of a tracheostomy tube (Fig. 1, 3, 4), the sputum suction structure comprising:
an insertion tube (Fig. 4; 1),
comprising an insertion section (Fig. 1, 4; 2), a connection section (Fig. 1,4; 8) connected to the insertion section (Fig. 1,4; 2 is connected to 8), and a cuff (Fig. 4; 6) disposed on the insertion section (Fig. 4);
a movable baffle (Fig. 4; 7), positioned between the insertion section and the connection section (Fig. 4; the baffle is in between 8 and 2);
a suction pad (Fig. 4; 3), located on an upper edge of the cuff facing the insertion section and enclosing at least a part of an outer periphery of the insertion section (Fig. 4), comprising a coupling part (Fig. 2; cover 3 has connecting part that connects to the insert tube “5”) that disposed on one side thereof and a suction part (Fig. 1, 2, 4; inside the cover) disposed on another side thereof, wherein the coupling part is tightly attached to the outer periphery of the insertion section (Pg. 6, para. 1) and comprises a sputum suction port (the ports are 5a, 4) communicating with the suction part (Pg. 1 para. 8; Pg. 2 para. 5: examiner notes: Schnell teaches he cover forms a mechanical barrier which prevents a suction tube guided through the proximal opening into the cannula tube from accidentally pushing through the phonatory opening into the trachea and damaging the tracheal wall), and the suction part comprises a side suction opening (Fig. 2; 5a, 4 are side opening into under the cover 3) communicating with the suction space (inside of 3) and defined on two sides thereof respectively (Fig. 2; Pg. 3 para. 5; Examiner notes: the opening 5a, 4 all are two different sides).
Schnell does not specifically disclose a suction space (inside of 3) is defined between the suction part and the upper edge of the cuff.
However, Schnell does teach that the that the cover projects radially beyond the outer surface of the cannula tube and the interruptions 5a of the projection 5 each form a permanently open air passage 4 through which breathing air can flow in and out through the phonatory opening 2d (Pg. 6, para. 1), the air passages 4 are arranged diametrically opposite to each other in pairs.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to include the a suction space is defined between the suction part and the upper edge of the cuff as taught by Schnell for the purpose of saliva and waste to be able to be suction up and be directed to the suction tube.
Modified Schnell does not specifically disclose that a suction tube, one end thereof being inserted in the sputum suction port and another end thereof extending and protruding from an outer side of the movable baffle.
However, Blom teaches a suction tube (Fig. 2-4; 70), one end thereof being inserted in the sputum suction port (Fig. 3-4; 66 and 72) and another end thereof extending and protruding from an outer side of the movable baffle (shown best in Fig. 5; para. 0030).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cover of Schnell to include a suction tube, one end thereof being inserted in the sputum suction port and another end thereof extending and protruding from an outer side of the movable baffle as taught by Blom for the purpose of extraction of secretions is somewhat more predicable and complete (para. 0030).
Regarding Claim 2, Modified Schnell discloses the sputum suction structure according to claim 1, further comprising an inflation tube, wherein the inflation tube is inserted in the insertion section and communicates with the cuff (Pg. 4 para. 6; Schnell teaches a cuff usually consists of an inflatable, very thin-walled hose, the end sections of which closely abut on the outside of the cannula tube and are fastened there and which at least in a central section has a distinct excess compared to the cannula tube or can be inflated to such an excess, so that this section can be inflated after the introduction of the cannula into the trachea and comes into contact with the wall of the trachea along its circumference in a sealing manner and with preferably low pressure).
Regarding Claim 3, Modified Schnell discloses the sputum suction structure according to claim 1, wherein the sputum suction port (Fig. 2, 4; 4 and 5a; Schell and Fig. 2-6; 66; Blom) is structured as a concave arc surface located on an inner wall of the suction pad facing the insertion section (Shown big in Fig. 2; Schnell), and the suction pad (Fig. 2, 4; 3; Schnell) comprises a convex arc surface located on an outer surface thereof away from the insertion section (Shown best in Fig. 2 and in Fig. 4 as it connects to the cannula).
Regarding Claim 4, Modified Schnell discloses the sputum suction structure according to claim 1, wherein the sputum suction port (Fig. 2, 4; 4 and 5a; Schell and Fig. 2-6; 66; Blom) extends from the coupling part (Fig. 2; 5) to the suction part (Fig. 2; inside of 3; Examiner notes the coupling parts are the protrusion 5 and the suction part is where all the air can flow under the cover 3 so the ports 5a,4 are going to extend away from the protrusion to the inner space).
Regarding Claim 5, Modified Schnell discloses the sputum suction structure according to claim 1, wherein the suction pad (Fig. 4; 3) comprises a semicircular ring plate (Examiner notes: Examiner is interpreting that since it does not circle the whole cannula it is semicircular ring). The prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125)).
Regarding Claim 6, Modified Schnell discloses the sputum suction structure according to claim 5, wherein an extension angle is defined on the suction pad(Fig. 4; 3), and the extension angle is less than or equal to 180 degrees (Examiner notes; Examiner is interpreting that since it do not circle the half of the cannula the angel should be less than 180 degrees). The prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125)).
Regarding Claim 7, Modified Schnell discloses the sputum suction structure according to claim 1, wherein a step portion (“A” in Fig. A below) is disposed between the coupling part (“B” in Fig. A below) and the suction part (“C” in Fig. A below).
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Figure A: Adapted Fig. 2 from Schnell
Regarding Claim 8, Modified Schnell discloses the sputum suction structure according to claim 1, wherein the coupling part (Fig. 2,4; 5) comprises a convex binding surface (in Fig. 2; 5 is convex and it binds onto the cannula; Pg. 6; para. 1) and a plurality of blocking ribs connected to the convex binding surface (very 4and 5a are blocking ribs), and the blocking ribs are located on two sides of the suction pad (Fig. 2; Schnell), and the side suction opening is defined on outer sides of the blocking ribs (Fig. 2; the blocking ribs define how the air and/or secretions are able to enter the cover 3).
Regarding Claim 9, Modified Schnell discloses the sputum suction structure according to claim 8, wherein each blocking rib (very 4and 5a are blocking ribs) extends from the convex binding surface (in Fig. 2; 5 is convex and it binds onto the cannula; Pg. 6; para. 1), and a side flow channel is defined between each blocking rib and a side edge of the suction pad (Fig. 2; the blocking ribs define how the air and/or secretions are able to enter the cover 3).
Regarding Claim 10, Modified Schnell discloses the sputum suction structure according to claim 1, wherein a gap (Fig. 2; all 4, 5a are gaps, see “A” in Fig. B below) is defined between a side edge suction pad (Fig. 4) and the upper edge of the
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Figure B: Adapted Fig. 4 from Schnell
Claim(s) 1, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loescher (US 20090126740 A1) in view of Madsen et al. (US 20070044806 A1), hereafter as Madsen.
Regarding Claim 1, Loescher discloses a tracheostomy tube (Fig. 9-10),
an insertion tube (Fig. 9-10, comprising an insertion section (Fig. 9-10; 22), a connection section (Fig. 9-10; 26), connected to the insertion section, and a cuff disposed on the insertion section(Fig. 10; 25); a movable baffle (fig. 9-10; 20), positioned between the insertion section and the connection section( 20 is in-between 22 and 26);
Loescher does not discloses a sputum suction structure of the sputum suction structure comprising: a suction pad, located on an upper edge of the cuff facing the insertion section and enclosing at least a part of an outer periphery of the insertion section, comprising a coupling part disposed on one side thereof and a suction part disposed on another side thereof, wherein the coupling part is tightly attached to the outer periphery of the insertion section and comprises a sputum suction port communicating with the suction part, a suction space is defined between the suction part and the upper edge of the cuff, and the suction part comprises a side suction opening communicating with the suction space and defined on two sides thereof respectively; and a suction tube, one end thereof being inserted in the sputum suction port and another end thereof extending and protruding from an outer side of the movable baffle.
Madsen discloses a sputum suction structure (Fig. 1-4; adapter 24, and suction lumen 16) of the sputum suction structure comprising: a suction pad (the adapter 24; Figs. 1-4), located on an upper edge of the cuff (Fig. 1-1A; 42, 43: Examiner notes that it is location on the upper edge of the cuff on the cuff collar 43) facing the insertion section (faces the tube 18) and enclosing at least a part of an outer periphery of the insertion section (best shown in Fig. 1A and 2), comprising a coupling part (Fig. 2; 40) disposed on one side thereof and a suction part (Fig. 2; duct 30) disposed on another side thereof, wherein the coupling part is tightly attached to the outer periphery of the insertion section (Fig. 2; para. 0023-0029)and comprises a sputum suction port (Fig. 2; outlet 34; para. 0027) communicating with the suction part, a suction space is defined between the suction part and the upper edge of the cuff(Fig. 2; para. 0027) , and the suction part comprises a side suction opening (on the side of duct 30; specifically 32; Fig. 1-4) communicating with the suction space (inside the adapter Fig. 2) and defined on two sides thereof respectively; and a suction tube (Fig. 2; 16) one end thereof being inserted in the sputum suction port (at 34) and another end thereof extending and protruding from an outer side of themovable baffle (para. 0024; Examiner notes Madsen teaches A suction source (not shown) is connected to the proximal end 20 and used to create a vacuum or suction within the suction lumen 16) and bumps (“A” in Fig. C below).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the t tracheostomy tube of Madsen to include the a sputum suction structure of the sputum suction structure comprising: a suction pad, located on an upper edge of the cuff facing the insertion section and enclosing at least a part of an outer periphery of the insertion section, comprising a coupling part disposed on one side thereof and a suction part disposed on another side thereof, wherein the coupling part is tightly attached to the outer periphery of the insertion section and comprises a sputum suction port communicating with the suction part, a suction space is defined between the suction part and the upper edge of the cuff, and the suction part comprises a side suction opening communicating with the suction space and defined on two sides thereof respectively; and a suction tube, one end thereof being inserted in the sputum suction port and another end thereof extending and protruding from an outer side of the movable baffle as taught by Madsen for the purpose of overlapping the cuff collar thereby extending the suction closer to the cuff while keeping the adapter inlet close to the tube thereby minimizing trauma to the trachea and vocal cord during intubation and also be about to suck all waste/saliva as such (para. 0027).
Regarding Claim 11, Modified Loescher discloses the sputum suction structure according to claim 1, wherein the suction pad (the adapter 24; Figs. 1-4; Madsen) comprises a bump (“A” Fig. C below) located on two sides of a bottom edge of the suction part (Fig. 2; 30), and the side suction opening (“B” Fig. C below) is defined between the coupling part (Fig. 1; 40) and the bump.
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Figure C: Adapted Fig. 2 from Madsen
Regarding Claim 12, Modified Loescher discloses the sputum suction structure according to claim 1, wherein the suction pad the adapter 24; Figs. 1-4; Madsen) comprises bumps (“A” in Fig. C above) located on a bottom edge of the suction part (duct 30; Madsen) and distanced from two sides of the suction part, and the side suction opening (“B” in Fig. C above) is defined between the coupling part (40) and the bump (“A” in Fig. C. above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Other prior art of particular note include:
Tang et al. (CN 217612374 U) teaches tracheotomy sleeve pipe that has a suction tube that fits into drum 4
Neubauer (DE 202015004850 U1) teaches tracheotomy tube that has suction lumen and casing that directs into the suction gap
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAAP A ELLABIB whose telephone number is (571)272-5879. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MAAP A. ELLABIB
Examiner
Art Unit 3785
/M.A.E./ Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
