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
Applicant’s amendment of claims 10-14, and 19-20 are acknowledged by the Examiner.
Applicant’s amendments of claims 10-14 and 19-20 has overcome most of the previous claim objections. The remaining claim objections are described below.
Applicant’s amendments of claims 10-14 and 19-20 has overcome most of the previous claim objections. The remaining claim objections are described below.
Applicant’s amendments of claims 10, 12-14, and 19 has overcome most of the previous claim rejections under 35 U.S.C. 112(b). The remaining claim rejections under 35 U.S.C. 112(b) are described below.
Claims 10-20 are pending in the current Application, with claims 16-18 being withdrawn from consideration as being drawn to a non-elected invention.
Response to Arguments
Applicant's arguments filed 07/08/2026 have been fully considered but they are not persuasive.
In regards to Applicant’s arguments against the combination of Harrington as now modified by Sheridan, Examiner respectfully disagrees.
With respect to Applicant’s arguments that Harrington fails to suggest the annular ring portion and the boss that together form the outer spherical element is deformable so as to be stretchable, for it is apparent that the outer spherical element and the inner spherical element each have to be solid in order to provide the required angular rotation between the spherical elements, Examiner respectfully disagrees. First, the Examiner asserts that solid objects can be stretchable (rubber for example is a solid, but is stretchable). Second, as discussed in the rejection of claim 10, 30 is made from soft PVC material (see [0023]), soft PVC or “plasticized PVC” is an amorphous thermoplastic made by adding plasticizers (e.g., phthalates) to PVC resin. These additives reduce intermolecular forces, giving the material rubber-like flexibility, elasticity, and toughness; thus, 30 is capable of being stretched as claimed.
With respect to Applicant’s arguments that “by fixedly attaching the inner and outer spherical elements using the solvent welding or adhesive as described by Sheridan would defeat the essence of the Harrington tracheostomy tube”, Examiner respectfully disagrees. As discussed in the rationale, the combination of Harrington in view of Sheridan does not fixedly attach both the inner and outer spherical elements of Harrington to the shaft, it attaches a first portion of the flange (i.e. structure 30) to the shaft (12) while still allowing the movement of the inner spherical bearing element (26) within the outer spherical bearing element (32) as required by Harrington ([0015]).
Therefore, Applicant’s arguments are non-persuasive and the previous rejections under 35 U.S.C. 103 are maintained.
Claim Objections
Claims 10 is objected to because of the following informalities:
Claim 10 should be amended to include a comma to divide the preamble from the body of the claim.
Claim 10 recites the limitation “the collar”, in line 7. This limitation, while not unclear, should be amended to recite “the retaining collar” to maintain consistency in the claims.
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.
Claims 10-15, and 19-20 are 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 10 recites the limitation “such that the shaft and the mounting flange are not moveable relative to each other”. This limitation renders the claim indefinite because it is unclear how an adhesive applied between the first and second retaining formations can prevent any and all movement of the mounting flange with respect to the shaft (i.e. does the adhesive applied to the first and second retaining formations somehow make the remainders of the shaft and mounting flange completely rigid and incapable of movement with respect to one another?). For the purpose of examination, Examiner will interpret this limitation as best understood.
Claims 11-15, and 19-20 are rejected under 35 U.S.C. 112(b) as being dependent on rejected claim 10, and thus, contain the same offending limitations.
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.
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) 10-14, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrington (US 2012/0247478 A1) in view of Sheridan et al. (US 3,973,569 A) (hereinafter Sheridan).
In regards to claim 10, Harrington discloses a tracheostomy tube (10; see [0019]; see figure 1) including a shaft (12; see [0019]; see figure 1) and a mounting flange (30; see [0023]; see figure 1) on the shaft (see figure 1), characterised in that the shaft includes at least a first retaining formation (58; see [0022]; see figure 2) at a location of the shaft whereto the mounting flange is assembled (see figure 2), that the mounting flange is separately formed from the shaft (see figure 2 that 30 and 12 are separate structures and thus, are formed separately from one another) and has a retaining collar (64; see [0029]; see figure 2) embracing the shaft (see figure 3), that the retaining collar (64) has at least a second retaining formation (69; see [0029]; see figure 2) on an inner surface (see figures 2 and 5) with which the first retaining formation (58) on the shaft is engaged to restrict a longitudinal movement of the shaft relative to the collar (the retaining formations enclose the protrusions and thus, restrict longitudinal movement of 12 relative to 30 to only small movements of 12 with respect to 30; see [0024]), that the retaining collar is deformable so as to be stretchable outwardly to enable the first and second retaining formations to be engaged with one another (30 is made from soft PVC material; see [0023]; soft PVC or “plasticized PVC” is an amorphous thermoplastic made by adding plasticizers (e.g., phthalates) to PVC resin. These additives reduce intermolecular forces, giving the material rubber-like flexibility, elasticity, and toughness; thus, 30 is capable of being stretched as claimed).
Harrington discloses the necessity of some movement of the flange with respect to the cannula (see [0015]). Harrington does not disclose that the shaft and the mounting flange are permanently secured to each other by a bonding substance applied between an outside of the shaft and an inside of the retaining collar such that the shaft and the mounting flange are not moveable relative to each other.
However, Sheridan teaches an analogous tracheostomy tube (2; see [col 2 ln 25-30]; see figure 1) comprising an analogous shaft (8; see [col 2 ln 25-30]; see figure 1) and an analogous mounting flange (10 and 22; see [col 2 ln 30-38]; see figure 1); wherein the shaft (8) and the mounting flange (10 and 22) are permanently secured to each other by a bonding substance (solvent weld or adhesive; see [col 2 ln 35-36]) applied between an outside of the shaft and an inside of the retaining collar (as can be seen in figures 1 and 2 the only location in which 10 and 8 attach to one another are on the outside of 8 and inside of 10, thus, the adhesive or solvent is applied as claimed) such that the shaft and the mounting flange are not moveable relative to each other (solvent weld or adhesive fixes 10 onto 8 and therefore, prevents the relative movement 10 with respect to 8 (see [col 2 ln 35-37])) for the purpose of fixing a first portion of the flange onto the shaft while still allowing for sliding or translational movement of a second portion of the flange with respect to the shaft (see [col 2 ln 35-45]).
Therefore 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 the mounting flange and shaft as disclosed by Harrington and to have secured the mounting flange and shaft together using the bonding substance as taught by Sheridan in order to have provided an improved tracheostomy tube assembly that would add the benefit of fixing a first portion of the flange onto the shaft at a desired location while still allowing for sliding or translational movement of a second portion of the flange with respect to the shaft (see [col 2 ln 35-45]), and thus, still allowing for the movement (i.e. the movement of 26 within 32) as required by Harrington ([0015]).
In regards to claim 11, Harrington as now modified by Sheridan discloses the invention as discussed above.
Harrington further discloses characterised in that the first retaining formation (58) on the shaft (12) is a projecting lug (58 is a protrusion and thus, a projecting lug; see [0027]) and the second retaining formation (69) on the retaining collar (64) is a recess (see [0029]).
In regards to claim 12, Harrington as now modified by Sheridan discloses the invention as discussed above.
Harrington further discloses characterised in that the shaft (12) has two first retaining formations (58 and 60; see [0027]; see figure 2) arranged diametrically opposite one another on the shaft (12; see figure 2), and that the retaining collar (64) of the flange (30) has two retaining formations (two 69’s; see figure 2) with which the respective retaining formations on the shaft are received (see [0029]; see figure 2).
In regards to claim 13, Harrington as now modified by Sheridan discloses the invention as discussed above.
Harrington further discloses characterised in that the shaft (12) has an outer surface (27; see [0022]; see figure 2) and includes one or more longitudinally extending alignment formations on the outer surface (see figure 2), and that the mounting flange (30) includes cooperating alignment formations on the inner surface (70; see [0030]; see figure 5) of the retaining collar (64; 70 provides a track for receiving and maintaining 27 in a desired alignment, thus, 27 and 70 are alignment formations as claimed).
In regards to claim 14, Harrington as now modified by Sheridan discloses the invention as discussed above.
Harrington further discloses characterised in that a machine end (end of 12 comprising 24; see figure 1) of the shaft (12) is provided with a connector (24; see [0022]; see figure 1), that the first retaining formation (58) on the shaft (12) is provided on a boss (26; see [0022]; see figure 2) projecting outwardly of the shaft (see figure 2), and that the boss (26) is spaced from both a patient end (16; see [0019]; see figure 1) of the shaft and the connector (24; see figure 2 that 26 is spaced from 16 and figure 6 that 26 is spaced from 24) at the machine end of the shaft so that when the mounting flange (30) is positioned against a patient's neck a length of the shaft projects outwardly of the patient (see [0019] that 14 is flush with the anterior surface of the patient’s neck and thus, projects outwardly of the patient as claimed).
In regards to claim 19, Harrington as now modified by Sheridan discloses the invention as discussed above.
Harrington further discloses wherein the first retaining formation (58) is at a boss (26; see [0022]; see figure 2) projecting outwardly of the shaft (12; see figure 2) and adapted to be inserted in the retaining collar (64) of the mounting flange (30; see figure 2-3 that 26 is adapted to be inserted in 64).
In regards to claim 20, Harrington as now modified by Sheridan discloses the invention as discussed above.
Harrington further discloses wherein the second retaining formation (69) comprises at least one recess at the inner surface of the retaining collar (64; see [0029]; see figure 2 and 5).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrington in view of Sheridan as applied to claim 10 above, and further in view of Loescher (US 8,469,024 B2).
In regards to claim 15, Harrington as now modified by Sheridan discloses the invention as discussed above.
Harrington further discloses the mounting flange (30) is of a suitable flexible thermoplastic material, and may be formed from any of a variety of suitable materials, as would be understood by one skilled in the art (and thus, may include deformable silicone material as claimed; see [0023]). Nonetheless, Harrington as now modified by Sheridan does not explicitly disclose the wherein the mounting flange is of a deformable silicone material.
However, Loescher teaches an analogous tracheostomy tube (tracheostomy tube assembly; see [col 3 ln 35-40]) comprising a shaft (22; see [col 3 ln 35-40]; see figure 9) and a mounting flange (tracheostomy pad; see [col 2 ln 20-25]; see figure 1 and 9) which intended to rest against a patient’s neck (see [abstract]); wherein the mounting flange (tracheostomy pad) is of a deformable silicone material (see [col 3 ln 1-2]) for the purpose of providing a material of the pad which is soft, pliant, and flexible (see [col 3 ln 5-13]) and prevents irritation of the patient’s skin (see [col 4 ln 5-10]).
Therefore 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 the material of the mounting flange as disclosed by , Harrington as now modified by Sheridan and to have formed the mounting flange from the deformable silicone material as taught by Loescher in order to have provided an improved mounting flange that would add the benefit of providing a material of the pad which is soft, pliant, and flexible (see [col 3 ln 5-13]) and which prevents irritation of the patient’s skin due to these properties (see [col 4 ln 5-10]).
Conclusion
THIS ACTION IS MADE FINAL. 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 DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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, Alireza Nia can be reached at 571-270-3076. 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.
/DANIEL A MILLER/Primary Examiner, Art Unit 3786
Prosecution Insights