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 .
Claim Objections
Claim1 is objected to because of the following informalities:
Lines 4-5 of claim 1 reads “first segment”, however to remain consistent with the terminology used in the rest of claim, “first segment” should be replaced with --primary segment--, as primary segment is the term used in line 3.
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 4 is 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.
Lines 3-4 of claim 4 recites the limitation “first access port or a second access port”, however line 4 recites “the second access port being open to the second patency” – therefore line 4 further limits an optional limitation, due to the presence of the term “or” in line 3. For the purpose of examination, the Examiner will interpret the claim as only requiring a first access port, due to the presence of the term “or” used line 3.
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, 4, 6-7, 11-13, 15, 18-19, 26, 45, 47-50, and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoftman et al. (US 2017/0043111 A1).
Regarding claim 1, Hoftman discloses a device for intubation of a subject (endobronchial tube device, Abstract and Figure 1), the device comprising: a compliant body configured to form, upon placement into a bodily orifice of a subject and subsequent pressurization therein (shaft 12 made from a soft and flexible material, such as silicone, Paragraph 0054 and Figure 1; shaft 12 is pressurized via valve assembly 16, Paragraph 0053), (i) a primary segment configured to extend to the back of the laryngopharynx of the subject (primary shaft 12 is inserted into patient’s airways to include the laryngopharynx, Paragraph 0054), (ii) a secondary segment configured to extend from the first segment and into a trachea of the subject (at the center of the primary shaft 12, a tracheal lumen 28 is present and extends from the opening of the Y-connector 14 and terminates with the trachea opening 18, Paragraph 0055 and Figure 1), and (iii) at least one patency from the first segment to the second segment to provide a pathway from a bodily orifice of the subject to the trachea of the subject (shaft 12 and tracheal lumen 28 forms a patency from the shaft 12 to the tracheal opening 18 to provide a pathway from the user’s mouth to the trachea, Paragraph 0053 and Figures 1-2).
Regarding claim 2, Hoftman further discloses wherein the compliant body comprises one or more walls defining a first patency and a separate second patency (shaft 12 comprises shaft walls 26 enclosing tracheal lumen 28, therefore forming a first and second patency, Paragraph 0053 and Figures 1-3), the first patency permitting pressurization of the compliant body to form the primary and secondary segments (shaft 12 is pressurized via valve assembly 16, therefore pressurizing both the shaft body 12 and tracheal lumen 28, Paragraph 0053), and the second patency extending from the primary segment into the secondary segment to provide the pathway from the bodily orifice of the subject into the trachea of the subject (shaft 12 and tracheal lumen 28 forms a patency from the shaft 12 to the tracheal opening 18 to provide a pathway from the user’s mouth to the trachea, Paragraph 0053 and Figures 1-2).
Regarding claim 4, Hoftman further discloses an introducer coupled to the compliant body and configured for placement at least partially into the bodily orifice of the subject (y-connector 14 and fill assembly 16 configured for placement at least partially in patient’s mouth, Paragraph 0053 and Figures 1-2), wherein the introducer comprises one or more of a first access port or a second access port, the first access port being open to the first patency (valve assembly 16 has two access ports, Figure 1) and the second access port being open to the second patency (the Examiner notes the 112b rejection for this particular part of the claim).
Regarding claim 6, Hoftman further discloses wherein the second patency is configured to provide ventilation for the subject directly through the pathway provided therefrom shaft 12 is pressurized via valve assembly 16, therefore providing ventilation for the subject through the shaft body 12 and tracheal lumen 28, Paragraph 0053).
Regarding claim 7, Hoftman further discloses wherein the portion of the one or more walls defining second patency is supported by one or more rigid elements (the shaft body 12 and bronchial tube 19 are also rigid enough to prevent buckling, folding or kinking when inserted in the airways, therefore possess a degree of rigidity, Paragraph 0054).
Regarding claim 11, Hoftman further discloses wherein the second patency is disposed at least partially within the first patency (at the center of the primary shaft 12, a tracheal lumen 28 is present and extends from the opening of the Y-connector 14 and terminates with the trachea opening 18, Paragraph 0055 and Figure 1).
Regarding claim 12, Hoftman further discloses wherein the first and second patency are at least partially coaxial (see coaxially relationship between shaft 12 and tracheal lumen 28, Figure 3).
Regarding claim 13, Hoftman further discloses wherein the device further comprises a cuff coupled to the secondary segment and configured to protect the at least one patency (tracheal balloon cuff 22, Paragraph 0053 and Figures 1-2).
Regarding claim 15, Hoftman further discloses wherein the cuff is expandable (balloon cuff 22 is inflatable, Paragraph 0056).
Regarding claim 18, Avitsian further teaches wherein the cuff is coupled to a distal portion of the secondary segment (see cuff 22 coupled to distal portion of tracheal lumen 28, Figures 1-3).
Regarding claim 19, Hoftman further discloses an introducer coupled to the compliant body and configured for placement and securement at least partially into the bodily orifice of the subject (y-connector 14 and fill assembly 16 configured for placement at least partially in patient’s mouth, Paragraph 0053 and Figures 1-2).
Regarding claim 26, Hoftman further discloses an introducer coupled to the compliant body, the introducer being configured for placement and securement at least partially into the bodily orifice of the subject (y-connector 14 and fill assembly 16 configured for placement at least partially in patient’s mouth, Paragraph 0053 and Figures 1-2)).
Regarding claim 45, Hoftman further discloses wherein the bodily orifice is a mouth of the subject (device is inserted in patient’s airways, Abstract).
Regarding claim 47, Hoftman further discloses wherein one or more of the primary or secondary segments are configured to evert in response to pressurization (shaft 12 and bronchial lumen 19 are soft and pliant enough to bend, therefore fully capable of everting in response to positive pressure incoming from valve assembly 16, paragraph 0054 and Figures 1-2).
Regarding claim 48, Hoftman further discloses wherein the secondary segment has a smaller cross-sectional area than the primary segment (tracheal lumen 28 is enclosed within walls of outer shaft body 12, therefore having a smaller cross-sectional area, Paragraph 0054 and Figures 1-3).
Regarding claim 49, Hoftman further discloses wherein the primary segment has as a predetermined shape configured to place and orient the secondary segment toward the trachea (see Figures 1-3 showing shaft 12 and tracheal lumen 28 having predetermined shape, with the tracheal lumen 28 having a tracheal opening 18).
Regarding claim 50, Hoftman further discloses wherein the primary and secondary segments are unitarily formed (tracheal lumen 28 is enclosed within walls of outer shaft body 12, therefore formed unitarily, Paragraph 0054 and Figures 1-3).
Regarding claim 53, Hoftman further discloses wherein at least a portion of the compliant body is supposed by one or more rigid elements (the shaft body 12 and bronchial tube 19 are also rigid enough to prevent buckling, folding or kinking when inserted in the airways, therefore possess a degree of rigidity, Paragraph 0054).
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.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hoftman et al. (US 2017/0043111 A1) in view of Alfrey et al. (US 2006/0032505 A1).
Regarding claim 3, Hoftman teaches the device of claim 2, however is silent wherein the first and second patency are configured to be pressurized by different pressurization streams.
However, Alfrey teaches a multi-lumen endotracheal device (Abstract and Figure 1), comprising a first segment/patency (laryngeal tube 19, Figure 1 and Paragraph 0018) and a second segment/patency (secondary tubes 20, 22, Figure 1 and Paragraph 0018), wherein the first and second segments are configured to be pressurized by different pressurization streams and/or sources (laryngeal tube 19 may be connected to a respiratory circuit or anesthesia circuit, Paragraph 0018, whereas secondary tubes 20, 22 may be pressurized via other accessory devices such as suction devices or various instrument devices, Paragraph 0018).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hoftman’s device by having the first and second segments be configured such that they may be pressurized via different pressurization streams, as taught by Alfrey, as providing two independent pressurization streams and/or pressure sources would thereby allow for independent control and/or pressurization of each segment, providing more overall versatility to the device.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Hoftman et al. (US 2017/0043111 A1) in view of Nave et al. (US 2017/0232216 A1).
Regarding claim 28, Hoftman teaches the device of claim 1, however is silent wherein the primary segment comprises a first sub-segment and one or more lateral sub-segments, the one or more lateral sub-segments being partially closed to fluid communication with the primary sub-segment.
However, Nave teaches an endotracheal tube device (Abstract and Figure 1) comprising a primary segment (tube 101, Paragraph 0094 and Figures 1-2) wherein the primary segment comprises a first sub-segment and one or more lateral sub-segments (tube 101 comprises various sub-segments, such as two lateral injection channels 133 having their own fluid pathway, therefore closed to the ventilation lumen 110, Paragraph 0105 and Figure 3D).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hoftman’s device by including various sub-segments of the primary segment, as taught by Nave, as providing various channels within the primary segment and/or tube body allows the medical caregiver to administer various medications the user may need, without interfering with the primary tubing/endotracheal tube.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Hoftman et al. (US 2017/0043111 A1) in view of Zachar (US 2011/0290246 A1).
Regarding claim 29, Hoffman teaches the device of claim 1, however is silent wherein the primary segment has a non-circular cross-section such that the primary segment orients to a preferred orientation to the trachea as the primary segment is pressurized.
However, Zachar teaches an endotracheal tube device (Abstract and Figure 1) comprising a primary segment configured to contact/orient towards the trachea (primary sleeve element 220 configured to contact trachea, Paragraph 0075 and Figures 2a-2b) wherein the primary segment has a non-circular cross section (the sleeve may have a non-circular cross-section, Paragraph 0031).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hoftman’s device by having the primary segment comprise a non-circular cross-section, as taught by Zachar, as providing a non-circular cross-sectional segment may better conform to the geometry of the user’s trachea, as the trachea comprises geometry that is not perfectly circular (Paragraph 0105 of Zachar).
Claims 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Hoftman et al. (US 2017/0043111 A1) in view of Molnar (US 2014/0309494 A1).
Regarding claim 32, Hoftman teaches the device of claim 1, however is silent on at least one shifting element configured to shift the surrounding tissue of the subject and facilitate advancement of the secondary segment into the trachea.
However, Molnar teaches an intubation device (Abstract and Figure 1) comprising a segment configured to be inserted into the patient’s trachea (endotracheal tube 23, Figures 1-8 and Paragraph 0052) wherein the segment comprises at least one shifting element configured to shift the surrounding tissue of the subject and facilitate advancement of the subject into the trachea (the end 73 of cuff 32 seats against the epiglottis 74, pushing it towards the tongue 76 of the patient, to thereby facilitate advancement of the tubing into the trachea, Paragraph 0063 and Figures 6-7).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hoftman’s device by including at least one shifting element, configured to shift the surrounding tissue to facilitate advancement of the device into the trachea, as taught by Molnar, as providing such a component aides in pushing the patient’s epiglottis tissue towards the tongue of the user, therefore making it easier for the advancement of the tubing into the user’s trachea (Paragraph 0063 of Molnar).
Regarding claim 33, Hoftman teaches the device of claim 1, however is silent on at least one shifting element configured to shift an epiglottis of the subject and facilitate advancement of the secondary segment into the trachea.
However, Molnar teaches an intubation device (Abstract and Figure 1) comprising a segment configured to be inserted into the patient’s trachea (endotracheal tube 23, Figures 1-8 and Paragraph 0052) wherein the segment comprises at least one shifting element configured to shift the surrounding tissue of the subject and facilitate advancement of the subject into the trachea (the end 73 of cuff 32 seats against the epiglottis 74, pushing it towards the tongue 76 of the patient, to thereby facilitate advancement of the tubing into the trachea, Paragraph 0063 and Figures 6-7).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hoftman’s device by including at least one shifting element, configured to shift the surrounding tissue to facilitate advancement of the device into the trachea, as taught by Molnar, as providing such a component aides in pushing the patient’s epiglottis tissue towards the tongue of the user, therefore making it easier for the advancement of the tubing into the user’s trachea (Paragraph 0063 of Molnar).
Regarding claim 38, Molnar further teaches wherein the at least one shifting element comprises a flexible shim configured to slide posteriorly of the epiglottis upon advancement into the laryngopharynx (the end 73 of cuff 32 seats against the epiglottis 74, pushing it towards the tongue 76 of the patient, to thereby facilitate advancement of the tubing into the trachea, Paragraph 0063 and Figures 6-7; cuff 32 is made of a flexible plastic material, Paragraph 0058).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Scarberry (4,231,365) and Bertram (US 2012/0234328 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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