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 .
DETAILED ACTION
1. This office action is in response to the filing of the application on 12/01/2023. Since the initial filing, no claims have been amended, added, or canceled. Thus, claims 1-20 are pending in the application.
Priority
2. Acknowledgement is made of applicant’s claim for foreign priority regarding PCT/QA22/50011 (filing date of 06/03/2022). PCT/QA22/50011 provides sufficient support for the subject matter of claims 1-20. Therefore, the current application will be assigned the effective filing date of 06/03/2022.
Claim Interpretation- 35 USC § 112 – Sixth Paragraph/35 USC § 112(f)
3. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
At present, no claims are interpreted under 35 USC 112(f).
Claim Rejections - 35 USC § 112
4. 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 4-5 and 10 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. Specifically:
Regarding claim 4, it is unclear if “the contrast agent” (In 1) is required by the claim. Claim 4 depends from claim 1, which recites that the second expandable bag is “configured to contain a contrast agent,” but does not positively require that a contrast agent is contained within the second expandable bag. Claim 4 subsequently recites “the contrast agent” as though a particular contrast agent has previously been positively introduced. Therefore, it is unclear if “the contrast agent” is required by the claim. For the purposes of examination, claim 4 will be interpreted as introducing and requiring a contrast agent as part of the claimed endotracheal tube system.
Regarding claim 5, it is unclear if “the contrast agent” (In 1) is required by the claim. Claim 5 depends from claim 1, which recites that the second expandable bag is “configured to contain a contrast agent,” but does not positively require that a contrast agent is contained within the second expandable bag. Claim 5 subsequently recites “the contrast agent” as though a particular contrast agent has previously been positively introduced. Therefore, it is unclear if “the contrast agent” is required by the claim. For the purposes of examination, claim 5 will be interpreted as introducing and requiring a contrast agent as part of the claimed endotracheal tube system.
Regarding claim 10, the limitation reciting “while ultrasonography is performed on a target patient” renders the scope of the claim unclear. Claim 10 is directed to an endotracheal tube system; however, the recited limitation appears to require performance of an ultrasonography on a target patient (i.e. a method step). It is therefore unclear whether the claim is directed solely to the structure (device) of the endotracheal tube system or requires performance (method) of the recited ultrasonography procedure. For the purposes of examination, claim 10 will be interpreted as a device claim that is configured to undergo ultrasonography when the second port and the third port are connected to the second expandable bag and the first expandable bag, respectively.
Claim Rejections - 35 USC § 102
5. 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 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.
6. Claims 1-5, 12, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Pendleton et al. (20160228662).
Regarding claim 1, Pendleton discloses an endotracheal tube system (Pendleton, FIGS. 10-11) comprising: an endotracheal tube (40); a first expandable bag disposed on the endotracheal tube (46); and a second expandable bag surrounding the first expandable bag (48), wherein the second expandable bag (48) is configured to contain a contrast agent. (Pendleton discloses that the inner cuff (46) and outer cuff (48) are bonded to tracheal tube (40) and the outer cuff (48) completely surrounds the inner cuff (46) [0046-0047]). Pendleton further discloses that the inner cuff (46) is inflatable with air or another gas, and the outer cuff (48) is inflatable with a fluid (66), preferably a liquid (contrast agent) such as water or saline [0048; 0051-0052]). See Annotated FIG. 11 Below.
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Regarding claim 2, Pendleton discloses the first expandable bag (46) is disposed on a distal portion (54) of the endotracheal tube [Pendleton, 0034; 0046]. See Pendleton FIGS. 10 & 11.
Regarding claim 3, Pendleton discloses the first expandable bag (46) is configured to contain air (Pendleton discloses that inner cuff (46) is inflated with air via inner inflation lumen (58) using manometer (62) [Pendleton, 0048; 0051]) See Pendleton FIG. 11.
Regarding claim 4, Pendleton discloses the contrast agent is ultrasound- visible (Pendleton further discloses that an outer cuff (48) is inflatable with a fluid (66), preferably a liquid (contrast agent) such as water which in turn is configured as a contrast agent for ultrasonic visualization [0042; 0048]).
Regarding claim 5, Pendleton discloses the endotracheal tube system of claim 1, wherein the contrast agent comprises agitated water or saline (Pendleton further discloses that an outer cuff (48) is inflatable with a fluid (66), preferably a liquid (contrast agent) such as water which in turn is configured as a contrast agent [0048]).
Regarding claim 12, Pendleton discloses a method of inserting the endotracheal tube system of claim 1 into a patient's trachea, the method comprising: inserting the endotracheal tube (40) in the patient's trachea (70); inflating the first expandable bag (46) by injecting a first material into the first expandable bag (manometer 62 is used to inflate cuff 46); inflating the second expandable bag (48) by injecting the fluid into the second expandable bag (fluid 66 inflates the cuff 48); and partially deflating the first expandable bag ([0051] discloses overinflating the inner cuff 46 followed be deflating the cuff to a lower pressure). See Annotated FIG. 11 Above.
Regarding claim 16, Pendleton discloses a method of claim 12, wherein the first material (46) comprises air (Pendleton discloses that inner cuff (46) is inflated with air via inner inflation lumen (58) using manometer (62) [Pendleton, 0048; 0051])
Regarding claim 17, Pendleton discloses the method of claim 12, wherein the first expandable bag (46) is partially deflated while the second expandable bag (48) is inflated, thereby preventing overpressure on the patient's trachea (Pendleton teaches that inner cuff (46) is initially inflated and subsequently deflated to a lower pressure, after which outer cuff (48) is inflated [Pendleton, 0051-0052]. Pendleton further teaches controlling cuff pressure to prevent patient discomfort and tracheal ischemia associated with excessive pressure against the tracheal wall [Pendleton, 0007; 0056].
Regarding claim 18, Pendleton discloses a method of claim 12, wherein the first expandable bag (46) is disposed on a distal portion (54) of the endotracheal tube [Pendleton, 0034; 0046]. See Pendleton FIG. 11.
Regarding claim 19, Pendleton discloses a method of claim 12, wherein the contrast agent comprises agitated water or saline (Pendleton teaches that contrast agent/fluid (66) used to inflate outer cuff (48) may comprise a liquid such as water or saline [Pendleton, 0048; 0052].
Claim Rejections - 35 USC § 103
7. 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 of this title, 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.
8. Claims 6, 7, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Pendleton et al. (20160228662) in view of La Rosa (4227534).
Regarding claim 6, Pendleton discloses an endotracheal tube system of claim 1. See FIG. 11.
Pendleton does not disclose an injection device, wherein the injection device comprises: a body; and one or more ports on or in the body, wherein the body comprises: an inner space; and a flexible surface facing the inner space, wherein the injection device is in a deflated state when the flexible surface is pressed down towards the inner space.
However, La Rosa discloses an injection device (2), wherein the injection device (2) comprises: a body (reservoir structure including substantially rigid cylinder 16); and one or more ports on or in the body (passage 17 connecting the interior of cylinder 16 to inflation lumen 14), wherein the body comprises: an inner space (the interior of cylinder 16 forming an inflation-fluid reservoir); and a flexible surface facing the inner space (flexible diaphragm or membrane 18 sealed at its periphery to the inner surface of cylinder 16), wherein the injection device is in a deflated state when the flexible surface is pressed down towards the inner space. La Rosa further teaches that the membrane (18) is an elastic or elastomeric member formed of rubber, silicone, or another fluid-proof stretchable material, and that plunger 22 is depressed to act upon diaphragm 18 and pressurize the reservoir [0004-0008]. See Annotated FIGS. 2, 2A, 2B Below)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device of Pendleton to include injection device taught by La Rosa, comprising a body; and one or more ports on or in the body in communication with an expandable bag of Pendleton, in order to provide a manually operable inflation device capable of supplying inflation fluid under pressure through an inflation lumen to inflate the expandable bag. Such a modification is additionally considered the simple substitution of one known cuff inflation means (i.e. the injection device of La Rosa) for another known cuff inflation means (i.e. the injection device of Pendleton to achieve the expected result of controlling the inflation of a cuff on a tube
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Regarding claim 7, the modified device of Pendleton discloses an endotracheal tube system of claim 6, wherein the injection device (La Rosa 2) is in an inflated state when a pressure pressing the flexible surface down towards the inner space is removed. [La Rosa, 0002-0008]. (La Rosa discloses that inner space (16) is an elastic or elastomeric flexible membrane and illustrates the diaphragm is relaxed, unstressed condition when the reservoir is unpressurized and in a stressed condition when the reservoir is pressurized by operation of [0005-0006]). See Annotated FIGS. 2, 2A, 2B Above.
Regarding claim 20, the modified device of Pendleton (as modified in the rejection of claim 6) discloses a method of claim 12, wherein the endotracheal tube system further comprises an injection device (La Rosa 2), wherein the injection device comprises: a body (16); and one or more ports on or in the body (17), wherein the body comprises: an inner space; and a flexible surface facing the inner space, wherein the injection device is in a deflated state when the flexible surface is pressed down towards the inner space. (La Rosa discloses an injection device (2), wherein the injection device (2) comprises: a body (reservoir structure including substantially rigid cylinder 16); and one or more ports on or in the body (passage 17 connecting the interior of cylinder 16 to inflation lumen 14), wherein the body comprises: an inner space (the interior of cylinder 16 forming an inflation-fluid reservoir); and a flexible surface facing the inner space (flexible diaphragm or membrane 18 sealed at it’s periphery to the inner surface of cylinder 16), wherein the injection device is in a deflated state when the flexible surface is pressed down towards the inner space. La Rosa further teaches that the membrane (18) is an elastic or elastomeric member formed of rubber, silicone, or another fluid-proof stretchable material, and that plunger 22 is depressed to act upon diaphragm 18 and pressurize the reservoir [0004-0008]. See FIGS. 2, 2A, 2B)
9. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Pendleton et al. (20160228662) in view of Nasir (20100288289) as applied to the rejection of claim 1 above.
Regarding claim 11, Pendleton discloses the endotracheal tube system of claim 1. See FIG. 11.
Pendleton does not disclose the first and second expandable bags are transparent.
However, Nasir discloses an endotracheal system having a cuff assembly comprising inner inflatable region 12 and outer region 13. Nassir further teaches that an important factor in selecting a suitable material for the device is a transparency, and the material or materials of construction should ideally be substantially clear or transparent to enable an anesthetist or operator to visually inspect the inner lumen of the airway [Nasir, 0092; 0101-0102].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second expandable bags of the modified device of Pendleton to comprise transparent material, as taught by Nasir, in order to permit visual inspection and for visualization to be transparent to inspect the inner lumen of the airway.
10. Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Pendleton et al. (20160228662) in view of Charpie et al. (20220233819).
Regarding claim 13, Pendleton discloses a method of providing a a contrast agent such as water or saline within the outer cuff of a trachea tube [0048; 0051-0052]).
Pendleton does not disclose checking a position of the endotracheal tube using an extracorporeal scanner, wherein the contrast agent is visible when viewed using the extracorporeal scanner.
However, Charpie teaches that a fluid-filled cuff of a trachea tube, which may contain saline, facilitates accurate confirmation of the location of the endotracheal tube in situ, and that an ultrasound probe is used to detect the endotracheal tube, with the saline-filled cuff being discernible in the ultrasound image [Charpie, 0040; 0042-0046]. See Charpie’s FIGS. 3-7.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pendleton’s method of the inflatable cuff intended for visualization containing the ultrasound-visible fluid to be configured for ultrasonic scanning taught by Charpie because Charpie teaches that such medium permits ultrasonic visualization and confirmation of endotracheal tube position. Such a modification would have predictably provided visualization of Pendleton’s disclosed dual-cuff to ensure proper placement within the airway.
Regarding claim 14, the modified device of Pendleton additionally discloses a method of claim 13, wherein the extracorporeal scanner comprises an ultrasound probe (Charpie teaches positioning an ultrasonic transducer and further teaches an ultrasound probe [Charpie, 0042; 0052]. See FIGS. 3-7.
Regarding claim 15, the modified device Pendleton additionally discloses a method of claim 13, responsive to checking the position, deflating the second expandable bag (48) by removing the contrast agent (66) from the second expandable bag, and inflating the first expandable bag (46), thereby stabilizing the first expandable bag (Pendleton, [0053-0055] discloses releasing the pressure applied to the outer cuff 48 to allow the fluid 66 to flow back into syringe 64).
Allowable Subject Matter
11. Claims 8-10 would be allowable if rewritten or amended to overcome the
rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth
in this Office action.
Regarding claim 8, the modified device of Pendleton in view of La Rosa discloses an endotracheal tube system of claim 6, including injection device comprises: a body; and one or more ports on or in the body, wherein the body comprises: an inner space; and a flexible surface facing the inner space, wherein the injection device is in a deflated state when the flexible surface is pressed down towards the inner space.
However, the modified device of Pendleton in view of La Rosa does not disclose or suggest that one or more ports comprises: a first port configured to be in fluid communication with a source of the contrast agent; a second port configured to be in fluid communication with the second expandable bag; and a third port configured to be in fluid communication with the first expandable bag.
La Rosa teaches an inflation apparatus having a reservoir communicating through a passage with an inflation lumen for supplying inflation fluid to an inflatable balloon, but does not disclose the claimed three-port arrangement providing respective fluid communication between a contrast-agent source, the second expandable bag, and the first expandable bag. Pendleton teaches independently inflatable primary and secondary cuffs through respective fluid conduits, but likewise does not disclose the claimed injection device having the recited first, second, and third ports.
Therefore, since Pendleton in view of La Rosa and the prior art of record does not disclose or suggest all of the claimed limitations, claim 8 contains allowable subject matter.
Conclusion
12. Any inquiry concerning this communication or earlier communications from the
examiner should be directed to LEROME PRATT whose telephone number is (571)272-
8454. The examiner can normally be reached on Mon - Fri 7:00-4:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
supervisor, Timothy Stanis can be reached on 571-272-5139. The fax phone number
for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEROME PRATT/
Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
