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
This Office Action is in response to a preliminary amendment filed on 11/20/2023. As directed by the preliminary amendment, no claims were canceled, claims 1-10 were amended, and no new claims were added. Thus, claims 1-10 are pending for this application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “sealing device” (claim 1), “retaining means” (claim 1), “at least two sealing means” (claim 2), “a conical recess in the centrally arranged passage” (claim 3), “locking means” (claim 4), “detection means” (claim 5), “means for detecting” (claim 8), “means for controlling” (claim 8), “a sealing cap with a sealing device” (claim 9), and “means for isolating a biological sample” (claim 10) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-9 is objected to because of the following informalities:
In claim 1 line 1, “Closed intubation system” should be changed to --A closed intubation system-- in order to adhere to proper claim formatting.
In claim 1 lines 14-15, “on the adapter attachment; d) an attachment” should be changed to --on the adapter attachment; and d) an attachment-- in order to adhere to proper claim formatting.
In claims 2-9, “Intubation system” in line 1 of each claim should be changed to --The closed intubation system-- in order to adhere to proper claim formatting.
Appropriate correction is required.
Claim Interpretation
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.
This application includes one or more claim limitations that use the word “means,” and are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “retaining means” in claim 1, “at least two sealing means” in claim 2, “locking means” in claim 4, “detection means” in claim 5, “means for detecting” in claim 8, and “means for isolating a biological sample” in claim 10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Specifically, the corresponding structure of the “at least two sealing means” in claim 2 described in paragraph [0023] of the specification include: O-rings; the corresponding structure of “locking means” in claim 4 described in paragraph [0025] of the specification includes: a spring or other mechanical locking means; the corresponding structure of the “detection means” of claim 5 described in paragraph [0026] of the specification includes: a mechanical switch; the corresponding structure of the “means for detecting” in claim 8 described in paragraph [0029] of the specification include: an electronic pressure sensor; and the corresponding structures of the “means for isolating a biological sample” in claim 10 described in paragraph [0031] includes: closures.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Additionally, this application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “sealing device” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Specifically, the corresponding structure of the “sealing device” as described in paragraph [0022] of the specification includes: an O-ring.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-10 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.
Claim limitation “retaining means” in claim 1 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding claim 2, the phrase “substantially centrally arranged passage” is unclear as to the meaning of the term “substantially” in this context. A structure is either centrally disposed or not centrally disposed, it is not clear how something can be “substantially centrally” arranged, and to what extent (metes and bounds unclear).
Claim 3 recites the limitation "the cone angle" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 6, the phrase “individually rotatable” in line 3 is unclear whether applicant is intending to claim relative rotation (and if so, relative to what?) or whether applicant is just claiming the components are each rotatable.
The remaining claims are rejected due to dependence on a rejected base claim.
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.
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.
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.
Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang (US 2014/0121607) in view of Zachar (US 2014/0142496) and Vazales (US 2014/0150782).
Regarding claim 1, Chang discloses (Fig. 3 and 6) a closed intubation system comprising
at least one tube suitable for insertion into the trachea of a patient (tracheostomy tube, paragraph [0025]),
a tubular connection (tube connected to side port 103 shown in Fig. 3) to a ventilation device (paragraph [0022]) and
an adapter arrangement (adapter 10, attachment 104, collars 402, sleeve 40 and valve adapter 501) with at least three cylindrically shaped receptacles (adapter 102, side port 103, and catheter adapter 104) for producing a gas-tight coupling between the tube, the connection of the ventilation device and at least one further receptacle (collar 402, paragraph [0020]), wherein the adapter arrangement comprises at least:
a) an adapter base body (adapter 10) designed in a T-shape via the arrangement of the receptacles (see T shape in Fig. 2) with at least one shut-off device (shut off device 20), the shut-off device being designed to open or close the air path between the further receptacle and the two receptacles for the ventilation device and the endotracheal tube in a gas-tight manner (paragraphs [0021] and [0030]),
b) an adapter attachment (attachment 104) which can be coupled to the further receptacle (collar 402), wherein the adapter attachment can be connected in a gas-tight manner via a seal (“seal bushing”, paragraph [0028]) to the adapter base body and can be mechanically fixed to the latter via retaining means;
c) a tubular sheath (flexible sleeve 40, paragraph arranged gas-tight with one end on the adapter attachment (paragraph [0028]);
d) an attachment (collar 402 and valve adapter 501 of valve 50) connected in a gas-tight manner to the other end of the tubular sheath (paragraphs [0028]-[0029]), the attachment comprising a passage (interior of attachment as shown in Fig. 6) to the tubular sheath wherein the attachment is designed to receive cylindrically shaped devices and to guide these through the attachment, the tubular sheath, the adapter attachment, the adapter base body and the endotracheal tube in a displaceable and gas-tight manner (paragraph [0026).
Chang does not disclose a sealing device arranged in the passage of the attachment wherein the sealing device is designed to receive cylindrically shaped devices and to guide these through the attachment, the tubular sheath, the adapter attachment, the adapter base body and the endotracheal tube in a displaceable and gas-tight manner, and that the tube insertable into trachea of patient is an endotracheal tube.
However, Zachar teaches (Figs. 1A and 17A-17C) an endotracheal catheter system comprising an attachment (input portion 216) having a sealing device (sealing separator 373 in form of O-ring, paragraph [0475]) designed to receive cylindrically shaped devices (i.e. catheter 210) and to guide these through the attachment, the tubular sheath (sleeve 610), the adapter attachment (interface 630), the adapter base body (adapter 158) and the endotracheal tube (ventilation tube 160 that can include an endotracheal tube or tracheostomy tube, paragraph [0322]) in a displaceable and gas-tight manner (see Figs. 17a-17c and paragraphs [0323] and [0475]-[0477]).
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 system of Chang to include a sealing device arranged in the passage of the attachment wherein the sealing device is designed to receive cylindrically shaped devices and to guide these through the attachment, the tubular sheath, the adapter attachment, the adapter base body and the endotracheal tube in a displaceable and gas-tight manner, and that the tube insertable into trachea of patient is an endotracheal tube, as taught by Zachar, for the purpose of preventing fluid from leaking to environment or entering into system from environment and to allow the device to be used for patients who don’t require a tracheostomy due to being compatible with endotracheal tube.
Modified Chang does not disclose the sheath is elastic.
However, Vazales teaches (Fig. 3a) a catheter system comprising an elastomeric sheath (sleeve 124 described as “elastomeric”, paragraph [0169]-[0170]).
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 sheath of modified Chang to be elastic, as taught by Vazales, for the purpose of allowing the sleeve to be stretchable to allow the catheter/scope to be easily maneuvered (paragraph [0029] Vazales).
Regarding claim 7, modified Chang discloses wherein at least a part of the adapter base body is made of a transparent material (adapter base body 10 is transparent so that markings of catheter 401a can be seen by clinician, see Fig. 5A Chang and paragraph [0023]).
Claims 2-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (US 2014/0121607) in view of Zachar (US 2014/0142496) and Vazales (US 2014/0150782), and further in view of Wolf (US 20210220604).
Regarding claim 2, modified Chang discloses the shut-off device comprises a rotatable closure mechanism (rotatable switch valve 20 Chang, paragraph [0030] Chang) consisting of a substantially cylindrically designed base body with a substantially centrally arranged passage (see cylindrical shape of valve 20 in Fig. 2 Chang), but does not disclose wherein at least two sealing means spaced apart along the axis of symmetry are arranged in the passage.
However, Wolf teaches (Fig. 11-12) a shut off device (shut off unit 7) at least two sealing means spaced apart along the axis of symmetry are arranged in the passage (O-rings arranged on inner wall of unit 6 and outer wall of unit 7, which based on Fig. 11 are shown to be along an axis of symmetry of the passage of unit 7. See also paragraph [0146]).
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 system of modified Chang to include at least two sealing means spaced apart along the axis of symmetry are arranged in the passage, as taught by Wolf, for the purpose of preventing gas from leaking to environment or from environmental gas to leak into system, thereby improving patient safety.
Regarding claim 3, modified Chang discloses the cylindrically designed base body of the rotatable closure mechanism comprises a recess in the centrally arranged passage in the direction of the further receptacle (see recess in central passage 201 in Fig. 3 Chang), but does not disclose the recess is conical wherein the cone angle is greater than or equal to 20° and less than or equal to 90°. However, it has been held that changes in shape are a matter of design choice that would have been obvious to one of ordinary skill absent evidence of criticality. See in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Regarding the cone angle being between 20 to 90 degrees, one of ordinary skill in the art before the effective filing date of the claimed invention would find it obvious to try a cone angle between 20 to 90 degrees for the purpose of providing a tapered connecting point between components, since discovering the optimum value only involves routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, modified Chang discloses the shut-off device in the adapter base body (shut off valve 20) but does not disclose the shut off device comprises at least one locking means, wherein the locking means is arranged to hold the shut-off device in a closed position.
However, Wolf teaches (Figs. 2-3) a shut off device (7) comprising at least one locking means (locking unit 10) arranged to hold the shut-off device in a closed position (paragraph [0144]).
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 shut off device of modified Chang to include at least one locking means, wherein the locking means is arranged to hold the shut-off device in a closed position, as taught by Wolf, for the purpose of holding the shut off device in the open or close position until a user wishes to unlock the device so that inoperative use is prevented (paragraph [0144] Wolf).
Regarding claim 8, modified Chang discloses an adapter base body but does not disclose wherein the adapter base body comprises means for detecting the applied pressure and means for controlling the shut-off device, wherein the opening or closing of the shut-off device is controllable as a function of the applied pressure.
However, Wolf teaches (Figs. 1-3) an adapter base body (adapter 1) that comprises means for detecting the applied pressure (pressure sensor 15) and means for controlling the shut-off device (pressure relief mechanism 8), wherein the opening or closing of the shut-off device is controllable as a function of the applied pressure (paragraph [0161]).
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 system of modified Chang such that the adapter base body comprises means for detecting the applied pressure and means for controlling the shut-off device, wherein the opening or closing of the shut-off device is controllable as a function of the applied pressure, as taught by Wolf, for the purpose of preventing over pressurization of the system which could harm a user (paragraph [0161] Wolf).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Chang (US 2014/0121607) in view of Zachar (US 2014/0142496), Vazales (US 2014/0150782), and Wolf (US 20210220604), and further in view of Tassitano (US 2022/0062574).
Regarding claim 5, modified Chang discloses a shut-off device, but does not disclose the shut off device comprises at least one detection means for detecting an object inside the passage of the shut-off device.
However, Tassitano teaches (Figs. 1-7A) an intubation system comprising a device having at least one detection means (sensor 46) for detecting an object inside the passage of the device (sensing vacuum pressure changes to determine if an object i.e. debris, is inside passage of device, paragraph [0080]).
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 system of modified Chang to include at least one detection means for detecting an object inside the passage of the shut-off device, as taught by Tassitano, for the purpose of determining whether device is occluded so that operator can determine if intervention is needed (paragraph [0080] Tassitano).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Chang (US 2014/0121607) in view of Zachar (US 2014/0142496), and Vazales (US 2014/0150782), and further in view of Anderson (US 2006/0005841).
Regarding claim 6, as best understood, modified Chang discloses a connection of the elastic sheath to the adapter attachment as well as the connection of the elastic sheath to the attachment, but does not disclose these connections are individually rotatable.
However, Anderson teaches (Fig. 1) a connection of a sheath (26) to adapter attachment (36) and connection of elastic sheath (26) to attachment (24) are individually rotatable (connections between 26,36 and 26,24 are rotatable relative to manifold 22 and thus all individually rotatable).
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 connections of modified Chang to be individually rotatable, as taught by Anderson, for the purpose of allowing for rotational repositioning of the components to better fit the setup of the clinical setting so that patient therapeutic outcome can be improved.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Chang (US 2014/0121607) in view of Zachar (US 2014/0142496), and Vazales (US 2014/0150782), and further in view of Glenn (US 7,573,219).
Regarding claim 9, modified Chang discloses an adapter base body, but does not disclose a sealing cap with a sealing device is arranged on the adapter base body via a mechanical connecting means, wherein the sealing cap is designed to mechanically close the further receptacle of the adapter base body when the adapter attachment is not coupled.
However, Glenn teaches (Fig. 2) an adapter base body (adapter shown in Fig. 2) comprising a sealing cap (cap 18) with a sealing device (valve 50) arranged on the adapter base body via a mechanical connecting means (see mechanical connection between port 60 and valve 50 in Fig. 2), wherein the sealing cap is designed to mechanically close the further receptacle of the adapter base body when the adapter attachment is not coupled (Col. 4 lines 15-41).
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 system of modified Chang to include a sealing cap with a sealing device is arranged on the adapter base body via a mechanical connecting means, wherein the sealing cap is designed to mechanically close the further receptacle of the adapter base body when the adapter attachment is not coupled, as taught by Glenn, for the purpose of preventing external air to enter the system when not in use which would otherwise contaminate and cause potential injury to user.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Chang (US 2014/0121607) in view of Zachar (US 2014/0142496), and Vazales (US 2014/0150782, hereinafter Vazaels ‘782), and further in view of Vazales (US 2013/0104884, hereinafter Vazales ‘884).
Regarding claim 10, modified Chang discloses an elastic tubular sheath, but does not disclose the sheath includes means for isolating a biological sample.
However, Vazales ‘884 teaches (Figs. 24E-24F) a sheath (coupling member 2440) that includes means for isolating a biological sample (includes an inner sleeve member 2441 that can be used to isolate a biological sample, paragraph [0251]).
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 sheath of modified Chang to include means for isolating a biological sample, as taught by Vazales ‘884, for the purpose of allowing for clinician to test for microorganisms within user which can then be used to improve therapy for user (paragraph [0251] Vazales ‘884).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Matter Neto (US 6,935,339) discloses an endotracheal system having a sheath.
Devlin (US 5,300,043) discloses an endotracheal system having a sheath and seals on either side.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
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, Timothy Stanis can be reached at 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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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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