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
Claims 5 and 11 are objected to because of the following informalities:
Claim 5, lines 3-4: “the lock end having a fitting disposed thereon sized and dimensioned to be coupled to a syringe” should read “the lock end having a fitting disposed thereon, where the fitting is sized and dimensioned to be coupled to a syringe” for clarity.
Claim 11, lines 3-4: “wherein the flow passage of the valve member is equal to the inner diameter of the first connector flow passage” should read “wherein the inner diameter of the flow passage of the valve member is equal to the inner diameter of the first connector flow passage” for clarity.
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 13 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.
Claim 13 recites the limitation “the curvature of the tubing body has a radius of 140 millimeters ± 20 millimeters” in lines 1-2. It is unclear the above limitation is disclosing the radius of the tubing body itself, an indication to quantify how curved the tubing body is, or if Applicant intended an alternate interpretation to those provided by the Examiner. For the purpose of examination, the above limitation of claim 13 will be interpreted as – half of a distance from the proximal end and the distal end of the tubing body to an apex of the curved tubing body is 140 millimeters ± 20 millimeters.
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.
Claims 1-4 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Perez et al. (US 8511311 B2), hereinafter Perez, in view of Chang (US 20140121607 A1).
Regarding claim 1, Perez discloses an endotracheal tube assembly (Fig. 1), comprising:
a tubing body (12; Fig. 1) having a proximal end (20; Fig. 1), a distal end (18; Fig. 1), and a lumen extending through an entirety of the tubing body between the proximal end and the distal end (14; Fig. 1).
Perez does disclose a connector and suction connection line detachably connected (see 22 and 62, see Figs. 6 and 8) with a first connector portion (22) defining a first connector flow passage with a first length (64; Fig. 5) and a second connector portion (62) defining a second connector flow passage having a second length (70; Fig. 5), the first connector flow passage (64) being enclosed along an entirety of the first length (see Fig. 5), the first connector portion (22) arranged on a proximal half of the tubing body (see Fig. 1, where 22 is located on a proximal half of 12) so the and the connector and suction connection line assembly (22 and 62) extends in a radial direction from the proximal half of the tubing body (see Fig. 1). The connector and suction connection line assembly (22 and 62) disclosed by Perez does not have a valve member, a valve chamber, the first connector portion matingly engaged with the proximal end of the tubing body so the adapter body extends from the proximal end of the tubing body and the first connector flow passage is in fluid communication with the lumen of the tubing body.
However, Perez does teach a connector with a first connector portion (first half of connector, see Annotated Fig. 1 below) defining a first connector flow passage having a first length (flow passage within first half of connector) and a second connector portion (second half of connector, see Annotated Fig. 1 below) defining a second connector flow passage having a second length (flow passage within second half of connector), the first connector being enclosed along an entirety of the first length (see Annotated Fig. 1 below), the first connector portion matingly engaged at the proximal end of the tubing body so the connector extends from the proximal end of the tubing body (see Annotated Fig. 1 below), where the first connector portion has a first connector flow passage in fluid communication with the lumen of the tubing body (Fig. 1; col. 4, lines 50-51). But the connector (see Annotated Fig. 1 below) disclosed by Perez does not include a valve member or a valve chamber in fluid communication with the first connector flow passage and the second connector flow passage.
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Annotated Fig. 1
However, Chang teaches an analogous connector assembly (1; Fig. 2) with a device body (10; Fig. 2) having a catheter adapter (104; Fig. 2), a patient tubing adapter (102; Fig. 2), and a cavity (101a; Fig. 3) to hold a switch valve (20; Fig. 3), where the switch valve (20) has a flow passage extending therethrough (passageway created by openings 201a and 201b; Fig. 3) and is rotatable between an open and closed position (see Figs. 4A-4B) such that the flow passage of the switch valve aligned with and fluidically connected to the flow passage ways of the catheter adapter and the patient tubing adapter (see Fig. 4A) or can be misaligned with and fluidically sealed from the flow passage ways of the catheter adapter and the patient tubing adapter (see Fig. 4B).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the connector assembly taught by Perez with the connector assembly taught by Chang, such that the endotracheal ube assembly taught by Perez further teaches a tubing adapter (Chang 1; Chang Fig. 2), comprising:
an adapter body (Chang 10; Chang Fig. 2) having a first connector portion (Chang 104; Chang Fig. 2) defining a first connector flow passage having a first length (Chang: flow passage of 104, see Chang Figs. 3 and 4A) and a second connector portion (Chang 102; Chang Fig. 2) defining a second connector flow passage having a second length (Chang: flow passage of 102, see Chang Figs. 3 and 4A), the adapter body (Chang 10) defining a valve chamber (Chang 101a; Chang Fig. 3) in fluid communication with the first connector flow passage (see Chang Figs. 3 and 4A) the first connector flow passage being enclosed along an entirety of the first length (see Chang Figs. 3 and 4A), the first connector portion matingly engaged with the proximal end of the tubing body (Chang 104 matingly engaged with proximal end of Perez 12, see Perez Fig. 1) so the adapter body extends from the proximal end of the tubing body (Chang 10 extends from proximal end of Perez 12, see Perez Fig. 1) and the first connector flow passage (Chang: flow passage of 104) is in fluid communication with the lumen of the tubing body (flow passage of Chang 104 fluidically connected to Perez 14, see Perez Fig. 1); and
a valve member (Chang 201; Chang Fig. 3) having a flow passage extending therethrough (passageway created by openings Chang 201a and Chang 201b; Chang Fig. 3), the valve member positioned in the valve chamber (Chang 201 is arranged in Chang 101a; Chang Figs. 2-3) and movable between an open position, wherein the flow passage of the valve member is aligned with the first connector flow passage and the second connector flow passage to provide fluid communication between the first connector flow passage and the second connector flow passage (Chang Fig. 4A, where Chang 201 is rotatable within Chang 101), and a closed position, wherein the flow passage of the valve member is misaligned with the first connector flow passage and the second connector flow passage to fluidically seal the first connector flow passage from the second connector flow passage (Chang Fig. 4B) and thereby prevent fluid flow through the adapter body between the first connector flow passage and the second connector flow passage (Chang [0021]; first sentence of Chang [0030]) to provide a lost cost structure for controlling flow provided to a patient (Chang [0002] and [0030], lines 5-8).
Regarding claim 2, Perez as modified teaches the invention as set forth in claim 1, wherein the distal end of the tubing body (18) defines a bevel (see Fig. 1, where distal end 18 of tubing body 12 defines a bevel).
Regarding claim 3, Perez as modified teaches the invention as set forth in claim 1, wherein the tubing body has an opening adjacent to the distal end (see Fig. 1, where opening of 14 is at distal end 18), the opening being in fluid communication with the lumen of the tubing body (opening of 14 in fluid connection with central lumen 14).
Regarding claim 4, Perez as modified teaches the invention as set forth in claim 1, further comprising an inflatable cuff (26; Fig. 1) adjacent to the distal end of the tubing body (see Fig. 1).
Regarding claim 8, Perez as modified teaches the invention as set forth in claim 1, wherein the first connector flow passage is axially aligned with the second connector flow passage (see Chang Figs. 3-4B, where the flow passageway of Chang 104 and the flow passageway of Chang 102 are axially aligned).
Regarding claim 9, Perez as modified teaches the invention as set forth in claim 8. While Perez as modified teaches a second connector portion (Chang 102) of the adapter body as shown above (see claim 1), Perez as modified does not explicitly teach the second connector portion of the adapter body has an outer diameter of 15 millimeters.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the outer diameter of the second connector portion (Chang 102) because Applicant has not disclosed that the second connector portion having an outer diameter of 15 millimeters provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, Applicant’s specification discloses “the outer diameter d2 of the second connector portion 128b is 15 mm; however, in other implementations, the outer diameter d2 of the second connector portion 128b may be more or less than 15 mm” (see [0041] of Applicant’s specification). One of ordinary skill in the art, furthermore, would have expected the second connector portion (Chang 102) of the endotracheal tube assembly taught by Perez as modified and Applicant’s second connector portion to perform equally well because both mechanisms perform the same function of providing a second connector flow passageway within an adapter body to facilitate a fluidic connection that is detachable between an outside source and the adapter.
Therefore, it would have been prima facie obvious to modify the outer diameter of the second connector portion (Chang 102) taught by Perez as modified to obtain the invention as specified in claim 9 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired outer diameter of the second connector portion and thus fails to patentably distinguish over the prior art of Perez as modified by Chang (see claim 1 above).
Regarding claim 10, Perez as modified teaches the invention as set forth in claim 9, wherein the first connector portion (Chang 104) has an outer diameter less than the outer diameter of the second connector portion (see Chang Figs. 2-3, where the outer diameter of Chang 104, not including the ribs Chang 104c, is less than the outer diameter of Chang 102).
Regarding claim 11, Perez as modified teaches the invention as set forth in claim 1, wherein the flow passage of the valve member has an inner diameter (inner diameter of flow passageway formed between Chang 201a and Chang 201b, see Annotated Chang Fig. 4A below), wherein the first connector flow passage of the adapter body has an inner diameter (inner diameter of flow passageway of Chang 104, see Annotated Chang Fig. 4A below), and wherein the flow passage of the valve member is equal to the inner diameter of the first connector flow passage (see Annotated Chang Fig. 4A below).
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Annotated Chang Fig. 4A
Regarding claim 12, Perez as modified teaches the invention as set forth in claim 1, wherein the tubing body has a curvature to accommodate an upper airway of a patient (tubing body 12 is curved, see Fig. 1, hence it would be well-understood by one of ordinary skill in the art that the curve of tubing body 12 accommodates the upper airway of a patient).
Regarding claim 13, Perez as modified teaches the invention as set forth in claim 12. While Perez as modified discloses a curved tubing body (see claim 12 above), Perez as modified does not explicitly teach the curvature of the tubing body has a radius of 140 millimeters ± 20 millimeters.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to modify the curvature of the tubing body (12) taught by Perez as modified to have a radius of 140 millimeters ± 20 millimeters because Applicant has not disclosed that a tubing body having a radius of 140 millimeters ± 20 millimeters provides an advantage, is used for a particular purpose, or solves a stated problem. Specifically, Applicant discloses “the curvature has a radius of 140 millimeters (mm) ± 20 mm; however, in other implementations, the curvature may have a radius more or less than 140 mm ± 20 mm” (see [0031] of Applicant’s specification). One of ordinary skill in the art, furthermore, would have expected the tubing body of Perez as modified and Applicant’s tubing body to perform equally well because both mechanisms perform the same function of providing a flow to a patient’s airway, are both endotracheal tubes, and both tubes have a curvature to accommodate an upper airway of a patient (see claim 12 above).
Therefore, it would have been prima facie obvious to further modify Perez to obtain the invention as specified in claim 13 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired radius of the curvature of the tubing body (12) and thus fails to patentably distinguish over the prior art of Perez as modified (see claim 1 above).
Regarding claim 14, Perez as modified teaches the invention as set forth in claim 1, wherein the valve member is rotatable between the open position and the closed position (Chang Figs. 4A-4B; Chang [0021]).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Perez (US 8511311 B2) in view of Chang (US 20140121607 A1) as applied to claims 1 and 4 above, and further in view of Linder (US 4655214 A).
Regarding claim 5, Perez as modified teaches the invention as set forth in claim 4, further comprising a pilot line (30; Fig. 1) having a cuff end (28; Fig. 1), a lock end (end of 30 proximate to proximal end of inflation tube 34, see Fig. 1), and a pilot lumen extending between the cuff end and the lock end (flow passageway of 30 and 28, where 30 and 28 are fluidically connected; col. 4, lines 58-63; Fig. 1), the cuff end (28) being coupled to the inflatable cuff (Fig. 3; col. 5, lines 43-47) and the lock end (end of 30 proximate to proximal end of inflation tube 34) being capable of coupling to a source of air for inflation (col. 4, lines 62-63). But Perez as modified fails to explicitly teach the lock end having a fitting disposed thereon sized and dimensioned to be coupled to a syringe.
However, Linder teaches an analogous pilot line (12; Fig. 1) with a connector fitting of a female luer lock (22; Fig. 1) arranged thereon, where a conventional medical syringe can be received by the female luer lock (col. 3, lines 37-40).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the fitting on the lock end of the pilot line taught by Perez with the connection fitting taught by Linder, such that the lock end (end of 30 proximate to proximal end of inflation tube 34) has a fitting (Linder connection fitting 22, where the connection fitting is a female luer lock, see Linder Fig. 1) disposed thereon sized and dimensioned to be coupled to a syringe (Linder col. 4, lines 37-40) as it would have been obvious to one of ordinary skill in the art to substitute the known connection fitting taught by Perez with the known connection fitting taught by Linder to obtain the predictable results of providing a connection point on the pilot line such that the pilot line can be connected to a source to inflate the inflatable cuff (see MPEP §2143(I)(B)).
Regarding claim 6, Perez as modified teaches the invention as set forth in claim 5, wherein the fitting is a female luer lock fitting (Linder Fig. 1; Linder col. 4, lines 37-40).
Regarding claim 7, Perez as modified teaches the invention as set forth in claim 5, further comprising a pilot balloon disposed adjacent to the lock end of the pilot line (36, see Fig. 1), the pilot balloon being coupled to the pilot line (36 coupled to 30, see Fig. 1).
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Perez (US 8511311 B2) in view of Chang (US 20140121607 A1) as applied to claims 1 and 14 above, and further in view of Black & Martin (US 20110237896 A1), hereinafter Black.
Regarding claim 15, Perez as modified teaches the invention as set forth in claim 14. Perez as modified is fails to teach a locking mechanism configured to secure the valve member in the open position.
However, Black teaches an analogous control valve assembly (40; Figs. 7A-8D) with a knob (41; Figs. 7A-7B and 8A-8B), a valve body (44 and 47; Fig. 7B) and a rotatable element (50; Fig. 7B), where the valve body has a spring block anchor (45; Figs. 7B and 7D) and a stop block (46; Fig. 7D) to limit the rotation of an attachment post (51; Figs. 7B and 7D) and the rotatable element (50; [0083] and [0085]) such that the attachment post (51) and rotatable element (50) are only able to rotate ninety degrees between an open and closed position (Figs. 7B, 7D, 8B, and 8D; [0083], [0087], and [0089]). Black further teaches a spring connected to the spring anchor block (45) and the attachment post (51) keeps the rotatable element (50) in a closed position ([0083] and [0085]), and the spring anchor block (45) also functions as a stop block and keeps the rotatable element (50) in an open position ([0089]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify valve taught by Perez as modified by Chang (see claim 1 above) with the locking mechanism of the control valve taught by Black, such that the endotracheal tube assembly taught by Perez as modified further comprises a locking mechanism configured to secure the valve member in the open position (Black 45 and Black 51; Black Fig. 8D; Black [0087] and Black [0089]) to prevent over rotation of the of the valve member when changing from an opened position to a closed position, or from a closed position to an opened position (Black [0083], lines 10-13 and Black [0089], lines 5-6).
Regarding claim 16, Perez as modified teaches the invention as set forth in claim 15, wherein the locking mechanism is configured to secure the valve member in the closed position (Black 45, Black 51, Black 46; Black 7D; Black [0083] and Black [0085]).
Regarding claim 17, Perez as modified teaches the invention as set forth in claim 14, wherein the valve member (Chang 201) has a channel formed therein (channel created between Black 45 and Black 46 in the space between Black 50 and Black 47, see Black Fig. 7B; Black [0083]), and wherein the adapter body (Chang 10) has a protrusion (Black 51) sized and dimensioned to engage the channel such that rotation of the valve member is restricted to a quarter turn (see Black Figs. 7B, 7D, 8B, and 8D; Black [0083] and Black [0089]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ho (US 20130312755 A1): Regarding a suction device with a patient-end connector, an oxygen supply connector, and a rotary switch, where the rotary switch is limited to a rotation of ninety degrees between an open and a closed position.
Morejon (US 11395897 B1): Regarding a connector assembly to be connected to an endotracheal tube and a medical ventilation system, where the connector assembly has a rotatable valve structure.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785